Full Text CA-95-021

SPECIALIZED PROGRAMS OF RESEARCH EXCELLENCE IN GASTROINTESTINAL
CANCER

NIH GUIDE, Volume 24, Number 34, September 29, 1995

RFA:  CA-95-021

P.T. 34

Keywords: 
  Cancer/Carcinogenesis 
  Digestive Diseases & Disorders 


National Cancer Institute

Letter of Intent Receipt Date:  December  4, 1995
Application Receipt Date:  February 14, 1996

PURPOSE

The Organ Systems Coordinating Branch of the Division of Cancer
Treatment, Diagnosis and Centers (DCTDC) at the National Cancer
Institute (NCI) invites grant applications (P50) for Specialized
Programs of Research Excellence (SPORE) that address Gastrointestinal
(GI) Cancers of highest incidence and mortality, i.e., colorectal
and/or pancreatic cancers.  The intent of this initiative is to
recompete the SPORE in GI Cancer and to expand the program with the
addition of at least one new SPORE through open recompetition by
making awards to those institutions that can conduct the highest
quality balanced translational research approaches on the prevention,
etiology, screening, diagnosis, and treatment of colorectal and/or
pancreatic cancers.  Because basic research in pancreatic cancer has
lagged behind that of the other major solid tumors, greater leeway is
given for basic research studies on pancreatic cancer.  However, such
studies must have translational potential or significance.  SPOREs
are at institutions that have made or will make a strong
institutional commitment to the organization and conduct of these
programs.  SPORE applicants will be judged on their current and
potential ability to translate basic research findings into
innovative research settings involving patients and populations.
Each SPORE is encouraged to conduct rehabilitation and quality-of-
life research.  Each SPORE must provide career development
opportunities for new and established investigators who wish to
pursue active research careers in translational GI cancer research;
develop and maintain human GI cancer tissue resources that will
benefit translational research; develop extended collaborations in
critical areas of research need with laboratory scientists and
clinical scientists within the institution and in other institutions;
and participate with other SPORES on a regular basis to share
positive and negative information, assess scientific progress in the
field, identify new research opportunities, and promote inter-SPORE
collaborations to resolve areas of scientific controversy.  Each
SPORE and the "network" of SPOREs is expected to conduct research
that will have the most immediate impact possible on reducing
incidence and mortality to human GI cancer.  Each SPORE should
support a mix of basic and clinical researchers whose formal
interactive and collaborative research efforts will result in new
approaches for early detection, diagnosis, therapy, and prevention
and control.  The SPORE mechanism is not intended to support basic
research to the exclusion of clinical research or vice versa.

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 RFA,
Specialized Programs of Research Excellence (SPORE) in
Gastrointestinal Cancer, is related to the priority area of cancer.
Potential applicants may obtain a copy of "Healthy People 2000" (Full
Report:  Stock No. 017-001-00473-1 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 for-profit and non-profit
organizations, public and private, such as universities, colleges,
hospitals, laboratories, units of State and local governments, and
eligible agencies of the Federal government.  To be considered,
applicant organizations must have (1) a minimum of three independent
investigators who are successful in obtaining peer-reviewed research
support directly related to GI cancer, and who together represent
experience in both laboratory and clinical research, or in the
alternate, a minimum of three independent investigators, each having
published articles that significantly address GI cancer in peer-
reviewed research journals, and who as a group represent experience
in both laboratory and clinical research; (2) access to a patient
care and service facility that serves GI cancer patients and, if the
facility is not part of the parent institution, a statement that
assures access to GI cancer patients for clinical research; the
statement must be signed by the responsible officials of the
applicant institution and the consortial care facility; (3) although
applications must be submitted from one institution, they may include
subcontracted collaborative scientific arrangements with scientists
from other institutions as long as these arrangements are clearly
delineated, and formally and officially confirmed by signed
statements from the responsible officials of each institution.
However, a full institutional commitment must come from the parent
institution receiving the award.

Support will not be provided for applications with research
activities focused exclusively on basic research, clinical research
or trials, or epidemiological research. NCI staff (See INQUIRIES
below) should be consulted if there are questions regarding any of
the above requirements or exclusions.

