**GUIDELINES**

**SPECIALIZED PROGRAMS OF RESEARCH EXCELLENCE (SPOREs)**

**ORGAN SYSTEMS BRANCH**

**OFFICE OF CENTERS, TRAINING, AND RESOURCES**

**OFFICE OF DEPUTY DIRECTOR FOR EXTRAMURAL SCIENCES**

**NATIONAL CANCER INSTITUTE**

**June 2001**

**SECTION I. GENERAL GUIDELINES** 3-27

A. INTRODUCTION 3-4

B. SPORE DEFINITION OF TRANSLATIONAL RESEARCH 4

C. GENERAL DESCRIPTION OF THE SPORE PROGRAM 5-6

D. FUNDING OF SPORE GRANTS 6-7

E. ELIGIBILITY AND REQUIRED COMPONENTS 7-14

F. SUBMISSION REQUIREMENTS AND RECEIPT DATES 14-20

G. REVIEW CONSIDERATIONS 20-27

H. INQUIRIES 27

**SECTION II. SPECIAL INSTRUCTIONS FOR PREPARING A COMPETING**

**SPORE GRANT APPLICATION** 27-41

A. GENERAL INFORMATION 28

B. DETAILED DIRECTIONS 28-41

**SECTION III. SUPPLEMENTAL GUIDELINES FOR PREPARING A**

**NONCOMPETING CONTINUATION SPORE GRANT APPLICATION** 41-46

# A. INTRODUCTION 41-42

B. GENERAL ISSUES 42

C. PROGRESS REPORT SUMMARY 42-46

**SECTION I. GENERAL GUIDELINES**

**A. INTRODUCTION**

Specialized Programs of Research Excellence (SPOREs) were conceived and
implemented by the National Cancer Institute (NCI) through a special
\$20 million appropriation from Congress in Fiscal Year 1992. SPOREs
evolved from the original NCI Organ Site Programs, which were
organ-specific but without translational research focus, established
shortly after the National Cancer Act of 1971. SPOREs represented a
strategic response to the rapid expansion of information about cancer
being developed through basic research using model systems. At that
time, there was no funding mechanism designed exclusively to focus on
translational research that would take a systematic approach to
exploring which basic research discoveries were potentially the most
likely to have an impact on human cancers. In order to address this
need, the SPORE Program was initiated by the NCI as an experiment to
promote interactions between basic scientists and applied scientists and
provide them with the flexibility to rapidly test new approaches to the
prevention, early detection, diagnosis and treatment of human cancer.

When the SPORE program was initiated in FY92, Request for Applications
(RFAs) were issued that resulted in the funding of four breast cancer
SPOREs, two prostate cancer SPOREs and two lung cancer SPOREs. The
objective of the SPORE program was and is to encourage a wide range of
scientific approaches focused on translational research (see the SPORE
definition of translation below). Of particular importance was choosing
a grant mechanism (i.e., the P50) that has all of the features necessary
to enable SPOREs as translational research instruments. These P50 grants
are designed so that every research project is inherently translational:
specialized infrastructures are established to support translational
research; scientists work as teams rather than as independent
investigators; scientists have the flexibility to start and stop
research projects without additional peer review; scientists have
flexible funds to develop pilot projects and test new technologies in
collaboration with scientists in or outside of their institutions; and
SPOREs combine their resources to ask questions that no one institution
could address alone.

The first P50 SPORE grants were funded for three rather than five years
in order to ensure that the translational research concept was working;
as the experiment proved more promising, all applicants were allowed to
request five years of support. Using the RFA process, the SPORE Program
evolved to include five sites: breast, prostate, lung, gastrointestinal
and ovary. However, by limiting the submission of SPORE applications to
every five years in response to RFAs, the Program was relatively
"closed" and unable to capitalize on investigator-initiated scientific
opportunities. In addition, the Program was not open to all cancer
sites. These issues were discussed with NCI advisory groups. In
particular, the NCI Board of Scientific Advisors suggested that the
initial results of the SPORE Program were very promising and, although
it favored additional evaluation with time, it saw no reason to restrict
the expansion of the SPORE Program. As a result, in 1999 the NCI
approved restructuring the SPORE program from one that was RFA-driven to
one that was investigator-initiated, utilizing a program announcement
(PA) open to grant applications for all types of cancers on a scheduled
competitive basis.

**B. SPORE DEFINITION OF TRANSLATIONAL RESEARCH**

There is currently no consensus definition of translational research.
For purposes of the SPORE program the NCI defines it as follows:
**translational research uses knowledge of human** **biology to develop
and test the feasibility of cancer-relevant interventions in humans
AND/OR determines the** **biological basis for observations made in
individuals with cancer or in populations at risk for cancer**. The term
"interventions" is used in its broadest sense to include molecular
assays, imaging techniques, drugs, biologicals and/or other
methodologies that are relevant to the prevention, early detection,
diagnosis, prognosis or treatment of cancer. Translational research in
SPOREs is always founded on and directly connected to some aspect of
human biology and may encompass any form of cellular, molecular,
structural, biochemical, genetic, or other appropriate experimental
approach.

SPOREs conduct early-stage interventions to establish the feasibility or
proof of principle of specific approaches in cancer. All research
projects whose goal is the development and testing of an intervention
are expected to reach the feasibility testing stage in humans within the
anticipated five-year period of grant support. Similarly, studies that
seek to determine the biological basis for an observation in human
cancer should do so within five years. Some, but not all, types of
behavioral research are appropriate for SPOREs. Biobehavioral research
that clearly focuses on links between biological variables, processes,
and mechanisms pertaining to behavior or psychosocial variables is
appropriate. Psychosocial variables might include cognitions, affect,
personality, or interpersonal context or processes (e.g., social
support, familial interactions, physician-patient communication).
Behavioral research that focuses on psychosocial processes or behavior
change without a clear, specific linkage to a biological process (e.g.,
disease susceptibility, etiology, or progression) is not appropriate.
SPOREs are also not the place for definitive validation of new
interventions, which are supported by other programs in several
divisions of the NCI.

Within the limits of the definitions and time frames outlined above,
SPOREs have considerable flexibility in selecting and developing areas
of research with the greatest anticipated potential for improving cancer
outcomes. Investigators who question whether their research goals adhere
to the above definition of translation and/or the expectations of the
SPORE Program are advised to consult with NCI program staff in the Organ
Systems Branch.

![](media/image1.png){width="3.8541666666666665in"
height="3.6666666666666665in"}

Figure 1. Translational research focus of a SPORE. Research projects
should be designed to (a) test the relevance of a biological discovery
in human cancer risk, prevention, diagnosis, prognosis, or treatment or
(b) determine the biological basis of an observation made in the clinic
or population within the five-year term of the grant.

**C. GENERAL DESCRIPTION OF THE SPORE PROGRAM**

Specialized Programs of Research Excellence (SPOREs) utilize the P50
grant mechanism to support interdisciplinary teams of investigators who
are dedicated to translational research focused on an organ-specific
human cancer (e.g., breast cancer) or a highly related group of human
cancer types (e.g., gastrointestinal). SPOREs are open to any scientific
approaches that can have an impact on the disease and are dependent upon
team approaches in the design and implementation of the research. SPOREs
differ from program project grants (P01s) in that SPORE grants focus on
human disease and exclusively support translational research, have a
flexible approach to starting and stopping research projects, and have a
required tissue bank core as well as required programs for career
development and developmental projects. In addition to their organ-site
orientation, the common features of all SPOREs are the following:

**1. Translational Research Focus**

All SPOREs focus on translational research that meets the definition
provided in Section I.B. above. The research of a SPORE is dedicated to
obtaining experimental results that will have a direct impact on
improving approaches to the prevention, detection, diagnosis and/or
treatment of human cancer. SPOREs may support basic science projects if
the objective of the research will be directly relevant to human cancer
and realize a human application during the five year term of the grant.
If a project has lost its translational focus or the likelihood of
having an impact on human cancer, it should be discontinued and another
funding source sought.

**2. Collaborative Design and Implementation of Research Projects**

Every project in a SPORE is inherently translational because it is
collaboratively designed and executed by basic scientists working at the
cellular and molecular levels, physicians experienced in
patient-oriented research, and population scientists experienced in
studying the patterns of disease.

**3. Flexibility to Change Research Direction/Team Approach**

SPOREs continually select the most promising research approaches that
are likely to have a more immediate impact on improving cancer
prevention, detection, diagnosis, prognosis and/or treatment. The
flexibility of the SPORE program promotes the discontinuance of research
projects demonstrating little or no translational significance or
scientific progress and enables new projects with greater potential to
be initiated. While the team of scientists that participates in the
SPORE remains largely the same, the lead roles of co-investigators on
projects may change through the course of the research.

**4. Specialized Research Infrastructure**

SPOREs are expected to develop the critical research infrastructure
needed to sustain translational research objectives for projects within
the SPORE, as well as for potential collaborative research with other
SPOREs and other research groups within the biomedical research
community. SPOREs are expected to be in a position to facilitate the
complex research objectives inherent in studying human cancer.

**5. Fostering Translational Research Careers**

SPOREs provide a unique environment for translational research that can
be used to prepare new scientists for careers in this evolving field or
provide the opportunity for established scientists to re-orient their
research careers toward translational research.

**6. Research Collaborations, Networks, and Consortia**

SPOREs are expected to identify the kinds of research questions that can
only be accomplished through research collaborations, networks, and
consortia. SPOREs collaborate with other scientists in the field to
answer research questions that can take full advantage of SPORE
scientific expertise and infrastructure. Through the promotion of
Inter-SPORE research, SPOREs also conceive and initiate research that is
linked to other key programs of the NCI.

