IN VIVO CELLULAR AND MOLECULAR IMAGING CENTERS (ICMICs)
 
Release Date:  August 7, 2000

RFA:  CA-01-014
 
National Cancer Institute
 
Letter of Intent Receipt Date:  October 17, 2000
Application Receipt Date:       November 28, 2000

This Request for Application (RFA) replaces RFA-CA-99-004, which was 
published in NIH Guide on March 30, 1999.

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).  A separate Request for Applications (RFA), CA-01-010, 
describing a complementary initiative, the P20 Planning Grant for Pre-In Vivo 
Cellular and Molecular Imaging Centers (Pre-ICMICs), has also been issued.  
This RFA is available at:  
(http://grants.nih.gov/grants/guide/rfa-files/RFA-CA-01-010.html. 
Both of these initiatives are 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.  They 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, computer science, biomedical engineering, 
immunology 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, 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.  The 3-year 
P20 Pre-ICMIC awards described in RFA CA-01-010 will be appropriate for those  
Institutions that have most of the separate scientific components necessary 
for productive interaction but have no previous track-record of performing 
multidisciplinary scientific research.  Following completion of the P20 
funding period, grantees will hopefully compete for a P50 award (see below) 
that will be competitively reviewed on the organizational and scientific 
progress made during the planning stage.

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 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).

3)   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.

4)   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.

An example of a ICMIC structure is described below.  This is just an example, 
and other multidisciplinary formats are encouraged.

An ICMIC would be defined by a long-term, multidisciplinary scientific vision 
focused on the advancement of in vivo cellular and molecular imaging.  In 
order to accomplish its long-term goals, the ICMIC may be structured into a 
series of Research Components.  A Research Component may be defined by one or 
more research projects focused on a specific scientific goals, which are 
accomplished and readily disseminated throughout the ICMIC.  For example, 
research project(s) focused on the discovery, characterization and refinement 
of new genetic targets might be accomplished within a Molecular Biology 
Component.  A Chemistry/Radiochemistry Component might be responsible for 
projects aimed at designing new imaging agents directed towards targets 
defined in the Molecular Biology Component.  A Computing/Database Component 
would be responsible for ongoing research in molecular modeling and 
structural analyses as it relates to ICMIC projects.  A Biochemistry 
Component might be responsible for aspects of imaging agent development that 
encompass cell biology and pharmacology, in addition to development of 
kinetic models for studying complex issues involving agent delivery and 
metabolism.  The most promising potential imaging agents would be refined and 
tested in the Imaging Component.  Each Component would have access to ICMIC 
Specialized Resources, designed to provide support facilities to ICMIC 
research projects.  Developmental Projects would be initiated in response to 
new discoveries made through the ICMIC, and would be supported through 
Specialized Resources.  Opportunities for trainees would be available through 
the investigators involved with the ICMIC, and their ongoing projects.

SPECIAL REQUIREMENTS

ICMIC investigators will be expected to participate in an annual ICMIC/Pre-
ICMIC workshop 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 August 1, 2001.

There will be a single receipt date for P50 grants to be funded in FY 2001.  
However, contingent upon the future availability of funds for these grants, 
the NCI anticipates 2 additional receipt dates for P50 applications, one each 
for funding in FY 2003 and FY 2004.

FUNDS AVAILABLE

The NCI anticipates that two 5-year awards will be made in FY 2001, and plans 
to set aside $4.0 million total (to include both direct and Facility and 
Administrative costs) for the initial year’s funding.  Funding in response to 
this RFA is dependent upon the receipt of a sufficient number of applications 
of high scientific merit. Although this program is provided for in the 
financial plans of NCI, the award of grants pursuant to this RFA is 
contingent upon the anticipated availability of funds for this purpose.

ELIGIBILITY REQUIREMENTS

Applications for P50 ICMIC grants may be submitted by domestic non-profit and 
for-profit organizations, public and private, such as universities, colleges, 
hospitals and laboratories.  Applications from foreign institutions will not 
be accepted.  Foreign components of applications from domestic organizations 
will be accepted with adequate justification. Racial/ethnic minority 
individuals, women, and persons with disabilities are encouraged to apply as 
Principal Investigators.

If an institution has a previously funded, active P20 Pre-ICMIC planning 
grant, an application from that same institution for a P50 ICMIC grant can be 
submitted in response to this RFA.  If an Institution has submitted an 
application for a P20 Pre-ICMIC planning grant in response to RFA-CA-01-010, 
that Institution is not eligible to submit a P50 ICMIC application in 
response to this RFA [please refer to the eligibility criteria outlined in 
RFA-CA-01-010 (http://grants.nih.gov/grants/guide/rfa-files/RFA-CA-01-010.html)]. 
All Institutions will be eligible to submit applications for 
future P50 receipt dates (anticipated to occur for funding in FY 2003 and 
2004).  

