Full Text CA-97-017
 
CANCER RESEARCH NETWORK ACROSS HEALTH CARE SYSTEMS
 
NIH GUIDE, Volume 26, Number 30, September 5, 1997
 
RFA:  CA-97-017
 
P.T.


Keywords: 

 
National Cancer Institute
 
Letter of Intent Receipt Date:  October 17, 1997
Application Receipt Date:  November 25, 1997
 
PURPOSE
 
The purpose of this Request for Applications (RFA) is to encourage
the expansion of collaborative cancer research among health care
provider organizations that are oriented to community care, have
access to large, stable and diverse patient populations and are able
to take advantage of existing integrated data-bases that can provide
patient-level information relevant to research studies on cancer
control and cancer-related population studies.  Health care provider
organizations range from traditional staff model health maintenance
organizations (HMO) to extended health care networks associated with
academic medical centers. A CRN would consist of a research network
of such health care provider organizations that possess in-house
clinical research capacity, that collaborate with other provider
organizations with such capacity, or with clinical researchers
affiliated with academic health centers. A CRN should consist of
diverse members drawn from a number of financially autonomous and
managerially distinct organizations. In this RFA, organizations which
affiliate for research purposes as components of the Cancer Research
Network will be referred to as CRN members.
 
The Division of Cancer Control and Population Studies (DCCPS),
National Cancer Institute, invites applications for cooperative
agreements to develop and support a cancer research infrastructure,
consisting of 1 or more networks, composed of health care provider
organization researchers who will be capable of conducting studies of
cancer epidemiology, treatment, and prevention and control. The
central objective of this RFA is to encourage cancer research
uniquely well-suited to the research interests and strengths of
researchers affiliated with health care provider organizations as
well as of high priority to NCI.  The RFA is also intended to
encourage collaboration between researchers based as health care
provider organizations and researchers affiliated with academic
medical centers.
 
HEALTHY PEOPLE 2000
 
The Public Health Service (PHS) is committed to achieving the health
promotion and disease prevention objectives of "Healthy People 2000,"
a PHS-led national activity for setting priority areas.  This Request
for Applications (RFA), Cancer Research Networks Across Health Care
Systems, is related to multiple priority areas, but centrally related
to cancer surveillance and data systems.  Potential applicants may
obtain a copy of "Healthy People 2000" (Full Report:  Stock
No.017-001-00474-0) or "Healthy People 2000" (Summary Report:  Stock
No. 017-001-00473-1) through the Superintendent of Documents,
Government Printing Office, Washington, DC 20402-9325 (telephone
202-512-1800).
 
ELIGIBILITY REQUIREMENTS
 
The CRN will be led by a Principal Investigator, a researcher
affiliated with one of the CRN members, who will coordinate of
overall activities of the CRN.  Each CRN member will also be
represented by a co-Principal Investigator, who may also be
designated as lead researcher on one or more of the specific research
projects of the CRN.  The organizational entity with which the CRN
Principal Investigator is affiliated will be the awardee institution
for this RFA and the lead institution for the CRN.  The application
must name the CRN Principal Investigator, co-Principal Investigators
and the respective CRN organizational members.
 
Applications may be submitted by domestic for-profit and non-profit
health care provider organizations (network members) acting jointly
as a U.S. research network.  A domestic application may not include
an international component.  Networks must include a sufficient
number of  health care provider organization members, such that total
patient enrollment is at least 2 million adults (ages 18 and over).
Also, network covered populations must include diverse populations
with respect to gender, race/ethnicity and, to the extent that is it
practical, rural/urban and geographic location.  Applicants must
demonstrate a shared commitment among all participating network
members to working together on proposed research studies.  Applicants
must show evidence of ability to access and organize data collection
from all participating network members.  Applicants are encouraged to
demonstrate the capability of data linkages with local centralized
tumor registries, pathology and radiologic facilities, and state
vital records.  If these capabilities do not currently reside within
one or more of the network members,  the applicant may assemble a
group with plans to develop the necessary expertise across all
network members. Each network member must have access to a resource
unit that supports research data management locally or centrally.
Racial/ethnic minority individuals, women, and persons with
disabilities are encouraged to apply as Principal Investigators.
 
MECHANISM OF SUPPORT
 
The administrative and funding instrument to be used for this program
will be a cooperative agreement (U19), an "assistance" mechanism
(rather than an "acquisition" mechanism), in which substantial NIH
scientific and/or programmatic involvement with the awardee is
anticipated during performance of the activity.  (The U19 is a
program project cooperative agreement. Therefore, the NCI Program
Project Guidelines must be used in the preparation of applications in
response to this RFA [vide infra]).  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 partner role, but it is not to assume direction,
prime responsibility, or a dominant role in the activity. Details of
the responsibilities, relationships and governance of the study to be
funded under cooperative agreement(s) are discussed later in this
document under the section "Terms and Conditions of Award."
 
