and Human Services (HHS)
EXPIRED
NETWORK FOR TRANSLATIONAL RESEARCH: OPTICAL IMAGING
Release Date: August 27, 2002
RFA: CA-03-002 (Reissued as RFA-CA-08-002)
National Cancer Institute (NCI)
(http://www.nci.nih.gov/) or
(http://cancer.gov)
Public Meeting of Potential Applicants: September 27, 2002
Letter of Intent Date: December 17, 2002
Application Receipt Date: January 21, 2003
THIS RFA CONTAINS THE FOLLOWING INFORMATION:
o Purpose of this RFA
o Research Objectives
o Pre-Application Meeting
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 Preparing and Submitting an Application
o Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations
PURPOSE
The National Cancer Institute (NCI) invites applications for cooperative
agreement (U54) awards to establish a Specialized Research Resource Center
that will participate as a member of a network of inter-disciplinary, inter-
institutional research teams for the purpose of supporting translational
research in optical imaging and/or spectroscopy in vivo. The network is to be
named the "Network for Translational Research: Optical Imaging" (NTROI) and
will operate under the guidance of a Steering Committee (SC). The goal of
this Request for Applications (RFA) is to organize a consortium with
flexibility in scope, funding, and incentives to encourage inter- and intra-
team collaborations on translational cancer research. The objective is to
accelerate the pace of translational research by developing a consensus
process to improve methods for system integration, optimization and
validation of next-generation in vivo optical imaging and/or spectroscopy
methods and technologies, including contrast agents. Investigators are
encouraged to include in vivo molecular imaging methods that give information
about molecular events in cells or the extra-cellular milieu. The research
scope includes feasibility studies for the detection of pre-cancerous
lesions, cancer detection and diagnosis, and measurement or prediction of
response to therapy.
Applications are solicited from preformed consortia, to be referred to as
Teams. Approximately three such teams will be selected from applications that
receive high priority scores and are most responsive to the goals of this
RFA. Each team must include investigators from at least two different
institutions, and the team may include investigators from academia, national
laboratories, industry or intramural laboratories of the National Institutes
of Health. (NIH investigators may participate in applications as
investigators or collaborators, but not as principal investigators. They may
not request or receive funds from this program.) Broad, multi-disciplinary
teams are expected to include a variety of expertise, such as molecular
biologists, chemists, physicists, optical and computer engineers, imaging
scientists and physicians. Involvement of basic and clinical scientists who
may not have a specific research record in cancer research, but who have the
potential to provide experience crucial for the success of this network are
considered important. Partnerships with industry and small business are
encouraged for each team to enhance technology dissemination.
RESEARCH OBJECTIVES
Participants in three recent NIH sponsored workshops described new in vivo
biophotonics methods applicable to the early detection, diagnosis and
treatment monitoring of cancer and other diseases. The next generation of
biophotonics systems, described in this RFA as in vivo optical imaging and/or
spectroscopy technologies and methods, present NCI with an opportunity to
promote the better prospects among them through an efficient transition from
laboratory prototypes to cancer applications. Clinical applications
identified in the workshops include, but are not limited to cancer of the
cervix, esophagus, breast, brain, lung, prostrate and colon. Optical
techniques provide unique advantages over other imaging modalities for a
number of applications, particularly molecular imaging. In vivo optical
measurements extend across a wide range of resolution, from molecular and
cellular to tissue and organ levels. Some of these optical methods complement
advances in targeted or activated optical contrast agents that may provide
better sensitivity and specificity at the molecular level than other
modalities. For example, they may permit deterministic methods for early
cancer detection, drug discovery, and monitoring of therapy response. The
identification of strong prospects among optical methods and contrast agents,
and their validation and translation to cancer applications pose significant
challenges, particularly for human investigations. The intent of this RFA is
to establish a multi-institutional network of inter-disciplinary research
teams that collectively has the breadth of expertise needed to identify the
necessary approaches to validate and translate optical methods for a variety
of cancer applications, using both pre-clinical models and human
investigations. The following sections provide background on developments of
optical contrast mechanisms and optical devices, with examples of clinical
applications and kinds of validation studies anticipated under this RFA.
Optical contrast mechanisms: Optical measurements of either intrinsic or
extrinsic contrast yield optical signatures comprised of optical spectra or
multi-spectral images. Measurement methods exploiting intrinsic (endogenous)
contrast include (a) photon reflection or fluorescence of early pre-cancerous
changes in cellular structure imaged by optical microscopy, (b) single point
multi-spectral detectors that identify early changes in cellular structure
preceding cervical, esophageal or oral cancer, (c) single point reflectance
signatures to determine zones of microscopic extension of cancer, useful for
interventional decisions, and (d) macroscopic changes in photon scattering
and absorption detectable by optical tomography for cancer diagnosis or
determining cancer risk. Extrinsic contrast agents include fluorescent and
non-fluorescent dyes, which are often non-specific. Specificity is emerging
with the development of new targeted agents such as fluorophore-labeled
antibodies that serve a role analogous to radio-labeled agents for tumor
detection and classification, or new classes of optical agents, so-called
"smart agents," that use enzyme-mediated activation of fluorophores to
selectively illuminate the target site. New contrast agents using near-
infrared fluorophores have been shown to significantly improve target
contrast-to-noise in comparison with other imaging modalities such as PET.
Their use can improve upon the limited depth penetration achieved by some
tissue optical measurements, including tomography. Dual-labeled probes, e.g.,
targeted fluorophore plus gadolinium chelates, offer the potential to improve
target sampling and its classification using MR imaging to guide high-
spatial-resolution fiber-optical devices. Developments of multiple optical
molecular probes using nanoparticles as a platform for fluorophore support
and delivery have been proposed. Imaging of more than one molecular probe
could be used to measure several parameters simultaneously, for example, to
image the molecular target of a drug such as tyrosine kinase inhibitor,
measure a drug"s biological effect, such as apoptosis, and provide a
pathological or morphomertic measure of tissue response.
Optical Methods: Optical systems for imaging and spectroscopy include (a)
non-invasive external methods such as time resolved diffuse optical
tomography (DOT), (b) direct optical methods for accessible epithelial
surfaces, or (c) minimally invasive optical fiber methods for localized in
vivo tissue measurements that require some form of image guidance, including
insertion of optical fibers into tissues or the use of implanted systems.
External optical tomographic applications under current investigation include
breast cancer imaging and small animal imaging using both intrinsic contrast
and extrinsic contrast agents. Minimally invasive methods include catheter-
delivered optical systems capable of confocal or multi-photon microscopy, 2D
optical coherence tomography, or localized spectroscopy measurements. Among
next generation optical hardware components under development are (a) new
light sources, such as pulsed, ultra-fast tunable lasers, and light sources
capable of multi-spectral narrow band emissions, (b) miniaturized fiber optic
systems and optical systems with micro-electromechanical system (MEMS) aiming
and focusing technology with signal capture by multiple optical sensors or
multi-modality sensors placed at the end of a thin catheter, and (c)
detectors with improved sensitivity, spectral selectivity and photon energy
band width suitable for enhanced multi-spectral techniques. Another area of
active development includes computer-based methods for more nearly real-time
quantitative analysis, which are often essential for detection, diagnosis, or
some form of intervention. These advances would allow (a) a broad range of
intrinsic and extrinsic signatures to be measured, (b) 3D imaging such as 3D
OCT, as opposed to point measurements, (c) greater depth penetration than is
available with current optical tomographic technology, and (d) approaches to
multi-spectral imaging that will allow the imaging of multiple molecular
probes. An important goal of the research would be optimization of overall
optical properties (photon energy characteristics) by better matching of
system transmit-receive characteristics with the optical properties of
molecular probes and target tissues.
