SPECIALIZED PROGRAM OF RESEARCH EXCELLENCE IN OVARIAN CANCER

Release Date:  September 4, 1998

RFA:  CA-98-008

P.T. 

National Cancer Institute

Letter of Intent Receipt Date: October 1, 1998
Application Receipt Date:  January 15, 1999

PURPOSE

The Organ Systems Branch of the Office of the Deputy Director Extramural
Science at the National Cancer Institute (NCI) invites grant applications
(P50) for a Specialized Program of Research Excellence (SPORE) in Ovarian
Cancer.  Applicant institutions must be able to conduct the highest quality
balanced translational research on the prevention, etiology, screening,
diagnosis, and treatment of ovarian cancer.  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.  A SPORE is
encouraged to conduct rehabilitation and quality-of-life research.  A SPORE
must provide career development opportunities for new and established
investigators who wish to pursue active research careers in translational
ovarian cancer research; develop and maintain human ovarian 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 ovarian cancer.  A 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 Program of
Research Excellence (SPORE) in Ovarian 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 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.  Racial/ethnic minority individuals, women, and
persons with disabilities are encouraged to apply as Principal Investigators.

To be considered, applicant organizations must have (1) a minimum of three
independent investigators who have already been successful in obtaining
peer-reviewed research support directly related to ovarian cancer (R01, P01,
etc.), and who together represent experience in both laboratory and clinical
research; (2) access to a patient care and service facility that serves
ovarian cancer patients and, if the facility is not part of the parent
institution, a statement that assures access to ovarian cancer patients for
clinical research; the statement must be signed by the responsible officials
of the applicant institution and the consortia care facility.  Although an
application must be submitted by a sole applicant institution, subcontracted
collaborative scientific arrangements with scientists from other institutions
may be included if 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
applicant institution.

Support will not be provided for applications with research activities focused
exclusively on basic research, or clinical research or trials, or
epidemiological research.

NCI program staff listed under INQUIRIES should be consulted if there are
questions regarding any of the above eligibility requirements or exclusions.

MECHANISM OF SUPPORT

Support of this program will be through the 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 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 PHS grants policy as stated in the
PHS Grants Policy Statement.

NCI policy for SPORE grants establishes the following limits to the requested
budgets: A new P50 SPORE application may request a maximum annual direct cost
of $1.5 million and maximum annual total cost of $2.5 million.  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 three percent but may not exceed this
cap.  A SPORE grant application may request up to five years of funding.

FUNDS AVAILABLE

This RFA is a one-time solicitation.  The NCI anticipates making at least one
award.  Additional awards will be considered based on availability of funds. 
An applicant may request up to five years of support. The NCI anticipates
setting aside at least $2.5 million 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.

RESEARCH OBJECTIVES

Background

Ovarian cancer is currently the leading cause of death from gynecologic
malignancy in the United States.  It is estimated that 26,800 new cases of
ovarian cancer will be diagnosed in this country in 1999, and that 14,200
women will die from the disease.  Although the cure rate for Stage I disease
is nearly 90%, the majority of patients present with disease spread beyond the
ovary. Despite aggressive surgical debulking and platinum-based chemotherapy,
the 5-year survival rates for women with clinically advanced disease is only
15-20%.  The magnitude of this problem is reflected in the recent SEER data
which indicates the 5 year survival of patients with ovarian cancer has
increased only from 36% in 1976 to 46% in 1993.

In 1992, the Organ Systems Coordinating Branch of the NCI convened a Workshop
on Investigational Strategies for Detection and Intervention in Early Ovarian
Cancer.  The workshop was divided into six interrelated areas: 1) genetic
events in ovarian carcinogenesis, 2) inheritance of risk, 3) early pathology
and progression, 4) markers for detecting early ovarian cancer,  5)  models
for ovarian carcinogenesis and 6) strategies for intervening in early ovarian
cancer. It became clear from this workshop that the scientific base for
ovarian cancer is expanding, and that new investigators are turning to
research in this field.  Since then, the scientific information base for
ovarian cancer has continued to expand; however, application of this
scientific base to clinical and preventive activities has not been
commensurate with this expansion.  Based on evidence from the workshop and in
view of increasing numbers of investigators entering the field, it would
appear that research in this area could benefit from a SPORE. 