**7. Sharing Information**

SPOREs readily share information within their organ site network, as
well as with other SPOREs, to take advantage of research results that
are applicable to various cancer sites.

**D. FUNDING OF SPORE GRANTS**

**1. Grant Mechanism**

Support of this program is through the specialized center grant (P50)
mechanism employed by the National Institutes of Health. Applicants are
responsible for the planning, direction, and execution of the proposed
SPORE program. Awards can be made for up to five years and will be
administered under NIH grants policy as stated in the NIH Grants Policy
Statement.

**2. Basis of Funding**

Applications will be awarded on a competitive basis. The following will
be considered in making decisions: quality of the application as
determined by peer review, availability of funds, and programmatic
priorities.

**3. Planning Grants**

While applicants cannot apply directly for planning grants (P20s), under
special circumstances, the NCI may consider funding a P50 SPORE
application at a reduced level for up to two years using the P20 grant
mechanism. Circumstances leading to the funding of a P20 rather than a
P50 include: (1) the research projects in the SPORE application have
high scientific merit but other essential components of the application
require further development; (2) the peer review criticisms can be
readily addressed within two years; and/or (3) the application meets
important NCI program objectives (e.g., the organ site to be studied is
under-represented).

**4. Expanded Authorities**

Both NCI P50 and P20 grants may be administered by the awardee under
Expanded Authorities which can be viewed at:
[http://grants.nih.gov/grants/policy/nihgps/part_ii_5.htm#expandauth]{.underline}.
The expanded authorities allow additional flexibility to take advantage
of research opportunities as they arise throughout the term of the
grant. Under the expanded authorities, NIH has waived the requirement
for its approval of specified actions under certain awards and has
provided the authorities to grantees to take such actions without NIH
prior approval. These actions include the carryover of unobligated funds
and extensions of the project period without additional funds.

**E. ELIGIBILITY AND REQUIRED COMPONENTS**

Applications must meet all of the following eligibility criteria \[items
1(a)-(d)\] as well as contain the required components of a SPORE listed
in items 2-9 below. Applications that are not responsive to these
requirements will be returned to the applicant by NCI program staff and
will not undergo scientific peer review.

1.  **Eligibility**

> *(a) Institutional*
>
> Applications may be submitted by domestic for-profit and non-profit
> organizations, either public or private, including 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.
>
> *(b) Minimum Research Base*
>
> In order for a SPORE application to be accepted by NCI, the
> application must include four or more independent investigators who
> currently serve as principal investigators (or project leaders) on
> *peer-reviewed* research grants (e.g., R01, P01, U01, U10, ACS, DOD,
> or equivalent) **directly related to the cancer(s)** being
> investigated. The applicant is encouraged to provide a separate list
> of these grants or, alternatively, can highlight them on Other Support
> pages.
>
> *(c) Cancer Patient Population*

Each SPORE must document access to a substantial patient population in
the cancer-site focus of the application and provide reasonable
assurance that the patients and tissues needed for translational
research are readily available. If the appropriate patient population is
not available to the applicant institution, a consortium agreement may
be established with a different institution to provide adequate access
to clinical specimens (tissue) and patients at another site.

> *(d) Budget Limitation*

By NCI policy, all competing SPOREs are subject to both *direct cost and
total cost budget caps, which currently are \$1.75 million and \$2.75
million, respectively*. In complying with the direct cost cap of \$1.75
million, the indirect costs related to subcontracts to other
institutions or organizations do not apply toward the direct cost cap.
However, these consortium indirect costs must be included in the total
cost which, overall, may not exceed the \$2.75 million cap. Applications
with requests exceeding these financial limits will be returned to the
applicant without peer review. In non-competing years, applications can
exceed these caps as a result of standard (yearly) cost-of-living
increases or as a result of special supplements approved by the NCI. For
more information about the cap in any given year, applicants must
contact the Organ Systems Branch using the telephone number, fax number
or e-mail address listed under INQUIRIES below.

**2. Statement of Institutional Commitment**

An institution considering applying for a SPORE should demonstrate a
commitment to the SPORE\'s stability and success by incorporating the
SPORE high within its institutional priorities. The application must
provide a statement of commitment that includes a plan addressing how
the institutional commitment will be established and sustained, how the
institution will maintain accountability for promoting scientific
excellence, and how the SPORE research effort will be given a high
priority within the institution relative to other research efforts. The
institutional commitment may be in the form of support for recruitment
of scientific talent, provision of discretionary resources to the SPORE
Director, assignment of specialized research space, cost sharing of
resources, or other ways proposed by the applicant institution. *A
letter from the Dean or Cancer Center Director should be attached
confirming this commitment*. In the case of a SPORE that involves a
consortium arrangement between two or more institutions, the institution
that submits the P50 application must receive a formal written
agreement(s) from the other participant organization(s). This agreement
should clearly delineate the institutional commitment of the
participating organization(s) (in the ways outlined above) to the SPORE
program.

**3. Intellectual Property Rights**

The institution should provide a written assurance that it will protect
the intellectual property rights of the SPORE investigators and their
collaborators and under no circumstances engage in formal/legal
agreements with commercial sources (e.g., pharmaceutical companies) that
would compromise the ability of SPORE investigators to have unhampered
access to institutional resources in SPORE-related research or
participate fully in collaborations with any other researchers. The
statement of commitment should also include a written assurance that in
its interactions with commercial entities under sponsored research
agreements, the SPORE will comply with the requirements of the Bayh-Dole
Act and NIH funding agreements while upholding basic principles of
academic freedom. Sponsored research agreements with commercial entities
should be entered into by the SPORE only upon due consideration of the
points outlined in \"Developing Sponsored Research Agreements:
Considerations for Recipients of NIH Research Grants and Contracts
(Federal Register, Vol. 59, No. 215, Tuesday, November 8, 1994, pp.
55674-55679)\", a copy of which can be viewed at:

[http://ott.od.nih.gov/NewPages/text-com.htm]{.underline}. The statement
of commitment should also include a written assurance that the SPORE
will manage its interactions with third parties so that they do not
restrict the SPORE\'s ability to receive and disseminate biomedical
research materials from and to the scientific community*. Likewise,
letters should be supplied by any relevant third parties confirming
their adherence to these policies*.

**4. Research Projects**

Research projects may be conducted solely through the parent
institution, or through collaborative associations that have been
developed or are planned with other SPOREs or with other investigators
in the biomedical research community. However, all SPOREs must meet the
following requirements:

(a) **Each** proposed research project must meet the definition of
    translational research as described in Section I.B above.
    Investigators who are not certain about whether their project fits
    this definition are advised to consult with NCI staff.

(b) Each proposed research project must be designed to test the
    relevance and/or potential importance of the research to human
    cancer **within the five-year term of the grant** (e.g., validation
    of a new screening mechanism or diagnostic test, early phase
    therapeutic trial, analysis of human tissues such as tumor or blood
    samples). Basic research projects, such as those employing animal
    models or cell lines, qualify as translational only if a human
    application is included in the specific aims of the research. A
    project(s) proposed in a competitive renewal application may focus
    solely upon the human application or laboratory effort if it marks
    the final stage of an ongoing translational SPORE study. *Applicants
    are encouraged to contact the Organ Systems Branch (see INQUIRIES
    below) if they have any questions concerning this essential
    requirement.*

(c) **Each** proposed research project must be led by **co-(principal)
    investigators** in biological science and applied sciences who
    commit adequate percent efforts and who use their combined
    conceptual and experimental skills in designing and implementing the
    project. It should be evident from this collaboration that
    translational research objectives will be accelerated such that it
    will be possible to test the relevance of the underlying hypotheses
    or to generate new hypotheses relevant to human disease. It is not
    necessary that the co-investigators commit equal effort to the
    project. There are **NO** exceptions to this requirement.

(d) At least **ONE** research project must focus on early detection,
    screening, prevention, and/or population science research. (Note
    that at least one scored project in this category will be required
    for award, see REVIEW CONSIDERATIONS, Section G.1. below.) If the
    application is funded, a project with this research focus must be
    maintained throughout the entire term of the grant.

(e) A minimum of **four research projects** are required representing a
    **balance and diversity** of translational research objectives
    (e.g., screening, prevention, diagnosis, treatment). Applications
    with a specific theme (e.g., gene therapy in prostate cancer) are
    discouraged. (Note that four projects scored by the peer review
    group will be required for award, see REVIEW CONSIDERATIONS,
    Sections G.1. and G.5. below.)

(f) A plan must be proposed for evaluating the scientific progress and
    translational potential of all projects and replacing them as
    necessary. During the period of award, replacement projects will be
    reviewed by the grantee institution and NCI program staff, but will
    not undergo additional peer review. Competing renewal applications
    will be evaluated based on their track record for fostering
    significant translational research during the prior grant period.

(g) Research projects involving **HUMAN SUBJECTS** must include women,
    children, and members of minority groups and their subpopulations
    unless a clear and compelling rationale establishes inclusion is
    inappropriate with respect to the health of the subjects, the
    purpose of the research, or another extenuating circumstance.
    Applicants are required to address this issue in developing a
    research design appropriate to the scientific objectives of their
    study. Instructions for responding to this issue are provided at:

and

> [http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm.]{.underline}
>
> Recruitment plans, as well as Gender and Minority Inclusion Reports
> must be
>
> included for **each** project/ resource that involves human subjects.
>
> **Only early (Phase I and Phase II) clinical trials may be supported
> by the SPORE mechanism**. A plan for a clinical trial must include
> provisions for rigorous data management, quality assurance, and safety
> monitoring. These monitoring activities are distinct from the
> requirement for study review and approval by an Institutional Review
> Board (IRB). For details about the Policy of the NCI for Data Safety
> Monitoring of Clinical Trials see
> <http://deainfo.nci.nih.gov/grantspolicies/datasafety.htm>. Applicants
> should provide evidence that they will utilize Data and Safety
> Monitoring systems in place at their institution. A general
> description of the data and safety monitoring plans should be included
> in the application (see [)]{.underline}. This description should
> explain the rules and procedures for detecting, monitoring, and
> reporting any adverse drug reaction or event during a clinical trial.
> A copy of the trial protocol, along with informed consent forms, are
> also required if the trial is already underway or is anticipated to
> begin soon after an award is made. If the trial will be performed
> during the latter part of the grant term, submission of these items to
> NCI program staff is required prior to the initiation of the trial.

