MOUSE MODELS OF HUMAN CANCERS CONSORTIUM
RELEASE DATE: October 10, 2002
RFA: CA-04-002 - (Reissued as RFA-CA-08-018)
National Cancer Institute (NCI)
(http://www.nci.nih.gov/)
LETTER OF INTENT RECEIPT DATE: February 19, 2003
APPLICATION RECEIPT DATE: March 19, 2003
This RFA is a reissue of RFA CA-98-013, which was published in the NIH Guide
on July 29, 1998
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 NCI invites new and competing renewal cooperative agreement (U01) and NIH
intramural applications from groups of investigators to continue the Mouse
Models of Human Cancers Consortium (MMHCC). The scientific scope of this
integrative human/mouse cancer research program may be expanded through
incorporation of individuals or groups with additional new perspectives and
expertise, such as chemistry, computational and mathematical modeling, and
systems biology, to create trans-disciplinary approaches to the design,
analysis, and applications of mouse cancer models.
RESEARCH OBJECTIVES
Background
The original purpose of the MMHCC was "to accelerate the pace at which mice
with heritable malignancies that are accurate, reproducible models of human
cancers are made available to the research community for further investigation
or application." Since its inception in October 1999, the component groups of
the MMHCC have vigorously pursued this purpose. With the resources in their
individual grants, the Consortium members evolve and test novel strategies to
recapitulate the natural history and clinical course of human cancers in the
laboratory mouse. Collectively, the MMHCC investigates the genetics and
biology of the resulting strains for their ability to inform human research.
They explore approaches to expand the role of mouse cancer models for
translational research, using models to guide selection of, and credential,
new targets for therapy, and test molecularly targeted agents, expose
premalignant molecular genetic changes for early detection, disclose the
genetic determinants of cancer susceptibility, test novel agents for tumor
prevention and new concepts for prevention research, and incorporate imaging
technologies to detect developing malignant lesions, follow their progression
to invasive, metastatic tumors, and monitor response to therapy.
In addition to advancing the original goals, the MMHCC is an active partner
with the NCI to implement and continue to evolve the infrastructure that
informs the research community about mouse cancer models and deploys them to
the research community. The Consortium members organize numerous cancer
models workshops and symposia, and participate in hands-on laboratory courses
that are open to the greater research community. They also work with the NCI
to establish and maintain a website (http://emice.nci.nih.gov) that provides
disease-site specific information about cancer models, and has links to the
Cancer Models Database and the NCI-MMHCC mouse repository. The NCI
anticipates that the MMHCC will continue to provide leadership in the future
to sustain the mouse modeling research infrastructure already in place and to
advise the NCI on emerging needs for additional infrastructure.
The Cancer Models Database (http://cancermodels.nci.nih.gov) houses
histopathologic, genetic, expression profiling, and other biological data
about cell, tissue, and animal cancer models, and their use for therapy or
prevention studies. The database, developed with help from the MMHCC, is a
fundamental data source for the bioinformatics network deployed by the NCI
Center for Bioinformatics (http://ncicb.nci.nih.gov). The network integrates
genomic, expression profile, proteomic, histopathologic, preclinical,
clinical, and image data from NCI preclinical models and human research
programs sources. The MMHCC is a core component of this bioinformatics
infrastructure, which creates the context for the Consortium at the present,
and in the future. The NCI Cancer Molecular Analysis Project interface
(http://cmap.nci.nih.gov) illustrates the exceptional potential for progress
in cancer research that can result from merging information from human and
cancer models investigations.
The activities of the MMHCC include fresh approaches to mouse genetic
engineering and phenotyping that have significantly advanced the field and
stimulated interest in derivation and application of mouse cancer models to
cancer research. Many challenges remain that will be pursued most effectively
through continued support for the MMHCC; the challenges include the need for
continued innovation to discern how widely and effectively cancer models can
be applied to sustain discovery in human basic, translational, clinical, and
population science. However, the routine application of mouse cancer models
to translational research goals is not the intent of this RFA. Such
applications are appropriate for a variety of support mechanisms, including
investigator-initiated research projects and program project grants, competing
supplements to existing research grants, and applications in response to other
NCI special initiatives.
As it was for the original RFA for the MMHCC, the intent of the NCI in this
RFA is to foster research investigations, technological innovation, and
extensive collaboration that cannot be pursued with traditional grant support.
Applicants to this RFA are encouraged to propose risky approaches that
incorporate broad knowledge of human cancer research into design, analysis,
and applications of mouse cancer models, and to incorporate biocomputational,
mathematical modeling, and systems biology strategies to inform design of
genetic models and their cross-comparisons to human cancer. The newly
implemented trans-disciplinary nature of the MMHCC will sustain discoveries
that should stimulate mechanistic hypotheses for future research and generate
additional tools in support of translational and clinical cancer science.
Significant advances in the science of mouse cancer modeling reflect the rapid
acquisition of mouse and human genome sequence information, the informatics
tools to analyze and compare them, innovative technologies to derive molecular
signatures of human and mouse cancer, and the evolution of new approaches to
mouse engineering and phenotyping. The MMHCC has contributed to, and
capitalized on, these advances. In-depth characterization of the latest mouse
cancer models reveals that the diseases they develop more closely parallel the
corresponding human cancers than did previous models. However, major
challenges remain that will benefit considerably by increased incorporation of
chemistry, bioinformatics, mathematical modeling, and other disciplines into
this next phase of mouse cancer modeling research.
At this time, molecular signatures of human tumors are one major starting
point to define which genes to manipulate in mice. However, the pace at which
new genes, pathways, and processes are identified as causally related to human
cancers is accelerating, and understanding the phenotypes that result from
altering expression of one or more genes in the mouse is increasingly complex.
These realities suggest that future modeling efforts require better decisions
about what to manipulate to produce novel, informative, and useful models. It
may be possible to employ short-term phenotype alteration as an initial screen
to guide selection of the parameter(s) to alter permanently in a model. Such
technologies as siRNA, antisense, libraries of small molecules, or morpholinos
may be useful to derive functional information about the role(s) of specific
genes or proteins prior to germline modification. Incorporation of
information about cancer-causing mutations in mice that are produced in large-
scale mutagenesis screens or arise spontaneously could be instructive. It
will also be valuable to integrate knowledge from models of other human
disease processes, such as inflammation and obesity, and from developmental
biology and its anomalies, environmental exposures, reproductive biology, and
normal immunity. However, for these diverse areas of investigation to be
effective information resources for cancer research, there must be inventive
new bioinformatics strategies to integrate the data.
