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05-19-1992, 06:27 PM
MEDICAL REHABILITATION RESEARCH (U.S.A.)

NIH GUIDE, Volume 21, Number 7, February 21, 1992

PA NUMBER: PA-92-42

P.T. 34; K.W. 0415001, 0415002, 0415003, 0765035, 0740070

National Institute of Child Health and Human Development

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 children and
adults with disabilities. Medical rehabilitation research is directed
towards restoration and improvement of functional capability lost as a
consequence of injury, disease and congenital disorder. The mission of
the NCMRR is to improve the ability of medical rehabilitation to
restore or improve function through research on: (1) functional
problems associated with diminished mobility, (2) body systems response
to lost function, (3) adaptive behavior systems modifications to
functional loss, (4) treatment intervention effectiveness in restoring
function, (5) assistive devices that replace or enhance function, and
(6) outcome measurement systems that provide an integrative method for
tracking functional change over time in many different domains.

This research includes basic science studies related to the
pathophysiologic mechanisms and processes underlying functional loss.
Basic and clinical studies of the physical impairment that reduces
function are included in the science of medical rehabilitation.
Fundamental knowledge of functional development, change in functional
capacity during development, and alteration of functional abilities
post injury or disease is a focal point of medical rehabilitation
research. The individual's adaptive and maladaptive behavioral
responses to a physical impairment and functional change are the
subject of a wide variety of basic, clinical and applied studies. The
societal impact, both positive and negative, of how persons with
disabilities adjust to the demands of culture (e.g., family, work,
support systems) and to natural and man-made environmental barriers
frames the outcome success or failure of medical rehabilitation
programs.

These studies of assisted recovery from or adaptation to functional
loss are conducted by researchers from a wide variety of scientific
disciplines such as specialists in physical and rehabilitation medicine
(physiatry), neurology, pediatrics, urology, orthopedics, neurosurgery,
nursing, physical therapy, occupational therapy, rehabilitation
psychology, sociology, demography, epidemiology, biomedical
engineering, rehabilitation engineering, orthotists, prosthetists, and
other related health professionals. In addition, the basic sciences
contribute to understanding mechanisms and processes fundamental to
functional recovery. These disciplines include genetics, molecular
biology, neurosciences, physiological sciences and other physical
sciences. Both intradisciplinary and interdisciplinary research are
needed and encouraged.

HEALTHY PEOPLE 2000

The Public Health Service (PHS) is committed to achieving the health
promotion and disease prevention goals of "Healthy People 2000," a
PHS-led national activity for setting priorities. 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 a copy of "Healthy People 2000"
(Full Report: No. 017-001-474-0, or Summary Report: Stock No
017-001-00473-1) through the Superintendent of Documents, Government
Printing Office, Washington, DC 20402-9325 (Telephone:
202-783-3238).

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 or local governments,
and eligible agencies of the Federal government. Applications from
minority individuals and women are encouraged. Additional eligibility
requirements must be met for institutional training grants (T32),
fellowships (F32, F33), and career development awards (K series).

MECHANISMS OF SUPPORT

The mechanisms available for support of this program announcement are:
Individual Research Grants (R01), First Independent Research Support
and Transition (FIRST) Awards (R29), Program Project Grants (PO1),
Research Career Development Awards (K04), The Academic/Teacher Awards
(K07), The Clinical Investigator Award (K08), The Physician Scientist
Award (K11), National Research Service Award Institutional Training
Grants (T32), and Individual Fellowships (F32, F33).

RESEARCH OBJECTIVES

Background

Between 35 million and 43 million Americans, or 1 in 7, have a
disability. Almost four percent of the U.S. population are unable to
carry out the major activity of their age group because of severe
disabilities. An additional six percent of the population are
restricted in their major activity, and another 4 percent are limited
in other types of activity. The NCMRR provides an opportunity for
scientists to conduct research on the functional changes resulting from
illness, injuries, and developmental processes that begin before birth
and continue until the last stages of life. The emphasis will be on
health-related improvement in human functioning at the
pathophysiological, physical impairment, functional impairment,
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 of interest would extend from the molecular level
to the functioning of individuals in their physical and social
environment.

