Full Text DC-93-003

NIDCD-NASA CENTER FOR VESTIBULAR RESEARCH

NIH GUIDE, Volume 21, Number 37, October 16, 1992

RFA:  DC-93-003

P.T. 34

Keywords: 
  Aerospace Biomedicine 
  Physiology, Human 


National Institute on Deafness and Other Communication Disorders

Letter of Intent Receipt Date:  November 15, 1992
Application Receipt Date:  December 22, 1992

PURPOSE

The National Institute on Deafness and Other Communication Disorders
(NIDCD) of the National Institutes of Health (NIH), in collaboration
with the Life Sciences Division of the Office of Space Science and
Applications, National Aeronautics and Space Administration (NASA),
invites applications for the support of a ground-based research
center to carry out research applicable to vestibular issues
associated with space flight, and fundamental knowledge about the
vestibular system.  In addition to research, the Center will include
a research training component.  The Center will conduct a number of
research projects in humans and/or animals integrated into a program
and centered around the vestibular control of balance and posture and
the regulation of locomotion and other volitional movements.

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 RFA,
NIDCD-NASA Center for Vestibular Research, is related to the priority
areas of physical activity fitness, educational and community-based
programs, unintentional injuries, occupational safety and health,
diabetes and chronic disabling diseases, and clinical prevention
services.  Potential applicants may obtain a copy of "Healthy People
2000" (Full Report:  Stock No. 017-001-11474-0) or "Healthy People
2000" (Summary Report:  Stock No. 017-001-11473-1) through the
Superintendent of Documents, Government Printing Office, Washington,
DC 20402-9325 (telephone 202-783-3238).

ELIGIBILITY REQUIREMENTS

Applications may be submitted by domestic 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.  Applications from
minority individuals and women are encouraged.

MECHANISMS OF SUPPORT

This RFA will use the NIH Comprehensive Center (P60) grant mechanism.
The Application Guidelines for Program Project and Clinical Research
Center Grants issued by the NIDCD (rev. Nov. 1991) applies to this
solicitation and should be consulted by the applicant.  In addition,
certain provisions in the announcement on National Research Service
Awards for Institutional Training Grants issued in the NIH Guide for
Grants and Contracts (Vol. 21, No. 11, March 20, 1992) also apply to
this solicitation.  Responsibility for the planning, direction, and
execution of the proposed project will be solely that of the
applicant.

The total project period for applications submitted in response to
the present RFA must be five years.  The anticipated award date will
be July 1, 1993.

This RFA is a one-time solicitation.  At present, the NIDCD and NASA
have made no commitment to continue support for the Center beyond
five years.
 Applicants from institutions that have a General Clinical Research
Center (GCRC) funded by the NIH National Center for Research
Resources (NCRR) may wish to identify the GCRC as a resource for
conducting the proposed research.  In such a case, a letter of
agreement from either the GCRC program director or Principal
Investigator may be included with the application.

FUNDS AVAILABLE

One Center will be supported jointly by NIDCD and NASA at a level of
up to $1 million total (direct plus indirect) costs per annum for a
project period of five years.  Budget increments after the first year
will be limited to necessary cost-of-living increases.  Although
funds for stipends for research trainees will be provided from funds
for the center, the stipend levels should be set at the level of the
NIH National Research Service Award (NRSA) program.  Although this
Center is provided for in the financial plans of the NIDCD and NASA,
awards pursuant to this RFA are contingent upon the availability of
funds for this purpose.

RESEARCH OBJECTIVES

Background

The importance of vestibular function in the motor performance of
humans in both the terrestrial and aerospace environments has long
been recognized.  Vestibular-deficient individuals, including
astronauts during flight and the early postflight period, show
abnormalities in trunk and head coordination. Indeed, acute
vestibulogenic changes, the effects of a lesion or the functional
unloading of the otolithic gravity receptors in space result in
dramatic symptoms of imbalance and disorientation, including reduced
muscle tone, gait and postural ataxia, and illusory self-orientation
and self-motion sensations.  Typically, these symptoms abate as
central nervous system motor programs for the reinterpretation of
sensory inputs and coordination of muscle actions undergo adaptation.

Postural control results from the integration of vestibular signals
with input from the visual and somatosensory receptors and other
motor control systems.  These integrated inputs, in turn, generate
complex activation patterns of arm, leg, trunk, and neck muscles
resulting in stabilizing movements.  To date, there has been little
systematic study of the contributions of the vestibular system to
balance control.  Early studies have underscored the primacy of
proprioceptive afferent signals from the lower leg muscles in
postural control.  Only when experimental manipulations render
proprioception inaccurate will vestibular inputs acquire greater
importance.  It has, therefore, been suggested that stabilizing
reactions may be triggered or gated by proprioceptive inputs and then
amplitude-modulated by vestibulo-spinal inputs.  Somatosensory input
from the limbs may be of greater importance to terrestrial balance
control than vision.  In the weightlessness of space, however,
vision is of primary importance in maintaining a spatial reference
for self-orientation.

