IN VIVO CELLULAR AND MOLECULAR IMAGING CENTERS (ICMICs)
 
Release Date:  August 7, 2002 (see addendum NOT-CA-02-025)

RFA: CA-03-015
 
National Cancer Institute (NCI)  
 (http://www.nci.nih.gov/)

LETTER OF INTENT RECEIPT DATE: October 21, 2002

APPLICATION RECEIPT DATE: November 25, 2002

This RFA is a reissue of RFA-CA-01-014, which was published in the NIH Guide 
on August 7, 2000.

THIS RFA CONTAINS THE FOLLOWING INFORMATION

o Purpose of this RFA
o Research Objectives
o Mechanism of Support
o Funds Available
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements
o Where to Send Inquiries
o Letter of Intent
o Submitting an Application
o Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations

PURPOSE

The Biomedical Imaging Program, Division of Cancer Diagnosis and Treatment of 
the National Cancer Institute (NCI) invites applications for P50 Research 
Center Grants for the establishment of In Vivo Cellular and Molecular Imaging 
Centers (ICMICs).  This initiative is designed to capitalize on the 
extraordinary opportunity for studying cancer non-invasively, and in many 
cases, quantitatively due to recent advances in molecular imaging modalities, 
as well as molecular and cellular biology.  ICMICs will facilitate the 
interaction of scientists from a variety of fields such as, but not limited 
to: imaging sciences, chemistry, radiopharmaceutical chemistry, cellular and 
molecular biology, pharmacology, physics, computer science, biomedical 
engineering, immunology, pathology and neuroscience, and provide resources to 
conduct multidisciplinary research.

The 5-year P50 grants described in this RFA will be appropriate for those 
Institutions in which investigator-initiated multidisciplinary research 
involving imaging and molecular technologies are currently ongoing.  These 
efforts may be generating important preliminary data, but the teams may be 
loosely associated or not consistently supported and therefore lack the 
overall structure and resources necessary to take full advantage of emerging 
opportunities.  The P50 Center grant will provide a formal framework through 
which scientific synergy can occur on a stable and continuing basis, and will 
provide 1) an organizational structure specifically designed to facilitate 
scientific cross-fertilization between seemingly disparate groups of 
investigators; 2) specialized resources to support research activities; 3) 
developmental funds for feasibility testing of new projects; and 4) career 
development opportunities for new and established investigators.

RESEARCH OBJECTIVES

Background:

Imaging sciences are at a stage in which human anatomic imaging can occur in 
vivo at submillimeter resolution, and significant advances have occurred in 
molecular imaging modalities, including the nuclear medicine techniques of 
SPECT and PET, MR spectroscopy and optical imaging.  At the same time, a 
myriad of new cancer-related genes and proteins are being discovered at an 
increasing pace by molecular and cellular biologists.  However, there remains 
a scientific gulf between basic scientists who discover new cancer genes and 
intracellular pathways, any of which could serve as a diagnostic or 
therapeutic target, and the imaging scientists who could transform those 
discoveries into non-invasive means for a greater understanding of neoplasia 
in humans.

Research Goals and Objectives:

The formation of multidisciplinary research teams will stimulate and 
streamline cancer imaging research from inception to use in patient care.  
Each Institution will define the structure and research objectives that create 
the most synergistic and creative scientific interactions.  In general, an 
ICMIC will provide researchers with the following critical resources:

Special Features

1) The ICMICs will provide an organizational structure specifically designed 
to facilitate intellectual multi-disciplinary interactions between 
seemingly disparate groups of investigators.  This structure will provide 
researchers with access to a concentrated pool of expertise in a wide range 
of disciplines, and the resources necessary to analyze and predict the 
likelihood of success in areas outside their immediate realm of expertise.  
The structure of the ICMIC will be designed to provide investigators with 
the means of conducting multidisciplinary research in a highly 
collaborative atmosphere, and the consistent access to expertise with 
minimal wasted time and effort.  Personnel may be scientists from a variety 
of fields such as, but not limited to: imaging sciences, chemistry, 
radiopharmaceutical chemistry, cell and molecular biology, pharmacology, 
computer science and biomedical engineering.  Other specialists in fields 
such as MRI physics, immunology or neuroscience, for example, may also be 
involved.  Most importantly, ICMIC personnel must demonstrate an eagerness 
to collaborate outside of their own discipline.  The nature of these 
interactions will be determined by the applicants, and emphasis will be 
placed on establishing creative, productive interactions.

