MEDICAL REHABILITATION RESEARCH

Release Date:  January 20, 1999

PA NUMBER:  PA-99-041

P.T.

National Institute of Child Health and Human Development

THIS PROGRAM ANNOUNCEMENT REPLACES PA-92-042, WHICH WAS PUBLISHED IN NIH GUIDE,
VOL. 21, NO. 7, FEBRUARY 21, 1992

PURPOSE

The National Center for Medical Rehabilitation Research (NCMRR) of the National
Institute of Child Health and Human Development (NICHD) invites qualified
researchers to submit grant applications for research on restoring, replacing,
or enhancing the function of adults and children with disabilities.  Medical
rehabilitation research is directed towards restoration and improvement of
functional capability lost as a consequence of injury, disease, or congenital
disorders.  The mission of the NCMRR is to increase the effectiveness of medical
rehabilitation practices through research on: (1) improving functional mobility, 
(2) promoting behavioral adaptation to functional losses, (3) assessing the
efficacy and outcomes of medical rehabilitation therapies and practices, (4)
developing improved assistive technology, (5) understanding whole body system
responses to physical impairments and functional changes, (6) developing more
precise methods to measure impairments, disabilities, and societal and functional
limitations, and (7) training research scientists in the field of medical
rehabilitation.

Medical rehabilitation research concerns the scientific acquisition of knowledge
about potential or existing interventions that have the goal of maximizing the
health-related functioning of people with conditions associated with
disabilities.  Interventions concerned with the life-long maintenance and
promotion of the health of people with disabilities are a part of this goal. 
Relevant research includes basic science studies related to the pathophysiologic
mechanisms and processes underlying functional loss; likewise, changes in these
underlying mechanisms during and following rehabilitative interventions are
highly relevant.  Basic, applied, and clinical research on the adaptive and
maladaptive behavioral responses to physical impairments and functional changes
are important components of medical rehabilitation research.

Studies of assisted recovery from or adaptation to functional losses are
conducted by researchers from a wide variety of professions such as physical
medicine and rehabilitation (physiatry), neurology, pediatrics, urology,
orthopedics, neurosurgery, rheumatology, nursing, physical therapy, occupational
therapy, speech and language pathology, engineering, psychology, sociology, and
epidemiology.  Physiology, developmental biology, neuroscience, cell biology,
materials science, computer science, and other basic science disciplines
contribute to understanding mechanisms and processes fundamental to functional
recovery.  Interdisciplinary research is needed and encouraged.

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 program announcement, Medical
Rehabilitation Research, is related to the priority areas of nutrition, physical
activity and fitness, heart disease and stroke, cancer, and diabetes and chronic
disabling conditions.  Potential applicants may obtain a copy of "Healthy People
2000" at http://www.crisny.org/health/us/health7.html.

ELIGIBILITY REQUIREMENTS

Applications for research project grants (R01) 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 or local
governments, and eligible agencies of the Federal government.  Foreign
institutions are not eligible for the R03 mechanism.  Racial/ethnic minority
individuals, women, and persons with disabilities are encouraged to apply as
Principal Investigators.

MECHANISM OF SUPPORT

The mechanisms of support available for applications submitted in response to
this program announcement are research project grants (R01) and the NICHD Small
Grant (R03).  Potential applicants are encouraged to contact staff listed under
INQUIRIES or visit the NCMRR home page at http://silk.nih.gov/silk/NCMRR/ for
information on the NICHD Small Grant Program.  In addition to the R01 and R03
grants, NCMRR funds several other research and research training grant
mechanisms.

RESEARCH OBJECTIVES

Background

Approximately 49 million Americans have a disability (Brandt and Pope, 1997). 
Almost four percent of the U.S. population is unable to carry out the major
activity of their age group (e.g. personal care, work, school) because of severe
disabilities.  An additional six percent of the population are restricted in
their major activities, and another four percent are limited in other types of
activity (e.g. recreation, social pursuits).  The NCMRR provides an opportunity
for scientists to conduct research on the functional changes that result from
illness, injuries, or congenital conditions whose influence may continue
throughout life.  The emphasis is on health-related improvement in human
functioning at the pathophysiological, physical impairment, functional
limitation, disability, and societal impact levels of analysis.  Explicitly
included are studies of the application of new knowledge to the development of
medical, behavioral, psychological, social, and technological interventions
designed to optimize functioning after impairment.  Research interests extend
from the molecular level to the functioning of individuals in their physical and
social environments. 

