Subject: NIH GUIDE - RFA HD-92-08 - V21(04) 01/31/92
From: Dot Baker <[email-masked]>
To: [email-masked]
Date: Thu, 30 Jan 92 07:56 EST

Hi,
   Please post to the NIH LIstserver as:
   RFAHD-92-08.920131
 ---------------------------- Text of forwarded message -----------------------
 
$$XID RFA HD9208 HD-92-08 P1O1 *****************************************
 
ORTHOTICS AND PROSTHETICS RESEARCH
 
RFA:  HD-92-08
 
P.T. 34; K.W. 0415003, 0740070, 0710020, 1004015, 0710030
 
National Institute of Child Health and Human Development (NICHD)
 
Application Receipt Date:  May 26, 1992
 
PURPOSE
 
The National Center for Medical Rehabilitation Research (NCMRR) of the
National Institute of Child Health and Human Development (NICHD)
invites research grant applications (R01) to develop new knowledge in
the area of orthotic devices and internal and external prosthetic
devices.  Basic, clinical, and applied research applications that
examine the development and improvement of orthotic and prosthetic
devices are of high priority.  Interdisciplinary, collaborative
projects between specialists in physical and rehabilitation medicine
(physiatry), basic and social sciences, and biomedical engineering are
encouraged to apply improved understanding of human functioning and
behavior to the development and improvement of rehabilitation devices.
 
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), Orthotics and Prosthetics 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" (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 public and private non-profit and for-
profit organizations such as universities, colleges, hospitals,
laboratories, units of State or local governments, and eligible
agencies of the Federal Government.  Women and minority investigators
are encouraged to apply.
 
MECHANISM OF SUPPORT
 
The support mechanism for this RFA is the regular research project
grant (R01).  Awards will be administered under PHS grants policy as
stated in the Public Health Service Grants Policy Statement.
Applicants must furnish estimates of the duration required to conduct
the proposed research.  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 will be
September 1992.
 
This RFA is a one-time solicitation.  Future unsolicited competing
continuation applications will compete with all investigator-initiated
applications and be reviewed according to the customary NIH peer review
procedures.
 
FUNDS AVAILABLE
 
Applications submitted in response to this announcement will compete
for approximately $1,000,000 in grant money that has been made
available for this purpose in Fiscal Year 1992.  This is a one-time
announcement.  The number of awards depends upon the scientific merit
of the applications, the degree of relevance to the stated goal of the
announcement and the availability of funds.
 
RESEARCH OBJECTIVES
 
Background
 
On November 16, 1990, the President signed P.L. 101-613, establishing
the NCMRR within the NICHD.  The mandate of the NCMRR includes the
conduct and support of research on the development of orthotic and
prosthetic devices.  Earlier in 1990, the NIH organized a task force of
more than 100 clinicians and researchers with expertise in a wide range
of medical, biological, allied health, and social sciences to assess
medical rehabilitation research.  These experts conducted a sweeping
survey of research needs, challenges, and opportunities in
rehabilitation medicine (Report of the Task Force on Medical
Rehabilitation Research, 1990).  One of the priority areas identified
for research was orthotics and prosthetics.
 
This RFA also implements the recommendation concerning research on the
development and improvement of orthotic and prosthetic devices
contained in the language of the National Institutes of Health
Amendments of 1990.
 
Scope
 
During the past decade, new developments in robotics, artificial
intelligence, ergonomics, computer hardware and software, biomechanics,
and voice entry of language have set the stage for the development of
a new generation of orthotics and prosthetics.  Opportunities exist for
improving the design, performance, and biocompatibility of materials
used in these devices, creating a better customized fit, devising more
lifelike operation of prosthetics, developing adjustable and expandable
prostheses that permit expansion for growing children, and improving
braces and seating systems.  Advances in functional neuromuscular
stimulation (FNS) have moved out of the laboratory into clinical
application.  The field of rehabilitation is poised to benefit
significantly from the cross-fertilization among engineering, material
science, and ergonomics.
 
This RFA invites scientists to submit grant applications for research
on the development and improvement of prosthetics and orthotics.
Applicants must propose investigations that employ interdisciplinary
tactics for conducting research with the goals of maximizing function,
comfort and support, cost effectiveness, and the highest degree of
replication of natural function possible.  Specific topics cited below
are examples and should not be considered exhaustive of the potential
types of research questions on orthotics and prosthetics that could be
supported under this RFA.
 
o     Biomaterials - development of new composite materials for
prosthetics and orthotics
 
o     Energy consumption and prosthetic use - physiological costs of
ambulation
 
o     Gait changes with different prosthetic devices - optimal mobility
using device
 
o     Prosthetic and orthotic device design development for different
functions - new functions for different settings
 
o     Biomechanics of prosthetic attachment to limbs - simulation of
normal motion
 
o     Tissue properties under physiological loads - in situ evaluation
of tissue properties
 
o     Methods of powering prosthetic devices - e.g., myoelectric or
mechanically powered devices
 
o     Computers in the design and manufacture of prosthetic devices -
dynamic CAD (computer assisted design)
 
o     Sensory feedback systems which are adaptable to prosthetic and
orthotic devices - improvement in tactile, proprioceptive, and pressure
sensors
 
o     Impact of surgery as related to orthotics and prosthetics
 
o     Effects of long-term use of orthotics and prosthetics
 
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
 
Applications are to be 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, NIH, Westwood
Building, Room 449, Bethesda, MD 20892, telephone (301) 496-7441.  The
receipt deadline for applications prepared in response to this RFA is
May 26, 1992.  Late applications will be returned to the applicant
without review.
 
The RFA label available in the 9/91 version of application form 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 two on the face page of the application and type
"Orthotics and Prosthetics Research, HD-92-08."  The original and four
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 to applications and copies mailed to the Division of
Research Grants, two copies of the application must be sent under
separate cover to:
 
Laurance Johnston, Ph.D.
Acting Director, Division of Scientific Review
National Institute of Child Health and Human Development
Executive Plaza North, Room 520
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 an unsolicited application during one of the three yearly
review cycles (February 1, June 1, and 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 has not yet
been reviewed, the applicant will 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 the substantial revisions of
applications already reviewed, but such applications must include an
introduction addressing the previous critique.
 
Responsive applications may be evaluated by preliminary triage in a
peer review group to determine scientific merit relative to other
applications received in response to this RFA.  Those applications
judged to be non-competitive will be withdrawn and the applicant and
the institutional business official will be notified. Those
applications judged to be competitive will be further evaluated for
technical and scientific merit by a review panel convened for this
purpose by the Division of Scientific Review, NICHD.
 
Review criteria will be those used by the PHS to evaluate investigator-
initiated R01 applications:
 
o  Thorough knowledge of scientific literature in appropriate fields
 
o  Scientific, technical, or medical significance and originality of
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 resources necessary to perform the research
 
o  Appropriateness of the proposed budget and duration in relation to
the proposed research
 
Following the initial review by study section applications will be
reviewed by the NICHD National Advisory Council.
 
AWARD CRITERIA
 
Applications will compete for available funds with all other approved
applications assigned to NCMRR, NICHD.  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 announcement
 
INQUIRIES
 
Requests for additional information 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
Executive Plaza North, Room 501
6130 Executive Boulevard
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.