Clinical Investigations: Optical imaging and spectroscopy are rapidly
advancing modalities in medical imaging. For example, current clinical
studies using intrinsic contrast signatures, such as optical fluorescence or
reflectance measurements, or extrinsic contrast afforded by optical dyes,
show promise for cancer screening applications. For example, point
measurements are being explored for cervical cancer screening, where
comparisons of colposcopic (visual microscopic) methods with PAP smears are
underway. Preliminary results show optical signature differences between
colposcopically normal and abnormal regions of cervix that correlate with
biological differences between normal and diseased tissue. Further advances
in multi-spectral imaging devices, such as miniaturized 2D optical microscopy
and 3D OCT devices, should significantly improve lesion localization, depth
of tissue visualization, and tissue characterization over current methods,
particularly when combined with advances in targeted and activated contrast
agents. The use of endoscopes to collect optical signatures (optical biopsy)
has been proposed for cancer diagnosis. The use of 2D and 3D multi-sensor
systems for optical biopsy should greatly improve localization, sampling, and
characterization of lesions. There is potential for optical biopsy to
precisely direct the clinician to the most suspicious site or eventually
supplant tissue excision for cancer diagnosis in Barrett"s esophagus, colon
and lung cancer. Optical tomography is being explored currently for breast
cancer characterization, using measurement of intrinsic optical signatures
derived from photon scattering and absorption due to blood oxygenation levels
and indocyanine green contrast agent. Preliminary data suggest sensitivities
comparable to dynamic contrast-enhanced MRI methods. Advances in contrast
agents to extend the capabilities of optical tomography would further improve
sensitivity and specificity for cancer detection and classification.
Validation Methods: Another important objective of the proposed network is
validation of new optical imaging methods for specific cancer applications.
Validation refers to quantitative comparisons of performance with other
imaging modalities or histopathology on biopsy specimens. These validation
methods would precede a clinical trial designed to demonstrate the clinical
efficacy of any optical method. Since in vivo optical measurements usually
preserve tissue structure, verification of optical signatures should then be
possible by correlation with measurements in vitro. The latter may include
biopsy and histopathological confirmation, serial imaging and/or spectroscopy
of excised tissue at higher spatial resolution, micro-array analysis of
tissue, or other in vivo or in vitro measurements that serve as either
reference methods or gold standards. It is envisioned that investigations
involving pre-cancer or cancer detection, effects of the microenvironment, or
measurements of response to therapy may involve optical methods that share
features, optical signatures, and analytical features in common. Validation
of the observations and their interpretations will be necessary, and will
extend to understanding the optical signatures that may characterize
molecular pathways to disease. Validation methods are anticipated to be
complex and an important challenge in successful translational research. Thus
there is a critical need for NTROI investigators to explore diverse
approaches to validation, and compare and share the results of their optical
imaging methods, contrast agents, software implementations of their
algorithms, and together develop consensus on robust methods for their
validation for various cancer applications.
System Development and Integration: Prototype systems often are not
sufficiently robust to support independent validation studies or clinical
investigations. Hence there is a critical need for the network teams to
include industrial research partners to take advantage of their expertise in
(a) preparing robust optical systems and contrast agents, (b) disseminating
optical devices and contrast agents to the imaging research and clinical
communities, and (c) experience and flexibility in development of
imaging/spectroscopy acquisition and data processing protocols to provide
platform independent methods, such as harmonization of acquisition and
analysis methods, which may be required later for multi-center clinical
trials.
Objectives and Scope:
A network of Specialized Research Resource Centers consisting of
approximately three multi-disciplinary inter-institutional research teams
will be established for the purpose of supporting translational research
applied to optical imaging and spectroscopy in vivo for human and/or pre-
clinical models.
The network is to be named the "Network for Translational Research: Optical
Imaging" (NTROI), and will operate under the guidance of a Steering Committee
(SC) comprised of senior investigators from the teams and NCI program staff
scientists. The goal of the RFA is to organize a consortium with flexibility
in scope and funding incentives to support inter- and intra-team research
collaboration to encourage translational research. The objective is to
accelerate translational research by developing a consensus-based approach to
improved methods for system integration, optimization, and validation of next
generation optical imaging, spectroscopic methods, and contrast agents.
Applications that include molecular imaging methods are encouraged.
Definition of Translational Research:
Translational Research in the context of this Network means the development
of a consensus process and methodology to move the application of emerging
optical imaging and spectroscopy methods and their intrinsic or extrinsic
(agent mediated) contrast mechanisms closer to uses in clinical oncology or
research with humans or animal models. The range of work may encompass
system integration, optimization, validation, and development of methods and
related software for analysis towards proof of feasibility. It includes a
consensus approach for the development of a framework or process to encourage
platform independent methods, such as harmonization of acquisition and
analysis methods, which may be required later for multi-center clinical
trials. It is anticipated that iterative data collection will be used to
further optimize and retest system performance. It includes efforts to
understand the mechanisms underlying optical signatures and the extraction of
information from them as required for overall system validation. Clinical
investigations specifically to demonstrate proof of feasibility or to provide
feedback to improve the sensitivity and specificity of the imaging protocols
are acceptable, but larger trials to establish clinical utility are beyond
the scope of this RFA.
The flexibility intended for NTROI teams includes the promotion of
developmental projects into primary projects as they show promise and
importance, and discontinuation and replacement of developmental or primary
projects that are completed, or which demonstrate insufficient translational
significance or progress. It is anticipated that the original teams of
investigators might remain largely the same during the period of the
cooperative agreement, but that lead roles among investigators may change as
projects evolve or are replaced.
It is expected that Teams, with Steering Committee guidance, will develop the
research infrastructure and approaches necessary to sustain translational
research objectives and continually develop collaborative research
relationships necessary for the most effective path to completion of
translations. The NTROI is expected to identify and focus on translational
research that is best accomplished through research collaborations, networks
and consortia.
