and Human Services (HHS)
EXPIRED
Department
of Health and Human Services
Participating
Organizations
National Institutes of Health
(NIH) (http://www.nih.gov/)
Components of
Participating Organizations
National Institute of Biomedical Imaging and Bioengineering
(NIBIB) (http://www.nibib1.nih.gov/)
National
Cancer Institute (NCI) (http://www.cancer.gov/)
Title: Technology
Development of Image-Guided Interventions: Phase I
(R21)
Announcement Type
New
Update: The following update relating to this announcement has been issued:
NOTICE: Applications submitted in response to this Funding Opportunity Announcement (FOA) for Federal assistance must be submitted electronically through Grants.gov (http://www.grants.gov) using the SF424 Research and Related (R&R) forms and the SF424 (R&R) Application Guide.
APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.
This FOA must be read in conjunction with the application guidelines included with this announcement in Grants.gov/Apply for Grants (hereafter called Grants.gov/Apply).
A registration process is necessary before submission and applicants are highly encouraged to start the process at least four weeks prior to the grant submission date. See Section IV.
Request For Applications (RFA) Number: RFA-EB-06-003
Catalog of Federal
Domestic Assistance Number(s)
93.286, 93.394, 93.395
Key Dates
Release/Posted Date: August 24,
2006
Opening Date: September 15, 2006 (Earliest date an application may be
submitted to Grants.gov)
Letters
of Intent Receipt Date(s): September 25, 2006
NOTE: On time submission
requires that applications be successfully submitted to Grants.gov no later
than 5:00 p.m. local time (of the applicant institution/organization).
Application Submission/Receipt
Date(s): October 23, 2006
Peer Review Date(s): February-March,
2007
Council Review Date(s): May 2007
Earliest Anticipated Start Date(s): July 15, 2007
Additional
Information To Be Available Date (Activation Date): Not Applicable
Expiration
Date: October
24, 2006
Due Dates for E.O. 12372
Not
Applicable
Additional
Overview Content
Executive Summary
This funding opportunity announcement (FOA) solicits Exploratory-Developmental (R21) grant applications from applicant organizations that propose to develop high-impact, disruptive technologies for image-guided interventions. As defined here, image-guided interventions (IGI) integrate treatment with imaging technologies at the point of patient care. The long-term goal of the IGI initiative is to produce disruptive technologies that will replace current treatments with minimally invasive, image-guided interventions. A disruptive technology is a new technological innovation that displaces the existing dominant technology. Examples of disruptive technologies include minimally invasive, image-guided procedures that replace invasive surgery or low-cost image-guided interventions.
This FOA is intended to support the first phase of a two-phase project that will deliver high clinical impact, image-guided interventions. Multidisciplinary collaborations and partnerships with industry are encouraged. In addition, development of multi-potential technologies that might have applicability across a range of clinical conditions is also encouraged.
Table of Contents
Part I Overview Information
Part II Full Text of Announcement
Section I. Funding Opportunity
Description
1. Research Objectives
Section II. Award Information
1. Mechanism of Support
2. Funds Available
Section III. Eligibility
Information
1. Eligible Applicants
A. Eligible Institutions
B. Eligible Individuals
2. Cost Sharing or Matching
3. Other - Special Eligibility Criteria
Section IV. Application and
Submission Information
1. Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Submission, Review, and Anticipated
Start Dates
1. Letter of Intent
B. Submitting an Application Electronically
to the NIH
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements
Section V. Application Review
Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review Considerations
C. Sharing Research Data
D. Sharing Research Resources
3. Anticipated Announcement and Award Dates
Section VI. Award Administration
Information
1. Award Notices
2. Administrative and National Policy Requirements
3. Reporting
Section VII. Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/Grants Management Contact(s)
Section VIII. Other Information
- Required Federal Citations
Part II
- Full Text of Announcement
Section I. Funding Opportunity Description
1.
Research Objectives
The
goal of this image-guided interventions (IGI)
initiative is to foster the invention and development of innovative minimally
invasive image-guided procedures that will
replace traditional surgery and invasive techniques. Image-guided procedures have the potential to improve patient care by enabling
new and faster procedures, minimizing unintended damage to healthy
tissue, decreasing incidents of medical error, producing fewer
complications, and allowing for clinical intervention
at a distance. This Funding Opportunity Announcement (FOA) is intended to
support the first phase of a two-phase project that will deliver high-impact IGI.
Respondents to this FOA should have a clear plan for the rapid advancement,
development, and deployment of IGI technologies to the
clinical arena, potentially across a range of clinical applications in a
variety of disease processes. As defined here, image-guided
interventions integrate imaging technologies with clinical
treatment at the point of patient care.