A SPORE must address the scientific information base and provide focal points
for sustaining and maintaining state-of-the-art research that will contribute
to improved detection, diagnosis, treatment and prevention of ovarian cancer. 
SPORES are not only 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, the
development of improved research model systems 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 potential or significance.  It will
require interdependence between basic and clinical investigators in planning
and implementing 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 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.

Research Goals and Scope

The goal of this RFA is to establish at least one new Ovarian Cancer SPORE.  
A SPORE assembles critical masses of laboratory and clinical scientists to
work together on human ovarian cancer and to focus on innovative translation
of basic findings into research settings involving patients and populations. 
The ultimate objective is to reduce ovarian cancer incidence and mortality,
and improve survival.  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  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 ovarian cancer, (4) a human ovarian 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 ovarian
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 its dependency on intra- and inter-project interactions. Thus,
each project is expected to interact inside and outside the SPORE institution.

Pilot 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 funds for support of new and established investigators will
generate leading scientists in the field who have the experience and
capability to develop independent ovarian cancer research programs that
emphasize translational research objectives.

In order to facilitate achievement of SPORE program goals, a SPORE must
develop resources specialized for ovarian cancer research activities.  This
must include human ovarian 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 ovarian 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 participating in an annual meeting
coordinated by the Organ Systems 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 SPORE's stability
and success.  The application must provide a plan that 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 substantial ovarian cancer patient population.  Each SPORE should be
recognized as a leading program in the treatment of ovarian cancer. The grant
application must demonstrate and document access to a patient population that
can participate in and can benefit from the innovative clinical and population
research activities of the SPORE.

4.  Research projects.  Each SPORE application must propose details for at
least three research projects, which together represent diverse experimental
approaches.  Each 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  critically needed areas of ovarian cancer research, and
toward translational activities that address new innovative possibilities in
ovarian cancer research.  As indicated above, each project must involve
multidisciplinary laboratory and clinical interactions in conception,
planning, design and implementation of research. Projects should be
interactive with each other whenever possible. The SPORE program will not
support basic research that is without translational potential 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 be justified.  The proposed
provisions should not duplicate review and monitoring systems already in place
at the institution.  For any ovarian cancer treatment protocol supported
directly or indirectly by the SPORE, 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 protocols subsequent to
funding of a SPORE, to the NCI program director.

At least one research project must be on ovarian cancer prevention or early
detection and screening.  The NCI is particularly interested in early
detection and screening efforts.  There is also a strong interest in
developing genetic methods for determining high risk to ovarian cancer either
through inheritance or through environmental exposures.  However, the NCI is
open to all novel innovative approaches to prevention.

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 a SPORE will have a balanced approach to ovarian cancer
that encompasses the areas of prevention, etiology, screening, diagnosis and
treatment.  This balanced approach may be either through research being
conducted in its own institution, or through collaborative associations it has
developed or plans to develop with other SPOREs or with other investigators in
the biomedical research community.

5.  Pilot Research Funds.  A SPORE should continually allocate a significant
effort to pilot projects that explore innovative ideas.  It is important that
a SPORE use pilot funds to stimulate projects that take maximum advantage of
new research opportunities.  Such 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
ovarian cancer incidence and mortality, and increasing and improving survival
and quality-of-life of ovarian 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., R01.

6.  Specialized Resources.  The SPORE is encouraged to develop and maintain
resources of special significance to translational ovarian cancer research. 
While all types of resources may be proposed, each SPORE must have a dedicated
activity for collecting and distributing human ovarian cancer tissue.  Tissue
collection should include the essential pathologic and clinical information
needed for conducting research.  This resource should 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 ovarian cancer research.  This plan should be flexible enough to
accommodate and complement broader national priorities as they are developed.

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 ovarian cancer and who would acquire the
necessary research experience to develop independent ovarian 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 ovarian cancer research
program.  Candidates are expected to devote full time to research.  Any
deviation will require prior NCI approval.  Recruitment must include qualified
women and minorities.  To this end, each applicant should propose a clear
policy and plan for recruitment of career development candidates.  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.  Investigators participating in Ovarian Cancer
SPOREs will be expected to participate in an annual meeting with the Organ
Systems 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 policy results from the NIH Revitalization Act of 1993
(Section 492B of Public Law 103-43).