2) The ICMICs will provide funding for several Research Components.  Research 
Components will apply multidisciplinary approaches to the integration of 
molecular imaging and cancer.  Individual research projects will be 
structured in order to maximize the utilization of the Specialized 
Resources (see below).  The Research Components will be similar in size and 
scope to a typical R01 or subproject of a P01, and will be expected to meet 
the same standards of preliminary data in support of the hyptheses.  P01.

3) The ICMICs will provide Specialized Resource Facilities and Services.  A 
barrier to productive scientific interaction is the lack of available 
facilities for cross-disciplinary experiments.  Demands on equipment, 
resources, and reagents in every scientific area are extremely high, and 
this demand prohibits ready access to investigators interested in expanding 
their studies into new areas of research.  The establishment of Specialized 
Resources dedicated to ICMIC-related research will provide this access.  
The Specialized Resource(s) would be determined by the requirements of the 
Institution, the defined scientific goals of the Research Components of the 
ICMIC, and budgetary limits.  Prioritization of the research projects 
supported through ICMIC Specialized resources would be an essential 
function of the ICMIC's leadership, and the mechanism to be employed for 
prioritization must be delineated by the applicants.  Resource facilities 
may be utilized by active members of the ICMIC and would also be available 
to investigators supported through the Development Fund (see below).

4) ICMICs will provide Developmental Funds for feasibility testing of new 
projects.  A high priority of each ICMIC will be the identification and 
support of pilot projects that identify and stimulate interdisciplinary 
projects that will take full advantage of emerging research opportunities.  
The selection of projects will be through a review process established by 
the ICMIC's leadership.  The portfolio of ongoing projects in any given 
Program is expected to be extremely dynamic.  This fund is not to be used 
to support traditional, ongoing projects that could readily be supported 
through R01s.  It is not appropriate for projects that utilize single areas 
of expertise or to support the continuation of previously funded research 
projects, and Developmental Projects may not be supported for more than 2 
years.  Necessary equipment should be provided through the appropriate 
Specialized Resource. These projects are to be monitored closely by the 
ICMIC leadership.  Investigators working on projects supported through the 
Development Fund must understand that when the projects become sufficiently 
mature, they will be expected to compete for independent R01 funding.  
Alternatively, if it becomes obvious that it will not provide the expected 
results, a plan should be in place for terminating a development project.

5) ICMICs will provide career development opportunities for new and 
established investigators.  Current graduate programs are generally focused 
on single disciplines and may be inadequate to train the needed cadre of 
inter-disciplinary imaging scientists.  The ICMICs will provide support for 
a limited number of pre-and post-doctoral trainees in a program to be 
defined by the applicants.  Career development opportunities through the 
ICMIC will be expected to be highly cross-disciplinary.

SPECIAL REQUIREMENTS

ICMIC investigators will be expected to participate in ICMIC/Pre-ICMIC 
workshops and investigators meetings as necessary to share results with other 
ICMICs/Pre-ICMICs, share materials, assess progress, identify new research 
opportunities, and establish interactions and research priorities and 
collaborations.  Travel funds for the Principal Investigator and selected 
ICMIC investigators and collaborators may be budgeted for this purpose.

MECHANISM OF SUPPORT
 
Support of this program will be through the National Institutes of Health 
(NIH) P50 Specialized Centers Grant Mechanism.  Responsibility for the 
planning, direction, and execution of the proposed project will be solely that 
of the applicant.  The total project period for a P50 application submitted in 
response to this RFA may not exceed 5 years.  The anticipated award date is 
July 1, 2003.

There will be a single receipt date for P50 grants to be funded in FY 2003.  
However, contingent upon the future availability of funds for these grants, 
the NCI anticipates 1 additional receipt date for P50 applications to be 
funded in FY 2004.

FUNDS AVAILABLE
 
NCI intends to commit approximately $4,000,000 total costs in FY 03 to fund 2 
new ICMIC grants in response to this RFA.  An applicant may request a project 
period of up to 5 years and a budget for direct costs of up to $2,000,000 per 
year.  Because the nature and scope of the proposed research will vary from 
application to application, it is anticipated that the size and duration of 
each award will also vary. Although the financial plans of NCI provide support 
for this program, awards pursuant to this RFA are contingent upon the 
availability of funds and the receipt of a sufficient number of meritorious 
applications. 

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 Domestic
 
Applications from foreign institutions will not be accepted.  Applications 
from institutions which are current recipients of P50 ICMIC awards will not be 
accepted.  Foreign components of applications from domestic organizations will 
be accepted with adequate justification. 

