IN VIVO CELLULAR AND MOLECULAR IMAGING CENTERS (ICMICS)
RELEASE DATE: February 27, 2004
PA NUMBER: PAR-04-069 (see reissue PAR-06-406 and addendum NOT-CA-04-028)
EXPIRATION DATE: July 22, 2005, unless reissued.
Department of Health and Human Services (DHHS)
PARTICIPATING ORGANIZATION:
National Institutes of Health (NIH)
(http://www.nih.gov)
COMPONENT OF PARTICIPATING ORGANIZATION:
National Cancer Institute (NCI)
(http://www.nci.nih.gov)
CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.393 - 93.396
LETTER OF INTENT RECEIPT DATE: June 22, 2004; June 21, 2005
APPLICATION RECEIPT DATE: July 22, 2004; July 21, 2005
THIS PAR CONTAINS THE FOLLOWING INFORMATION
o Purpose of the PAR
o Research Objectives
o Mechanism of Support
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 Supplementary Instructions
o Peer Review Process
o Review Criteria
o Award Criteria
o Receipt and Review Schedule
o Required Federal Citations
PURPOSE OF THIS PAR
The Cancer Imaging Program, Division of Cancer Diagnosis and Treatment of the
National Cancer Institute (NCI), invites applications for new or competing
P50 Research Center Grants for In Vivo Cellular and Molecular Imaging Centers
(ICMICs). This initiative is designed to capitalize on the extraordinary
opportunity for molecular imaging to have an impact on the diagnosis and
treatment of cancer patients non-invasively and quantitatively. Molecular
imaging technologies can provide valuable laboratory tools for the
interrogation of biological pathways relevant to cancer, as well as to
provide imaging agents and technologies that will be directly utilized in the
clinic. The 5-year P50 ICMIC grants described in this PAR are designed to
bring together interdisciplinary scientific teams to lead the nation in
cutting-edge cancer molecular imaging research with clinical relevance,
provide unique core facilities to support oncology imaging research, provide
flexibility to respond to exciting pilot research opportunities, and provide
interdisciplinary career development opportunities for investigators new to
the field of molecular cancer imaging. The P50 mechanism will promote
coordination, interrelationships and scientific synergy among the research
components and resources, leading to a highly integrated imaging center.
RESEARCH OBJECTIVES
The field of molecular imaging has made significant advances in recent years.
The formation of multidisciplinary research teams has stimulated and
streamlined cancer imaging research from inception to use in patient care.
The P50 ICMIC structure allows mechanistic flexibility for each Institution
to capitalize on its own unique scientific strengths, and to 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 multi-disciplinary interactions among investigators focused on
the ultimate goal of discovering, developing and translating molecular
imaging technologies that will have eventual impact in the clinic. This
structure will provide researchers with access to a concentrated pool of
expertise in a wide range of disciplines. The structure of the ICMIC will be
designed to provide investigators with the means of conducting
multidisciplinary research in a highly collaborative atmosphere, and
consistent access to expertise with minimal wasted time and effort.
Personnel may be scientists from a variety of fields including, but not
limited to: imaging sciences, chemistry, radiopharmaceutical chemistry, cell
and molecular biology, pathology, pharmacology, computational sciences, 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 disciplines. The nature of these interactions will be
determined by the applicants, and emphasis will be placed on establishing
creative, productive, and synergistic interactions with eventual clinical
impact.
2. The ICMICs will provide funding for a minimum of three Research
Components. Research Components will apply multidisciplinary approaches to
molecular imaging. Individual research projects will be structured in order
to maximize appropriate scientific interaction between the projects, and
coordinated utilization of the Specialized Resources (see below). Each
Research Component 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 hypotheses.
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) will 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 will 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 will also be available to
investigators supported through Developmental Funds (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 two 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 they will be expected to compete for independent R01 funding
when the projects become sufficiently mature. Alternatively, if it becomes
obvious that the project 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.
MECHANISM OF SUPPORT
This PAR will use the NIH P50 Specialized Centers Grant Mechanism. As an
applicant, you will be solely responsible for planning, directing, and
executing the proposed project. The total project period for a P50
application submitted in response to this PAR may not exceed five years. The
total costs requested for a new or competing renewal P50 ICMIC application
may not exceed a maximum of $2,000,000 per year. The NCI anticipates
awarding two new or competing P50 ICMICs each year.
This PAR uses just-in-time concepts. It also uses the non-modular budgeting
formats). Follow the instructions for non-modular budget research grant
applications. This program does not require cost sharing as defined in the
current NIH Grants Policy Statement at
http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part2.htm#Toc54600040
ELIGIBLE INSTITUTIONS
You may submit (an) application(s) if your institution has any of the
following characteristics:
o For-profit or non-profit organizations
o Public or private institutions, such as universities, colleges, hospitals,
and laboratories
o Units of State and local governments
o Eligible agencies of the Federal government
o Domestic institutions/organizations
o Foreign institutions are not eligible to apply; foreign components of
applications from domestic organizations will be accepted with adequate
justification
An institution may only have one funded ICMIC.