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 published in the Federal Register of March 28,
1994 (FR 59 14508-14513) and in the NIH Guide for Grants and Contracts, Vol.
23, No. 11, March 18, 1994.

Investigators may obtain copies from these sources or from the program staff
or contact person listed under INQUIRIES.  Program staff may also provide
additional relevant information concerning the policy.

NIH POLICY AND GUIDELINES ON THE INCLUSION OF CHILDREN AS PARTICIPANTS IN
RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of NIH that children (i.e., individuals under the age of 21)
must be included in all human subjects research, conducted or supported by the
NIH, unless there are scientific and ethical reasons not to include them. 
This policy applies to all initial (Type 1) applications submitted for receipt
dates after October 1, 1998.

All investigators proposing research involving human subjects should read the
"NIH Policy and Guidelines on the Inclusion of Children as Participants in
Research Involving Human Subjects" that was published in the NIH Guide for
Grants and Contracts, March 6, 1998, and is available at the following URL
address:  http://grants.nih.gov/grants/guide/notice-files/not98-024.html


LETTER OF INTENT

Prospective applicants are asked to submit, by October 1, 1998,  a letter of
intent that includes the name, address, and telephone number of the principal
investigator and identifies the component research projects, core units and
their principal investigators, 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 to avoid
conflict of interest in the review.

The letter of intent is to be sent to Dr. Jorge Gomez at the address listed
under INQUIRIES.

APPLICATION PROCEDURES

The research grant application form PHS 398 (rev. 5/95) is to be used in
applying for these grants.  Application kits are available at most
institutional offices of sponsored research and may be obtained from the
Division of Extramural Outreach and Information Resources, National Institutes
of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone
301/435-0714, email: grantsinfo@nih.gov.

Additional instructions for preparing a SPORE grant application are available
from the program staff listed under INQUIRIES.  These instructions must be
requested and used in preparing a SPORE application.

The RFA label available in the PHS 398 (rev. 9/95) application form 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 Ovarian Cancer" must be typed on line 2 of the face page of the
application form and the YES box must be marked.

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

CENTER FOR SCIENTIFIC REVIEW
NATIONAL INSTITUTES OF HEALTH
6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710
BETHESDA, MD  20892-7710
BETHESDA, MD  20817 (for express/courier service)

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

Ms. Toby Friedberg
Division of Extramural Activities
National Cancer Institute
6130 Executive Boulevard, Room 636
Bethesda, MD  20892-7399
Rockville, MD  20852 (for express/courier service)

It is important to send these copies at the same time that the original and
three copies are sent to the Center for Scientific Review (CSR); otherwise,
the NCI cannot guarantee that the applications will be reviewed in competition
with other applications received by the receipt date.

Complete applications must be received by January 15, 1999.  If an application
is received after that date, it will be returned to the applicant without
review.  The CSR will not accept any application in response to this RFA that
is essentially the same as one already reviewed.  This does not preclude the
submission of substantial revisions of applications already reviewed, but such
applications must include an introduction addressing the previous critique.
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.

REVIEW CONSIDERATIONS

A.  Review Procedures

Upon receipt, applications will be reviewed by CSR for completeness and  for
responsiveness by the NCI.  Applications that are incomplete and/or non-
responsive to this RFA will be returned without further consideration.

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, all applications will receive a written critique and undergo a
process in 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.

B.  Review Criteria

The major factors to be considered in the evaluation of all applications are
given below.  

1.  The Institutional Commitment, including:

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 for strengthening 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.  scientific qualifications and demonstrated scientific and administrative
leadership capabilities of the SPORE Principal Investigator; adequacy of the
time commitment of the Principal Investigator;

b.  depth and breadth of the proposed research activities, and plans to
effectively pursue translational research objectives;

c.  adequacy of access to patients and populations for conducting current and
projected therapeutic, prevention and control research;

d.  adequacy of the procedures, processes, and plans for promoting
interactions;

e.  adequacy of plans for synergistic and effective interactions with existing
P30 programs, if applicable.

