DEVELOPMENT OF NOVEL TECHNOLOGIES FOR IN VIVO IMAGING (PHASED INNOVATION AWARD)
Release Date: May 29, 2001 (see replacement PAR-03-124)
PA NUMBER: PAR-01-101
National Cancer Institute
Letter of Intent Receipt Dates: June 11, 2001, February 11, 2002 and
June 11, 2002
Application Receipt Dates: July 16, 2001, March 18, 2002, and July 16,2002
This PAR is a reissue of PAR-00-089, which was published in the NIH
Guide on April 27, 2000.
PURPOSE
The National Cancer Institute (NCI) invites applications for the
development of novel image acquisition or enhancement methods for in
vivo oncology, and which incorporate limited pilot or clinical
feasibility evaluations using either pre-clinical models or clinical
studies. This initiative is primarily intended to facilitate the
development of novel imaging technologies for early detection,
screening, diagnosis or image guided treatment of cancer and to
facilitate specifically limited evaluation studies to show proof of
concept. Specific emphasis of this PAR is directed at (a) the
development of highly innovative image acquisition and enhancement
methods, including high risk/high gain research on technologies that
exploit our knowledge of the molecular basis of cancer, and (b) the
development of other novel imaging methods and the integration of these
technologies with emerging molecular imaging methods, where
appropriate, for more effective health care delivery.
The primary motivation for this Program Announcement (PA) is that
current technologies for the molecular analysis of disease are largely
restricted to in vitro methods and need to be extended to the in vivo
situation. Furthermore, the use of molecular probes or tracers for
imaging molecular events in pre-clinical and clinical investigations
are essential for detection of molecular changes in vivo. Developments
of innovative, high-resolution imaging methods at the cellular or
molecular scales are needed, with particular emphasis on identification
and characterization of processes in the early formation of disease or
early molecular changes during intervention or therapy. Integrations of
these emerging molecular imaging methods with advances in traditional
imaging methods are also required for more effective cancer
investigations in vivo.
This solicitation (Development of Novel Technologies for in vivo
Imaging) will utilize the Phased Innovation Award Mechanism that is
designed to encourage technology development. Specific features of
this mechanism include:
o Single submission and evaluation of both the R21 and R33 phases as
one application. An R33 application also may be submitted alone.
o Expedited transition from the R21 feasibility phase to the R33
development phase, based on successful completion of negotiated
quantitative Milestones.
o Flexible staging of feasibility (R21) and development (R33) phases.
Applications from industry or industrial partnerships with other groups
are encouraged.
o Review of submissions by an NCI special study section, and expedited
NCI program review for transition from the R21 to the R33 phase.
Small businesses are encouraged to respond to the parallel PA, PAR-01-
102 (see http://grants.nih.gov/grants/guide/pa-files/PAR-01-102.html).
Its objectives are identical, but it uses the Small Business Innovation
Research (SBIR) and Small Business Technology Transfer Research (STTR)
granting mechanisms. The same expedited review and transition from
Phase I to Phase II funding apply, as do the same cost and time limits
as this program announcement for Phased Innovation Awards.
The National Center for Research Resources (NCRR) has recently issued a
PA for Technology Development for Biomedical Applications: Phased
Innovation Award (R21/R33),
http://grants.nih.gov/grants/guide/pa-files/PAR-01-057.html.
The NCRR phased innovation awards for medical
technology developments include imaging developments that are not
cancer or disease specific.
BACKGROUND
Significant advances in medical imaging technologies have been made
over the last 25 years in such areas as magnetic resonance imaging
(MRI), computed tomography (CT), nuclear medicine and ultrasound.
However, these advances largely focused on structural or anatomical
imaging at the organ or tissue level. Now there is a clear need and
opportunity to stimulate the development and integration of novel
imaging technologies that exploit our current knowledge of the genetic
and molecular bases of cancer. Molecular biological discoveries have
great implications for prevention, detection, and targeted therapy.
