IMAGE-GUIDED INTERVENTIONS
 
RELEASE DATE:  December 9, 2002
 
RFA:  EB-03-008

National Institute of Biomedical Imaging and Bioengineering (NIBIB) 
 (http://www.nibib.nih.gov/) 

APPLICATION RECEIPT DATE:  March 25, 2003
 
THIS RFA CONTAINS THE FOLLOWING INFORMATION

o Purpose of this RFA
o Research Objectives
o Mechanism(s) of Support 
o Funds Available
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements 
o Where to Send Inquiries
o Letter of Intent
o Submitting an Application
o Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations

PURPOSE OF THIS RFA 

The National Institute of Biomedical Imaging and Bioengineering (NIBIB) 
invites applications for NIH Research Project Grant (R01) awards to 
support interdisciplinary basic research or Exploratory/Developmental 
Research (R21) awards that support novel investigations in image-guided 
interventions.  

The primary purpose of this Request for Applications (RFA) is to 
support research and development for image-guided interventions, 
including biopsies, surgery, and image-guided therapies. This 
initiative is intended to drive the development of new technology in 
areas related to image-guided interventions because of the need for 
minimally invasive, image-guided treatment of disease and injury. 
Applications are expected to describe how image-guided interventions 
will benefit from the proposed technology or research.

This RFA supports the spectrum of technological advances related to 
image-guided technologies. Thus, applications are sought that advance 
imaging science and engineering as they relate to minimally invasive 
treatments, biopsies, surgical procedures and image-guided therapies 
that improve human health. 

RESEARCH OBJECTIVES

The need to support research and development in the area of image-
guided procedures has been identified at workshops sponsored or co-
sponsored by NIH and NSF including the Image-Guided Interventions 
Workshop, September 12-13, 2002, and the Innovation and Research in 
Interventional Radiology: Interventional Oncology, From Benchtop to 
Bedside conference September 18-19, 2002. Scientific needs that were 
addressed included technical requirements, clinical needs, barriers to 
new developments, integration of components, enabling technologies and 
systems engineering of technology for image-guided interventions. 
Information associated with Image-Guided Interventions and the 
associated workshop may be found at: 
http://www.nibib1.nih.gov/events/IGI2002/IGI2002.htm

Research areas for image-guided interventions include technologies for 
detecting, monitoring, locating, navigating and treating disease and 
injury.  Research areas should emphasize the multidisciplinary nature of 
the research.

Below are examples of research and technology development in biomedical 
imaging and engineering related to image-guided interventions.  
Research areas can be integrated or individually developed with the 
overall goal of improving image-guided interventions.  The following 
research areas are examples of appropriate topics for applications in 
response to this RFA. This list is meant to be representative and not 
all-inclusive:

Examples of biomedical imaging areas of research and development are:
o   New technologies for tracking anatomical targets and 
instruments/delivery devices.
o   Development of tools used with targeted probes, including tools for 
both better target definition and real-time applications.
o   Improvements in image co-registration, image fusion and deformable 
models for image-guided interventions.
o   Integration of optical/endoscopic with other radiologic images.
o   Image segmentation tools that enhance visualization in image-guided 
systems.
o   Improve 3D visualization software and hardware to communicate 
critical information used in image-guided interventions (e.g., 
vascular mapping, functional areas).
o   Minimally invasive imaging devices or other probes, which can 
distinguish malignant from non-malignant tissue.
o   Imaging technologies development including MRI guidance, improved 
use of ultrasound, optical coherence tomography, biodegradable 
fiducials, etc. 
o   Real-time treatment monitoring.

Examples of engineering areas of research and development are:
o   Computer-assisted, real-time control of interventional devices.
o   Mathematical and computer models to aid diagnosis and treatment 
decision-making.
o   Physiological and predictive models used in image-guided 
interventions.
o   Development of robotics, artificial intelligence, smart algorithms, 
and/or expert systems for image-guided interventions.
o   Development of steerable devices including catheters, endoscopes and 
needles.
o   Microfabricated instrumentation for in vivo tissue analysis and 
image-guided treatments.
o   Development of multi-purpose tools for image-guided interventions 
across medical specialties, across multiple organ systems, and 
across pathologies.
o   Real-time therapy monitoring (e.g., tissue viability, temperature 
measurement).
o   Novel software and hardware development.

MECHANISM OF SUPPORT

This RFA will use the NIH investigator-initiated research grant award 
mechanism (R01) and the development/exploratory grant award mechanism 
(R21).  As an applicant you will be solely responsible for planning, 
directing, and executing the proposed project.  This RFA is a one-time 
solicitation.  Future unsolicited, competing-continuation R01 
applications based on this project will compete with all investigator-
initiated applications and will be reviewed according to the customary 
peer review procedures.  The anticipated award date is September 30, 
2003.