Increasingly, human tumors of a single disease site are analyzed by expression
profiling, and the results enable segregation of the tumors into discrete
subtypes. Use of comparable genomic technologies for mouse tumors, although
not yet widely applied, suggests that one particular model is more likely to
reflect the features of a single human tumor subtype rather than represent the
heterogeneity of human disease. For cross-comparisons, bioinformatics will
assist in ensuring that appropriate conclusions are reached and then used to
guide derivation of additional models or refinement of existing ones to fill
gaps in the collection of models for a particular disease site.
Although gene expression and protein profiling of tumors is a good starting
point to assess how closely a given engineered mouse strain models a specific
cancer subtype, it substantially limits what may be learned about human
disease by focusing on the end stage of cancer only. An inherent strength of
mouse cancer models is that researchers can interrogate the diseases along the
continuum of stages and not just at the point at which there is clinical
manifestation. The ability to collect data on changes in cancers at many pre-
malignant and malignant disease stages the biology, gene expression and
protein profiles, histopathology, response to various interventions, and
appearance by non-invasive imaging techniques is a powerful approach with
significant potential for impact on human disease outcomes. Another strength
of mouse cancer models is that they enable researchers to test hypotheses
about the natural history and clinical course of human diseases in a
genetically tractable experimental system, exploring questions that cannot be
approached experimentally in human populations or patients.
Other aspects of the cancer phenotype, such as host immune response,
endocrinology, and physiological and metabolic profiling, are much less well
characterized in the mouse cancer models than are the tumors themselves. In
this regard, the relative ease with which such data can be gathered from
cancer models compared to human subjects along the continuum of cancer
initiation, tumor establishment, and progression to invasion and metastasis is
an important application of mouse cancer models as research tools. No doubt
there are measurable parameters of mouse physiology and biology that are
important to catalog to expose changes that may relate to cancer initiation
and progression. However, the technologies needed to analyze physiological
changes easily and reproducibly are likely to require additional development
or refinement. To recognize potential cancer-related deviations will require
effective incorporation of information from collections of research data on
normal mouse development and biology.
As new observations about human cancer biology emerge, additional mouse
germline or other engineering approaches may be needed to recapitulate them in
mice. Recently, genomic scans of tumors and the underlying stroma reveal that
cells in the microenvironment of the tumor have different patterns of
chromosomal aberrations. Changes in patterns of signal cross-talk among the
various cell types in a tissue occur during cancer progression. These and
similar observations in many human cancers suggest the need for additional
experimentation in genetic engineering to recapitulate such phenomena and to
interrogate the processes for their relevance to cancer progression and
clinical course. Inspecting all mouse cancer models for differences in the
molecular signatures of tumor cells and the diverse types of cells in the
stroma may be an important phenotyping strategy as well.
One key emerging use for mouse cancer models is as tools for research on
interventions to define molecular targets and to test molecularly targeted
agents for therapy and prevention. Models can be used to illuminate the
mechanisms for less than optimal clinical experience of a given agent. In a
number of instances, mouse cancer models have been used with considerable
effect for therapy-related research because they display much of the natural
history and response to standard therapy of the related human cancer. To
explore how to improve clinical outcome, researchers can test new combination
therapies in mice; with this strategy, they often find that the mutated genes
drive cancer progression by a different mechanism than first hypothesized.
Such discoveries can lead to the development of new classes of agents that
reflect better knowledge about the function of particular genes in tumors.
Published results of this kind suggest that there are many potential avenues
yet to investigate. It will be an essential goal of the MMHCC to apply the
most promising cancer models to identify the range of clinical questions for
which they are useful. For example, there are questions about the prognostic
value of costly or invasive post-therapy analysis of residual tumors that can
easily be addressed using comparable models exposed to the same therapy.
There are many opportunities to invent and test new delivery systems,
including those enabled by recent advances in nanotechnology. In addition,
mouse cancer models can be used to define the genetic determinants of response
or resistance to interventions.
Incorporation of functional and structural imaging permits researchers to
identify animals that are developing tumors or metastases without invasive
procedures, visualize delivery of agents to a tumor and measure rate of
uptake, show the temporal and regional response of a tumor to therapy, and
follow development of recurrences. However, as the means to phenotype cancer
models from the initiation of disease, through tumor establishment,
progression to an invasive malignancy, and metastasis to distant sites, there
are unprecedented opportunities for invention, refinement, and application of
imaging techniques. To expand imaging as a routine part of the
characterization and translational application of mouse cancer models requires
new methods for animal handling and data collection, developing novel imaging
agents, mathematical modeling, and data reconstruction and visualization.
Significant advances in this area of research will enable investigators to
incorporate imaging in early detection and prevention applications of cancer
models. As is true for other aspects of cancer modeling, the questions about
human disease processes that can be tested by integrating innovative imaging
strategies in mouse model design and application transcend the limitations of
imaging as used in clinical settings.
Rare, high penetrance genes account for only a small proportion of human
cancers, which are regarded as complex traits. However, the very common genes
of low penetrance that collectively contribute to human susceptibility are
difficult to identify from population studies. Mouse models and normal inbred
mouse strains are invaluable for finding low penetrance susceptibility genes
and genes that modify aspects of disease progression or clinical course, and
for exploring cancers as complex traits. Recent studies illustrate that it is
feasible to use cancer models to identify general susceptibility genes for
major epithelial cancers, as well as tissue-specific genetic modifiers of
malignancies. It is also important to determine how genes or genetic loci
identified with other complex traits, such as immune function, or chronic
inflammatory diseases, obesity, and other traits that are low-level risk
factors for cancer etiology, are involved in human malignancies.
The expanding base of genomic information from mouse and human sequencing,
increasingly well characterized normal inbred mouse strains, and an abundance
of appropriate cancer models provide substantial opportunities for comparative
human/mouse approaches to discover the genetic basis of human cancer
susceptibility and interactions among genetic and environmental factors.
However, although the associations among genes may be comparable between mouse
and human, the mechanisms that underlie association of particular genes or
loci with risk in human populations may differ from those in the mouse. It
will be important to incorporate suitable study designs, statistical analyses,
and data mining tools to integrate this aspect of mouse modeling with human
translational science goals.