Image-guided navigation technologies have the potential to replace more invasive technologies that are commonly used today. IGI techniques are faster, safer, and less expensive than traditional invasive procedures. An image-guided intervention is often a treatment or procedure that is more precisely targeted. In the case of interventions such as image-guided neurosurgery, this may mean decreased risk of damage to normal surrounding tissue. For assessment procedures, such as biopsies, this means better targeting of smaller masses. These improved capabilities are particularly important in light of the shifting trend in medicine towards a model of early, pre-symptomatic detection of disease. Early detection often means treatment of anatomic regions that are smaller, more localized, and harder to reach.
Furthermore, image-guided technologies may involve robotic manipulators that can operate in small and difficult-to-reach spaces, such as the inner ear or the fetal patient. Thus, IGI increases the variety of interventions at the clinicians disposal. Providing yet another advantage to these procedures, image-guided interventions can be done remotely, bringing clinical expertise to underserved communities and remote locales.
The need to support research and development in the area of image-guided procedures has been identified at workshops sponsored by NIH and other federal agencies including the Image-Guided Interventions Workshops, in September 2002 and May 2004; the Innovation and Research in Interventional Radiology in September 2002; the Biomedical Imaging Research Opportunities Workshops I, II, III, IV (BIROW); the Image-Guided Interventions Federal Inter-Agency Retreat in January 2006. Recent BIROW meetings have established the need for research into the design, development, deployment and evaluation of the new methods, devices and procedures for image-guided interventions. Scientific needs that have been identified include technical requirements, clinical needs, barriers to new developments, integration of components, real-time imaging, enabling technologies and systems engineering of technology for image-guided interventions.
This FOA intends to foster research and development in a broad range of IGI technologies. One area of particular interest is technological developments that facilitate the integration of multi-dimension, multi-source data. This includes image data, such as real time MRI, endoscope, ultrasound, MRI, CT, and optical imaging data, as well as critical information about a patient’s physiological status and vulnerable anatomic structures. Interventions that result from this initiative will be guided by such multi-dimensional, multi-source data. Other areas of interest include: 4D visualization, feedback for IGI, novel signals, combination therapies that involve external image-guided activation, image-guided robotics, and combined screening, diagnosis and treatment. These interventions may be applied in any clinical area such as orthopaedics, cardiology, pulmonology, psychiatry, neurology, obstetrics, neonatology, urology, gynecology, ophthalmology, nephrology, and gastroenterology.
In Phase I (R21) of this funding initiative, investigators may either develop individual IGI components or integrate technologies with the goal of demonstrating the feasibility of a new IGI system. Furthermore, improvements in image-guided technologies may include algorithms that are coupled with available imaging modalities and interventional devices. In other words, other components may already exist, but could be combined with a new component or algorithm that improves interventions. If the applicant proposes the development of a component, he/she must describe clearly how such a component would be integrated into a complete IGI system. The Phase I proposal should foresee a timeline in which first in human testing will be done within Phase II. A second FOA is planned for Phase II funding, which will support further development, testing, validation, and translation into clinical practice, potentially across a range of clinical conditions. Recipients of Phase I funding and other eligible institutions or individuals may apply for Phase II funding. Phase II is envisioned to be 4-5 years in duration with a $300K-$750K direct costs per year, using a cooperative agreement or grant mechanism. Applicants are expected to include as part of their application a Technology Development Plan that describes the prototype IGI system, provides quantitative milestones that will be achieved by the end of the Phase I, and outlines a general research plan for Phase II (details are provided in Section IV.6).
The following are areas of research and development that would be responsive to this FOA. This list is meant to be representative and not comprehensive.
See Section VIII, Other Information - Required Federal
Citations, for policies related to this announcement.
Section
II. Award Information
1.
Mechanism of Support
This Funding Opportunity Announcement (FOA)
will use the R21 award
mechanism. The R21 mechanism will be used for Phase I feasibility
studies to explore various approaches to the development of interdisciplinary
programs that offer potential solutions to problems of special significance to
the mission of the NIBIB and NCI.
As an applicant you will be solely responsible for planning, directing, and executing the proposed project. This RFA is a one-time solicitation.
An applicant may request a project period of up to three years and a budget for total direct costs of up to $300,000 per year. It is anticipated that most applications will request $100,000 to $300,000 per year for total direct costs.
This FOA uses Just-in-Time information concepts. It also uses the modular budget formats (see the Modular Applications and Awards section of the NIH Grants Policy Statement. Specifically, if you are submitting an application with direct costs in each year of $250,000 or less (excluding consortium Facilities and Administrative [F&A] costs), use the PHS398 Modular Budget component provided in the SF424 (R&R) Application Package and SF424 (R&R) Application Guide (see specifically Section 5.4, Modular Budget Component, of the Application Guide).