The NIH now also requires that all investigators proposing research
involving human subjects are educated on the protection of human
research participants. This policy was effective as of October 1, 2000
and was published in the NIH Guide for Grants and Contracts, June 5,
2000 (Revised August 25, 2000) which is available at:

[http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.]{.underline}

**5. Shared Resources (or Cores)**

(a) Each SPORE must have a dedicated component for collecting and
    distributing **human cancer site-specific tissue**. The tissues may
    be frozen or archived paraffin blocks, slides, or fluids such as
    serum, plasma, urine, or sputum samples. This should be a true
    tissue resource that can be used to generate and test translational
    hypotheses, rather than a small collection of heterogeneous samples.
    The tissue core should also include the essential pathological,
    clinical and family history information needed for conducting a wide
    range of translational research. Appropriate informatics capability
    for tracking, as well as linkage to clinical and follow-up data
    sets, should be demonstrated.

> This resource should benefit the specific research activities of the
> SPORE, as well as the research activities of other scientists within
> and outside the parent institution who are concentrating on
> translational research issues. A plan must be proposed for
> prioritizing distribution of tissues to SPORE scientists and others
> based on the merit of translational cancer research projects.
>
> \(b\) Additional shared resources (e.g., administrative, clinical,
> statistical, animal) may also be proposed that are supportive of one
> or more of the research projects of the SPORE.

**6. Developmental Research Program**

Every SPORE must allocate a significant effort to support pilot 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 for funding pilot projects that
generate feasibility data and have the most promising translational
research potential*.* These funds are intended to remain flexible and to
support studies of a limited duration, e.g., two years or less. The
expectation is that successful feasibility studies will replace full
projects that are not progressing satisfactorily with regard to
translational research objectives within the SPORE (see above). New
applicants may supply a short description (1-2 page(s) maximum) of
eligible projects as examples. Renewal applicants should supply their
track record of funding pilot projects, ongoing pilot projects, and
short descriptions of other potentially eligible projects.

A Developmental Research Program, as a required element of a SPORE, must
be maintained throughout the entire term of the grant.

**7. Career Development Program**

The SPORE must demonstrate a consistent and significant commitment to a
career development program in translational cancer research. This may
focus on advanced post-doctoral candidates, junior faculty, or
established investigators who wish to develop or refocus their careers
on translational research. SPORE career development programs are not
intended for predoctoral candidates.

An appropriate portion of the total SPORE budget should be dedicated to
this program and support the salary and research costs of candidates
with outstanding potential. Each candidate should have a mentor(s) and
devote a significant percentage of his/her effort to translational
research. The description of this program should include the policies,
criteria, and processes for selecting candidates, including **special
efforts to recruit qualified women and minorities**. The plan should
include the number and types of positions (e.g., advanced post-docs,
junior faculty, established investigators) that will be made available,
the criteria for eligibility and selection of candidates, and a
description of the selection process. New applicants should provide a
list and short description of potential candidates, as well as the names
and research activities of mentors. Renewal applicants should provide
this in addition to the track record of candidates supported on the
SPORE.

A Career Development Program, as a required element of a SPORE, must be
maintained throughout the entire term of the grant.

**8. Annual SPORE Workshop**

SPORE investigators will be expected to participate in an annual
workshop organized by the Organ Systems Branch of the NCI to share
positive and negative results with other SPOREs, share materials, assess
progress, identify new research opportunities, as well as establish
interactions, 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 SPORE investigators and collaborators may be budgeted for this
purpose. In conjunction with the workshop, SPORE Directors will be
required to attend an administrative and planning meeting with program
staff from the NCI.

**9. Other Provisions**

If a SPORE application originates from an institution that is supported
by an NCI Cancer Center Grant (P30), the following items should also be
addressed (generally within the Program Description).

> \(a\) Once a SPORE is funded, the Principal Investigator of the SPORE
> should become a senior leader in the Cancer Center. The Principal
> Investigator of the SPORE may or may not be the Cancer Center
> Director.
>
> \(b\) Lines of authority should be clearly indicated such that the
> SPORE is an integral part of the Cancer Center but does not interfere
> with the P30 chain of authority. **A letter of commitment which
> delineates these organizational relationships is required.** This
> letter must be signed by the proposed Principal Investigator of the
> SPORE, as well as the Cancer Center Director.

(c) The applicant should discuss how the SPORE will interact
    synergistically with existing P30 programs in order to maximize both
    SPORE and Cancer Center research objectives. While the SPORE is
    expected to become an integral element within the NCI-designated
    Cancer Center, a distinct institutional commitment to the SPORE must
    still be maintained throughout the term of the SPORE grant (see
    Section E.2. above).

> \(d\) The resources (or cores) within the SPORE should not duplicate
> any available facility already in place and supported by another
> granting mechanism (e.g., P30, P01, U01, U10, DOD, etc.). Applicants
> can, however, use SPORE funds to augment pre-existing Cancer Center
> resources in order to direct these activities towards more effectively
> fulfilling the requirements of the SPORE. This is especially true of
> the SPORE tissue resource, which should be designed to prioritize the
> needs of SPORE investigators over those of others. The SPORE should
> also utilize the IRB, Data and Safety Monitoring Board(s), as well as
> clinical resources available throughout the Cancer Center whenever
> possible.

#### F. SUBMISSION REQUIREMENTS AND RECEIPT DATES 

**1. Pre-application Consultation (Strongly Recommended)**

NCI program staff strongly encourages each prospective applicant to
schedule a pre-application consultation. The consultation should be
scheduled **four to six months** in advance of the due date for
submission and is intended to help the applicant (**along with one or
more of his/her intended co-investigators)** understand the SPORE
Program and discuss strategies for preparing a competitive application.
NCI staff will clarify the intent of the guidelines, discuss funding
trends, discuss potential alternative SPORE organizational structures
and allowable resources, and describe the peer-review process. The
applicant can define which issues would be most helpful to discuss and
then work with NCI program staff to decide what information is most
appropriate to provide. The following are examples of items that help
NCI program staff understand the plans of applicants:

-   A brief description of the background and proposed responsibilities
    of the SPORE Director and key senior leaders of the SPORE.

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-   A diagram showing the proposed reporting, programmatic, and advisory
    structure of the SPORE and how it relates to the structure of the
    institution as a whole.

• A brief description of the proposed translational research projects,
along with their specific aims and the names of project leaders.

-   Estimated budgets for each component (i.e., full projects,
    resources, developmental/career programs) of the anticipated SPORE
    application.

• A list of active peer-reviewed research grants, cooperative
agreements, and contracts that form the research base of the scientific
leaders of the SPORE.

**2. Letter of Intent**

Although it is not required and does not enter into the review of an
application, all prospective applicants are requested to submit a letter
of intent **at least 60 days prior to the receipt date** for the
application. The letter of intent should include a descriptive title of
the proposed research, the name, address, and telephone number of the
Principal Investigator, the identities of other key personnel and
participating institutions, and the number and title of the RFA in
response to which the application may be submitted. This letter allows
NCI staff to estimate the potential review workload and avoid conflict
of interest in the review. Furthermore, NCI staff can make sure
applicants are fully aware of all applicable NIH and NCI policies, meet
eligibility requirements and understand the peer review process before
the application is submitted.

The letter of intent should to be sent to the following address:

#####  Organ Systems Branch

OCTR, ODDES, NCI

6116 Executive Blvd.

Suite 7013, MSC 8347

######  Bethesda, MD 20892

**3. Application Procedures**

The NIH application form PHS 398 (rev. 4/98) is to be used in applying
for these grants. Application forms and guidelines are available
through:

, most institutional offices of sponsored research, or from:

#####  Division of Extramural Outreach and Information Resources

National Institutes of Health

#######  6701 Rockledge Drive, Suite 6095

Bethesda, MD 20892-7910

Ph. (301) 435-0714

FAX (301) 480-0525

E-mail:

Copies of the SPORE guidelines and program announcements are available
at the following URL addresses, respectively:
[http://spores.nci.nih.gov]{.underline} and

. Instructions in these documents must be followed in preparing a SPORE
application. On line 2 of the face page of the application form, the
applicant should provide the Program Announcement (PA) number, the title
"SPORE in (Organ) Cancer", and check the YES box.

At the time of submission, the **original signed application**,
including the checklist, should be sent along with **three copies
(without appendices)** to:

#####  

#####  Center for Scientific Review

National Institutes of Health

6701 Rockledge Drive

Room 1040, MSC 7710

######  Bethesda, MD 20892-7710

(use 20817 zip code for express service)

########  Ph. (301) 435-0715

**Two additional copies** of the application **and five copies of any
appendices** must also be sent to:

#########  Ms. Toby Friedberg

Referral Officer

Division of Extramural Activities

######  National Cancer Institute

6116 Executive Blvd., Room 8109

Rockville, MD 20852 (if hand or express delivered)

Bethesda, MD 20892-8329 (if using US Postal Service)

The copies to the Center for Scientific Review (CSR) and the Division of
Extramural Activities (DEA) should be sent at the same time to assure
that the NCI will be able to review the application along with others
submitted for the same receipt date. The applicant is encouraged to keep
documentation of their mailing date(s) rather than contact the CSR or
DEA for confirmation of receipt. The CSR will not accept any application
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 ELIGIBILITY AND REQUIRED COMPONENTS, above) in these
guidelines.