The efforts envisioned here are oriented toward proofs of feasibility, given
the limitations imposed by available funding. It is therefore anticipated
that as projects mature, investigators will seek independent investigator-
initiated funding to carry projects beyond technical and clinical feasibility
toward clinical utility. To these ends, cooperation and collaborations with
other NCI funded programs are encouraged. The following list represents a
partial listing of possibilities:
ACRIN: American College of Radiology Imaging Network,
http://www3.cancer.gov/bip/arin.htm
ICMIC: In vivo Cellular and Molecular Imaging Centers and Pre-ICMICs,
http://www3.cancer.gov/bip/ICMICs.htm
CTEP: Cancer Therapy Evaluation Program,
http://resresources.nci.nih.gov/categorydisplay.cfm?catid=7 - 21
MMHCC: Mouse Models of Human Cancers Consortium,
http://web.ncifcrf.gov/researchresources/mmhcc/default.asp
ERDN: Early Detection Research Network,
http://www3.cancer.gov/prevention/cbrg/edrn/
SPORE: Specialized Programs of Research Excellence,
http://spores.nci.nih.gov/
IMAT: Innovative Molecular Analysis Technologies,
http://otir.cancer.gov/tech/imat.html
A submitted application must describe a pre-formed research consortium, to be
known as a Research Team. A network of approximately three such Specialized
Research Resource Center teams will be formed from applications that receive
high priority scores and are most responsive to the goals of the RFA. Each
team must include investigators from at least two different institutions. A
team may include participants from research laboratories in academia,
national laboratories, large or small businesses, and/or NIH intramural
research programs. NIH intramural investigators may participate in a Team
application, but they must be supported by NIH intramural funds and cannot
request or receive funds from this program (see special instructions under
SPECIAL SUPPLEMENTAL INSTRUCTIONS FOR NIH INTRAMURAL INVESTIGATORS, CO-
INVESTIGATORS, AND/OR COLLABORATORS.
It is anticipated that translational research will require broad, multi-
disciplinary teams. They should include representatives of fields necessary
for successful completion of the proposed basic research and translational
projects, and might include molecular biologists, chemists, physicists,
optical and computer engineers, imaging scientists and physicians, among
others. Involvement of basic and clinical scientists who may not have a
specific research record in cancer research, but who have the potential to
provide experience crucial for the success of this network are considered
important. Each team is encouraged to include industrial partnerships formed
with large or small businesses to enhance the development of technology
suitable for dissemination for cancer applications for both human and pre
clinical model investigations.
Each application must provide a Team Description, describe an Organizational
and Administrative Structure, and propose Primary Research Projects. The
Organizational and Administrative Structure must include plans for how the
team will initiate and select Developmental Projects for years 2-5, including
recruitment of Associate Members to bring outside expertise to Primary and/or
Developmental Projects. Each application must propose one or more Research
Support Cores and an Administrative Core. Specifics on projects and cores
are described below. The budget should consist of a Summary Budget followed
by detailed individual research project and core budgets and justifications.
Network members may have concurrently funded, related projects or seek
additional investigator initiated funding for projects that complement the
objectives of the NTROI.
Primary Projects (Support: Years 1-5):
Primary Projects are key to the success of the research program of a
Specialized Research Resource Center, so the submitted application must
provide a succinct, yet complete research plan for each one.
1. Each application must propose at least three Primary Projects. These may
involve the same or different imaging methods and organ systems.
2. The Primary projects shall address at least two of the following three
topical areas:
(a) Basic Research: Interdisciplinary studies to improve fundamental
understanding of molecular processes or cellular environment in vivo that
influence the measurement, interpretation, and/or validation of optical
signatures from extrinsic and/or intrinsic contrast mechanisms.
(b) Optical contrast agents: Examples might include development and
validation of target-based optical contrast agents or molecular probes that
may be activated to improve sensitivity and/or specificity of cancer
investigations, or agents for dual modality imaging.
(c) Technology optimization and validation: Examples might include
system integration, optimization, algorithm and software development for pre-
and/or post-processing, optimization of tomographic or localized optical
imaging or spectroscopy systems.
As primary projects mature and their aims accomplished by translation to
cancer applications, teams may terminate a primary project and replace it
with a new project. Team investigators are encouraged to seek additional
investigator-initiated external funding and collaborations for follow up pre
clinical or clinical studies as primary projects mature. The Steering
Committee will review and advise on proposals for all primary projects.
Research and Administrative Cores (Support: Years 1-5):
A Research Support Core is to provide core services to at least one Primary
Project and is expected to provide services for future Developmental Projects
that require them. It must not duplicate any available resource facility
already in place and supported by another funding mechanism, e.g., P30, P41,
P01, U01, DOD, etc. However, investigators may (are encouraged) to present a
proposal to augment an existing resource facility with funds and/or personnel
effort in order to fulfill their needs for core resources. A Research
Support Core or Cores may include, for example, (1) shared imaging and/or
spectroscopic systems, perform prototype system maintenance and improvements,
or related software for data analysis for small animal and/or human
investigations, (2) laboratory capability for development and production of
targeted and/or activated contrast agents, and/or (3) facilities for data
analysis. Each Research Support Core must have its own budget and
justification.
An Administrative Core is to provide (1) administration and coordination
among all intra-team research projects, including access for any project that
requires Research Support Core services, and (2) inter-team projects
coordinated through the administering team"s participation on the Steering
Committee. The Administrative Core must have its own budget and
justification.
Developmental Project Plans (Support: Years 2-5): The application"s section
on Organization and Administration must include a section that describes
plans for generating developmental projects to start in years 2 and later.
Do not provide descriptions of actual developmental projects, a plan for a
process to identify future projects is what is required.
These plans are to result in (a) feasibility studies and pilot projects that
have the potential to mature into new primary projects, or (b) have potential
to expand the scale and translational scope of primary projects. It is
anticipated that after the formation of the NTROI that intra-team and in
particular inter-team translational research scale-up of primary projects or
common pilot projects would be encouraged by the Steering Committee,
including access to the research resources among the teams of the overall
network (NTROI). A plan for termination of unproductive Developmental
Projects should be proposed. Do not provide descriptions of actual
developmental projects, a plan for a process to identify future projects is
what is required.
Associate Members: The plans for Developmental Projects must include
outreach to the academic, national laboratory, industry and small business
communities to attract new collaborating researchers who would then become
Associate Members of the NTROI. Outreach to Associate Members may provide,
for example, access to expertise on new ideas, optical systems, probes or
validation methodologies that are not available within the team.
The Development Project Plan should budget approximately two-thirds of
developmental funds for intra-team and inter-team developmental projects, and
one-third for Associate Members. The Steering Committee will review and
advise on team proposals for use of funds for Developmental Projects,
including their scope, relevance to the NTROI, amount, and duration of
support.
Investigators gaining support for Developmental Projects will be encouraged
by the Steering Committee to seek independent investigator initiated support,
e.g., R01, R21, R21/R33, Fast-track SBIR, STTR, etc., as the projects mature.
Budget and Related Issues:
NCI will set aside approximately $3 million total costs in year 1, and $18M
total costs for all 5 years for the NTROI. Average direct and total costs
per Team are estimated as follows:
o Primary Projects, Research and Administrative Cores: Average annual direct
costs of $650 thousand (total costs of $1 million) and average direct and
total costs for all 5 years of $3.25 direct, and approximately $5M total
costs per funded application.
o Developmental Projects: Average annual direct costs per team of $150
thousand (total costs of $225 thousand) are estimated for years 2 through 5
(not funded in year 1), with average direct and total costs for years 2-5 of
$600k direct and approximately $900k total.
PRE-APPLICATION MEETING
A pre-application meeting for potential applicants will be organized to help
communicate the goals of this RFA and answer questions. It will be held the
afternoon of September 27, 2002, in Bethesda MD. Information on preliminary
and final plans on venue and agenda will be emailed to interested
investigators who submit contact information to Dr. Houston Baker, below. The
venue and agenda also will be posted on the NCI"s Biomedical Imaging Program
website, http://cancer.gov/bip.