The NCI anticipates that augmenting the mouse cancer modeling expertise of the
MMHCC with a broader base of perspectives in the future will enable the
Consortium to design and generate additional mouse cancer models and modeling
strategies, invent new ways and employ existing methods to characterize the
models much more fully for cross-comparisons to human cancer, substantially
expand the repertoire of applications to many more aspects of human cancer
research, and employ bioinformatics to an unprecedented degree to ensure full
integration of human and mouse model cancer research.
Objectives and Scope
In the original RFA, the NCI invited applications from groups with the
scientific and technical expertise "to derive mouse models, characterize them
thoroughly, and validate them for various aspects of basic, developmental, and
applied cancer research." The significant advances in the science of mouse
cancer models and their increasing integration into translational cancer
research, coupled with the accumulation of exceptional amounts of human and
mouse cancer data for comparison, reinforces the need to augment the original
scope of the MMHCC with expertise in new domains of science.
In this RFA, the NCI encourages applications from groups with broad expertise
that may include, but is not limited to: Mouse-related research, such as
genetics, genetic engineering, biology, physiology, and phenotyping;
application of cancer models to human basic, translational, clinical, and
population science; application of computational, statistical sciences,
mathematical modeling, and bioinformatics to integrate human and mouse cancer
research; use of chemistry, genomics, proteomics, imaging, and image analysis
to inform model design, characterization, and application; development of
innovative technologies to support derivation, phenotyping, and translational
applications of new or existing mouse cancer models. To implement the MMHCC,
the NCI will select as components up to 18 new and competing renewal U01
applications, and up to 4 NIH intramural projects, each supporting a multi-
disciplinary team. Each component will be a self-assembled team of
investigators who contributes to the MMHCC effort a unique blend of
complementary research experience. The NCI anticipates that an applicant team
will incorporate the appropriate mix of expertise that team believes they need
to achieve their own goals and to contribute substantially to achieving the
overall MMHCC goals.
Teams of investigators composed of researchers in NIH intramural laboratories
may submit applications to be components of the MMHCC; however, they may not
receive salary, equipment, supplies, or other remuneration from the extramural
RFA set-aside funds for this program. An NIH intramural PI must obtain the
approval of her/his NIH Institute Scientific or Division Director to allocate
resources to the project, and must follow both the general application format
instructions and the additional guidelines for NIH intramural project
applications under "APPLICATION PROCEDURES". NIH intramural project
applications will be reviewed and scored with the U01 applications. The NIH
intramural projects selected by the NCI to be components of the MMHCC will
participate in a manner that is analogous to the U01 awardees.
There are many outstanding research questions and opportunities related to
mouse cancer models that applicants to this RFA may propose in their programs.
The following paragraphs are intended to illustrate, but certainly not to
limit, the possibilities.
o To reflect the natural history of human cancers in laboratory mice generally
requires genetic engineering or other strategies to modify the mouse germline.
Applicants are encouraged to consider whether the current mouse genetic
engineering tools are adequate to enable future models to encompass more
aspects of the biology of human cancers than do the present models. For
example, mice that model or investigate the distinct and diverse roles of all
of the component cell types of specific tissue microenvironments are under-
represented in the current mouse cancer models. Such models may present a
substantial challenge to derive, and are an important opportunity to
incorporate what is known about developmental and normal adult biology of a
specific tissue or organ context. Applicants are encouraged to consider if
there are other biologic, genomic, or epigenetic phenomena or observations
unique to cancer for which the present modeling approaches are inadequate, and
to propose to modify the current techniques or to devise and test new ones.
o There are some excellent examples of how well mouse cancer models apply to
human translational cancer research, but the full range of potential
applications is untapped. Applicants are encouraged to explore the
translational uses for which models that reflect the natural history and
clinical course of human cancers are appropriate. There are likely to be
significant opportunities to propose novel strategies to address any gaps in
model design to enlarge the scope of translational application. Widespread
incorporation of imaging is also encouraged, because the potential for non-
invasive approaches to observe disease processes, to understand cancer
etiology, progression, metastasis, response to interventions, and recurrence,
and to correlate image properties with histopathology and expression profiles
is significant.
o The starting point for many cancer models is what is documented about
aberrations in crucial genes, pathways, or processes and their roles at
particular stages in specific human malignancies. However, perhaps due to
species differences, the equivalent mutation in a mouse gene may not produce a
cancer model that resembles the human cancer associated with that mutant gene,
although perturbations in other nodes of the same pathway or process may.
Applicants are encouraged to consider whether there are approaches to model
derivation in addition to those that employ known human tumor molecular
signatures that will support discovery about human cancer etiology and
progression. For example, there may be new strategies for short-term or
permanent phenotype alteration (e.g., siRNA, anti-sense, drug-sensitive
alleles, etc.) that can help to define which genes or pathways to manipulate,
and there are likely to be bioinformatics or modeling tools that can be
employed to refine the priorities about which pathways or processes to alter
in a model. Applicants are encouraged to integrate information about key cell
pathways and processes derived from research in other model systems into
related data from mouse and human cancer studies.
o One important use for mouse cancer models is for research related to cancer
therapy. Applicants are encouraged to propose optimal ways to use cancer
models to inform research on human cancer treatment. For example, there may
be experimental approaches using mice that can guide clinicians in determining
what are the most valuable assays to perform or information to collect from
patients and patient specimens. Applicants are encouraged to consider the
most important and pressing clinical questions for which use of preclinical
cancer models are best suited, and to propose how to integrate cancer models
into research to define and test interventions, to understand why clinical
experience with particular agents is sub-optimal, and to increase the
effectiveness of preclinical models.
o There are important opportunities to apply mouse models to define the host
and environmental determinants of cancer susceptibility and progression, as
well as the genetic factors that influence response or resistance to therapy.
There is ample evidence that quantitative traits in mice can inform studies of
cancer risk in human populations. It is possible that the associations among
the genes that define a quantitative trait in the mouse are true for human
populations despite significant mechanistic differences between mouse and
human. Applicants are encouraged to consider approaches to define and exploit
mechanistic variation in association among cancer-related genes in human and
mouse. It may be possible to apply both quantitative and qualitative
approaches to analyze mouse models to identify and stratify human risk
factors. Applicants are encouraged to consider approaches that better define
the priorities for development of mouse cancer susceptibility models. In
addition, there may be value in integrating analysis strategies used for gene
association studies in mice with those used for human population research.
