kristoff@GENBANK.BIO.NET (Dave Kristofferson) (05/01/91)
$$XID RFA MH9113 MH-91-13 P1O1 *****************************************
STATE SERVICE SYSTEMS IMPROVEMENT THROUGH
CONSUMER AND FAMILY SUPPORT ACTIVITIES
RFA: MH-91-13
P.T. 34; K.W. 0730050, 0715095, 0715129, 0403004
National Institute of Mental Health
Application Receipt Date: June 24, 1991
PURPOSE
Since its inception, the Community Support Program
(CSP) of the National Institute of Mental Health (NIMH)
has supported a variety of initiatives to enhance the
involvement of consumers and family members in the
public mental health system and to increase the number
of consumer self-help and family support groups. These
efforts have been reinforced by recent statutory
requirements for consumer and family roles in planning
community-based services, for example through the
Advisory Councils mandated under P.L. 99-660, The State
Comprehensive Mental Health Services Plan Act of 1987.
To support the developing role of consumers and family
members in service delivery and systems planning, NIMH
is inviting applications under this Request for
Applications (RFA) for three-year grants to demonstrate and
evaluate service system improvement strategies that
integrate consumers and family members into the
planning and provision of mental health and support
services at State and local levels.
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 RFA, "State
Service Systems Improvement Through Consumer and Family Support
Activities," is related to the priority area of mental health.
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, D.C. 20402-9325
(telephone 202-783-3238).
NIMH intends that the activities supported in this
effort be relevant to the State's comprehensive mental
health service plan submitted to NIMH for review in
accordance with the requirements of Title V of P.L. 99-
660 and its subsequent amendments, and to the required
involvement of consumers and family members on the
Advisory Councils.
POPULATION OF CONCERN
The population of concern for CSP grants includes
individuals 18 years and over with a severe and
persistent mental disorders that seriously impair
functioning in primary aspects of daily living, such as
interpersonal relations, living arrangements, and
employment. Applicants should pay attention to the
unique needs and special concerns of racial and ethnic
minorities and women.
SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF
NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN
CLINICAL RESEARCH STUDY POPULATIONS
NIH and ADAMHA policy is that applicants for NIH/ADAMHA clinical
research grants and cooperative agreements will be required to
include minorities and women in study populations so that
research findings can be of benefit to all persons at risk of the
disease, disorder or condition under study; special emphasis
should be placed on the need for inclusion of minorities and
women in studies of diseases, disorders and conditions which
disproportionately affect them. This policy is intended to apply
to males and females of all ages. If women or minorities are
excluded or inadequately represented in clinical research,
particularly in proposed population-based studies, a clear
compelling rationale should be provided.
The composition of the proposed study population must be
described in terms of gender and racial/ethnic group. In
addition, gender and racial/ethnic issues should be addressed in
developing a research design and sample size appropriate for the
scientific objectives of the study. This information should be
included in the form PHS 398 in Section 2, A-D of the Research
Plan AND summarized in Section 2, E, Human Subjects.
Applicants/offerors are urged to assess carefully the feasibility
of including the broadest possible representation of minority
groups. However, NIH recognizes that it may not be feasible or
appropriate in all research projects to include representation of
the full array of United States racial/ethnic minority
populations (i.e., Native Americans (including American Indians
or Alaskan Natives), Asian/Pacific Islanders, Blacks, Hispanics).
The rationale for studies on single minority population groups
should be provided.
For the purpose of this policy, clinical research includes human
biomedical and behavioral studies of etiology, epidemiology,
prevention (and preventive strategies), diagnosis, or treatment
of diseases, disorders or conditions, including but not limited to
clinical trials.
The usual NIH policies concerning research on human subjects also
apply. Basic research or clinical studies in which human tissues
cannot be identified or linked to individuals are excluded.
However, every effort should be made to include human tissues
from women and racial/ethnic minorities when it is important to
apply the results of the study broadly, and this should be
addressed by applicants.
For foreign awards, the policy on inclusion of women applies
fully; since the definition of minority differs in other
countries, the applicant must discuss the relevance of research
involving foreign population groups to the United States'
populations, including minorities.
If the required information is not contained within the
application, the application will be returned.
Peer reviewers will address specifically whether the research
plan in the application conforms to these policies. If the
representation of women or minorities in a study design is
inadequate to answer the scientific question(s) addressed AND the
justification for the selected study population is inadequate, it
will be considered a scientific weakness or deficiency in the
study design and will be reflected in assigning the priority
score to the application.
All applications for clinical research submitted to NIH are
required to address these policies. NIH funding components will
not award grants or cooperative agreements that do not comply
with these policies.
ELIGIBILITY
Only mental health authorities in States and
Territories that do not currently have a CSP State
Service System Improvement Demonstration Grant or are
in the final year of a CSP State Service System
Improvement Demonstration Grant for general community
support development activities are eligible to apply
for these grants. Each State and Territory may submit
only one application.
PROGRAM GOALS
NIMH encourages the demonstration and evaluation of
strategies that are directed toward the following
programmatic goals:
o Integrating primary consumers and family members
into State and local service delivery, systems
planning, decision-making, and research activities in
order to develop mental health and support services
that are considered responsive to consumer and family
needs and preferences;
o Improving linkages between consumer self-help and
family support groups and the formal community support,
treatment, and rehabilitation service systems;
o Increasing the effectiveness of consumers and family
members in identifying and fostering needed system,
program, and service improvements;
o Fostering participation of minority individuals in
consumer self-help and family support groups;
o Increasing opportunities for consumer employment
within the formal service system.
PROJECT ACTIVITIES
The following are examples of supportable project
activities:
o Demonstrating and evaluating approaches to support
the establishment or ongoing maintenance of consumer
self-help and family support activities (e.g.,
providing start-up funding or ongoing funding,
staffing, office space, supplies, travel).
o Assessing the effectiveness of providing training
and educational opportunities for consumers and family
members (areas for assistance could include leadership
training; educating families on mental illness;
informing families and consumers on the organization
and delivery of mental health services in the
applicant's State or Territory; providing information
on state-of-the-art service approaches; disseminating
information on starting, operating, and evaluating
self-help groups; providing support to attend key
conferences and meetings; and training families and
consumers on how to use data and research outcomes to
improve mental health service systems).
o Assessing effective approaches for recruiting and
training consumers and family members to participate on
State and local mental health planning councils,
planning committees, governing boards, and task forces.
etc.
o Developing and evaluating a program to hire and
train consumers for employment at the State level or in
local programs in various positions such as peer
support counselors, case management aides, research
assistants, data technicians, computer programmers, and
word processors.
o Evaluating the impact of using consumers at in-
service training sessions for mental health program
staff in order to educate them on the consumer
perspective of having a mental disorder and the
consumer experience in the mental health system.
o Conducting statewide surveys to determine consumer
and family needs and preferences with respect to mental
health and supportive services.
NIMH funds may not be used for lobbying activities to
influence Federal legislation.
APPLICATION PROCEDURES
All applicants must use form PHS-5161 (revised 3/89).
The title of the announcement, "CSP State Systems
Improvement, RFA MH-91-13," must be typed in Item 10
on the face page of the application.
The
descriptive title of the application should be entered
in Item 11 but should not exceed 56 typewritten spaces.
Applications must be complete and contain all
information needed for initial and Advisory Council
review. No subsequent addenda will be accepted unless
specifically requested by the Science Review
Administrator of the review committee. No site visits
will be made.