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.   

WHERE TO SEND INQUIRIES

We encourage inquiries concerning this RFA and welcome the opportunity to 
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:

Anne E. Menkens, Ph.D.
Bomedical Imaging Program
National Cancer Institute
Executive Plaza North, Room 6068
Bethesda, MD  20892
Telephone:  (301) 496-9531
FAX:  (301) 480-3507
Email:  am187k@nih.gov

o Direct your questions about peer review issues to:

Referral Officer
National Cancer Institute
Division of Extramural Activities
6116 Executive Boulevard, Room 8041, MSC 8329
Bethesda, MD 20892-8329
Telephone: (301) 496-3428
FAX: (301) 402-0275 
Email:  ncidearefof@mail.nih.gov

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

Eileen Natoli
Grants Administration Branch
National Cancer Institute
6120 Executive Boulevard, EPS-243
Bethesda, Maryland 20892
Telephone: 301-496-8791
Fax: 301-496-8601
Email: natolie@gab.nci.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 RFA 

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:

Anne E. Menkens, Ph.D.
Biomedical Imaging Program
National Cancer Institute
Executive Plaza North, Room 6068
Bethesda, MD  20892
Telephone:  (301) 496-9531
FAX:  (301) 480-3507
Email:  am187k@nih.gov

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 
http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive 
format.  For further assistance contact GrantsInfo, Telephone (301) 435-0714, 
Email: GrantsInfo@nih.gov.
 
SUPPLEMENTAL INSTRUCTIONS:

1) Budget(s):

The budget(s) should be presented in logical, discrete units for each section 
of the application using the standard PHS-398 form pages 4-5.  The budgets to 
be submitted should include:

a)  A detailed composite budget for the entire ICMIC
b)  A separate budget for Administrative and Organizational activities
c)  A separate budget for each individual Research Component
d)  A separate budget for each Specialized Resource
e)  A single budget section for the Developmental Component
f)  A single budget for the Career Development Component.  

Additional pages for budget justification are to be used when necessary.

2) Research Plan

The following format is suggested for completing the "Research Plan" section 
(see pages 19 through 23 of the PHS 398 application brochure).  The 
application should be as concise as possible to ensure a thorough review.

A. ICMIC Description (not to exceed 10 pages)

This section should be used to present the overall vision for the ICMIC.  
This summary should include the long and short-term scientific objectives, 
a description of the ICMIC as an integrated functioning unit, and how the 
research supported through the ICMIC will significantly advance cellular 
and molecular imaging technologies.  Summarize the organizational structure 
for the ICMIC, concisely defining Research Components, Specialized 
Resources, the Developmental Fund and the Career Development Component, and 
their relationships to each other. In addition, describe relationships 
between the ICMIC and other research, academic, and administrative units of 
the institution (such as centers, institutes, departments) and the central 
administration..  The ICMIC description should serve as an overview of the 
ICMIC, with more detailed description of each component to be presented in 
a later section.

B. Organization and Administration (not to exceed 20 pages, including any 
organizational charts).  A separate budget should be prepared and included 
for centralized administrative and organizational activities.  The 
Organizational and Administrative Component should describe all of the 
infrastructure and decision-making needs of the ICMIC.  Appropriate for 
inclusion in this component would be (not necessarily in the following 
order):
o description of the role(s) and responsibilities of lead investigators, 
internal and external advisory committees as well as participating 
investigators.
o description of decision-making and oversight responsibilities for each 
Research Component.
o description of decision-making, oversight responsibilities and 
anticipated utilization for each Specialized Resource.  If existing 
resources are to be utilized by the ICMIC, state explicitly how they differ 
from new Specialized Resources to be established as a part of the ICMIC, 
and what arrangements have been made to ensure access by ICMIC 
Investigators to those existing resources.
o description of decision-making and oversight responsibilities for the 
Developmental Fund, including the process for selecting, monitoring and 
terminating the Developmental Projects.
o description of decision-making and oversight responsibilities for the 
Career Development Component, including the process for selecting, 
monitoring and terminating trainees.
o description of ICMIC-sponsored activities designed to foster 
multidisciplinary interactions, such as regularly scheduled forums for the 
presentation and discussion of multidisciplinary research topics.
o detailed description of Institutional commitment to the ICMIC.
o commitment to interact with other ICMICs and Pre-ICMICs, including 
Inter-ICMIC meetings in the Washington DC area.

