SPECIALIZED PROGRAMS OF RESEARCH EXCELLENCE (SPOREs) IN PANCREATIC CANCER FOR 
THE YEAR 2002

Release Date:  February 25, 2002

PA NUMBER:  PAR-02-068

EXPIRATION DATE:  This Program Announcement expires on October 2, 2002, 
unless reissued.

National Cancer Institute (NCI)
 (http://www.nci.nih.gov/)

LETTER OF INTENT RECEIPT DATE:  September 1, 2002
APPLICATION RECEIPT DATE:       October 1, 2002

THIS PA CONTAINS THE FOLLOWING INFORMATION

o Purpose of the PA
o Research Objectives
o Mechanism(s) of Support 
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Where to Send Inquiries
o Letter of Intent
o Submitting an Application
o Peer Review Process
o Review Criteria
o Award Criteria
o Required Federal Citations

PURPOSE

The Organ Systems Branch of the Office of the Deputy Director for Extramural 
Science at the National Cancer Institute (NCI) invites grant applications 
(P50) for Specialized Programs of Research Excellence (SPOREs) in Pancreatic 
Cancer.  The purpose of these SPOREs is to: 1) build capacity for 
interdisciplinary translational research in pancreatic cancer; 2) establish 
consortia to ensure appropriate access to pancreatic cancer patients and 
tumor tissues and promote the development of pancreatic cancer family 
registries; 3) expand the research base in pancreatic cancer via development 
and improvement of animal and in vitro model systems that can be translated 
into human disease applications; 4) foster collaborations between basic and 
clinical or applied research scientists; 5) provide career development 
opportunities in translational pancreatic cancer research for both junior 
investigators and established scientists wishing to refocus their careers; 
and 6)  develop extended collaborations in critical areas of research need 
with laboratory, clinical, and population scientists in the parent and other 
institutions. 

Pancreatic cancer is the 5th leading cause of cancer death in the United 
States.  In 2001, an estimated 29,000 new cases of pancreatic cancer were 
diagnosed and an equivalent number of persons died of the disease.  Most of 
these tumors were ductal adenocarcinomas, from which there is currently 
little chance of long-term survival.  Despite its incidence and almost 
universal fatality, pancreatic cancer research lags behind research on 
cancers of other major organ sites in terms of both financial support and 
number of scientific investigators.  Efforts to make progress against this 
disease are hampered by a dearth of key resources, such as pancreatic tissues 
and reagents for translational studies, as well as a lack of infrastructure 
to support training of investigators and development of a scientific research 
base.  These deficiencies, as recently confirmed in the final report of the 
Pancreatic Cancer Progress Review Group (http://prg.nci.nih.gov/), should be 
addressed by SPORE applications in response to this Program Announcement 
(PA).

The pancreatic cancer SPOREs funded through this mechanism will be similar to 
SPOREs in other organ sites, but the requirements for human translational 
research endpoints have been relaxed, and more emphasis is being placed on 
collaborative science, greater use of preclinical model systems, 
establishment of networks to meet tissue resource requirements and build 
pancreatic cancer family registries, and development of career investigators 
in translational pancreatic cancer research. Additionally, budget caps 
established for SPOREs in other organ sites may be exceeded by applicants 
proposing a consortium for the purpose of broader tissue collection and 
distribution efforts and/or accrual of patients and their families to 
pancreatic cancer registries.  For SPORES in pancreatic cancer, see the 
Special Guidelines posted at http://deainfo.nci.nih.gov/flash/awards.htm.  DO 
NOT follow the Guidelines for SPORES in other organ sites.  