2. Funds Available
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 the Institutes and
Centers (ICs) provide support for this program, awards pursuant to this funding
opportunity are contingent upon the availability of funds and the submission of
a sufficient number of meritorious applications.
$5,000,000 is committed in FY2007 to fund 10-15 applications. Competing renewal applications will not be accepted and this FOA will not be reissued.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.
Facilities
and Administrative (F&A) costs
requested by consortium participants are not included in the direct cost
limitation. See NOT-OD-05-004,
November 2, 2004.
Section
III. Eligibility Information
1. Eligible Applicants
1.A. Eligible Institutions
You may submit an application(s) if your organization
has any of the following characteristics:
1.B. Eligible Individuals
Any individual with the skills, knowledge, and resources necessary to carry out the proposed research as the Project Director/Principal Investigator (PD/PI) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
2.
Cost Sharing or Matching
This program does not require cost sharing as defined in the current NIH
Grants Policy Statement.
3. Other-Special
Eligibility Criteria
Research proposals that do not include both
imaging AND an intervention will be considered non-responsive to this Program
and will not be peer reviewed.
Proposals must identify a clinical problem (or problems) that will potentially be addressed by the project.
Proposals describing incremental technology advances will be considered non-responsive and will not be peer reviewed.
The focus of the work must be on the development of the technology or methods NOT on the utilization or testing of the method in humans. Applications focusing on utilization or testing will be considered non-responsive and will not be peer reviewed.
A one page or less, general outline for Phase II must be included in the research plan. Applications that do not outline Phase II in the research plan will be considered non-responsive and will not be peer reviewed.
Applications must include a detailed plan for software sharing, as described in Section V, 2.D. The expectation is that the code developed as part of the proposed research will be shared freely. Applications that do not include either a software dissemination plan or the justification for that lack of such a plan will not be peer reviewed.
Proposed components of IGI systems must be designed with open architecture and incorporate a non-proprietary interface to other systems. Applications should include a plan describing the interoperability of hardware and software. Applications that do not describe a plan for interoperability and the use of open architecture or provide justification for their use of a proprietary interface will be considered non-responsive and will not be peer reviewed.
Applicants may submit more than one application, provided each application is scientifically distinct.
Section IV. Application and Submission Information
To download a SF424 (R&R) Application Package and
SF424 (R&R) Application Guide for completing the SF424 (R&R) forms for
this FOA, link to http://www.grants.gov/Apply/ and follow the directions provided on that Web site.
A one-time registration is required for institutions/organizations at both:
PDs/PIs should work with their institutions/organizations to make sure they are registered in the eRA Commons.
Several additional separate actions are required before an applicant institution/organization can submit an electronic application, as follows:
1) Organizational/Institutional Registration in Grants.gov/Get Started
2) Organizational/Institutional Registration in the eRA Commons
3) Project Director/Principal Investigator (PD/PI) Registration in the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.
Note that if a PD/PI is also an NIH peer-reviewer with an Individual DUNS and CCR registration, that particular DUNS number and CCR registration are for the individual reviewer only. These are different than any DUNS number and CCR registration used by an applicant organization. Individual DUNS and CCR registration should be used only for the purposes of personal reimbursement and should not be used on any grant applications submitted to the Federal Government.
Several of the steps of the registration process could take four weeks or more. Therefore, applicants should immediately check with their business official to determine whether their organization/institution is already registered in both Grants.gov and the Commons. The NIH will accept electronic applications only from organizations that have completed all necessary registrations.
1. Request Application Information
Applicants must download the SF424 (R&R)
application forms and SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.
Note: Only the forms package
directly attached to a specific FOA can be used. You will not be able to use
any other SF424 (R&R) forms (e.g., sample forms, forms from another FOA),
although some of the "Attachment" files may be useable for more than
one FOA.
For further assistance, contact GrantsInfo: Telephone
301-710-0267, Email: [email protected].
Telecommunications for the hearing impaired: TTY
301-451-5936.
2. Content and Form of Application Submission
Update: The following update relating to this announcement has been issued:
Prepare all applications using the SF424 (R&R) application forms and in accordance with the SF424 (R&R) Application Guide (MS Word or PDF).
The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to NIH. There are fields within the SF424 (R&R) application components that, although not marked as mandatory, are required by NIH (e.g., the Credential log-in field of the Research & Related Senior/Key Person Profile component must contain the PD/PI’s assigned eRA Commons User ID). Agency-specific instructions for such fields are clearly identified in the Application Guide. For additional information, see Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.
The SF424 (R&R) application is comprised of data arranged in separate components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY will include all applicable components, required and optional. A completed application in response to this FOA will include the following components:
Required
Components:
SF424 (R&R) (Cover component)
Research & Related Project/Performance Site
Locations
Research & Related Other Project Information
Research & Related Senior/Key Person
PHS398 Cover Page Supplement
PHS398 Research Plan
PHS398 Checklist
PHS398 Modular Budget
Optional
Components:
PHS398 Cover Letter File
Research & Related Subaward Budget Attachment(s)
Form
Note: While both budget components are included in the SF424 (R&R) forms package, the NIH R21 uses ONLY the PHS398 Modular Budget. (Do not use the detailed Research & Related Budget.)