MECHANISM OF SUPPORT

Support of this program will be through the P50 Specialized Center
Grant (P50) mechanism.  This mechanism supports any part of the full
range of research and development from basic to clinical and
intervention studies.  The spectrum of activities comprises a
multidisciplinary attack on a specific disease entity or biomedical
problem.  These grants differ from program project grants in that
they are more complex and flexible in terms of the types of
activities that can be supported.  In addition to support for
multidisciplinary research projects, support is also provided for
career development, pilot research projects, specialized resources,
and shared core facilities.  Applicants will be responsible for the
planning, direction, and execution of the proposed SPORE program.
Awards will be administered under the Public Health Service Grants
Policy Statement.

FUNDS AVAILABLE

This RFA is a one-time solicitation.  NCI anticipates making one and
possibly two awards.  Applicants applying for competitive renewals
may request up to five years of support.  New applicants or
applicants that have received P20 SPORE feasibility awards in the
past may request up to three years of support.  The NCI anticipates
setting aside $3 million total for the initial year's funding.
Funding in response to this RFA is dependent upon the receipt of a
sufficient number of applications of high scientific merit. Although
this program is provided for in the financial plans of NCI, the award
of grants pursuant to this RFA is contingent upon the anticipated
availability of funds for this purpose.

NCI policy for SPORE grants establishes the following limits to the
requested budgets:  All new and competing renewal P50 SPORE
applications may request up to a maximum annual direct cost of $1.5
million and maximum annual total cost of $2.5 million per individual
SPORE.  In complying with the direct cost cap of $1.5 million, the
indirect costs related to subcontracts to other institutions or
organizations will not apply toward the direct cost cap, but the
total dollar request may not exceed $2.5 million.  Future year
increases are limited to four percent, but may not exceed this cap.
Funding for successful P50 renewal applications will be for up to
five years.  Initial funding for new P50 SPOREs will be for no more
than three years.  Recognizing that the initial three year funding
period for new SPOREs may be too short for multiple substantive
scientific accomplishments, any future recompetition for this group
will be evaluated on scientific accomplishment and on interim
progress in pursuit of SPORE organizational, collaborative and
research objectives.  This would include, for example, progress
toward planning, developing and implementing new innovative
translational research programs, progress toward developing the
careers of new scientists, progress toward procuring and distributing
tissue specimens, progress toward developing substantive
collaborative interactions.

RESEARCH OBJECTIVES

Background

Gastrointestinal cancers pose major public health problems in this
country.  In 1995, there are an estimated 100,000 cases of colon
cancer and 38,000 cases of rectal cancer with 47,500  and 7,800
deaths respectively.  Although there have been recent advances in
adjuvant therapy, there have been no major breakthroughs in the
treatment of colorectal cancers. Animal studies have provided
important insights into the etiology of colon cancer, but there have
been no major advances in the prevention of this disease.

Pancreatic cancer remains a significant and intransigent problem.
The incidence of this cancer (24,000 cases in 1994) approaches the
mortality rate (25,000 deaths). Average survival time from time of
diagnosis is less than a year. There have been no advances in
understanding the causes of this disease, in detecting or diagnosing
it early, and there is no effective treatment.  Although there have
been recent advances in the biology of this disease, pancreatic
cancer remains an intransigent cancer.

In recent years, the scientific information base for gastrointestinal
cancers has expanded significantly. Similarly, there has been
increasing interest and opportunity in pancreatic research.  This was
documented at a workshop on pancreatic cancer convened by the NCI in
1994. The proceedings and research recommendations from this workshop
are published in the International Journal of Pancreatology, Volume
16, nos. 2-3, October/November 1994.  Application of this scientific
base to clinical and preventive activities has not been commensurate
with this expansion.  Specialized Programs of Research Excellence
provide focal points for sustaining and maintaining state- of-the-art
research that will contribute to improved detection, diagnosis,
treatment and prevention of GI cancer. SPORES will not only be
expected to conduct a wide spectrum of research activities, but also
to contribute significantly to the development of specialized
research resources, career development of new investigators, and the
expansion of the research base through collaborative research with
scientists and clinicians in other institutions locally and
nationwide. The research supported through this program must have
translational significance.  It will require interdependence between
basic and clinical investigators in both the planning and
implementation of research and would emphasize clinical application
of basic research findings with patients and populations.
Translational research also applies clinical findings to advance
basic research that ultimately may lead to hypothesis-driven clinical
trials or prevention and control interventions.  It should be noted
that clinical research that is not based on nor derived from
laboratory findings is not considered translational for purposes of
this RFA.