Each of the lead investigators (the Principal Investigator of the ICMIC, and 
the Principal Investigator(s) of each Research Component)  must be the 
principal investigator of a major, peer-reviewed research project, such as an 
R01, a P01, or their equivalent from another funding agency.  In addition, 
each of the lead investigators must demonstrate that they have had 
significant and productive scientific interactions with at least one of the 
other lead investigators, either as co-investigators on funded grants and/or 
as co-authors on peer-reviewed publications.

INQUIRIES
 
Written and telephone inquiries concerning this RFA are encouraged.  The 
opportunity to clarify any issues or questions from potential applicants is 
welcome.
 
Direct inquiries regarding programmatic issues to:
 
Anne E. Menkens, Ph.D.
Bomedical Imaging Program
National Cancer Institute
Executive Plaza North, Suite 800
Bethesda, MD  20892
Telephone:  (301) 496-9531
FAX:  (301) 480-5785
Email:  am187k@nih.gov

Direct inquiries regarding review issues to:

Ms. Toby Friedberg 
Referral Officer 
Division of Extramural Activities 
National Cancer Institute 
6116 Executive Blvd., Room 8062, MSC-8329
Rockville, MD 20852 (express courier)
Bethesda MD 20892-8329
Telephone (301) 496-3428
Fax: (301) 402-0275
Email: tf12w@nih.gov

Direct inquiries regarding fiscal matters to: 
 
Kelli Oster
Grants Administration Branch
National Cancer Institute
6120 Executive Boulevard, Suite 243
Bethesda, MD  20892-7340
Rockville, MD  20852 (for express/courier service) 
Telephone:  (301) 496-8627
Email: Kelli.Oster@nih.gov

LETTER OF INTENT

Prospective applicants are asked to submit, by Oct. 17, 2000, a letter of 
intent that includes a descriptive title of the proposed research, the name, 
address, telephone and FAX numbers, and email address of the Principal 
Investigator, and the number and title of the RFA in response to which the 
application may be submitted.  Although a letter of intent is not required, 
is not binding, and does not enter into the review of a subsequent 
application, it allows NCI staff to estimate the potential review workload 
and plan the review.

The letter of intent is to be sent to Anne E. Menkens, Ph.D. (see contact 
information above) by the letter of intent receipt date listed.

SCHEDULE
 
Letter of Intent Receipt:         Oct. 17, 2000
Application Receipt Date:         Nov. 28, 2000
Peer Review Date:                 February/March 2001
Review by NCAB Advisory Board:    May, 2001
Earliest Anticipated Start Date:  August 1, 2001

APPLICATION PROCEDURES
 
The research grant application form PHS 398 (rev. 4/98) is to be used in 
applying for these grants.  Applications kits are available at most 
institutional offices of sponsored research and may be obtained from the 
Division of Extramural Outreach and Information Resources, National 
Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-
7910, telephone 301/435-0714, E-mail: grantsinfo@nih.gov.  For those 
applicants with internet access, the 398 kit may be found at 
http://grants.nih.gov/grants/forms.htm.  

Special Instructions for Preparation of the Application
1)     Budgets:

The budget should be presented in logical, discrete units for each section of 
the application, as well as the composite ICMIC request.  The standard PHS-
398 form pages 4-5 are to be completed for each individual Research Component 
and Specialized Resource.  A single budget section should be prepared for the 
Developmental Component, as well as a separate budget section 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 “Research 
Plan” section is not subject to the page limitations as stated in the form 
PHS 398.  However, the suggested format and page recommendations are noted 
below.  The application should be as concise as possible to ensure a thorough 
review.

A.    ICMIC Description (10 pages)

This section should be used to present the overall vision for the ICMIC, the 
long and short-term scientific objectives, 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.  Describe how each 
component will contribute to the functioning of the ICMIC.  The ICMIC 
description should serve as a broad overview of the ICMIC, with more detailed 
description of each component to be presented in a later section.

B.   Organization and Administration (20 pages, including any organizational 
charts) 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 
Component and/or Specialized Resource.
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 an 
annual Inter-ICMIC meeting in the Washington DC area.
o   evidence (grants and publications) of ongoing scientific interactions 
amongst the PI and lead investigators (may be presented in tabular format - 
not to be included in 20 page limit )

C.   Research Components (25 pages each)

Research components will be defined according to the scientific goals of the 
ICMIC.  These components will provide the leadership and infrastructure for 
ongoing ICMIC research focused on achieving its long-term goals.  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.  More than one Research Project may be present within each Research 
Component.  However, each Research Project is expected to be well developed, 
and careful consideration will be given to the relevance and potential impact 
of each Project on the ICMIC goal during the review process.  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. Include in each Research Component an overview of the scientific 
objective(s) of the Component, a description of how the Component will 
contribute to the long-term goals of the ICMIC, and a description of the 
specific Research Project(s) that will be supported through the Component.  
Each Research Project 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)], but the total number of pages for each Research Component 
is not to exceed 25.