C. Research Components (not to exceed 25 pages each)

Research Components will define the scientific projects supporting the 
long-term goals of the ICMIC, and are to be presented using the format of a 
traditional research project [Research Plan: Include Sections a-d 
(Instructions for PHS 398, Pages 15-17)].  The leader(s) of each Research 
Component will be responsible for ensuring that ongoing research project(s) 
are relevant to the ICMIC goals, and that the investigators and projects 
remain highly integrated with other ongoing ICMIC research.  Research 
Components may rely on the support of the Specialized Resources.  To ensure 
a sufficient level of multidisciplinary interaction, no fewer than three 
Research Components should be included in the application; the maximum 
number will be determined by the identified needs of the investigators and 
budgetary constraints. The total number of pages for each Research 
Component is not to exceed 25.  Describe each Research Component in 
sufficient detail to enable reviewers to judge the scientific merit from 
the written application.  Do not present separate "subprojects." All 
projects are to have a single theme, project leader and budget. 
Following the description of the scientific goals, each Research Component 
should summarize exactly how the project integrates with the goals of the 
ICMIC, how it will communicate and complement the other Research 
Components, and how it will utilize the Specialized Resources.  Describe in 
this section the relevance of the project to the primary theme of the ICMIC 
and the collaborations with investigators within the ICMIC.  Explicitly 
state which Specialized Resources will be used by this Research Component, 
and, if possible, quantitate the anticipated usage of Specialized Resources 
in tabular format.  This summary should not exceed 1-2 pages, which are 
included in the 25 page limit for each Research Component section.

D.	Specialized Resources (not to exceed 15 pages each)

Specialized Resources may include laboratory and clinical facilities, 
equipment, and services. For each Specialized Resource, describe in detail 
the resource(s) that it will provide to the ICMIC.  In addition, describe 
its role in the overall functioning of the ICMIC, including how each 
resource will enhance multidisciplinary research, and a description of the 
projects that will be supported by the Specialized Resource.  
1. Using a Form PHS 398 Continuation Page, denote "Specialized Resource" 
and the Specialized Resource director's name. If there is to be more than 
one core component, prepare a separate section for each core (i.e., 
Specialized Resource A, Specialized Resource B, etc.). 
2. For each Specialized Resource, describe the role of the Specialized 
Resource as a core to the ICMIC as a whole. Clearly present the facilities, 
resources, services, and professional skills that the core component 
provides. 
3. To aid in the review, it is suggested that a table to show the estimated 
or actual proportional use of this Specialized Resource by each project, be 
included in the application.  Justify this core component by discussing 
ways in which these centralized services improve quality control, produce 
an economy of effort, and/or save overall costs compared to their inclusion 
as part of each project in the P50 ICMIC. 

E. Developmental Fund (not to exceed 20 pages)

This section should include a description of the Developmental Project(s) 
that will be initiated during the first year of ICMIC funding, including a 
summary of which Specialized Resources will support the projects, and to 
what level that support will occur. The description of decision-making and 
oversight responsibilities,including the process for selecting, monitoring 
and terminating the Developmental Projects should be included in the 
"Organization and Administration" Section of the application.  This section 
should include only the scientific portion of the Developmental Projects.  
The Developmental Projects should provide an avenue for introducing and 
integrating new investigators and innovative technologies / methodologies 
into the ICMIC infrastructure (in specific) and molecular imaging (in 
general).  It should not be viewed as a supplemental source of funding for 
investigators that are already heavily invested in the success of the 
ICMIC.  Since the Developmental Projects will be flexible, only the first 
year of projects should be included in the application.  However, 
applicants should include in their budgets appropriate funds to also 
support Developmental Projects in Years 2-5 of the award.  The 
Developmental Fund projects must be multidisciplinary, and each is to be 
presented using the format of a traditional research project [Research 
Plan: Include Sections a-d (Instructions for PHS 398, Pages 15-17)].  The 
number of Developmental Projects to be initiated will be determined by the 
ICMIC applicants.