The total project period for applications submitted in response to
the present RFA may not exceed 4 years.  The anticipated award dates
will be Summer 1998.
 
Because the nature and scope of the research proposed in response to
this RFA may vary, it is anticipated that the sizes of awards will
vary also.
 
Awards and level of support depend on receipt of a sufficient number
of applications of high scientific merit.  Although this program is
included in the financial plans of the National Cancer Institute,
awards pursuant to this RFA are contingent upon the availability of
funds for this purpose.
 
At this time, the National Cancer Institute has not determined
whether or how this solicitation will be continued beyond the present
RFA.
 
FUNDS AVAILABLE
 
The estimated funds (total costs) available for the first year of
support for this program is $4 million. It is anticipated that 1 or 2
applicants will receive awards.
 
RESEARCH OBJECTIVES
 
The purpose of this RFA is to enhance research on cancer
epidemiology, prevention, early detection and control in the context
of  health care delivery systems.  To accomplish this, the initiative
will support the development of research capabilities across multiple
healthcare provider organizations for the conduct of cancer research
projects.  The CRN will accomplish two major objectives:
 
- Formulate and implement a joint CRN research agenda resulting in
the conduct of three or more specified research projects in selected
areas of cancer control and population studies.
 
- Develop standardized data collection instruments, surveys and
analytical methods to promote the development of consistent and
uniform data bases, and other research materials that can be shared
across member institutions and utilized in joint research projects
using uniform protocols when appropriate.
 
Meeting these research objectives will be facilitated by ongoing
meetings and communication.  These meetings would be structured to
foster collaboration between clinical practice and research personnel
within individual CRN organizations, between researchers at different
CRN organizations and between CRN researchers, researchers affiliated
with academic medical centers and NCI.
 
In accomplishing these objectives NCI anticipates the development of
increased cancer research capacity through increased sharing of
specific expertise, thereby raising research competence of all CRN
members.  This would enable more CRN based researchers to participate
more fully in existing NCI-sponsored research mechanisms, such as
CCOPs and Cooperative Groups and to collaborate with NCI-sponsored
cancer centers.
 
Background
 
The National Cancer Institute has long supported a program of
research in cancer control that is designed to identify promising
innovations in cancer prevention, detection, treatment and
rehabilitation and to demonstrate, through controlled studies, which
interventions are efficacious.  As cancer control research matures
there is a growing need to identify existing patient care settings
and existing data resources that will facilitate the conduct of
cancer control translational research.  Once efficacy for specific
interventions has been demonstrated in selected populations, research
on effectiveness in larger, more diverse populations found in
representative community settings is essential to ensure the full
benefit of the intervention is realized.  Efficacy, which denotes how
well the intended objectives of a procedure or treatment are realized
in ideal settings, such as a research trial, is a necessary but not
sufficient prerequisite of effectiveness.  Effectiveness implies that
an efficacious intervention is also feasible and can be replicated in
diverse settings at reasonable economic cost. Settings that capture
large, diverse care populations also constitute a valuable resource
for conducting studies of primary prevention interventions, novel
methods of early detection and interventions designed to increase the
quality-of-life and reduce the risk of recurrent disease in cancer
survivors.
 
In order to conduct studies of effectiveness at the national level,
it is necessary to capture a large and diverse patient population
with adequate representations of individuals by age, gender, income,
education, minority status and urban/rural and geographical
locations.  Sample size requirements will vary from study to study,
but many studies may require a CRN population of a few million
persons.  This would be true of many studies that require cancer
incidence, stage-at-diagnosis, survival, or cancer patterns of care
as study endpoints.  For example, a health care provider organization
with a membership of one million individuals over the age of 18 would
expect about 750 newly diagnosed breast cancer cases each year and
about 133 deaths from breast cancer.  Much smaller numbers of cases
would be expected for specific sub-populations that may be of
interest or for the less common cancer sites. Effectiveness research
often requires large and diverse populations because the
effectiveness of an intervention may vary as a function of such
individual characteristics as education, income, age, gender and
minority status as well as by health care system characteristics.
Effectiveness research is greatly facilitated when pre-existing
database systems can be used to track, retrospectively or
prospectively, longitudinal patterns of health services resource use
and clinical outcomes at the individual patient level.
 
While historically less research oriented than academic medical
centers, some large health care provider organizations have
substantial records of conducting clinical research supported by R01
grants as well as internal funds.  There is currently growing
interest on the part of provider organizations in participating in
clinical research,  and there has been rapid development and
standardization, among these organizations, of integrated
epidemiological-clinical-financial databases that would greatly
facilitate the conduct of cancer control research on a large
population-based scale.  In addition, many academic health centers
have developed extensive primary care networks that provide formal
links between primary care delivery systems and the research
capabilities of traditional academic centers.
 