There are doubtless many opportunities to propose new computational,
statistical, and modeling tools.
As with the previous RFA for the MMHCC, the NCI does not anticipate that the
expertise in any single applicant group will encompass all, or be restricted
to, the research areas cited above. The NCI intends this RFA as an
opportunity for the cancer research community to propose innovative approaches
and unique perspectives to the challenges of mouse cancer modeling and
integration of models with human science. Applicant groups are not required
to focus on a single disease site; however, groups should include any required
experience if they propose to explore a broad range of malignancies. The NCI
expects that the assembled MMHCC will encompass the necessary and relevant
expertise to accomplish the overall goals of the program. The NCI will ensure
that the goals of the Consortium reflect the highest priorities of the
Institute. Because the MMHCC is an on-going activity, the NCI expects that
new investigators included in the Consortium through funding from this RFA
will participate in any MMHCC-related projects that are underway and are
carried over from the previous project period.
Each applicant group should provide evidence of institutional and on-going
research resources that augment and sustain the research strengths of the
team. Applicant institutions are encouraged to commit additional resources,
or leverage existing ones, in support of any application from their
institution. Applicants are encouraged to incorporate partners or
collaborators from the private sector where their participation is
appropriate. In structuring these partnerships or collaborations, applicants
should take into account pre-existing intellectual property rights associated
with the use of these models and make appropriate licensing arrangements.
Applicants and their technology licensing offices are encouraged to seek
assistance as needed from the NCI Technology Transfer Branch
(http://www-otd.nci.nih.gov/) in determining whether arrangements are adequate.
In assembling their teams, applicants are encouraged to consider the
availability of research expertise, technologic innovations, and potential
collaborations from NCI-funded networks and consortia. The Director's
Challenge (http://dc.nci.nih.gov), SPORE (Specialized Programs of Research
Excellence) programs (http://spores.nci.nih.gov), Early Detection Research
Network (http://www3.cancer.gov/prevention/cbrg/edrn), Small Animal Imaging
Resource Program (http://www3.cancer.gov/dip/sairp.htm), the Cancer Genetics
Network (http://epi.grants.cancer.gov/CGN), the Cancer Family Registries
programs (http://epi.grants.cancer.gov/CFR), and others are listed on the NCI
website (http://cancer.gov/research_programs/extramural).
U01 applicant groups may identify researchers who are intramural staff of NIH
Institutes or Centers as potential collaborators or consultants. The
intended roles and contributions that the intramural investigator might have
in the project should be delineated in the application in APPLICATION
PROCEDURES Section 3, "Internal and External Collaborations". However, for
purposes of this RFA, no NIH intramural scientist may be a formal collaborator
or consultant, commit time and effort to, or be a co-PI of, any U01
application. When the MMHCC is assembled from the component projects, if
there are NIH intramural investigators whose expertise is identified in the
funded U01 applications as desirable to achieve the applications' goals, the
NIH intramural investigators, with approval of their Institutes' Scientific
Directors, will collaborate with one or more of the MMHCC U01 components in
specified roles, including time and effort. NIH intramural investigators who
are designated in this manner to collaborate in the Consortium may not serve
on the MMHCC Steering Committee. The participation of any NIH intramural
scientist, including those on the Steering Committee who represent the NIH
intramural project components of the MMHCC, is independent of, and unrelated
to, the roles of the NCI Project Coordinator and NCI Program Director as
described under "Cooperative Agreement Terms and Conditions of Award." The
NCI anticipates that NIH intramural investigators will contribute
substantially to the breadth of scientific and technical expertise of the
MMHCC.
MECHANISM OF SUPPORT
This RFA will use NIH U01 award mechanism. Applicants are solely responsible
for planning, directing, and executing the proposed project. The anticipated
award date is April 01, 2004. The NIH U01 is a cooperative agreement award
mechanism in which the Principal Investigator retains the primary
responsibility and dominant role for planning, directing, and executing the
proposed project, with NIH staff being substantially involved as a partner
with the Principal Investigator, as described under the section "Cooperative
Agreement Terms and Conditions of Award."
The source of support for NIH intramural components will be from existing
intramural resources. Extramural grant funds will not be expended to support
the intramural components that are selected as part of the MMHCC, or
extramural collaborations that are part of intramural applications.
FUNDS AVAILABLE
NCI intends to commit approximately $18,000,000 in FY2004 extramural funds to
support up to 18 new and competing renewal U01 grants in response to this RFA.
Any new or competing renewal applicant may request a project period of up to
five years and a budget of total costs of $1,000,000 (including third party
facility and administrative costs) in the first year; budgets for out-years
may not exceed the usual incremental increase of 3%. Because the nature and
scope of the proposed research will vary from application to application, the
NCI anticipates that the size of each award may also vary. In addition, the
NCI anticipates incorporating up to 4 NIH intramural projects as components of
the Consortium. No funds from the amount set aside for this RFA will be used
to support intramural projects. For further budget information pertaining
specifically to NIH intramural applications, see the SUBMITTING AN APPLICATION
section below regarding "Additional Instructions for NIH Intramural Project
Applicants."
Although the financial plans of NCI provide support for this program, awards
pursuant to this RFA are contingent upon the availability of funds for this
purpose in fiscal year 2004, and the receipt of a sufficient number of
meritorious applications. The anticipated award date is April 1, 2004. At
the present time, the NCI has not determined whether or how this solicitation
will be continued beyond the present RFA.
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 or foreign
o Intramural components of the Institutes of the National Institutes of Health
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 her/his 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.
NIH intramural applicants must be designated by their Institutes as Principal
Investigators; however, they may not receive salary, equipment, supplies, or
other remuneration from the RFA set-aside funds for this program. An NIH
intramural PI must obtain the approval of her/his NIH Institute Scientific
Director to allocate resources to the project, and must follow both the
general application format instructions and the additional guidelines for NIH
intramural project applications under "APPLICATION PROCEDURES." An intramural
applicant group may include extramural collaborators as subcontracts, but the
resources to support any subcontract must be available from intramural sources
and not from any set-aside funds for this RFA.
