INNOVATIVE REHABILITATION INTERVENTIONS

Release Date:  June 27, 2000

RFA:  HD-00-016

National Institute of Child Health and Human Development
 (http://www.nichd.nih.gov)
National Institute on Aging
 (http://www.nih.gov/nia)
National Institute on Deafness and Other Communication Disorders
 (http://www.nidcd.nih.gov/)

Letter of Intent Receipt Date:    August 15, 2000
Application Receipt Date:         October 12, 2000
Peer Review Date:                 February/March 2001
Council Review:                   June 2001
Earliest Anticipated Start Date:  July 1, 2001

THIS RFA USES THE "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS.  IT INCLUDES 
DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS THAT MUST BE USED 
WHEN PREPARING APPLICATIONS IN RESPONSE TO THIS RFA.

PURPOSE

The National Center for Medical Rehabilitation Research (NCMRR) of the 
National Institute of Child Health and Human Development (NICHD), the 
National Institute on Deafness and Other Communication Disorders (NIDCD), and 
the National Institute on Aging (NIA) seek to apply advances in 
bioengineering, cognitive science and neuroscience to the clinical 
environment by encouraging the development of new techniques and therapies 
for rehabilitation treatments.  The purpose of the Innovative Rehabilitation 
Interventions grant is to provide support for the initial development and 
testing of non-pharmaceutical and non-surgical rehabilitation interventions, 
including development of an effective research group, preliminary proof-of-
concept projects, development of new therapeutic modalities, fabrication of 
new devices, and pilot studies to determine safety and effect size in 
preparation for future formal clinical trials.

Detailed information regarding the rationale of the new technique or therapy, 
based on preclinical science and preliminary clinical research, must be 
included in the application for the Innovative Rehabilitation Intervention 
grant.  Involvement of representatives from the targeted patient population 
in planning and evaluating the intervention is highly recommended.

ELIGIBILITY REQUIREMENTS

Applications may be submitted by domestic for-profit and non-profit 
organizations, public and private, such as universities, colleges, hospitals, 
laboratories, units of State and local governments, and eligible agencies of 
the Federal government.  Foreign institutions are not eligible for these 
grants.  Racial/ethnic minority individuals, women, and persons with 
disabilities are encouraged to apply as Principal Investigators. 

Innovative Rehabilitation Interventions support is for new projects and may 
not be used to supplement research projects already being supported or to 
provide interim support of projects under review.  Simultaneous submissions 
of applications for both an innovative grant and a regular research project 
grant (R01) on the same topic will not be accepted. Only one Innovative 
Rehabilitation Intervention grant application from an individual Principal 
Investigator will be considered.

MECHANISM OF SUPPORT

This RFA will use the National Institutes of Health (NIH) 
Exploratory/Developmental Grant (R21) award mechanism.  Responsibility for 
the planning, direction, and execution of the proposed project will be solely 
that of the applicant.  

Specific application instructions have been modified to reflect "MODULAR 
GRANT" and "JUST-IN-TIME" streamlining efforts being examined by the NIH.  
Complete and detailed instructions and information on Modular Grant 
applications can be found at 
http://grants.nih.gov/grants/funding/modular/modular.htm.  For this RFA, 
funds must be requested in $25,000 direct cost modules, up to a total direct 
cost of $150,000 per year.

FUNDS AVAILABLE

The NICHD intends to commit approximately $900,000, the NIA intends to commit 
approximately $300,000, and  the NIDCD intends to commit approximately 
$500,000.00 in total costs [direct plus Facilities and Administrative (F&A) 
costs] in FY 2001 to fund six to eight new grants in response to this RFA.  
An applicant may request a project period of up to three years and a budget 
for direct costs of up to $150,000 per year.  Because the nature and scope of 
the research proposed may vary, it is anticipated that the size of awards 
also will vary.  Although the financial plans of NICHD, NIA, and NIDCD 
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.  This RFA is a one-time solicitation.  Future 
unsolicited competing continuation applications will compete with all 
investigator-initiated applications and be reviewed according to the 
customary peer review procedures.