As with SPOREs in other organ sites, institutions must be able to conduct the 
highest quality, balanced research on the prevention, etiology, screening, 
diagnosis, and treatment of pancreatic cancer.  There must be a strong 
institutional commitment to the organization and conduct of these programs.  
Applicants are judged on their current and potential ability to move basic 
research findings into a clinical or population setting or, conversely, to 
take a finding from the clinic/population and expand upon it in the 
laboratory.  Proof of principle in in vitro systems or animal models are 
acceptable in scientific projects proposed in response to this PA, but clear 
potential for translation into the human population or clinical setting must 
be demonstrated.  Applicants must present a plan for developing and 
maintaining human pancreatic cancer tissue resources that will benefit 
translational research; multi-institutional tissue collection systems are 
encouraged to increase the acquisition and availability of pancreatic cancer 
tissue for such research.  Applicants must foster critical areas of research 
need with laboratory, applied, and clinical scientists within the 
institution, as well as in other institutions, and participate with other 
SPOREs on a regular basis in sharing positive and negative findings, 
assessing scientific progress in the field, identifying new research 
opportunities, and promoting inter-SPORE collaborations.  Each SPORE and the 
"network" of SPOREs are expected to conduct research that will have the most 
immediate impact possible on reducing incidence and mortality of human 
pancreatic cancer.  A SPORE should support a mix of basic and clinical 
researchers whose formal interactive and collaborative research efforts will 
result in new approaches for early detection, diagnosis, therapy, prevention 
and control of pancreatic cancer.  The SPORE in pancreatic cancer is 
expected to demonstrate a significant and sustained commitment to a career 
development program.  Support of senior scientists who wish to refocus their 
careers on translational research is especially encouraged.

This Program Announcement (PAR) addresses only applications for SPOREs in 
Pancreatic Cancer, due October 1, 2002.  It is a one-time solicitation and no 
applications will be accepted after the above receipt date.  As it is 
intended to build capacity for translational research, grantees receiving 
awards from this solicitation will be expected to meet requirements pertinent 
to SPORE applications in all other organ sites at the time of competing 
reapplication.  Receipt dates for SPORE applications in other specific organ 
sites may be found in PAR 01-110, which was released in the NIH Guide on June 
20, 2001 (https://grants.nih.gov/grants/guide/pa-files/PAR-01-110.html).

RESEARCH OBJECTIVES

SPOREs in pancreatic cancer must provide focal points for sustaining 
state-of-the-art research that will contribute to improved detection, 
diagnosis, treatment and prevention of this disease. They are expected not 
only to conduct a wide spectrum of research activities, but should also 
contribute significantly to the development of specialized research resources 
(or cores), improved research model systems, and collaborative research 
projects with other institutions. The research supported through this program 
must demonstrate clear translational potential.  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. Inherently, 
this process involves interdependence between basic and applied or clinical 
investigators.  For applications in response to this PA only, proof of 
principle in animal models or in vitro systems within the 5-year term of the 
grant award are acceptable, but the clinical or applied perspective must be 
evident in the conceptualization and development of proposed research 
projects and there must be potential to study human endpoints within a 
reasonable time frame.

MECHANISM OF SUPPORT

This PA will use the NIH specialized center (P50) grant mechanism.  As an 
applicant, you will be solely responsible for planning, directing, and 
executing the proposed project.  A SPORE is supported through the specialized 
center (P50) grant mechanism.  This mechanism provides funding for a broad 
range of research and developmental activities, from basic to human 
intervention studies.  These grants are intended to promote multidisciplinary 
research focused upon pancreatic cancer.  SPORE grants differ from 
traditional Program Project (P01) grants in that they also provide support 
for pilot research projects and a career development program, as well as 
enable investigators more flexibility to modify their research activities 
when new opportunities arise.  Applicants are responsible for the planning, 
direction, and execution of their proposed SPORE.  NIH grants policies apply 
to these awards.

NCI policy for SPORE grants establishes the following limits to the requested 
budgets: new or competing renewal P50 SPORE applications may request a 
maximum annual direct cost of $1.75 million and maximum annual total cost of 
$2.75 million. The facilities and administrative costs related to 
subcontracts to other institutions or organizations are included in the total 
cost cap of $2.75 million, but not the direct cost cap of $1.75 million.  
Applications responding to this PA for SPOREs in pancreatic cancer may exceed 
both the direct and total cost caps for the additional costs related to 
participation of outside institutions in collecting and distributing 
pancreatic cancer tissue or in pancreatic cancer registries; caps may not be 
exceeded for any other purpose.  Funded applications may exceed the initial 
budget request in subsequent years as a result of standard cost-of-living 
increases or special supplements approved by NCI.  A SPORE grant application 
may be submitted for up to five years of funding.