There is a great diversity in the operation and structure of health
care provider organizations.  However, certain provider organizations
possess characteristics that make them particularly well suited for
population-based medical research.  This is especially true of
provider organizations that have:
 
-  Patient populations enrolled in the provider organization over an
extended period that are roughly representative of the general
population, and that receive most or all of their medical care
services through those organizations.
 
-  Research resources including qualified and experienced clinical
research personnel with institutional access to research-oriented
primary care and specialty physicians.
 
- A history and/or willingness to establish collaborative research
relationships with clinical research personnel affiliated with
academic medical centers.
 
- Practice settings with an emphasis on prevention, detection and
treatment of early stage disease.
 
-  The capability to track individual patients longitudinally and, by
record linkage from diverse sources, to integrate information on
patient clinical characteristics with information on behavior,
knowledge and attitudes, health status, and medical care use, cost
and cancer outcomes.
 
-  An organizational structure that facilitates the collection of
study specific data on  organization members, recruitment of members
into intervention trials and demonstration projects, and the linkage
of these data with existing patient-specific clinical data.
 
 - An emphasis on the practice of evidence-based medicine, with a
priority on the public health and welfare of organization members.
 
Objectives and Scope
 
The ultimate purpose of the type of research funded by this RFA is to
reduce the burden of cancer morbidity and mortality.  Therefore, it
is appropriate that studies funded by this RFA focus on cancer sites
that are responsible for substantial components of cancer morbidity
and mortality.  Research funded by this RFA  might address any of the
diverse areas noted below.  The following broad areas are of
particular interest:
 
- Studies which address the distribution of  preventable cancer risk
factors and the burden of disease in the covered population of the
CRN;
 
- Studies which evaluate how innovative cancer prevention and control
programs, based on rigorous intervention research, can be effectively
disseminated throughout and implemented in the context of health care
provider systems;
 
- Studies of the relationship between health care delivery system
organizational structure and patterns of cancer prevention and
control service delivery associated with access to care and favorable
outcomes.
 
In addition, research funded by this RFA should be designed to take
advantage of the large patient populations and diverse patient care
settings, the integrated data systems and the other complimentary
research resources made available by the CRN to achieve research
objectives that would otherwise be infeasible or prohibitively
expensive.
 
Areas of  research that would be particularly enhanced by this
mechanism include, but are not limited to:
 
Epidemiological Studies
 
- Epidemiological studies in which longitudinal medical records are
particularly useful in identifying cancer risk factors, including the
potential risks associated with pharmaceuticals, medical devices, and
other forms of non- cancer treatment.
 
- Studies of the long-term risk of second cancers or other late
effects of cancer treatment.
 
Behavioral Cancer Prevention and Control
 
- Studies of the feasibility, cost-effectiveness and dissemination of
efficacious bio-behavioral cancer prevention and control
interventions.
 
- Studies of innovative behavioral cancer prevention and control
interventions targeted to specific populations in different
organization settings, e.g., physician practice, ancillary health
personnel, or public education.
 
- Studies of delivery systems for counseling and other approaches
used for genetic testing, monitoring for cancer occurrence and
preventive interventions..
 
Evaluation and Methodological Studies Related to Clinical Trials
 
- Research on the costs and benefits to patient enrollees and health
care provider institutions that result from participation in NCI or
other trials.  One purpose of this research is to identify strategies
for increasing accrual to NCI trials.
 
- Methodological research on the incorporation of quality- of-life,
patient satisfaction and economic endpoints in NCI trials through
direct clinical trial data collection or by other methods such as
using modeling or other extrapolation methods to make it possible to
use retrospective data to supplement the analysis of within-trial
data.
 
Survivorship Issues
 
- Studies of  indirect costs, quality-of-life, complications and
recurrence as a function of treatment approach, care setting and
referral patterns.
 
- Studies of interventions to prevent morbidity associated with
cancer and its treatment
 
Cancer Control Surveillance and Outcomes Research
 
- Studies of existing patterns of care for cancer prevention,
screening, treatment, and rehabilitation in relationship to existing
evidence of efficacy, cost-effectiveness, clinical recommendations
and practice guidelines.
 
- Studies of the effectiveness of preventive medicine and
evidence-based medical practice.
 
- Studies of the diffusion of state-of-the-art cancer prevention,
screening, treatment, care and rehabilitation.
 
- Studies of the formulation and implementation of organizational
policy regarding the dissemination of innovative technology, e.g.,
counseling,  screening for genetic predisposition to cancer and newly
approved advanced diagnostic imaging tools.
 
Clinical Informatic Studies
 
- Studies of the feasibility, effectiveness and cost of using
clinical informatic systems to identify, recruit and track
organization members for targeted cancer prevention and screening
interventions.
 