Scope

The NCMRR of the NICHD seeks research project, research training,
fellowship, and research career award grant applications for the study
of medical rehabilitation. This is not a one-time invitation for
applications, but rather a continuing call for research on this topic.
Many research issues fall within the scope of this announcement.
Basic, clinical, and applied research is encouraged through
intervention strategies, measurement strategies, and the development of
assistive devices to improve the knowledge and understanding of the
medical rehabilitation process (pathophysiology, physical impairment,
functional limitation, disability and societal impact) contributing to
functional loss in the broad and overlapping areas of mobility, body
systems, and behavioral systems. The following are offered as
illustrations of appropriate topics, but applications are not be
limited to these areas:

A. MOBILITY ENHANCEMENT RESEARCH IN MEDICAL REHABILITATION

1) Treatment Effectiveness

o Effectiveness of different treatment interventions for long-term
rehabilitation of patients with mobility problems resulting from
cardiovascular disease, myocardial infarction, stroke, and
hypertension.

o Studies of the neuroplasticity of the nervous and muscular systems
and whether or not interventions might improve the motor functioning of
individuals with neuromotor deficits.

o Research on hormonal, neurochemical, and potential pharmacological
agents (such as growth hormone) that might improve the physical
functioning or the mobility of individuals with disabilities.

2) Assessment and Measurement

o Assessment of the effects of the use of mobility aids (i.e., canes,
wheelchairs, prosthetics, and orthotic devices) on the muscles and
joints.

o Assessment of the potential physiological and metabolic benefits of
varying the means and modes of mobility for people with impaired
mobility.

o Identification and quantification of the factors and mechanisms
involved in performing important motor tasks such as walking, ascending
stairs, reaching, sitting, and crouching.

o Improving the analytical tools for evaluating the performance of
work-related tasks.

3) Assistive Devices

o Development of mechanical and electrical devices that can assist
individuals with physical disabilities to control their environment,
including prosthetic and orthotic equipment, mobility enhancement
(wheelchairs, walkers, safety equipment for transportation vehicles),
remote control of home and work place appliances or tools, and
recreational equipment for use in family, school, and community
settings.

o Development and testing of devices and/or techniques designed to
teach, supplement, replace or restore communicative and language
functions (e.g., gesturing, listening, speaking, reading, and writing)
of individuals with physical disabilities including alternative forms
of communication (e.g., computer-assisted speech output, speech
substitution), and/or environmental control systems for home, school,
and work.

o Development of devices and techniques for the mechanical testing of
tissue properties under physiologically representative conditions.

o Evaluation of the utility, functional impacts, and dependability of
assistive devices.

B. BEHAVIORAL SYSTEMS RESEARCH IN MEDICAL REHABILITATION

1) Treatment Effectiveness

o Development of skill-training and educational program products and
therapeutic techniques that supplement, replace, or restore the
functional social, cognitive, adaptive, and motor abilities of
individuals who are physically disabled.

o Development of: behavioral techniques for improvement of cognitive
function (e.g., academic training), motor skills (e.g., mobility
difficulties, bowel and bladder control, feeding, and dressing), the
decrease or elimination of destructive behaviors (e.g., self abuse,
aggression, hyperactivity) for individuals with disabilities.

o Studies of the differential between the functional capacity of older
adults with disabilities and their actual level of performance.

2) Assessment and Measurement

o Development of data collection and surveillance systems necessary to
generate epidemiologically sound evidence of the incidence and
prevalence of impairments, functional changes, and disabilities in
different societal contexts, and the conduct of such studies.

o Development and testing of theoretical formulations of the
determinants of impairments, functional changes, and disabilities and
the progression leading from impairment to societal impact.

o Assessments of patterns and models of care in terms of their impact
on the quality of life of people with disabilities.

o Rehabilitation assessment of persons with disabilities who are
losing function due to the aging process.

3) Assistive Devices

o Development and testing of software programs for computer- assisted
instruction, measurement, and assessment of cognitive, vocational, and
social skill acquisition for children and adults with physical
disabilities.