D.   Specialized Resources (10 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.

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.  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 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 investigations 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, minorities, and 
scientists with disabilities.  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).

The RFA label available in the PHS 398 (rev. 4/98) 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 sample RFA label available at: 
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf has been modified to 
allow for this change. Please note this is in pdf format.
 
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 must also 
be sent to:

Ms. Toby Friedberg 
Referral Officer 
Division of Extramural Activities 
National Cancer Institute 
6116 Executive Blvd., Room 8062, MSC-8329 
Rockville, MD 20852 (express courier)
Bethesda, MD 20892-8329

Applications must be received by Nov. 28, 2000.  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 announcement 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 an application must follow the guidance in the PHS Form 398 application 
instructions for the preparation of revised applications, including an 
introduction addressing the previous critique.

All clinical trials supported or performed by NCI require some form of 
monitoring. 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 to 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 of the NCI for Data Safety 
Monitoring of Clinical Trials see 
http://deainfo.nci.nih.gov/grantspolicies/datasafety.htm
 
REVIEW CONSIDERATIONS

Upon receipt, applications will be reviewed for completeness by CSR and 
responsiveness by the National Cancer Institute.  Incomplete and/or non-
responsive 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 of the National Cancer 
Institute in accordance with the review criteria stated below.  As part of 
the initial merit review, all applications will receive a written critique 
and undergo a process in which only those applications deemed to have the 
highest scientific merit, generally the top half of the applications under 
review, will be discussed assigned a priority score, and receive 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 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?

Innovation: Are the experimental designs of the proposed research focused on 
cellular and molecular imaging, 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?  Have the participating 
investigators demonstrated significant scientific interaction and 
productivity prior to the submission of this application?

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.

1) Significance.  Does the Research Component address an important research 
problem? Does the scientific merit and experimental design of the Research 
Project(s) adequately address issues of substantive importance?
2) 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?
3) 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?
4) 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?
5) Environment.  Does the scientific environment in which the work will be 
done contribute to the probability of success?  Do the proposed experiments 
take advantage of unique features in the scientific environment or reach out 
to useful collaborative arrangements? Is there evidence of adequate 
institutional support?

Is the project interactive with other components of the ICMIC
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:

Do the Developmental Projects demonstrate innovate approaches that integrate 
multiple scientific disciplines?  Do the Developmental Projects establish 
new, multidisciplinary collaborations focused on cellular and molecular 
imaging, and are the projects original and innovative? The five review 
criteria delineated for the research projects will also be applied to the 
Developmental Projects.  However, the Developmental Projects will be reviewed 
as a “cluster”, reflecting the cumulative scientific merit of the projects, 
rather than assigning each project an independent merit rating.
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.

In addition to rating the merit of individual components, peer reviewers will 
be asked to judge the overall program in the following areas:
1. scientific merit and innovativeness;
2. evidence of interdependent, multidisciplinary design and conduct of the 
research;
3. impact, or potential for impacting on the discipline of in vivo cellular 
and molecular imaging;
4. institutional commitment;
5. overall program organization.

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

 
AWARD CRITERIA
 
ICMIC awards will be based primarily on the basis of scientific merit as 
determined by peer review, availability of funds, and programmatic priorities.  

INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS
 
It is the policy of the NIH that women and members of minority groups and 
their sub populations must be included in all NIH supported biomedical and 
behavioral research projects involving human subjects, unless a clear and 
compelling rationale and justification is provided that inclusion is 
inappropriate with respect to the health of the subjects or the purpose of the
research.  This policy results from the NIH Revitalization Act of 1993.
 
All investigators proposing research involving human subjects should read the 
"NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical 
Research," which have been published in the Federal Register of March 28, 1994 
(FR 59 14508-14513) and in the NIH Guide for Grants and Contracts, Volume 23, 
Number 11, March 18, 1994, available on the web at the following URL address: 
http://grants.nih.gov/grants/guide/notice-files/not94-100.html

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS.

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

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

Investigators may also obtain copies of these policies from the program staff 
listed under INQUIRIES.  Program staff may also provide additional relevant 
information concerning the policy.

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.

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, In Vivo Cellular and Molecular 
Imaging Centers (ICMICs), is related to priority area of cancer.  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. 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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