Several lines of evidence support the contemporary view that both the
vestibular and somatosensory systems play a direct and prominent role
in terrestrial balance control, although the specific role of each in
triggering and coordinating postural corrections in response to
mechanical perturbations of the support surface, the head and the
trunk, remain to be elucidated.  There is convincing anatomic and
physiologic evidence of the convergence and interaction of the
vestibular and somatosensory systems at multiple levels throughout
the neuroaxis, at both the sensory input and motor output stages.
Furthermore, there is experimental evidence of a sensory substitution
process following the loss of either vestibular or somatosensory
inputs.  Both visual and vestibular inputs have been implicated in
the control of head stabilizing mechanisms during natural motion.
The otolithic organ-dependent response of the lower extremity
postural reflexes have been shown to be reduced in humans during
parabolic flight and space orbit in response to sudden "falls."  In
addition, patients with vestibular loss have been shown to exhibit
alterations in the magnitude, timing and adaptation of stabilizing
reactions to mechanical support surface perturbations.

Scope

The challenge of this initiative is to define the contributions of
the vestibular system to the control of balance and posture and the
regulation of locomotion and other volitional movements.  Such
knowledge will provide a solid empirical basis for the improved
rehabilitation of patients with balance disorders and for management
of the sensorimotor and perceptual difficulties associated with space
travel.  Our understanding of postural adaptation to microgravity is
limited, but clearly predicated on an understanding of normal
function in the terrestrial gravito-inertial environment.  Hence the
need for ground-based studies.

While the neural pathways subserving the gaze-stabilizing reflexes
are well-understood, we have a very rudimentary understanding of the
neuronal substrates of the postural reflexes.  Mathematical modeling
of reflex behavior has proven to be an important method for relating
reflex behavior to its neural substrates.  To date, the dynamic
three-dimensional spatial transformations associated with the
vestibulo-ocular and vestibulo-collic reflexes have been modeled.

The major research objective of this RFA is to characterize the
relative roles of the semicircular canal, otolithic organ and
canal-otolithic organ interactive inputs to the vestibulo-spinal
reflexes and the balance motor control systems.  A requisite
component of this research effort includes the development of a
computational model of the sensory-to-motor transformation relating
the vestibular balance control system to its neural substrates.  This
model should be driven and validated by experimental data generated
by this project.  The Center is intended to support a team of
investigators pursuing basic and applied studies at the systems and
neuronal substrate levels to conduct an integrated, multidisciplinary
inquiry into the vestibular bases of balance control.

The purpose of the research training component of the Center is to
develop opportunities for training individuals to conduct research in
the vestibular sciences.  The research training program will provide
multidisciplinary training for physicians, predoctoral trainees and
postdoctoral trainees in the areas of vestibular science that are
encompassed by the application.  The research training component of
the Center must provide opportunities for individuals with varying
levels of research experience.  Program directors are expected to
select postdoctoral trainees who are genuinely interested in a career
in research.  Plans for recruitment of underrepresented minorities,
women, and persons with disabilities must be included within this
component of the application (see the announcement in the NIH Guide
for Grants and Contracts, Vol. 18, No. 20, June 9, 1989).

The Center will be established exclusively for ground-based research
and analysis; budgets of the approved center will not support space
flight experiments.  Center investigators wishing to propose space
experiments should submit appropriate applications in response to
formal NASA solicitations open for general competition.

It is required that a description of the institution's plan to
provide instruction on the responsible conduct of research be
included in the application (see the announcement in the NIH Guide
for Grants and Contracts, Vol. 19, No. 30, August 17, 1990).

SPECIAL REQUIREMENTS

The program director and one additional investigator of the Center
will meet annually in the Washington, DC area with the scientific
program staffs of the Division of Communication Sciences and
Disorders, NIDCD, and the Life Sciences Division, NASA, to review the
progress of the Center in the areas of research and research
training.

Budget requests for travel must reflect the costs associated with
this meeting.  In addition, applicants should state their willingness
to participate in this meeting.

STUDY POPULATIONS

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

NIH policy is that applicants for NIH clinical research grants and
cooperative agreements are 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 must be placed on the need for inclusion of
minorities and women in studies of diseases, disorders and conditions
which 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 must be provided.

The composition of the proposed study population must be described in
terms of gender and racial/ethnic group.  In addition, gender and
racial/ethnic issues must be addressed in developing a research
design and sample size appropriate for the scientific objectives of
the study.  This information must be included in the form PHS 398 in
Sections 1-4 of the Research Plan AND summarized in Section 5, Human
Subjects.  Applicants are urged to assess carefully 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/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 is defined as human
biomedical and behavioral studies of 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 tissues 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.

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 questions(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 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.

LETTER OF INTENT

Prospective applicants are asked to submit, by November 15, 1992, a
letter of intent that includes a descriptive title of the proposed
research, the name, address, and telephone number of the Center
director, 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 subsequent applications, the information
that it contains is helpful in planning for the review of
applications.  It allows NIDCD staff to estimate the potential review
workload and to avoid conflict of interest in the review.

