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
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.
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:
https://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.)
(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 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:
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: 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
(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 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
https://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.