Foreign Organizations
Several special provisions apply to applications
submitted by foreign organizations:
Proposed research should provide special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States or that augment existing U.S. resources.
3. Submission Dates and
Times
See Section IV.3.A for
details.
3.A.
Submission, Review, and Anticipated Start Dates
Opening Date: September 15, 2006 (Earliest date an application may be submitted
to Grants.gov)
Letters
of Intent Receipt Date(s): September 25, 2006
Application Submission/Receipt Date(s): October 23, 2006
Peer Review
Date(s): February-March, 2007
Council Review
Date(s): May 2007.
Earliest
Anticipated Start Date(s): July 15,
2007
3.A.1. Letter of Intent
Prospective applicants are asked to submit a letter of intent that includes the following information:
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 IC staff to
estimate the potential review workload and plan the review.
The letter of intent is to be sent by the date listed
in Section IV.3.A.
The letter of intent should be sent to:
John Haller, Ph.D.
Division of Applied Science and Technology
National Institute of Biomedical Imaging and Bioengineering
6707 Democracy Blvd. Suite 200
Bethesda, MD 20892
Telephone: (301) 451-4780
Fax: (301) 480-1614
Email: [email protected]
A letter of intent is not required for the funding opportunity.
3.B. Submitting an Application Electronically to the
NIH
To submit an application in response to this FOA, applicants should access this
FOA via http://www.grants.gov/Apply and follow steps 1-4. Note: Applications must only be submitted
electronically. PAPER APPLICATIONS WILL NOT BE ACCEPTED.
3.C.
Application Processing
Applications may be submitted on or after
the opening date and must be successfully received by Grants.gov no
later than 5:00 p.m. local time (of the
applicant institution/organization) on the
application submission/receipt date(s). (See Section IV.3.A. for all dates.) If an application is not submitted by the receipt
date(s) and time, the application may be delayed in the review process or not
reviewed.
Once an application package has been successfully submitted through Grants.gov, any errors have been addressed, and the assembled application has been created in the eRA Commons, the PD/PI and the Authorized Organization Representative/Signing Official (AOR/SO) have two business days to view the application image.
Upon receipt, applications will
be evaluated for completeness by the Center for Scientific Review, NIH.
Incomplete applications will not be reviewed.
There will be an acknowledgement of receipt of
applications from Grants.gov and the Commons. Information related to the
assignment of an application to a Scientific Review Group is also in the Commons.
The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.
4. Intergovernmental Review
This initiative is not subject to intergovernmental
review.
5.
Funding Restrictions
All NIH awards are subject to the terms and
conditions, cost principles, and other considerations described in the NIH Grants
Policy Statement.
Pre-Award Costs are allowable. A grantee may, at
its own risk and without NIH prior approval, incur obligations and expenditures
to cover costs up to 90 days before the beginning date of the initial budget
period of a new award if such costs: are necessary to conduct the project, and
would be allowable under the grant, if awarded, without NIH prior approval. If
specific expenditures would otherwise require prior approval, the grantee must
obtain NIH approval before incurring the cost. NIH prior approval is required
for any costs to be incurred more than 90 days before the beginning date of the
initial budget period of a new award.
The incurrence of pre-award costs in anticipation of a
competing or non-competing award imposes no obligation on NIH either to make
the award or to increase the amount of the approved budget if an award is made
for less than the amount anticipated and is inadequate to cover the pre-award
costs incurred. NIH expects the grantee to be fully aware that pre-award costs
result in borrowing against future support and that such borrowing must not
impair the grantee's ability to accomplish the project objectives in the
approved time frame or in any way adversely affect the conduct of the project.
See the NIH Grants
Policy Statement.
6. Other Submission
Requirements
The NIH requires the PD/PI to fill in his/her Commons User ID in the PROFILE Project Director/Principal Investigator section, Credential
log-in field of the Research & Related Senior/Key Person Profile
component. The applicant organization must include its DUNS number in its
Organization Profile in the eRA Commons. This DUNS number must match the DUNS
number provided at CCR registration with Grants.gov. For additional
information, see Registration FAQs Important Tips -- Electronic Submission
of Grant Applications.
Warning: Please be sure that you observe the direct cost, project period, and page number limitations specified above for this FOA. Application processing may be delayed or the application may be rejected if it does not comply with these requirements.