Objectives

The goal of this RFA is to expand the current GI Cancer SPORE program
with the addition of at least one new SPORE. Each SPORE assembles
critical masses of laboratory and clinical scientists to work
together on GI cancer and to focus on innovative translation of basic
findings into research settings involving patients and populations.
The ultimate objective is to reduce incidence and mortality, and to
increase and improve survival to the disease.  The essential
characteristics of a SPORE include (1) a strong scientific program
that will have a clear impact on the human disease, (2) a strong
innovative developmental or pilot research program that can respond
quickly to new research opportunities, (3) a strong career
development program to develop and expand the scientific cadre of
investigators dedicated to translational research on human GI cancer,
(4) a human GI cancer tissue procurement resource, and other
resources specifically dedicated to translational research
objectives, and (5) a willingness and commitment to work with other
SPOREs and scientists in order to maximize research progress.

The special features of SPORE grants provide opportunities for
investigators with mutual or complementary interests to engage in
multidisciplinary research that will impact on prevention, diagnosis,
or treatment of human GI cancer, as well as rehabilitation or quality
of life.  Individual research projects must be highly interactive and
must be conceived, planned, and implemented through the
multidisciplinary interactions of independent laboratory and clinical
scientists.  Such interactions should demonstrate the potential for
accelerating the translation of research findings into practical
benefits for patients and populations.  A distinguishing feature of a
SPORE P50 grant is the highly dependent nature of the research
objectives upon intra- and inter- project interactions.  Thus, each
project may, but ordinarily would not, be expected to stand on its
own in the absence of interactions with other research projects.

Developmental research funds provide support for highly innovative
pilot projects that take maximum advantage of new research
opportunities.  This provides a flexible means for responding quickly
to new research opportunities.  Career development of new and
established investigators will generate a cadre of scientists who
could leave the SPORE with research experience to develop independent
GI cancer research programs that emphasize translational research
objectives.

In order to facilitate achievement of SPORE program goals, each SPORE
must develop resources specialized for GI cancer research activities.
This must include human GI cancer tissue collection for research
activities of the SPORE and for use by scientists who are
concentrating on translational research within and outside the parent
institution.  The development of additional resources specialized for
GI cancer research is also encouraged.

Interactions among SPOREs is an important objective of this
initiative.  This may be in the form of research collaborations,
exchange of scientists on a visiting basis, exchange of resources and
materials, and other innovative ways.  A requirement for all SPOREs
is an annual meeting coordinated by the Organ Systems Coordinating
Branch of the NCI.  The purpose of the meeting is to share scientific
information, assess scientific progress, identify new research
opportunities, and establish priorities that will accelerate the
translation of basic research findings to applied settings in
patients and populations.

SPECIAL REQUIREMENTS

Each SPORE must include the following elements:

1.  A strong institutional commitment.  An institution receiving this
award should incorporate the SPORE high within its institutional
priorities.  The institution should demonstrate a strong commitment
to the program's stability and success.  The application must provide
a plan which addresses how the institutional commitment will be
established and sustained, how it will maintain accountability for
promoting scientific progress, and how the SPORE research effort will
be given a high priority within the institution relative to other
research efforts. This institutional commitment may be in the form of
commitments to recruit scientific talent, provision of discretionary
resources to the SPORE director, faculty appointments for SPORE
investigators, assignment of research space, cost sharing of
resources, or other ways to be proposed by the applicant.

2.  A qualified principal investigator.  A leader should be selected
as principal investigator who can oversee and conduct planning
activities, provide direction to the SPORE and ensure a translational
research emphasis.

3.  A substantive GI cancer patient population.  Each SPORE should be
recognized as a leading program in the treatment of GI cancer.  The
grant application must demonstrate and document access to a patient
population which can participate in and can benefit from the
innovative clinical and population research activities of the SPORE.

