TELEHEALTH TECHNOLOGIES DEVELOPMENT
RELEASE DATE: November 18, 2002
RFA: EB-03-005
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
(http://www.nibib.nih.gov)
LETTER OF INTENT RECEIPT DATE: February 13, 2003
APPLICATION RECEIPT DATE: March 13, 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
Grant (R21) awards to support design and development of novel
telehealth instrumentation or technologies that can be applied to a
broad spectrum of disorders and diseases. There is also a parallel
Program Announcement (PA) for Small Business Innovative Research (SBIR)
and Small Business Technology Transfer (STTR) award on this topic PA-
03-030 (https://grants.nih.gov/grants/guide/pa-files/PA-03-030.html).
Telehealth is defined by the Federal Communications Commission and by
the DHHS Office of Health Promotion and Disease Prevention as "the use
of communications technologies to provide and support health care at a
distance. Examples include the use of communications to provide
patient treatment, often via still images or video, and the exchange
and distribution of public health information." Issues amenable to
technical solution arise in the diagnosis, treatment, and follow-up
with a patient at a distance. The technical feasibility of telehealth
applications has been well demonstrated for several specific
applications in the past (as reported in the NIH Telemedicine Symposium
March 2001, http://www.nlm.nih.gov/research/telesymp.html). The
current need is to generalize remote access technology to be adaptable
to a broad range of telehealth applications, to develop mechanisms in
which the technology can be integrated seamlessly into the routine of
the provider and the patient, and to develop technology for
standardizing and incorporating state-of-the-art security protocols for
verifying user identities and preserving patient confidentiality.
This Request for Applications (RFA) is intended to support an
integrated approach on the part of biomedical engineers or imaging
scientists with medical care professionals.
RESEARCH OBJECTIVES
The main objective of broadening the usability issues in telehealth
cover but are not limited to the following application areas:
One type of telehealth, store and forward, involves image-based
consults, where medical diagnosis or treatment of a patient in a remote
clinical care setting is accomplished through the forwarding of the
locally-obtained medical images to the pertinent specialist. Examples
include teleradiology, telepathology, and teledermatology. To
facilitate this practice, there is a need for specialized hardware and
software for image compression, storage, transmission, and display.
The research objective is the development and validation of the
specialized hardware or software. In addition, the quality of the
workstation monitors at the receiving end is important. In this case,
the research objective can range from the determination of quantitative
measures of the necessary workstation image quality, or technical
improvements in workstation monitors.
For real-time but not necessarily image-based examinations with a
distant health-care consultant, additional considerations come in to
play. The research objective is to design and develop the needed easy-
to-use peripheral devices that can aid in a remote interactive
examination.
Another type of telehealth takes place in a non-clinical setting.
Home-based health care using physiological monitoring devices would
benefit from development of low-cost, low-power physiological sensors,
wireless technologies, and inexpensive interactive video for pre-
operative or follow-up interactions with a health care provider.
In mass casualty situations on-the-scene health professionals could do
with hand-held or portable digital imaging and display devices.
Additional areas in need of development are wearable patient monitors,
which are lightweight and non-invasive, long-life batteries, and
telemetry hardware and software.
Since the R21 mechanism is intended to encourage exploratory research,
no preliminary data are required. However, the application should make
clear that the proposed research is scientifically sound, the
qualifications of the investigators are appropriate, and the resources
available to the investigators are adequate. Applications from groups
interested in developing suitable novel approaches are encouraged. It
is expected that this research will require expertise from a variety of
disciplines, including engineering, computer science, physics,
mathematics, and medicine.
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 2003.
The R01 mechanism is recommended for applications that emphasize basic
discovery or cross-cutting research that addresses specific aspects of
telehealth technology. 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 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
15 to 20 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
three areas: scientific/research, peer review, and financial or grants
management issues:
o Direct your questions about scientific/research issues to:
Mary S Pastel, ScD
Division of Biomedical Imaging
National Institute of Biomedical Imaging and Bioengineering
National Institutes of Health/DHHS
Democracy Two, Suite 200
Bethesda, MD 20892-5469
Telephone: (301) 451-4781
Email: pastelm@mail.nih.gov
o Direct your questions about peer review issues to:
David T. George, Ph.D.
Chief, Office of Scientific Review
Division of Extramural Activities
National Institute of Biomedical Imaging and Bioengineering
National Institutes of Health/DHHS
Suite 920
6707 Democracy Blvd.
Bethesda, MD 20892-5469
Telephone: (301) 496-8633
FAX: (301) 480-0675
Email: georged@nih.gov
o Direct your questions about financial or grants management matters
to:
Mr. Nick Mitrano
Grants Management Specialist
Grants Management Branch
National Institute of Biomedical Imaging and Bioengineering
National Institutes of Health/DHHS
Democracy Two, Suite 900
Bethesda, MD 20892-5469
Telephone: (301) 451-4782
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 IC 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. at the address listed under WHERE TO SEND INQUIRIES.
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 three signed,
photocopies, in one package to:
Center For Scientific Review
National Institutes Of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710
Bethesda, MD 20817 (for express/courier service)
At the time of submission, two additional copies of the application and
all five collated sets of Appendix material must be sent to Dr. David
T. George at the address listed under WHERE TO SEND INQUIRIES.
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.
Principal investigators should not send supplementary material without
first contacting the Scientific Review Administrator (SRA). The SRA
will be identified in the letter sent to you indicating that your
application has been received. If you have not received such a letter
within three weeks after submitting the application, contact Dr. David
George at the address listed under WHERE TO SEND INQUIRIES.
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 the CSR
and responsiveness by NIBIB. Incomplete applications will be returned
to the applicant without further consideration. And, if the
application is not responsive to the RFA, NIBIB 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 NIBIB 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
For both the R01 and R21 grant applications, 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 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 13, 2003
Application Receipt Date: March 13, 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.