Application kits are available from:
Grants Management Branch
National Institute of Mental Health
Parklawn Building, Room 7C-15
5600 Fishers Lane
Rockville, MD 20857
Telephone: (301) 443-4414
The original and two (2) permanent, legible copies of
the completed application must be received (not
postmarked) by the close of business June 24, 1991.
Applications must be sent to:
Division of Research Grants
National Institutes of Health
Westwood Building, Room 240
Bethesda, MD 20892**
To facilitate the timely review of your application, it
is also requested that one additional copy of the
application be sent directly to:
Ms. Edna M. Hardy-Hill
Division of Extramural Activities
National Institute of Mental Health
5600 Fishers Lane, Room 9C-15
Rockville, MD 20857
The mailing envelope (including that provided by an
express carrier) for this additional copy must be
clearly marked, "RFA MH-91-13, CSP Demonstrations,
SSIP."
APPLICATION REQUIREMENTS
The application must be written in a manner that is
self-explanatory to objective, outside reviewers who
may not be familiar with prior related activities of
the applicant. The application must be as brief as
possible. The narrative is limited to 20 single-spaced
pages and must contain the necessary information for
reviewers to understand the project. Appendices may be
attached but must not be used to merely extend the
narrative; extensive appendices are discouraged. It is
important that the relationship between the proposed
project and ongoing State and/or local activities be
clearly explained. It is also important that the
activities that are specific to the proposed project be
clearly identified.
To ensure that sufficient information is included for
technical merit review, please follow the instructions
for Program Narrative on page 16 of form PHS-5161. In
addition, include the following:
o Project abstract, which must not exceed one-half
of a single-spaced, typewritten page
o Summary description of the proposed project and
discussion of the rationale for the project, including
factors such as gaps in consumer and family
involvement; relationship to the State's comprehensive
mental health services P.L. 99-660 plan and Advisory
Council, review of the literature and other relevant
knowledge that provides justification for the proposed
project; and previous activities and accomplishments
that the proposed project builds upon
o Discussion of involvement of primary consumers and
family members in planning the project
o Management plan that identifies the organizational
location for the project, describes how the project
will be managed, and explains the roles and
responsibilities of consumers and family members in
managing the project
o Evidence of support from all organizations and
entities to be involved in the project
o If the State proposes to fund single or multiple
projects through a Request for Proposals (RFP) process,
inclusion of the rationale for selecting this approach,
copy of the RFP, list of eligible applicants, and
description of the advertisement and review process
o Evaluation plan that describes who will conduct the
evaluation of the project (should be an objective,
outside evaluator), how State evaluation staff will be
involved, and how the project will be evaluated
o In addition to the budget information requested in
form PHS-5161, for the funds to be requested in this
application, a detailed justification for each line item of the
budget for each year of the project
o Identification of all key staff and consultants who
will have major roles in implementing or evaluating the
project, including position descriptions and resumes
CLIENT SAFEGUARDS
If the project will be collecting identifiable
information about individual clients or project staff
for project evaluation purposes, assurances for
protecting client and staff confidentiality and
anonymity must be included.
TERMS AND CONDITIONS OF SUPPORT
Period of Support
Support may be requested for a period of up to 3 years.
Annual awards will be made, subject to continued
availability of funds and progress achieved.
In Fiscal Year 1991, it is estimated that approximately
$1 million will be available to support approximately
10 projects. The expected average amount of an award,
for direct costs, is estimated to be $100,000 per year.
However, the amount of funding available will depend on
appropriated funds and program priorities at the time
of award.
Allowable Costs
Applicants must include the following agreement in
their applications: "(Applicant) agrees that not more
than 10 percent of any resultant grant award will be
expended for administrative purposes."
Grants are intended to assist in meeting the costs of
planning, developing, and implementing activities to
support attainment of the project objectives.
Applicants are expected to determine the costs of the
project for the proposed project period. Grant funds
are to be additive, not substitutive; they are not to
be used to replace existing resources.
Grant funds may be used for expenses clearly related
and necessary to carry out the proposed project,
including both direct and indirect costs that are
specifically identified with the proposed project.
Grant funds may be used to obtain consultation (e.g.,
from primary consumers, family members, community
organizers, evaluators, and trainers) related to project
activities. States are expected to provide in-kind
support for the staffing necessary to implement the
activities under the approved project. States may,
however, request grant support for salaries, wages, and
fringe benefits for non-State agency staff involved in
project-related activities who are consumers or family
members.
Other items of expenditures, for which applicants may
request grant support include:
o Travel and training directly related to carrying out
activities under the approved project (each grantee
will be asked to participate, along with a consumer and
a family leader, in one annual technical
assistance/problem-solving meeting to be held in the
Washington, D.C. area and to send a minimum of five
consumers to the NIMH-supported National Alternatives
Conferences);
o Supplies, communications, and rental of space
directly related to approved project activities;
o Contracts to consumer or family organizations or
programs and to consultants (preferably consumers or
family members) as necessary for performance of
activities under the approved project;
o Other such items necessary to support project
activities, as approved by NIMH.
REVIEW PROCEDURES
Applications received under this announcement will be
assigned to an Initial Review Group (IRG) in accordance
with established PHS Referral Guidelines. The IRGs,
consisting primarily of non-Federal scientific and
technical experts, will review the applications for
scientific and technical merit. Notification of the
review recommendations will be sent to the applicant
after the initial review. Applications will receive a
second-level review by the National Mental Health
Advisory Council whose review may be based on policy
considerations as well as technical merit. Only
applications recommended for approval by the Council
may be considered for funding.
Applicants must comply with the intergovernmental
review requirements of Executive Order 12372, as
implemented through DHHS regulations at 45 CFR Part
100. Through this process, States, in consultation
with local governments, are provided the opportunity to
review and comment on applications for Federal
financial assistance. Applicants should contact the
State's single point of contact (SPOC) as early as
possible to determine the applicable procedure. A
current listing of SPOCs will be enclosed with the
application kit. SPOC comments should be forwarded to
Neal Brown, Chief, Community Support Section, System
Development and Community Support Branch, Division of
Applied and Services Research, National Institute of
Mental Health, Parklawn Building, Room 11C-22, 5600
Fishers Lane, Rockville, Maryland 20857, by August 1,
1991. NIMH does not guarantee to accommodate or
explain comments from the SPOC after August 1, 1991.
REVIEW CRITERIA
Each grant application is evaluated on its own merits.
The following are the review criteria that will be
used:
o Quality and clarity of the description of the
proposed project, rationale, relationship to the State
comprehensive mental health P.L. 99-660 services plan,
relationship to previous activities and
accomplishments, and potential benefits;
o Evidence that the project was planned by and has the
endorsement of the major consumer and family support
organizations in the State;
o Relevance of the project to the goals of the
announcement;
o Quality, feasibility, and thoroughness of the
project plan;
o Quality of the evaluation plan;
o Capability and experience of the project director,
consultants, and other key staff proposed for the
project;
o Quality of the management plan;
o Potential of the project to empower consumers and
family members
o Attention to racial, ethnic, and minority population
issues and concerns;
o Appropriateness of budget estimates for the proposed
project activities.
RECEIPT AND REVIEW SCHEDULE
Receipt of Council Earliest
Applications Initial Review Review Start Date
June 24, 1991 July 1991 Sept. 1991 Sept. 1991
Applications received after the above receipt date will
be returned to the applicant without review.