**4. Application Receipt Dates**

Due to the logistical problems that would be created by simultaneously
accepting and reviewing grant applications for all cancer sites, the NCI
has implemented a transition plan that will move the program towards one
receipt date per organ site per year by the year 2005.

Receipt dates for cancer sites will be announced each year with a formal
program announcement in the NIH Guide *.* The tentative receipt dates
for organ sites during this transition period are as follows:

February 1, 2001: Skin, Prostate

June 1, 2001: Gastrointestinal (upper/lower GI, pancreatic, and spleen
cancers), Prostate

October 1, 2001: Lymphoma, Brain, Head and Neck, Prostate

February 1, 2002: Breast, GYN

June 1, 2002: Lung, Myeloma, Leukemia (acute, chronic)

October 1, 2002: Prostate, Genitourinary

### February 1, 2003: Skin, Ovary

June 1, 2003: Gastrointestinal, Leukemia (acute, chronic)

October 1, 2003: Lymphoma, Brain, Head and Neck

February 1, 2004: Breast, Ovary, GYN

June 1, 2004: Lung, Gastrointestinal, Myeloma

October 1, 2004: Prostate, Genitourinary, Leukemia (acute, chronic)

February 1, 2005: Breast, Skin, Ovary, GYN

June 1, 2005: Lung, Myeloma, Gastrointestinal

October 1, 2005: Prostate, Genitourinary, Brain, Head and Neck,
Leukemia, Lymphoma

Applications for a given organ site will be accepted only on the
specified receipt date. Incomplete applications will be returned without
peer-review (see ELIGIBILITY AND REQUIRED COMPONENTS, above). For
competing renewal applications, consultation with NCI program staff is
encouraged to ensure adherence to the organ-specific submission schedule
and avoid gaps in funding.

**5. Inclusion of Women, Minorities, and Children in Research Involving
Human Subjects**

All investigators proposing research involving human subjects should
read the UPDATED \"NIH Guidelines for Inclusion of Women and Minorities
as Subjects in Clinical Research,\" published in the NIH Guide for
Grants and Contracts on August 2, 2000
([http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html]{.underline});
a complete copy of the updated Guidelines is available at
[http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm]{.underline}:

It is also the policy of the NIH to include children (i.e., individuals
under the age of 21) in all human subjects research conducted or
supported by the NIH, unless there are scientific or ethical reasons to
exclude them. This policy applies to all initial (Type 1) applications
submitted for receipt 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 URL address:

As part of the scientific and technical merit evaluation of the research
plan, reviewers are instructed to consider the adequacy of the plan for
including women, minorities, and children. Omission of this information
(including reasons for exclusion) can have a negative impact on the
priority score of a specific project and/or the overall application. In
preparing these sections of the application, investigators are
encouraged to follow the additional instructions provided under Section
E.4.f. above.

**6. URLS in NIH Grant Applications or Appendices**

All applications and proposals for NIH funding must be self‑contained
within specified page limitations. Unless otherwise specified in an NIH
solicitation, internet addresses (URLs) should not be used to provide
information necessary to the review because reviewers are under no
obligation to view the Internet sites. Reviewers are cautioned that
their anonymity may be compromised when they directly access an Internet
site.

**7. Required Education in the Protection of Human Research
Participants**

Investigators proposing research involving human subjects are now
required to demonstrate that they have been trained in the protection of
human research participants according to the policy published in the NIH
Guide for Grants and Contracts, June 5, 2000 (Revised August 25, 2000),
available at the following URL address:

<http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html>.

**8. The Office of Management (OMB) Circular A-110**

The Office of Management and Budget (OMB) Circular A-110 has been
revised to provide public access to research data through the Freedom of
Information Act (FOIA) under some circumstances. Data that are (1) first
produced in a project that is supported in whole or in part with Federal
funds and (2) cited publicly and officially by a Federal agency in
support of an action that has the force and effect of law (i.e., a
regulation) may be accessed through FOIA. It is important for applicants
to understand the basic scope of this amendment. NIH has provided
guidance at
<http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm>.
Applicants may wish to place data collected under this RFA (PA) in a
public archive, which can provide protections for the data and manage
the distribution for an indefinite period of time. If so, the
application should include a description of the archiving plan in the
study design and include information about this in the budget
justification section of the application. In addition, applicants should
think about how to structure informed consent statements and other human
subjects procedures given the potential for wider use of data collected
under this award.

**G. REVIEW CONSIDERATIONS**

**1. Review Policies**

Upon receipt of an application, the Scientific Review Administrator
(SRA) in the NCI Division of Extramural Activities (DEA) reviews it for
completeness and conformance to NIH policies. The application is then
evaluated for responsiveness to all required components in the PA by OSB
program staff. Applications that are incomplete or are non-responsive to
the NCI SPORE Program will be returned to the applicant without further
consideration (See section E above).

Applications that are complete and responsive will be evaluated for
scientific and technical merit by an appropriate peer review group
convened by the National Cancer Institute and informed of the review
criteria provided below. While all eligible applications will receive a
written critique, some may be removed from further consideration by the
peer review group in the initial stages of the merit review process. In
these instances, only applications deemed to have the highest scientific
merit will be discussed further by the review panel. In addition*,* if a
required component(s) of an otherwise meritorious SPORE application is
of such low merit that it is not recommended for further consideration
(NRFC) by the peer review committee, the entire application will be
unscored. See Section I.E. of this document for a description of the
required components of a SPORE application. Applications that receive a
full review are assigned a priority score and receive a second level
review by the National Cancer Advisory Board (NCAB).

**2. Application Receipt and Referral**

SPORE (P50) applications, like all other PHS applications, are received
and initially processed by the NIH Center for Scientific Review (CSR).
Following the current NCI referral guidelines, the application is
assigned to NCI and subsequently to the Organ Systems Branch and SPORE
program area. An SRA in the Grants Review Branch in the NCI Division of
Extramural Activities will be assigned to manage the review.

After application submission, all correspondence should be directed to
the SRA. Applicants are expected to submit complete applications by the
specified receipt dates. The decision on whether to accept additional
supplementary documentation is that of the SRA.

**3. Review Procedures**

As the manager of the review process, the SRA serves as the resource for
both applicants and reviewers with respect to NIH review policies,
guidelines, rules, regulations, options available, procedures, etc. He
or she ensures that the review is conducted in accordance with NIH and
NCI policies. The NCI Program Director serves as a resource, as needed,
concerning the history, intent and development of the program, changes
in program direction, objectives and any other relevant programmatic
matters.

The scientific merit of a SPORE application is assessed by the peer
review committee. Review of a SPORE application will include
participation of senior scientists with review experience, a broad
perspective on cancer research, and a wide variety of expertise. Breadth
is a necessary component of the review committee. Patient advocates also
provide important points of view in regard to translational research
conducted by SPOREs and therefore will also serve as members of this
review committee*.* *Applicants should take into account the fact that
their application is reviewed by multiple individuals. Any piece of
information that is critical to a particular project, resource, or
program should be presented within the section designated for that
activity (and not just within the overall "Program Description", for
example).*

Following assignment of a priority score by the review committee, action
by the NCAB completes the peer-review process.

**4. Review Criteria**

The evaluation of applications is based on the following:

> *(a) Full Projects*
>
> Within the SPORE concept of translational research (see definition in
> Section I.B. above), reviewers will evaluate each research project
> using the five review criteria and additional factors noted below.
> Each criterion will be considered by the reviewers in assigning the
> overall merit score of the project, although a project does not need
> to be strong in **all** criteria in order to be viewed as meritorious.

*(a.1) Significance*

> The importance of the **translational** research objective to human
> cancer and its likelihood of completion within the maximum five year
> project period. For competitive renewals, completed and ongoing
> projects will be critically evaluated for their scientific progress
> and success in adhering to the five-year project period.

*(a.2) Approach*

> The adequacy of the experimental design and methods to achieve the
> research objectives, as well as clear evidence of **co-leadership** by
> a scientist with a basic biological background, basic and/or applied
> scientist with a clinical research or population science research
> background in the conception, design, and proposed implementation of
> the project. Rationale for changing scientific direction and/or
> approach will also be evaluated for competitive renewals.
>
> *(a.3) Innovation*

Originality and novelty of experimental concept, design, and/or
approaches **as they relate to the SPORE definition of translational
research (See Section I.B.).**

*(a.4) Investigators*

> The qualifications of the basic biological and more applied
> co-investigators to conduct the proposed research and the
> appropriateness of the time commitments of each co-investigator to
> conduct the project.

*(a.5) Environment*

> The scientific environment in which the translational research work
> will be done and the unique features, if any, of the environment to
> support the proposed work.
>
> The following factors are also evaluated on each research project:

-   Evidence of the full protection of human subjects in
    clinical/epidemiological research components and appropriate
    mechanisms for the rigorous management and quality control of
    research data involving human subjects;

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-   Adequacy of the plans to include both genders, minorities and their
    subgroups, and children, as appropriate, to meet the scientific
    goals of the research.

