Full Text HD-93-012

ASSISTIVE DEVICES AND SKIN INTEGRITY

NIH GUIDE, Volume 22, Number 4, January 29, 1993

RFA:  HD-93-012

P.T. 34

Keywords: 
  Vaccine 
  BIOMEDICAL ENGINEERING 
  Biomaterials 


National Institute of Child Health and Human Development

Letter of Intent Receipt Date:  March 29, 1993
Application Receipt Date:  May 25, 1993

PURPOSE

The National Center for Medical Rehabilitation Research (NCMRR) of
the National Institute of Child Health and Human Development (NICHD)
invites research grant applications on issues related to measurement,
biomaterials, clinical and behavior aspects of assistive devices and
skin integrity that will improve or enhance functional mobility in
persons with mobility limitations.  Basic, clinical and applied
research applications that address these areas are of high priority.
Interdisciplinary collaborative projects that focus study on the
human-machine interface of assistive devices and skin integrity are
also 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 Request for
Applications (RFA), Assistive Devices and Skin Integrity, 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.
017-001-474-0, or Summary Report:  Stock No. 017-001-473-1) 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, public and
private non-profit and for-profit organizations such as universities,
colleges, hospitals, laboratories, units of state and local
governments, and eligible agencies of the Federal government.  Women
and minority investigators are encouraged to apply.

MECHANISM OF SUPPORT

This RFA will use the National Institutes of Health (NIH) individual
research project grant (R01).  Responsibility for the planning,
direction, and execution of the proposed project will be solely that
of the applicant.  Project support may be requested for one to five
years and may be renewed according to the conventional procedures
that pertain to PHS grants.  The earliest anticipated award date will
be September 1993.

This RFA is a one-time solicitation.  Future unsolicited competing
applications will compete with all investigator-initiated
applications and will be reviewed according to the customary NIH peer
review procedures.

FUNDS AVAILABLE

Applications submitted in response to this announcement will compete
for approximately $900,000 in grant money that has been made
available for this purpose in Fiscal Year 1993.  It is expected that
five awards will be made.  The number of awards depends upon the
overall scientific merit of the applications and the availability of
funds.

RESEARCH OBJECTIVES

The goal of the NCMRR is to promote research that will lead to the
replacement, enhancement or restoration of function in persons with
physical disabilities in order to maximize their functional
capabilities, both immediately after the onset of the disabling
condition and throughout the lifespan.  The NCMRR has identified
seven research priority areas.  This RFA will address three of these
areas:  the improvement of mobility, the whole body system response
to chronic injury, and advances in assistive technologies.

The purpose of this RFA is to expand fundamental knowledge  on the
human-machine interface of assistive devices.  One major aspect of
this is improving the fit of devices to reduce secondary
complications associated with skin breakdown and subsequent reduction
in functional mobility.  The socket interface is one of the most
important components in a prosthesis.  Even the most advanced
prosthetic knee joint or foot component does not compensate for a
poorly designed socket. Human tissue must be contained in the socket
so that forces across the stump/socket interface permit biological
function and provide for comfortable weight-bearing distribution.

Another major focus of this RFA will be on identifying underlying
factors that will reduce integumentary breakdown and enhance skin
integrity at the stump socket interface.  Studies are needed to
identify biological factors that either reduce or prevent the
formation of decubitus ulcers, as well as those that promote skin
healing.  In order to maximize the function of prosthetic devices
and, hence, the human function of their users, we encourage basic,
clinical, and applied research on the human/machine interface, where
a residual limb meets the socket of an artificial limb.

This RFA invites scientists to submit grant applications to support
research on assistive devices and skin integrity that will improve or
enhance functional mobility in persons with mobility limitations.  A
partial list of representative research topics is cited below to
serve as a guide for applications solicited by this RFA.

Measurement

Development of measurement techniques to capture the individual's
residual limb topography and internal morphology.

Development of devices, biosensors, or microprocessors to measure
thermal, pressure or shear forces associated with use of assistive
devices.

Biomaterials

Development of a socket design to decrease pressures and shear forces
on the residual limb or dissipate heat, increase suspension, enhance
fit of the prosthesis despite fluctuations in residual limb volume
due to swelling and/or perspiration and improve functional mobility.

Development of materials to diminish shear force, friction and pain
while maintaining functional mobility.