MECHANISM OF SUPPORT
This RFA will use the NIH Specialized Center Cooperative Agreement (U54)
award mechanism for the Network for Translational Research: Optical Imaging.
With this award mechanism, each Principal Investigator of a cooperative
agreement retains the primary responsibility and dominant role for planning,
directing, and executing the proposed team project, maintaining active
collaborations to be formed with other Specialized Research Resource Center
teams competitively selected for the Network, and maintaining active
participation in the Network"s Steering Committee. There is NCI staff
involvement in partnership with the Principal Investigator, described in
"Cooperative Agreement Terms and Conditions of Award," below. The NCI may
expand or reduce the scope and direction of the Network by amendment during
the course of the initial five-year period of set-aside funding, terminate it
upon expiration, or extend or expand it prior to expiration by reissuing the
RFA soliciting competitive applications for translational research in optical
and/or other imaging technologies for oncology. It is anticipated that
individual projects of a team will mature, complete aims, add new aims, end,
and/or be replaced by other projects. Developments that successfully
translate to clinically feasible or research-oriented instruments and methods
are expected to stimulate investigator-initiated applications for clinical
and basic research grants under other support mechanisms, such as the R01,
R21, R21/R33, R33, R41, R42, R43, and R44.
FUNDS AVAILABLE
NCI intends to commit up to $3 million total costs in FY 2003 to fund
approximately 3 new cooperative agreements in response to this RFA, and $3.75
million total costs in each of FY2004 through 2007, for a total commitment of
$18 million. An applicant Team may request a project period of up to 5 years
and a budget for direct costs of up to $1 million per year. Because the
nature and scope of the proposed research will vary from application to
application, it is anticipated that the size and duration of each award will
also vary. Although the financial plans of NCI include support for this
program, awards pursuant to this RFA are contingent upon the annual
availability of funds and receipt of a sufficient number of meritorious
applications. At this time, it is not known if this RFA will be reissued.
NCI extramural funds are not available to fund research by NIH intramural
investigators. Intramural participants must verify the availability of
funding allocated from intramural sources to support their role as
collaborators on a team.
ELIGIBILITY
Eligible Institutions:
o For-profit or non-profit organizations,
o Domestic or foreign organizations,
o Public or private institutions, such as universities, colleges, hospitals,
and laboratories,
o Medical and technology research units of State and local governments,
o Eligible agencies of the Federal government. (Intramural NIH scientists
who are supported by intramural funds may provide Primary and Developmental
Projects, and Research Support Core services to an application, or provide
expertise to Network projects as Associate Members. The extramural funds set
aside for this RFA are not available for support of NIH intramural research
staff).
A responsive application will include a minimum of two eligible institutions
and present at least three Primary Projects, one Research Support Core, one
Administrative Core, and plans for establishing Developmental Projects to
start in year 2. Cost sharing by adding employee effort and support to an
existing core facility is encouraged to reduce overall core costs and start-
up time.
INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS
Any individual from an eligible organization and who has the skills,
knowledge, and resources necessary to direct and carry out the proposed
research is invited to work with their organization to develop an application
for support. Individuals from underrepresented racial and ethnic groups as
well as individuals with disabilities are encouraged to apply for NIH
programs.
SPECIAL REQUIREMENTS
In order to ensure maximal progress by the teams funded by this initiative
and to realize the maximum benefit for the cancer research community and
ultimately for the ongoing battle against cancer, specific obligations will
be required of the funded investigators.
Applicants should state in their applications the following agreements:
o Their commitment to actively participate in the group activities of the
proposed Network of Specialized Research Resource Centers, NTROI.
o Their commitment to consider modifications of Primary Project aims to
accommodate new opportunities, needs and developments by the Network as a
result of progress or completion of Primary Project aims, and submit these
ideas to the Steering Committee for input and advice.
o Their commitment to submit proposals for Developmental Projects to review
by the Steering Committee for importance and relevance to the stated goals of
the proposed Network.
o Their commitment to actively seek and participate in Associate Member,
inter- and intra-team research collaborations as proposed by this RFA.
o Their commitment to jointly publish and otherwise disseminate appropriate
NTROI research findings and technological translational developments based on
consensus approaches for the validation of imaging/spectroscopy methods for
specific cancer applications.
o Their commitment to jointly organize a NTROI public meeting in year 2 and
annual meetings thereafter, based on Steering Committee recommendations. .
o Their commitment to participate in organized meetings of the NTROI,
conference calls, and group discussions related to encouraging inter- and
intra-team collaboration.
COOPERATIVE AGREEMENT TERMS AND CONDITIONS OF AWARD
The administrative and funding instrument used for this program is the NIH
Specialized Center Cooperative Agreement (U54), which anticipates
participation by NCI Program Staff. Under the cooperative agreement, the NIH
purpose is to support and/or stimulate the cooperative agreement awardee"s
activity by involving NIH program staff in and otherwise working jointly with
the award recipient in a partnership 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 Specialized Research Resource Center awardee for the project
as a whole, although specific tasks and activities in conducting the studies
will be shared among the awardees and the NCI Program Staff, as described
below.
The following terms and conditions pertaining to the scope and nature of the
interaction between NCI and the investigators will be incorporated in the
Notice of Grant Award. These terms will be in addition to the customary
programmatic and financial negotiations that occur in the administration of
grants. The terms and conditions described in this section are in addition
to, and not in lieu of, otherwise applicable OMB administrative guidelines,
HHS Grant Administration Regulations at 45 CFR part 74, other HHS, PHS, and
NIH Grant Administration policy statements, and other NCI administrative
terms of award.
1. Awardee"s Rights and Responsibilities
Each Specialized Research Resource Center Awardee will have primary and lead
responsibilities for its Team projects as a whole, including research design
and protocol development, participant recruitment and follow-up, data
collection, quality control, interim data and safety monitoring, final data
analysis and interpretation, preparation of publications, as well as
collaboration with other awardees in this Network. In coordination with
policy decisions of the Steering Committee, the dominant role and prime
responsibility for overseeing and directing the activity of each Specialized
Research Resource Center team, including assignment of duties of
participating personnel, resides with its Principal Investigator.
An awardee will retain custody of and have primary rights to the data
developed under these awards, subject to Government rights of access
consistent with current HHS, PHS, and NIH policies, and consistent with the
objectives of the NTROI Specialized Research Resource Center.
An awardee has the responsibility of collaborating with other Specialized
Research Resource Center teams of the NTROI and participating in its Steering
Committee (described under 3. Collaborative Responsibilities).
2. NCI Program Staff Scientist Responsibilities
The NCI Program Staff Scientists, consisting of the Imaging Technology
Development Branch Chief and an additional scientific advisor from the
Biomedical Imaging Program, will have scientific and programmatic involvement
above and beyond normal stewardship in decisions and recommendations on
overall project directions and allocations of all Project Funds. One staff
scientist provides experience in device, algorithm and software development,
and system integration. The other provides experience in cellular molecular
science, imaging probe and drug development, and medical oncology. This
oversight will be accomplished primarily through their participation as
voting members on the NTROI Steering Committee, and secondarily through
discussions with the team Principal Investigators. Specific tasks and
activities in carrying out the studies will be shared among the Network Teams
and may include participation by the NCI program staff scientists. NCI
program staff scientists will also assist in stimulating broader NCI and NIH
program interaction to accelerate the translational research efforts towards
feasibility studies. NCI program staff will help identify candidate Associate
Members from successful application submissions to NIH ICs or the NSF
Biophotonics initiatives, including SBIR funded investigators, and encourage
further interactions with other ongoing relevant NIH or other federal
programs. An NCI Program Director will be assigned to perform normal
programmatic stewardship and scientific administration of the cooperative
agreement to be awarded. The Program Director responsible for this RFA will
attend Steering Committee meetings as a non-voting observer.