> • Appropriateness of the budget to achieve the stated research
> objectives.
>
> *(b) Shared Resources (Cores)*
>
> *(b.1) Tumor Bank/Tissue Resource*

-   Adequacy of the proposed plan and/or track record to develop and
    maintain a human cancer site-specific tissue resource, store the
    tissue, link the tissue with appropriate pathological, clinical, and
    family history data that maximize their potential use in
    translational research.

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-   Adequacy of the proposed plan and/or track record to prioritize the
    distribution of tissues within and outside the SPORE.

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-   Evidence of experienced and available personnel dedicated to the
    activities of tissue collection, quality control of tissue
    specimens, tissue storage, tissue distribution, collection of
    initial and follow-up clinical information, data entry, and
    maintenance of database and computer networks.

-   When appropriate, adequacy of the proposed plan/track record to
    augment and/or complement any existing tissue resource supported by
    a Cancer Center Support Grant (P30) to avoid duplication and
    maximize productivity.

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-   Adequacy of the proposed plan and/or track record to obtain informed
    written consent for all prospectively collected tissues and protect
    confidentiality.

-   Appropriateness of the budget to conduct and integrate tissue
    banking activities.

*(b.2) Other Resources*

-   Degree to which plans and/or track record indicate that shared
    resources (will) effectively and efficiently support the research of
    the SPORE in a manner that can not be supported through other
    available (institutional or outside) resources.

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-   When appropriate, adequacy of the proposed plan/track record to
    augment and/or complement an existing shared resource supported by
    an NCI Cancer Center Support Grant (P30).

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-   Demonstration that the resource is essential to the success of the
    SPORE.

-   Adequacy of qualifications and performance (if applicable) of
    resource directors.

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-   Appropriateness of requested budgets to conduct each resource
    operation.

> *(c) Developmental Research Program*
>
> (c.1) Adequacy of the process and/or track record for attracting new
> ideas and pilot studies within and outside of the SPORE institution.
>
> (c.2) Adequacy of the proposed process and/or track record for
> continuously reviewing and funding a spectrum of pilot projects (e.g.,
> research, technology development, resources) based on their relevance
> to translational research and impact on human cancer. For competitive
> renewals, this program should also be evaluated by the SPORE's ability
> to promote outstanding translational pilot projects to full projects
> and/or demonstrate the successful competition of these projects for
> outside funds.

(c.3) Appropriateness of the budget relative to the needs and
demonstrated capabilities of the SPORE.

> *(d) Career Development Program*
>
> (d.1) Adequacy of the plan, in general, to sustain a significant
> activity for career development of translational research scientists.
>
> (d.2) Adequacy of the process and/or track record for selecting
> candidates for independent careers in translational cancer research.
>
> (d.3) Adequacy of the procedures and/or track record to seek out and
> include qualified minorities and women.
>
> (d.4) If applicable, current status and research activities of
> individuals who have been supported by the career development program.
>
> (d.5) Appropriateness of the budget (whether derived entirely from the
> SPORE or a combination of sources) relative to the proposed plans for
> sustaining a significant effort in career development.
>
> *(e) Overall Program Organization and Capability*
>
> (e.1) Scientific qualifications and involvement of the SPORE Principal
> Investigator as well as his/her demonstrated scientific and
> administrative leadership capabilities and time commitment.

(e.2) Adequacy of the planning and evaluation process to include:
determining translational research productivity of existing projects and
resources; discontinuing activities of low productivity; initiating new
activities in response to important translational research
opportunities; establishing collaborations; and utilizing the advice of
external advisors.

> (e.3) Adequacy of access to patients and populations for conducting
> current and projected therapeutic, prevention, detection and control
> research.
>
> (e.4) A balance and diversity of research activities within a minimum
> of four scored projects, including at least one devoted to early
> detection, screening, prevention, and/or population science.
>
> (e.5) Effectiveness of and/or plans for promoting interdisciplinary
> scientific interactions.
>
> (e.6) Effectiveness of and/or plans for integrating SPORE research and
> resources with existing Cancer Center/Institutional programs (e.g.,
> use of clinical data and safety management systems, biostatistical
> cores, etc.).
>
> (e.7) Adequacy of tangible institutional commitments that will enable
> and facilitate the research objectives of the SPORE (e.g., special
> facilities, recruitments, discretionary resources such as dollars and
> space).
>
> (e.8) Degree to which the organization and leadership of the SPORE
> promote and facilitate scientific interactions between projects, pilot
> projects, etc., and effective use of the SPORE infrastructure (e.g.,
> tissue bank, other shared resources) in the conduct of research.
>
> (e.9) Written assurance that SPORE interactions with commercial
> entities will uphold the principles of academic freedom, including the
> ability of SPORE investigators to collaborate freely and to send and
> receive biomedical research materials without restriction to other
> scientific researchers.
>
> (e.10) Facilitation of technology transfer; management of the
> intellectual property rights of the SPORE under the requirements of
> the Bayh-Dole Act and NIH funding agreements.

*(f) Interactions with Other SPOREs*

> (f.1) Adequacy of plans (new applications) or progress (competing
> renewal applications) to promote and maintain communication and
> integration of scientific projects of mutual interest with other
> SPOREs; examples include the development of core resources that serve
> either the same organ site or multiple organ sites, as well as
> clinical or research activities performed in a multi-institutional
> setting.

(f.2) Willingness to interact with other SPOREs and with the NCI in
sharing information and participating in committees to assess current
scientific issues, research activities, and priorities.

**5. Overall Evaluation and Scoring of Applications**

A single numerical priority score will be assigned to the SPORE
application as a whole after discussing all of the review elements
listed above. The score will be based on the overall quality of the
research projects (using the SPORE definition of translational research
in Section I.B.) and career development and developmental research
programs, the overall effectiveness and adequacy of shared resources,
the overall program organization and capability, and the plans for and
productivity of interactions with other SPOREs. Although primary
emphasis will be placed on scientific merit and progress where
applicable (competing renewal applications), significant consideration
will also be given to interdisciplinary interactions, potential for
impacting on the disease, Inter-SPORE collaborations and institutional
commitment.

The overall score will be weighted as follows:

60% scientific merit of the translational research

15% evidence of multidisciplinary/team approaches in the conduct of
research objectives

15% potential of the research to impact on the disease

10% institutional commitment

If a required component(s) of an otherwise meritorious SPORE application
is of such low merit that it is not recommended for further
consideration (NRFC) by the peer review committee, the entire
application will also receive a NRFC.

**6. Summary Statements**

The findings and recommendations of the reviewers are summarized in a
written report (i.e., Summary Statement) which conveys the evaluation of
the P50 application. This Summary Statement is transmitted to the NCAB
for second level review, to the NCI official file and to the appropriate
NCI staff. NCI program staff will automatically send a copy to the
principal investigator as soon as the final document is available.

**7. Award**

Final funding decisions are made by NCI Executive Committee (EC) based
on overall priority scores of the applications as determined by peer
review, recommendations by the NCAB, the availability of funds, and NCI
research priorities during each fiscal year.

The EC may consider funding a P50 application as a P20 planning grant.
Applications considered for P20 awards will be funded on the basis of
their scientific merit and NCI programmatic priorities.

The award and administration of the P50 and P20 grants are subject to
the same policies and procedures as other research grants. These
policies and cost principles are set forth in the current NIH Grants
Policy Statement, other NIH and NCI issuances and Federal legislation
and regulations.

#### H. INQUIRIES

For further clarification of the different topics contained in the
present guidelines, individuals may contact the Organ Systems Branch by
e-mail ( phone (301-496-8528), or fax (301-402-5319).

**SECTION II. SPECIAL INSTRUCTIONS FOR PREPARING A COMPETING SPORE GRANT
APPLICATION**

These instructions provide information needed for the preparation of
either a new or competing renewal grant application for a Specialized
Program of Research Excellence (SPORE). The application receipt dates
are specified in the program announcement (PA) and "GENERAL SPORE
GUIDELINES, Section I.F., above" prepared by the Organ Systems Branch,
NCI.

**A. GENERAL INFORMATION**

General instructions for the preparation of NIH grant applications are
contained in the standard NIH grant application kit (PHS Form 398,
revised April 1998) which should be available at an applicant's
institutional business office. Even though the application kit is
intended primarily for a single research project grant (i.e. R01), many
of the [general]{.underline} instructions and forms also apply to SPORE
grant applications. However, as outlined in Section I, SPORE grants have
unique requirements and review criteria. Accordingly, the
[special]{.underline} instructions in this document were prepared for
use along with the PHS Form 398 grant application kit.

#### B. DETAILED DIRECTIONS 

**1. Face Page**

The face page is the same as the face page (form page AA) in the PHS 398
kit. In item 1, enter the title "SPORE in (Organ-Specific) Cancer". In
item 2, insert the PA number, and enter the title "Specialized Program
of Research Excellence". In item 3, indicate the name, degree, and
position (or equivalent) title of the SPORE Principal Investigator.
Complete the rest of the page according to the instructions in the
application kit, including the signature of the appropriate institution
official(s).

**2. Description, Performance Sites, and Key Personnel (Page 2)**

Page 2 is the same as page 2 in the PHS 398 application kit. Provide a
brief description of the proposed SPORE in the space provided,
specifically addressing each project and proposed resource core. Fill in
all the performance sites and all key professional personnel including
all project and core leaders and key personnel of the Developmental
Research and Career Development Programs, using continuation pages as
required.

**3. Table of Contents (Page 3)**

Instead of using form page 3 in the PHS 398 application kit, prepare a
Table of Contents that identifies by page number all major parts of the
SPORE application so that they can be readily located. When listing
individual projects and core components, identify each by a project or
core number, title and responsible investigator(s) in the order in which
they appear in the application.

