Full Text CA-97-019
 
CANCER GENETICS NETWORK - INFORMATICS AND INFORMATION TECHNOLOGY
GROUP
 
NIH GUIDE, Volume 26, Number 24, July 25, 1997
 
RFA: CA-97-019
 
P.T.


Keywords: 

 
National Cancer Institute
 
Letter of Intent Receipt Date: August 21, 1997
Application Receipt Date:  October 7, 1997
 
PURPOSE
 
The Extramural Epidemiology and Genetics Program (EEGP), Division of
Cancer Epidemiology and Genetics (DCEG), National Cancer Institute
(NCI) and the US Public Health Service (PHS) Office on Women's
Health(OWH) invite applications for cooperative agreements (U01s) to
form an Informatics and Information Technology Group to provide
informatics support for the NCI's Cancer Genetics Network.  The
Cancer Genetics Network, supported under a separate RFA (RFA
CA-97-004), is a multicenter interdisciplinary cooperative that will
provide the infrastructure for research investigations of the genetic
basis of human cancer susceptibility, explore mechanisms for
integrating this information into medical practice, and identify
means to address the public health issues associated with human
cancer genetics.
 
Funding through the present RFA (RFA CA-97-019) will be used to
support the formation of a group responsible for the development of
the informatics infrastructure necessary to perform these
investigations.The group will be responsible for the design,
implementation, and maintenance of an information management system
that supports multicenter Network-wide research protocols. The group
will also be responsible for developing information systems that
facilitate the exchange of human cancer genetics information and
resources within the larger cancer genetics community.  This includes
electronic mechanisms to broaden public and health- professional
access to genetic services and educational material, the
establishment of a clearinghouse of  human cancer genetics resources
and development of means to extend access to and connections between
researchers, service providers, and the general public.
 
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), the Cancer Genetics Network - Informatics,
Education and Management Group, 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 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
 
Applications may be submitted by domestic and foreign non-profit and
for-profit organizations, public and private, such as universities,
colleges, hospitals, businesses, laboratories, units of State and
local governments, and eligible agencies of the Federal Government.
Applications may represent a single organization or a consortium of
several institutions or organizations.
 
MECHANISM OF SUPPORT
 
Support for this program will be through the cooperative agreement
(U01).  Awardees supported through this RFA will form a consortium
providing technical expertise for the development and support
functions critical to the Cancer Genetics Network.  This consortium
will be known as the Informatics and Information Technology Group
(ITG).
 
Substantial NCI involvement with the recipients is anticipated during
ITG development, implementation, and operation. Under the cooperative
agreement, NCI will support and/or stimulate the recipient's activity
by involvement in the Network, working jointly with the Network
participating centers and with the ITG in a partnership role.
Participating organizations will be responsible for planning and
executing  the proposed consortium.  Details of the responsibilities,
relationship and  governance of the project to be funded under
cooperative agreements 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 should not exceed five years. The anticipated award
date is March, 1998.  Although this program is provided for in the
financial plans of the NCI, awards pursuant to this RFA are
contingent upon the availability of funds for this purpose. This RFA
is a one-time solicitation. At this time the NCI has not determined
whether or how this solicitation will be continued beyond the present
RFA.
 
FUNDS AVAILABLE
 
Approximately $1.0 million in total costs per year for five years
will be committed to fund applications that are submitted in response
to this RFA. This funding level is dependent on the receipt of a
sufficient number of applications of high merit.  It is anticipated
that three to six awards will be made in response to this initiative,
with at least one  award for each objective of the ITG.
 
RESEARCH OBJECTIVES
 
Background
 
The NCI has undertaken an aggressive program to capitalize on
advances in the area of human genetics in order to assist in
preventing, detecting, diagnosing and treating cancer. This
initiative has three major goals:
 