SPECIAL REQUIREMENTS
Cooperative Agreement Terms and Conditions of Award
These special Terms of Award are in addition to and not in lieu of otherwise
applicable OMB administrative guidelines, HHS Grant Administration Regulations
at 45 CFR Parts 74 and 92, and other HHS, PHS, and NIH Grant Administration
policy statements. (Part 92 applies when state and local governments are
eligible to apply as a "domestic organization.")
The administrative and funding instrument used for this program is a
cooperative agreement (U01), an "assistance" mechanism (rather than an
"acquisition" mechanism) in which substantial NCI scientific and/or
programmatic involvement with the awardee is anticipated during performance of
the activity. Under the cooperative agreement, the NCI purpose is to support
and/or stimulate the recipient's activity by involvement in, and otherwise
working jointly with, the award recipient in a partner role, but it is not to
assume direction, prime responsibility, or a dominant role in the activity.
Consistent with this concept, the dominant role and prime responsibility for
the activity resides with the awardee(s) for the project as a whole, although
specific tasks and activities in carrying out the studies will be shared among
the awardees and the NCI Project Coordinator.
1. Awardee Rights and Responsibilities
o The PI of a U01 or NIH intramural project has primary authority and
responsibility to define objectives and approaches, and to plan, conduct,
analyze, and publish results, interpretations, and conclusions of studies
conducted under this program.
o The PI of a U01 or NIH intramural project will assume responsibility and
accountability to the applicant organization officials and to the NCI for the
performance and proper conduct of the research supported by the U01 or NIH
intramural project in accordance with the terms and conditions of the award.
o The PI and an additional senior investigator from each U01 or NIH intramural
project serve as voting members of the MMHCC Steering Committee and are
required to attend the twice-yearly Steering Committee meetings.
o The PI of a U01 or NIH intramural project will be responsible for accepting
and implementing the goals, priorities, procedures, and policies agreed upon
by the Steering Committee.
o The PI of a U01 or NIH intramural project will be responsible for close
coordination and cooperation with the other components of the MMHCC and with
NCI staff.
o Awardees will retain custody of, and have primary rights to, the data
developed under these awards, subject to Government rights of access
consistent with what are the current HHS, PHS, and NIH policies throughout the
length of awards under the auspices of this RFA. Awardees will be responsible
for implementing the approved data sharing plan for their project.
o The NCI anticipates that awardees under the auspices of this RFA will
develop unique research resources. The policy of the NIH is to make available
to the public the results and accomplishments of the activities that it funds.
Awardees will be responsible for implementing the approved research resource
sharing plan and intellectual property plan for their project.
o The NCI reserves the right to require the transfer of appropriate mouse
stocks, related reagents, and pertinent data that are generated as the result
of participation in research supported under these awards to an eligible third
party, in order to preserve the mouse models and data about them and/or to
continue the research. Third parties supported under these awards must be
informed of this right.
o Awardees under the auspices of this RFA should obtain appropriate licenses
for technologies that are necessary for the conduct of the proposed research.
o Effective continuation of the MMHCC requires that any bioinformatics,
computational, and statistical, data modeling, or data visualization projects
that are funded as a result of this RFA are compatible with the on-going
bioinformatics schema that is designed and implemented by the NCI Center for
Bioinformatics (http://ncicb.nci.nih.gov).
2. NCI Staff Responsibilities
The NCI Project Coordinator will have substantial scientific-programmatic
involvement during conduct of this activity, through technical assistance,
advice, and coordination beyond normal program stewardship for grants.
o The NCI Project Coordinator will coordinate and facilitate the MMHCC
programs, will attend and participate as a voting member in all meetings of
the MMHCC Steering Committee, and will provide liaison between the Steering
Committee, the MMHCC, and the NCI.
o The NCI Project Coordinator, in cooperation with the NCI Center for
Bioinformatics, will ensure that there are effective mechanisms to enable
electronic communication among the MMHCC components, and between the MMHCC and
the NCI.
o The NCI Project Coordinator will assist the Steering Committee in developing
and drafting operating policies and policies for dealing with recurring
situations that require coordinated action.
o The Director, NCI Center for Bioinformatics, will ensure that there are
appropriate core services for the integration of mouse data emerging from the
MMHCC with data from other NCI programs of human cancer research. Any
bioinformatics activities funded on the individual U01 grants or NIH
intramural projects will be required to be conducted coordinately with the
activities of the NCI Center for Bioinformatics.
An NCI Program Director will be responsible for the normal stewardship of the
awards, including:
o The NCI Program Director will review the scientific progress of individual
U01 grants and NIH intramural projects, and review them for compliance with
the operating policies developed by the Steering Committee.
o The NCI Program Director may recommend withholding of support, suspension,
or termination of a U01 award for lack of scientific progress or failure to
adhere to policies established by the Steering Committee.
o The NCI Program Director will transmit to the appropriate NIH Institute
Scientific Director any recommendation from the Steering Committee concerning
failure of an NIH intramural component of the MMHCC to adhere to policies
established by the Steering Committee.
The NCI Program Director may also serve as the NCI Project Coordinator.
3. Collaborative Responsibilities
Steering Committee
The NCI Project Coordinator and the Principal Investigators of the U01 grants
and the NIH intramural projects that comprise the MMHCC will be responsible
for forming a Steering Committee, the main governing board of the MMHCC, as
defined below. An arbitration system, as detailed below, will be available to
resolve disagreements between the NCI Project Coordinator and the members of
the Steering Committee.
o The Steering Committee will be composed of the Principal Investigator and
another senior scientist from each MMHCC U01 or NIH intramural project, the
NCI Project Coordinator, one representative from each extramural NCI Division,
a representative from the NCI Center for Bioinformatics, and an MMHCC Consumer
Liaison. Each member will have one vote.
o The Steering Committee chairperson(s) may not be an NCI staff member(s).
The Steering Committee may establish committees, as it deems appropriate; the
NCI Project Coordinator will serve on committees, as s/he deems appropriate.
o The Steering Committee may, when it deems it to be necessary, invite
additional, non-voting scientific advisors to the meetings. The NCI reserves
the right to augment the scientific or consumer expertise of the MMHCC when
necessary.
o The Steering Committee will meet twice every year, at locations selected by
the Steering Committee in consultation with the NCI. The PI and another
senior investigator from each U01 or NIH intramural project must attend every
Steering Committee meeting.