AWARD CRITERIA
In the decision to fund approved applications, the
following criteria will be considered:
o Quality of the proposed project as determined by the
review process;
o Consistency of the proposed initiative with the
State's mental health service plan submitted to NIMH in
October 1989, in accordance with the requirements of
Title V of Public Law 99-660;
o Geographical location in order to include States
from all sectors of the Nation to the extent possible;
o Availability of funds.
FOR FURTHER INFORMATION
Neal Brown, Chief
Community Support Section
System Development and Community Support Branch
Division of Applied and Services Research
National Institute of Mental Health
Parklawn Building, Room 11C-22
5600 Fishers Lane
Rockville, MD 20857
Telephone: (301) 443-3653
Inquiries pertaining to grants management should be
directed to:
Steven Hudak
Chief, Grants Management Section
Grants Management Branch
National Institute of Mental Health
Parklawn Building, Room 7C-23
Rockville, MD 20857
Telephone: (301) 443-4456
The Catalog of
Federal Domestic Assistance Number is 93.125.
Grants must be administered in accordance with the PHS
Grants Policy Statement (revised October 1, 1990).
Federal regulations, 45 CFR Part 92, are applicable to
these awards, and
under the authority of Section 520 of the Public Health Service
Act, as amended by P.L. 101-93.
$$XID RFA CA9109 CA-91-09 P1O1 *****************************************
REQUEST FOR APPLICATIONS
COOPERATIVE NETWORK FOR EVALUATION OF PROGNOSTIC MARKERS
OF URINARY BLADDER CANCER
RFA: CA-91-09
P.T. 34; K.W. 0715035, 0785220, 0765033
National Cancer Institute
Letter of Intent Receipt Date: May 31, 1991
Application Receipt Date: July 31, 1991
I. Purpose
The Cancer Diagnosis Branch of the Division of Cancer
Biology, Diagnosis and Centers at the National Cancer
Institute (NCI) invites applications for cooperative agreements
from institutions capable of, and interested in,
participating in the "Cooperative Network for Evaluation
of Prognostic Markers of Urinary Bladder Cancer." The
goal of the network is to test biochemical, immunologic,
genetic, and other quantifiable markers of urinary bladder
cancer. The network will perform collaborative studies
requiring expertise in urology, pathology, and/or basic
cancer biology to evaluate appropriate quantifiable
markers of urinary bladder cancer and to define relevant
clinical applications. This network will continue and
expand the collaborative studies of bladder cancer
markers currently supported by the Marker Network for
Bladder Cancer.
Awards will be made as cooperative agreements that
create an assistance relationship with substantial NCI
programmatic involvement with the recipients during the
performance of the project, as outlined in this request
for applications (RFA). The cooperative agreement
mechanism is used when the NCI wishes to stimulate
investigator interest and proposes to advise or assist in
an important and opportune area of research. The NCI
anticipates making four to six awards for project periods
of up to four years. A total of $950,000 is expected to
be set aside for funding these activities in the initial
year. Although this project is provided for in the
financial plans of the NCI, the award of cooperative
agreements pursuant to this RFA is contingent on the
availability of funds appropriated in fiscal year 1992.
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 RFA, "Cooperative Network
for Evaluation of Prognostic Markers of Urinary Bladder
Cancer," is related to the priority area of cancer.
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, D.C. 20402-9325 (telephone 202-783-3238).
II. Background Information
Advances in immunology, molecular biology, and genetics
have opened new possibilities for developing markers to
detect cancer and its recurrence, invasion, and
metastasis. This is expected to lead to new and more
effective approaches to improve diagnostic accuracy,
make prognostic and therapeutic decisions, more
effectively monitor response to therapy, detect cancer
at earlier stages, and identify high-risk populations.
Different cell markers appear to correlate with
particular biological behaviors of urinary bladder
tumors. Separate markers may be useful for predicting
recurrence, progression, or metastasis in early stage
disease (Ta, T1) or for detecting carcinoma in situ.
Markers for prediction of treatment response may prove
useful in selecting the most appropriate treatment. DNA
ploidy studies of exfoliated tumor cells have
demonstrated some utility in predicting tumor behavior.
The addition of other quantitative markers that can be
evaluated by flow cytometric or other techniques will
expand the range of diagnostic measurements and may add
to the accuracy and range of diagnostic information
available to the clinician.
A variety of immunological, biochemical, and genetic
markers are currently being evaluated by the "Marker
Network for Bladder Cancer." While these activities are
expected to continue, activities of the proposed network
need not be confined to markers currently under study.
Investigators are encouraged to propose interesting
markers and appropriate studies for their evaluation.
III. Research Goals and Scope
The objective of this RFA is to invite applications for
cooperative agreements to support a network of
laboratories to cooperatively evaluate promising
diagnostic and prognostic markers of urinary bladder
cancer. The existing network has already demonstrated
the feasibility of an inter-institutional network for
collaborative clinical studies of urinary bladder cancer
markers. Studies of new methods for cell
marker identification and analysis, including:
evaluation of additional genetic, biochemical, and
immunological markers of urinary bladder cancer;
evaluation of the most appropriate techniques for
quantitatively assaying these markers; and development of
tumor classification systems useful in patient
management, are needed. Awardees will share clinical material and
develop a plan to optimize research opportunities offered
by the strengths of the participating institutions and
the patient populations available to the network. The
cooperative approach will expand the available patient
resources, improve evaluation of potentially useful
markers and allow comparison of their utility in
different clinical and laboratory settings.
SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING
IMPLEMENTATION OF NIH POLICIES CONCERNING WOMEN AND
MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS
NIH and ADAMHA policy is that applicants for NIH/ADAMHA
clinical research grants and cooperative agreements will
be required to include minorities and women in study
populations so that research findings can be of benefit
to all persons at risk of the disease, disorder or
condition under study. Special emphasis should be placed
on the need for inclusion of minorities and women in
studies of diseases, disorders or conditions which
disproportionately affect them. This policy is intended
to apply to males and females of all ages. If women or
minorities are excluded or inadequately represented in
clinical research, particularly in proposed population-
based studies, a clear, compelling rationale should be
provided.
The composition of the proposed study population must be
described in terms of gender and racial/ethnic group,
together with a rationale for its choice. In addition,
gender and racial/ethnic issues should be addressed in
developing a research design and sample size appropriate
for the scientific objectives of the study. This
information should be included in the form PHS 398 in
Section 2 A-D of the Research Plan AND summarized in
Section 2E Human Subjects.
Applicants are urged to assess carefully the feasibility
of including the broadest possible representation of
minority groups. However, the NIH recognizes that it may
not be feasible or appropriate in all research projects
to include representation of the full array of the United
States racial/ethnic minority populations (i.e. Native
Americans (including American Indians, or Alaskan
Natives), Asian/Pacific Islanders, Blacks, Hispanics).
The rationale for studies on single minority population
groups should be provided.
For the purpose of this policy, clinical research
includes human biomedical and behavioral studies of
etiology, epidemiology, prevention (and prevention
strategies), diagnosis or treatment of diseases,
disorders or conditions, including but not limited to
clinical trials.
The usual NIH policies concerning human subjects also
apply. Basic research or clinical studies in which human
tissues cannot be identified or linked to individuals are
excluded. However, every effort should be made to
include human tissues from women and racial/ethnic
minorities when it is important to apply the results of
the study broadly and this should be addressed by
applicants.