1.  Identification of  the genes that predispose to cancer;
 
2.  Integration of genetic susceptibility information into medical
practice;  and
 
3.  Addressing cancer genetics public health issues.
 
The NCI is establishing a National Cancer Genetics Network with the
goal  of enabling investigations in these areas. The principal
objective of the  Cancer Genetics Network is the establishment of a
multicenter cooperative  with the capacity to conduct
interdisciplinary studies cross-cutting all  aspects of cancer
genetics research. This consortium will represent a  unique synthesis
of expertise and will facilitate access to resources that  are beyond
the scope of a single institution. These resources include,  but are
not limited to:
 
o  Research study populations such as families, groups of cases  and
controls, and/or cohorts with sizes ranging from hundreds to
thousands  of individuals
 
o  Epidemiological survey data from these study populations
 
o  Clinical data from these study populations, including in some
instances genetic testing results
 
o  Human biological specimens
 
o  Genetic detection reagents (probes, primer pairs, DNA sequence)
 
o  Educational material related to genetic counseling and genetic
testing
 
These resources will be interconnected through the diverse
multidisciplinary expertise present within the Network. For example,
clinicians who identify families and describe new syndromes that
predispose to cancer can share these resources with researchers who
can map the genes.  Basic researchers' discoveries about how a tumor
develops can be passed on to those who treat and counsel cancer-prone
families.  The latest developments in genetic mapping can be
converted into useful clinical genetic tests.
 
A key component of the Network will be a registry of individuals
seeking  and/or receiving genetic testing and related resources.
Individuals who  consent to participate will be asked to provide a
core collection of  information, agreed upon through consensus of the
Network consortium. Core information will likely include demographic,
family history, dietary history, risk factor data, and information on
cancer occurrence and preventative practices. Individual participants
will be followed annually to provide updates and will be asked to
release genetic information tothe Network if such information is
available.
 
To accomplish the mission of the Cancer Genetics Network,
geographically separated Participating Centers (which represent the
nodes of the Network) will need to collect, manage, and analyze large
volumes of diverse data.  These resources will need to be coordinated
and shared with other consortium members as well as the larger cancer
genetics community. Moreover, these Centers will serve as the focal
point for the regional and national distribution of cancer genetics
information.  This information includes, but is not limited to where
and how to access cancer-related clinical genetic services such as
genetic counseling and testing.
 
Central to the success of the Network will be the establishment of an
informatics infrastructure utilizing state-of-the-art information
technology. Individual participating organizations will need to be
electronically linked into a single, virtual Center.  Information and
resources compiled by the Network will need to be electronically
accessible within the Network and by the broader cancer genetics
research community.  All this, though, must be accomplished in a
manner that ensures appropriate confidentiality of  study
participants and their clinical information.
 
Goals and Scope
 
It is the purpose of this RFA to assemble a consortium which will
design,  implement, and maintain the informatics infrastructure for
the Cancer Genetics Network.  This infrastructure must represent a
cost-effective solution to the problem and must be able to be
implemented in a manner which is as unobtrusive as possible to the
Participating Centers.  For it to achieve its desired mission, it
must be enabling, permitting the Network Centers and larger cancer
genetics community to address issues and research questions that
would not be possible in its absence.  Therefore, the design and
implementation of the infrastructure will be tightly interwoven with
the scientific agenda of the Cancer Genetics Network consortium.
 
The infrastructure that is developed should fully exploit the
opportunities that widespread Internet access provide. However, for
mission-critical aspects such as patient information, an intranet
and/or proprietary  networks may need to be considered. It can be
presumed that each  Participating Center node will have high-speed
access to the Internet (T1 or greater) and local data management
capacity.  These sites, and the  larger cancer genetics community,
though, are composed of heterogeneous computing environments and
differ dramatically in their local informatics capabilities.   The
informatics infrastructure developed for the Network  must address
(and accommodate, where practical) this physical heterogeneity.
 
The Cancer Genetics Network cooperative will present a diverse
collection  of needs that must be supported through the informatics
infrastructure.  The infrastructure developed by the ITG consortium
will address the  three key objectives listed below. Activities for
each objective should  include, but are not limited to, those
described following each objective.  A single application should be
prepared for the work for each objective.
 
Key Objectives:
 
    Informatics Support for a Registry of Individual Network
Participants.  The goal of this registry will be to establish a
resource that facilitates the enrollment of individuals identified
through Cancer Genetics Network Participating Centers and the larger
cancer genetics community, who are interested in participating in
studies of the genetics of cancer and other related investigations.
Of highest priority in the construction of this data repository is
the protection of confidentiality of the individuals who consent to
participate.
 