Imaging technologies that can provide the same kinds of cellular and
molecular information in vivo that are currently available only from
techniques in vitro would be very useful. This is commonly known as in
vivo molecular imaging.
The need for NCI to encourage and support bioengineering and technology
development by academic and industrial researchers was stressed by
participants at several NIH- and NCI-supported forums over the past few
years [Imaging Sciences Working Group (ISWG) July 1997; Lung Imaging
Workshop: Technology Transfer, Jan 1997; Computer Aided Diagnosis and
3D Image Analysis, Oct 1998; Quantitative in-vivo Functional Imaging in
Oncology, Jan 1999; Focus Group on Magnetic Resonance Spectroscopy
(MRS) in Clinical Oncology, April 1999; and NIH BECON Symposium, June
1999]. The needs are to (a) promote the development of novel, high
risk, high gain technologies, including continued support for their
maturation and full exploitation, (b) promote system integration of
technologies for targeted applications, including the development of a
system prototype and small number of copies, as required, for research
and clinical feasibility studies, and (c) improve technology transfer
by promoting partnerships between academia and industry.
Developments of novel imaging technologies usually will require
multidisciplinary approaches to provide teams with broad expertise in a
variety of research areas. Such varied expertise might include imaging
physics, chemistry, molecular and cellular biology, informatics and
biostatistics. The coordination and collaboration of investigators with
the necessary variety of disciplines to demonstrate the utility and
applicability of new imaging methods is encouraged.
RESEARCH OBJECTIVES
This initiative is primarily intended to facilitate the development of
novel imaging technologies for early detection, screening, diagnosis or
image guided treatment of cancer and to facilitate clinical evaluation
studies of the development that are specifically limited to proof of
concept. Specific emphasis of this PAR is directed at (a) developments
of highly innovative image acquisition and enhancement methods,
including high risk/high gain research on technologies that exploit our
knowledge of the molecular basis of cancer, and (b) developments of
other novel imaging methods and their integration with emerging
molecular imaging methods, where appropriate, for more effective health
care delivery. In particular, developments of innovative, high-
resolution imaging methods at the cellular or molecular scales are
needed for both pre-clinical models and clinical studies, with emphasis
on identification and characterization of either the early formation of
disease or early molecular changes during intervention or therapy.
Methods that establish “ground truth” are required at appropriate
levels of resolution to validate these emerging imaging methods. They
may include the imaging of excised tissue using protocols similar to
those used for imaging in vivo. Developments of probes or tracers are
considered essential for detection of molecular changes in vivo to take
better advantage of many technologies with potential for molecular
imaging.
The following objectives would make appropriate topics for proposed
projects. This list is not meant to be all-inclusive.
o Imaging to detect early changes. Developments of innovative high-
resolution imaging methods at the cellular or molecular scales are
encouraged, with a particular intent to identify and characterize pre-
malignant abnormalities or other early changes, including molecular
events on the path to disease. Novel solutions for in-vivo microscopic
imaging systems, or microscopic implanted devices with high spatial,
contrast and temporal resolution are encouraged. Similarly,
developments of contrast enhancement methods and imaging probes are
also encouraged.
o Large scale screening applications for cancer may include, but are
not limited to: development and optimization of efficient, low-cost
imaging systems for rapid and automated large-scale screening with the
intent of achieving significantly higher sensitivity and specificity
for cancer detection are encouraged. Applications could address
significant innovative improvements to current imaging methods or new
emerging imaging sensors. Research topics of interest include, but are
not limited to, technologies for molecular imaging, means to
significantly reduce imaging time or motion effects, use of novel
contrast agents or imaging probes, and use of technologies that do not
involve ionizing radiation. System integration could include a variety
of image processing techniques including temporal analysis of serial
studies, close to real-time image processing, novel image display
methods, and related imaging informatics and information reduction
methods for more cost-effective solutions for screening.
o Imaging for diagnosis, staging, or monitoring the effects of
therapy. This initiative encourages, but is not limited to the
development of novel imaging methods such as functional or molecular
imaging or spectroscopy methods that would significantly improve the
specificity of diagnosis of cancer, allow deterministic methods or
patient-specific staging, or measure early effects of therapy.
