Full Text HD-96-007
 
PEDIATRIC REHABILITATION
 
NIH Guide, Volume 25, Number 20, June 21, 1996
 
RFA:  HD-96-007
 
P.T. 34

Keywords: 
  Pediatrics 
  Rehabilitation/Therapy, Physical 

 
National Institute of Child Health and Human Development
National Institute of Arthritis and Musculoskeletal and Skin Diseases
 
Letter of Intent Receipt Date:  July 24, 1996
Application Receipt Date:  November 13, 1996
 
PURPOSE
 
The National Institute of Child Health and Human Development (NICHD)
invites applications for research project grants (R01) and First
Independent Research Support And Transition (FIRST) Awards (R29) to
conduct rehabilitation research to improve the management of the
movement limitations of infants or children with physical
disabilities due to injury, disease or disorders existing at birth.
The National Institute of Arthritis and Musculoskeletal and Skin
Diseases (NIAMS) is interested in promoting research on the
development of new and improved rehabilitation protocols for patients
with juvenile rheumatoid arthritis.  A primary purpose of this
initiative is to encourage the development and evaluation of specific
interventions to clinically evaluate, reduce or reverse the movement
limitations of infants or children with physical disabilities.
Another purpose is to understand the causes, consequences, and
prevalence of movement limitations within defined populations.
 
HEALTHY PEOPLE 2000
 
The Public Health Service (PHS) is committed to achieving the health
promotion and disease prevention objectives of "Healthy People 2000,"
a PHS-led national activity for setting priority areas.  This Request
for Applications (RFA), Pediatric Rehabilitation, is related to the
priority area of chronic and disabling conditions and the goal to
reduce health disparities among Americans.  Potential applicants may
obtain a copy of "Healthy People 2000" (Full Report:  Stock No.
017-001-00474-0 or Summary Report:  Stock No. 017-001-00473-1)
through the Superintendent of Documents, Government Printing Office,
Washington, DC 20402-9325 (telephone 202-512-1800).
 
ELIGIBILITY REQUIREMENTS
 
Applications may be submitted by domestic and foreign, 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 the First Independent
Research Support and Transition (FIRST) Awards (R29). Racial/ethnic
minority individuals, women, and persons with disabilities are
encouraged to apply as Principal Investigators.
 
MECHANISM OF SUPPORT
 
This RFA will use the National Institutes of Health (NIH) research
project grant (R01) and FIRST award (R29) mechanism.  The direct
costs for the R01 may not exceed $100,000 per year.  The total
project period for an R29 application submitted in response to the
present RFA must be for five years.  The total costs for the R29 will
be determined by the guidelines currently in affect on the receipt
date of the RFA.  Responsibility for the planning, direction, and
execution of the proposed project will be solely that of the
applicant.  The anticipated award date is July 1, 1997.
 
This RFA is a one-time solicitation.  Future unsolicited continuation
applications will compete with all unsolicited investigator-initiated
applications and be reviewed according to the customary peer review
procedures.
 
FUNDS AVAILABLE
 
Applications submitted in response to this RFA will compete for
direct costs of approximately $750,000 that have been made available
for the first year of support for the program.  It is expected that
approximately six awards will be made by NICHD.  The number of awards
depends on the overall scientific merit of the applications, their
relevance to the stated goals of this RFA, and the availability of
funds. The NIAMS estimated funding (total costs) available for the
first year of support is $250,000.  Funding is contingent upon
receipt of scientifically meritorious applications.  The NIAMS
expects to fund one award in the area of rehabilitation in juvenile
arthritis.
 
RESEARCH OBJECTIVES
 
Background
 
Currently there are approximately 3.8 million individuals, 17 years
old or younger, living with chronic physical impairments and
disabilities in the United States. Movement impairments are
characteristic of many infants and children with disabilities due to
conditions such as cerebral palsy, metabolic disorders, burns,
juvenile arthritis, AIDS, amputation, cancer, injury to the brain or
spinal cord, spina bifida or muscular dystrophy.  These conditions
are managed by a variety of therapies including orthopaedic surgery,
physiotherapeutic interventions, medication, and the provision of
adaptive equipment such as prostheses, orthoses, and wheelchairs.
The goals of therapy include assisting the infant or child to achieve
a greater level of independent movement and optimizing functional
capacity. Although these interventions are widely used, very little
systematic information exists regarding their effectiveness,
especially in terms of the longer term development of the individual.
A need exists as well to develop and evaluate new approaches to the
clinical assessment and treatment of these conditions.
 