ELIGIBLE INSTITUTIONS 

You may submit (an) application(s) if your institution has any of the 
following characteristics: 

o For-profit or non-profit organizations 
o Public or private institutions, such as universities, colleges, hospitals, 
and laboratories 
o Units of State and local governments
o Eligible agencies of the Federal government  
o Domestic 

INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS

Any individual with the skills, knowledge, and resources necessary to carry 
out the proposed research is invited to work with their institution to 
develop an application for support.  Individuals from underrepresented racial 
and ethnic groups as well as individuals with disabilities are always 
encouraged to apply for NIH programs.

ELIGIBILITY REQUIREMENTS
 
Eligible institutions may include foreign components as full research 
projects, or as part of a research project.  SPOREs may also use 
developmental funds to establish collaborative research efforts with foreign 
entities.  Consortia agreements with foreign institutions must include 
provisions that ensure adequate representation of women, minorities, and 
children in all research components that involve clinical trials or any other 
type of human intervention and must be in compliance with NIH policies.  

To be considered, applications must have: (1) a statement of institutional 
commitment that addresses how the SPORE will be given high priority within 
the institution; (2) a minimum of two independent scientists who either 
currently serve as principal investigators on peer-reviewed research grants 
(e.g., R01, P01, U01, U10, ACS, DOD, or equivalent) in human pancreatic 
cancer (or pre-malignant lesions of the pancreas) or have published on 
pancreatic cancer research in peer-reviewed journals within the last three 
years, and who will serve an active role in the Pancreatic Cancer SPORE ; (3) 
a minimum of three research projects,  representing a balance and diversity 
of approaches.  All projects must be focused on pancreatic cancer.  
Applicants are encouraged, but not required, to include at least one research 
project that focuses on early detection, screening, prevention, or population 
science.  Projects with a human application are encouraged, but proof of 
principle in animal models or in vitro systems within the five-year term of 
the award are equally acceptable.  Basic research projects, such as those 
employing mouse models or cell lines therefore qualify, but there must be a 
reasonable expectation that the project will reach a human endpoint.  Long-
term basic research projects, with no foreseeable human application or 
translational endpoint, are not appropriate.  All proposed research projects 
must be led by co-investigators in basic 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 the potential for generating new 
hypotheses relevant to translational research in pancreatic cancer will be 
accelerated; (4) a qualified principal investigator who is a scientific 
leader in the field; (5) a patient care facility (or a consortium of 
facilities) that serves a pancreatic cancer patient population. Consortium 
agreements to ensure adequate access to pancreatic cancer patients are 
encouraged; if a consortium is involved, agreements with all associated 
institutions that assure adequate access to pancreatic cancer patients for 
clinical research must be included with the application; the statement must 
be signed by the responsible officials of the applicant and the consortia 
care facilities; (6) a developmental research program which includes a plan 
for export of funds to external investigators for collaborative science; (7) 
a substantive career development program in translational pancreatic cancer  
research that includes a plan for recruitment of both junior and senior 
scientists; (8) a tissue resource (or consortium of resources, with 
requirements for consortium agreements as discussed above in item 5) to 
ensure appropriate access to pancreatic cancer tissue, along with an 
integrated plan for collecting, prioritizing, and correlating tissues with 
appropriate clinical and family history data, even if tissues will not 
directly benefit the research projects proposed in the application; and (9) 
other appropriate shared resources to support the proposed research 
objectives of the SPORE.  Development of multi-institutional pancreatic 
cancer family registries as a shared resource, or allotment of shared 
resource funds to support participation in existing registries, is 
encouraged, even if there will be no direct benefit to the research projects 
proposed in the application.  Although an application can only be submitted 
by a single institution, subcontracted collaborative arrangements with 
scientists from other institutions may be included if these arrangements are 
clearly delineated and officially confirmed by signed statements from the 
responsible official at each institution.  This circumstance, however, does 
not preclude the need for a full institutional commitment from the applicant 
organization. 

NCI program staff listed under INQUIRIES should be consulted if there are 
questions regarding eligibility or the required components of a SPORE.