RESEARCH OBJECTIVES

Background

Millions of people in the United States suffer disabling injuries or diseases 
each year.  Over 50 million individuals live with chronic physical and 
sensory impairments and disabilities due to conditions such as cerebral 
palsy, metabolic disorders, burns, arthritis, AIDS, amputation, cancer, 
injury to the brain or spinal cord, spina bifida or muscular dystrophy.  
Additionally, dysfunction can result from aging/age-related changes in a 
variety of systems (including musculoskeletal, neuromuscular, sensory and 
cognitive changes) and innovative rehabilitation strategies for older persons 
are presently lacking.  Rehabilitation of these conditions can involve a wide 
array of non-pharmaceutical, non-surgical techniques and therapies used in 
clinical practice.  These practices range from muscle- and joint-related 
techniques such as exercise, splinting and bracing, and physical modalities 
(e.g., heat, cold, ultrasound, electrical stimulation, etc.), to cognition-
related practices such as executive function, speech/language and memory 
training, to combinations, such as mobility and self-care training.  
Historical precedent without definitive outcome research drives many of these 
therapies.  Unlike pharmaceuticals and medical devices, which can be 
patented, many rehabilitation techniques are less interesting to large 
corporations and need support from the public sector.

With the advances in biotechnology, many new techniques and therapies are 
available for rehabilitation treatments and need evaluation. These include a 
variety of methods of electrical stimulation, computer-controlled devices to 
extend various rehabilitative techniques outside of the traditional hospital 
or clinic, miniaturized performance monitoring devices (such as load cells, 
video, etc.) that can monitor “dosage” of physical therapies, and many other 
innovative techniques that have not yet been reported in the literature.

This RFA crosses multiple emphases in the NCMRR Research Plan including 
improving functional mobility, improving behavioral adaptation, improving 
whole body system response, and improving assistive technology.  In addition, 
it addresses a major priority in the NIDCD strategic plan, the development 
and improvement of devices, pharmacologic agents, and strategies for 
habilitation/rehabilitation of human communication disorders.

Scope
 
The following items provide examples of subject areas that are within the 
scope of the RFA. The NIA would be specifically interested in any of the 
following areas as they relate to physical and/or cognitive dysfunction in 
older persons.  This list is not exhaustive, and applicants are encouraged to 
communicate with program staff regarding the responsiveness of other topics 
to this RFA.

1. Interventions to improve the functional balance and mobility of persons 
with chronic disability, including physiotherapy, electrical stimulation, and 
other physical modalities.

2. Interventions to improve the cognitive, sensory, communicative, and 
behavioral functioning of people with disabling conditions such as traumatic 
brain injury or stroke, including cognitive retraining and remediation, 
speech/language therapy, environmental modifications, and other behavioral 
therapies and techniques.

3. Interventions to prevent and/or ameliorate secondary conditions with a 
higher prevalence among people with physical disabilities.  These conditions 
include depression, memory loss, muscle atrophy, pressure ulcers, 
cardiopulmonary deconditioning, and bowel, bladder, and sexual dysfunction.

4. Interventions that utilize assistive technology to improve the daily 
function of persons with chronic disability, including prosthetics and 
orthotics, cognitive, sensory and communicative aids, and other devices.

Supported Activities

Innovative interventions are often trans-disciplinary; thus, the types of 
activities that may be supported through this RFA include:

o Development of an effective research group resulting in a definitive 
research plan for a future regular research grant application.  Activities 
may include:  salary support for collaborative investigators, travel to 
multidisciplinary academic conferences or to meetings outside the 
researchers’ general area of expertise, and hosting a small trans-
disciplinary meeting to explore innovative treatments.

o Exploratory projects, including:  basic animal and preclinical human 
studies on the mechanism(s) underlying the innovative intervention, 
identification of markers and endpoints appropriate to the intervention, 
identification and validation of measures, especially measures of 
dose/quantity of treatment, and descriptive trials in related groups of 
subjects.

o Fabrication of new devices necessary to apply the intervention.
 
o Pilot clinical studies designed to:  identify side-effects and 
complications associated with the intervention, develop inclusion and 
exclusion criteria for future clinical trials, develop estimates of effect 
size and select specific methods of data analysis, and provide preliminary 
data for subsequent grant applications.

INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS

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 biomedical and 
behavioral research projects involving human subjects, unless a clear and 
compelling rationale and justification are 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 research involving human subjects should read the 
"NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical 
Research," published in the Federal Register of March 28, 1994 (59FR 14508-
14513) and in the NIH Guide for Grants and Contracts, Volume 23, Number 11, 
March 18, 1994, available on the Internet at:  
http://grants.nih.gov/grants/guide/notice-files/not94-100.html. 

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of the NIH that children (i.e., individuals under the age of 
21) must be included in all human subject research, conducted or supported by 
the NIH, unless there are scientific and/or 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," published in the NIH Guide for Grants and 
Contracts, March 6, 1998, and available on the Internet at:  
http://grants.nih.gov/grants/guide/notice-files/not98-024.html.

URLs IN NIH GRANT APPLICATIONS AND 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.  Reviewers are cautioned that their anonymity may 
be compromised when they directly access an  Internet site.

LETTER OF INTENT

Prospective applicants are asked to submit a letter of intent that includes a 
descriptive title of the proposed research, the name, address, and telephone 
number of the Principal Investigator, the identities of other key personnel 
and participating institutions, and the 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 NICHD staff to estimate the potential review workload and 
plan the review.  

The letter of intent is to be sent to Dr. Louis Quatrano, at the address 
listed under INQUIRIES, below, by August 15, 2000.

APPLICATION PROCEDURES

The research grant application form PHS 398 (rev. 4/98) is to be used in 
applying for these grants.  These forms are available at most institutional 
offices of sponsored research, on the Internet at:   
http://grants.nih.gov/grants/funding/phs398/phs398.html, and from the 
Division of Extramural Outreach and Information Resources, National 
Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-
7910, telephone 301-435-0714, E-mail:  GrantsInfo@nih.gov. 

Application Instructions

The modular grant concept establishes specific modules in which direct costs 
may be requested, as well as a maximum level for requested budgets.  Only 
limited budgetary information is required under this approach.  The just-in-
time concept requires the submission of certain information only when there 
is the possibility of an award.  It is anticipated that these changes will 
reduce the administrative burden for applicants, reviewers, and institute 
staff.  The research grant application form PHS 398 (rev. 4/98) is to be used 
in applying for these grants, with the modifications noted below.

Modular Grant applications will request direct costs in $25,000 modules, up 
to a total direct cost request of $150,000 per year.  The total direct costs 
must be requested in accordance with the program guidelines and the 
modifications made to the standard PHS 398 application instructions described 
below:

o  FACE PAGE:  Items 7a and 7b should be completed indicating Direct Costs 
(in $25,000 increments up to a maximum of  $150,000) and Total Costs [Modular 
Total Direct plus Facilities and Administrative (F&A) costs] for the initial 
budget period.

Items 8a and 8b should be completed indicating the Direct and Total Costs for 
the entire proposed period of support.

o  DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD:  Do not complete Form Page 
4 of the PHS 398.  It is not required and will not be accepted with the 
application.

o  BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT:  Do not complete the 
categorical budget table on Form Page 5 of the PHS 398.  It is not required 
and will not be accepted with the application.

o  NARRATIVE BUDGET JUSTIFICATION:  Prepare a Modular Grant Budget Narrative 
page.  (See http://grants.nih.gov/grants/funding/modular/modular.htm for 
sample pages.)  At the top of the page, enter the total direct costs 
requested for each year.  This is not a Form Page.