Considerable variation exists among infants and children with
movement limitations that reflects a) the type and origin of physical
disability, b) responses to treatment, and c) the presence of
concomitant conditions.  Some of these individuals become grossly
inactive, resulting in a downward spiral of unhealthy development.
Understanding the causes, consequences and prevalence of mobility
limitations in different populations of infants and children with
disabilities will provide a scientific basis for their more effective
clinical management.
 
Scope
 
Applications must address one or both of the following research
themes.
 
I.  Development and evaluation of new or improved evaluation
techniques or interventions relevant to the movement limitations of
infants and children.
 
Illustrative of such research is examination of both shorter- and
longer-term outcomes of  defined interventions to improve the
independence of infants and children with movement limitations. This
could include the development and empirical validation of models
linking diagnostic information (e. g., images or strength
measurements), interventions (e.g., surgery, prosthetics, or
physiotherapy) and outcomes (e.g., improved mobility or health).
 
The NIAMS is interested in research projects that focus on the
development and testing of new and improved rehabilitation techniques
for children with juvenile arthritis.  Research projects that examine
efficacy, cost-effectiveness and explore the mechanisms underlying
clinically significant beneficial effects are encouraged.
 
II.  Achievement of better knowledge of the causes, consequences and
prevalence of mobility limitations in different populations of
infants and children with physically disabling conditions.
 
Illustrative of such research are longitudinal studies of
interactions among biological factors,  psychosocial and personality
attributes, developmental landmarks, changing health status, and
kinds of interventions received.
 
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 subpopulations must be included in all NIH supported
biomedical and behavioral research projects involving human subjects,
unless a clear and compelling rationale and justification is provided
that inclusion is inappropriate with respect to the health of the
subjects or the purpose of the research.  This new policy results
from the NIH Revitalization Act of 1993 (Section 492B of Public Law
103-43) and supersedes and strengthens the previous policies
(Concerning the Inclusion of Women in Study Populations, and
Concerning the Inclusion of Minorities in Study Populations), which
have been in effect since 1990. The new policy contains some
provisions that are substantially different from the 1990 policies.
 
All investigators proposing research involving human subjects should
read the "NIH Guidelines For Inclusion of Women and Minorities as
Subjects in Clinical Research," which have been published in the
Federal Register of March 28, 1994 (FR 59 14508- 14513) and reprinted
in the NIH Guide for Grants and Contracts, Volume 23, Number 11,
March 28, 1994.
 
Investigators also may obtain copies of the policy from the program
staff or contact person listed under INQUIRIES.  Program staff may
also provide additional relevant information concerning the policy.
 
LETTER OF INTENT
 
Prospective applicants are asked to submit, by July 24, 1996, 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 the RFA in response to
which the application may be submitted.  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
NIH staff to estimate the potential review workload and avoid
conflict of interest in the review.
 
The letter of intent is to be sent to:
 
Louis A. Quatrano, Ph.D.
National Center for Medical Rehabilitation Research
National Institute of Child Health and Human Development
Building 6100, Room 2A03
Bethesda, MD  20892
Telephone:  (301) 402-2242
FAX:  (301) 402-0832
Email:  quatranl@hd01.nichd.nih.gov
 
APPLICATION PROCEDURES
 
The research grant application form PHS 398 (rev. 5/95) is to be used
in applying for these grants.  These forms are available at most
institutional offices of sponsored research; from the Office 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 ASKNIH@odrockm1.od.nih.gov; and from
the program administrator listed under INQUIRIES.
 
Applications for the FIRST award (R29) must include at least three
sealed reference letters attached to the face page of the original
application.  FIRST award (R29) applications submitted without the
required number of reference letters will be considered incomplete
and will be returned without review.
 
The RFA label available in the PHS 398 (rev. 5/95) application form
must be affixed to the bottom of the face page of the application.
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.
 