C. BODY SYSTEMS RESEARCH IN MEDICAL REHABILITATION

1) Treatment Effectiveness

o Methods to stimulate bone and soft-tissue growth in prosthetic
devices.

o Rehabilitation research in cancer survivors such as improving
treatment techniques for breast reconstruction and dealing with
dysfunctions associated with breast cancer therapies (behavioral and
psychological problems, vaginal dryness, hot flashes, lymphedema, and
shoulder dysfunction); treatments of sensory or functional deficits
induced by cancer treatments.

o Clinical intervention effectiveness in attempts to prevent or
remediate adverse long-term effects of kidney transplantation, e.g.,
multiple organ effects, behavioral changes, vocational and social
effects.

o Rehabilitation of neurophysiological dysfunction including
investigation of therapies that might reduce the extent of neurologic
damage caused by disease or injury, induce functional plasticity and
enhance restoration of function.

o Medical rehabilitation intervention effectiveness for people with
chronic lung disease.

o Effectiveness of interventions designed to prevent or remediate the
adverse long-term physical, behavioral, and social effects of asthma.

o Treatment interventions designed to improve rehabilitation of
musculoskeletal disorders.

o Treatments to maintain and improve integumentary integrity.

2) Assessment and Measurement

o Assessment and measurement of joint mechanics and pathophysiology,
musculoskeletal physiology and plasticity, interaction of
musculoskeletal impairments, and the mechanisms governing muscle and
bone development in the presence of normal and abnormal neural
function.

o Development of clinical tools for the quantitative assessment of
muscle function, mobility, and postural control.

o Development of quantitative measures for assessing and comparing the
functional capacity to carry out routine tasks and the level of
performance achieved in doing so.

o Development of procedures and standardized protocols for determining
sites of fatigue in the neuromotor systems in people with and without
impairments and disabilities.

3) Assistive Devices

o Devices to improve measurement of joint mechanics and
pathophysiology, musculoskeletal physiology and plasticity, interaction
of musculoskeletal impairments, and the mechanisms governing muscle and
bone development in the presence of normal and abnormal neural
function.

o Development of durable waterproof, life-like cosmesis and
alternative prosthetic covers.

STUDY POPULATIONS

SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH
POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL
RESEARCH STUDY POPULATIONS

National Institutes of Health (NIH) policy is that applicants for NIH
clinical research grants will be required to include minorities and
women in study populations so that research findings can be of benefit
to all persons at risk of the disease, disorder or condition under
study. Special emphasis should be placed on the need for inclusion of
minorities and women in studies of diseases, disorders and conditions
that disproportionately affect them. This policy is intended to apply
to males and females of all ages. If women or minorities are excluded
or inadequately represented in clinical research, particularly in
proposed population-based studies, a clear compelling rationale should
be provided.

The composition of the proposed study population must be described in
terms of gender and racial or ethnic group together with a rationale
for its choice. In addition gender and racial or ethnic issues should
be addressed in developing a research design and sample size
appropriate for the scientific objectives of the study. This
information should be included on the grant application form PHS 398 in
Section 2, A-D of the research plan and summarized in Section 2, E,
(Human Subjects).

Applicants are urged to carefully assess the feasibility of including
the broadest possible representation of minority groups. However, NIH
recognizes that it may not be feasible or appropriate in all research
projects to include representation of the full array of United States
racial or ethnic minority populations (i.e., Native Americans
(including American Indians or Alaskan Natives), Asian/Pacific
Islanders, Blacks, Hispanics). The rationale for studies on single
minority population groups should be provided.

For the purpose of this policy, clinical research includes human
biomedical and behavioral studies on etiology, epidemiology, prevention
(and preventive strategies), diagnosis, or treatment of diseases,
disorders or conditions, including but not limited to clinical trials.
The usual NIH policies concerning research on human subjects also
apply. Basic research or clinical studies in which human tissues
cannot be identified or linked to individuals are excluded. However,
every effort should be made to include human tissue from women and
racial/ethnic minorities when it is important to apply the results of
the study broadly, and this should be addressed by applicants.
For foreign awards, the policy on inclusion of women applies fully;
since the definition of minority differs in other countries, applicants
must discuss the relevance of research involving foreign population
groups to the United States' populations, including minorities.

If the required information is not contained within the application,
the application will be returned.

Peer reviewers will address specifically whether the research plan in
the application conforms to these policies. If the representation of
women or minorities in a study design is inadequate to answer the
scientific question(s) addressed and the justification for the selected
study population is inadequate, it will be considered a scientific
weakness or deficiency in the study design and will be reflected in
assigning the priority score to the application.

