IMPROVEMENTS IN IMAGING METHODS AND TECHNOLOGIES
 
RELEASE DATE:  November 20, 2002
 
RFA:  EB-03-007
 
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
 (http://www.nibib1.nih.gov/)
 
LETTER OF INTENT RECEIPT DATE:  February 24, 2003

APPLICATION RECEIPT DATE:  March 24, 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 to support novel investigations for the purpose 
of improving and extending methodologies and technologies for 
biomedical imaging.

The primary focus of this Request for Applications (RFA) is on 
technological and methodological advances in human imaging.  Other 
NIBIB-sponsored initiatives are focused on the development of new and 
improved probes/contrast agents for molecular imaging studies 
http://grants.nih.gov/grants/guide/rfa-files/RFA-EB-03-003.html and on 
the development of dedicated small animal imaging devices 
http://grants.nih.gov/grants/guide/rfa-files/RFA-EB-03-002.html and 
http://grants.nih.gov/grants/guide/pa-files/PA-03-031.html.  

Biomedical imaging devices have been used to obtain anatomical images, 
and to provide localized biochemical and physiological analysis of 
tissues and organs.  These approaches have included magnetic resonance 
(e.g., MRI, MRS), computed tomography (CT), nuclear medicine (e.g., 
PET, SPECT), optical (e.g., OCT, DOT), ultrasound, EEG/MEG, and other 
imaging devices. The ability of these devices to provide anatomical 
images and physiological information has provided unparalleled 
opportunities for biomedical and clinical research, and has the 
potential for important improvements in the diagnosis and treatment of 
a wide range of diseases.  However, all biomedical imaging devices 
suffer from various limitations that can restrict their general 
applicability.  Some major limitations are sensitivity, spatial 
resolution, temporal resolution, and ease of interpretation of data.  
One way to circumvent these limitations is to develop technological and 
methodological approaches that improve and extend the sensitivity, 
spatial and temporal resolution, and "information content" of 
individual imaging techniques.  Another way is to combine two or more 
complementary biomedical imaging techniques. 
 
RESEARCH OBJECTIVES

The need to support the development of human biomedical imaging 
techniques has been identified at several workshops and conferences on 
biomedical imaging.  For example, a June 25-26, 1999, symposium 
entitled "Biomedical Imaging Symposium: Visualizing the Future of 
Biology and Medicine" which was coordinated by the NIH Bioengineering 
Consortium (BECON), addressed three scientific areas: (1) imaging at 
the cellular and molecular levels for early detection of disease; (2) 
imaging for the clinical diagnosis, staging and recurrence of disease; 
and (3) imaging applied to therapeutic applications and monitoring for 
various disease processes.  This symposium also emphasized the need to 
support fundamental methodological development of imaging techniques 
before disease-oriented and organ-specific applications are determined.  
The general conclusions of the BECON symposium were emphasized in a 
September 26-27, 2002, workshop held at the NIH entitled the "Third 
Inter-Institute Workshop on Diagnostic Imaging and Spectroscopy – The 
Clinical Adventure", which was sponsored by NICHD, NCI, NHLBI, NINDS, 
and NIBIB, and in a July 7-10, 2002, IEEE workshop held in Washington, 
DC, entitled "International Symposium on Biomedical Imaging".  

The following research areas are examples of appropriate topics for 
applications in response to this initiative.  These research areas are 
focused on imaging humans, but could also include preliminary studies 
using animal models to validate new imaging technologies and 
methodologies.  The list is meant to be representative and not 
inclusive:  

o   Development of technological and methodological advances that 
improve the sensitivity, spatial resolution and temporal resolution 
of human biomedical imaging devices.  These devices include (but are 
not restricted to) magnetic resonance (e.g., MRI, MR spectroscopic 
imaging), computed tomography, nuclear medicine (e.g., PET, SPECT), 
optical (e.g., OCT, DOT), ultrasound and EEG/MEG devices.  Examples 
could include the use of high-field magnets to improve sensitivity 
and resolution in MRI/MRS, the use of surface coils and multiple-
coil techniques (coupled with new RF and gradient sequences) to 
improve temporal and spatial resolution in MRI, the use of extended 
source and detector arrays to improve the spatial resolution of DOT, 
the design of new or improved sources or detectors for optical 
imaging devices, and the novel use of existing or new detector 
materials for nuclear medicine imaging.