Scope

The NCMRR seeks applications for support of research projects in disciplines
related to medical rehabilitation.  Many research issues fall within the scope
of this announcement.  Understanding the medical rehabilitation process requires
knowledge of the pathophysiology of physical impairment, the functional
limitations that arise, the personal and behavioral aspects of specific
disabilities, and the impacts of societal limitations.  Basic, clinical, and
applied research is encouraged, embodying a wide variety of approaches.  Clinical
trials of specific rehabilitation strategies are highly relevant.  The following
sections describe examples of appropriate topics for research within the existing
NCMRR programs.

Behavioral Science and Rehabilitative Engineering Program

Behavioral and Social Science Interventions.  This program area is concerned with
potential or existing behavioral or social science interventions that maximize
the health-related functioning of people with conditions associated with
disabilities.  Studies examining interrelationships among health, behavior, and
disability are encouraged.  Clinical research examining relationships between
environmental factors and behavioral adaptation to chronically disabling physical
conditions is welcomed as well.  Examples of relevant research include, but are
not limited to:

o  Basic studies examining intrapersonal (e.g. perceptual-motor, cognitive or
emotional) changes that occur while people with physical disabilities perform
particular tasks in specific environments; 

o  Studies delineating environmental factors (physical, familial, social, or
cultural) that influence behavioral adaptation to disability;

o  Development and evaluation of interventions (e.g., training in self-care
skills or health maintenance techniques) to promote adaptation; and

o  Methodological or measurement-oriented studies pertinent to issues highlighted
above.

Rehabilitation Engineering.  This program area emphasizes the role of biomedical
engineering in the rehabilitation process by supporting research that pertains
to restoration of functioning or substitution for functional losses.  Biomedical
engineers draw from the knowledge base of many of the life and physical sciences
and apply this knowledge to developing meaningful applications that improve a
person's physical and mental functioning and their contributions to society. 
Examples of research topics include, but are not limited to:

o  Development of orthotic and prosthetic devices as well as technologies that
facilitate sensory functioning, communication, or control of their physical
environment;

o  Research to characterize and assess functional loss in chronic disabling
conditions; and

o  Development of new strategies to restore functioning or to substitute for
functional losses.

Biological Sciences and Career Development Program

Biological Sciences.  Research on the biological mechanisms that underlie
disabling conditions may suggest new rehabilitation treatments to reverse or
overcome the impairments present in disabling conditions.  In addition, existing
rehabilitation strategies have biological consequences, that need to be
understood more fully.  Research areas include, but are not limited to:
o  Animal models of chronic disabling conditions;
o  Neuroplastic responses to chronic injury or disease;
o  Endocrine changes that accompany long-term disorders;
o  Immune function in primary and secondary disabling disorders;
o  Secondary impairments that result from primary disabling conditions and
prevention of such impairments;
o  Strategies for repairing or replacing lost organ/tissue function, including
use of implanted tissues, cell lines, stem cells, biomaterials, and in vitro
models;
o  Imaging of chronically injured or impaired organ systems; and
o  Interactions among organ and tissue systems in disability.

Career Development.  Research training and career development are critical for
the growth of medical rehabilitation research.  The NCMRR is committed to
increasing the number of active researchers in medical rehabilitation and to
expanding the scope of research disciplines that are brought to bear on the
field.  Several mechanisms for support are offered that allow persons at all
levels of their academic careers to be mentored in research related to improving
the functional capacity of individuals with disabling conditions.  Training
opportunities exist for persons with interests in each of NCMRR's program areas
including the behavioral, social, and biological sciences; engineering and
biomaterials; and the development and evaluation of clinical practices.  Both
basic science and patient-oriented research training and career development is
supported.

Clinical Practices Program

Rehabilitation encompasses a wide array of techniques and therapies used in
clinical practice, including many non-pharmaceutical, non-surgical practices such
as exercise, splinting and bracing, physical modalities, cognitive and memory
training, and functional activity retraining.  Additional research is needed for
many rehabilitation techniques and therapies that have only implicit theoretical
bases and that have not been rigorously evaluated in clinical trials.  Research
areas include, but are not limited to:
o  Single- and multi-center clinical trials of existing rehabilitation therapies;
o  Examinations of the theoretical basis of current rehabilitation clinical
practices;
o  Clinical investigations and clinical trials of innovative rehabilitation
treatments, including novel physical therapies, cognitive remediation techniques,
and rehabilitation engineering products; and
o  Clinical trials of rehabilitation-related interventions that promote health
maintenance and the prevention of secondary conditions in people with physical
disabilities.