4. Arbitration
Any disagreement that may arise on scientific/programmatic matters (within the
scope of the award), between award recipients and the NCI may be brought to
arbitration. An arbitration panel will be composed of three members - one
selected by the Steering Committee (with the NCI member not voting) or by the
individual awardee in the event of an individual disagreement, a second member
selected by NCI, and the third member selected by the two prior selected
members. This special arbitration procedure in no way affects the awardee's
right to appeal an adverse action that is otherwise appealable in accordance
with the PHS regulations at 42 CFR Part 50, Subpart D and HHS regulation at 45
CFR Part 16.
WHERE TO SEND INQUIRIES
The NCI encourages inquiries concerning this RFA and welcomes the opportunity
to answer questions from potential applicants. Inquiries fall into four
areas: scientific/research, intellectual property, peer review, and financial
or grants management issues:
o Direct questions about scientific/research issues to:
Cheryl L. Marks, Ph.D.
National Cancer Institute
Division of Cancer Biology
Executive Plaza North, Room 5000
Bethesda, MD 20892-7380
Telephone: (301) 594-8778
FAX: (301) 496-8656
Email: marksc@mail.nih.gov
Because of the multi-disciplinary scientific content of the RFA, potential
applicants may be referred to additional NCI extramural program staff for
further advice and clarification of the intent of the RFA, or for consultation
regarding the design and implementation of bioinformatics projects that are
intended to coordinate with those developed by the NCI Center for
Bioinformatics.
o Direct questions about intellectual property, technology licensing, data
sharing, and research tools issues to:
Wendy E. Patterson, Esq.
National Cancer Institute
Technology Transfer Branch
Executive Plaza South, Suite 450
Bethesda, MD 20892-7182
Telephone: (301) 435-3110
FAX: (301) 402-2117
Email: pattersw@mail.nih.gov
o Direct 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 questions about financial or grants management matters to:
William Wells
Grants Administration Branch
National Cancer Institute
Executive Plaza South, Room 243
Bethesda, MD 20892
Telephone: (301) 496-8796
FAX: (301) 496-8601
Email: ww14j@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, email address, and telephone number of the Principal
Investigator
o Names of other key personnel
o Names of all participating institutions and key personnel at those
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 February 19, 2003 by mail, FAX, or email
to:
Cheryl L. Marks, Ph.D.
National Cancer Institute
Division of Cancer Biology
Executive Plaza North, Room 5000
Bethesda, MD 20892-7380
Telephone: (301) 594-8778
FAX: (301) 496-8656
Email: marksc@mail.nih.gov
SUBMITTING AN APPLICATION
Applications must be prepared using the PHS 398 research grant application
instructions and forms (rev. 5/2001). The PHS 398 is available at
http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive
format. For further assistance contact GrantsInfo, Telephone (301) 710-0267,
Email: GrantsInfo@nih.gov.
SUPPLEMENTAL INSTRUCTIONS:
For U01 and NIH intramural applicants to this RFA, only the "Research Plan"
section of the PHS 398 grant application is changed. The remainder of the PHS
398 application form remains the same.
The "Research Plan", sections a. to d. (the subsequent sections e. to i.
remain the same), is altered as follows:
o The number of pages is increased from 25 to 35 pages; the 35-page limitation
applies to the replacement for sections a. to d. only, and does not include
the pages for sections e. to i.
o The 35 pages should be apportioned as desired by the applicant to cover new
sections 1. to 3. that replace sections a. to d. The three sections are: 1.
Applicant Group; 2. Scope of Research; and, 3. Collaborations.
Section 1 Applicant Group. Applicants should briefly state the major
objectives of the project and describe what expertise the group encompasses,
as well as specialized or unique facilities, core resources, and services that
are available to support these objectives. In this section, applicants should
describe any ongoing grant-supported, institutional, or private sector
resources that augment or complement resources for which funding from this RFA
is sought. The roles of all key personnel, collaborators, and consultants who
are associated with the application may be briefly described; however, the
full extent of activities for each participant should be covered in Section 2.
Section 2 Scope of Research. For competing renewal applicants, Section 2
should have a description of the goals of the previous grant and include the
scientific progress from the previous project period. For all applicants,
depending on the composition and structure of the group, this section may be
organized as distinct projects or as one integrated plan; in either case, the
page limitation is the same. There is no requirement for applicants to use
the format of an R01 application. Instead, applicants should define the major
research questions and opportunities related to mouse cancer modeling that
their group effort proposes to undertake, and the importance of those
questions to human cancer research. Applicants should describe the approaches
to be taken by the group in the aggregate or as inter-dependent projects, and
should describe the rationale for approaches to be used or planned for
development. Applicants are encouraged to use this section of the application
to highlight how the diverse expertise of the group members contributes to the
innovation of which the group is capable, the flexibility they possess to
redirect research when scientific progress warrants it, and their ability to
anticipate new directions, based on their individual experience and ability to
contribute to a collective effort. The roles and expertise of all key
personnel, collaborators, and consultants who are associated with the
application should be documented; letters from collaborators and consultants
should be included in Section i. of the research plan format as specified in
the instructions for the Form 398 application.
Section 3 Collaborations. For competing renewal applications, applicants
should describe their participation in the MMHCC and involvement in its
activities, and the contribution of collaborations within, and outside, the
Consortium to the successes of their projects. For new applications,
applicants should describe the experience of their group in collaborative
programs and activities.
Specific issues related to cooperative agreements must also be addressed in
the application as follows.
o In Section 3, applicants must include their specific plans for responding to
the "Cooperative Agreement Terms and Conditions of Award" section. Applicants
should state their willingness to collaborate and share data freely with the
other MMHCC components, to participate in planning and attending workshops and
symposia, to serve on the Steering Committee and be bound by its decisions,
and to be able and willing to share data and research resources with each
other and the NCI.
o At the end of Section 3, applicants must append a letter from the applicant
institution describing how that institution intends to meet the NIH policies
for sharing of data or why data sharing is not possible. In this regard,
attention is drawn to the NIH Draft Statement on Sharing Research Data
(http://grants1.nih.gov/grants/policy/data_sharing/index.htm). Investigators
submitting an NIH application will be required to include a plan for data
sharing or to state why data sharing is not possible. NIH has invited
comments on the draft statement cited above, and, following consideration of
public comments and appropriate revisions, it is expected that NIH will
announce a new policy.