WHERE TO SEND INQUIRIES

We encourage your inquiries concerning this PA and welcome the opportunity 
answer questions from potential applicants.  Inquiries may fall into three 
areas:  scientific/research, peer review, and financial or grants management 
issues:

o Direct your questions about scientific/research issues to:

Organ Systems Branch
Office of Centers, Training, and Resources
Office of Deputy Director for Extramural Science
National Cancer Institute
6116 Executive Boulevard, Suite 7013,  MSC 8347
Rockville, MD  20852 (for express/courier service)
Bethesda, MD 20892-7008 (for U.S. Postal Service)
Telephone:  (301) 496-8528
FAX: (301) 402-5319

Questions of a general programmatic nature may be submitted to the e-mail 
address of the Organ 
Systems Branch:  nciosb-r@mail.nih.gov.  

o Direct your questions about financial or grants management matters to:

Ms. Eileen Natoli
Grants Administration Branch
National Cancer Institute
Executive Plaza South, Room 243
6120 Executive Boulevard  MSC 7150
Rockville, MD 20852-7150 (for express/courier service)
Bethesda, MD  20892-7150
Telephone:  (301) 496-8791
Email:  natolie@mail.nih.gov

o Direct your questions about peer review issues to:

Referral Officer
Division of Extramural Activities
6116 Executive Boulevard, Room 8041, MSC 8329
Bethesda, MD  20892-8329
Rockville, MD  20852 (for express/courier service)
Telephone: (301) 496-3428
Fax: (301) 402-0275
Email:  dearefof-r@mail.nih.gov

LETTER OF INTENT
 
Prospective applicants are asked to submit a letter of intent that includes 
the following information:

o Descriptive title of the proposed research
o Name, address, and telephone number of the Principal Investigator
o Names of other key personnel 
o Participating institutions
o Number and title of this PA 

Although a letter of intent is not required, is not binding, and does not 
enter into the review of a subsequent application, the information that it 
contains allows NCI staff to estimate the potential review workload and plan 
the review.
 
The letter of intent is to be sent by the date listed at the beginning of 
this document.  The letter of intent should be sent to:

Organ Systems Branch
Office of Centers, Training, and Resources
Office of Deputy Director for Extramural Science
National Cancer Institute
6116 Executive Boulevard, Suite 7013,  MSC 8347
Rockville, MD  20852 (for express/courier service)
Bethesda, MD 20892-7008 (for U.S. Postal Service)

SUBMITTING AN APPLICATION

Applications must be prepared using the PHS 398 research grant application 
instructions and forms (rev. 5/2001).  The PHS 398 is available at 
https://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive 
format.  For further assistance contact GrantsInfo, Telephone (301) 710-0267, 
Email: GrantsInfo@nih.gov.

The title "SPORE in Pancreatic Cancer" and number of the PA should be typed 
on line 2 of the face page of the application form and the YES box marked.

APPLICATION RECEIPT DATES: Applications submitted in response to this program 
announcement will be accepted by the receipt date listed at the beginning of 
this program announcement.  

Funding for the performance of a Phase I or II clinical trial can be 
requested in a SPORE application.  The general components and procedures for 
preparing a Pancreatic Cancer SPORE application are outlined in this PA under 
Eligibility Requirements, Application Procedures, and Review Considerations. 
SPECIAL GUIDELINES that address programmatic, review and award concerns in 
more detail, however, must be followed when preparing a Pancreatic Cancer 
SPORE application.  GUIDELINES for Pancreatic Cancer SPOREs may be requested 
from the program staff listed under INQUIRIES above or obtained at  
http://deainfo.nci.nih.gov/flash/awards.htm
 
SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of 
the application, including the checklist, and three signed photocopies in one 
package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive
Room 1040, MSC 7710
Bethesda, MD  20892-7710
(20817 for express service)

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

Referral Officer
Division of Extramural Activities
National Cancer Institute
6116 Executive Boulevard, Room 8041, MSC8329
Bethesda, MD  20892-8329
Rockville, MD  20852 (for express/courier service)

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

APPLICATIONS HAND-DELIVERED BY INDIVIDUALS TO THE NATIONAL CANCER INSTITUTE 
WILL NO LONGER BE ACCEPTED.  This policy does not apply to courier deliveries 
(i.e. FEDEX, UPS, DHL, etc.) (https://grants.nih.gov/grants/guide/notice-
files/NOT-CA-02-002.html)  This change in practice is effective immediately.
This policy is similar to and consistent with the policy for applications 
addressed to Centers for Scientific Review as published in the NIH Guide 
Notice https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-012.html.