For foreign awards, the policy on inclusion of women
applies fully; since the definition of minority differs
in other countries, the applicant must discuss the
relevance of research involving foreign populations to
the United States' populations, including minorities.
If the required information is not contained within the
application, the application will be returned.
Peer reviewers will address specifically whether the
research plan in the application conforms to these
policies. If the representation of women or minorities
in a study design is inadequate to answer the scientific
question(s) addressed AND the justification for the
selected study population is inadequate, it will be
considered a scientific weakness or deficiency in the
study design and will be reflected in assigning the
priority score to the application.
All applications for clinical research submitted to NIH
are required to address these policies. NIH funding
components will not award grants or cooperative
agreements that do not comply with these policies.
IV. Mechanism of Support
Support of this program will be through the cooperative
agreement, an assistance mechanism in which substantial
NIH programmatic involvement with the recipients during
performance of the planned activity is anticipated as
outlined in this RFA. Applicants will be responsible for
the planning, direction, and execution of the proposed
project. Except as otherwise stated in this
RFA, awards will be administered under PHS
grants policy as stated in the Public Health Service
Grants Policy Statement, DHHS Publication No. (OASH) 90-
50,000, revised October 1, 1990.
This RFA is a one-time solicitation. Generally, future
unsolicited competitive continuation applications will
compete as research project applications with all other
investigator-initiated applications and be reviewed by
the Division of Research Grants (DRG). However, should
the NCI determine that there is a sufficient continuing
program need, the NCI will invite recipients of awards
under this RFA to submit competitive continuation
cooperative agreement applications for review, according
to the procedures described in Section VII.
NCI anticipates making four to six awards for project
periods of up to four years and anticipates that a total
of $950,000 will be set aside for the initial year's
funding. Funding in response to this RFA is dependent on
the receipt of a sufficient number of applications of
high scientific merit. The earliest feasible start date
for the initial awards will be April 1, 1992. Although this
program is provided for in the financial plans of the
NCI, the award of cooperative agreements pursuant to this
RFA is contingent on the availability of funds
appropriated for fiscal year 1992.
The purpose of the proposed awards is to stimulate
cooperative efforts to identify and evaluate diagnostic
and prognostic markers of urinary bladder cancer. The
cooperative agreement funding mechanism was selected
because of substantial NCI programmatic involvement
required to coordinate activities among several
laboratories working toward a common goal.
V. Terms of Cooperation
The cooperative agreements will require cooperation
between an NCI representative and the Principal
Investigators of the individual projects in order to
assure smooth interactions among the cooperating
institutions. The NCI representative will assist in
coordinating the activities of the research groups and
in facilitating exchange of information. Awardees will
retain custody and primary rights to their data developed
under these awards, subject to government, e.g., NCI, NIH,
or PHS, rights of access consistent with current DHHS,
PHS, and NIH policies.
A. Responsibilities of the NCI Representative
The NCI representative will coordinate and facilitate the
programs supported by these cooperative agreements, will
attend and participate in all meetings as a member of the
Coordinating Committee, and will serve as a liaison between
the Coordinating Committee and participating research
groups. The NCI representative will assist the
Coordinating Committee in developing operating policies,
quality control procedures, and consistent policies for
dealing with recurring situations that require
coordinated action. To assure consistency and quality,
the NCI representative must concur in operating policies
and clinical protocols prior to their implementation.
The NCI representative may review the operations of
individual laboratories for compliance with protocols and
other operating policies developed by the Coordinating
Committee. The NCI representative may recommend
withholding of support, suspension, or termination of an
award for lack of progress or failure to adhere to
policies established by the Coordinating Committee.
B. Responsibilities of Awardees
Awardees are responsible for developing individual
research projects to facilitate the activities of the
network and to participate in the development of clinical
protocols for network studies. All studies conducted
under this RFA by members of the network must be approved
by the Coordinating Committee. Responsibility for
specific aspects of collaborative network studies, e.g.,
statistical design and analysis, will be determined by
the Committee at the time each study is planned. Two
members of each research group are required to attend
meetings of the Committee (as detailed below), to help
formulate the Committee's policies (which will be
submitted to the NCI representative for approval), and to
implement those policies. Awardees are required to have
access to appropriate tumor tissue and normal tissue.
They are required to submit progress reports at each
meeting of the Coordinating Committee.
C. Coordinating Committee
The NCI representative and the participating research
groups will be responsible for forming a Coordinating
Committee as defined below. Operating policies will be
developed by the Coordinating Committee and submitted to
the NCI representative for concurrence prior to
implementation. The NCI representative will facilitate
the review of operating policies and clinical research
protocols. Results of the review will be discussed with
the Coordinating Committee and an arbitration system, as
detailed below, will be available to resolve disagreements
between the NCI representative and the other members of
the Coordinating Committee.
The Coordinating Committee will review the plans proposed
in the applications by the individual research groups
to ensure that they are compatible with the overall goals
of the RFA. Members of the Coordinating Committee will
be responsible for redefining research objectives and
defining strategies for network studies to optimize
progress and efficient use of patient and tissue
resources. The Coordinating Committee will also be
responsible for coordinating activities such as plans for
statistical design and analyses, developing forms,
distributing reagents and biological samples, data
collection and data analysis, monitoring the progress of
the network, and maintaining quality assurance.
The Coordinating Committee will consist of the NCI
representative and two members from each cooperating
institution, one of whom is the Principal Investigator.
The NCI representative will be appointed by the Chief of
the Cancer Diagnosis Branch, Division of Cancer Biology,
Diagnosis and Centers. The Coordinating Committee will
be responsible for electing a Chairperson (who may not be
the NCI representative). The Chairperson of the
Coordinating Committee will be responsible for
coordinating the Committee activities, preparing
meeting agendas, and scheduling and chairing
meetings. The NCI representative will attend and
participate in all meetings of the Coordinating Committee
and should be informed of major inter-group interactions.
The Coordinating Committee will prepare an annual
progress report that will include individual reports
from each participating research group; each group is
responsible for timely preparation of its report.
The Coordinating Committee will meet initially to map
strategies and set up operating procedures. The
Coordinating Committee will meet at least twice a year
thereafter. Meetings may be held at any of the
participating institutions or at another convenient
location. These meetings are aimed at coordinating the
activities of the participating laboratories,
establishing new policies and priorities, and reviewing
progress. The NCI representative will participate in the
discussions at these meetings. Travel funds for
Coordinating Committee meetings are to be set aside as a
budget line item in each project budget.
D. Arbitration Procedure
An arbitration panel of external consultants will be
created as needed to resolve any irreconcilable
differences of opinion related to scientific/programmatic
matters between the NCI representative and the
Coordinating Committee with respect to implementation of
a proposed operating policy. The panel will include one
member selected by the Coordinating Committee, one member
selected by the NCI, and a third member chosen by the
other two members of the arbitration panel. The NCI
arbitration process for the cooperative agreement in no
way affects the rights of awardees to appeal selected
post award administrative decisions in accordance with PHS
regulations at 42 CFR part 50, subpart D and HHS
regulations at 45 CFR part 16.
VI. Eligibility Requirements
Applicant organizations must be located in the United
States, Canada, or Mexico. Non-profit and for-profit organizations and
institutions, and government agencies are eligible to
apply.