- Studies of the feasibility, effectiveness and cost of using
clinical informatic systems to aid patient/physician decision making
for cancer prevention, screening and treatment.
 
- Studies of the feasibility, effectiveness and cost of using
clinical informatic systems as an aid to multi-disciplinary
management of cancer care.
 
SPECIAL REQUIREMENTS
 
Applications in response to this RFA are required to describe four
components: the CRN research agenda component,  a research study
component consisting of three or more specific research studies, an
infrastructure component and an evaluation component.  The research
agenda component should discuss the theme of the CRN research agenda
and the rational for this them. The research study component should
describe the specific collaborative studies that the CRN proposes to
conduct.  The infrastructure component would describe the proposed
means by which the CRN would build the collaborative cancer research
capacity of the network to support the proposed studies.  The
evaluation component should describe an evaluation study designed to
determine how successful the development of the CRN has been in
meeting the goals of this RFA.
 
The following issues should also be addressed in the infrastructure
component of the application:
 
CRN Member Characteristics
 
- The nature of health care provider organization patient enrollment
for each of the CRN members must be documented.  The following
characteristics of the enrollment are relevant to the application:
 
-  size of enrollment;
-  geographical location of enrollment;
-  sociodemographic characteristics of membership (age, gender,
race/ethnicity, socioeconomic status, health status);
-  length and continuity of enrollment (for enrollees with and
without a history of cancer);
-  benefit coverage;
-  longevity and stability of health care provider organization;
-  size and composition (practice specialty) of medical staff;
-  structure (staff model, IPA, point-of-service, etc.);
-  type and/or proportion of services offered "within plan" and
"contracted-out."
 
- The nature of CRN member data systems must be documented.  What
type of systems are available for the acquisition, storage and
analysis of epidemiological, clinical and resource use and cost data?
Are data systems automated?  How much retrospective data is
available?  Do capacities exist to link data across CRN members?
What planned centralized data coordination or management is in place?
What type of data elements can be shared for research purposes?  What
mechanisms and procedures exist to protect the confidentiality of
research subjects.
 
Data Linkage
 
- Linkage to cancer registry.  The feasibility and willingness of CRN
members to link data to a SEER cancer registry or other
population-based (e.g., state cancer registries) or hospital-based
tumor registries should be described.  Existing linkage to cancer
registries should be documented in the application.
 
- Linkage to other data resources.  The feasibility and willingness
of CRN members to link to other types of data resources, such as
registries related to cancer surveillance or genetics, health related
survey data, radiology and pathology facilities data, demographic and
socioeconomic data, data on use of out-of-plan services, and state
vital records should be described.  Through letters of intent, or
other documentation,  the application should demonstrate that the CRN
has identified appropriate data resources of value to the overall
research goals of the CRN and initiated efforts to implement data
linkage with these resources.
 
Research Capacity Development
 
- Research capacity and experience.  The institutional research
capacity and experience of each member of the CRN must be documented,
including the number and qualifications of in-house research staff.
All research capacity and experience related to cancer research must
be documented, including collaboration with or membership in existing
NCI cancer centers, cooperative groups, CCOP research bases, or
consortia.  Emphasis should be placed on the research capacity and
experience which is expected to be most relevant to the activities of
the proposed CRN. Individual members of the CRN must demonstrate a
capacity and willingness to facilitate professional interaction
between research and clinical care staff of the health care provider
organization.
 
- The applicant must describe how the activities of the CRN will
result in the increased capacity of individual members of the CRN or
the CRN as a whole to conduct research under existing NCI mechanisms.
 
Administrative Procedures
 
- The applicant CRN must specify a set of criteria and a process to
be used to consider adding new (organizational) members to the CRN,
in the event that this warranted by the research needs of the
project. Addition of new members would require the consultation and
approval of the NCI Program Director.
 
- The applicant must specify a set of criteria and a process to be
used to consider extending or modifying research studies initially
proposed in the application and approved for funding, and initiating
new or related research studies within the scope of the approved
award, in the event that such extensions, modifications or
initiations are warranted by scientific considerations and can be
accommodated by the time schedule and funding of the project (or
through various mechanisms that might become available to extend time
and/or funding).  The proposed process should take the interactive
nature of the funding mechanism into account and provide a
consultative role for the NCI Program Director and the NCI Review
Committee..
 
It is recommended that the infrastructure component of the study
comprise approximately one-third of the (total 4 year) budget of the
CRN.  The infrastructure component should be designed to meet two
goals: support of the specific research studies proposed and
development of the general research capacity of the CRN and its
affiliated network members.  The infrastructure component may
include, but is not necessarily limited to, meetings of researchers
to share research expertise and engage in joint planning, development
of research support personnel, development of standardized data
acquisition and processing systems, development of central data
coordination centers, and development of communications systems for
facilitating interaction between researchers.
 