APPLICATION PROCESSING: Applications must be submitted by the date listed on 
the first page of this PA.  The CSR will not accept any application in 
response to this PA that is essentially the same as one currently pending 
initial review unless the applicant withdraws the pending application.  The 
CSR will not accept any application that is essentially the same as one 
already reviewed.  This does not preclude the submission of a substantial 
revision of an application already reviewed, but such application must 
include an Introduction addressing the previous critique.

Applications must meet all eligibility requirements summarized above and must 
address all programmatic requirements further described in the GUIDELINES for 
Pancreatic Cancer SPOREs (http://deainfo.nci.nih.gov/flash/awards.htm)

PEER REVIEW PROCESS

Upon receipt, applications will be reviewed for completeness by the CSR and 
the NCI program staff for adherence to the guidelines of this PA.  
Applications not adhering to the guidelines of this PA, and those 
applications that are incomplete as determined by CSR or by NCI program 
staff, will be returned to the applicant without review.

As part of the initial merit review, all applications will:

o Receive a written critique
o Undergo a selection process in which only those applications deemed to have 
the highest scientific merit, generally the top half of applications under 
review, will be discussed and assigned a priority score
o Receive a second level review by the appropriate national advisory council 
or board
 
REVIEW CRITERIA

a.  TRANSLATIONAL RESEARCH PROJECTS

Within the SPORE concept of translational research, reviewers will evaluate 
each research project using the five criteria listed below.  Each of these 
criteria will be addressed and considered by the reviewers in assigning a 
merit score to the project.  Note that the project does not need to be strong 
in all categories to be judged likely to have a translational impact and, 
thus, deserve a high priority score.  For example, an investigator may 
propose to carry out important work that by its nature is not innovative 
(e.g., correlative or hypothesis generating studies) but is essential to 
assess the relevance of a research finding in a clinical/population setting.  

a.1.  Significance.  The importance of the research objectives to human 
pancreatic cancer and their likelihood of completion within the maximum five-
year project period.  For projects focusing on animal models or in vitro 
systems, the feasibility of reaching a human endpoint in the near future.

a.2.  Approach.  The adequacy of the experimental design and methods to 
achieve the research objectives; clear evidence of co-leadership by a basic 
and more applied scientist in the conception, design and proposed 
implementation of the project.

a.3.  Innovation.  Originality and novelty of the experimental design as it 
relates to translational research.

a.4.  Investigators.  The qualifications of the basic and more applied co- 
investigators to conduct the proposed research and the appropriateness of the 
time commitments of each co-investigator to the conduct of the project.

a.5.  Environment. The scientific environment in which the research work will 
be done, and the unique features, if any, of the environment to support the 
proposed work.

a.6.  Human Subjects. The adequacy of plans to include both genders, 
minorities and their subgroups, and children (defined as under age 21) as 
appropriate for the scientific goals of the research and of plans for the 
recruitment and retention of subjects; the provisions for the protection of 
human subjects; and the safety of the research environment.

The initial review group will also examine provisions for animal subjects and 
the appropriateness of proposed project budgets and durations. 

b.  SHARED RESOURCES (CORES)

b.1. Tumor Bank/Tissue Resources

b.1.a.  adequacy of the proposed plan to develop and maintain a human 
pancreatic tissue resource, store the tissues and link them with appropriate 
pathological, clinical, and family history data to maximize their potential 
use in translational research; if a consortium is involved, adequacy of the 
proposed plan to integrate samples and data from multiple sources (Note: Use 
of human tissues in projects proposed at the time of application is 
encouraged but not required); 

b.1.b.  adequacy of the proposed plans to prioritize the distribution of 
tissues within and outside the SPORE
	
b.1.c.  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;

b.1.d.  adequacy of proposed plan to obtain informed written consent for all 
prospectively collected tissues;

b.1.e.  when appropriate, adequacy of the proposed plan to augment and/or 
complement any existing tissue resource supported by a Cancer Center Support 
Grant (P30) to avoid duplication and maximize productivity;	

b.1.f.  appropriateness of the budget to conduct and integrate tissue banking 
activities. 

b.2. Other Resources 

b.2.a.  degree to which plans indicate that shared resources (will) 
effectively and efficiently support the research of the SPORE in a manner 
that cannot be supported through available resources;

b.2.b.  demonstration that the resource is essential to the success of the 
SPORE;

b.2.c.  adequacy of qualifications and performance (if applicable) of 
resource directors;

b.2.d.  appropriateness of the requested budgets to conduct each resource 
operation;

b.2.e	when appropriate, adequacy of the proposed plan to augment and/or 
complement an existing shared resource supported by an NCI Cancer Center 
Support Grant (P30). 