Research Plan Component Sections
While each section of the Research Plan component needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan component as a single document, separating sections into distinct PDF attachments just before uploading the files. This approach will enable applicants to better monitor formatting requirements such as page limits. All attachments must be provided to NIH in PDF format, filenames must be included with no spaces or special characters, and a .pdf extension must be used.
Appendix Materials
The following materials may be included in the Appendix:
Annual Meeting
An annual meeting of all investigators funded through this program will be held to share progress, research insights and technology developments that may accelerate developments in the field of image-guided interventions. For this purpose, applicants should request travel funds for the principal investigator and one additional senior investigator to attend a meeting each year in the Washington, D.C. area. Applicants should also include a statement in their applications indicating their willingness to participate in such meetings and to cooperate with other researchers.
Plan for Sharing Research Data
The precise content of the data-sharing plan will vary, depending on the data
being collected and how the investigator is planning to share the data.
Applicants who are planning to share data may wish to describe briefly the
expected schedule for data sharing, the format of the final dataset, the
documentation to be provided, whether or not any analytic tools also will be
provided, whether or not a data-sharing agreement will be required and, if so,
a brief description of such an agreement (including the criteria for deciding
who can receive the data and whether or not any conditions will be placed on
their use), and the mode of data sharing (e.g., under their own auspices by
mailing a disk or posting data on their institutional or personal website,
through a data archive or enclave). Investigators choosing to share under their
own auspices may wish to enter into a data-sharing agreement. References to
data sharing may also be appropriate in other sections of the application.
All applicants must include a plan for sharing research data in their
application. The data sharing policy is available at http://grants.nih.gov/grants/policy/data_sharing.
All investigators responding to this funding opportunity should include a
description of how final research data will be shared, or explain why data
sharing is not possible.
The reasonableness of the data sharing plan or the rationale for not sharing
research data will be assessed by the reviewers. However, reviewers will not
factor the proposed data sharing plan into the determination of scientific
merit or the priority score.
Sharing Research Resources
NIH
policy requires that grant awardee recipients make unique research resources
readily available for research purposes to qualified individuals within the
scientific community after publication (See the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131).
Investigators responding to this funding opportunity should include a sharing
research resources plan addressing how unique research resources will be shared
or explain why sharing is not possible.
The adequacy of the resources sharing plan and any
related data sharing plans will be considered by Program staff of the funding
organization when making recommendations about funding applications. The
effectiveness of the resource sharing will be evaluated as part of the
administrative review of each Non-Competing Grant
Progress Report (PHS 2590). See Section VI.3.,
Reporting.
Section V. Application Review Information
1. Criteria (Update: Enhanced review criteria have been issued for the evaluation of research applications received for potential FY2010 funding and thereafter - see NOT-OD-09-025). (Update: Enhanced review criteria have been issued for the evaluation of research applications received for potential FY2010 funding and thereafter - see NOT-OD-09-025).
Only the review criteria described below will be
considered in the review process.
2.
Review and Selection Process
Applications that are complete and responsive to the FOA will be
evaluated for scientific and technical merit by an appropriate peer review
group convened by National Institute of Biomedical Imaging and Bioengineering in accordance with the
review criteria stated below.
As part of the initial
merit review, all applications will:
Applications submitted in response to this funding opportunity will compete for available funds with all other recommended applications. The following will be considered in making funding decisions:
The NIH R21 exploratory/developmental grant is a mechanism for supporting novel scientific ideas or new model systems, tools, or technologies that have the potential to significantly advance our knowledge or the status of health-related research. Because the Research Plan component is limited to 15 pages, an exploratory/developmental grant application need not have extensive background material or preliminary information as one might normally expect in an R01 application. Accordingly, reviewers will focus their evaluation on the conceptual framework, the level of innovation, and the potential to significantly advance our knowledge or understanding. Reviewers will place less emphasis on methodological details and certain indicators traditionally used in evaluating the scientific merit of R01 applications, including supportive preliminary data. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or, when available, from investigator-generated data. Preliminary data are not required for R21 applications; however, they may be included if available.
The goals of NIH supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria 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 an application does not
need to be strong in all categories to be judged likely to have major
scientific impact and thus deserve a high priority score. For example, an
investigator may propose to carry out important work that by its nature is not
innovative but is essential to move a field forward.
Significance: Does this study address an important scientific health problem? If the aims of
the application are achieved, how will scientific knowledge or clinical
practice be advanced? What will be the effect of these studies on the concepts,
methods, technologies, treatments, services, or preventative interventions that
drive this field?
Approach: Are the conceptual or clinical framework, design, methods,
and analyses adequately developed, well integrated, well reasoned, and
appropriate to the aims of the project? Does the applicant acknowledge
potential problem areas and consider alternative tactics? Does the
application describe appropriate and achievable Phase I milestones? Are the
milestones well described, quantified, and scientifically justified? Does the
application describe an adequate outline for Phase II?