    Electronic Access to Cancer Genetic Services, Educational
Materials, Clinical and Research Protocols, and Research Resources.
The ITG will strive to enable electronic access to resources and
information not already in such a form. It should permit individuals
to identify providers of different cancer genetics services and
facilitate convenient access to thoseindividuals and/or institutions.
It should provide electronic access to high quality information on
cancer genetics that can be either used on-line or downloaded for
hardcopy distribution. These educational materials will likely be
diverse, multimedia, and customizable both to site and individual.
It should provide detailed and comprehensive information on clinical
and research protocols, to facilitate involvement by the general
cancer genetics community and to permit coordination of efforts and
resources among individuals and institutions actively involved in
cancer genetics research. It should facilitate electronic access to
and connections between cancer genetics research resources, reagents,
and service providers.
    Coordination and Implementation of Network Research Protocols.
For research protocols conducted within the Network infrastructure,
the ITG will support protocol implementation and coordinate
activities such as training of study personnel; recruitment of
subjects; collection of epidemiologic information; collection,
processing, distribution and storage of tissue samples; and
assistance with data analysis.  The ITG will coordinate and supervise
central Network functions (e.g., centralized data collection, quality
assurance for entral data base, statistical analyses of pooled data,
biospecimen storage and tracking)  and will provide operational
support for other Network activities (e.g.,communications, committee
meetings). The ITG should also provide expertise in study design and
statistical analysis for projects undertakenby Network investigators.
 
It is recognized that needs identified today will be rapidly
augmented and replaced by new demands.  Therefore, the infrastructure
developed needs to be flexible enough to quickly respond to new
challenges as they arise. It should also be scalable in order to
accommodate anticipated increases in demand.  Finally, it is clear
that current information management and analytic tools in use within
the human genetics community are insufficient to address problems of
the size and complexity presented by the Cancer Genetics Network.  It
will therefore be critical to the success of the Network that the
consortium actively extend the available informatics tools. These
efforts should both import technology from other disciplines as well
as develop new solutions to problems unique to the field of cancer
genetics.
 
SPECIAL REQUIREMENTS
 
The information management and analysis goals of the Cancer Genetics
Network are diverse.  Nevertheless, each of the objectives are
critically important to the overall success of the Network. To
address this diversity yet to guarantee excellence in all components,
the ITG will be assembled from applications addressing individual
objectives drawn from multiple institutions and/or organizations.
This will permit individual groups to contribute in areas in which
they may have specific expertise without having to address components
beyond their scope of experience or research interest.
 
Because the ITG objectives have both general and specific
requirements, each application should address a single objective (as
described Goals and Scope) and, to facilitate review, should
identify which of the three objectives is addressed by the
application on line 1 of the application face page.  In addition the
application "Description" should clearly do the same.  A single
institution, organization, or group of organizations may submit
separate applications addressing each of the objectives for the ITG.
 
Applicants must describe in detail the development, implementation,
and maintenance plans for the individual component of the Network
addressed within their application.  These plans should include
description of the design, personnel requirements, infrastructure
(hardware, software, other), and costs.  Applications that argue
economy of scale through component-wise cost savings or other
efficiencies should explicitly delineate these economies.
 
A critical component of the Cancer Genetics Network will be the
establishment of an expansive registry of individuals inquiring about
genetic testing. Given the sensitive nature of this information, the
infrastructure established to support this registry must assure
confidentiality.  It is critical for applications addressing this
objective that security of this clinical information be guaranteed.
Applications addressing this objective must present, in detail, plans
for assuring security of the registry and confidentiality of the
participating individuals.
 
Much of the infrastructure required to support the Cancer Genetics
Network can be derived from presently available information
technology.  Applicants are encouraged to detail in their application
the cost-efficient use of existing technology.  It is recognized,
though, that many standard tools in information technology have never
been exploited in the area of cancer genetics. Applications are
encouraged that facilitate the integration of the individual
Participating Center nodes into a single, virtual Center.  Applicants
are encouraged to include technology solutions that are novel to the
area of cancer genetics and that deal with large collections of
diverse types of data. Applications may include funding for the
prototyping of such novel informatics solutions.
 