It is recommended that all applicants follow a format similar to that
outlined below:

I.  Face Page

II. Description, Performance Sites, Key Personnel (PHS 398 Form Page 2)

III. Table of Contents (PHS 398 Form Page 3)

IV. Initial Budget (PHS 398 Form Page 4; see item 4 below)

V.  Summary Budget (PHS 398 Form Page 5; see item 5 below)

VI. Biographical Sketches (PHS Form Page 6; see item 6 below)

VII. Other Support (see item 7 below)

VIII. Resources (see item 8 below)

IX. Eligibility Statement (see item 9 below)

X.  Program Description (see item 10 below)

> A. Introduction
>
> B. Institutional Commitment

C.  Scientific and Administrative Leadership

D.  Relationship to Cancer Center

E.  Scientific Integration - Interactions and Collaborations

F.  Cancer Patient Population

> G. Translational Research Objectives

H.  Planning and Evaluation Activities

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XI. Research Projects (Minimum of four projects required; see item 11
    below)

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A.  For competing renewals, describe, outline the scientific
    accomplishments and discuss the potential impact on the disease for
    each project completed in the last grant period. Limit this to two
    narrative pages plus publications for each project.

B.  Project 1

> 1\. Title Page with **Co-(Principal) Investigators**
>
> 2\. Abstract Page
>
> 3\. Budget/Budget Justification Pages

4.  Research Proposal (If an ongoing project, discuss scientific
    progress and adhere to the original five-year time frame)

5.  Human Subjects and Vertebrate Animals

B. Project 2

> 1\. Title Page with **Co-(Principal) Investigators**
>
> 2\. Abstract Page
>
> 3\. Budget/Budget Justification Pages

4.  Research Proposal (If an ongoing project, discuss scientific
    progress and adhere to the original five-year time frame)

5.  Human Subjects and Vertebrate Animals etc.

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XII. Core Resources (Tissue Core required; see item 12 below)

> A. Core 1

1\. Title Page with Director(s)/Leader(s)

2\. Abstract Page

3\. Budget/Budget Justifications

4.  Plan/Interactions/Progress (for competing renewals)

5.  Human Subjects and Vertebrate Animals

> B. Core 2
>
> 1\. Title Page with Director(s)/Leader(s)

2\. Abstract Page

3\. Budget/Budget Justifications

4.  Plan/Interactions/Progress (for competing renewals)

5.  Human Subjects and Vertebrate Animals etc.

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XIII. Developmental Research Program (see item 13 below)

1\. Title Page with Director(s)/Leader(s)

2\. Budget/Budget Justification Pages

3.  Plan/Examples

4.  For competing renewals describe each project funded during the last
    grant period and the outcome of each project relative to the SPORE
    objectives.

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XIV. Career Development Program (see item 14 below)

1\. Title Page with Director(s)/Leader(s)

2.  Budget/Budget Justification Pages

3.  Plan/Examples

4.  For competing renewals, denote individuals supported during the last
    grant period, their scientific accomplishments while supported by
    the SPORE, and how SPORE support has advanced their translational
    research careers.

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XV. Checklist (see item 15 below)

XVI. Appendix Material (see item 16 below)

**4. Summary Program Budget for the Initial Budget Period**

Use form page 4 in the PHS 398 application kit to present the summary
budget for the first year. For each category, show separately the total
amounts requested for each research project and core.

If the grant application includes research activities that involve
institutions other than the applicant organization, the proposed program
represents a consortium effort. It is essential to explain the
programmatic, fiscal, and administrative arrangements for such
activities. These matters should be discussed in general terms in the
program introduction, and more specifically within descriptions for
pertinent projects. Include in the designated blocks on this page the
total (direct and indirect) costs associated with such third party
participation. The published policy governing consortia should be
available in the business office of the grantee institution.

**5. Summary Program Budget for Entire Project Period**

Use form page 5 in the PHS 398 application kit to show the total SPORE
budget requested for each of the five years. Justifications for
increases in succeeding years should not be included here; they should
be delineated in the [detailed]{.underline} budgets for
[individual]{.underline} projects (as described below in item 11). Note
that current NIH practice limits overall budget escalation per year to
3% cost-of- living. Also note that NCI policy for SPORE grants
establishes an annual **direct cost cap of \$1.75 million** and maximum
annual **total cost cap of \$2.75 million** for new and competing
applications. In complying with the direct cost cap of \$1.75 million,
the indirect costs related to subcontracts to other institutions or
organizations do not apply toward the direct cost cap. However, these
consortium indirect costs must be included in the total costs which,
overall, may not exceed the \$2.75 million cap. In non-competing years,
applications can exceed these caps as a result of the standard
cost-of-living increases or special supplements approved by the NCI.

**6. Biographical Sketches**

Prepare biographical sketches as described in the PHS 398 application
kit. Begin with the Principal Investigator/SPORE Director and then
proceed in alphabetical order. Biographical sketches are required for
all professional personnel participating in the individual SPORE
projects and core(s). The \"Biographical Sketch\" form is provided as
form page 6 in the PHS 398 application kit.

**7. Summary of Other Support**

Information on all current and pending research support of all personnel
should be presented in this section. Please indicate by an asterisk,
research support that overlaps with projects proposed in the subject P50
application. Beginning with principal investigator/program director and
in alphabetical order thereafter, list in two separate sections for each
investigator: (1) Current Support and (2) Applications Pending Review
and/or Funding*. After listing all support, summarize for each
individual any potential overlap with active or pending projects and
this application in terms of the science, budget, or committed effort
and describe modifications to be made if an award is received*.
Information contained in the Other Support section should use the format
shown on page 7-GG of the PHS 398 application kit.

*In addition, if any of the projects in (1) or (2) above are to be
integrated into the SPORE with modifications, briefly explain how this
integration will be accomplished*.

**8. Resources**

Complete form page 8 of PHS 398 application kit, as instructed. If
applicable, additional Resource pages should be provided in consortia
projects or cores. An extensive discussion of the institution\'s
commitment to the SPORE is also required in item 10b below.

**9. Eligibility Statement**

In considerable detail, specifically address how this application meets
the eligibility requirements under ELIGIBILITY AND REQUIRED COMPONENTS,
Section I.E.1." above.

**10. Program Description**

(a) *Introduction*

> Describe the purpose and intent of the research program; the overall
> breadth of the scientific capabilities of the program to address
> critical issues in the *organ-specific* human cancer from basic
> laboratory to clinical to prevention and control research; the
> organization of the SPORE to maximize the potential of the institution
> to achieve translational research objectives. Applicants for competing
> renewal grants should address overall progress of the SPORE in meeting
> these objectives, as well as the evolution of project goals over time.

(b) *Institutional Commitment*

> Describe how the institution will make the SPORE an area of high
> priority. Describe the space, personnel and all other resources that
> the institution will make available to ensure that the SPORE exists in
> an appropriate environment for conducting an effective translational
> research program. Outline plans for the commitment of future resources
> in space and personnel to strengthen the research capability of the
> SPORE. The application should describe how the institution will
> participate in overseeing research progress, identifying research
> needs, and generally assuming a high level of accountability for the
> success of the SPORE in achieving research goals and objectives.

(c) *Scientific and Administrative Leadership*

> Describe the authority, scientific experience, and administrative
> experience of the principal investigator to provide leadership and
> direction to the SPORE. Similarly, describe the responsibilities of
> other senior scientific leaders and administrators and their
> qualifications to meet these responsibilities. Describe the processes
> and chain of responsibility for scientific decision-making and
> day-to-day administration and management of the SPORE.

(d) *Relationship to Cancer Center*

> If the SPORE application is being submitted from an institution
> already designated as a NCI Clinical or Comprehensive Cancer Center, a
> special section under this heading should clearly delineate the
> relationship of the SPORE (P50) to the cancer center (P30) as noted
> under \"ELIGIBILITY AND REQUIRED COMPONENTS, Section I.E.9,\" above. A
> statement signed by the appropriate institutional official(s), Cancer
> Center Director and SPORE Principal Investigator confirming and
> agreeing to this relationship [must]{.underline} be included in the
> appendix.
>
> *(e) Scientific Integration - Interactions and Collaborations*
>
> Specifically discuss how interactions will be maintained and fostered
> between basic and more applied researchers within the research
> projects to produce a truly collaborative program that takes maximum
> advantage of research opportunities. Describe how the program will
> operate to collectively maximize research objectives. Discuss the
> critical interactions with other scientists within and outside of the
> institution that are specifically proposed to enhance the overall
> research objectives of the SPORE.
>
> Describe the involvement of any other research, academic or
> administrative entities outside of the applicant institution, and how
> these other entities enhance the research capability. This should
> include all programmatic, administrative and fiscal consortial
> arrangements and how the effects of geographic separation will be
> overcome to maximize critical scientific interactions.
>
> Describe how the core resources will be integrated effectively into
> the program and into existing cores in the Cancer Center (if
> applicable) to maximize the research capability and effectiveness of
> the SPORE.

*(f) Cancer Patient Population*

Describe how the clinical patient care and service resources will be
integrated with the research activities of the SPORE. Delineate the
number and distribution of stages of cancer patients relevant to this
organ cancer SPORE that are routinely cared for and how this patient
population will meet all current and anticipated research needs. If the
care and service facility is not part of the parent institution, the
consortial arrangements should be clearly stated and officially
confirmed as noted under \"ELIGIBILITY AND REQUIRED COMPONENTS
I.E.1.c.\" above.

> *(g) Translational Research Objectives*

It is critical that the application delineate in considerable detail how
the program will focus on translational research objectives in moving
basic research findings into studies for improving the detection,
diagnosis, treatment and prevention of human cancer, or moving clinical
observations into the laboratory environment (see Section I.B. for SPORE
DEFINITION OF TRANSLATIONAL RESEARCH). Describe how the SPORE will
strengthen its research capability through the use of developmental
research funds to explore innovative research ideas.