In the research component of the application the applicant CRN must
describe at least three specific research studies planned for the
funding period.  It is recommended that the research component of the
study comprise approximately two-thirds of the (total 4 year) budget
of the CRN.  The application must include proposals for specific
research studies along the lines suggested in the section on
Objectives and Scope.  All or some sub-group of all CRN network
members should be involved in each of the proposed studies.
Descriptions for each proposed study should include all the elements
that would be included in a standard R01 grant application for a
research study, including budget.
 
It is recommended that the evaluation component comprise between 2-5%
of the budget of the CRN.  The purpose of the evaluation component is
to evaluate how well the CRN, and especially the infrastructure
component, performs to meet the goals of this RFA.  The evaluation
component should describe objective criteria and methods for
evaluation, including a baseline assessment of  the research
strengths and weakness of  the CRN and individual network members at
the beginning of the project and identify existing barriers to
network members participation in cancer research activities as well
as opportunities for overcoming these barriers through the CRN
mechanism.  Specific criteria that should be considered in the
evaluation are:  the extent to which the overall cancer research
capacity of the CRN has increased as a result of the funded project,
the extent to which cancer research capacity of the network members
has been enhanced through the complementary sharing of resources
across network members and through collaboration with academic
medical center affiliated researchers,  the extent to which network
members ability to compete for R01 grants and participate in other
research mechanisms has been enhanced, the extent to which "research
culture" has been engendered and enhanced in the clinical care
setting of network members, and the extent to which enduring
research-oriented data systems, research methods and collaborative
relationships have been established and institutionalized.  The
evaluation budget should be carefully described and justified for
each budget period.
 
To promote the orderly development of a CRN, a number of issues must
be addressed in the application.  The applicant must describe or
propose an organizational structure consisting of a network of health
care provider organizations with documented institutional commitment
from each member of the proposed CRN to participate in the proposed
activities of the CRN.  The CRN need not have a centralized physical
location, but it must have an identifiable Steering Committee which
will work with an NCI Program Director in the context of a
Cooperative Agreement. Membership of the Steering Committee shall
consist of the CRN Principal Investigator, the co-Principal
Investigators of the CRN, and the NCI Program Director.  The Steering
Committee will convene Working Groups for planning and supervising
the specific research activities of the CRN.
 
Terms and Conditions of Award
 
These special Terms of Award are in addition to and not in lieu of
otherwise applicable OMB administrative guidelines, HHS Grant
Administration Regulations at 45 CFR Part 74, and other HHS, PHS, and
NIH Grant Administration policy statements.
 
The administrative and funding instrument used for this program is a
cooperative agreement (U19), an "assistance" mechanism (rather than
an "acquisition" mechanism) in which substantial NIH scientific
and/or programmatic involvement with the awardee is anticipated
during performance of the activity. 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 partner 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 Director, with
consultation from other NCI scientists as appropriate..
 
The inability of an awardee 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 adjustment of
funding, withholding of support, suspension or termination of award.
 
1.  Awardee Rights and Responsibilities
 
Awardees will have primary and lead responsibilities for the
development and formation of a Cancer Research Network with a central
objective to conduct approved research projects and develop
standardized data collection instruments, surveys and methods.
 
The Principal Investigator and Co-Principal Investigators associated
with each CRN member institution and/or major research project will
meet at the initiation of the award with the NCI Program Director to
discuss scientific and technical direction and strategies relating to
the conduct of specific studies proposed by each Network.  CRN
members will agree to follow common protocols approved by the
Steering Committee.  In the event that more than 1 CRN award is made,
representatives from  all CRNs will meet annually to jointly discuss
ongoing research plans and progress.  The award recipients are
encouraged to provide information to NCI of progress on other funded
projects external to the collaborative activities but relating to the
activities funded under this RFA.  While joint research projects are
strongly encouraged under this RFA, research projects conducted at
individual CRN member institutions under the supervision of a single
Co-Principal Investigator, that otherwise contribute to meeting the
goals and objectives of this RFA , are allowed.  Co- Principal
Investigators of such single institution studies will have equivalent
status with all other Co-Principal Investigators in regard to
participation on the CRN Steering Committees and other CRN
committees.
 
Awardees will retain custody of and have primary rights to the data
developed under these awards, subject to Government rights of access
consistent with current HHS, PHS, and NIH policies.  All awardees and
NCI will jointly develop appropriate confidentiality procedures for
data collection, processing, storage and analysis to ensure the
confidentiality of data on individual health care provider
organization patients, health care providers and other institutions
involved in CRN research projects.  No identifying information of
individual patients or providers should be available through pooled
CRN research databases.  Encrypted study identification numbers will
be used for all pooled CRN studies.
 