b.2.f	for family registries, adequacy of proposed plan to develop and 
maintain the registry (or participate in an existing registry), with 
appropriate follow-up data collection; if a consortium is involved, adequacy 
of the proposed plan to integrate data from multiple sources (Note: Use of 
family registries by projects proposed at the time of application is 
encouraged but not required).

c.  DEVELOPMENTAL RESEARCH PROGRAM

c.1.  adequacy of the process for attracting new ideas for pilot studies 
within and outside of the SPORE institution.

c.2.  adequacy of the proposed process for continuously reviewing and funding 
a spectrum of pilot projects (e.g., research, technology development, 
resources) based on their relevance to human pancreatic cancer.

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 significant activity for 
career development of translational research scientists, including both 
junior scientists beginning their research careers and senior scientists 
wishing to refocus their careers on translational pancreatic cancer research;

d.2.  adequacy of the process for selecting candidates for independent 
careers in translational pancreatic cancer research

d.3.  adequacy of the process to seek out and include qualified minorities, 
women, and persons with disabilities in the career development program;

d.4.  appropriateness of the budget 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; adequacy of the time commitment of the principal 
investigator;

e.2.  adequacy of the planning and evaluation process to include: determining 
pancreatic cancer research productivity and translational potential of 
existing projects and resources; discontinuing activities of low 
productivity; initiating new activities in response to important pancreatic 
cancer  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 with a minimum of three 
scored projects;

e.5.  plans for promoting interdisciplinary scientific interaction;

e.6.  plans for integrating SPORE research and resources with existing Cancer 
Center 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 to promote and maintain communication and integration 
of scientific projects of mutual interest with other SPOREs;

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

ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your 
application will also be reviewed with respect to the following:

PROTECTIONS:  The adequacy of the proposed protection for humans, animals, or 
the environment, to the extent they may be adversely affected by the project 
proposed in the application.

INCLUSION:  The adequacy of plans to include subjects from both genders, all 
racial and ethnic groups (and subgroups), and children as appropriate for the 
scientific goals of the research.  Plans for the recruitment and retention of 
subjects will also be evaluated. (See Inclusion Criteria included in the 
section on Federal Citations, below)

DATA SHARING:  The adequacy of the proposed plan to share data. 

BUDGET:  The reasonableness of the proposed budget and the requested period 
of support in relation to the proposed research.

OVERALL EVALUATION AND SCORING OF APPLICATIONS

Each component of the SPORE will be given a score.  A single numerical 
priority score will then be assigned to the SPORE application as a whole. 
Although this score will be based primarily on scientific merit, 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 and translational potential of the research
15%	evidence of interdependent, multidisciplinary design and conduct of the 
research
15%	potential for impacting 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.
See section E of Guidelines for Pancreatic Cancer SPOREs
(http://deainfo.nci.nih.gov/flash/awards.htm) for a more detailed description 
of each of the required components.

AWARD CRITERIA

Applications submitted in response to a PA will compete for available funds 
with all other recommended applications.  The following will be considered in 
making funding decisions:  

o Scientific merit of the proposed project as determined by peer review
o Availability of funds 
o Relevance to program priorities

REQUIRED FEDERAL CITATIONS 

MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD:  Research components 
involving Phase I and II clinical trials must include provisions for 
assessment of patient eligibility and status, rigorous data management, 
quality assurance, and auditing procedures.  In addition, it is NIH policy 
that all clinical trials require data and safety monitoring, with the method 
and degree of monitoring being commensurate with the risks (NIH Policy for 
Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 
1998: https://grants.nih.gov/grants/guide/notice-files/not98-084.html).  