4.  Research projects.  Each SPORE application must include at least
three approved research projects, which together represent reasonably
diverse experimental approaches.  Each research project must be
headed by basic and clinical co- investigators.  It is not necessary
that both co- investigators commit equal effort to the project, but
it should be evident from this collaboration that translational
research objectives will be accelerated.  The research must be
oriented toward the most critically needed areas of GI cancer
research, and toward translational activities which address new
innovative possibilities in GI cancer research. As indicated above,
each project must involve multidisciplinary laboratory and clinical
interaction in the conception, planning, design and implementation of
research. Projects should be interactive with each other whenever
possible.  This program will not support basic research that is
without translational potential or significance nor will it support
clinical studies that are not "translated" from basic research.

Research components involving clinical trials must include provisions
for rigorous data management, quality assurance, and auditing
procedures.  Funds should be budgeted for these activities and should
appear as a separate budget page in the application.  They should not
duplicate internal review and monitoring systems that are already in
place at the institution.  For any treatment protocols supported
directly or indirectly by the SPORE, copies of Informed Consent
forms, Early Stopping rules and procedures to detect and monitor
Adverse Drug Reactions (ADR) must be provided in the application, or
in the case of future protocols, to the NCI program director.

Collaborative arrangements within the SPORE, within the parent
institution and with other institutions are encouraged.
Collaborations with scientists outside the immediate SPORE should be
documented with appropriate letters of commitment as applicable.
Collaborations with other institutions may involve subcontracting
arrangements but an award will be made to one institution only; that
institution is expected to demonstrate the full institutional
commitment noted in 1. above.

It is expected that all SPOREs will have a balanced approach to GI
cancer that encompasses the areas of prevention, etiology, screening,
diagnosis and treatment.  This balanced approach may be either
through research being conducted in their institution, or through
collaborative associations they have developed or plan to develop
with other SPOREs or with other investigators in the biomedical
research community.

5.  Developmental Research Funds.  Each SPORE should continually
allocate a significant proportion of its budget and effort to pilot
projects that explore innovative ideas. It is important that SPOREs
use developmental funds to stimulate projects that take maximum
advantage of new research opportunities.  Pilot projects may be
collaborative among scientists within one or more SPOREs, or with
scientists outside the SPORE environment.  The SPORE application
should propose an institutional review process that selects pilot
projects for funding which represent the most innovative ideas and
which are likely to have the greatest impact on reducing GI cancer
incidence and mortality, and increasing and improving survival and
quality-of-life of GI cancer patients.  These funds are intended to
remain flexible and to support feasibility and pilot studies of a
limited duration, e.g., two years or less, rather than the duration
of the entire grant period. The expectation is that successful
feasibility studies will become fully developed projects within the
SPORE, or funded through other forms of research support, e.g., R29,
R01.

6.  Specialized Resources.  The SPORE must have a dedicated activity
to human gastrointestinal cancer tissue collection. This resource
must benefit the specific research activities of the SPORE as well as
the research activities of other scientists within and outside of the
parent institution who are concentrating on translational research
issues.  The SPORE must be willing to participate in any national
prioritization for distribution of tissues through NCI supported
tissue networks.  A plan must be proposed for prioritizing
distribution of tissues to SPORE scientists and others based on the
most innovative ideas in translational gastrointestinal cancer
research.  This plan should be flexible enough to accommodate and
complement broader national priorities as they are developed.

The development of other resources of special significance to
translational research in these cancers is also encouraged.  For
example, human samples of normal and neoplastic tissues are not
easily available.  A registry that could organize material from many
institutions in a form optimal for laboratory investigation would be
invaluable.

If the SPORE is part of an NCI-designated Cancer Center, the
development of resources should not duplicate resources already
provided by the center on an existing Cancer Center Support Grant
(P30).  The applicant should show that the P50 will become an
effective, integrated research arm of the cancer center when it is
supported by a P30 grant.