VII. Special Instructions for Preparation of Cooperative
Agreement Applications
The grant application form PHS 398 (revised 10/88,
reprinted 9/89) must be used for the cooperative
agreement application. The general instructions, e.g., for
format and budget issues, included in the application
packet must be followed.
Specific issues related to cooperative agreements must be
addressed as follows: It is critical that each applicant
include specific plans for responding to the Terms of
Cooperation discussed in Section V above. Plans must
describe how the applicant will comply with the
involvement of the NCI representative, as well as how all
the responsibilities of awardees will be fulfilled.
Individual proposals for both network studies and
individual studies must be included in order to provide
the Coordinating Committee with a basis for planning
network activites. For competing renewal applications,
a complete description of past collaborative efforts
must be included in the progress report.
VIII. Review Procedures and Criteria
A. Review Procedures
Upon receipt, applications will be initially reviewed
by the DRG for
completeness. Incomplete applications will be returned
to the applicant without further consideration.
Evaluation for responsiveness to the program requirements
and criteria stated in the RFA is an NCI program staff
function. Applications that are judged to be
non-responsive will be returned to the applicant, but may be
submitted as investigator-initiated research
grant applications at the next receipt date.
In cases where the number of applications is large
compared to the number of awards to be made, the NCI may
conduct a preliminary scientific peer review to eliminate
those that clearly are not competitive for award. The
NCI will remove from further competition those
applications judged to be noncompetitive and notify the
applicant Principal Investigator and institutional
official.
Those applications judged to be both competitive and
responsive will be further evaluated according to the
review criteria stated below for scientific and technical
merit by an appropriate peer review group convened by the
Division of Extramural Activities, NCI. The second level
of review by the National Cancer Advisory Board considers
the special needs of the Institute and the priorities of
the National Cancer Program.
B. Review Criteria
Factors considered to be important for review include:
demonstrated expertise in urology, pathology, and/or basic
cancer biology applied to the diagnosis and treatment of
urinary bladder cancer; expertise and an active research
program in cell marker studies; availability of an
appropriate population of patients for study; good
interaction among collaborating researchers;
demonstration of adequate facilities; and willingness to
interact within the terms of a cooperative agreement as
outlined in this document.
Reviewers will be asked to review the grant applications
by considering the following criteria:
1) Scientific merit, feasibility, and relevance of the
proposed project to the overall goals and objectives
of the RFA;
2) Demonstration of availability of, and access to,
appropriate patients (including representative numbers
of women and minorities or sufficient justification
for their exclusion), archival tissue, and appropriate
clinical data;
3) Proposed collaborations among urologists,
pathologists, basic cancer biologists, and other key
personnel;
4) Qualifications, experience, and proposed
responsibilities of the Principal Investigators and of
key support personnel;
5) Facilities and resources, and their availability for
this project;
6) Plans for effective interaction and coordination among
cooperating projects and with the NCI, including a
proposed timetable; and
7) Plans to protect the rights of human subjects.
The review group will recommend an appropriate budget and
period of support for each approved application.
IX. Method of Applying
The most recent revision of the research grant
application form PHS 398 (revised 10/88, reprinted 9/89)
must be used in applying for cooperative agreements.
These forms are available at most institutional business
offices and from:
Office of Grants Inquiries
Division of Research Grants
National Institutes of Health
Westwood Building, Room 449
5333 Westbard Avenue
Bethesda, MD 20892-4500
and from the NCI Program Director named below.
The RFA label available in the application form PHS 398
(revised 10/88, reprinted 9/89) must be affixed to the
bottom of the face page. Failure to use this label could
result in delayed processing of your application such
that it may not reach the review committee in time for
review. In addition, the RFA number and title must be
typed on line 2 of the face page of the application form.
Submit a signed, typewritten original of the application,
including the checklist, and four signed exact
photocopies, in one package to the Division of Research
Grants at the address below. Photocopies must be clear
and single sided.
Division of Research Grants
National Institutes of Health
Westwood Building, Room 240
Bethesda, MD 20892-4500**
At the time of submission send two additional copies of
the application to:
Referral Officer
Division of Extramural Activities, DEA, NCI
Room 838, Westwood Building
5333 Westbard Avenue
Bethesda, MD 20892-9912
Applications must be received by July 31, 1991. If an
application is received after this date, it will be
returned.
If the application submitted in response to this RFA is
substantially similar to a research grant application already
submitted to the NIH for review, but has not yet been reviewed,
the applicant will be asked to withdraw either the pending
application or the new one. Simultaneous submission of identical
applications will not be allowed, nor will essentially identical
applications be reviewed by different review committees.
Therefore, an application cannot be submitted in response to this
RFA that is essentially identical to one that has already been
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.
X. Letter of Intent
Prospective applicants are asked to submit by May 31,
1991, a letter of intent that includes a descriptive title
of the proposed project, the name and address of the
Principal Investigator, the names of other key personnel,
the participating institutions, and the number and title
of the RFA in response to which the application is being
submitted. Although a letter of intent is not required,
is not binding, and does not enter into the review of
subsequent applications, it is requested in order to
provide an indication of the number and scope of the
applications to be reviewed.
The letter of intent is to be sent to:
Roger L. Aamodt, Ph.D.
Program Director for Pathology and Cytology
Cancer Diagnosis Branch, DCBDC, NCI
Executive Plaza South, Room 638
6120 Executive Boulevard
Rockville, MD 20892-9904
Telephone: (301) 496-7147
FAX: (301) 496-8656
XI. Inquiries
Written and telephone inquiries concerning the objectives
and scope of this RFA, about the activities of the
currently funded marker network, or inquiries about
whether specific proposed research would be
responsive, are encouraged and should be directed to Dr.
Roger L. Aamodt at the above address. The program
director welcomes the opportunity to clarify any issues
or questions from potential applicants.
This program is described in the Catalog of Federal
Domestic Assistance No. 93.394, Cancer Detection and
Diagnosis Research. Awards are made under authorization of
the Public Health Service Act, Title IV, Part A (Public
Law 78-410 as amended: 42 USC 241) and administered under
PHS grant policies and Federal Regulations 42 CFR Part 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.
$$XID RFA CA9110 CA-91-10 P1O1 *****************************************
REQUEST FOR APPLICATIONS
RFA: CA-91-10
COOPERATIVE NETWORK FOR MOLECULAR GENETIC AND CYTOGENETIC
STUDIES OF PROSTATE CANCER
P.T. 34; K.W. 0715035, 1002058, 1002004, 0413001
National Cancer Institute
Letter of Intent Receipt Date: June 10, 1991
Application Receipt Date: September 6, 1991
Introduction
The Cancer Diagnosis Branch of the Division of Cancer Biology, Diagnosis
and Centers (DCBDC) at the National Cancer Institute (NCI) invites
applications for cooperative agreements from institutions capable of and
interested in participating in a cooperative network for studies of
molecular genetics and cytogenetics of prostate cancer. The goals of
this Request for Applications (RFA) are: 1) to promote collaborations
and interactions between basic scientists and clinicians in order to
advance prostate cancer research; 2) to identify genetic alterations
that may distinguish the behavior of clinically silent prostate cancer
from that of clinically evident cancer; 3) to determine whether there is
a molecular genetic basis for differences in prostate cancer incidence
between Blacks and Whites; 4) to explore the biological basis for the
striking increase in prostate cancer incidence with age. Groups
participating in the network will attempt to assess biological
differences in prostate cancer using molecular genetic and cytogenetic
approaches with the long-term goal of developing a more informative
classification system. Cooperative studies will facilitate the
application of molecular techniques to prostate cancer research through
the efficient use of prostate cancer and normal prostate tissue.