F. Career Development Component (not to exceed 15 pages)

Career Development opportunities sponsored by ICMICs  will provide a limited 
number of trainees with access to a highly cross-disciplinary experience.  The 
extent of the Career Development Component is to be defined by the applicant, 
based on the needs and capabilities of the ICMIC participants.  Applicants for 
career development support may be new investigators or established 
investigators who wish to change research directions.  Candidates should be 
scientists who have demonstrated outstanding research potential but who need 
additional time in a productive scientific environment to establish an 
independent, multidisciplinary research program.  Recruitment must include 
qualified women and minorities.  To this end, each applicant should propose a 
clear policy and plan for recruitment of career development candidates.  The 
ICMIC application should propose the number of slots available, the criteria 
for eligibility and for selection of candidates, and describe the selection 
process.  Also, the application should indicate prospective mentors who are 
already in place at the proposed ICMIC, briefly describe their research 
programs, and describe complementary activities that contribute to the 
environment for career development (e.g., existing training grants, other 
career development mechanisms and relevant programs).

USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001) 
application form must be affixed to the bottom of the face page of the 
application.  Type the RFA number on the label.  Failure to use this label 
could result in delayed processing of the application such that it may not 
reach the review committee in time for review.  In addition, the RFA title and 
number must be typed on line 2 of the face page of the application form and 
the YES box must be marked. The RFA label is also available at: 
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf.
 
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
Bethesda, MD  20817 (for express/courier service)
 
At the time of submission, two additional copies of the application must be 
sent to:
 
Referral Officer 
Division of Extramural Activities 
National Cancer Institute 
6116 Executive Blvd., Room 8041, MSC-8329
Rockville, MD 20852 (express courier)
Bethesda MD 20892-8329

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.) 
(http://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 http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-012.html.

APPLICATION PROCESSING: Applications must be received by the application 
receipt date listed in the heading of this RFA.  If an application is received 
after that date, it will be returned to the applicant without review.
 
The Center for Scientific Review (CSR) will not accept any application in 
response to this RFA 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 substantial 
revisions of applications already reviewed, but such applications must include 
an Introduction addressing the previous critique.

PEER REVIEW PROCESS  
 
Upon receipt, applications will be reviewed for completeness by the CSR and 
for responsiveness by the NCI program staff.  

Incomplete applications will be returned to the applicant without further 
consideration.  

Applications that are complete and responsive to the RFA will be evaluated for 
scientific and technical merit by an appropriate peer review group convened by 
the Division of Extramural Activities (DEA) at NCI in accordance with the 
review criteria stated below.  As part of the initial merit review, all 
applications will:

o  Receive a written critique
o  Undergo a process in which only those applications deemed to have the 
highest scientific merit, generally the top half of the applications under 
review, will be discussed and assigned a priority score
o Those that receive a priority score will undergo a second level review by 
the National Cancer Advisory Board. 
 
REVIEW CRITERIA

The goals of NIH-supported research are to advance our understanding of 
biological systems, improve the control of disease, and enhance health.  The 
reviewers will comment on the following aspects of the application in their 
written critiques in order to judge the likelihood that the proposed research 
will have a substantial impact on the pursuit of these goals.  Each of these 
criteria will be addressed and considered by the reviewers in assigning the 
overall score weighting them as appropriate for each application.

The overall ICMIC applications will be reviewed using the criteria listed 
below.

Significance:  Does the ICMIC address an important cancer-related imaging 
research problem?  Are the scientific objective(s) of the Research Components, 
Specialized Resources, Developmental Projects and Career Development Plans 
appropriate and adequate to achieve the long-term goals of the ICMIC?

Approach: Is the conceptual framework and the experimental design, methods and 
analyses proposed for each of the ICMIC components  sound and feasible?  Do 
the individual Research Components interact appropriately with the other 
Research Components and Specialized Resources?

Innovation: Are the experimental designs of the proposed research  focused on 
cellular and molecular imaging of cancer, and are they original, novel, and 
innovative?

Investigator(s): Is the ICMIC Director and leadership appropriately trained 
and well suited to the organizational and scientific responsibilities of the 
ICMIC?  Is there evidence that ICMIC participants are committed to productive, 
multidisciplinary interactions?  

Environment:  Is there evidence of significant commitment of the institution 
to fulfilling the objectives of the ICMIC?  Does the scientific environment in 
which the work will be done contribute to the probability of success?  Do the 
proposed experiments take advantage of unique features in the scientific 
environment?

In addition, each ICMIC component will be reviewed using the following 
criteria:

1) Organization and Administration:

Is the organizational, scientific and operational framework reasonable, well-
integrated and appropriate to the aims of the ICMIC?  Does the ICMIC employ 
novel approaches or methods for facilitating scientific interaction?  Is the 
ICMIC Director and leadership appropriately trained and well suited to the 
organizational and scientific responsibilities associated with this project?  
Is there sufficient oversight and monitoring of Research Components, 
Specialized Resources, Developmental Funds and Career Development Programs?  
Is there evidence of significant commitment of the institution to fulfilling 
the objectives of the ICMIC?  If collaborative arrangements are proposed, is 
there a convincing demonstration that these interactions will be consistent 
enough to meet the needs of the ICMIC?