The human genetics community has a large armamentarium of statistical
tools for the analysis of human data.  However, few of these tools
are designed to address the cancer genetics problem directly.  For
example, it is not routinely possible to statistically integrate
somatic and germline genetic information from the same individual in
an analysis.  Moreover, the large and diverse data that will be
collected by the Network may overwhelm current analytic algorithms.
Therefore, applications that propose the development of  new analytic
software are encouraged. This software should have the capacity to
accommodate human genome-wide analysis and should be able to extract
novel information from large collections of data of diverse data
types.  Applicants should indicate in their application the need this
software addresses, how it will differ from existing analytic
approaches, as well as the strategy and timetable for its
development.
 
Informatics Infrastructure Requirements
 
The formal informatics infrastructure requirements for the Cancer
Genetics Network will be established by the Participating Centers
working in combination with members of the ITG. As a starting point,
applicants may make projections for required infrastructure based on
the assumptions detailed below. Additional needs identified in the
formal definition of requirements beyond the capacity of the ITG's
collective applications will be eligible for supplemental support
from resources outside this RFA.
 
Current plans for the Network call for the establishment of up to
eight Participating Centers. These Centers will act as hubs for
dozens of regional hospitals, universities, and research
institutions.  It is projected that the Network information system
will need to manage/maintain information on 10,000's of individuals
distributed among 1000's of families.  Biosamples obtained from
individuals participating in future Network research projects will
need to be cataloged and tracked. For these individuals, 100's to
1000's of genetic characterizations (results of clinical genetic
tests and marker genotypes) may need to be stored and manipulated.
For these same individuals detailed clinical data and comprehensive
survey (epidemiologic and psychometric) data will need to be
collected and maintained.  It is anticipated that 1000's of
individuals will be followed over multiple time points resulting in
the redundant sampling of much of the above.
 
To coordinate research among the Network's Participating Centers and
to communicate opportunities to the larger cancer genetics community,
the ITG will have to manage and distribute 100's of research and
clinical protocols. To achieve its outreach mission the ITG will need
to maintain an electronic information resource on 100's of diverse
services.  Finally, to enable new research investigations within the
Network and in the broader cancer genetics community, 10,000's of
reagents (e.g., probes, primer pairs, cell lines, survey instruments,
educational materials) will need to be cataloged, tracked, and
distributed.
 
Study Organization and Function
 
The Informatics and ITG will be a consortium of organizations
assembled from the applications submitted in response to the RFA.
Each individual organization will be headed by a single Principal
Investigator who will provide scientific and administrative
leadership for the proposed activity.
 
A Steering Committee for the ITG (ITG-SC) will serve as the main
governing board of the ITG (see "Terms and Conditions of Award"). It
will be responsible for the design, implementation and maintenance of
the Network's informatics infrastructure.   Its membership includes
the PIs of the participating groups and the NCI Program Coordinator.
Additional members may be appointed by mutual agreement of the
ITG-SC.
 
To ensure that the infrastructure is designed to address the needs of
the Network and that Network does not propose projects which are
beyond the capacity of the infrastructure, members of the ITG-SC will
also be voting participants in the Steering Committee (SC) of the
Cancer Genetics Network. The Cancer Genetics Network SC is
responsible for the design and execution of Network research
projects(see RFA CA-97-004).
 
An Advisory Committee (AC) overseeing the entire Cancer Genetics
Network will be composed of senior scientists with multidisciplinary
expertise in cancer genetics research and will be responsible for
reviewing, evaluating and prioritizing all research applications
involving use of Network resources and developmental funds (see RFA
CA-97-004). The ITG may nominate members for the AC (two nominees per
awarded group); members will be appointed by the NCI for a two-year
tenure.
 
NIH intramural laboratories may also participate in the ITG
consortium, but may not receive salary, equipment, supplies, or other
remuneration from this program. The intramural principal investigator
must obtain appropriate NIH clearances. The principal investigator
must incorporate into the application, in the usual format, a full
description of the collaborative project, including technical details
and methodology.  The participation of an intramural scientist is
independent of and unrelated to the role of the NCI Program
Coordinator as described under "Terms and Conditions of Award."
 