Awards will be made as cooperative agreements that
create an assistance relationship with substantial
involvement of NCI staff during the performance of the
project, as outlined in this
RFA. The cooperative agreement mechanism is used when
the NCI wishes to stimulate investigator interest and
proposes to advise or assist in an important and
opportune area of research. The NCI anticipates making
three to five awards for project periods of up to four
years. A total of $1,000,000 is expected to be set aside
for funding these activities in the initial year.
Although this project is provided for in the financial
plans of the NCI, the award of cooperative agreements
pursuant to this RFA is contingent on the availability of
funds appropriated in fiscal year 1992.
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 RFA, "Cooperative Network
for Molecular Genetic and Cytogenetic Studies of Prostate
Cancer", is related to the priority area of cancer.
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, D.C. 20402-9325 (telephone 202-783-3238).
A Background Information
Prostate cancer is the most common cancer diagnosed in
men and the second leading cause of cancer deaths in
American men. In 1990, there were an estimated 106,000
cases that represents more than 10 percent of the expected new
cases of cancer in the population (Silverberg, 1990).
Thirty thousand deaths from prostate cancer were expected
in 1990. The rate of prostate cancer is low before age
50, but rises sharply with age thereafter. The incidence
of prostate cancer has increased from 62.4 cases per
100,000 in White males in 1973 to 73.9 in 1977 and 99.2
in 1987 (Ries et al., 1990, p. II-16). The age-specific
incidence is 50 percent higher among Black males (ibid. p. I-
11).
Nearly a third of males 50 years or older who have died
of causes other than prostate cancer and have undergone
autopsies have been shown to have microscopic foci of
cancer within their prostates. Only about 1 percent of these
potential patients are diagnosed each year as having
prostate cancer. These foci of cancer, which seem to
progress slowly or not at all in the majority of men,
have been called "latent" or "histological" cancers. The
major dilemma is that these cancers cannot be readily
distinguished from those that will progress rapidly to
clinically evident tumors. A means to differentiate
those that will remain "latent" from those that will
progress to "clinically evident" is required in order to
treat patients most effectively.
It has been shown with other tumors that genetic
characteristics of the tumor can provide information
about its behavior. Elegant studies of colorectal
carcinoma have shown that specific gene deletions and
alterations accumulate as tumors progress, and that these
alterations may be useful in assessing prognosis
(Vogelstein et al., 1988; Fearon and Vogelstein, 1990).
Amplification of the N-MYC oncogene has been shown to be
associated with poor prognosis in children with
neuroblastoma (Seeger et al., 1985). Amplification and
over-expression of the HER-2/neu oncogene appear to be
associated with poor prognosis in breast cancer patients
(Slamon et al., 1987, 1989) and also in ovarian cancer
(Slamon et al., 1989). Molecular genetic studies of
prostate cancer have been limited. One recent study of
prostate tumors showed loss of heterozygosity on a number
of different chromosomal arms; the highest frequency of
loss of heterozygosity was on chromosome arms 10q and 16q
(Carter et al., 1990). In-depth studies of molecular
genetic alterations in prostate cancer are needed in
order to determine whether such changes are useful
in predicting the behavior of these tumors.
A recent review of cytogenetic studies carried out in
prostate cancer has shown that only a small percentage of
the tumors revealed clonal abnormalities (Brothman et
al., 1990). A correlation between the presence of
karyotypic abnormalities and the Gleason grade of the
tumor has been suggested. Additional cytogenetic studies
are needed since these types of studies often point to
important chromosomal regions for molecular exploration.
References
Brothman AR, Peehl DM, Patel AM, and 1 other. Frequency
and Pattern of Karyotypic Abnormalities in Human Prostate
Cancer. Cancer Res 50:3795-3803, 1990.
Carter BS, Ewing CM, Ward SW, and 5 others. Allelic Loss
of Chromosomes 16q and 10q in Human Prostate Cancer.
Proc Natl Acad Sci US 87:8751-8755, 1990.
Fearon ER and Vogelstein B. A Genetic Model for
Colorectal Tumorigenesis. Cell 61:759-767, 1990.
Ries LAG, Hankey BF, and Edwards BK (Eds.). Cancer
Statistics Review 1973-87. U.S. Dept Health Human
Services NIH Publication no. 90-2789, 1990.
Seeger RC, Brodeur GM, Sather H, and 4 others.
Association of Multiple Copies of the N-myc Oncogene with
Rapid Progression of Neuroblastomas. N Engl J Med
313:1111-1116, 1985.
Silverberg ES, Boring CC, Squires TS. Cancer Statistics
1990. CA 40:9-26, 1990.
Slamon DJ, Clark GM, Wong SG, and 3 others. Human Breast
Cancer: Correlation of Relapse and Survival with
Amplification of the HER-2/neu Oncogene. Science
235:177-181, 1987.
Slamon DJ, Godolphin W, Jones LA, and 8 others. Studies
of the HER-2/neu Proto-oncogene in Human Breast and
Ovarian Cancer. Science 244:707-712, 1989.
Vogelstein B, Fearon ER, Hamilton SR, and 7 others.
Genetic Alterations during Colorectal Tumor Development.
New Engl J Med 319:525-532, 1988.
B Research Goals and Scope
The objective of this RFA is to invite applications for
cooperative agreements to establish a network of
laboratories to study the molecular genetic
characteristics of prostate cancer and to relate the
results to clinical parameters of the tumors.
Collaborations among researchers with expertise in
molecular genetics or cytogenetics and urologists or
other clinical researchers engaged in studies of prostate
cancer are encouraged. A number of important questions
need to be addressed, including the following: Why are
some prostate cancers aggressive, progressing rapidly, and
metastasizing while others appear indolent? Are there
genetic alterations that can explain why incidence and
mortality rates vary so greatly among ethnic groups? Can
genetic markers be developed to predict tumor behavior or
response to treatment? Are there different genetic
alterations in tumors from younger versus older men?
Applicants are encouraged to address these and/or other
questions that will advance our understanding of the
behavior of prostate tumors. The cooperative approach
outlined in this RFA is designed to optimize use of
patient resources, tissues, and reagents. Comparisons of
various markers and methods of detection or measurement
in different laboratory settings will be possible.
SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING
IMPLEMENTATION OF NIH POLICIES CONCERNING WOMEN AND
MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS
NIH and ADAMHA policy is that applicants for NIH/ADAMHA
clinical research grants and cooperative agreements will
be required to include minorities and women in study
populations so that research findings can be of benefit
to all persons at risk of the disease, disorder or
condition under study. While inclusion of women is not
relevant to this RFA, special emphasis should be placed
on the need for inclusion of minorities in studies of
diseases, such as prostate cancer that
disproportionately affect them. This policy is intended
to apply to persons of all ages. If minorities are
excluded or inadequately represented in clinical
research, particularly in proposed population-based
studies, a clear, compelling rationale should be
provided.
The composition of the proposed study population must be
described in terms of racial/ethnic group, together with
a rationale for its choice. In addition, racial/ethnic
issues should be addressed in developing a research
design and sample size appropriate for the scientific
objectives of the study. This information should be
included in the form PHS 398 in Section 2, A-D of the
Research Plan AND summarized in Section 2, E, Human
Subjects.