Reference
Brandt, EN, Pope, AM, Eds. Enabling America: Assessing the Role of Rehabilitation
Science and Engineering.  Washington, DC: National Academy Press, 1997.

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
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," which have been published in the Federal Register of March 28, 1994
(FR 59 14508-14513) and in the NIH Guide for Grants and Contracts, Volume 23,
Number 11, March 18, 1994., available on the web at:
http://www.nih.gov/grants/guide/1994/94.03.18/notice-nih-guideline008.html.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of NIH 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 was published in the NIH Guide for Grants
and Contracts, March 6, 1998, and is available at:
<http://www.nih.gov/grants/guide/notice-files/not98-024.html>.

Investigators also may obtain copies of these policies from the program staff
listed under INQUIRIES.

APPLICATION PROCEDURES

Applications are to be submitted on the grant application form PHS 398 (rev.
4/98) and will be accepted at the standard application deadlines as indicated in
the application kit.  Application kits are available at most institutional
offices of sponsored research and from the Division of Extramural Outreach and
Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC
7910, Bethesda MD 20892-7910, telephone 301-710-0267, Email
Grantsinfo@od.nih.gov. 

Applicants planning to submit an investigator-initiated new (type 1), competing
continuation (type 2), competing supplement, or any amended/revised version of
the preceding grant application types requesting $500,000 or more in direct costs
for any year are advised that he or she must contact NICHD program staff before
submitting the application, i.e., as plans for the study are being developed. 
Furthermore, the applicant must obtain agreement from the NICHD staff that NICHD
will accept the application for consideration for award.  Finally the applicant
must identify, in a cover letter sent with the application, the NICHD staff
member who agreed to accept assignment of the application.  This policy requires
an applicant to obtain agreement for acceptance of both any such application and
any such subsequent amendment.  Refer to the NIH Guide for Grants and Contracts,
March 20, 1998 at http://www.nih.gov/grants/guide/notice-files/not98-030.html.

The title and number of this program announcement must be typed on line 2 of the
face page of the application and the YES box must be marked.

Submit a signed, typewritten original of the application, including the
Checklist, and five signed photocopies in one package to the following address:

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)

REVIEW CONSIDERATIONS

Applications will be assigned on the basis of established PHS referral
guidelines.  Several institutes (e.g., National Institute of Nursing Research,
National Institute of Deafness and Communication Disorders) have interests that
relate to rehabilitation research in specific disease areas.  For example,
research grant applications involving visual impairment, blindness, and their
rehabilitation will be assigned to the National Eye Institute.

Applications will be evaluated for scientific and technical merit by an
appropriate scientific review group convened in accordance with the standard NIH
peer review procedures.  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, generally the top half
of applications under review, will be discussed, assigned a priority score, and
receive a second level review by the appropriate national advisory council or
board.

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 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, weighting them 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 method? 
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.

The scientific review group will also examine the provisions for the protection
of human subjects and the safety of the research environment.

AWARD CRITERIA

Applications will compete for available funds with all other scored applications. 
The following will be considered in making funding decisions: 1) scientific and
technical merit of the proposed project as determined by peer review, 2)
availability of funds, and 3) program balance among research areas.

INQUIRIES 

Inquiries 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.
Behavioral Sciences and Rehabilitation Engineering Program
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 2A03
Rockville, MD  20852
Telephone:  (301) 402-2242
Email:  lq2n@nih.gov

Mary Ellen Cheung, Ph.D.
Biological Sciences and Career Development
National Institute of Child Health and Human Development 
6100 Executive Boulevard, Room 2A03
Rockville, MD  20852
Telephone:  (301) 402-2242
Email:  mm108w@nih.gov

Stephen A. Tuel, M.S.E, M.D.
Clinical Practices Program
National Institute of Child Health and Human Development 
6100 Executive Boulevard, Room 2A03
Rockville, MD  20852
Telephone:  (301) 402-2242
Email:  st100v@nih.gov

Direct inquiries regarding fiscal and administrative matters to:

Ms. Mary Ellen Colvin
Grants Management Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 8A17G
Rockville, MD  20852
Telephone:  (301) 496-1304
Email:  mc113b@nih.gov

In addition to this program announcement, NCMRR supports several funding
mechanisms, including SBIR and STTR grants, program projects, career development
awards and fellowships.  Information on other funding mechanisms is available at:
http://silk.nih.gov/silk/NCMRR/

AUTHORITY AND REGULATION

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 and contract 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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