Under Personnel, list all project personnel, including their names, percent 
of effort, and roles on the proposed project.  No individual salary 
information should be provided.  However, the applicant should use the NIH 
appropriation language salary cap and the NIH policy for graduate student 
compensation in developing the budget request.

For Consortium/Contractual costs, provide an estimate of total costs (direct 
plus F&A costs) for each year, each rounded to the nearest $1,000.  List the 
individuals/organizations with whom consortium or contractual arrangements 
have been made, the percent effort of key personnel, and role on the proposed 
project.  Indicate whether the collaborating institution is foreign or 
domestic.  The total cost for a consortium/contractual arrangement is 
included in the overall requested modular direct cost amount.  Include the 
Letter of Intent to establish a consortium.

Provide an additional narrative budget justification for any variation in the 
number of modules requested.

o  BIOGRAPHICAL SKETCH:  The Biographical Sketch provides information used by 
reviewers in the assessment of each individual's qualifications for a 
specific role in the proposed project, as well as to evaluate the overall 
qualifications of the research team.  A Biographical Sketch is required for 
all personnel, following the instructions below.  No more than three pages 
may be used for each person.  A sample Biographical Sketch may be viewed at 
http://grants.nih.gov/grants/funding/modular/modular.htm.

- Complete the educational block at the top of the Form Page;
- List position(s) and any honors;
- Provide information, including overall goals and responsibilities, on 
research projects ongoing or completed during the last three years;
- List selected peer-reviewed publications, with full citations.

o  OTHER SUPPORT:  Do not complete this section.  It is not required and will 
not be accepted with the application.

o  CHECKLIST:  This page should be completed and submitted with the 
application.  If the F&A rate agreement has been established, indicate the 
type of agreement and the date.  All appropriate exclusions must be applied 
in the calculation of the F&A costs for the initial budget period and all 
future budget years.

o  The applicant should provide the name and telephone number of the 
individual to contact concerning fiscal and administrative issues if 
additional information is required following the initial review.

Submission Instructions

The RFA label available in the PHS 398 (rev. 4/98) application form must be 
affixed to the bottom of the face page of the application and must display 
the RFA number HD-00-016.  A sample RFA label is available at: 
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf.  Please note that 
this is in the pdf format.  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 and the YES box must be marked. 

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 should be 
sent to:

L.R. Stanford, Ph.D.
Director, Division of Scientific Review 
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 5E-03, MSC 7510
Bethesda, MD 20892-7510
Rockville, MD 20852 (for express/courier service)
Telephone:  301-496-9254

Applications must be received by October 12, 2000.  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 submission of substantial revisions 
of applications already reviewed, but such applications must include an 
introduction addressing the previous critique.

REVIEW CONSIDERATIONS

Upon receipt, applications will be reviewed for completeness by the CSR and 
for responsiveness by the NICHD, NIA, and NIDCD.  Incomplete and/or non-
responsive applications will be returned to the applicant without further 
consideration.

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 NICHD in accordance with the review criteria stated below.  
As part of the initial merit review, all applications will receive a written 
critique and undergo a process in which only those applications deemed to 
have the highest scientific merit will be discussed, assigned a priority 
score, and receive a second level review by the National Advisory Child 
Health and Human Development Council, the National Advisory Council on Aging, 
or the National Advisory Deafness and Other Communication Disorders Council.

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 
their written comments, reviewers will be asked to discuss the following 
aspects of the application in order to judge the likelihood that the proposed 
research will have a substantial impact on the pursuit of these goals.  Each 
of these criteria will be addressed and considered in assigning the overall 
score, weighted by the reviewers as appropriate for each application.  Note 
that the 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, an investigator 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 this study address an important problem?  If the aims 
of the application are achieved, how will scientific knowledge be advanced?  
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?  Does the applicant acknowledge potential problem areas and consider 
alternative tactics?