Innovation: Is the project original and innovative? For example: Does
the project challenge existing paradigms or clinical practice; address an innovative
hypothesis or critical barrier to progress in the field? Does the project
develop or employ novel concepts, approaches, methodologies, tools, or
technologies for this area?
Investigators: Are the investigators appropriately trained and well suited
to carry out this work? Is the work proposed appropriate to the experience
level of the PD/PI and other researchers? Does the investigative team bring
complementary and integrated expertise to the project (if applicable)?
Environment: Does the scientific environment in which the work will be
done contribute to the probability of success? Do the proposed studies benefit
from unique features of the scientific environment, or subject populations, or
employ useful collaborative arrangements? Is there evidence of institutional
support?
2.A.
Additional Review Criteria:
In addition to the above criteria, the following items
will continue to be considered in the determination of scientific merit and the
priority score:
Protection of
Human Subjects from Research Risk: The
involvement of human subjects and protections from research risk relating to
their participation in the proposed research will be assessed. See item 6 of
the Research Plan component of the SF424 (R&R).
Inclusion of Women, Minorities and Children
in Research: The adequacy of plans
to include subjects from both genders, all racial and ethnic groups (and
subgroups), and children as appropriate for the scientific goals of the
research will be assessed. Plans for the recruitment and retention of subjects
will also be evaluated. See item 7 of the Research Plan component of the SF424
(R&R).
Care and Use of Vertebrate Animals in
Research: If vertebrate animals are to
be used in the project, the five items described under item 11 of the Research
Plan component of the SF424 (R&R) will be assessed.
Biohazards: If materials or procedures are proposed that are
potentially hazardous to research personnel and/or the environment, determine
if the proposed protection is adequate.
2.B.
Additional Review Considerations
Budget and Period of Support: The reasonableness of the proposed budget
and the appropriateness of the requested period of support in relation to the
proposed research may be assessed by the reviewers. Is the number of person
months listed for the effort of the PD/PI appropriate for the work proposed? Is
each budget category realistic and justified in terms of the aims and methods?
2.C.
Sharing Research Data
The reasonableness of the data
sharing plan or the rationale for not sharing research data will be assessed by
the reviewers. However, reviewers will not factor the proposed data sharing
plan into the determination of scientific merit or the priority score. The
presence of a data sharing plan will be part of the terms and conditions of the
award. The funding organization will be responsible for monitoring the data
sharing policy.
2.D. Sharing Research
Resources
NIH policy requires
that grant awardee recipients make unique research resources readily available
for research purposes to qualified individuals within the scientific community
after publication (See the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131).
Investigators responding to this funding opportunity should include a sharing
research resources plan addressing how unique research resources will be shared
or explain why sharing is not possible.
For those applicants developing new software,
a software dissemination plan must be included in the application. Reviewers
will be instructed to evaluate the dissemination plan with respect to these
goals but not consider it in assigning a priority score:
1. The software should be freely available to biomedical researchers and educators in the non-profit sector, such as institutions of education, research institutions, and government laboratories.
2. To preserve utility to the community, the software should be transferable such that another individual or team can continue development in the event that the original investigators are unwilling or unable to do so.
3. The terms of software availability should include the ability of researchers to modify the source code and to share modifications with other colleagues.
4. Commercialization of enhanced or customized versions of the software, or incorporation of the software or pieces of it into other software packages should be permissible.
5. The software should adhere to community-based standards for image formats and data communications. Where open standards are not available, the proposed software should be designed with an open-architecture whose specifications are made public (i.e. the interface to other systems should be non-proprietary). The use of open architecture will allow for the future integration and inter-operation of new IGI components developed either by the applicant or other IGI developers.
The adequacy of the resources
sharing plan and any related data sharing plans will be considered by Program
staff of the funding organization when making recommendations about funding
applications. The effectiveness of the resource sharing will be evaluated as
part of the administrative review of each Non-Competing Grant
Progress Report (PHS 2590), See Section VI.3.,
Reporting.
Model Organism
Sharing Plan: Reviewers are
asked to assess the sharing plan in an administrative note. The sharing plan itself
should be discussed after the application is scored. Whether a sharing plan is
reasonable can be determined by the reviewers on a case-by-case basis, taking
into consideration the organism, the timeline, the applicant's decision to
distribute the resource or deposit it in a repository, and other relevant
considerations
3.
Anticipated Announcement and Award Dates
Not Applicable
Section
VI. Award Administration Information
1.
Award Notices
After the peer review of the application is completed, the PD/PI will be able
to access his/her Summary Statement (written critique) via the NIH eRA Commons.
If the application is under
consideration for funding, NIH will request "just-in-time"
information from the applicant. For details, applicants may refer to the NIH
Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards,
Subpart A: General.