7.  Career Development.  The SPORE should demonstrate a consistent
commitment to career development.  A sufficient portion of the budget
should be dedicated to the salaries and research activities of
investigators who wish to pursue careers in translational research on
GI cancer and who would acquire the necessary research experience to
develop independent GI cancer translational research programs within
or outside of the parent institution.  These may be new investigators
or established investigators who wish to change research directions.
Candidates should be scientists who have demonstrated outstanding
research potential but who need additional time in a productive
scientific environment to establish an independent GI cancer research
program. Candidates are expected to devote full time to research. Any
deviation will require prior NCI approval.  Recruitment should
encourage the participation of qualified women and minorities where
possible.  To this end, each applicant should include a clear policy
and plans for recruiting minorities and women.  The SPORE application
should propose the number of slots available, the criteria for
eligibility and for selection of candidates, and describe the
selection process.  Also, the application should indicate prospective
mentors who are already in place at the proposed SPORE, briefly
describe their research programs, and describe complementary
activities that contribute to the environment for career development
(e.g., existing training grants, other career development mechanisms
and relevant programs).

8.  Annual Meeting of SPORE.  GI Cancer SPOREs will be expected to
participate in an annual meeting with the Organ Systems Coordinating
Branch of the NCI to share positive and negative results with other
SPOREs, share materials, assess progress, identify new research
opportunities, and establish interactions and research priorities and
collaborations that will maximize the impact of the research on
reducing incidence and mortality, and improving survival.  Travel
funds for the Principal Investigator and selected Project
Investigators may be budgeted for this purpose.  This may include
Project Investigators from other institutions who are actively
collaborating with SPORE investigators.  In addition, travel funds
should be budgeted for the SPORE Director to attend an annual SPORE
Directors' administrative and planning meeting at the NCI.  This
Directors' meeting is in addition to the annual SPORE Investigators'
meeting.

A SPORE application can originate from an institution with or without
an existing NCI Cancer Center Support Grant or
P30 core grant.  However, if a P30 grant already exists:

a)  the Principal Investigator of the SPORE should be a senior leader
in the cancer center;
b)  the P30 Center Director may be the Principal Investigator of the
P50 SPORE, but this is not necessary;
c)  lines of authority should be indicated clearly such that the
SPORE is an integral part of the Cancer Center and does not interfere
with the P30 chain of authority;
d)  a letter of commitment which delineates organizational
relationships and lines of authority is required; the letter must be
signed by the proposed Principal Investigator of the SPORE, the
Cancer Center Director and the appropriate institutional official; e)
the SPORE must be an integrated major programmatic element in the
cancer center; however, there must also be a separate and distinctive
institutional commitment to the SPORE as opposed to the NCI-
designated Cancer Center;
f)  the development of resources in the SPORE should not duplicate
resources already provided by the existing P30 grant; however, SPORE
resources can be used to augment existing center resources to orient
these resources more effectively to SPORE research objectives if this
is a more efficient and more cost effective alternative; g)  the
applicant should describe how the P50 SPORE will interact
synergistically and effectively with the existing P30 programs in
order to maximize SPORE research objectives and contribute to cancer
center research objectives.

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 was reprinted in the Federal
Register of March 28, 1994 (59 FR 14508-14513), and reprinted in the
NIH GUIDE FOR GRANTS AND CONTRACTS of March 18, 1994, Volume 23,
Number 11.

Investigators may obtain copies from these sources or from the
program staff or 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 December 4, 1995, a
letter of intent that includes the name and address of the principal
investigator and other key personnel, any collaborating 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 that it contains allows NCI
staff to estimate the potential review workload and avoid conflict of
interest in the review. Furthermore, NCI staff can discuss the most
recent policies of the NCI relative to funding issues, potential
problems in meeting program requirements or clarification of the peer
review process before the final application is submitted.

The letter of intent is to be sent to:

Andrew Chiarodo, Ph.D.
Division of Cancer Treatment, Diagnosis, and Centers
National Cancer Institute
Executive Plaza North, Suite 512
6130 Executive Boulevard MSC 7386
Bethesda, MD  20892-7386
Rockville, MD  20852 (for express/courier service)
Telephone: (301) 496-8528
FAX: (301) 402-0181

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; from the Office of
Grants Information, Division of Research Grants, National Institutes
of Health, 6701 Rockledge Drive, Room 3034, MSC 7762, Bethesda, MD
20892-7762, telephone 301/435-0714, email: girg@drgpo.drg.nih.gov;
and from the NCI Program Director listed under INQUIRIES.