The NCI reserves the right to terminate or curtail an individual award in the
event of insufficient progress, substantial shortfall in participant
recruitment, follow-up, data reporting, quality control, or other major
breach of NTROI objectives.
3. Collaborative Responsibilities
Steering Committee
A Steering Committee (SC) will be the main governing board for the proposed
Network of Specialized Research Resource Centers (NTROI). The members of the
SC will consist of three members from each of the funded teams and the two
designated NCI Program staff for an anticipated total of 11 voting members.
The three members from each team will include the PI and two additional co-
investigators from each team, at least one of whom is from a different
institution than the PI, and one of whom is a co-investigator from the team"s
administrative core. Voting members from the NCI Program staff will include
the Branch Chief of the Imaging Technology Development Branch and another
scientific advisor from the NCI Biomedical Imaging Program. All members from
teams and the two designated NCI staff will be voting members of the SC. The
SC will elect one of the team principal investigators to chair this
committee. The SC may include additional non-voting members, such as the
Program Director responsible for scientific administration of this RFA, other
NCI and NIH program staff or program staff from other federal agencies such
as the FDA, NSF or NIST who would serve in advisory capacities.
The Steering Committee will have primary responsibility for the overall
organization of the NTROI and for coordinating research goals and resources
among the teams. For example, they will review primary projects to encourage
inter-and intra-team collaborations. One important role will be to develop a
consensus on the best means for system integration, optimization, validation,
and translation of all projects.
Before the end of year 1 the Steering Committee will initiate a review
process for proposals for Developmental Projects, either for pilot projects
that have the potential to become new primary projects, or to expand the
scale and scope of primary projects towards translational research.
Developmental projects selected for funding are to have significant potential
to contribute to advancing the translational research of any team in the
NTROI.
The SC will encourage inter-team collaborations where pooling of resources
for Developmental Projects or expansion of Primary Projects would enhance or
accelerate the timetable for translational research, and will actively seek
new collaborators (Associate Members). The SC will develop a plan for
terminating Development Projects that become unpromising or unproductive.
The SC will organize an open scientific meeting in year 2 to report on
progress of the NTROI, solicit input from the broader scientific community,
and attract prospective Associate Members.
The SC will schedule quarterly meetings and telephone conference calls as
necessary for conduct of its business.
The SC will schedule one annual meeting at which all NTROI team members will
present their scientific progress and future plans.
Each team"s Administrative Cores will share costs and effort for support of
the above-described administrative activities of the SC.
Each awardee is required to submit a written semi-annual report on research
progress to the NCI Program Director and the NTROI SC. The SC will develop
recommendations for the scope and format of these reports, which will include
scientific progress, plans, and description and evaluation of the extent and
progress of inter-and intra-team collaboration. Both the Steering Committee
and NCI program staff will review reports.
4. Arbitration
Any disagreement that may arise on scientific or 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 members not voting) or by
the individual awardees in the event of an individual disagreement, a second
member selected by NCI, and the two arbitration panel members so selected
shall select a third member. This special arbitration panel will establish a
procedure to arbitrate the dispute and deliver a recommendation. Its actions
do not abridge the awardee"s right to appeal an adverse action that may be
otherwise appealed 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
Inquiries concerning this RFA are strongly encouraged. Potential applicants
may pose questions directly and/or choose to participate in a meeting for
potential applicants scheduled September 27, 2002, prior to the Letter of
Intent due date (December 17, 2002).
Inquiries may fall into three areas: program and scientific research, peer
review, and financial or grants management issues.
o Direct questions about program and scientific research for the National
Cancer Institute to
Houston Baker, Ph.D.
Program Director
Imaging Technology Development Branch
Biomedical Imaging Program
Division of Cancer Treatment and Diagnosis
National Cancer Institute
EPN Room 6060
Bethesda MD 20892-7412
(or for courier service, Rockville MD 20852)
Telephone: 1-301-594-9117
FAX: 1-301-480-3507
Email: [email protected]
or
Laurence P. Clarke, Ph.D.
Branch Chief
Imaging Technology Development Branch.
Biomedical Imaging Program
Division of Cancer Treatment and Diagnosis
National Cancer Institute
EPN Room 6054
Bethesda MD 20892-7412
(or for courier service, Rockville MD 20852)
Telephone: 1-301-435-9190
FAX: 1-301-480-3507
Email: [email protected]
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: 1-301-496-3428
FAX: 1-301-402-0275
Email: [email protected]
o Direct questions about financial or grants management matters to
Kelli Oster
Grants Administration Branch
National Cancer Institute
6120 Executive Boulevard, EPS Room 243
Bethesda MD 20892
Telephone: 1-301-496-8627
Fax: 1-301-496-8601
LETTER OF INTENT
Prospective applicants are asked to submit a letter of intent that includes
the following information:
o Number and title of this RFA
o Descriptive title of the proposed team research
o Name, address, and telephone number of the Principal Investigator
o Names of other key personnel
o Participating organizations
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 expected by December 17, 2002. The Letter of Intent
should be sent to
Houston Baker, Ph.D.
Biomedical Imaging Program
Division of Cancer Treatment and Diagnosis
National Cancer Institute
EPN Room 6060
Bethesda MD 20892-7412
(or for express or courier service, Rockville MD 20852)
Telephone: 1 301 594 9117
Fax: 1 301 480 3507
Email: [email protected]
PREPARING AND SUBMITTING AN APPLICATION
Applications must be prepared using the PHS 398 research grant application
instructions and forms (rev. 5/2001). PHS 398 Forms and Instructions are
available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an
interactive format. For further assistance contact Grants Info, Telephone
(301) 710-0267, e-mail: [email protected].
SUPPLEMENTAL INSTRUCTIONS:
Preliminary Research Plan and Budget: Early in the Team"s application
planning cycle, the Principal Investigator should discuss the outline plans
and budget with the NCI Program Director (named above) to gain understanding
of current policies, priorities, and budget environment.
Face Page, Line 2. Type number, RFA: CA-03-002 and the RFA title "Network
for Translational Research: Optical Imaging" on line 2 of the face page of
the application form, and mark the YES box.
Page 2, Key Personnel: List all key personnel, organization for each, and
role on the Team.
Page 3, Table of Contents: Adapt to include the Organization and
Administration section, title of each Primary Project, Developmental Project
Plan, each Research Support Core, and Administrative Core. Use additional
pages as necessary. Appendix A, Sample Table of Contents, Guidelines for the
NCI Program Project, is exemplary of the level of detail sought for a large
application, although it differs in specifics from this RFA.
See http://deainfo.nci.nih.gov/awards/P01.pdf#A.