2.  NCI Staff Responsibilities
 
The NCI Program Director will have substantial
scientific-programmatic involvement during conduct of this activity,
through technical assistance, advice and coordination above and
beyond normal program stewardship for grants, as described below.
 
a. Establishment of NCI /CRN Review Committee
 
NCI oversight of the CRN will be the responsibility of the NCI
Program Director, with the advice of a CRN Review Committee composed
of NCI professional staff drawn from relevant NCI Divisions and
Programs.  The NCI Program Director, or a designated NCI staff person
from the NCI CRN Review Committee, will have voting membership on the
CRN Steering Committee(s), and, as determined by those committee(s),
their subcommittees.
 
The NCI Program Director, with assistance of NCI staff from the
Review Committee, will have scientific-programmatic involvement in
the conduct of the proposed research studies. The dominant role and
prime responsibility for the studies resides with the awardee for the
studies as a whole, although specific tasks and activities in
carrying out particular studies may be shared among awardees and NCI
staff.  The NCI Program Director will provide assistance and guidance
as needed on an ad hoc basis, in developing shared study protocols
among CRN members, selecting data elements, obtaining cooperation
from the CRN members, linking databases, and analyzing pooled data.
 
b.  Strategy Sessions
 
The NCI Program Director or designee, in cooperation with the CRN,
will sponsor strategy sessions (to be held in conjunction with
selected biannual meetings of the CRN Steering Committee), attended
by CRN co-Principal Investigators and other appropriate staff from
the CRN and appropriate NCI staff.
 
c.  Data Management
 
Each awardee will retain custody of and primary rights to their own
data and is responsible for statistical analysis, computer processing
and statistical interpretations. The NCI Program Director will have
access to all data generated under this award and will periodically
review the data management and analysis procedures.
 
d.  Monitoring and Program Review
 
In addition to normally prescribed duties of program and grants
staff, an on-site program review will occur as early as 10 months but
no later than 18 months after award.  The program review will be
conducted to evaluate progress of  the CRN  in meeting the goals and
objectives of this RFA.  The inability of a participating CRN member
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.
 
e.  Rights Reserved to NCI
 
The NCI reserves the right to terminate or curtail the study (or an
individual award) in the event of shortfalls in participant
recruitment, follow-up, data reporting, quality control, or other
major breach of study protocols, reaching a major study endpoint
substantially before schedule with persuasive statistical
significance, or human subject ethical issues that may dictate a
premature termination.
 
3.  Collaborative Responsibilities
 
The CRN Steering Committee will be the main governing board of the
CRN and will have primary responsibility for overall policies and
procedures of the CRN and for decisions about and approval of
specific research protocols and pooled data analysis.  The CRN
Principal Investigator, named in the CRN application, will serve as
the Chairperson of the Steering Committee. The CRN Steering Committee
will convene as needed to discuss collaborative study progress and
address scientific-technical aspects of implementation.  The voting
membership of the Steering Committee shall consist of the CRN
Principal Investigator, all CRN Co-Principal Investigators and the
NCI Program Director. The Steering Committee should plan on at least
2 meetings per year, with at least the co-P.I. representing each
participating CRN member in attendance.  When deemed necessary at
least one data manager as well as one co-P.I. from each CRN member
will attend such meetings. Subcommittees will be established by the
Steering Committee, as it deems appropriate.
 
In the event that more than one CRN is funded, the respective CRN
steering committees, in consultation with the NCI Program Director,
will determine the need for joint activities across the CRNs.
 
4.  Arbitration Process
 
The Terms and Conditions of Award require that the NCI Program
Director make post-award decisions related to program performance and
programmatic decisions on scientific-technical matters.  NCI will
establish an arbitration process when a mutually acceptable agreement
cannot be obtained between the awardee and the NCI Program Director.
An arbitration panel (with appropriate expertise) composed of one
member selected by 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, NCI.
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 DHHS regulations 45 CFR Part 16.
 
INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN
SUBJECTS
 
It is the policy of the NIH that women and members of minority groups
and their subpopulations must be included in all NIH supported
biomedical and behavioral research projects involving human subjects,
unless a clear and compelling rationale and justification is provided
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.
 
All investigators proposing research involving human subjects should
read the "NIH Guidelines For Inclusion of Women and Minorities as
Subjects in Clinical Research," which have been published in the
Federal Register of March 28, 1994 (FR 59 14508-14513) and in the NIH
Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994.
 
LETTER OF INTENT
 
Prospective applicants are asked to submit, by October 17, 1997, a
letter of intent that includes a descriptive title of the proposed
research, name, address, and telephone number of the Principal
Investigator, identities of other key personnel and participating
institutions, and number and title of the RFA in response to which
the application may be submitted.
 
Although a letter of intent is not required, is not binding, and does
not enter into the review of subsequent applications, the information
allows NCI staff to estimate the potential review workload and to
avoid conflict of interest in the review.
 