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 RFA number and title "SPORE in Gastrointestinal Cancer"
must be typed on line 2 of the face page of the application form.

Complete applications are due by February 14, 1996.  Applications
must meet all eligibility requirements as described above and must
address all programmatic requirements (see SPECIAL REQUIREMENTS
above) in the RFA. Applications received after this date will not be
accepted. Also, the Division of Research Grants (DRG) will not accept
any application in response to this RFA, any part of which is the
same as one currently being considered by any other review group or
NIH awarding unit.

Specific instructions for preparing a SPORE grant application are
available from NCI program staff listed under INQUIRIES.  These
instructions should be used in preparing the application.

Submit a signed typewritten original of the application, including
the Checklist, and three signed exact photocopies, in one package to:

DIVISION OF RESEARCH GRANTS
NATIONAL INSTITUTES OF HEALTH
6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710
BETHESDA MD 20892-7710
BETHESDA MD 20817 (for express/courier service)

At the time of submission, two additional copies of the application
must be sent to:

Ms. Toby Friedberg
Division of Extramural Activities,
National Cancer Institute
Executive Plaza North, Room 636
6130 Executive Boulevard MSC 7405
Bethesda, MD  20892-7405
Rockville, MD 20852 (if hand-delivered or delivery service)

It is important to send these copies at the same time that the
original and three copies are sent to DRG; otherwise, the NCI cannot
guarantee that the applications will be reviewed in competition with
other applications received in response to this RFA.

REVIEW CONSIDERATIONS

A.  Review Procedures

Upon receipt, applications will be reviewed initially by the Division
of Research Grants for completeness.  Applications that are
incomplete or have not addressed all of the required elements noted
above under SPECIAL REQUIREMENTS, or do not meet the ELIGIBILITY
REQUIREMENTS as noted above, will be returned to the applicant
without further consideration. Evaluation for responsiveness to the
program requirements stated in the RFA is an NCI program staff
function; this will be done stringently and will be based primarily
on the clear orientation of the application to human GI cancer,
translational research objectives, and an absence of duplication
between the proposed research and currently supported research.
Applications judged to be non- responsive to this RFA will be
returned without review.

Applications that are complete and responsive to the RFA will be
evaluated for scientific and technical merit and for special SPORE
characteristics and requirements 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, a process may be used by
the initial review group in which applications will be determined to
be competitive or non-competitive based on their scientific merit
relative to other applications received in response to the RFA.
Applications judged to be non-competitive will be withdrawn from
further consideration and the principal investigator/program director
and the official signing for the applicant organization will be
promptly notified.  Applications judged to be competitive will be
discussed and be assigned a priority score.  The second level of
review will be provided by the National Cancer Advisory Board.

B.  Review Criteria

The major factors to be considered in the evaluation of all
applications are given below.  Additional factors are noted in a
separate section below for applications from P50 SPOREs applying for
competitive renewal.

1.  The Institutional Commitment

a)  adequacy of facilities, equipment and space to promote
translational research objectives;
b)  adequacy of institutional procedures and plans for monitoring,
evaluating and assuming accountability for the general success of the
SPORE; adequacy of the institutional infrastructure for assessing
progress and needs;
c)  adequacy of recruitment objectives and plans to strengthen the
scientific capabilities of the SPORE;
d)  presence of other tangible commitments, i.e., discretionary
resources, to the SPORE, e.g., dollars and space.

2.  Overall Program Organization and Capability

a)  the scientific qualifications and demonstrated scientific and
administrative leadership capabilities of the SPORE Principal
Investigator; adequacy of the time commitment of the Principal
Investigator;
b)  the depth and breadth of the proposed research activities and
plans to effectively pursue translational research objectives;
c)  the adequacy of access to patients and to a population for
conducting current and projected therapeutic, prevention and control
research;
d)  the adequacy of the procedures, processes, and plans for
promoting interactions;
e)  if applicable, the adequacy of plans for synergistic and
effective interactions with existing P30 programs.