Submit a signed, typewritten original of the application, including
the Checklist, and three signed photocopies, in one package to:
 
DIVISION OF RESEARCH GRANTS
NATIONAL INSTITUTES OF HEALTH
6701 ROCKLEDGE DRIVE, ROOM 1040- MSC 7710
BETHESDA, MD  20892-7710
BETHESDA, MD  20817 (for express/courier services)
 
At the time of submission, two additional copies of the application
must be sent to:
 
Susan Streufert, Ph.D.
Division of Scientific Review
National Institute of Child Health and Human Development
Building 6100, Room 5E03H
6100 Executive Boulevard
Bethesda, MD  20892-7510
Rockville, MD  20852 (for express/courier service)
 
Applications must be received by November 13,1996.  If an application
is received after that date, it will be returned to the applicant
without review.  The Division of Research Grants (DRG) 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 DRG 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.
 
REVIEW CONSIDERATIONS
 
Upon receipt, applications will be reviewed for completeness by DRG
and responsiveness by the NICHD.  Incomplete applications will be
returned to the applicant without further consideration. If the
application is not responsive to the RFA, NICHD 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 review cycle.  Applications that are
complete and responsive to the RFA will be evaluated for scientific
and technical merit by an appropriate peer review group convened by
the NICHD in accordance with the review criteria stated below.
 
As part of the initial merit review, a process may be used by the
initial review group in which applications will be determined to be
competitive or non-competitive based on their scientific merit
relative to other applications received in response to the RFA.
Applications judged to be competitive will be discussed and be
assigned a priority score.  Applications determined to be non-
competitive will be withdrawn from further consideration and the
Principal Investigator and the official signing for the applicant
organization will be notified.  Principal Investigators of
applications judged to be non-competitive will receive summary
statements containing reviewers' comments.
 
Review Criteria
 
o  scientific, technical, or medical significance and originality of
the proposed research;
 
o  appropriateness and adequacy of the experimental approach and
methodology proposed to carry out the research;
 
o  qualifications and research experience of the Principal
Investigator and staff, particularly, but not exclusively, in the
area of the proposed research;
 
o  availability of the resources necessary to perform the research;
 
o  appropriateness of the proposed budget and duration in relation to
the proposed research;
 
o adequacy of plans to include both genders and minorities and their
subgroups as appropriate for the scientific goals of the research.
Plans for the recruitment and retention of subjects will also be
evaluated.
 
The initial review group will also examine the provisions for the
protection of human and animal subjects and the safety of the
research environment.
 
AWARD CRITERIA
 
Applications will be selected based on scientific merit of the
proposal, the availability of funds, and program relevance.
 
INQUIRIES
 
Inquiries concerning this RFA are encouraged.  The opportunity to
clarify any issues or questions from potential applicants is welcome.
 
Direct inquiries regarding programmatic issues to:
 
Louis A. Quatrano, Ph.D.
National Center for Medical Rehabilitation Research
National Institute of Child Health and Human Development
Building 61E, Room 2A03
Bethesda, MD  20892-7510
Telephone:  (301) 402-2242
FAX:  (301) 402-0832
Email:  quatranl@hd01.nichd.nih.gov
 
Susana Serrate-Sztein, M.D.
Arthritis Branch
National Institute of Arthritis and Musculoskeletal and Skin Diseases
Natcher Building, Room 5AS-37G
45 Center Drive MSC 6500
Telephone:  (301) 594-5032
FAX:  (301) 480-4543
Email:  szteins@ep.niams.nih.gov
 
Direct inquiries regarding fiscal matters to:
 
Mary Ellen Colvin
Grants Management Branch
National Institute of Child Health and Human Development
Building 61E, Room 8A017
Bethesda, MD  20892-7510
Telephone:  (301) 493-1303
FAX:  (301) 402-0915
Email:  colvinm@hd01.nichd.nih.gov
 
Sally Nichols
Grants Management Office
National Institute of Arthritis and Musculoskeletal and Skin Diseases
Natcher Building, Room 5AS-53
45 Center Drive MSC 6500
Bethesda, MD  20892-6500
Telephone:  (301) 549-3535
FAX:  (301) 480-5450
Email:  Nicholss@ep.niams.nih.gov
 
AUTHORITY AND REGULATIONS
 
This program is described in the Catalog of Federal Domestic
Assistance No. 93.929 Medical Rehabilitation Research.  Awards are
made under authorization of the Public Health Service Act, Title IV,
Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC
241 and 285) and administered under PHS grants policies and Federal
Regulations 42 CFR 52 and 45 CFR Part 74.  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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