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 his or her institution to
develop an application for support. Individuals from under-represented
racial and ethnic groups as well as individuals with disabilities are always
encouraged to apply for NIH programs.
SPECIAL REQUIREMENTS
ICMIC investigators will be expected to participate in ICMIC workshops and
investigator meetings as necessary to share results with other 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.
For those projects that involve clinical trials, investigators must include a
general description of the Data and Safety Monitoring Plan
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html) in the
application. All clinical trials supported or performed by NIH 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 NIH 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 Data
and Safety Monitoring of Clinical Trials see,
http://deainfo.nci.nih.gov/grantspolicies/datasafety.htm.
All investigator-initiated applications with direct costs greater than
$500,000 in any single year will be expected to address data sharing
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html) in
their application.
WHERE TO SEND INQUIRIES
We encourage your inquiries concerning this PAR 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.
Cancer Imaging Program
National Cancer Institute
6130 Executive Blvd., EPN Room 6068
Bethesda, MD 20892-8329
Rockville, MD 20852 (for express/courier service)
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: ncirefof@dea.nci.nih.gov
o Direct your questions about financial or grants management matters to:
Kathryn Dunn
Grants Management Specialist
Grants Administration Branch
National Cancer Institute
6120 Executive Blvd., EPS Room 243
Bethesda, MD 20892
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 846-6829
FAX: (301) 846-5720
Email: dunnkath@mail.nih.gov
LETTER OF INTENT
Prospective applicants are encouraged 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 PAR
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.
Cancer Imaging Program
National Cancer Institute
6130 Executive Blvd., EPN Room 6068
Bethesda, MD 20892-8329
Rockville, MD 20852 (for express/courier service)
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). Applications must have a Dun and
Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the
Universal Identifier when applying for Federal grants or cooperative
agreements. The DUNS number can be obtained by calling (866) 705-5711 or
through the web site at http://www.dunandbradstreet.com/. The DUNS number
should be entered on line 11 of the face page of the PHS 398 form. The PHS
398 document is available at
http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive
format. For further assistance contact GrantsInfo, Telephone:(301) 710-0267,
Email: GrantsInfo@nih.gov.
The title and number of this program announcement must be typed on line 2 of
the face page of the application form and the YES box must be checked.
SUPPLEMENTARY 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 separate budget section for the Developmental Component; and
f) A single separate 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 contain the long and short-term scientific objectives,
specifically addressing how the molecular imaging research supported through
the ICMIC will impact clinical cancer care. 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, relationships between the
ICMIC and other research, academic, and administrative units of the
institution (such as centers, institutes, departments) and the central
administration should be described in this section. The ICMIC description
should serve as an overview of the ICMIC, with a 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; and
o description(s) of commitment(s) to interact with other ICMICs, including
Inter-ICMIC meetings.
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 directly support or impact clinical cancer care, 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 and/or
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 integregally 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).
APPLICATION RECEIPT DATES: Applications submitted in response to this program
announcement will be accepted by the receipt date(s) listed on the first page
of this program announcement.
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 or courier service)
At the time of submission, two additional copies of the application and all
copies of the appendix material must be sent to:
Referral Officer
Division of Extramural Activities
National Cancer Institute
6116 Executive Boulevard, Room 8041, MSC 8329
Bethesda, MD 20892-8329
Rockville, MD 20852 (for express/courier service)
Appendices should be comprised of single-sided, unbound materials, with
separators between documents.
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 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 on or before the
receipt date(s) listed on the first page of this program announcement. The
CSR will not accept any application in response to this PAR 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 unfunded version
of an application already reviewed, but such application must include an
Introduction addressing the previous critique.
Although there is no immediate acknowledgement of the receipt of an
application, applicants are generally notified of the review and funding
assignment within eight weeks.
PEER REVIEW PROCESS
Upon receipt, applications will be reviewed for completeness by the CSR and
responsiveness by the NCI. Incomplete and/or non-responsive applications
will not be reviewed.
Applications that are complete and responsive to the PAR will be evaluated
for scientific and technical merit by an appropriate peer review group
convened by the Division of Extramural Activities of the NCI in accordance
with the review criteria stated below. As part of the initial merit review,
all applications will:
o Undergo a selection process in which only those applications deemed to have
the highest scientific merit, generally the top half of applications under
review, will be discussed and assigned a priority score
o Receive a written critique
o 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. In
the written comments, reviewers will be asked to evaluate the application in
order to judge the likelihood that the proposed research will have a
substantial impact on the pursuit of these goals. The scientific review
group will address and consider each of these criteria in assigning the
application’s overall score, weighting them as appropriate for each
application.
o Significance
o Approach
o Innovation
o Investigator
o Environment
The application does not need to be strong in all categories to be judged
likely to have major scientific impact and thus deserve a high priority
score. For example, an investigator may propose to carry out important work
that by its nature is not innovative but is essential to move a field
forward.
The overall ICMIC applications will be reviewed using the criteria listed
below. For competing renewals, evidence of productivity and productive
collaborations, such as joint publications, will also be considered.
SIGNIFICANCE: Does the ICMIC address an important cancer-related imaging
research problem? Will the overall research have an impact on clinical
cancer care? 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): Are 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?