A formal notification in the form of a Notice of Award
(NoA) will be provided to the applicant organization. The NoA signed by the
grants management officer is the authorizing document. Once all administrative
and programmatic issues have been resolved, the NoA will be generated via email
notification from the awarding component to the grantee business official.
Selection of an application for award is not an
authorization to begin performance. Any costs incurred before receipt of the
NoA are at the recipient's risk. These costs may be reimbursed only to the
extent considered allowable pre-award costs. See Section
IV.5., Funding Restrictions.
2.
Administrative and National Policy Requirements
All NIH grant and cooperative agreement awards include
the NIH Grants Policy Statement as part of the NoA. For these terms of
award, see the NIH
Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards,
Subpart A: General and Part
II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions
for Specific Types of Grants, Grantees, and Activities.
3. Reporting
When multiple years are involved, awardees will be
required to submit the Non-Competing Grant
Progress Report (PHS 2590) annually and financial statements as required in
the NIH
Grants Policy Statement.
Section
VII. Agency Contacts
We encourage your inquiries
concerning this funding opportunity and welcome the opportunity to answer
questions from potential applicants. Inquiries may fall into three areas:
scientific/research, peer review, and financial or grants management issues:
1. Scientific/Research
Contacts:
John Haller, Ph.D.
Division of Applied Science and Technology
National Institute of Biomedical Imaging and Bioengineering
6707 Democracy Blvd. Suite 200
Bethesda, MD 20892
Telephone: (301) 451-4780
Fax: (301) 480-1614
Email: [email protected]
Keyvan Farahani, Ph.D.
Cancer Imaging Program
Division of Cancer Treatment and Diagnosis
National Cancer Institute
6130 Executive Boulevard, EPN Room 6048, MSC 7412
Bethesda, MD 20892-7412
Rockville, MD 20852 (for express/courier delivery)
Phone: (301) 496-9531
Fax : (301) 480-3507
E-mail: [email protected]
2. Peer Review Contacts:
David T. George, Ph.D.
Office of Scientific Review
National Institute of Biomedical Imaging and Bioengineering
6707 Democracy Blvd,
Democracy II, 920
Bethesda, MD 20892
Telephone: (301) 496-8633
FAX: (301) 480-0675
Email: [email protected]
3. Financial or Grants
Management Contacts:
Angela Eldridge
Office of Grants Management
National Institute of Biomedical Imaging and Bioengineering
Democracy II, 900
6707 Democracy Blvd
Bethesda, MD 20892
Telephone: (301) 451-4762
Email: [email protected]
Eileen Natoli
Office of Grants Management
National Cancer Institute
Democracy II, 900
6120 Executive Blvd, EPS Room 243, MSC 7148
Bethesda, MD 20892
Telephone: (301) 496-7800
Email: [email protected]
Section
VIII. Other Information
Required Federal Citations
Use of Animals in Research:
Recipients of PHS support for activities involving
live, vertebrate animals must comply with PHS Policy on Humane Care and Use of
Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf)
as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm),
and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm)
as applicable.
Human Subjects Protection:
Federal regulations (45 CFR 46) require that applications
and proposals involving human subjects must be evaluated with reference to the
risks to the subjects, the adequacy of protection against these risks, the
potential benefits of the research to the subjects and others, and the
importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).
Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types
of clinical trials, including physiologic toxicity and dose-finding studies
(phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative
trials (Phase III). Monitoring should be commensurate with risk. The
establishment of data and safety monitoring boards (DSMBs) is required for
multi-site clinical trials involving interventions that entail potential risks
to the participants ( NIH Policy for Data and Safety Monitoring, NIH Guide
for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).
Sharing Research Data:
Investigators submitting an NIH application are
expected to include a plan for data sharing or state why this is not possible. (http://grants.nih.gov/grants/policy/data_sharing).
Investigators should seek guidance from their
institutions, on issues related to institutional policies and local IRB rules,
as well as local, State and Federal laws and regulations, including the Privacy
Rule. Reviewers will consider the data sharing plan but will not factor the
plan into the determination of the scientific merit or the priority score.
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 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 funding opportunity in a
public archive, which can provide protections for the data and manage the
distribution for an indefinite period of time. If so, the application should
include a description of the archiving plan in the study design and include
information about this in the budget justification section of the application.
In addition, applicants should think about how to structure informed consent
statements and other human subjects procedures given the potential for wider
use of data collected under this award.
Sharing of Model Organisms:
NIH is committed to support efforts that encourage
sharing of important research resources including the sharing of model
organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm).
At the same time the NIH recognizes the rights of grantees and contractors to
elect and retain title to subject inventions developed with Federal funding
pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement.
