Subject: (Copy) NIH GUIDE - Vol. 19, No. 45, December 14, 1990 - RFA NS
From: Dot Baker <[email-masked]>
To: [email-masked]
Date: Mon, 10 Dec 90 08:16 EST

Hi Paul,
  Number two coming to you.  Please post as: RFANS-91-02.901214
   Thanks.  Dottie
 ---------------------------- Text of forwarded message -----------------------
 
CLINICAL RESEARCH CENTERS ON HEAD INJURY, SPINAL CORD
INJURY, AND CNS TRAUMA
 
RFA:  NS-91-02
 
P.T. 34; K.W. 0715027, 0715210, 0705010, 0705055
 
National Institute of Neurological Disorders and Stroke
 
Letter of Intent Receipt Date:  March 1, 1991
Application Receipt Date:  April 26, 1991
 
PURPOSE
 
The National Institute of Neurological Disorders and Stroke
(NINDS) invites applications for clinical research centers
dealing with head injury, or spinal cord injury, or central
nervous system (CNS) trauma; or feasibility (exploratory)
grants for the development of such centers.  The major
purpose of this Request for Applications (RFA) is to
increase the extent and depth of basic research that will
lead to improved clinical treatment and to increase
clinical research on the restoration and preservation of
function after head and (or) spinal cord injury.
 
DISCIPLINES AND EXPERTISE
 
The Center Director or Principal Investigator must be
active in a discipline related to central nervous system
trauma, such as neurosurgery, neurology,
neurorehabilitation, neuropsychology, neurophysiology,
neuropharmacology, or neuroanatomy, and have demonstrated
the capability for developing and directing a research
program.  Interrelated biomedical research projects
included in the interdisciplinary research centers should
be conducted by  scientists who represent a variety of
disciplines within basic, applied, and clinical science and
who are willing and able to relate to each other so that
new scientific leads may be freely developed and
effectively utilized by others.  For purposes of planning,
it is important to recognize that the content of the
individual components of a research center is critical; the
research center program must be organized around a central
research theme and must encompass a sufficient number of
scientifically meritorious research activities to permit an
effective collaborative effort among the participating
investigators.
 
ELIGIBILITY
 
To be eligible for competition under this RFA, applicants
must document the existence of, or potential for, ongoing
basic, applied, and clinical research related to
CNS trauma; research resources in
neurosciences; clinical facilities that demonstrate the
ability to adequately receive and track patients suffering
CNS injuries; cooperation among investigators within
represented disciplines so that scientific leads may be
effectively implemented; and a plan for the further
development of individual investigators, fellows, or
clinicians in specialized techniques or procedures relevant
to research in central nervous system trauma.
 
SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF
NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN
CLINICAL RESEARCH STUDY POPULATIONS
 
NIH and ADAMHA policy is that applicants for NIH/ADAMHA clinical
research grants and cooperative agreements 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 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 for non-conformance to the policy should 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 should be addressed in
developing a research design and sample size appropriate for the
scientific objectives of the study.  This information should be
included in the form PHS 398 in Section 2, A-D of the Research
Plan AND summarized in Section 2, E, Human Subjects.
Applicants/offerors 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., 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 of etiology, epidemiology,
prevention (and preventive strategies), diagnosis, or treatment
of diseases, disorders or conditions, including but 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.
 
For foreign awards, the policy on inclusion of women applies
fully; since the definition of minority differs in other
countries, the applicant must discuss the relevance of the
proposed study for specific racial/ethnic minorities in the
United States.
 
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 or do not have an approved compelling
rationale for non-compliance.
 
BACKGROUND
 
Each year, over 500,000 Americans sustain an injury to the
CNS.  It is especially tragic that many of the victims are
young adults.  Often these injuries result in permanent
impairment of function that may prevent the victims from
returning to their previous participation in society or
from functioning adequately and independently.  Depending
on the regions within the brain or spinal cord that are
damaged and on the severity of that damage, the injury can
result in loss of motor function, sensation, intellect, or
memory--or any combination of these.  Some victims of
injury to the central nervous system remain in coma for
extended periods; some remain in a persistent vegetative
state for years; and many experience only partial return of
function that limits their physical, emotional, or
intellectual capabilities.
 
Traditionally, scientists and clinicians believed that the
damaged nerve cells in the brain and spinal cord were
incapable of survival or repair after a traumatic lesion;
however, recent results from basic research and clinical
trials demonstrate that damaged nerve cells may be able to
function again.  It is now accepted that there is a
time-related series of complex biochemical events that
occur within the first hours after injury and appear to
increase damage (secondary injury).  Scientists have shown
that nerve cells from the mammalian central nervous system
sprout new branches after injury, that glial cells respond
to minimize damage to the environment of the CNS, and that
prevention of certain biochemical alterations enhances
neuronal survival.  These results combine to indicate that
trauma to the nervous system is a treatable condition.  New
treatments need to be developed, tested against existing
forms of therapy, and evaluated in carefully designed,
controlled clinical trials.  Research leads must be
followed if improved methods of CNS repair and restitution
of function are to be developed.
 