o   Development of "multi-modality" approaches that combine two (or 
more) biomedical imaging techniques.  The approaches could be used 
to combine information that might not be available from a single 
imaging technique (e.g., high temporal resolution and high spatial 
resolution), or to compare/validate results obtained with one 
imaging technique with results obtained using another imaging 
technique.  Examples could include the sequential use of two 
separate imaging devices (e.g., MRI/PET or MRI/MEG), the combination 
of two imaging techniques into a single device (e.g., optical/MRI or 
fluoroscope/CT), or the multiplexing of different imaging techniques 
within the same device (e.g., BOLD/AST in MRI, simultaneous multi-
nuclear imaging in MRI or MRS, and multi-band optical tomography).  
Approaches that use separate imaging devices could explore improved 
methods for retrospective image registration. 

o   Development of improved methods for image reconstruction and 
processing.  Examples could include the development of faster and 
more efficient algorithms for reconstruction of large 3D data sets 
for DOT, CT and US, and improved algorithms for spatial 
reconstruction in MEG. 

o   Development of improved approaches for analysis and optimization of 
complex multi-component biomedical imaging devices. 

o   Development of flexible research interfaces for imaging devices that 
would allow the application of these devices to a broad range of 
organs and diseases.  An example could be the development of 
flexible interfaces for ultrasound or optical imaging devices that 
would give a range of options similar to the wide range of RF and 
gradient pulse sequences available with MRI.

o   Development of improved methods for imaging perfusion and metabolism 
in humans.  Examples could include the use of arterial spin tagging 
or bolus-tracking approaches (e.g., MR, CT) for perfusion imaging, 
the use of 17O and 13C MR approaches for imaging oxygen consumption 
and other metabolic pathways, the use of 31P approaches for imaging 
energy production/consumption, the use of BOLD/AST approaches for 
imaging changes in oxygen consumption during functional 
"activation," and the use of optical approaches for monitoring 
tissues oxygen levels and oxygen consumption.

o   Development of improved approaches for "simultaneous" imaging of 
multiple physiological or biochemical parameters.  An example could 
be the use of multi-modality approaches (see above) to perform 
simultaneous imaging of perfusion and metabolism.  

o   Development of improved models for the interpretation of biochemical 
and physiological data, and/or validation of these models. An 
example could be more comprehensive models for the interpretation of 
bolus tracking data (e.g., MR or CT) to obtain blood flow, transit 
time, vascular volume, probe permeability, etc.

o   Development of improved methodologies for sub-cellular localization 
of biochemical and physiological components.  An example could be 
the use of multiple-quantum filtered MR approaches to study trans-
membrane sodium gradients.  

o   Development of improved imaging methodologies that could be used to 
study receptor binding, gene expression and cell trafficking in 
humans.  One example could be the use of combined optical/MRI 
techniques (see above) for "simultaneous" perfusion/molecular 
imaging.  Another example could be the use of multi-band optical 
tomography techniques (see above) for "simultaneous" imaging of 
multiple probes.  

MECHANISM OF SUPPORT
 
This RFA will use NIH R01 (Research Project Grant) and R21 
(Exploratory/Developmental Grant) award mechanisms.  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 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 
improving and extending imaging devices.   Research periods associated 
with the R01 proposals are limited to five years.   

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 
$150,000 direct costs per year and a maximum page limit of 10 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 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 $8,000,000 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 $150,000 per year will be accepted for an R21.  
There is no budget limitation for R01 applications.

Applications requesting up to $250,000 per year in direct costs must be 
submitted in a modular grant format.  Since the total costs for a 
subcontract or consortium are included in the direct cost request, one 
additional module of $25,000 may be requested for the facilities and 
administrative costs associated with third party agreements.  Under 
these guidelines, R21 applications requesting $150,000 may request 
$175,000 to cover the facilities and administrative costs described 
above.  A module requested for this purpose must be clearly identified 
in the budget justification section of the application, and will be 
restricted for this purpose only at the time of award.  

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. At this time, it is not 
known if this RFA will be reissued.
 
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.

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:

Alan C. McLaughlin, Ph.D.
Program Director
Division of Biomedical Imaging 
National Institute of Biomedical Imaging and Bioengineering 
NIH/DHHS
6707 Democracy Boulevard, Suite 200
Bethesda, MD 20892-5469
Phone: (301) 496-9321
Fax: (301) 480-4974
Email: mclaugal@mail.nih.gov

o Direct questions regarding financial or grants management matters to:

Mr. Nick Mitrano
Grants Management Specialist
National Institute of Biomedical Imaging and Bioengineering
NIH/DHHS
6707 Democracy Blvd., Suite 900
Bethesda, MD  20892-5469
Telephone:  301-451-4793
Fax:  301-480-4974
Email:  mitrannic@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 the 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 
also 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

Letter of Intent Receipt Date: February 24, 2003
Application Receipt Date: March 24, 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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