3.  Individual Research Projects

a)  qualifications and demonstrated competence of the investigators
to conduct the proposed research; the adequacy of the time commitment
of all key laboratory and clinical researchers associated with the
project;
b)  clear evidence of significant multidisciplinary basic and
clinical interactions in the conception, design and proposed
implementation of the project;
c)  degree to which the project addresses an issue of substantive
importance for reducing incidence and mortality or for increasing
survival in human GI cancer;
d)  the scientific merit and adequacy of experimental design of the
project;
e)  in clinical research components, clear evidence of full
protection of human subjects, and appropriate mechanisms for the
rigorous management and verification of research data;
f)  the adequacy of quality assurance and audit processes, and
related budget for research involving clinical trials;
g)  the originality, novelty, and innovativeness of the experimental
design and relevance to the overall goals and objectives of the
SPORE;
h)  the degree to which the project is interactive with other
projects in the SPORE conceptually, experimentally, and
translationally;
i)  appropriateness of the budget to achieve research objectives.

4.  Developmental Funds

a)  adequacy of the proposed process for continuously reviewing and
funding pilot projects for their quality, innovativeness and
potential impact on reducing incidence and mortality, and/or
improving survival to GI cancer;
b)  quality, innovativeness and potential impact of proposed pilot
projects;
c)  degree to which developmental funds will be used to stimulate
pilot projects with multidisciplinary interactions and/or
collaborative interactions with other scientists within or outside of
the parent institution;
d)  appropriateness of the proposed budget relative to the proposed
pilot projects and potential of the program to generate innovative
pilot projects on a consistent basis.

5.  Career Development

a)  the adequacy of the process for selecting candidates for career
development who demonstrate potential for independent research
careers or who are established investigators and are changing the
direction of their research careers;
b)  adequacy of the policies to seek out and include qualified
minorities and women in the career development program;
c) adequacy of the individuals available in the program to serve as
possible mentors of career development candidates; the current
availability and adequacy of projects for career development
candidates;
d)  complementary activities that contribute to the environment for
career development;
e)  capacity of the overall program to absorb career development
candidates and prepare them for independent GI cancer research
careers;
f)  appropriateness of the budget relative to the proposed plans for
sustaining a strong activity in career development.

6.  Shared Resources

a)  adequacy of the proposed plans to develop, maintain and
distribute a fresh/frozen human GI cancer tissue resource with
pathological and clinical data;
b)  willingness to participate in any national prioritization for
distribution of tissues through NCI- supported tissue networks;
c)  confirmation that the plan does not duplicate resources already
available within the institution (e.g. as part of a Cancer Center
Support Grant or P30) or through readily available national
resources;
d)  adequacy of the justification for other specialized resources
essential for the conduct of SPORE research;
e)  adequacy of qualifications of proposed managers of resources to
conduct  high quality, reliable resource operations;
f)  appropriateness of the requested budgets to conduct each resource
operation.

7.  Interactions with other SPOREs

a)  adequacy of plans to promote and maintain communication and
integration with other SPOREs;
b)  willingness to interact with other SPOREs and with the NCI in
sharing information, in assessing scientific progress, in identifying
new research opportunities and in establishing scientific priorities.

The above criteria apply to all new and competing applications.
Additional factors to be considered in the evaluation of competing
renewal applications from current P50 SPORE grantees, will be:

1.  Research Projects

a)  progress in establishing a high quality research effort and
scientific productivity in translational research over the previous
funding period;
b)  degree to which applied researchers (e.g., clinical researchers,
prevention and control researchers) are interacting with basic
investigators in the planning, design, and implementation of research
projects;
c)  collaborative efforts that have been established within and
outside the SPORE institution;
d) results (positive or negative) from each research project;
e) degree to which each project is interacting with other projects;
f)  translational potential or significance of each individual
research project;

2.  Developmental Projects

a)  progress in the effective use of developmental funds to explore
new research opportunities and/or stimulate the field;
b)  quality, innovativeness, and potential or actual impact of funded
pilot projects;
c)  positive and/or negative results for each developmental project;
d) how the SPORE has set priorities in the use of developmental
funds;
e)  impact of developmental projects in stimulating new full
translational research projects within the SPORE, or through other
support mechanisms;
f)  impact of developmental projects in stimulating new
multidisciplinary or collaborative interactions within or outside the
SPORE.

