LOW-COST MEDICAL IMAGING DEVICES
RELEASE DATE: January 6, 2003
RFA: EB-03-006
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
(http://www.nibib1.nih.gov/)
LETTER OF INTENT RECEIPT DATE: February 17, 2003
APPLICATION RECEIPT DATE: March 14, 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 reduced cost
imaging devices that can be broadly applied to research on biological
or disease processes.
The primary purpose of this Request for Applications (RFA) is to
support research and development of low-cost imaging devices used for
detection, screening, diagnosis, and treatment of human disease and
injury. Medical imaging is critical for quality health care, yet
remains widely unavailable to many patients in small hospitals, rural
communities and underdeveloped nations. Thus, this initiative is
directed at the invention and development of low-cost imaging devices
for more efficient application and worldwide use of medical imaging
devices. Applications are expected to describe how the proposed
technology or research will reduce the cost of medical imaging, and the
expected magnitude of the cost-reduction.
Most current imaging devices used for diagnosis and treatment planning
are expensive and unavailable to large segments of humanity, therefore
the primary motivation of this initiative is to stimulate research that
will lead to lower cost imaging devices. Development of inexpensive,
innovative, high-resolution imaging devices is needed, with particular
emphasis on early detection and efficient treatment of disease and
injury. Furthermore, cost reductions in high technology imaging devices
will result in reduced health care costs.
The integration of new, low-cost improvements of existing and emerging
imaging technologies is also sought. For example, cost reductions are
sought for detectors, sensors or other essential components of imaging
devices. Thus, new technologies are needed that enhance, augment, and
improve devices for biomedical imaging while reducing the overall cost
of imaging procedures. Associated improvements in imaging technology
may include, but are not limited to: increasing the speed of data
acquisition, enabling real-time imaging, improving the efficiency of
information processing, or otherwise reduce the cost of acquiring and
processing biomedical images. The intent of these kinds of improvements
would be the reduction of imaging time and processing time, while
maintaining image quality.
In some cases it may be desirable to sacrifice image quality to
significantly reduce the cost of an imaging device. However, useful
imaging devices for detection, diagnosis and treatment remain the goal,
and it is left to the investigator to demonstrate the cost/benefit of
such devices. In other words, the trade-off between significant cost
reduction and loss of image quality must be described, while the
benefit of the imaging device to human health must be clearly defined.
In summary, this initiative will facilitate the development of low-
cost, generic, in vivo imaging technologies applicable to multiple
organs and diseases. This RFA is intended to stimulate (a) development
of low-cost image technologies, including high risk/high gain research
on innovative technologies and (b) development useful biomedical
imaging systems and methods for more cost effective health care.
RESEARCH OBJECTIVES
The need to support research and development of low-cost imaging devices
has been identified at scientific meetings and NIH workshops on
biomedical imaging including the IEEE Biomedical Imaging Conference,
2002 the Image Guided Interventions Workshop, September 2002 and the
NIBIB Workshop on Future Research Directions, December 2002. As a part
of its global health initiative under the Department of Health and
Human Services (DHHS), the need for imaging technologies in
underdeveloped nations was recently mentioned in a Federal Agency
report. This RFA contributes to the NIBIB mission and to the broad NIH
initiative to reduce health disparities among nations by strengthening
medical technologies and research infrastructure in developing
countries.
Technological and scientific and needs that will be addressed include
1) the need for imaging devices that are unavailable to large segments
of humanity, particularly in underdeveloped nations; 2) the need to
reduce the rising costs of imaging technologies used in the health care
system of the United States; and 3) the need for the invention and
development of low-cost imaging devices that will make imaging
technologies widely available, particularly in remote or rural
communities and small hospitals that do not have ready access to these
technologies.
The following research areas are examples of appropriate topics for
applications in response to this RFA. This list is meant to be
representative and is not all-inclusive:
o Expansion of less costly imaging techniques into broader
applications that currently can only be done with more expensive
technologies. It will be the responsibility of the investigator to
demonstrate the cost/benefit of their technique. Cost/benefit
should be demonstrated with measures of performance that demonstrate
the instrument can meet the design objectives.
o Imaging device components that reduce the cost of existing imaging
devices (e.g. MRI, CT, PET, ultrasound, or optical devices). For
example, development of high temperature superconductors for MRI
magnets or cost/benefit improvements in RF coils or pulse gradient
systems.
o New imaging devices that are low-cost and provide novel methods for
the diagnosis or treatment of disease or injury.