The letter of intent is to be sent to --

Earleen Elkins, Ph.D.
Chief, Scientific Review Branch
National Institute on Deafness and Other Communication Disorders
Room 400-B, Executive Plaza South
6120 Executive Boulevard
Rockville, MD  20892

APPLICATION PROCEDURES

The research grant application form PHS 398 (rev. 9/91) is to be used
in applying for these grants.  These forms are available at most
institutional business offices; from the Office of Grants Inquiries,
Division of Research Grants, National Institutes of Health, 5333
Westbard Avenue, Room 449, Bethesda, Maryland 20892, telephone
301/496-7441; and from the NIH program administrator named below.

The RFA label available in the PHS 398 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 2a 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
Westwood Building, Room 240
Bethesda, MD  20892**

At the time of submission, two additional copies of the application
must also be sent to Dr. Earleen Elkins at the address listed under
LETTER OF INTENT.

Applications must be received by December 15, 1992.  If an
application is received after that date, it will be returned to the
applicant.  The Division of Research Grants (DRG) will not accept any
application in response to this announcement 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 by NIH staff for
completeness and responsiveness.  Incomplete applications will be
returned to the applicant without further consideration.  If the
application is not responsive to the RFA, NIDCD staff will return the
application to the applicant.

If the number of applications is large, the NIDCD may conduct a
preliminary scientific peer review to eliminate those applications
that are clearly not competitive.  The NIDCD will withdraw from
further competition those applications judged to be noncompetitive
and notify the applicant and institutional official.

Those applications judged to be competitive will undergo further
scientific merit review and a site visit or applicant interview in
the Washington, DC area.  Those applications that are complete and
responsive will be evaluated in accordance with the criteria stated
below for scientific/technical merit by an appropriate peer review
group convened by the NIDCD and NASA.  The second level of review
will be provided by the National Deafness and Other Communication
Disorders Advisory Council and the NASA Life Sciences Division.

The Special Review Committee will use the following criteria in
evaluating applications:

a.  The criteria for reviewing the Center as an integrated effort
are:

o  the integration of the multidisciplinary enterprise with adequate
plans for interaction and communication of information among the
collaborating investigators;

o  the coordination and interrelationship among the individual
research projects and cores and the relationship of the project
objectives to the common theme;

o  leadership ability and scientific stature of the Center director
and his/her commitment of sufficient time and effort for effective
leadership;

o  participation of a suitable number of responsible, experienced
investigators;

o  an organizational and administrative structure appropriate for
effective attainment of program objectives;

o  arrangements for internal quality control of ongoing research, the
allocation of funds, day-to-day management, collaborative
arrangements with other institutions, if any;

o  the adequacy of facilities to support the components of the
Center;

o  institutional commitment to the requirements of the Center;

o  appropriateness of the overall budget for the proposed program;
and

o  the technical merit and justification of each core unit; the
appropriateness of each research project's use of core services; and
the cost effectiveness and quality control of core units.

b.  The criteria for reviewing individual research components are:

o  approach and adherence to the scientific requirements of the RFA;

o  the scientific merit of each project;

o  qualifications, experience, and commitment of the investigators
and their ability to devote the required time and effort to the
program;

o  the appropriateness of the budget for each research project;

o  adequacy of the means proposed for protecting against risks to
human subjects, animals and the environment; and

o  the inclusion of minorities and women in study populations,
whenever feasible and appropriate.

c.  The criteria for reviewing the research training component are:

o  the proposed research training objectives and program design;

o  qualifications and research experience of the participating
faculty in the proposed areas of research training;

o  adequacy of the training environment, including laboratory and
clinical facilities;

o  the previous training record of the research program; and

o  the plan to provide instruction to trainees on ethics and
scientific integrity in research.

In addition, the research training component must include an
affirmative plan for the recruitment of underrepresented minorities,
women, and disabled individuals.

AWARD CRITERIA

The anticipated date of award is July 1993.

Selection will be made jointly by the NIDCD and NASA on the basis of
assessment of the applications by peer review, considerations of
programmatic balance, and the appropriation of allocated funds for
this RFA.

INQUIRIES

Written and telephone inquiries concerning this RFA are encouraged.
The opportunity to clarify any issues and questions from potential
applicants is welcome.

Direct inquiries regarding programmatic issues to --

Daniel A. Sklare, Ph.D.
Division of Communication Sciences and Disorders
National Institute on Deafness and Other Communication Disorders
Executive Plaza South, Room 400-B
6120 Executive Boulevard
Rockville, MD  20892
Telephone:  (301) 402-3461
FAX:  (301) 402-6251

Direct inquiries regarding fiscal matters to --

Sharon Hunt
Grants Management Branch
Division of Extramural Activities
National Institute on Deafness and Other Communication Disorders
Executive Plaza South, Room 400-B
6120 Executive Boulevard
Rockville, MD  20892
Telephone:  (301) 402-0909
FAX:    (301) 402-1758

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic
Assistance No. 93.173 .  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 42CFR 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.

.

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