Are 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? Will the research have a direct or
indirect impact on clinical cancer care? 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: Are 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
Specialized Resource utilized by more than one Research Component? 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 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 merit rating. 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:
PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human
subjects and protections from research risk relating to their participation
in the proposed research will be assessed. (See criteria included in the
section on Federal Citations, below.)
INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: 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 will be assessed. Plans for the recruitment and retention of
subjects will also be evaluated. (See Inclusion Criteria in the sections on
Federal Citations, below.)
CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to
be used in the project, the five items described under Section f of the PHS
398 research grant application instructions (rev. 5/2001) will be assessed.
ADDITIONAL REVIEW CONSIDERATIONS
Sharing Research Data
Applicants requesting more than $500,000 in direct costs in any year of the
proposed research are expected to include a data sharing plan in their
application. The reasonableness of the data sharing plan or the rationale for
not sharing research data will be assessed by the reviewers. However,
reviewers will not factor the proposed data sharing plan into the
determination of scientific merit or priority score.
BUDGET: The reasonableness of the proposed budget and the requested period
of support in relation to the proposed research.
AWARD CRITERIA
Applications submitted in response to a PAR will compete for available funds
with all other recommended applications. The following will be considered in
making funding decisions:
o Scientific merit of the proposed project as determined by peer review;
o Availability of funds; and
o Relevance to program priorities.
RECEIPT AND REVIEW SCHEDULE
Letter of Intent Receipt Date: June 22, 2004; June 21, 2005
Application Receipt Date: July 22, 2004; July 21, 2005
Peer Review Date: October 2004; October 2005;
Council Review: February 2005; February 2006;
Earliest Anticipated Start Date: April 2005; April 2006;
REQUIRED FEDERAL CITATIONS
ANIMAL WELFARE PROTECTION: Recipients of PHS support for activities
involving live, vertebrate animals must comply with PHS Policy on Humane Care
and Use of Laboratory Animals
(http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf), as
mandated by the Health Research Extension Act of 1985
(http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA
Animal Welfare Regulations
(http://www.nal.usda.gov/awic/legislat/usdaleg1.htm), as applicable.
HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that
applications and proposals involving human subjects must be evaluated with
reference to the risks to the subjects, the adequacy of protection against
these risks, the potential benefits of the research to the subjects and
others, and the importance of the knowledge gained or to be gained. See
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm.
DATA AND SAFETY MONITORING PLAN: Data and safety monitoring is required for
all types of clinical trials, including physiologic, toxicity, and dose-
finding studies (phase I); efficacy studies (phase II), efficacy,
effectiveness and comparative trials (phase III). The establishment of data
and safety monitoring boards (DSMBs) is required for multi-site clinical
trials involving interventions that entail potential risk to the
participants. (See NIH Policy for Data and Safety Monitoring, NIH Guide for
Grants and Contracts, June 12, 1998 at
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. For
additional information, see NIH Guide Notice on Further Guidance on a Data
and Safety Monitoring for Phase I and II Trials at
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 at
http://www.cancer.gov/clinical_trials/.
SHARING RESEARCH DATA: Starting with the October 1, 2003 receipt date,
investigators submitting an NIH application seeking more than $500,000 or
more in direct costs in any single year are expected to include a plan for
data sharing (http://grants.nih.gov/grants/policy/data_sharing) or state why
this is not possible. Investigators should seek guidance from their
institutions, on issues related to institutional policies, local IRB rules,
as well as local, state and Federal laws and regulations, including the
Privacy Rule. Reviewers will consider the data sharing plan but will not
factor the plan into the determination of the scientific merit or the
priority score.
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 "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 is 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://stemcells.nih.gov/index.asp 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, in the project
description and elsewhere in the application as appropriate, 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 PAR 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.
STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION: The
Department of Health and Human Services (DHHS) issued final modification to
the Standards for Privacy of Individually Identifiable Health Information,
the Privacy Rule, on August 14, 2002. The Privacy Rule is a federal
regulation under the Health Insurance Portability and Accountability Act
(HIPAA) of 1996 that governs the protection of individually identifiable
health information, and is administered and enforced by the DHHS Office for
Civil Rights (OCR). Those who must comply with the Privacy Rule (classified
under the Rule as covered entities ) must do so by April 14, 2003 (with the
exception of small health plans which have an extra year to comply).
Decisions about applicability and implementation of the Privacy Rule reside
with the researcher and his/her institution. The OCR website
(http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including
a complete Regulation Text and a set of decision tools on Am I a covered
entity? Information on the impact of the HIPAA Privacy Rule on NIH
processes involving the review, funding, and progress monitoring of grants,
cooperative agreements, and research contracts can be found at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.
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
PAR 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 at http://www.cfda.gov/ and is not subject to the
intergovernmental review requirements of Executive Order 12372 or Health
Systems Agency review. Awards are made under the authorization of Sections
301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284)
and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92 .All
awards are subject to the terms and conditions, cost principles, and other
considerations described in the NIH Grants Policy Statement. The NIH Grants
Policy Statement can be found at
http://grants.nih.gov/grants/policy/policy.htm.
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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NIH Funding Opportunities and Notices
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