o Applicants to this RFA must also append a research tools and resources
sharing plan at the end of Section 3. Investigators conducting biomedical
research frequently develop unique research resources. The policy of the NIH
is to make available to the public the results and accomplishments of the
activities that it funds. To address the interest in assuring that research
resources are accessible, NIH requires applicants who respond to this RFA to
submit a plan (1) for sharing the research resources generated through the
grant, including engineered mice and genetic and phenotype data for all mouse
strains; and (2) addressing how they will exercise intellectual property
rights, should any be generated through this grant, while making such research
resources available to the broader scientific community. The sharing of
research resources plan and intellectual property plan must make unique
research resources readily available for research purposes to qualified
individuals within the scientific community in accordance with the NIH Grants
Policy Statement (http://grants.nih.gov/grants/policy/nihgps/) and the
Principles and Guidelines for Recipients of NIH Research Grants and Contracts
on Obtaining and Disseminating Biomedical Research Resources: Final Notice,
December 1999 (http://www.ott.nih.gov/policy/rt_guide_final.html and
http://ott.od.nih.gov/NewPages/64FR72090.pdf ). These documents also define
terms, parties, responsibilities, prescribe the order of disposition of
rights, prescribe a chronology of reporting requirements, and delineate the
basis for and extent of government actions to retain rights. Patent rights
clauses may be found at 37 CFR Part 401.14 and are accessible from the
Interagency Edison web page, http://www.iedison.gov. If applicant
investigators plan to collaborate with third parties, the research tools
sharing plan must explain how such collaborations will not restrict their
ability to share research materials produced with PHS funding.
o Awardees under the auspices of this RFA should obtain appropriate licenses
for technologies that are necessary for the conduct of the proposed research
so that the goals that are proposed in Section 2 of the "Research Plan" can be
accomplished. A statement from the applicant institution regarding their
intent to obtain any necessary licenses must be appended to Section 3.
o The NCI reserves the right to require the transfer of appropriate mouse
stocks, related reagents, and pertinent data that are generated as the result
of participation in research supported under these awards to an eligible third
party, in order to preserve the mouse models and data about them and/or to
continue the research. Third parties supported under these awards must be
informed of this right. A statement from the applicant institution to that
effect must be appended to Section 3.
o Applicants must budget for travel and per diem expenses for the semi-annual
Steering Committee meetings. In all years, applicants must budget for two
investigators, the principal investigator and another senior investigator, to
attend two Steering Committee meetings.
o In addition, applicants must budget for travel and per diem expenses for
participation by at least five members of their group (other than the PI and a
senior investigator) in either MMHCC Steering Committee meetings or other
MMHCC-organized workshops and symposia.
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, CA-04-002 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, MOUSE MODELS OF HUMAN CANCERS CONSORTIUM, and number, RFA CA-04-002,
must be typed on line 2 of the face page of the application form and the YES
box must be marked. The RFA label is also available at:
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf.
SENDING AN APPLICATION TO THE NIH: For U01 applicants only (NIH intramural
applicants must use the address in the Section below entitled "ADDITIONAL
INSTRUCTIONS FOR NIH INTRAMURAL PROJECT APPLICANTS"), submit a signed,
typewritten original of the application, including the Checklist, and three
signed photocopies, in one package to:
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710
Bethesda, MD 20817 (for express/courier service)
At the time of submission, two additional copies of the application must be
sent to:
Referral Officer
Division of Extramural Activities
National Cancer Institute
6116 Executive Blvd., Room 8041, MSC-8329
Rockville, MD 20852 (express courier)
Bethesda MD 20892-8329
APPLICATIONS HAND-DELIVERED BY INDIVIDUALS TO THE NATIONAL CANCER INSTITUTE
WILL NO LONGER BE ACCEPTED. This policy does not apply to courier deliveries
(i.e. FEDEX, UPS, DHL, etc.)
(http://grants.nih.gov/grants/guide/notice-files/NOT-CA-02-002.html) This
policy is similar to and consistent with the policy for applications addressed
to Centers for Scientific Review as published in the NIH Guide Notice
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-012.html.
APPLICATION PROCESSING: Applications must be received by the application
receipt date, March 19, 2003, listed in the heading of this RFA. If an
application is received after March 19, 2003, 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.
ADDITIONAL INSTRUCTIONS FOR NIH INTRAMURAL PROJECT APPLICANTS: NIH intramural
project applicants must use the PHS 398 application form and the modified
format and content described above with the following additional
modifications.
o On the Face Page, fill out only items 1., 2., 3. (leave item 3c. blank),
4., and 5. The remainder of the items should be left blank, AND THE
APPLICATION MUST NOT BE SIGNED BY EITHER THE PI OR AN NIH INSTITUTE OFFICIAL.
The RFA label must be affixed to the bottom of the Face Page, as described
above in the section entitled "USING THE RFA LABEL".
o Do not submit "Other Support", Checklist", "Personnel Report", or "Personal
Data" pages.
o The PI must obtain the approval of her/his NIH Institute Scientific Director
for applying, for collaboration, for participating as a component of the MMHCC
under the terms and conditions of the RFA, and for complying with the policies
of the Steering Committee. A copy of that letter of approval must be provided
as part of a cover letter, addressed to the NCI Referral Officer, for the
application.
o The budget pages should supply the time and effort for each project
participant, but no other budget figures should be included. The resources
available for the project and the research environment should be carefully
described, but no budget figures should be included. The NIH Institute
Scientific Director, as part of the letter of approval for participation, must
verify that appropriate intramural resources will be allocated to the project
described in the application if it merits funding, and provide assurance that
the conduct of the project will comply with the PHS regulations for research
involving human subjects (if applicable), with the PHS policy on vertebrate
animal research, and with the PHS policies for data sharing and access to
research tools.
o Submit an unsigned, typewritten original of the application, and five
photocopies 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
Do not send the application or any copies to the Center for Scientific Review.
NIH intramural project applications must be received by March 19, 2003. If an
application is received after that date, it will be returned to the applicant
without review.
PEER REVIEW PROCESS
Upon receipt, U01 applications will be reviewed for completeness by the CSR
and for responsiveness by NCI program staff. NIH intramural project
applications will be reviewed for completeness by the NCI Division of
Extramural Activities, and for responsiveness by NCI program staff.