(h) *Planning and Evaluation Activities*

> Describe how the SPORE will measure research progress collectively,
> identify new innovative research opportunities that can take maximum
> advantage of the multidisciplinary, translational research approaches,
> and identify projects for termination that are not achieving their
> translational research objectives.
>
> Provide a plan of how the SPOREs can utilize the annual SPORE workshop
> most effectively for sharing data, identifying new research
> opportunities, and setting priorities for future research.
> Specifically, incorporate the SPORE workshop into the Planning and
> Evaluation process of your organization.
>
> In all of the above, clearly distinguish how the SPORE will utilize
> internal and external advisors.

**11. Translational Research Projects**

As previously described, for the purposes of this program, the NCI has
defined translational research as follows: **"Translational research
uses knowledge of human** **biology to develop and test the feasibility
of cancer-relevant interventions in humans AND/OR determines the**
**biological basis for observations made in individuals with cancer or
in populations at risk for cancer"**. The term "interventions" is used
in its broadest sense to include molecular assays, imaging techniques,
drugs, biologicals and/or other methodologies that are relevant to the
prevention, early detection, diagnosis, prognosis or treatment of
cancer. Translational research in SPOREs is always founded on and
directly connected to some aspect of human biology and may encompass any
form of cellular, molecular, structural, biochemical, genetic, or other
appropriate experimental approach.

SPOREs conduct early-stage interventions to establish the feasibility or
proof of principle of specific approaches in cancer. All research
projects whose goal is the development and testing of an intervention
are expected to reach the feasibility testing stage in humans within the
anticipated five-year period of grant support. Similarly, studies that
seek to determine the biological basis for an observation in human
cancer should do so within five years. SPOREs are not the place for
definitive validation of new interventions, which are supported by other
programs in several divisions of the NCI.

Questions regarding the definition of translational research and its
applicability to specific research projects should be directed to OSB
program staff (see INQUIRIES, Section I.H. above).

For each research project provide the following as noted below. Page
limitations specified for individual (R01) grant applications in the PHS
398 application kit must be followed for individual project and core
unit research plans. Unnecessarily long, wordy or confusing
presentations are usually perceived as indicators of premature or poorly
planned research.

> \(a\) A title page with a project number, a title for the project and
> the co-principal investigators on a plain piece of paper.

\(b\) An \"Abstract of the Research Plan\" using page 2 of the PHS 398
application kit. The top section should contain a succinct summary of
the research project. The bottom section should include performance
sites and all key professional personnel as instructed.

(c) Budget Pages

> The detailed budget for the first 12 months and the overall budgets
> for each succeeding year for each research project should be presented
> using the PHS 398 application, form pages 4 and 5 Directions for
> completing these are on pages 11-13 of the instructions in the PHS 398
> application kit. For each category or individual listed on form page
> 4, provide a rationale in the budget justification.

(d) Research Plan

> Following the budget pages, use continuation pages to address items 9a
> through 9i as explained on pages 14-19 of the PHS 398 application kit.
> For renewal of ongoing projects, delineate the scientific progress
> over the past term of the grant and, if applicable, why the project
> has not completed its proposed objectives in the five year period.
>
> Page limitations are the same as those delineated in the PHS 398
> application kit; no more than 25 pages should be used for sections a-d
> of the Research Plan for each project proposed within the SPORE
> application. The 25-page limit also applies to all other
> self-contained components of the application, e.g., each Shared Core
> Resource, the Developmental Research Program, and the Career
> Development Program.

(e) Human Subjects

> For projects involving human subjects, applicants are required to
> address the six points on pages 17-18 of the PHS 398 instructions. The
> six points are as follows:

1.  Provide a detailed description of the proposed involvement of human
    subjects in the work previously outlined in the Research Design and
    Methods section. Describe the characteristics of the subject
    population, including their anticipated number, age, range and
    health status. Identify the criteria for inclusion or exclusion of
    any subpopulation. Explain the rationale for the involvement of
    special classes of subjects, such as fetuses, pregnant women,
    children, prisoners, institutionalized individuals, or others who
    are likely to be vulnerable.

2.  Identify the sources of research material obtained from individually
    identifiable **living** human subjects in the form of specimens,
    records, or data. Indicate whether the material or data will be
    obtained specifically for research purposes or whether use will be
    made of existing specimens, records, or data.

3.  Describe plans for the recruitment of subjects and the consent
    procedures to be followed. Include the circumstances under which
    consent will be sought and obtained, who will seek it, the nature of
    the information to be provided to prospective subjects, and the
    method of documenting consent. State if the Institutional Review
    Board (IRB) has authorized a modification or waiver of the elements
    of consent or the requirement for documentation of consent. The
    informed consent form, which must have IRB approval, should be
    submitted to the PHS only if requested.

4.  Describe potential risks (physical, psychological, social, legal or
    other) and assess their likelihood and seriousness. Where
    appropriate, describe alternative treatments and procedures that
    might be advantageous to the subjects.

5.  Describe the procedures for protecting against or minimizing
    potential risks, including risks to confidentiality, and assess
    their likely effectiveness. Where appropriate, discuss provisions
    for ensuring necessary medical or professional intervention in the
    event of adverse effects to the subjects. Also where appropriate,
    describe the provisions for monitoring the data collected to ensure
    the safety of subjects.

6.  Discuss why the risks to subjects are reasonable in relation to the
    anticipated benefits to subjects and in relation to the importance
    of the knowledge that may reasonably be expected to result.

> Plans for the recruitment of women, children, and members of minority
> groups and subpopulations into clinical studies must also be stated in
> this section. A completed table, formatted like the one shown on page
> 30 of the PHS 398 instructions must be included along with a
> description of the proposed subject population in terms of gender and
> racial/ethnic groups.
>
> \(f\) Vertebrate Animals
>
> If applicable, provide a brief description of any animal protocol,
> along with an IACUC approval number in this section. The five points
> for vertebrate animals listed below (as well as on page 18 of the PHS
> 398 instructions) should be addressed:

(1) Provide a detailed description of the proposed use of the animals in
    the work outlined in the Research Design and Methods section.
    Identify the species, strains, ages, sex and numbers of animals to
    be used in the proposed work.

(2) Justify the use of animals, the choice of species, and the numbers
    to be used. If animals are in short supply, costly, or to be used in
    large numbers, provide an additional rationale for their selection
    and numbers.

(3) Provide information on the veterinary care of the animals involved.

(4) Describe the procedures for ensuring that discomfort, distress, pain
    and injury will be limited to that which is unavoidable in the
    conduct of scientifically sound research. Describe the use of
    analgesic, anesthetic, and tranquilizing drugs and/or comfortable
    restraining devices, where appropriate, to minimize the discomfort,
    distress, pain, and injury.

(5) Describe any method of euthanasia to be used and the reasons for its
    selection. State whether this method is consistent with the
    recommendations of the Panel on Euthanasia of the American
    Veterinary Medical Association. If not, present a justification for
    not following the recommendations.

**12. Core Resources**

Core resources should [not]{.underline} duplicate products or services
that are fundamentally available through any other mechanism (including
a P30 and P01) or national resource~~s~~ supported by the NCI. SPORE
resources may, however, be used to augment an existing P30 resource to
enhance its capacity to serve SPORE research objectives. Cores can be
used for a small administrative component or for scientific resources
that clearly enhance the specialized research of the SPORE. Cores in the
latter category should serve at least one full project. For each Core
Resource, whether administrative or scientific, provide the following
information:

> \(a\) A title page with the Core Resource Number, a Core Resource
> Title, and Director/Leader on a plain piece of paper.
>
> \(b\) An abstract of the Core Resource, using page 2 of the PHS 398
> application kit as described for research projects in item 11, above.
> The abstract should describe the nature and purpose of the resource.

(c) Budget Pages

> Use same format as in item 11, above, for research projects.

(d) Resource Proposal

> (d.1) Describe the nature of the resource and its importance to the
> specialized research of the SPORE.
>
> (d.2) For a renewal application, describe how the resource has
> performed in the past in relationship to accomplishing SPORE related
> services or goals.
>
> (d.3) Describe the facilities available and the qualifications of the
> professional expertise assigned to operate the resource.
>
> (d.4) Discuss past (for renewal applications) and projected use of the
> core by individual research projects within the SPORE and any SPORE
> collaborators within or outside of the parent institution.
>
> (d.5) Describe the projected operation, placing special emphasis on
> cost effectiveness and/or quality control factors.
>
> \(e\) Human Subjects and Vertebrate Animals
>
> If applicable, address the six points regarding human subjects on
> pages 17-18 of the PHS 398 instructions and include a Gender and
> Minority Inclusion table(s) as outlined on page 30 of the PHS 398
> instructions. If vertebrate animals are being utilized, address the
> five points for vertebrate animal usage on page 18 of the PHS 398
> instructions. Also include the IACUC approval number(s) and provide a
> brief description of any animal protocol(s).