Applicants are urged to assess carefully the feasibility
of including the broadest possible representation of
minority groups. However, the NIH recognizes that it may
not be feasible or appropriate in all research projects
to include representation of the full array of the United
States racial/ethnic minority populations (i.e. Native
Americans (including American Indians, or Alaskan
Natives), Asian/Pacific Islanders, Blacks, Hispanics).
The rationale for studies on single minority population
groups should be provided.
For the purpose of this policy, clinical research
includes human biomedical and behavioral studies of
etiology, epidemiology, prevention (and prevention
strategies), diagnosis or treatment of diseases,
disorders or conditions, including but not limited to
clinical trials.
The usual NIH policies concerning human subjects also
apply. Basic research or clinical studies in which human
tissues cannot be identified or linked to individuals are
excluded. However, every effort should be made to
include human tissues from racial/ethnic minorities when
it is important to apply the results of the study broadly
and this should be addressed by applicants.
For foreign awards, since the definition of minority
differs in other countries, the applicant must discuss
the relevance of research involving foreign populations
to the United States' populations, including minorities.
If the required information is not contained within the
application, the application will be returned.
Peer reviewers will address specifically whether the
research plan in the application conforms to these
policies. If the representation of minorities in a study
design is inadequate to answer the scientific question(s)
addressed AND the justification for the selected study
population is inadequate, it will be considered a
scientific weakness or deficiency in the study design and
will be reflected in assigning the priority score to the
application.
All applications for clinical research submitted to NIH
are required to address these policies. NIH funding
components will not award grants or cooperative
agreements that do not comply with these policies.
C Mechanism of Support - Cooperative Agreement
Support of this program will be through the Cooperative
Agreement, an assistance mechanism in which substantial
NCI programmatic involvement with the recipients is
anticipated during performance of the planned activity,
as outlined in this RFA. Applicants will be responsible
for the planning, direction, and execution of the proposed
project. Except as otherwise stated in the RFA, awards
will be administered under PHS grants policy as stated in
the Public Health Service Grants Policy Statement, DHHS
Publication No. (OASH)) 90-50,000, revised October 1,
1990.
This RFA is a one-time solicitation. Generally, future
unsolicited competing continuation applications will
compete as research project applications with all other
investigator-initiated applications and be reviewed by
the Division of Research Grants (DRG). However, should
the NCI determine that there is a sufficient continuing
program need, the NCI will invite recipients of awards
under this RFA to submit competing continuation
cooperative agreement applications for review according
to the procedures described in Section F.
NCI anticipates making three to five awards for project periods
of up to four years and anticipates that a total of
$1,000,000 will be set aside for the initial year's
funding. Funding in response to this RFA is dependent on
the receipt of a sufficient number of applications of
high scientific merit. The earliest feasible start date
for the initial awards will be July 1, 1991. Although this
program is provided for in the financial plans of the
NCI, the award of cooperative agreements pursuant to this
RFA is contingent on the availability of funds
appropriated for fiscal year 1992.
The purpose of the proposed awards is to stimulate
cooperative efforts to assess biological differences in
prostate cancer and to identify and evaluate genetic
markers for prognosis in prostate cancer. The
cooperative agreement funding mechanism was selected
because of substantial NCI programmatic involvement
required to coordinate activities among several
laboratories working toward a common goal.
D Terms of Cooperation
The cooperative agreements will require cooperation
between an NCI representative and the Principal
Investigators of the individual projects in order to
ensure smooth interactions among the cooperating
institutions. The NCI representative will assist in
coordinating the activities of the research groups, and
in facilitating exchange of information. Awardees will
retain custody and primary rights to their data developed
under these awards, subject to government, e.g., NCI, NIH
or PHS, rights of access, consistent with current DHHS,
PHS, and NIH policies.
1. Organization and Role of the Coordinating
Committee
The NCI representative and the participating research
groups will be responsible for forming a Coordinating
Committee as defined below. Operating policies will be
developed by the Coordinating Committee and submitted to
the NCI representative for concurrence prior to
implementation. The NCI representative will facilitate
the review of operating policies and clinical research
protocols. Results of the review will be discussed with
the Coordinating Committee and an arbitration system, as
detailed below, will be available to resolve
disagreements between the NCI representative and the
other members of the Coordinating Committee.
The Coordinating Committee will review plans for network
studies and the operating procedures proposed by the
individual research groups to ensure that they are
compatible with the overall goals of the RFA. Members of
the Coordinating Committee will be responsible for
redefining research objectives and defining strategies
for Network studies to optimize progress and efficient
use of patient and tissue resources. The Coordinating
Committee will also be responsible for coordinating
activities such as plans for statistical design and
analyses, developing forms, distributing reagents and
biological samples, data collection and data analysis,
monitoring the progress of the network, and maintaining
quality assurance.
The Coordinating Committee will consist of the NCI
representative and two members from each cooperating
institution, a basic scientist and a
clinician (one of the two will be the Principal
Investigator). The NCI representative will be appointed
by the Chief of the Cancer Diagnosis Branch, DCBDC, NCI.
The Coordinating Committee will be responsible for
electing a chairperson (who may not be the NCI
representative). This can be a rotating position. The
Chairperson of the Coordinating Committee will be
responsible for coordinating the Committee activities,
for preparing meeting agendas, and for scheduling and
chairing meetings. The NCI representative will attend
and participate in all meetings of the Coordinating
Committee and must be informed of major inter-group
interactions. The Coordinating Committee will prepare an
annual progress report that will include individual
reports from each participating research group; each
group is responsible for timely preparation of its
report.
The Coordinating Committee will meet initially to plan
basic operating procedures and integration of the
participating programs, and will meet at least twice a
year thereafter. Meetings may be held at any of the
participating institutions or at another convenient
location. These meetings are aimed at planning research
activities, coordinating the tissue utilization,
establishing priorities, and reviewing progress. The NCI
representative will participate in the discussions at
these meetings. Travel funds for Coordinating
Committee meetings are to be set aside as a budget line
item in each project budget.
2. Role of NCI Representative
The NCI representative will coordinate and facilitate the
programs supported by these cooperative agreements, will
attend and participate in all meetings of the
Coordinating Committee, and will provide liaison between
the Coordinating Committee and participating research
groups. The NCI representative will assist the
Coordinating Committee in developing operating policies,
quality control procedures, and consistent policies for
dealing with recurring situations that require
coordinated action. To ensure consistency and quality,
NCI must concur in operating policies and proposed
Network studies prior to their implementation. The NCI
representative may review the operations of individual
laboratories for compliance with protocols, quality
control standards, and other operating policies developed
by the Coordinating Committee. The
NCI representative may recommend withholding of support,
suspension, or termination of an award for lack of
progress or failure to adhere to policies established by
the Coordinating Committee.
3. Responsibilities of Awardees
Awardees are responsible for proposing research projects
to advance the goals of the network and for participating
in the development and conduct of Network studies. All
studies approved by the Coordinating Committee will be
conducted by members of the network, and responsibilities
for specific aspects (e.g., statistical design and
analysis) will be determined by the committee for each
study at the time it is developed. Two members of each
research group are required to attend meetings of the
Committee (as detailed in Section D. 1.), to help
formulate the Committee's policies (which will be
submitted to the NCI representative for approval), to
implement those policies, and to participate in analysis
of the data submitted by the various research groups.