3.  Shared Resources

a)  effectiveness and efficiency of previously funded resources in
meeting the specific translational research needs of the scientific
projects in the SPORE;
b)  extent to which shared resources are being used by research and
pilot projects, both within and outside the SPORE;
c)  quality, utility, and efficiency of the shared resources;
d)  progress toward establishing the GI cancer tissue resource to
include pathological and clinical data;  nature, quality, and
distribution of tissues being procured;  plans for prioritizing
distribution of tissues within and outside the SPORE;

4.  Other Considerations

a)  special efforts to recognize unique research opportunities based
on incidence and mortality rates in the community or region of the
SPORE;
b)  special efforts to enhance the research capability of the SPORE
through interactions with individuals, organizations, and
institutions within the community;
c)  progress toward meeting previously stated (above) institutional
commitments;
d)  demonstrated effectiveness of the SPORE Director in terms of
scientific and administrative leadership;
e)  progress in refining and improving upon the translational
research infrastructure of the SPORE during the previous funding
period as it relates to a) through d) above.

Each component of the application will receive a recommendation of
approval, or not recommended for further consideration.  Approved
components will receive an appropriate verbal descriptor of merit.
The review group will critically examine the proposed budget for each
component of the application.

C.  Scoring the Applications

In addition to rating the merit of individual components, peer
reviewers will be asked to judge the overall program in the following
areas:

1) scientific merit and innovativeness;  progress, if applicable;
2)  evidence of interdependent, multidisciplinary design and conduct
of the research;
3) impact, or potential for impacting on the disease;
4) institutional commitment.

A verbal descriptor will be recorded for each of the above areas.

A single numerical priority score will be assigned to the program as
a whole.  Although primary emphasis will be placed on scientific
merit, innovativeness, and progress where applicable, significant
consideration will be given to multidisciplinary interactions,
potential for impacting on the disease, and institutional commitment.

A recommendation for no further consideration for any required
element of the program (see SPECIAL REQUIREMENTS above) will result
in an overall evaluation of "not recommended for further
consideration."

AWARD CRITERIA

The earliest anticipated date of award is December 1, 1996.
Applications considered by the National Cancer Advisory Board will be
considered for award based upon (a) priority score, (b) availability
of funds, and (c) programmatic priorities.  The NCI anticipates
making one and possibly two awards for project periods of five years
for successful P50 competitive renewal, and for project periods of
three years for applications from new applicants.

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.  The program director
welcomes the opportunity to clarify any issues or questions from
potential applicants.

Inquiries regarding programmatic issues and requests for SPORE
guidelines may be directed to:

Andrew Chiarodo, Ph.D.
Division of Cancer Treatment, Diagnosis, and Centers
National Cancer Institute
Executive Plaza North, Suite 512
6130 Executive Boulevard  MSC 7386
Bethesda, MD  20852-7386
Telephone: (301) 496-8528
FAX:  (301) 402-0181
Email:  chiaroda@dcbdcep1.nci.nih.gov

Inquiries regarding fiscal or administrative matters may be directed
to:

Joan Metcalfe
Grants Management Specialist
Grants Administration Branch
National Cancer Institute
Executive Plaza South, Room 243
6120 Executive Boulevard  MSC 7150
Bethesda, MD  20892-7150
Telephone: (301) 496-7800  ext. 228

AUTHORITY AND REGULATIONS

This program is described in the catalog of Federal Domestic
Assistance no. 13.397.  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.

The PHS strongly encourages all grant and contract recipients to
provide a smoke-free workplace and promote the non-use of all tobacco
products.  In addition, Public Law 103-227, the Pro-Children Act of
1994, prohibits smoking in certain facilities (or in some cases, any
portion of a facility) in which regular or routine education,
library, day care, health care, or early childhood development
services are provided to children.  This is consistent with the PHS
mission to protect and advance the physical and mental health of the
American people.

.

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