Examples of system integration would include image fusion or
registration from the different modalities employed, development of
software methods that would estimate the probability of malignancy or
of other specific disease identification, quantitative information for
monitoring the effects of therapy, and close to real-time image
analysis.
o Image guided biopsy (IGB), therapy (IGT), and interventional
procedures. Novel approaches using imaging technologies are needed to
significantly improve specificity, to identify lesion extent and
microscopic involvement, and to minimize the tissue damage accompanying
biopsy and therapy. Of particular interest are innovative approaches to
IGB, IGT or interventional methods that include novel imaging systems
that provide information at the cellular or molecular level. Examples
of system integration that are of interest include, but are not limited
to, navigational systems, registration methods for several imaging
modalities, real-time feedback mechanisms for controlling therapy or
the use of methods that are adaptive or allow patient-specific
optimization of treatment and computer-assisted surgery.
o The production of a limited number of systems based on the prototype
may be supported to facilitate research aims that require pre-clinical
or clinical investigations. Investigators anticipating this need are
advised to contact program staff.
MECHANISM OF SUPPORT
The following are points to note about the mechanism of support and its
implementation:
o Responsibility for the planning, direction, and execution of the
proposed project will be solely that of the applicant.
o Awards will be administered under NIH grants policy as stated in
the NIH Grants Policy Statement, March 2001, available at
http://grants.nih.gov/grants/policy/nihgps_2001/index.htm. Hard copies
are not available. Support for this program will be through the
National Institutes of Health (NIH) Exploratory/Developmental Research
Grant (R21) and the Exploratory/Developmental Research Grant Phase 2
(R33). The R33 is a relatively new NIH granting mechanism that
provides a second phase of support to continue innovative exploratory
and developmental research initiated under the R21 mechanism.
Transition from the R21 to R33 phase will be expedited, and will depend
on satisfactory completion of negotiated, quantitative R21 Milestones.
o Under this PA, applicants can submit either a combined R21/R33
application (Phased Innovation Award application), or an R33
application alone if feasibility can be documented, as described in the
APPLICATION PROCEDURES section, below.
o Applications for R21 support alone will not be accepted, but may
be eligible for submission under PA-01-030 (see
http://grants.nih.gov/grants/guide/pa-files/PA-01-030.html).
o The total project period for an application submitted in response
to this PA may not exceed 4 years. Its components are limited as
follows: R21, up to 2 years; R33, up to 3 years; combined R21/R33
application, up to 4 years.
o For a combined R21/R33 application, the R21 phase may not exceed
$100,000 direct costs per year. R21 budgets may exceed this cap to
accommodate facilities and administrative costs to subcontracts to the
project.
The combined R21/R33 application offers two advantages over the regular
application process:
1. Single submission and evaluation of both the R21 and R33 components
as one application.
2. Minimal or no funding gap between the R21 and R33 budget awards.
The award of R33 funds will depend upon program priorities, the
availability of funds, and successful completion of negotiated,
quantitative Milestones, as determined by NCI staff, who will take peer
review recommendations into consideration.
The R21 phase of the Phased Innovation Award must include (1) well-
defined, quantifiable Milestones that will be used to judge the success
of the proposed work to demonstrate the feasibility of the proposed
technology development, and (2) a credible plan for the development of
technology in the R33 phase. Include a separate section labeled
“Milestones” at the end of the Research Plan of the R21 application. In
addition to well-defined, quantifiable Milestones, include a discussion
of the suitability of the proposed Milestones for assessing the success
of the R21 phase, and a discussion of the implications of successful
completion of these Milestones for the proposed R33 study. Examples of
quantifiable milestones would be performance specifications of an
imaging system, or anticipated characteristics required for suitable
contrast agent performance, so that objective evaluations can be made
of progress at the end of the R21 phase.