The Letter of Intent is to be sent to:
 
Martin Brown, Ph.D.
Applied Research Branch
National Cancer Institute
Executive Plaza North, Room 313
6130 Executive Blvd.
Bethesda, MD  20892-7344
Telephone:  (301) 496-5716
FAX:  (301) 435-3710
Rockville, MD 20852 (if express/courier service)
 
APPLICATION PROCEDURES
 
The research grant application form PHS 398 (rev. 5/95) is to be used
in applying for these grants.  Applications kits are available at
most institutional offices of sponsored research and may be obtained
from the Division of Extramural Outreach and Information Resources,
National Institutes of Health, 6701 Rockledge Drive, Suite 6095, MSC
7910, Bethesda, MD 20892- 7910, telephone 301/435-0714, E-mail:
ASKNIH@odrockm1.od.nih.gov.  In addition since the U19 mechanism is
being used, applicants must use the instructions for NCI Program
Project Grant Applications.  These are available from the NCI
Referral Officer (301) 496-3428.
 
The RFA label available in the PHS 398 (rev.5/95) application form
must be affixed to the bottom of the face page of the application.
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.
 
Submit a signed, typewritten original of the application, including
the Checklist, and three signed exact photocopies, in one package to:
 
Division of Research Grants
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 also be sent to:
 
Ms. Toby Friedberg
Referral Officer
Division of Extramural Activities
National Cancer Institute
6130 Executive Boulevard
Executive Plaza North, Room 636
Bethesda, MD  20892
Rockville, MD 20852 (if using express/courier service)
 
It is important to send these copies at the same time that the
original and three copies are sent to DRG; otherwise, the NCI cannot
guarantee that the applications will be reviewed in competition with
the other applications received on or before the designated receipt
date.
 
Applications must be received by  November 25, 1997.  If an
application is received after that date, it will be returned to the
applicant without review.  The Division of Research Grants (DRG) will
not accept any application in response to this announcement that is
essentially the same as one currently pending initial review, unless
the applicant withdraws the pending application.  The DRG will not
accept any application that is essentially the same as one already
reviewed.  This does not preclude the submission of a substantial
revision of an application already reviewed, but such an application
must follow the guidance in the PHS Form 398 application instructions
for the preparation of revised applications, including an
introduction addressing the previous critique.
 
Application Preparation
 
All applications must be submitted on the form PHS 398 (rev. 5/95).
The rationale an theme of the proposed CRN research agenda should be
discussed in an introductory section. Separate research plans should
be prepared for the infrastructure component, each proposed research
study, and the evaluation component. Maximum page limitations for
each section are:  introductory section - 5 pages, research agenda
component - 10 pages, infrastructure component - 25 pages,  each
proposed research study - 25 pages,  evaluation component - 10 pages.
Regardless of the number of proposed research studies, the maximum
page limitation for the entire research plan is 200 pages.  Each
application must contain a detailed budget for the first 12-month
period and a budget for the entire proposed project period for direct
costs. Separate budgets should be submitted for each component of the
CRN: the infrastructure component, each proposed research study, and
the evaluation component.  Budgets for each CRN member organization
other than the lead CRN institution must be submitted as
sub-contracts the lead institution  (or consultant contracts to the
lead institution may be used when only the professional services of
specified individuals are involved).  Additional instructions are in
the NCI Program Project Grant Guidelines.
 
REVIEW CONSIDERATIONS
 
General Considerations
 
All applications will be judged on the basis of the scientific merit
of the proposed project and the documented ability of the
investigators to meet the RESEARCH OBJECTIVES of the RFA. Although
the scientific merit of the proposed research is important, it will
not be the sole criterion for evaluation of a study.  Other
considerations, such as the importance and timeliness of the proposed
studies, access to patients, and multi disciplinary nature of the
studies, will be part of the evaluation criteria.
 
Review Method
 
Upon receipt, applications will be reviewed for completeness by the
DRG and for responsiveness to the RFA by the NCI. Incomplete
applications will be returned to the applicant without further
consideration.  If NCI staff  find that the application is not
responsive to the RFA, it will be returned and receive no 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 NCI in accordance with the review
criteria stated below.  As part of the initial merit review, all
applications will receive a written critique and undergo a process by
which only those applications deemed to have the highest scientific
merit, generally the top half of applications under review, will be
discussed, assigned a priority score, and receive a second level
review by the National Cancer Advisory Board.
 
Review Criteria
 
Applicants are encouraged to submit and describe their own ideas
about how best to meet the general research and infrastructure goals
outlined in this RFA, and are expected to address issues identified
under SPECIAL REQUIREMENTS of the RFA.
 
Four general areas will be considered in review of applications:
research agenda; the feasibility of the infrastructure component of
the proposal and the likelihood that this component will effectively
contribute to meeting the goals of the RFA;  the importance and
scientific merits of the proposed research studies to be conducted by
the CRN; the objectivity and methodological soundness of the
evaluation component.
 