Development of assistive devices or materials for limb-deficient
children to accommodate growth and foster continued development in
functional mobility.

Basic research on compounds that promote skin healing, including
localized application of recombinant gene products or growth factors
and procedures that examine long-term changes in skin integrity in
persons who lack sensory or motor innervation.

Clinical

Characterization of techniques for limb length preservation to
maximize the effective interface of the limb and a prosthesis to
enhance function (walking, sitting balance, and bed mobility).

Examination of factors that can be predictive of or lead to the
reduction of skin breakdown that inhibits mobility.

Identification of factors that promote or enhance skin integrity on
residual limbs.

Behavioral

Behavioral research to identify predictive factors for skin breakdown
in people with mobility limitations who utilize assistive devices.

Research on the identification of behaviors that predispose mobility
impaired individuals to skin breakdown including self care, caregiver
behaviors and clinical interventions that reduce the incidence or
improve the healing of skin breakdown.

STUDY POPULATIONS

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

It is NIH policy that applicants for NIH clinical research grants
(i.e., research involving human subjects) 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 Sections 1-4 of the research plan and summarized in Section 5,
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 group 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 subject 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.

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.

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.

LETTER OF INTENT

Prospective applicants are asked to submit, by March 29, 1993, 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 affect the review of subsequent applications, the information
that it contains allows Institute staff to estimate the potential
review workload and to avoid possible conflict of interest in the
review.

The letter of intent is to be sent to Dr. Louis A. Quatrano at the
address listed under INQUIRIES.

APPLICATION PROCEDURES

Applications are to submitted on form PHS 398 (rev. 9/91).  This
application form is available in the business or grants and contracts
office at most academic and research institutions and from the Office
of Grants Inquiries, Division of Research Grants, National Institutes
of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone
(301) 496-7441.  The receipt deadline for applications prepared in
response to this RFA is May 25, 1993.  Late applications will be
returned to the applicant without review.

The RFA label available in the application from PHS 398 must be
affixed to the bottom of the face page.  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 evaluation.

Check "yes" in item 2a on the face page of the application and type
"Assistive Devices and Skin Integrity for Persons with Mobility
Limitations, HD-93-012."  The original and three copies of the
application must be sent or delivered to:

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

In addition, two copies of the application must be sent under
separate cover to:

Susan Streufert, Ph.D., Acting Director
Division of Scientific Review
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 5E01
Bethesda, MD  20892

REVIEW CONSIDERATIONS

Applications will be reviewed by NICHD staff for responsiveness to
the RFA.  Applications deemed non-responsive will be returned to the
applicant.  In the event that an application is returned, the
applicant has the option to resubmit the application to the Division
of Research Grants as a unsolicited application during one of the
three yearly review cycles (February 1, June 1, October 1).  If the
application submitted in response to this RFA is substantially
similar to a grant application already submitted to the NIH for
review, but not yet reviewed, the applicant will be asked to withdraw
either the pending application or the new one.  Simultaneous
submission of identical applications will not be allowed, nor will
essentially identical applications be reviewed by different review
committees.  Therefore, an application cannot be submitted in
response to this RFA that is essentially identical to one that has
already been 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 criteria will be those used by the PHS to evaluate
investigator-initiated R01 applications:

Thorough knowledge of scientific literature in appropriate fields.

Scientific, technical, or medical significance and originality of
proposed research.

Appropriateness and adequacy of the experimental approach and
methodology proposed to carry out the research.

Qualifications and research experience of the Principal Investigator
and staff, particularly but not exclusively in the area of the
proposed research.

Availability of resources necessary to perform the research.

Appropriateness of the proposed budget and duration in relation to
the proposed research.

Following the initial review for scientific and technical merit by a
special review committee convened by the NICHD Division of Scientific
Review, applications will be reviewed by the NICHD National Advisory
Council.

AWARD CRITERIA

The following will be considered in making awards:

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

INQUIRIES

Requests for additional information, the letter of intent, and
inquiries concerning this RFA are encouraged and may be addressed to:

Louis A. Quatrano, Ph.D.
Chief, Applied Rehabilitation Medicine 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 inquiries regarding this announcement,
potential applicants may contact:

E. Douglas Shawver
Office of Grants and Contracts
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 8A17F
Rockville, MD  20892
Telephone:  (301) 496-1303

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.

.

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