Potential applicants are encouraged to access the PHS SBIR and STTR
Omnibus Solicitation for information on eligibility requirements at the
following website: http://grants.nih.gov/grants/funding/sbirsttr1/index.pdf
ELIGIBILITY REQUIREMENTS
Applications may be submitted by foreign and domestic, for-profit and
non-profit organizations, public and private, such as universities,
colleges, hospitals, laboratories, companies, units of State and local
governments, and eligible agencies of the Federal government.
Racial/ethnic minority individuals, women, and persons with
disabilities are encouraged to apply as principal investigators.
INQUIRIES
Inquiries are encouraged. The opportunity to clarify any issues or
questions from potential applicants is welcome.
Direct inquiries regarding programmatic issues to:
Houston Baker, Ph.D.
Biomedical Imaging Program
National Cancer Institute
6130 Executive Plaza, Suite 6000
Bethesda MD 20892-7412
Rockville MD 20852 (for express/courier service)
Telephone: (301) 496 9531
FAX: (301) 480 3507
Email: bakerhou@mail.nih.gov
Direct inquiries regarding fiscal matters to:
Kathleen J. Shino, M.B.A.
Grants Administration Branch
National Cancer Institute
6120 Executive Blvd, EPS 243
Bethesda MD 20892-7150
Rockville MD 20852 (for express/courier service)
Telephone: (301) 846 1016
FAX: (301) 846 5720
Email: ks48e@nih.gov
Direct inquiries regarding review matters to:
Ms. Toby Friedberg.
Referral Officer
National Cancer Institute
6116 Executive Boulevard, Room 8109, MSC 8236
Bethesda MD 20892-8236
Rockville MD 20852 (for overnight/courier service)
Telephone: (301) 496 3428
FAX: (301) 402 0275
Email: tf12W@nih.gov
LETTER OF INTENT
Prospective applicants are asked to submit a Letter of Intent by the
date listed at the beginning of this PA. It should provide the number
and title of this program announcement, a descriptive title of the
proposed research, the name, address, telephone number, and e-mail
address of the Principal Investigator, and identify other key personnel
and participating institutions.
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 to
Dr. Houston Baker at the address listed under INQUIRIES, above.
SCHEDULE
Letter of Intent Receipt: June 11, 2001; February 11, 2002;
June 11, 2002
Application Receipt Date: July 16, 2001; March 18, 2002;
July 16, 2002
Peer Review Date: Oct-Nov, 2001; June-July, 2002;
Oct-Nov, 2002
Review by National Cancer Advisory Board: February, 2002; September, 2002;
February, 2003
Earliest Anticipated Start Date: March 2002; October, 2002; March 2003
APPLICATION PROCEDURES
SPECIFIC INSTRUCTIONS FOR PREPARING THE COMBINED R21/R33 PHASED
INNOVATION AWARD APPLICATION:
Applications for R21/R33 grants are to be submitted on the grant
application form PHS 398 and prepared according to the instructions
provided unless specified otherwise within this section. Application
kits are available at most institutional offices of sponsored research
and may be obtained from the Division of Extramural Outreach and
Information Resources, 6701 Rockledge Drive, MSC 7910, Bethesda MD
20892-7910, telephone 301 435 0714, email: grantsinfo@nih.gov. See
also the website for PHS 398:
http://grants.nih.gov/grants/funding/phs398/phs398.html
The R21/R33 application must include specific aims for each phase and
quantitative Milestones for the R21 component that would later help
justify transition to the R33 phase. See below, Item d., "Research
Design and Methods" for directions for including Milestones in the
application. After funding and completion of the R21 phase, a
comparison of progress with the R21 Milestones in an NCI expedited
review will determine whether or not the R33 continuation grant should
be awarded. Funds for R33 developments are contingent on program
priorities, the availability of funds, and satisfactory completion of
the negotiated Milestones. The expedited review may result in
additional negotiations of award.