**13. Developmental Research Program**

This program should primarily be used to promote the exploration of
innovative ideas through the funding of pilot projects. It can, however,
also be used to initiate a new shared resource, establish short-term
collaborations, and/or contract services required by the SPORE. This
required component of the SPORE must be maintained for the duration of
the grant period. This section of the application should include:

> \(a\) A Title Page with \"Developmental Research Program\" on a plain
> piece of paper.
>
> \(b\) Budget Pages
>
> Use same format as for research projects in item 11, above.
>
> \(c\) A program summary containing the following elements:
>
> (c.1) A description of the process used by the SPORE for identifying
> and selectively funding innovative, pilot studies within and outside
> of the SPORE institution.
>
> (c.2) For competing renewal applications, a summary identifying the
> achievements of all projects (ongoing or terminated) supported during
> the last project period, the staff associated with each project, and
> the publications and grant submissions resulting from the research.
> For all terminated projects, specifically discuss whether they
> replaced ongoing projects in the SPORE, led to other grant
> applications (either by SPORE investigators or SPORE collaborators),
> or were completely terminated because of lack of success.
>
> (c.3) A description of the process for continuously reviewing and
> funding a spectrum of pilot projects for their quality and importance
> to translational cancer research.
>
> (c.4) Brief examples of projects that may be supported during the
> grant period.
>
> (c.5) A description of the process by which projects will be (or have
> been) promoted to full translational research projects within the
> SPORE.

**14. Career Development Program**

This is a special fund available in a SPORE that can be used to prepare
new investigators or established investigators for careers in
translational cancer research. This section of the application should
include:

> \(a\) A title page using instructions in item 13, above.

(b) Budget Pages

> Use same format as in item 11, above, for research projects.
>
> \(c\) A summary of the program containing the following elements:
>
> (c.1) Describe the process for selecting candidates and how the
> program will place special emphasis on recruiting qualified women and
> minorities.
>
> (c.2) Provide a short description of prospective mentors who have
> experience in translational research and who will interact directly
> with chosen new or established career development candidates.
>
> (c.3) Describe any candidates that have already been selected for
> support under this program and the rationale for these selections.
>
> (c.4) For competing renewal applications, list all of the individuals
> supported by this program during the past term of the grant. The
> present position and recent accomplishments of these individuals
> (e.g., funded grants, publications) should also be described that
> clearly demonstrate how the SPORE has contributed to their careers in
> translational research.

**15. Checklist**

Complete the checklist as required in the PHS 398 application kit.

**16. Appendix Material**

The application should be a complete document that includes all
essential information necessary for its evaluation. Additional
appropriate material may be submitted as appendices. There is no page
limitation on appendices. However, appendices should not be used to
bypass page limitations in the application because only selected
reviewers will receive copies of the appendices. Follow the guidance in
the PHS 398 application kit on page 19 regarding appendices, in
particular noting what types of material may be included in an appendix.

**SECTION III. SUPPLEMENTAL GUIDELINES FOR PREPARING A NON-COMPETING
CONTINUATION SPORE APPLICATION**

A.  **INTRODUCTION**

These instructions are supplemental to those provided with the Form PHS
2590 (rev. 4/98), "Application for Continuation of a Grant," which is
required each year in order to receive continuing support. In general,
you should follow the "Information and Instructions for Using Form PHS
2590 to Apply for Continuation of a Grant Award." **To avoid a gap in
funding, non-competing continuation applications should be received 60
days prior to the anniversary date of the award.** Please note that
non-competing SPORE applications are [not]{.underline} eligible for the
streamlined non-competing award process (SNAP). Additional guidance
important in the preparation of a SPORE continuation application is
provided below.

B.  **GENERAL ISSUES**

The NCI advocates flexibility and innovation in the use of SPORE funds
to achieve translational research objectives and will administer these
grants in that spirit. Nevertheless it is important to highlight and
explain changes in the component budgets that differ significantly from
the approved peer-reviewed budget levels of the original competing
application. Areas requiring explanation and justification are as
follows:

\(a\) Any proposed increase or decrease in the level of effort of key
personnel.

> \(b\) Substitution, addition, or deletion of key personnel (e.g.,
> project leader, co-leader, resource director).
>
> \(c\) Redistribution of dollars among budget components (NOTE: this is
> encouraged in a SPORE when it is done to place greater emphasis on
> more promising *translational* research activities).
>
> \(d\) New research activities not included in the competing
> application and not peer reviewed (NOTE: this is encouraged,
> especially in the use of developmental funds, to pursue the
> feasibility of new hypotheses of potential importance to translational
> research).

C.  **PROGRESS REPORT SUMMARY**

The Progress Report Summary portion of the PHS 2590 application (pages
7-9) should be used for each full and developmental project within the
SPORE. Applications should also include the following:

> **1.** **Scientific Achievement of the SPORE Program**
>
> Describe the single most significant translational research
> achievement in the last year of support. Indicate the project, the
> achievement, and its potential impact on human cancer in one or two
> paragraphs.

2.  **Director's Overview**

> This is an important section in which the Director describes how the
> SPORE program is functioning in special ways to achieve translational
> research objectives. In this section address the following issues:
>
> \(a\) The levels at which applied researchers (e.g., clinical
> researchers, prevention and control researchers) interact with basic
> investigators in the design and implementation of research that is
> most likely to have an impact on human cancer (i.e., reducing
> incidence and mortality).
>
> \(b\) The different ways in which the members of the SPORE team are
> working together and exchanging ideas.
>
> \(c\) The specific research efforts that appear to be the most, as
> well as least, promising in achieving a translational research
> objective.
>
> \(d\) New ideas for translational research that have been generated by
> the SPORE.
>
> \(e\) New priorities affecting the distribution of SPORE research
> funds based on the research progress of existing projects and results
> obtained from the use of developmental funds.
>
> \(f\) Important collaborative efforts established within and outside
> the SPORE institution, through use of developmental or supplemental
> funds, that increase the exploration of new translational research
> opportunities.
>
> \(g\) By-products that have emerged from SPORE scientists, the SPORE
> environment and/or SPORE collaborative studies that have resulted in
> the submission of grant applications (e.g., R01s) which are likely to
> advance fundamental studies in this cancer site. Please list in
> tabular form grant applications that have been submitted, where and
> when submitted, and whether pending, funded or not funded.
>
> \(h\) Formal Inter-SPORE collaborative research activities that have
> been initiated and/or completed.
>
> \(i\) Special efforts to recognize unique research opportunities based
> on incidence and mortality rates in the community/region of the SPORE
> and/or to enhance the research capability of the SPORE through
> interactions with individuals, organizations, and institutions within
> the community.
>
> In all of the above, the intent should be to explain how the team of
> SPORE scientists at the basic and applied levels are pursuing research
> objectives using integrated, innovative, and flexible strategies and
> are maximizing the unique capabilities of SPORE support in achieving
> translational research objectives.
>
> **3. Research Projects**
>
> Adhering to the instructions provided in the PHS 2590 packet, please
> describe the following:

*(a) Specific Aims (no more that 500 words)*

> Briefly describe the specific aims of the project as actually funded
> and how basic/clinical interactions have been employed in the design,
> implementation, and interpretation of experiments. Provide a short
> rationale for any changes in specific aims that have occurred over the
> past year.

*(b) Studies and Results (no more than 750 words)*

> For the past year, describe positive or negative results associated
> with each specific aim that are important to the underlying
> hypothesis. For those projects that involve clinical trials, briefly
> describe the status of each trial.

*(c) Significance*

> Explain in [lay]{.underline} terms the importance and intent of the
> research in terms of translational research objectives that may impact
> on the disease in a reasonable time span.

*(d) Plans*

> Summarize plans for the next year to pursue existing specific aims
> and/or new or modified aims that may have a greater impact on the
> translational research objectives of the SPORE.

*(e) Publications*

> Append a list of published, submitted, or accepted manuscripts from
> the past year that **pertain to this grant (i.e., those that
> acknowledge support from this grant)**. Provide one copy of each new
> manuscript.

*(f) Project-Generated Resources*

> If the research supported by this grant resulted in data, research
> materials (e.g., cell lines, DNA probes, animal models), protocols,
> software, or other information available to be shared with other
> investigators, describe the resource(s) and how it may be accessed.
>
> All projects involving human subjects or tissue resources should
> include status of patient/specimen accrual and recruitment of gender
> and minorities where applicable. **An updated Gender and Minority
> Inclusion Table is required each year for each individual project**.
> This table is provided at the bottom of form page 5 of the PHS 2590
> application. Final assessment of closed or completed studies and
> pertinent publications and reports should also be included. A protocol
> and IRB approval must be on file with the NCI prior to the initiation
> of any new clinical trials.

**4. Resources**

Describe progress in establishing and maintaining the high-quality
operation of each resource outlined in the original competitive
application. Discuss any structural, organizational, logistical, or
administrative changes in the resource; problems that have developed in
the operation of the resource, as well as use of the resource by members
of the SPORE and by outside investigators where appropriate.

> **5. Developmental Funds**

In reporting on the use of developmental funds, describe the following:

> \(a\) How the funds are being used in a flexible manner to explore new
> research opportunities and how the SPORE sets priorities in the use of
> developmental funds.
>
> \(b\) The translational research objectives of each *current* pilot
> project being explored with developmental funds.
>
> \(c\) The positive and/or negative findings for each project during
> the past year. A final report is required on projects whose SPORE
> funding ended during the past year. Brief descriptions of newly
> initiated projects should also be supplied.
>
> \(d\) Projects in which developmental funds have stimulated new
> collaborative interactions with scientists within or outside the SPORE
> institution.
>
> \(e\) Pilot projects that have become full translational research
> projects within the SPORE or have resulted in research grant
> application of a more fundamental nature relevant to the cancer site
> (e.g., R01s).

**6. Career Funds**

> Briefly describe how each individual, whether recruited from within or
> outside the institution and supported from SPORE resources, is being
> prepared to pursue a career in translational research. As appropriate,
> indicate the current research activities of individuals who received
> career support from the SPORE program in the past.

**7. Supplemental Funds**

A progress report is also required on all activities that were supported
during the last year by supplemental funds provided through the SPORE
program.