All applications for clinical research submitted to NIH are required to
address these policies. NIH funding components will not award grants
or cooperative agreements that do not comply with these policies.

APPLICATION PROCEDURES

Applicants are to use the research project application form PHS 398
(revised 9/91), for the R01, R29, P01, K04, K07, K08, K11 and T32
applications. On line 2 (Response to Specific Program announcement)
on the face page of the application, type: "Medical Rehabilitation
Research, PA-92-42."

Applicants are advised also to review the appropriate guidelines for
the various funding mechanisms for unique features of each mechanism:
First Independent Research Support and Transition (FIRST) Award (R29),
September 23, 1991; NIH Research Career Development Award (K04), June
1991; Clinical Investigator Award (K08), October 1991; Physician
Scientist Award (K11), June 1991; and National Research Service Awards
Institutional Training Grants (T32), October 1990. These publications
are available at the applicant's institutional Application Control
Office and from the Office of Grants Inquiries, Division of Research
Grants, NIH (telephone 301-496-7441).

Because the PHS 398 form is designed primarily for the traditional R01
application, several sections, outlined on the instruction sheet, must
be modified and expanded to provide the additional information required
for a P01 or K07. Applicants for the P01 should use the application
format as described in the NICHD pamphlet, Program Project Guidelines,
1991, that may be obtained from the contacts listed under INQUIRIES.
Applicants for the K07 should also obtain guidance from the contacts
listed under INQUIRIES.

Fellowship applications (F32 and F33) must be submitted on the
Application for Public Health Service Individual Service Award (PHS
416-1). If the applicant is a noncitizen, a notarized statement of
permanent residence must accompany the application. Applicants must
submit with the application at least three letters of reference.

Receipt dates for Research Project Grants, Career Development Award,
and FIRST Award applications are February 1, June 1, and October 1 of
each year. The individual National Research Service Award applications
are accepted January 10, May 10, and September 10. Institutional
training grant applications are accepted once each year, January 10.

If using the PHS 398, submit the original application and six copies to
the following address. If using the PHS 416, submit the original
application and two copies to:

Grant Application Receipt Office
Division of Research Grants
National Institutes of Health
Westwood Building, Room 240
Bethesda, MD 20892**

REVIEW PROCEDURES

All applications will be received by the Division of Research Grants
(DRG), NIH. Research project grant (R01 and R29) applications,
fellowships (F32, F33) and research career development awards (K04)
will be reviewed for scientific and technical merit by an appropriate
study section in the Division of Research Grants. All other
applications will be reviewed by an appropriate institute review group.
The initial review for scientific and technical merit will be by a
review group composed mostly of nonfederal scientific consultants
(study section). Secondary review will be by the appropriate national
advisory council. The review criteria customarily employed by the NIH
PHS for applications will prevail. The specific criteria for each
mechanism are described fully in the publications listed in APPLICATION
PROCEDURES.

AWARD CRITERIA

Applications will compete for available funds with all other approved
applications. The following will be considered in making funding
decisions:

o Quality of the proposed project as determined by peer review
o Availability of funds
o Program balance among research areas of the announcement

INQUIRIES

Researchers considering an application in response to this announcement
are encouraged to discuss the project and the range of grant mechanisms
available with NCMRR staff listed below in advance of formal
submission.

Direct inquiries regarding programmatic issues to:

Louis A. Quatrano, Ph.D.
Chief, Applied Medical Rehabilitation Research Branch
National Center for Medical Rehabilitation Research
National Institute of Child Health and Human Development
Executive Plaza South, Room 450W
6120 Executive Boulevard
Rockville, MD 20852
Telephone: (301) 402-2242

or

Danuta Krotoski, Ph.D.
Chief, Basic Medical Rehabilitation Research Branch
National Center for Medical Rehabilitation Research
National Institute of Child Health and Human Development
Executive Plaza South, Room 450W
6120 Executive Boulevard
Rockville, MD 20852
Telephone: (301) 402-2242

For fiscal and administrative inquires regarding this announcement,
potential applicants may write or call:

E. Douglas Shawver
Office of Grants and Contracts
National Institute of Child Health and Human Development
Executive Plaza North, Room 501
6130 Executive Boulevard
Rockville Pike, MD 20892
Telephone: (301) 496-1303

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.