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 (http://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 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 $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 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 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 
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 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 
(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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