Terms and Conditions of Award
 
The Terms and Conditions of Award, below, will be included in all
awards issued as a result of this RFA. It is critical that each
applicant include specific plans for responding to these terms.
These special Terms of Award are in addition to and not in lieu of
otherwise applicable OMB administrative guidelines, HHS grant
administration regulations in 45 CFR Part 74 and 92, and other HHS,
PHS and NIH grant administration policy statements.
 
The administrative and funding instrument used for this program is a
cooperative agreement (U01).  This is an assistance mechanism for
support  of a research resource 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. Consistent with this concept, the
prime responsibility for the activity resides with the awardee(s) for
the project as a whole.
 
1. Awardee Rights and Responsibilities
 
Awardees will have primary rights and responsibilities for designing,
implementing and maintaining the informatics infrastructure necessary
to achieve the goals of the Cancer Genetics Network.
 
a.   Awardees must produce production class informatics tools and
infrastructure.  This infrastructure must be accompanied by
appropriate design, maintenance, and user documentation.
 
b.   The PI will participate as a permanent member of the ITG SC and
the Cancer Genetics Network SC to develop Network protocols and
procedures.  The awardee will be required to implement and comply
with  the common policies and procedures approved by each SC.
 
c.   Awardees must follow protocols and strategies agreed upon by the
ITG SC and the Cancer Genetics Network SC.  It is the responsibility
of
each awardee/site to ensure that implementation is performed in a
timely fashion.
 
d.   The Awardee must agree to provide access to resources developed
by the Awardee or Group to Network-affiliated and non-affiliated
investigators, based on review and prioritization of the research
proposals by the AC and approval by the Cancer Genetics Network SC.
 
e.   The Awardee must provide a semi-annual progress report to the
NCI Program Coordinator.  The NCI will have access to and may
periodically review all data generated under an award. The awardee(s)
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.
 
f.   The Awardee will cooperate in the scientific reporting of
Network findings.  However, publication or oral presentation of
results obtained under this Cooperative Agreement will require
appropriate acknowledgment of NCI support.
 
2. NCI Staff Responsibilities
 
An intramural laboratory will participate in a manner analogous to
the awardees and will be subject to the same requirements.
 
The role of the NCI Program Coordinator is to assist and facilitate,
but not to direct, the activities supported by the Network.
 
The NCI Program Coordinator will:
 
a.   Serve as liaison from the NCI, helping to coordinate activities
among the awardees;
 
b. Serve as scientific liaison between the awardees and other program
staff at NCI with experience in multicenter studies, cancer genetics,
and social and behavioral research;
 
c.   Serve as a full participant and voting member of the ITG SC;
serve as a liaison between the ITG SC and the AC, attending AC
meetings in a non-voting liaison member role;
 
d.   Assist in promoting the availability of Cancer Genetics Network
and ITG resources to the scientific community.
 
The NCI reserves the right to reduce the budget, to withhold support,
and to suspend, terminate or curtail a study or an award in the event
of substantial shortfall in informatics development or
implementation, inadequate operations management, refusal to carry
out the recommendations of the ITG-SC and the Network SC or AC, or
substantial failure to comply with the terms of the award.  Periodic
external progress reviews of the program will be carried out as NCI
deems appropriate.
 
3. Collaborative Responsibilities
 
a.   Informatics and Information Technology Group Steering Committee
(ITG SC) - The ITG SC will serve as the main governing board of the
ITG. It will be responsible for development, implementation and
maintenance of Cancer Genetics Network informatics infrastructure.
Its membership will include the Principal Investigators of the ITG
awards, the NCI Program Coordinator, and additional members appointed
by mutual agreement of the ITG-SC membership.
 
Members of the ITG-SC will serve as voting members of the Cancer
Genetics Network SC.  They will assist this Committee in developing
uniform procedures for (a) data collection,  management, and quality
control; (b) access to Network resources for research purposes; and
(c ) dissemination of educational materials and scientific
information.
 