The R21/R33 Phased Innovation Award application must be submitted as a
single application, with one face page. Although it is submitted as a
single application, it should be clearly organized into two phases. To
provide a clear distinction between the two phases, applicants are
directed to complete Sections a-d of the Research Plan twice: one
write-up of Sections a-d and Milestones for the R21 phase, and Sections
a-d again for the R33 phase. The Form 398 Table of Contents should be
modified to show Sections a-d for each phase as well as the Milestones.
There is a page limit of 25 pages for the composite a-d text (i.e.,
Sections a-d and Milestones for the R21 and Sections a-d for the R33
phase all must be contained within the 25-page limit). The initial
review group will assign a single priority score to the combined
R21/R33 application. Therefore, the clarity and completeness of the
R21/R33 application with regard to the R21 feasibility Milestones and
the specific goals of each phase are crucial. A weak R33 component will
impact the evaluation of both phases of the R21/R33 application.
Presentation of Milestones that are not sufficiently rigorous, and not
quantitative, such as procedural research plans, may not permit
adequate validation of the R21 feasibility studies and adversely affect
reviewer opinions of the merit of the application.
Page 1. Face Page of the application:
Item 2. Check the box marked "YES" and type the number and title of
this PA. Also indicate if the application is an R21/33 or R33. If for
an R21/R33, follow the next set of instructions. If for an R33 alone,
see instructions further below.
Item 7a, DIRECT COSTS REQUESTED FOR INITIAL PERIOD OF SUPPORT: Insert
the amount requested for first year R21 support in Item 7a. This PA
does NOT use the "Modular Grant" and "Just-in-time" concepts. For the
R21 phase of the combined R21/R33 application, direct costs are limited
to a maximum of $100,000 per year for a maximum of two years. The
award may not be used to supplement an ongoing project. The requested
budget may exceed this cap to accommodate for Facilities and
Administrative costs to subcontracts of the project.
Item 8a, DIRECT COSTS REQUESTED FOR PROPOSED PERIOD OF SUPPORT: Insert
the sum of all years of requested support for direct costs in Item 8a.
For the R21 phase, direct costs requested for the proposed period may
not exceed $100,000 per year for either one or two years of phase one
R21 feasibility study support. The statement in item 7a above
pertaining to subcontract costs also applies here.
2. Budget: The application should provide a detailed budget on Form
Page 4, Initial Budget Period, for each of the initial years of the R21
and R33 phases (use two Form Page 4s, one for each phase) as well as a
budget on Form Page 5 for the entire proposed period of support.
Indicate on the Form pages which years are for R21 and which are for
R33 support. All budgets should include written justifications for line
items requested.
An annual meeting of all investigators funded through this program will
be held to share progress and research insights that may further
progress in the program. Applicants should request travel funds in
their budgets for the principal investigator and one additional senior
investigator to attend this annual meeting.
3. Research Plan: A combined R21/R33 application should present two
sets of research plans (items a through d), one of them for R21
feasibility studies, and the other for R33 developmental work. The
entire Research Plan, consisting of two sets of items a through d, must
fit within a 25-page limit.
Item a., Specific Aims.
The application must present specific aims that the applicant considers
technically or scientifically appropriate for the relevant phases of
the project. The PHS 398 instructions for this section of research
grant applications suggest that the applicant state the hypotheses to
be tested. Since the goal of this PA is the development of innovative
imaging technologies, hypothesis testing per se may not be the driving
force in developing such a proposal, and therefore, may not be
applicable. For the R21 portion of the grant application, preliminary
data are not required, although they should be included when available.
Item d., Research Design and Methods. Follow the PHS 398 instructions.