2) Research Components:

The five criteria to be used to evaluate individual Research Components in 
ICMIC applications are listed below.
a) Significance.  Does the Research Component address an important research 
problem related to cancer imaging? Does the scientific merit and experimental 
design of the Research Project(s) adequately address issues of substantive 
importance?
b) Approach.  Are the conceptual research framework, design, methods, and 
analyses adequately developed, well-integrated, and appropriate to the aims of 
the project?  Does the applicant acknowledge potential problem areas and 
consider alternative translational approaches? Is there clear evidence of 
significant multidisciplinary basic and clinical interactions in the 
conception, design, and proposed implementation of the project?
c) Innovation.  Does the Research Project(s) develop new methodologies or 
technologies? Is the experimental design of sufficient originality, novelty, 
and innovativeness to make it highly relevant to the overall goals and 
objectives of the ICMIC?
d) Investigators.  Is the lead investigator and the co- investigators 
appropriately qualified with demonstrated competence to conduct the proposed 
research?  Is the proposed work appropriate to the experience level of the 
principal investigator and project researchers?  Are the proposed time 
commitments for all key laboratory and clinical researchers reasonable and 
adequately associated with the project?
e) Environment.  Does the scientific environment in which the work will be 
done contribute to the probability of success?  Do the proposed experiments 
take advantage of unique features in the scientific environment or reach out 
to useful collaborative arrangements? Is there evidence of adequate 
institutional support?

3) Specialized Resources:

Is each Specialized Resource essential for the conduct of ICMIC?  Is the 
access to, and distribution of, Specialized Resources focused on meeting the 
goals of the ICMIC?  Are the proposed managers of Specialized Resources 
adequately qualified of to conduct high quality, reliable resource operations?  
Are the requested budgets appropriate to conduct each resource operation?

4) Developmental Projects:

The Developmental Projects will be reviewed as a "cluster", reflecting the 
cumulative scientific strength of the projects and the process, rather than 
assigning each project an independent meritrating.   Do the Developmental 
Projects demonstrate innovate approaches that integrate multiple scientific 
disciplines?  Do these projects reflect a careful selection process focused on 
scientific quality and innovation?  Do the Developmental Projects establish 
new, multidisciplinary collaborations focused on cellular and molecular 
imaging of cancer, and are the projects original and innovative?

5) Career Development Program:

Is the Career Development Program well justified, and does it describe a 
program that will successfully train investigators capable of establishing 
independent multidisciplinary imaging research programs?  Are the proposed 
mentors in the Career Development Program experienced in the types of training 
proposed?  Is the process for selecting candidates for training adequate, and 
does it seek out and include qualified minorities and women?

The initial review group will also examine: the appropriateness of proposed 
project budget and duration; the adequacy of plans to include both genders and 
minorities and their subgroups as appropriate for the scientific goals of the 
research and plans for the recruitment and retention of subjects; the adequacy 
of plans for including children as appropriate for the scientific goals of the 
research, or justification for exclusion; the provisions for the protection of 
human and animal subjects; and the safety of the research environment.

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

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

o 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.

o 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)

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

RECEIPT AND REVIEW SCHEDULE

Letter of Intent Receipt Date:  October 21, 2002
Application Receipt Date:  November 25, 2002
Peer Review Date:  February/March 2003
Council Review:  May 2003
Earliest Anticipated Start Date: July 1, 2003

AWARD CRITERIA

Award criteria that will be used to make award decisions include:

o Scientific merit (as determined by peer review)
o Availability of funds
o Programmatic 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: 
http://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: 
http://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:  It 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 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete 
copy of the updated Guidelines are available at 
http://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 
http://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 
http://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 http://grants.nih.gov/grants/stem_cells.htm and at 
http://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 
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.

Applicants may wish to place data collected under this RFA 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 RFA 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 No. 93.394, Cancer Detection and Diagnosis Research,  and 
is not subject to the intergovernmental review requirements of Executive Order 
12372 or Health Systems Agency review.  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 described at 
http://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations 
42 CFR 52 and 45 CFR Parts 74 and 92. 

The PHS strongly encourages all grant recipients to provide a smoke-free 
workplace and discourage the 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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