Clinical trials supported or performed by NCI require special considerations.  
The method and degree of monitoring should be commensurate with the degree of 
risk involved in participation and the size and complexity of the clinical 
trial.  Monitoring exists on a continuum from monitoring by the principal 
investigator/project manager or NCI program staff or a Data and Safety 
Monitoring Board (DSMB).  These monitoring activities are distinct from the 
requirement for study review and approval by an Institutional review Board 
(IRB).  For details about the Policy for the NCI for Data and Safety 
Monitoring of Clinical trials see: 
http://deainfo.nci.nih.gov/grantspolicies/datasafety.htm.  For Phase I and II 
clinical trials, investigators must submit a general description of the data 
and safety monitoring plan as part of the research application.  See NIH 
Guide Notice on "Further Guidance on a Data and Safety Monitoring for Phase I 
and II Trials" for additional information: 
https://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html.  
Information concerning essential elements of data safety monitoring plans for 
clinical trials funded by the NCI is available:  
http://www.cancer.gov/clinical_trials/

INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH:  t is the policy of 
the NIH that women and members of minority groups and their sub-populations 
must be included in all NIH-supported clinical research projects unless a 
clear and compelling justification is provided indicating that inclusion is 
inappropriate with respect to the health of the subjects or the purpose of the 
research. This policy results from the NIH Revitalization Act of 1993 (Section 
492B of Public Law 103-43).

All investigators proposing clinical research should read the AMENDMENT "NIH 
Guidelines for Inclusion of Women and Minorities as Subjects in Clinical 
Research - Amended, October, 2001," published in the NIH Guide for Grants and 
Contracts on October 9, 2001 (https://grants.nih.gov/grants/guide/notice-
files/NOT-OD-02-001.html); a complete copy of the updated Guidelines are 
available at 
https://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition of clinical 
research; updated racial and ethnic categories in compliance with the new OMB 
standards; clarification of language governing NIH-defined Phase III clinical 
trials consistent with the new PHS Form 398; and updated roles and 
responsibilities of NIH staff and the extramural community.  The policy 
continues to require for all NIH-defined Phase III clinical trials that: a) 
all applications or proposals and/or protocols must provide a description of 
plans to conduct analyses, as appropriate, to address differences by 
sex/gender and/or racial/ethnic groups, including subgroups if applicable; 
and b) investigators must report annual accrual and progress in conducting 
analyses, as appropriate, by sex/gender and/or racial/ethnic group 
differences.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS:  
The NIH maintains a policy that children (i.e., individuals under the age of 
21) must be included in all human subjects research, conducted or supported 
by the NIH, unless there are scientific and ethical reasons not to include 
them. This policy applies to all initial (Type 1) applications submitted for 
receipt dates after October 1, 1998.

All investigators proposing research involving human subjects should read the 
"NIH Policy and Guidelines" on the inclusion of children as participants in 
research involving human subjects that is available at 
https://grants.nih.gov/grants/funding/children/children.htm

REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS:  NIH 
policy requires education on the protection of human subject participants for 
all investigators submitting NIH proposals for research involving human 
subjects.  You will find this policy announcement in the NIH Guide for Grants 
and Contracts Announcement, dated June 5, 2000, at 
https://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.  A 
continuing education program in the protection of human participants in 
research in now available online at: http://cme.nci.nih.gov/

HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on 
hESCs can be found at https://grants.nih.gov/grants/stem_cells.htm and at  
https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.  Only 
research using hESC lines that are registered in the NIH Human Embryonic Stem 
Cell Registry will be eligible for Federal funding (see http://escr.nih.gov).  
It is the responsibility of the applicant to provide the official NIH 
identifier(s)for the hESC line(s)to be used in the proposed research.  
Applications that do not provide this information will be returned without 
review. 

PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: 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 
https://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.

Applicants may wish to place data collected under this 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.

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.  Furthermore, 
we caution reviewers that their anonymity may be compromised when they 
directly access an Internet site.

HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to 
achieving the health promotion and disease prevention objectives of "Healthy 
People 2010," a PHS-led national activity for setting priority areas. This PA 
is related to one or more of the priority areas. Potential applicants may 
obtain a copy of "Healthy People 2010" at 
http://www.health.gov/healthypeople/

AUTHORITY AND REGULATIONS
  
This program is described in the Catalog of Federal Domestic Assistance Nos. 
93.397 and 93.121.  Awards are made under authorization of Sections 301 and 
405 of the Public Health Service Act as amended (42 USC 241 and 284) and 
administered under NIH grants policies and Federal Regulations 42 CFR 52 and 
45 CFR Parts 74 and 92. This program is not subject to the intergovernmental 
review requirements of Executive Order 12372 or Health Systems Agency review.

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

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