In addition, for the R21 phase only, the following information must be
included as a final section of Item d: Applications must include a
specific section labeled Milestones following the Research Design and
Methods section of the R21 component of the application. Milestones are
to be appropriate measures of whether the specific aims have been
accomplished and proof of principle established upon completion of the
R21 phase of work. Milestones should be well described, quantifiable,
and technically or scientifically justified. They are not to be simply
a restatement of the specific aims or be procedural in nature. A
discussion of the Milestones relative to the success of the R21 phase,
as well as the implications for successful completion of the Milestones
for the R33 phase, should be provided. The page number of the
Milestones section should be listed on the Table of Contents page.
Applications lacking adequate Milestone information, as determined by
the NCI program staff, will be returned to the applicant without
review.
SPECIFIC INSTRUCTIONS FOR PREPARATION OF THE R33 APPLICATION WHEN
SUBMITTED WITHOUT THE R21 PHASE.
Applications for R33 grants are to be submitted on the grant
application form PHS 398 and prepared according to the instructions
provided unless specified otherwise within items 1-5 below.
Application kits are available at most institutional offices of
sponsored research and may be obtained from the Division of Extramural
Outreach and Information Resources, 6701 Rockledge Drive, MSC 7910,
Bethesda, MD 20892-7910, telephone 301/435-0714, email:
grantsinfo@nih.gov. See also the website for PHS 398:
http://grants.nih.gov/grants/funding/phs398/phs398.html
Face Page of the application:
Item 2. Check the box marked "YES," type the number and title of this
PA, and indicate R33.
Budget: The application should provide a detailed budget on Form Page
4, Initial Budget Period, for the initial year of the R33 phase as well
as a budget on Form Page 5 summarizing the initial year and any
subsequent years (for up to three years). All budgets should include
written justifications for line items requested.
Research Plan:
Item a., Specific Aims.
The PHS 398 instructions for this section of research grant
applications suggest that the applicant state the hypotheses to be
tested. Because the goal of this PA is to develop innovative
technologies, hypothesis testing per se may not be the driving force in
developing such a proposal, and therefore, may not be applicable.
Item c., Preliminary Studies/Progress report
This section must document that feasibility (proof of principle)
studies have been completed, and progress achieved that is equivalent
to that expected through the support of an R21 project. The
application must clearly describe how the exploratory/developmental
work already performed is ready to scale up to an expanded
developmental stage. In the event that an applicant feels that the
technology is too proprietary to disclose, at a minimum the application
should provide a demonstration (results) of the capabilities of the
proposed technology development. Ideally, performance capabilities of
the proposed technology, or quantitative performance characteristics,
that may be objectively evaluated should be provided, and compared with
the published literature.
Item d., Research Design and Methods
Follow the PHS 398 instructions.
FOR ALL APPLICATIONS
Clinical Trials: All clinical trials supported by any NIH Institute or
Center require some form of safety monitoring plan. The method and
degree of monitoring to be included in the plan should be commensurate
with the degree of risk involved, 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 and in addition to the requirement for human subject
study review and approval by an Institutional Review Board (IRB). For
details about the Policy of the NCI for Data Safety Monitoring of
Clinical Trials, see http://deainfo.nci.nih.gov/grantspolicies/datasafety.htm.
For additional information, see
http://grants.nih.gov/grants/guide/notice-files/not98-084.html and
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html.
Submit a signed, typewritten original of the application, including the
Checklist, and three signed photocopies, in one package to:
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive
Room 1040 - MSC 7710
Bethesda MD 20892-7710
(20817 for overnight express or courier service)
At the time of submission, two additional copies of the application
must be sent to:
Ms. Toby Friedberg
Referral Officer
National Cancer Institute
6116 Executive Boulevard, Room 8109, MSC 8236
Bethesda MD 20892-8236
Rockville MD 20852 (for overnight express or courier service)
Telephone: (301) 496 3428
FAX: (301) 402 0275
The Center for Scientific Review (CSR) will not accept any application
in response to this PA 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.