The R01 mechanism is recommended for applications that emphasize basic 
discovery or cross-cutting research that addresses specific aspects of 
image-guided interventions.  Research periods associated with the R01 
proposals are limited to five years with no cap on budget amount.   

The R21 Exploratory/Developmental Award supports exploratory or 
developmental research aimed at proof-of-principle for high-risk 
projects where very little or no preliminary data is available.  An R21 
application can be for up to two years with a maximum budget request of 
$275,000 direct costs for the 2-year period and a maximum page limit of 
15 pages.  R21 applications are not renewable.  Investigators are 
encouraged to use data generated from the R21 application to apply for 
further funding through the R01 mechanism (or other appropriate 
mechanisms).
  
This RFA uses just-in-time concepts.  It also uses the modular as well 
as the non-modular budgeting formats
(see http://grants.nih.gov/grants/funding/modular/modular.htm).  
Specifically, if you are submitting an application with direct costs 
(including total costs of consortium arrangements) in each year of 
$250,000 or less, use the modular format.  Otherwise follow the 
instructions for non-modular research grant applications.

FUNDS AVAILABLE
 
The NIBIB intends to commit approximately $5,000,000 in FY 2003 to fund 
20 to 25 new and/or competitive continuation grants in response to this 
RFA. An applicant may request a project period of up to 5 years for an 
R01 and a project period of up to 2 years for an R21.  Budgets for 
direct costs of up to $275,000 for the 2-year period will be accepted 
for an R21.  There is no budget limitation for R01 applications.

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 NIBIB provides support for this program, awards pursuant to this 
RFA are contingent upon the availability of funds and the receipt of a 
sufficient number of meritorious applications. 

ELIGIBLE INSTITUTIONS
 
You may submit (an) application(s) if your institution has any of the 
following characteristics:

o For-profit or non-profit organizations 
o Public or private institutions, such as universities, colleges, 
hospitals, and laboratories 
o Units of State and local governments
o Eligible agencies of the Federal government  
o Domestic or foreign
 
INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS   

Any individual with the skills, knowledge, and resources necessary to 
carry out the proposed research is invited to work with their 
institution 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 programs.   

SPECIAL REQUIREMENTS

General Clinical Research Centers:  Applicants from institutions that 
have a General Clinical Research Center (GCRC) funded by the NIH 
National Center for Research Resources may wish to identify the GCRC as 
a resource for conducting the proposed research.  If so, a letter of 
agreement from either the GCRC program director or principal 
investigator should be included with the application.

Grantee Meetings:  Principal Investigators will be required to attend 
an annual meeting in the Bethesda, MD region organized by NIBIB.  
Investigators must include travel to this meeting as part of the budget 
request and state a willingness to participate in this meeting.
 
WHERE TO SEND INQUIRIES

We encourage inquiries concerning this RFA and welcome the opportunity 
to answer questions from potential applicants.  Inquiries may fall into 
two areas:  scientific/research and financial or grants management 
issues:

o Direct your questions about scientific/research issues to:

John Haller, Ph.D.
Division of Biomedical Imaging
National Institute of Biomedical Imaging and Bioengineering
NIH/DHHS
6707 Democracy Blvd., Suite 200
Bethesda, MD  20892-5469
Telephone:  (301) 451-4780
Fax: (301) 480-4973
Email: hallerj@mail.nih.gov

o Direct your questions about financial or grants management matters 
to:

Mr. Nicholas T. Mitrano
Grants Management Specialist
Grants Management Branch
Division of Extramural Activities
National Institute of Biomedical Imaging and Bioengineering
NIH/DHHS
6707 Democracy Blvd, Suite 900
Bethesda, MD  20892-5469
Telephone:  (301) 451-4782
FAX:  (301) 480-4974
Email: mitranni@mail.nih.gov

SUBMITTING AN APPLICATION

Applications must be prepared using the PHS 398 research grant 
application instructions and forms (rev. 5/2001).  The PHS 398 is 
available at http://grants.nih.gov/grants/funding/phs398/phs398.html in 
an interactive format.  For further assistance contact GrantsInfo, 
Telephone (301) 435-0714, Email: GrantsInfo@nih.gov.
  
SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: Applications 
requesting up to $250,000 per year in direct costs must be submitted in 
a modular grant format.  The modular grant format simplifies the 
preparation of the budget in these applications by limiting the level 
of budgetary detail.  Applicants request direct costs in $25,000 
modules.  Section C of the research grant application instructions for 
the PHS 398 (rev. 5/2001) at 
http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-
by-step guidance for preparing modular grants.  Additional information 
on modular grants is available at 
http://grants.nih.gov/grants/funding/modular/modular.htm.

USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 
5/2001) application form must be affixed to the bottom of the face page 
of the application.  Type the RFA number on the label.  Failure to use 
this label could result in delayed processing of the application such 
that it may not reach the review committee in time for review.  In 
addition, the RFA title and number must be typed on line 2 of the face 
page of the application form and the YES box must be marked. The RFA 
label is also available at: 
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf.
 
SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten 
original of the application, including the Checklist, and five signed, 
photocopies, in one package to:
 
Center For Scientific Review
National Institutes Of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD  20892-7710
Bethesda, MD  20817 (for express/courier service)
  
APPLICATION PROCESSING: Applications must be received by the 
application receipt date listed in the heading of this RFA.  If an 
application is received after that date, it will be returned to the 
applicant without review.
 
The Center for Scientific Review (CSR) will not accept any application 
in response to this RFA that is essentially the same as one currently 
pending initial review, unless the applicant withdraws the pending 
application.  The CSR will not accept any application that is 
essentially the same as one already reviewed. This does not preclude 
the submission of substantial revisions of applications already 
reviewed, but such applications must include an Introduction addressing 
the previous critique.

Please Note: As of November 27, 2001, all applications and other 
deliveries to the Center for Scientific Review must come via courier 
delivery or the USPS.  Applications delivered by individuals to the 
Center for Scientific Review will no longer be accepted.  For 
additional information, see the NIH Guide Notice 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-012.html.

PEER REVIEW PROCESS  

Upon receipt, applications will be reviewed for completeness by the CSR 
and responsiveness by the NIBIB.  Incomplete applications will be 
returned to the applicant without further consideration.  And, if the 
application is not responsive to the RFA, CSR staff may contact the 
applicant to determine whether to return the application to the 
applicant or submit it for review in competition with unsolicited 
applications at the next appropriate NIH review cycle.

Applications that are complete and responsive to the RFA will be 
evaluated for scientific and technical merit by an appropriate peer 
review group convened by CSR in accordance with the review criteria 
stated below.  As part of the initial merit review, all applications 
will:

o Receive a written critique
o Undergo a process in which only those applications deemed to have the 
highest scientific merit, generally the top half of the applications 
under review, will be discussed and assigned a priority score
o Receive a second level review by the National Advisory Council for 
Biomedical Imaging and Bioengineering
 
REVIEW CRITERIA

The goals of NIH-supported research are to advance our understanding of 
biological systems, improve the control of disease, and enhance health.  
In the written comments, reviewers will be asked to discuss the 
following aspects of your application in order to judge the likelihood 
that the proposed research will have a substantial impact on the 
pursuit of these goals: 

o Significance 
o Approach 
o Innovation
o Investigator
o Environment

The scientific review group will address and consider each of these 
criteria in assigning your application's overall score, weighting them 
as appropriate for each application.  Your 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, 
you 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 your study address an important problem? If the 
aims of your application are achieved, how do they advance scientific 
knowledge?  What will be the effect of these studies on the concepts or 
methods that drive this field?

(2) APPROACH:  Are the conceptual framework, design, methods, and 
analyses adequately developed, well integrated, and appropriate to the 
aims of the project?  Do you acknowledge potential problem areas and 
consider alternative tactics?

(3) INNOVATION:  Does your project employ novel concepts, approaches or 
methods? Are the aims original and innovative?  Does your project 
challenge existing paradigms or develop new methodologies or 
technologies?

(4) INVESTIGATOR: Are you appropriately trained and well suited to 
carry out this work?  Is the work proposed appropriate to your 
experience level as the principal investigator and to that of other 
researchers (if any)?

(5) ENVIRONMENT:  Does the scientific environment in which your work 
will be done contribute to the probability of success?  Do the proposed 
experiments take advantage of unique features of the scientific 
environment or employ useful collaborative arrangements?  Is there 
evidence of institutional support?

ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your 
application will also be reviewed with respect to the following:

o R21 MECHANISM ONLY:  Since the R21 mechanism is intended to encourage 
exploratory/developmental research, proposals submitted as an R21 will 
be reviewed based on their high risk/high impact potential and whether 
or not the proposal is significantly distinct from those traditionally 
submitted through the R01 mechanism.  

o PROTECTIONS:  The adequacy of the proposed protection for humans, 
animals, or the environment, to the extent they may be adversely 
affected by the project proposed in the application.

o INCLUSION:  The adequacy of plans to include subjects from both 
genders, all racial and ethnic groups (and subgroups), and children as 
appropriate for the scientific goals of the research.  Plans for the 
recruitment and retention of subjects will also be evaluated. (See 
Inclusion Criteria included in the section on Federal Citations, below)

o DATA SHARING:  The adequacy of the proposed plan to share data. 

o BUDGET:  The reasonableness of the proposed budget and the requested 
period of support in relation to the proposed research.