3.  Individual Research Projects:

The five criteria to be used to evaluate individual research projects in SPORE
grant applications are listed below.  Within the SPORE concept of
translational research, reviewers will comment on the following aspects of the
application in their written critiques.  Reviewers are asked to judge the
likelihood that the proposed research will substantially impact on the pursuit
of the goals implied within the following criteria.  Each criterion will be
addressed and considered by the reviewers in assigning the overall score,
after weighting the determinations as appropriate for each application.  Note
that the application does not need to be strong in all categories for the
research to be judged likely to have a major translational impact and thus
deserve a favorable priority score.  For example, an investigator may propose
to carry out work that by its nature is important but not innovative if it
translationally moves the field forward.
 
a.  Significance.  Does this study address an important research problem? 
Does the scientific merit and experimental design of the project adequately
address issues of substantive importance for reducing incidence and mortality,
or for increasing survival in human ovarian cancer?

b.  Approach.  Are the conceptual research framework, design, methods, and
analyses adequately developed, well-integrated, and appropriate to the aims of
the project?  Does the applicant acknowledge potential problem areas and
consider alternative translational approaches? Is there clear evidence of
significant multidisciplinary basic and clinical interactions in the
conception, design, and proposed implementation of the project?

c.  Innovation.  Does the project develop new methodologies or technologies in
the areas of prevention, diagnosis, and/or treatment of ovarian cancer? Is the
experimental design of sufficient  originality, novelty, and innovativeness to
make it highly relevant to the overall goals and objectives of the SPORE?

d.  Investigators.  Are the investigators appropriately qualified with
demonstrated competence to conduct the proposed research?  Is the proposed
work appropriate to the experience level of the principal investigator and
project researchers?  Are the proposed time commitments for all key laboratory
and clinical researchers reasonable and adequately associated with the
project? 
 
e.  Environment.  Does the scientific environment in which the work will be
done contribute to the probability of success?  Do the proposed experiments
take advantage of unique features in the scientific environment or reach out
to useful collaborative arrangements? Is there evidence of adequate
institutional support? Is the project interactive with other components of the
SPORE, conceptually, experimentally, and translationally?

f.  The following additional factors should be evaluated for individual
research projects:
o  evidence of full protection of human subjects for clinical research
components, and appropriate mechanisms for the rigorous management and
verification of research data;

o  adequacy of quality assurance and audit processes, and adequacy of the
related budget for research involving clinical trials;

o  appropriateness of the budget to achieve the stated research objectives.

o adequacy of plans to include both genders and minorities and their subgroups
as appropriate to meet the scientific goals of the research;

o  plans for the recruitment and retention of research subjects and patients
will also be evaluated.

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 ovarian 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.  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 ovarian 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 ovarian 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.

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;
5.  overall program organization.

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.

AWARD CRITERIA

The earliest anticipated date of award is September 30, 1999 Applications
considered by the National Cancer Advisory Board will be considered for award
based upon (a) priority score, (b) programmatic priorities, and (c)
availability of funds.  The NCI anticipates making at least one award for a
project period of five years.

SCHEDULE

Letter of Intent Receipt Date:  October 1, 1998
Application Receipt Date:       January 15, 1999
Review by NCAB Advisory Board:  September 1999
Anticipated Award Date:         September 1999

INQUIRIES

Written and telephone inquiries concerning the objectives and scope of the
RFA, and 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.

For inquiries regarding programmatic issues, contact:

Jorge Gomez, M.D., Ph.D.
Organ Systems Branch
National Cancer Institute
6130 Executive Boulevard, Suite 512, MSC 7386
Bethesda, MD  20892-7386
Rockville, MD 20852 (for express/courier service)
Telephone:  (301) 496-8528
Email: jg1w@nih.gov

For fiscal or administrative matters, contact:

Cynthia W. Mead
Grants Administration Branch
National Cancer Institute
6120 Executive Boulevard, Room 243, MSC 7150
Bethesda, MD  20892-7150
Telephone:  (301) 496-7800  ext. 254

AUTHORITY AND REGULATIONS

This program is described in the catalog of Federal Domestic Assistance No.
93.397.  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 285 ) 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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