The ITG SC will elect a Chairperson (other than the NCI Program
Coordinator).  The Chairperson will be responsible for coordinating
the Committee's activities, for preparing meeting agendas, and for
scheduling and chairing subsequent meetings. The NCI Program
Coordinator will attend and participate in all meetings. Subsequent
meetings will be planned and scheduled at this first meeting.  At
least two additional meetings will be held during the first year of
operation, and two meetings a year thereafter, one of which will be
with the AC.  Subcommittees will be established by the ITG-SC as it
deems appropriate.
 
b.   Advisory Committee (AC) - The Cancer Genetics Network AC will be
composed of senior scientists with multidisciplinary expertise in
cancer genetics research.  AC members may be nominated by members of
the Cancer Genetics Network SC and the ITG SC (two nominees per
award) and will be appointed by the NCI for a two-year tenure. At
least  75% of AC members will be non-government.
 
The AC will be responsible for reviewing, evaluating, and
prioritizing all research projects proposing use of Network resources
or developmental funds.  The AC will evaluate all research proposals
(those from Network investigators as well as from the research
community) which require Network resources.  All reviews will be held
according to rules pertaining to the conduct of reviews for NIH
grants, contracts, and cooperative agreements and to review
procedures established by the Cancer Genetics Network SC, with
special attention to issues of conflict of interest (whether real or
apparent). The AC will provide a recommendation to the Network SC as
to the priority of the proposed research projects.  The AC will also
provide dvice to the Network SC on scientific matters, as appropriate
and as needed.
 
The AC will meet jointly with the Cancer Genetics Network SC at least
once yearly.  Support for AC meetings and other AC functions will be
provided through a mechanism outside this RFA.
 
4. Arbitration Procedures
 
Any disagreement that may arise on scientific/programmatic matters
(within the scope of the award) between award recipients and the NCI
may be brought to arbitration. An arbitration panel will be composed
of three members -- one selected by the awardee, a second member
selected by NCI, and the third member selected by the two previously
selected members. These special arbitration procedures in no way
affect the awardee's right to appeal an adverse action that is
otherwise appealable in accordance with PHS regulations at 42 CFR
Part 50, Subpart D, and HHS regulations at 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 new policy results from
the NIH Revitalization Act of 1993 (Section 492B of Public Law
103-43) and supersedes and strengthens the previous policies
(Concerning the inclusion of Women in Study Populations and
Concerning the Inclusion of Minorities in Study Populations) which
have been in effect since 1990. The new policy contains some new
provisions that are substantially different from the 1990 policies.
 
All investigators proposing research involving human subjects should
read the "NIH Guidelines on the Inclusion of Women and Minorities as
Subjects in Clinical Research" which have been published in the
Federal Register of March 28, 1994 (59 FR 14508-14513) and reprinted
in the NIH GUIDE FOR GRANTS AND CONTRACTS, Volume 23, Number 11,
March 18, 1994.
 
Investigators may obtain copies of the policy from these sources or
from the program staff or the contact person listed below. Program
staff may also provide additional relevant information concerning the
policy.
 
LETTER OF INTENT
 
Prospective applicants are asked to submit, by August 7, 1997, a
letter of intent that includes a descriptive title of the proposed
project, the name, address and a telephone number of the Principal
Investigator, the names of other key personnel and participating
institutions, and the 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 is helpful in planning
for the review of applications. It allows NCI staff to estimate the
potential workload and to avoid conflicts of interest in the review.
The letter of intent is to be sent to Susan G. Nayfield, M.D., M.Sc.
at the address listed under INQUIRIES below.
 
APPLICATION PROCEDURES
 
The research grant application form PHS 398 (rev. 5/95) is to be used
in applying for these grants. These forms are available at most
institutional offices of sponsored research and may be obtained from
the Office of Extramural Outreach and Information Resources, Division
of Research Grants, National Institutes of Health, 6701 Rockledge
Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301-435-0714,
e-mail asknih@odrockm1.od.nih.gov.
 
The RFA label available in the application form PHS 398 (rev. 5/95)
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 number and title of the RFA must be typed on line 2 of
the face page of the application and YES must be checked.
 
Submit a signed, typewritten original of the application, including
the Checklist, and three signed, exact photocopies in one package to
the Division of Research Grants at the address below. The photocopies
must be clear and single sided.
 
Division of Research Grants
National Institutes of Health
Suite 1040
6701 Rockledge Drive MSC 7710
Bethesda, MD 20892-7710
 
At the time of submission, two additional copies of the application
must be sent to:
 
Ms. Toby Friedberg
Referral Officer
Division of Extramural Activities
National Cancer Institute
Executive Plaza North, Room 636
6130 Executive Blvd.
Rockville, MD 20850 (if hand delivered or delivery service)
Bethesda MD 20892-7399 (if using U.S. Postal 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 application will be reviewed in competition with
other applications received on or before the designated receipt date.
 