Budgets:
The standard PHS 398 form pages 4 and 5 are to be completed for a Summary
Budget, followed sequentially by budget form pages 4 and 5 for each
individual research component (research projects and core activities). Use
additional pages for budget justifications where necessary. The
Administrative Core budget will include a share for the Network Steering
Committee needs as well as the usual administrative core activities. Budgets
for projects and cores from one or more collaborating institutions are listed
in the section on Consortium/Contractual Arrangements in the Summary Budget,
and details provided in their budgets for individual research components
using Form Pages 4 and 5. Prepare separate budget pages and brief
justification for Developmental Projects for years 2-5. The amount expected
is $150k direct costs per year. The justification is generic because
Developmental Projects are not to be submitted with the application, only
plans for project identification and accrual to meet future needs and
opportunities.
Personnel participating in more than one project should be listed in the
budget for each, showing percent effort on that project and justified in its
budget justification. Percent efforts for each project should be listed by
individual in the Summary Budget and then sub-totaled by individual. Provide
a Table of Professional Effort, starting with the Team Principal
Investigator, followed by Project and Core Leaders, and then followed by the
remainder of the investigators. See Appendix B, Sample Table of Professional
Effort, ibid.(http://deainfo.nci.nih.gov/awards/P01.pdf#A).
o Capital Equipment: Quotes for capital equipment are not needed for
application review, but will be requested prior to issuing an award.
o Duplicate Equipment: The Budget for Equipment may include funds to
produce one or more copies of prototype translational equipment needed for
placement with another primary project or collaborating research or clinical
research site. Justify the request under Equipment in the Budget
Justification.
Research Plan:
The following adaptations of Form 398 instructions for the "Research Plan"
are suggested:
Large Project page limitations apply, as noted below. Applicants are urged
to use fewer than the allowed number by being as concise as possible in view
of the limited scope of the translational research aims for the NTROI, and to
facilitate review.
Team Description (10 pages):
Present an overall vision for the NTROI Team, including long and short-term
objectives, and how they will support the translation research as defined in
this RFA. Summarize the organizational structure of the Team, concisely
defining Research Components and how each will contribute to achieving the
objectives of the translational effort. Briefly describe the Team"s
anticipated organizational relationship with the Network, which will consist
of this Team and two others. This section should provide a broad overview of
the Team and its organization, reserving details for later sections.
Organization and Administration (20 pages):
Include organizational charts, the infrastructure, relation to the
administrative structures of the host institutions (applicant and
consortium/subcontracting institutions) and decision-making structure of the
Team. Among appropriate components to include are the following:
o Roles and responsibilities of the principal investigator, project leaders,
core project directors, participating investigators/collaborators, and
internal and external advisory committees.
o Describe the decision-making, oversight, and communication
responsibilities for each component.
o Describe how projects are planned, coordinated, and evaluated.
o Describe the process (plan) by which Developmental Projects for years 2
through 5 will be identified, selected, progress monitored, and promoted to a
Primary Project. Include a plan for termination of unproductive
Developmental Projects. Do not provide descriptions of actual developmental
projects, a plan for a process to identify future projects is what is
required.
o Provide a tabulation of all consultants and their institutional
affiliations, paid or unpaid.
o Describe plans to facilitate multi-disciplinary interactions both through
intra-team and inter-team collaborations, as well as collaborations from
outside NTROI (Associate Members).
o Describe the Applicant Institution"s commitments to support its applicant
Team and consortium/subcontract component(s) of the Team. Include a
description of the relationships between the Team, other departments, centers
and institutes, and the institutional central administration.
o Describe the Team"s anticipated relationship and intention to interact
with the other teams of the NTROI.
Research Projects (30 pages each):
o Identify each Research Project with a number, title, and project leader,
e.g., 1. Raman Optical Signatures, Jane Doe.
o Research Plan Sections A-D (Specific Aims, Background and Significance,
Preliminary Data and Progress, and Research Methods) must be presented within
the standard 25 page limit for each Primary Project. Follow Form 398
instructions, including those for Human Subject participation and vertebrate
animal use. Applicants are urged to use fewer than the allowed number of
pages by being concise.
o A minimum of 3 primary projects from at least two institutions must be
proposed. They are key to the success of the research program of a NTROI
Specialized Research Resource Center. Their evaluation will be the main
focus of the review committee organized by the NCI Division of Extramural
Activities. Research projects should include descriptions of how the work
will support translational research for cancer.
o The overall scope of the proposed primary projects must address at least
two of the following three topical areas:
(1) Basic Research to improve fundamental understanding, measurement,
interpretation, and validation of optical signatures from extrinsic and/or
intrinsic contrast mechanisms.
(2) Optical contrast agents: development and validation of optical
and/or multi-modality contrast agents to improve sensitivity and/or
specificity of cancer investigations.
(3) Technology optimization and validation, e.g., system integration,
optimization, algorithm development and software methods for pre- and/or
post-processing, etc.
Research Support Core:
o Identify each Core Project with a letter, title, and project leader, e.g.,
A. Ligand Labeling and Fluorophore Development Laboratory, John Doe.
Each team must propose one or more Research Support Cores, each of which is
to provide common support to at least one Primary Project. A Core may
provide laboratory facilities, equipment and services to be shared among
Research and Developmental Projects. After formation of the NTROI and its
Steering Committee, arrangements may be made to provide core services to
projects on other teams. Affiliations with existing Cores are encouraged to
minimize duplicate costs, share resources, and reduce start-up time.
Instead of a typical Research Plan, use Aims to provide a clear description
of methods and services that the Core activity will provide to a Team
Research Project(s) and potential future Developmental Projects. Use
Background and Significance to describe the importance of the proposed
services to the research project(s) and Team effort. In Progress, describe
any pre-existing capabilities or preliminary data that will strengthen the
proposed Core Project. Use Methods to address research activity, if any,
proposed to adapt, further develop, meet research project needs, or otherwise
strengthen the methods and services to be provided.
Administrative Core:
Each team must propose an Administrative Core to administer and facilitate
(1) intra-and inter-laboratory access and coordination for meeting primary
project needs among team members of the participating institutions, (2)
shared Network needs for organizing, administering, and arranging
representation at NTROI Steering Committee meetings, and (3) usual
administrative core duties (fiscal management, clerical support, manuscript
preparation, meeting organization, data management, quality control,
planning, evaluation, communication within the Team and with the community
external to the Team. It may include plans for internal executive committee
activity, and internal and external advisory committees, including the NTROI
SC).
Submitted Images and Figures:
Follow PHS398 instructions for submitting as appendix material original
quality copies of images and figures that don"t copy well.
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-03-002 on the label. Failure to use this label could delay
processing of the application such that it may not reach the review committee
in time for review. The RFA title and number must be typed on line 2 of the
face page of the application form and the YES box must be marked. The RFA
label is also available at:
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf.