Awardees are required to have access to appropriate tumor
tissue and normal tissue and to have the appropriate
clinical and molecular biology and/or cytogenetic
expertise. They are required to submit progress reports
at each meeting of the Coordinating Committee. Awardees
are required to publish worthwhile research results in
appropriate peer-reviewed journals in a timely fashion.
4. Arbitration Procedures
An arbitration panel of external consultants will be
created as needed to resolve any irreconcilable
differences of opinion related to scientific/programmatic
matters between the NCI representative and the other
members of the Coordinating Committee with respect to
implementation of a proposed operating policy. The panel
will include one member selected by the Coordinating
Committee, one member selected by the NCI, and a third
member chosen by the other two members of the arbitration
panel. The NCI arbitration process for the cooperative
agreement in no way affects the rights of awardees to
appeal selected post award administrative decisions in
accordance with PHS regulations at 42 CFR part 50,
subpart D and HHS regulations at 45 CFR part 16.
E Eligibility Requirements
Applicant organizations must be located in the United States, Canada, or
Mexico. Non-profit and for-profit organizations and institutions, and
government agencies are eligible to apply.
F Special Instructions for Preparation of Cooperative
Agreement Applications
The grant application form PHS 398 (revised 10/88,
reprinted 9/89) must be used for the cooperative
agreement application. The general instructions, e.g., for
format and budget issues, included in the application
packet must be followed.
Specific issues related to cooperative agreements must be
addressed as follows:
It is critical that each applicant include specific plans for
responding to the Terms of Cooperation discussed in Section D
above. Applicants must describe how they will comply with the
involvement of the NCI representative and how they will fulfill
their responsibilities in the cooperative agreement. Individual
proposals for both Network studies and individual studies must be
included in order to provide the Coordinating Committee with a
basis for planning network activities.
G Review Procedures and Criteria
1 Review Procedures
Upon receipt, applications will be reviewed initially by
the DRG for completeness.
Incomplete applications will be returned to the applicant
without further consideration. Evaluation for
responsiveness to the program requirements and criteria
stated in the RFA is an NCI program staff function.
Applications judged to be nonresponsive to this RFA will
be returned, but may be submitted as
investigator-initiated research grant applications at the
next grant application receipt date.
In cases where the number of applications is large
compared to the number of awards to be made, the NCI may
conduct a preliminary scientific peer review to eliminate
those that are clearly not competitive for award. The
NCI will remove from further competition those
applications judged to be noncompetitive and will notify
the applicant Principal Investigator and institutional
official. Those applications judged to be both
responsive and competitive will be further evaluated
according to the review criteria stated below for
scientific and technical merit by an appropriate peer
review group convened by the Division of Extramural
Activities, NCI.
The second level of review by the National Cancer
Advisory Board considers the special needs of the
Institute and the priorities of the National Cancer
Program.
2 Review Criteria
Factors considered to be important for review include a
demonstrated expertise in the biology or diagnosis of
prostate cancer; expertise in cytogenetics or molecular
genetics; an active research program relating
applications of molecular genetics or cytogenetics to
human cancer; interactions between basic scientists and
clinicians; availability of prostate cancer patients for
study; demonstration of adequate facilities; and
willingness to interact within the terms of a cooperative
agreement as outlined in this document.
Reviewers will be asked to review the applications by
considering the following criteria:
o Scientific merit and feasibility of the
proposed project.
o Proposed collaborations between basic scientists (e.g.,
molecular geneticists and/or cytogeneticists) and
clinicians (e.g., urologists and pathologists).
o Qualifications, experience, and proposed
responsibilities of the Principal Investigator and key
support personnel.
o Demonstration of availability of and access to
appropriate patients and to archival or fresh/frozen
human prostate tumor tissue with associated
pathological data. The patient population must include
appropriate numbers of Blacks and other minorities or
provide sufficient justification of their exclusion.
o The proposed techniques and methodologies to be used to
achieve the stated goals; demonstrated expertise in
both the appropriate basic and clinical sciences.
o Scientific plans and timetable for implementing the
proposed research program.
o Facilities and resources, and their availability for
this project.
o Plans for effective interaction and coordination among
cooperating projects and with the NCI.
o Plans to protect the rights of human subjects.
The review group will critically examine the submitted
budget and will recommend an appropriate budget and
period of support for each application.
H Application
Complete applications are due no later than September 6,
1991, and must address all requirements in the RFA.
Applications received after this date will be returned.
If the application submitted in response to this RFA is
substantially similar to a research grant application already
submitted to the NIH for review, but has not yet been reviewed,
the applicant will be asked to withdraw either the pending
application or the new one. Simultaneous submission of identical
applications will not be allowed, nor will essentially identical
applications be reviewed by different review committees.
Therefore, an application cannot be submitted in response to this
RFA that is essentially identical to one that has already been
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.
The research grant application form PHS 398
(revised 10/88, reprinted 9/89) must be used in applying
for these grants. These forms are available at most
institutional business offices and from:
Office of Grants Inquiries
Division of Research Grants
National Institutes of Health
Westwood Building, Room 449
5333 Westbard Avenue
Bethesda, MD 20892-4500
and from the NCI Program Director named below.
The RFA label available in the application form PHS 398
(revised 10/88, reprinted 9/89) must be affixed to the
bottom of the face page. 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 number and title must be
typed on line 2 of the face page of the application form.
Submit a signed typewritten original of the
application, including the checklist, and four signed
exact photocopies, in one package to:
Division of Research Grants
National Institutes of Health
Westwood Building, Room 240
Bethesda, MD 20892-4500**
The photocopies must be clear and single sided.
In addition, two copies must be sent to:
Referral Officer
Division of Extramural Activities, NCI
Westwood Building, Room 848
5333 Westbard Avenue
Bethesda, MD 20892-9912
I Letter of intent
Prospective applicants are asked to submit by June 10,
1991, a letter of intent that includes a descriptive title
of the proposed project, the name and address of the
Principal Investigator, the names of other key personnel,
any collaborating institutions, and the number and title
of the RFA in response to which the application is being
submitted. Although a letter of intent is not required,
is not binding and does not enter into the review of
subsequent applications, it is requested in order to
provide an indication of the number and scope of the
applications to be reviewed.
The letter of intent is to be sent to:
Roger L. Aamodt, Ph.D.
Program Director for Pathology/Cytology
Cancer Diagnosis Branch, DCBDC, NCI
Executive Plaza South, Room 638
6120 Executive Boulevard
Rockville, MD 20892-9904
Telephone: (301) 496-7147
FAX: (301) 496-8656
J Inquiries
Written and telephone inquiries concerning the objectives
and scope of the RFA, or inquiries about whether or not
specific proposed research would be responsive, are
encouraged and should be directed to Dr. Roger L. Aamodt
at the above address. The program director welcomes the
opportunity to clarify any issues or questions from
potential applicants.
For fiscal and administrative matters, contact:
Robert E. Hawkins
Grants Management Specialist
Grants Administration Branch
National Cancer Institute
EPS, Room 216
Bethesda, MD 20892
Telephone: (301) 496-7800 ext. 13
This program is described in the Catalog of Federal
Domestic Assistance No. 93.394, Cancer Detection and
Diagnosis Research. Awards are made under authorization of
the Public Health Service Act, Title IV, Part A (Public
Law 78-410 as amended: 42 USC 241) and administered under
PHS grant policies and Federal Regulations 42 CFR Part 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.