REVIEW CONSIDERATIONS
Upon receipt, applications will be reviewed by the CSR for
completeness, and by NCI program staff for adherence to the guidelines
of this PA. Applications not adhering to application instructions
described above and those applications that are incomplete as
determined by CSR or by NCI program staff will be returned to the
applicant without review.
Applications that are complete and responsive to the PA will be
evaluated for scientific and technical merit by an appropriate peer
review group convened by the NCI in accordance with the review criteria
stated below. As part of the initial merit review, all applications
will receive a written critique and undergo a process in which only
those applications deemed to have the highest scientific merit,
generally the top half of the applications under review, will be
discussed, assigned a priority score, and receive a second level review
by the National Advisory Council or Board.
Review Criteria:
The goals of NIH-supported research are to advance our understanding of
biological systems, improve the control of disease, and enhance health.
In the written comments reviewers will be asked to discuss the
following aspects of the application in order to judge the likelihood
that the proposed research will have a substantial impact on the
pursuit of these goals. Each of these criteria will be addressed and
considered in assigning the overall score, weighting them as
appropriate for each application. Note that the application does not
need to be strong in all categories to be judge likely to have major
scientific impact and thus deserve a high priority score. For example,
an investigator may propose to carry out important work that by its
nature is not innovative but is essential to move a field forward.
1. Significance. Does this study address an important problem? If the
aims of the application are achieved, how will in vivo imaging
technology or scientific knowledge be advanced? What will be the
effect of these studies on the concepts or methods that drive this
field? To what degree does the technology support the needs for the
targeted disease?
2. Approach. Are the conceptual framework, design, and methods
adequately developed, well integrated, and appropriate to the aims of
the project? Does the applicant acknowledge potential problem areas
and consider alternative tactics? What is the time frame for developing
the proposed technologies, and suitability of this time frame for
meeting the community's needs? How easy will it be to use the proposed
technology? Are the plans adequate for the proposed technology, its
integration as an effective solution for implementation, and
dissemination? If industrial partnerships are proposed, how will they
facilitate the development and integration of system components?
3. Innovation. Does the project employ novel concepts, approaches or
methods? Are the aims original and innovative? Does the project
challenge existing paradigms or develop new methodologies or
technologies? What additional uses can be projected for the proposed
technology?
4. Investigator. Is the principal investigator appropriately trained
and well suited to direct or carry out this work? Is the work proposed
appropriate to the experience level of the principal investigator and
other researchers (if any)?
5. Environment. Does the technical and scientific environment in
which the work will be performed contribute to the probability of
success? Does the proposed work take advantage of unique features of
the technical and scientific environment or employ useful collaborative
arrangements? Is there evidence of institutional support?
Additional Considerations
Milestones (for R21/R33 applications) and Proof of Principle (for R33
applications). For the R21/R33 applications, how appropriate are the
proposed Milestones against which to evaluate the demonstration of
feasibility for transition to the R33 development phase? For the R33
applications, how well has feasibility or proof of principle been
demonstrated?
For the R21/R33 Phased Innovation Award Application, the initial review
group will evaluate the specific goals for each phase and the
feasibility Milestones that would justify progression to the R33 phase.
A single priority score will be assigned to each scored application.
As with any grant application, the initial review group has the option
of recommending support for a shorter duration than that requested by
the applicant, and basing the final merit rating on the recommended
portion of the application. This may result in a recommendation that
only the R21 phase of the combined R21/R33 application be supported,
based on the relative merit of the two research plans, adequacy of the
milestones for determining the success of Phase I feasibility studies
and capacity to provide easily assessed justification for progression
to the R33 phase without further peer review. The Initial Review Group
may recommend modifications to or the addition of milestones. Deletion
of the R33 phase by the review panel or inadequate Milestones may
affect the merit rating of the application.