Sending an Application to the NIH:
Submit a signed, machine printed original of the application, including the
Checklist, and three signed photocopies, in one package to the
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 or
Bethesda, MD 20817 (for express or courier service)
At the time of submission, send two additional copies of the application to
Referral Officer
Division of Extramural Activities
National Cancer Institute
6116 Executive Blvd., Room 8041, MSC-8329
Rockville, MD 20852 (express or courier) or
Bethesda MD 20892-8329
SPECIAL SUPPLEMENTAL INSTRUCTIONS FOR NIH INTRAMURAL INVESTIGATORS, CO-
INVESTIGATORS, AND/OR COLLABORATORS
NIH Intramural investigators may submit a research project or core as part of
a NTROI application from an extramural institution. The NIH component must
use the PHS 398 application instructions and form pages (rev. 5/2001). PHS
398 Forms and Instructions are available at
http://grants.nih.gov/grants/funding/phs398/phs398.html. For further
assistance contact Grants Info, Telephone (301) 710-0267, e-mail:
[email protected].
NIH applicants must follow the PHS 398 Application Form Instructions and the
modified format and content described above under PREPARING AND SUBMITTING AN
APPLICATION and SUPPLEMENTAL INSTRUCTIONS, with the following modifications
or clarifications:
o On the Face Page, fill out only items 1., 2., 3.(leave 3c. blank), 4., 5.,
6., 7a., and 8a. The remainder of the items should be left blank. The
application must not be signed by either the Intramural NIH Investigator or
an NIH Institute official. Do not submit pages for Other Support, Checklist,
Personnel Report, or Personal Data.
o An Intramural NIH investigator must obtain prior approval of his or her
NIH Institute or Center Scientific Director to apply as a collaborator or
participate by submitting a research project, core project or other component
of a Network application, to work under the terms and conditions of this RFA,
to comply with the policies of the Steering Committee, and comply with the
policies of the National Cancer Institute. A copy of the Letter of IC
Approval, addressed to the NCI Referral Officer, must accompany the cover
letter submitted with the application. It must verify that the necessary
personnel effort and resources will be made available from intramural sources
to support the proposed collaborative work and Network application component.
The Letter of IC Approval must provide assurance that the conduct of the
project will comply with the DHHS regulations for research involving human
subjects (if applicable) and with PHS policy on vertebrate animal research.
o The Intramural Project Leader and Extramural Principal Investigator must
negotiate a project upper budget limit such that the sum of the Intramural
support plus Extramural funds requested in the application does not exceed an
application"s annual limit of $1,000,000 direct costs in any one year. NIH
IC Scientific Director, as part of the Letter of IC Approval to Participate,
must verify that no more than the negotiated upper limit to Intramural
support will be allocated to the Intramural project described in the
application.
o All information requested on the Budget Form pages 4 and 5 should be
provided, except that dollar figures must be omitted in all cases. The
personnel time and effort, intramural resources available for the project,
and the research environment should be carefully described (without dollar
figures). The Detailed Budget for Initial Project Period page and Budget for
Entire Proposed Period of Project Support (Form Pages 4 and 5) should provide
the time and effort of each project participant without dollar figures. The
resources available for the project and the research environment should be
carefully described without dollar figures.
Delivery of Applications:
The National Institutes of Health and National Cancer Institute no longer
accept applications hand-delivered by individuals
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-012.html). 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).
Application Processing:
Applications must be received by the application receipt date listed in the
heading of this RFA. If an application is received after that date, it may
be returned to the applicant without review.
PEER REVIEW PROCESS
Upon receipt, applications will be reviewed by the CSR for completeness and
by the NCI program staff for responsiveness.
Incomplete applications will be returned to the applicant without further
consideration.
Complete applications that are responsive to the RFA will be evaluated for
scientific and technical merit by an appropriate peer review group convened
by the NCI Division of Extramural Affairs (DEA). They will be reviewed in
accordance with the review criteria stated below. As part of the initial
merit review, all applications will
o Receive a written critique,
o Undergo a process in which only those applications deemed to have the
highest scientific merit, generally the stronger half of the applications
under review, will be discussed and assigned a priority score,
o Those that receive a priority score will undergo a second level review by
the National Cancer Advisory Board.
REVIEW CRITERIA
For a definition of Translational Research in the context of this proposed
Network, see the subsection, Objectives and Scope, under RESEARCH OBJECTIVES
of this RFA.
A. Primary Research Projects
Within the NTROI concept of translational research, reviewers will evaluate
each of the primary research projects using the five criteria listed below.
Each of the criteria will be addressed and considered by the reviewers in
assigning a merit score for the project. Note that the project does not need
to be strong in all categories to be judged likely to have a major
translational impact and thus deserve a high merit 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.
(1) SIGNIFICANCE: Does the study address important problems in optical
methods and their translation to cancer applications? What will be the effect
of the proposed research on development of consensus approaches for
optimization, validation and translation of optical methods for cancer
applications?
(2) APPROACH: Are the conceptual framework, rationale, design, methods,
analyses and organizational structure adequately developed, well integrated,
and appropriate to the aims of the Team? Does the application address
potential problem areas and describe alternative tactics? Does the
application describe efforts to include state of the art technological
advances and translational research towards cancer applications? Is the
experimental design adequate to achieve the proposed research and
translational objectives?
(3) INNOVATION: Does the application involve innovative concepts, approaches
or methods that will advance the state of the art of the proposed
technologies and proposed new innovative approaches for consensus in
translational research likely to gain broad acceptance by the imaging
community?
(4) INVESTIGATOR: Are the investigators appropriately trained and well suited
to carry out this collaborative work? Is the proposed work and level of
effort appropriately matched by the experience of the principal investigator
and the overall research team? Is there evidence that the investigators have
the background, leadership and skills to collaborate and coordinate
integration of basic biological sciences and clinical practices with the
applied sciences and engineering required for translational research? Do
they commit adequate effort?
(5) ENVIRONMENT: Does the scientific, technical and intellectual environment
of the team"s institutions contribute to the probability of success? Is
there evidence of each institution"s support for translation of optical
methods toward human or small animal investigations?
B. Research Support Cores:
Is the required time and talent committed to providing Research Support
Core Services?
Does it provide unique services (avoid duplication of existing
resources)?
Is it essential to the success of one or more Primary Projects (Does any
project state a need for the Core"s services)?
Does it provide a commitment to serve future Developmental Projects?
Are plans for charge back and priority management procedures for Core
services adequate?
Are plans to serve investigators at the other institution(s) on the team
adequate? Other NTROI teams?
C. Administrative Core:
Are the organizational plan, talent and time commitments adequate to
provide the administrative services needed for efficient operations of the
Team and its share of Steering Committee responsibilities?
D. Organization and Administration:
Does the organizational structure promote flexibility to adapt to
progress and new opportunities?
Does the structure promote development of consensus approaches to
translation and validation of optical methods?
Does the Developmental Project Plan appear sufficient to attract high
quality intra-team and inter-team Developmental Projects, attract
Developmental Projects from prospective Associate Members, help existing
Primary Projects stay current with new ideas or lead to new Primary Projects,
sufficient to promote expansions of Primary Project translational efforts and
validations, and adequate for termination of unproductive Developmental
Projects?
E. Overall Application:
Is there a focus on research questions best accomplished through research
collaborations, networks and consortia?
Will any Primary Project benefit from or need developments performed in
another Primary Project or Core?
Does the application show a focus on developing the research
infrastructure and approaches necessary to sustain translational research
objectives and continually develop collaborative research relationships
necessary for finding efficient paths to completion of translations?