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

(4) Investigator:  Is the investigator appropriately trained and well suited 
to carry out this work?  Is the work proposed appropriate to the experience 
level of the Principal Investigator and other researchers (if any)?

(5) Environment:  Does the scientific environment in which the 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?

In addition to the above criteria, in accordance with NIH policy, all 
applications will also be reviewed with respect to the following:

o  The adequacy of plans to include both genders, minorities and their 
subgroups, and children as appropriate for the scientific goals of the 
research.  Plans for the recruitment and retention of subjects will also be 
evaluated.

o  The reasonableness of the proposed budget and duration in relation to the 
proposed research.

o  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.

AWARD CRITERIA

Applications will be selected for funding based on their scientific and 
technical merit as determined by peer review, availability of funds, and 
program priorities. 
 
INQUIRIES

Inquiries concerning this RFA are encouraged.  The opportunity to clarify any 
issues or questions from potential applicants is welcome.  Investigators also 
may obtain copies of relevant policy documents from program staff contact.

Direct inquiries regarding programmatic issues to:

Louis Quatrano, Ph. D.
Behavioral Sciences and Rehabilitation Engineering 
National Institute of Child Health and Human Development 
6100 Executive Blvd., 2A03, MSC 7510
Bethesda, MD 20892-7510
Telephone:  301-402-4221
FAX:  301-496-0832
E-mail:  quatranl@exchange.nih.gov 

Judith A. Cooper, Ph. D.
Chief, Scientific Programs Branch
Division of Extramural Research
National Institute on Deafness and Other Communication Disorders, NIH
6120 Executive Blvd., EPS-400-C, MSC 7180
Bethesda, MD 20892-7180
Telephone: 301-496-5061
FAX:  301-402-6251
E-mail:  Judith_Cooper@nih.gov

Judith A. Finkelstein, Ph. D.
Neuroscience and Neuropsychology of Aging
National Institute on Aging
Gateway Building, Suite 3C-307
7201 Wisconsin Avenue, MSC 9205
Bethesda, MD 20892-9205
Telephone:  301-496-9350
E-mail:  Finkelsj@exmur.nia.nih.gov

Direct inquiries regarding fiscal matters to:

Mary Ellen Colvin
Grants Management Branch
National Institute of Child Health and Human Development
6100 Executive Blvd., 8A17, MSC 7510
Telephone:  301-496-1304
FAX:  301-402-0915
E-mail:  ColvinM@mail.nih.gov

Sharon Hunt
Chief, Grants Management Branch
National Institute on Deafness and Other Communication Disorders
6120 Executive Blvd., Room 400-B, MSC 7180
Bethesda, MD 20892-7180
Telephone:  301-402-0909
FAX:  301-402-1758
E-mail: Sharon_Hunt@nih.gov

Cynthia Riddick
Grants and Contracts Management Office
National Institute on Aging
Gateway Building, Suite 2N212
7201 Wisconsin Avenue, MSC 9205
Bethesda, MD 20892-9205
Telephone:  301-496-1472
FAX:  301-402-3672
E-mail:  RiddickC@exmur.nia.nih.gov 

HEALTHY PEOPLE 2001

The Public Health Service (PHS) is committed to achieving the health 
promotion and disease prevention objectives of "Healthy People 2001," a PHS-
led national activity for setting priority areas.  This Request for 
Applications (RFA) is related to one or more of the priority areas.  
Potential applicants may obtain "Healthy People 2001" at:  
http://www.health.gov/healthypeople. 

AUTHORITY AND REGULATIONS
 
This program is described in the Catalog of Federal Domestic Assistance Nos. 
93.929, Medical Rehabilitation Research, 93.866, NIA, and 93.173, NIDCD.  
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 and Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 
92.  This program is not subject to the intergovernmental review requirements 
of Executive Order 12372 or Health Systems Agency review.

The PHS strongly encourages all grant recipients to provide a smoke-free 
workplace and promote the non-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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