The following review criteria will be used:
 
-  Research Agenda
 
How well does the research agenda meet the goals and priorities of
the RFA?
 
How successful is the research agenda in providing a coherent basis
for the integration of the separate CRN research projects?
 
Does the proposed research agenda address an important set of
problems?  If the aims of the application are achieved, how will
scientific knowledge be advanced?  What will be the effect of these
studies on the concepts or methods that drive this field?
 
-  Infrastructure Component
 
Is the infrastructure proposal realistic and feasible given the
resources allocated to it and the characteristics of CRN members?
 
How well does the infrastructure component serve to support the
overall goals and priorities of the proposed research agenda and the
conduct of specific proposed research studies?
 
How well does the infrastructure component serve to increase the
cancer research capabilities of the CRN as a whole and individual CRN
members by facilitating the development of shared resources,
knowledge and information?
 
-  Evaluation Component
 
Are objective criteria and methods of evaluation proposed?
 
Are appropriate resources and expertise proposed to ensure an
adequate evaluation study?
 
Is the statistical design of the evaluations study sound?
 
-  Research Studies
 
Specific CRN research studies will be reviewed using the current
criteria that is applied to R01 grants (NIH GUIDE, Volume 26, Number
22, June 27, 1997), as follows:
 
(1) Significance:  Does this study address an important problem? If
the aims of the application are achieved, how will scientific
knowledge be advanced?  What will be the effect of these studies on
the concepts or methods that drive this field?
 
(2) Approach:  Are the conceptual framework, design, methods, and
analyses adequately developed, well-integrated, and appropriate to
the aims of the project?  Does the applicant acknowledge potential
problem areas and consider alternative tactics?
 
(3) Innovation:  Does the project employ novel concepts, approaches
or method? Are the aims original and innovative? Does the project
challenge existing paradigms or develop new methodologies or
technologies?
 
(4) Investigators:  Is the investigator appropriately trained and
well suited to carry out this work?  Is the work proposed appropriate
to the experience level of the principal investigator and other
researchers (if any)?
 
(5) Environment:  Does the scientific environment in which the work
will be done contribute to the probability of success?  Do the
proposed experiments take advantage of unique features of the
scientific environment or employ useful collaborative arrangements?
Is there evidence of institutional support?
 
In addition to the above criteria, in accordance with NIH policy, all
applications will also be reviewed with respect to the following:
 
*  The adequacy of plans to include both genders, minorities, and
their subgroups as appropriate for the scientific goals of the
research.  Plans for the recruitment and retention of subjects will
also be evaluated.
 
*  The reasonableness of the proposed budget and duration in relation
to the proposed research
 
*  The adequacy of the proposed protection for humans and animals,
and the safety of the research environment.
 
In addition to the above criteria, CRN proposals will be reviewed
with regard to commitment to conduct pooled analyses of combined data
across CRN members for research objectives that require pooled
analyses of data and adequate plans for central data coordination
centers when necessary to support pooled analyses. Such commitment
may be demonstrated by the identification of specific central data
coordination centers in the application, identification of data
managers for each CRN member and description of mechanisms for
ensuring data quality and comparability.
 
AWARD CRITERIA
 
Applications recommended by the National Cancer Advisory Board will
be considered for award based upon (a) scientific and technical
merit; (b) program balance, including in this instance, sufficient
compatibility of features to make a successful collaborative program
a reasonable likelihood; and (c) availability of funds.
 
Letter of Intent Receipt Date:  October 17, 1997
Application Receipt Date:       November 25, 1997
Review by NCI Advisory Board:   May 11-13, 1998
Anticipated Award Date:         August 1, 1998
 
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:
 
Martin Brown, Ph.D.
Applied Research Branch
National Cancer Institute
Executive Plaza North, Room 313
6130 Executive Boulevard
Bethesda, MD  20892-7344
Telephone:  (301) 496-5716
Email:  mb53o@nih.gov
 
Direct inquiries regarding fiscal matters to:
 
Crystal Wolfrey
Grants Administration Branch
National Cancer Institute
Executive Plaza South, Room 243
6120 Executive Boulevard
Bethesda, MD  20892-7150
Telephone:  (301) 496-7800 x213
Email:  wolfreyc@gab.nci.nih.gov
 
AUTHORITY AND REGULATIONS
 
This program is described in the Catalog of Federal Domestic
Assistance No. 93.3 . . . [use appropriate program number]. Awards
are made under authorization of the Public Health Service Act, Title
IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42
USC 241 and 285) and administered under PHS grants policies and
Federal Regulations 42 CFR Parts 52 and 45 CFR Part 74.  This program
is not subject to the intergovernmental review requirements of
Executive Order 12372 or Health Systems Agency review.
 
The PHS strongly encourages all grant and contract recipients to
provide a smoke-free workplace and promote the non-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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