U01 and NIH intramural project applications that are complete and responsive
to the RFA will be evaluated for scientific and technical merit by an
appropriate peer review group in accordance with the review criteria stated
below. As part of the initial merit review, all applications:
o will receive a written critique
o may 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 that receive a priority score will undergo a second level review by the
National Cancer Advisory Board at their September 2003 meeting.
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 discuss the following aspects
of your application in order to judge the likelihood that the proposed
research will have a substantial impact on the pursuit of these goals:
o Significance
o Approach
o Innovation
o Investigator
o Environment
The scientific review group will address and consider each of these criteria
in assigning your application's overall score, weighting them as appropriate
for each application.
(1) SIGNIFICANCE: Does your study address important problems in human cancer
research that will benefit from innovation in cancer mouse modeling? Are
there translational aspects of cancer research that will benefit from how you
plan to apply the models? If the goals of your project are achieved, how will
they support discovery in human cancer research or overcome challenges in
human cancer research? What will be the effect of these studies on the
concepts or methods that drive the field of cancer modeling and its
integration with human cancer research? Is there evidence that your applicant
group is capable of anticipating new directions in research and of channeling
resources to new opportunities?
(2) APPROACH: Are the conceptual framework, design, methods, and analyses
adequately developed, well integrated, and appropriate to the goals of the
project? Do you acknowledge potential problem areas and consider alternative
tactics?
(3) INNOVATION: Does your project employ novel concepts, approaches, methods,
or combinations of expertise? Are the goals original and innovative? Does
your project challenge existing paradigms, develop new methodologies or
technologies, or provide unique perspectives on cancer research through
derivation, in-depth characterization, or application of mouse cancer models?
(4) INVESTIGATORS: Are you and your team appropriately trained and well suited
to carry out this work? Is the work proposed appropriate to your experience
as the principal investigator and to that of other researchers? To what
extent does your group of investigators have the necessary complementary
skills? Have collaborations been established or consultants identified to
provide the appropriate depth and breadth of scientific expertise required for
the project? Will your team of investigators contribute unique skills to the
overall Consortium?
(5) ENVIRONMENT: Does the scientific environment in which your work, and that
of your group, will be conducted contribute to the probability of success? Do
the proposed experiments take advantage of unique features of the scientific
environment or employ useful collaborative arrangements? Is there evidence of
institutional support in the applicant institution and all cooperating
institutions?
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 SHARING OF DATA AND RESEARCH TOOLS: The adequacy of the proposed plan to
share data or the rationale for not doing so. The appropriateness of the
research tools sharing plan and the explanation of how third part
collaborations will not restrict the ability to share research materials
produced with PHS funding.
o INTELLECTUAL PROPERTY: An appropriate statement that the applicant
institution is willing to obtain appropriate licenses for technologies that
are necessary for the conduct of the proposed research.
o BUDGET: For U01 applications, the reasonableness of the proposed budget and
the requested period of support in relation to the proposed research. For NIH
intramural project applications, the commitment of effort and the adequacy of
the resources and environment.
o COLLABORATIONS: For competing renewal applications, the nature and extent
of collaborations within and outside the MMHCC, participation in internal
MMHCC activities, and contributions to the NCI efforts to establish and
maintain cancer research infrastructure for the entire community. For new
applicants, evidence of significant experience with collaborations within and
outside the applicant institution. For all applicants, evidence of
willingness to collaborate extensively and share information fully and to
abide by the priorities and policies agreed upon by the Steering Committee.
RECEIPT AND REVIEW SCHEDULE
Letter of Intent Receipt Date: February 19, 2003
Application Receipt Date: March 19, 2003
Peer Review Date: June July, 2003
Council Review: September, 2003
Earliest Anticipated Start Date: April 01, 2004
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
REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH
policy requires education on the protection of human subject participants for
all investigators submitting NIH proposals for research involving human
subjects. You will find this policy announcement in the NIH Guide for Grants
and Contracts Announcement, dated June 5, 2000, at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. A
continuing education program in the protection of human participants in
research in now available online at: http://cme.nci.nih.gov/. Although the
primary objective of this RFA is to derive mouse models for cancer research
that will be analogous to human malignancies, there may be instances in which
applicants must collect or use pathology specimens derived from human
subjects, or clinical or epidemiological data from projects involving human
subjects, to inform the design of the models or their characterization with
respect to human cancer. In those instances, the NIH policies apply and must
be addressed in the application.
PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The
Office of Management and Budget (OMB) Circular A-110 has been revised to
provide public access to research data through the Freedom of Information Act
(FOIA) under some circumstances. Data that are (1) first produced in a
project that is supported in whole or in part with Federal funds and (2) cited
publicly and officially by a Federal agency in support of an action that has
the force and effect of law (i.e., a regulation) may be accessed through FOIA.
It is important for applicants to understand the basic scope of this
amendment. NIH has provided guidance at
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this RFA in a public
archive, which can provide protections for the data and manage the
distribution for an indefinite period of time. If so, the application should
include a description of the archiving plan in the study design and include
information about this in the budget justification section of the application.
In addition, applicants should think about how to structure informed consent
statements and other human subjects procedures given the potential for wider
use of data collected under this award.
URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals
for NIH funding must be self-contained within specified page limitations.
Unless otherwise specified in an NIH solicitation, Internet addresses (URLs)
should not be used to provide information necessary to the review because
reviewers are under no obligation to view the Internet sites. Furthermore,
we caution reviewers that their anonymity may be compromised when they
directly access an Internet site.
HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to achieving
the health promotion and disease prevention objectives of "Healthy People
2010," a PHS-led national activity for setting priority areas. This RFA is
related to one or more of the priority areas. Potential applicants may obtain
a copy of "Healthy People 2010" at http://www.health.gov/healthypeople/
AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal
Domestic Assistance No. 93.396, and is not subject to the intergovernmental
review requirements of Executive Order 12372 or Health Systems Agency review.
Awards are made under authorization of Sections 301 and 405 of the Public
Health Service Act as amended (42 USC 241 and 284) and administered under NIH
grants policies described at http://grants.nih.gov/grants/policy/policy.htm
and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92.
The PHS strongly encourages all grant recipients to provide a smoke-free
workplace and discourage the use of all tobacco products. In addition, Public
Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain
facilities (or in some cases, any portion of a facility) in which regular or
routine education, library, day care, health care, or early childhood
development services are provided to children. This is consistent with the
PHS mission to protect and advance the physical and mental health of the
American people.
Weekly TOC for this Announcement
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