Applications must be received by September 23, 1997. If an
application is received after that date, it will be returned to the
applicant without review. 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.
 
Respondents must request sufficient funds in their budgets to
accommodate travel expenses for the PIs to attend regularly scheduled
ITG-SC meetings.
 
REVIEW CONSIDERATIONS
 
All applications will be judged on the basis of the scientific merit
of the proposal and the documented ability of the group to meet the
RESEARCH OBJECTIVES of the RFA addressed in the application. Although
the technical merit of the proposed protocol is important, it will
not be the sole criterion of evaluation of a study.
 
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 expected to address relevant issues described in
SPECIAL REQUIREMENTS of the RFA. The review group will assess the
scientific merit of the applications and related factors, including:
 
1.   The extent to which the application addresses the goals and
objectives of the RFA;
 
2.   Scientific and technical excellence of the overall application.
 
3.   Adequacy of plans (where appropriate) to collect, store and
distribute   data in a confidential/secure manner.
 
4.   Qualifications and research experience of the Principal
Investigator, staff, and organization, particularly, but not
exclusively, in the area of the proposed research; time availability
of the PI and staff; scientific and technical excellence of past and
current work by PI and staff in areas related to the objectives of
the RFA;
 
5.   Quality of existing physical facilities and resources of the
applicants' Institutions.
 
6.   Demonstrated commitment to structured planning and design,
generation of user documentation, and user support.
 
7.  Scalability, extensibility, and flexibility of proposed
infrastructure component.
 
8.  Cost-efficiency of strategy, in particular economies of scale
and/or synergy associated with related activities proposed for the
ITG
or other related informatics activities conducted by the group.
 
9.   Strategies for efficient and nondisruptive implementation of the
informatics system at Participating Centers.
 
10.  Innovation in approaches to informatics and/or analytic tool
development
 
The review group will also examine the proposed budget and will
recommend an appropriate budget and period of support for each
application that is recommended for further consideration.
 
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.
 
AWARD CRITERIA
 
Applications recommended by the National Cancer Advisory Board will
be considered for award based upon (a) technical merit of the
application as reflected in the priority score, (b) availability of
resources, and ( c) availability of funds.  Furthermore, the
applicant organization must indicate a commitment to accept
provisions outlined under the SPECIAL REQUIREMENTS section, Terms and
Conditions of Award. The earliest anticipated date of award is March
1, 1998.
 
INQUIRIES
 
Written and telephone inquiries concerning the RFA and the
opportunity to clarify any issues or questions from potential
applications are welcome.
 
Direct inquiries regarding programmatic and scientific issues to:
 
Susan G. Nayfield, M.D., M.Sc.
Division of Canceer Epidemiology and Genetics
National Cancer Institute
Executive Plaza North, Suite 535
6130 Executive Boulevard MSC 7395
Rockville, MD 20852 (if hand delivered or delivery service)
Bethesda, MD 20892-7395 (if using US Postal Service)
Telephone: (301) 496-9600
Fax: (301) 402-4279
E-mail: nayfiels@epndce.nci.nih.gov
 
Direct inquiries regarding fiscal matters to:
 
Ms. Crystal Wolfrey
Grants Management Specialist
National Cancer Institute
Executive Plaza South, Suite 243
6120 Executive Boulevard MSC 7150
Rockville, MD 20852 (if hand delivered or delivery service)
Bethesda, MD 20892-7150 (if using US Postal Service)
Telephone: (301) 496-7800, ext. 282
E-mail: wolfreyc@gab.nci.nih.gov
 
AUTHORITY AND REGULATIONS
 
This program is described in the Catalog of Federal Domestic
Assistance No.93.393, Cancer Cause and Prevention Research. 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 Part 52 and 45 CFR Part 74 and 92. This
program is not subject to the intergovernmental review requirements
of Executive Order 12372 or Health Systems Agency review. Unless
otherwise noted all PHS grants policies apply.
 
The Public Health Service strongly encourages all grant 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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