In addition to the above criteria, in accordance with NIH policy, all
applications will also be reviewed with respect to the following:
o The adequacy of plans to include both genders, minorities and their
subgroups, and children as appropriate for the scientific goals of the
research. Plans for the recruitment and retention of subjects will also
be evaluated.
o The reasonableness of the proposed budget and duration in relation
to the proposed research.
o 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.
AWARD CRITERIA
Applications recommended by the National Cancer Advisory Board will be
considered for award on the basis of (a) quality of the proposed
project as determined by peer review; (b) availability of funds; and
(c) program priority.
INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS
It is the policy of the NIH that women and members of minority groups
and their sub- populations must be included in all NIH-supported
biomedical and behavioral research projects involving human subjects,
unless a clear and compelling rationale and justification is provided
to indicate 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 research involving human subjects should
read the UPDATED "NIH Guidelines for Inclusion of Women and Minorities
as Subjects in Clinical Research," published in the NIH Guide for
Grants and Contracts on August 2, 2000
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html); a
complete copy of the updated Guidelines is available at
http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm:
The revisions relate to NIH defined Phase III clinical trials and
require a) all applications or proposals and/or protocols to 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) all investigators to report accrual,
and to conduct and report analyses, as appropriate, by sex/gender
and/or racial/ethnic group differences.
INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN
SUBJECTS
It is the policy of NIH that children (i.e., individuals under the age
of 21) must be included in all human subjects research conducted or
supported by the NIH, unless there are clear and compelling scientific
and ethical reasons not to include them. This policy applies to all
initial (Type 1) applications submitted for receipt dates after October
1, 1998.
All investigators proposing research involving human subjects should
read the “NIH Policy and Guidelines on the Inclusion of Children as
Participants in Research Involving Human Subjects” that was published
in the NIH Guide for Grants and Contracts, March 6, 1998, and which is
available at the following URL address:
http://grants.nih.gov/grants/guide/notice-files/not98-024.html
Investigators may also obtain copies of these policies from program
staff listed under INQUIRIES. Program staff may also provide
additional relevant information concerning the policy.
REQUIRED EDUCATION IN THE PROTECTION OF HUMAN RESEARCH PARTICIPANTS
All investigators proposing research involving human subjects should
read the NIH policy on education in the protection of human research
participants now required for all investigators, which is published in
the NIH Guide for Grants and Contracts, June 5, 2000 (Revised August
25, 2000), available at the following URL address
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. A
continuing education program on the protection of human participants in
research is now available online at http://cme.nci.nih.gov/.
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 a NIH
solicitation, Internet addresses (URLs) should not be used to provide
information necessary to the review because reviewers are under no
obligation to view the Internet sites. Reviewers are cautioned that
their anonymity may be compromised when they directly access an
Internet site.
HEALTHY PEOPLE 2010
The Public Health Service (PHS) is committed to achieving the health
promotion and disease prevention objectives of "Healthy People 2010," a
PHS led national activity for setting priority areas. This PA,
Development of Novel Technologies for In Vivo Imaging (Phased
Innovation Award), is related to the priority area of cancer. Potential
applicants may obtain a copy of "Healthy People 2010" at
http://www.health.gov/healthypeople/.
AUTHORITY AND REGULATIONS
This program is described in the Catalog of Federal Domestic Assistance
No. 93.394, Cancer Detection and Diagnosis Research (NCI). Awards are
made under authorization of Sections 301 and 405 of the Public Health
Service Act as amended (42 USC 241 and 284) and administered under NIH
grants policies and Federal Regulations 42 CFR 52 and 45 CFR Parts 74
and 92. This program is not subject to the intergovernmental review
requirements of Executive Order 12372 or Health Systems Agency review.
The PHS strongly encourages all grant recipients to provide a smoke-
free workplace and promote the non-use of all tobacco products. In
addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits
smoking in certain facilities (or in some cases, any portion of a
facility) in which regular or routine education, library, day care,
health care, or early childhood development services are provided to
children. This is consistent with the PHS mission to protect and
advance the physical and mental health of the American people.
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