Beginning October 1, 2004, all investigators submitting an NIH application or
contract proposal are expected to include in the application/proposal a
description of a specific plan for sharing and distributing unique model
organism research resources generated using NIH funding or state why such
sharing is restricted or not possible. This will permit other researchers to
benefit from the resources developed with public funding. The inclusion of a
model organism sharing plan is not subject to a cost threshold in any year and
is expected to be included in all applications where the development of model
organisms is anticipated.
Inclusion of Women And Minorities in Clinical
Research:
It is the policy of the NIH that women and members of
minority groups and their sub-populations must be included in all NIH-supported
clinical research projects unless a clear and compelling justification is
provided indicating that inclusion is inappropriate with respect to the health
of the subjects or the purpose of the research. This policy results from the
NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All
investigators proposing clinical research should read the "NIH Guidelines
for Inclusion of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines is 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 SF424 (R&R) application; 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 Clinical
Research:
The NIH maintains a policy that children (i.e.,
individuals under the age of 21) must be included in all clinical research,
conducted or supported by the NIH, unless there are scientific and ethical
reasons not to include them.
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 (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 applications
for research involving human subjects and individuals designated as key
personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs can
be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.
Only research using hESC lines that are registered in the NIH Human Embryonic
Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov).
It is the responsibility of the applicant to provide in the project description
and elsewhere in the application as appropriate, the official NIH identifier(s)
for the hESC line(s) to be used in the proposed research. Applications that do
not provide this information will be returned without review.
NIH Public Access Policy:
NIH-funded investigators are requested to submit to
the NIH manuscript submission (NIHMS) system (http://www.nihms.nih.gov) at
PubMed Central (PMC) an electronic version of the author's final manuscript
upon acceptance for publication, resulting from research supported in whole or
in part with direct costs from NIH. The author's final manuscript is defined as
the final version accepted for journal publication, and includes all
modifications from the publishing peer review process.
NIH is requesting that authors submit manuscripts
resulting from 1) currently funded NIH research projects or 2) previously
supported NIH research projects if they are accepted for publication on or
after May 2, 2005. The NIH Public Access Policy applies to all research grant
and career development award mechanisms, cooperative agreements, contracts,
Institutional and Individual Ruth L. Kirschstein National Research Service
Awards, as well as NIH intramural research studies. The Policy applies to peer-reviewed,
original research publications that have been supported in whole or in part
with direct costs from NIH, but it does not apply to book chapters, editorials,
reviews, or conference proceedings. Publications resulting from
non-NIH-supported research projects should not be submitted.
For more information about the Policy or the
submission process, please visit the NIH Public Access Policy Web site at http://publicaccess.nih.gov/
and view the Policy or other Resources and Tools, including the Authors' Manual.
Standards for Privacy of Individually Identifiable
Health Information:
The Department of Health and Human Services (HHS) issued
final modification to the "Standards for Privacy of Individually
Identifiable Health Information", the "Privacy Rule", on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance
Portability and Accountability Act (HIPAA) of 1996 that governs the protection
of individually identifiable health information, and is administered and
enforced by the HHS Office for Civil Rights (OCR).
Decisions about applicability and implementation of
the Privacy Rule reside with the researcher and his/her institution. The OCR
website (http://www.hhs.gov/ocr/)
provides information on the Privacy Rule, including a complete Regulation Text
and a set of decision tools on "Am I a covered entity?" Information
on the impact of the HIPAA Privacy Rule on NIH processes involving the review,
funding, and progress monitoring of grants, cooperative agreements, and
research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.
URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding
must be self-contained within specified page limitations. For publications
listed in the appendix and/or Progress report, internet addresses (URLs) must be used for publicly accessible on-line journal articles. Unless
otherwise specified in this solicitation, Internet addresses (URLs)
should not be used to provide any other information necessary for
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 FOA is related to one or more of the priority areas.
Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.
Authority and Regulations:
This
program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not
subject to the intergovernmental review requirements of Executive Order 12372
or Health Systems Agency review. Awards are made under the authorization of
Sections 301 and 405 of the Public Health Service Act
as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52
and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions,
cost principles, and other considerations described in the NIH Grants
Policy Statement.
The 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.
Loan Repayment Programs:
NIH encourages applications for educational loan
repayment from qualified health professionals who have made a commitment to
pursue a research career involving clinical, pediatric, contraception,
infertility, and health disparities related areas. The LRP is an important
component of NIH's efforts to recruit and retain the next generation of
researchers by providing the means for developing a research career unfettered
by the burden of student loan debt. Note that an NIH grant is not required for
eligibility and concurrent career award and LRP applications are encouraged.
The periods of career award and LRP award may overlap providing the LRP
recipient with the required commitment of time and effort, as LRP awardees must
commit at least 50% of their time (at least 20 hours per week based on a 40
hour week) for two years to the research. For further information, please see: http://www.lrp.nih.gov.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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