o New imaging technologies that replace extant imaging devices used
for diagnosis and treatment. For example, new optical imaging
devices that replace tomographic or MR imaging used for specific
diagnostic tests or interventions.
o More efficient detectors.
o New approaches to collimation that reduce imaging costs.
o Simple, inexpensive imaging devices such as portable ultrasound
machines or radiographic devices that could be cheaply and widely
distributed.
o Novel imaging devices that improve existing technologies and might
be used to replace alternative, high-cost imaging devices, yet
achieve the same result. For example, projection radiography used
in place of computed tomography for volumetric imaging.
o Reconstruction methods that improve diagnostic capabilities of
existing low-cost devices. For example, 3D reconstructions from
ultrasound or optical imaging.
MECHANISM OF SUPPORT
This RFA will use the 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 2003.
The R01 mechanism is recommended for applications that emphasize basic
discovery or cross-cutting research that addresses specific aspects of
reducing costs of 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
$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
https://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 $5,000,000 in FY 2003 to fund
12 to 15 new and/or competitive continuation grants in response to this
RFA. For R01s, an applicant may request a project period of up to 5
years. There is no cap on the budget. For R21s, an applicant may
request a project period of up to 2 years and a budget for direct costs
of up to $275,000 for the 2-year period. 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 provide 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
Restrictions and Exclusions: Development of animal imaging devices and
complementary devices such as contrast agents, molecular probes,
capsules, etc., are not part of the current initiative and would be
considered non-responsive to this RFA; however, these areas may be
covered by other related initiatives (e.g. small animal imaging,
molecular imaging and bioengineering (BECON and other) initiatives).
In addition, applications proposing to improve or invent imaging
methodologies without reducing costs will also be deemed non-responsive
to this RFA.
General Clinical Research Centers: Applicants from institutions that
have a General Clinical Research Center (GCRC) funded by the NIH
National Center for Research Resources (NCRR) 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.
Meetings: Principal Investigators will be required to attend an annual
meeting organized by NIBIB. Please include travel to the Bethesda, MD
area as part of the budget request.
WHERE TO SEND INQUIRIES
We encourage inquiries concerning this RFA and welcome the opportunity
to answer questions from potential applicants. Inquiries may fall into
these areas: scientific/research and financial or grants management
issues:
o Direct your questions about scientific/research issues to:
Dr. John W. Haller
Health Scientist Administrator
Division of Biomedical Imaging
National Institute of Biomedical Imaging and Bioengineering
National Institutes of Health/DHHS
6707 Democracy Blvd. Suite 200
Bethesda, MD 20892-5477
Telephone: 301-451-4772
Fax: 301-480-4971
Email: hallerj@mail.nih.gov
o Direct questions regarding financial or grants management matters to:
Ms. Lisa Moeller
Grants Management Specialist
National Institute of Biomedical Imaging and Bioengineering
National Institutes of Health/DHHS
6707 Democracy Blvd., Suite 900
Bethesda, MD 20892-5469
Telephone: 301-451-4782
Fax: 301-480-4974
Email: moellerl@mail.nih.gov
LETTER OF INTENT
Prospective applicants are asked to submit a letter of intent that
includes the following information:
o Descriptive title of the proposed research
o Name, address, and telephone number of the Principal Investigator
o Names of other key personnel
o Participating institutions
o Number and title of this RFA
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 staff to estimate the potential review workload
and plan the review.
The letter of intent is to be sent by the date listed at the beginning
of this document. The letter of intent should be sent to:
David T. George, Ph.D.
Chief, Office of Scientific Review
Division of Extramural Activities
National Institute of Biomedical Imaging and Bioengineering
NIH/DHHS
Suite 920
6707 Democracy Blvd.
Bethesda, MD 20892
Telephone: (301) 496-8633
Fax: (301) 480-0675
Email: georged1@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 https://grants.nih.gov/grants/funding/phs398/phs398.html in
an interactive format. For further assistance contact GrantsInfo,
Telephone (301) 710-0267, 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
https://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
https://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:
https://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
https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-012.html.
PEER REVIEW PROCESS
Upon receipt, applications will be reviewed for completeness by CSR and
responsiveness by NIBIB. Incomplete applications will be returned to
the applicant without further consideration. 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 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 17, 2003
Application Receipt Date: March 14, 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
(https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a
complete copy of the updated Guidelines are available at
https://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
https://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
https://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
https://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
https://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.