RECEIPT AND REVIEW SCHEDULE

Application Receipt Date: March 25, 2003
Peer Review Date: June/July, 2003
Council Review: September, 2003
Earliest Anticipated Start Date:  September 30, 2003

AWARD CRITERIA

Award criteria that will be used to make award decisions include:

o Scientific merit (as determined by peer review)
o Availability of funds
o Programmatic priorities.
 
REQUIRED FEDERAL CITATIONS 

INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: 
It is the policy of the NIH that women and members of minority groups 
and their sub-populations must be included in all NIH-supported clinical 
research projects unless a clear and compelling justification is 
provided indicating that inclusion is inappropriate with respect to the 
health of the subjects or the purpose of the research. This policy 
results from the NIH Revitalization Act of 1993 (Section 492B of Public 
Law 103-43).

All investigators proposing clinical research should read the AMENDMENT 
"NIH Guidelines for Inclusion of Women and Minorities as Subjects in 
Clinical Research - Amended, October, 2001," published in the NIH Guide 
for Grants and Contracts on October 9, 2001 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a 
complete copy of the updated Guidelines are available at 
http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition 
of clinical research; updated racial and ethnic categories in 
compliance with the new OMB standards; clarification of language 
governing NIH-defined Phase III clinical trials consistent with the new 
PHS Form 398; and updated roles and responsibilities of NIH staff and 
the extramural community.  The policy continues to require for all NIH-
defined Phase III clinical trials that: a) all applications or 
proposals and/or protocols must provide a description of plans to 
conduct analyses, as appropriate, to address differences by sex/gender 
and/or racial/ethnic groups, including subgroups if applicable; and b) 
investigators must report annual accrual and progress in conducting 
analyses, as appropriate, by sex/gender and/or racial/ethnic group 
differences.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN 
SUBJECTS: The NIH maintains a policy that children (i.e., individuals 
under the age of 21) must be included in all human subjects research, 
conducted or supported by the NIH, unless there are scientific and 
ethical reasons not to include them. This policy applies to all initial 
(Type 1) applications submitted for receipt dates after October 1, 
1998.

All investigators proposing research involving human subjects should 
read the "NIH Policy and Guidelines" on the inclusion of children as 
participants in research involving human subjects that is available at 
http://grants.nih.gov/grants/funding/children/children.htm. 

REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH 
policy requires education on the protection of human subject 
participants for all investigators submitting NIH proposals for research 
involving human subjects.  You will find this policy announcement in the 
NIH Guide for Grants and Contracts Announcement, dated June 5, 2000, at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: 
The Office of Management and Budget (OMB) Circular A-110 has been 
revised to provide public access to research data through the Freedom of 
Information Act (FOIA) under some circumstances.  Data that are (1) 
first produced in a project that is supported in whole or in part with 
Federal funds and (2) cited publicly and officially by a Federal agency 
in support of an action that has the force and effect of law (i.e., a 
regulation) may be accessed through FOIA.  It is important for 
applicants to understand the basic scope of this amendment.  NIH has 
provided guidance at 
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.

Applicants may wish to place data collected under this RFA in a public 
archive, which can provide protections for the data and manage the 
distribution for an indefinite period of time.  If so, the application 
should include a description of the archiving plan in the study design 
and include information about this in the budget justification section 
of the application. In addition, applicants should think about how to 
structure informed consent statements and other human subjects 
procedures given the potential for wider use of data collected under 
this award.

URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and 
proposals for NIH funding must be self-contained within specified page 
limitations. Unless otherwise specified in an NIH solicitation, Internet 
addresses (URLs) should not be used to provide information necessary to 
the review because reviewers are under no obligation to view the 
Internet sites.   Furthermore, we caution reviewers that their anonymity 
may be compromised when they directly access an Internet site.

HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to 
achieving the health promotion and disease prevention objectives of 
"Healthy People 2010," a PHS-led national activity for setting priority 
areas. This RFA is related to one or more of the priority areas. 
Potential applicants may obtain a copy of "Healthy People 2010" at 
http://www.health.gov/healthypeople.

AUTHORITY AND REGULATIONS: This program is described in the Catalog of 
Federal Domestic Assistance No. 93.286 and 93.287 and is not subject to 
the intergovernmental review requirements of Executive Order 12372 or 
Health Systems Agency review.  Awards are made under authorization of 
Sections 301 and 405 of the Public Health Service Act as amended (42 
USC 241 and 284) and administered under NIH grants policies described 
at http://grants.nih.gov/grants/policy/policy.htm and under Federal 
Regulations 42 CFR 52 and 45 CFR Parts 74 and 92.

The PHS strongly encourages all grant recipients to provide a smoke-
free workplace and discourage the use of all tobacco products.  In 
addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits 
smoking in certain facilities (or in some cases, any portion of a 
facility) in which regular or routine education, library, day care, 
health care, or early childhood development services are provided to 
children.  This is consistent with the PHS mission to protect and 
advance the physical and mental health of the American people.

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