Will the investigators produce more as a NTROI team than they would if
they worked independently with separately funded projects?
Is there evidence of each institution"s support for translation of
optical methods toward human or small animal investigations?
Does the application show a commitment by the team to cooperate and
coordinate activities with all members of the NTROI?
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, humane
care and use of animals, or protection of 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 women, racial and ethnic
groups (and subgroups), and children subjects as appropriate for the
scientific goals of the research. Plans for the recruitment and retention of
subjects will also be evaluated. (See Inclusion Criteria included in the
section on Federal Citations, below).
o BUDGET: The reasonableness of the proposed budget and the requested period
of support in relation to the proposed research.
RECEIPT AND REVIEW SCHEDULE
Public Meeting of Potential Applicants: September 27, 2002
Letter of Intent Receipt Date: December 17, 2002
Application Receipt Date: January 21, 2003
Peer Review Date: May/June, 2003
Council Review: September 8-10, 2003
Earliest Anticipated Start Date: September 30, 2003
AWARD CRITERIA
Award criteria that will be used to make award decisions include the
following:
o Scientific and technical merit (as determined by peer review)
o Availability of funds
o Programmatic priorities.
REQUIRED FEDERAL CITATIONS
DATA AND SAFETY MONITORING PLAN and DATA SAFETY AND MONITORING BOARD:
Research components involving Phase I and II clinical trials must include
provisions for assessment of patient eligibility and status, rigorous data
management, quality assurance, and auditing procedures. It is NIH policy
that all clinical trials require data and safety monitoring, with the method
and degree of monitoring commensurate with the risks (NIH Policy for Data
Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 1998:
http://grants.nih.gov/grants/guide/notice-files/not98-084.html).
Clinical trials supported or performed by NCI require special considerations.
The method and degree of monitoring should be commensurate with the degree of
risk involved in participation and the size and complexity of the clinical
trial. Monitoring exists on a continuum from monitoring by the principal
investigator/project manager or NCI program staff 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 for the NCI for Data and Safety
Monitoring of Clinical trials see:
http://deainfo.nci.nih.gov/grantspolicies/datasafety.htm. For Phase I and II
clinical trials, investigators must submit a general description of the data
and safety-monitoring plan as part of the research application. See NIH
Guide Notice on "Further Guidance on a Data and Safety Monitoring for Phase I
and II Trials" for additional information:
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html.
Information concerning essential elements of data safety monitoring plans for
clinical trials funded by the NCI is available:
http://www.cancer.gov/clinical_trials/
INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of
the NIH that women and members of minority groups and their sub-populations
must be included in all NIH-supported clinical research projects unless a
clear and compelling justification is provided indicating that inclusion is
inappropriate with respect to the health of the subjects or the purpose of the
research. This policy results from the NIH Revitalization Act of 1993 (Section
492B of Public Law 103-43).
All investigators proposing clinical research should read the AMENDMENT "NIH
Guidelines for Inclusion of Women and Minorities as Subjects in Clinical
Research - Amended, October, 2001," published in the NIH Guide for Grants and
Contracts on October 9, 2001
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html), a complete
copy of the updated Guidelines are available at
http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates the use of an NIH definition of
clinical research, updated racial and ethnic categories in compliance with
the new OMB standards, clarification of language governing NIH-defined Phase
III clinical trials consistent with the new PHS Form 398, and updated roles
and responsibilities of NIH staff and the extramural community. The policy
continues to require for all NIH-defined Phase III clinical trials that: a)
all applications or proposals and/or protocols must provide a description of
plans to conduct analyses, as appropriate, to address differences by
sex/gender and/or racial/ethnic groups, including subgroups if applicable,
and b) investigators must report annual accrual and progress in conducting
analyses, as appropriate, by sex/gender and/or racial/ethnic group
differences.
INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS:
The NIH maintains a policy that children (i.e., individuals under the age of
21) must be included in all human subjects research, conducted or supported
by the NIH, unless there are scientific and ethical reasons not to include
them. This policy applies to all initial (Type 1) applications submitted for
receipt dates after October 1, 1998.
All investigators proposing research involving human subjects should read the
"NIH Policy and Guidelines" on the inclusion of children as participants in
research involving human subjects that is available at
http://grants.nih.gov/grants/funding/children/children.htm.
REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH
policy requires education on the protection of human subject participants for
all investigators submitting NIH proposals for research involving human
subjects. You will find this policy announcement in the NIH Guide for Grants
and Contracts Announcement, dated June 5, 2000, at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. A
continuing education program in the protection of human participants in
research in now available online at: http://cme.nci.nih.gov/
HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research
on hESCs can be found at http://grants.nih.gov/grants/stem_cells.htm and at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Guidance
for investigators and institutional review boards regarding research
involving human embryonic stem cells, germ cells, and stem cell-derived test
articles can be found at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-044.html. Only
research using hESC lines that are registered in the NIH Human Embryonic Stem
Cell Registry will be eligible for Federal funding (see http://escr.nih.gov).
It is the responsibility of the applicant to provide the official NIH
identifier(s)for the hESC line(s) to be used in the proposed research.
Applications that do not provide this information will be returned without
review.
PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The
Office of Management and Budget (OMB) Circular A-110 has been revised to
provide public access to research data through the Freedom of Information Act
(FOIA) under some circumstances. Data that are (1) first produced in a
project that is supported in whole or in part with Federal funds, and (2)
cited publicly and officially by a Federal agency in support of an action
that has the force and effect of law (i.e., a regulation) may be accessed
through FOIA. It is important for applicants to understand the basic scope
of this amendment. NIH has provided guidance at
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this RFA in a public
archive that can provide protections for the data and manage the distribution
for an indefinite period of time. If so, the application should include a
description of the archiving plan in the study design and include information
about this in the budget justification section of the application. In
addition, applicants should think about how to structure informed consent
statements and other human subjects procedures given the potential for wider
use of data collected under this award.
URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals
for NIH funding must be self-contained within specified page limitations.
Unless otherwise specified in an NIH solicitation, Internet addresses (URLs)
should not be used to provide information necessary to the review because
reviewers are under no obligation to view the Internet sites. Furthermore,
we caution reviewers that their anonymity may be compromised when they
directly access an Internet site.
HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to
achieving the health promotion and disease prevention objectives of "Healthy
People 2010," a PHS-led national activity for setting priority areas. This
RFA is related to one or more of the priority areas. Potential applicants may
obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople/
AUTHORITY AND REGULATIONS: This program is described in the Catalog of
Federal Domestic Assistance No. 93.394 and 93.395, Cancer Detection and
Diagnosis Research and Cancer Treatment Research and is not subject to the
intergovernmental review requirements of Executive Order 12372 or Health
Systems Agency review. Awards are made under authorization of Sections 301
and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and
administered under NIH grants policies described at
http://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations
42 CFR 52 and 45 CFR Parts 74 and 92.
The PHS strongly encourages all grant recipients to provide a smoke-free
workplace and discourage the use of all tobacco products. In addition,
Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in
certain facilities (or in some cases, any portion of a facility) in which
regular or routine education, library, day care, health care, or early
childhood development services are provided to children. This is consistent
with the PHS mission to protect and advance the physical and mental health of
the American people.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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