RESEARCH GOALS AND SCOPE
 
The overall purpose of this RFA is to establish a regional
network of collaborating centers for the development and
implementation of treatment modalities based on promising
research.  Areas of research appropriate to this RFA
include, but are not limited to:  therapeutic approaches in
the treatment of acute, subacute, and chronic CNS injury;
identification of risk factors, prevention strategies, and
outcome results within local patient populations suffering
CNS injury; development and evaluation of improved methods
for restitution of function; molecular biology and
potential therapeutic use of putative growth and trophic
factors; models of injury to the nervous system, including
assessment criteria for return of function and biomechanics
of CNS injury; preclinical testing of pharmacological
agents that address specific mechanisms of neuronal damage;
cellular and tissue implantation as a treatment of CNS
injury; and molecular and cellular characteristics of
primary and secondary injury.
 
Center Grants (P50).  The minimum requirements for clinical
research centers (P50) include:
 
o  a research program devoted to the study of head and (or)
spinal cord injury.  This effort should be a combination of
basic, applied, and clinical research; however, emphasis
should be on a cooperative effort directed at a common
research theme relevant to the improvement of clinical
outcome;
 
o  a data center with biostatistical and epidemiological
competence responsible for tracking patients from the
applicant institution (or named collaborating institutions)
suffering trauma to the CNS.  This component should have
the capability to serve as a resource to define such issues
as patient accrual, cause of injury, and outcome parameters;
 
o  resources for furthering the development of
investigators in specialized methods relevant to the study
of CNS trauma.  These resources may include salary for
junior investigators, sabbatical periods for senior
investigators, and allotments to allow exchange programs
with other institutions involved in the study of CNS trauma
or relevant areas of basic or clinical neuroscience; and
o  an administrative core devoted to the integration and
coordination of activities within the research center and
among the colloquium of research centers selected for
funding.  Program directors will be required to meet
regularly among themselves and with NINDS staff to discuss
scientific issues resulting from the research efforts and
to promote exchange of new ideas and findings.
 
Feasibility grants (P20).  Applicants for the feasibility
grant (P20)  may be at an early stage of programmatic or
facilities development, but should base their applications
on the ultimate goal of creating a clinical research
center.  Therefore, the format of the application should
address the essential components as outlined above, that
is:
 
o  a research program centered around a unifying theme
relevant to restoration of function after head and (or)
spinal cord injury;
 
o  a data center in biostatistics and epidemiology
responsible for tracking patients from the applicant
institution (or named collaborating institutions) suffering
trauma to the CNS;
 
o  resources for furthering the development of
investigators in specialized methods relevant to the study
of CNS trauma; and
 
o  an administrative core devoted to the integration and
coordination of activities within the research center and
among the research centers selected for funding.
 
Emphasis should be placed on the existing and potential
strengths of the applicant organization related to the
development of a clinical research center.  Appropriate
areas may include, but are not limited to:  development of
additional research capabilities for basic, applied, and
clinical research; arrangements for improved capabilities
in biostatistics, epidemiology, or patient accrual;
arrangements for collaborations to augment existing
research strengths; identification of essential personnel
for recruitment; development of plans for acquiring or
providing special research skills; and collaborations to
ensure the availability of patients for clinical study.
 
MECHANISM OF SUPPORT
 
The support mechanism for this program will be the research
center grant (P50) or the exploratory (feasibility) grant
(P20).  Applicants are requested to furnish their own
estimates of the time required to achieve the objectives of
the proposed center or developmental program.  Center
grants will be awarded for up to five years (renewable);
feasibility grants will be awarded for up to three years
(not renewable).
 
The NINDS expects to make up to three awards for center
grants and (or) up to ten awards for exploratory grants,
depending upon availability of funds.  No research center
grant (P50) may exceed annual direct costs of $750,000 for
each of five years; no exploratory grant (P20) may exceed
annual direct costs of $250,000 for each of three years.
The current policies and requirements that govern the
research grant programs of the NIH will prevail.
 
REVIEW PROCEDURES AND CRITERIA
 
Review Method
 
Upon receipt, applications will be reviewed by NINDS staff
to determine administrative and programmatic responsiveness
to this RFA.  Applications judged unresponsive will be
returned to the applicant.  NOTE: APPLICATIONS THAT DO NOT
CONFORM TO THE INSTRUCTIONS CONTAINED IN THE PHS 398
(rev. 10/88, reprinted 10/89) APPLICATION KIT WILL BE JUDGED
NON-RESPONSIVE AND WILL BE RETURNED TO THE APPLICANT.
 
All applications that are complete and responsive to this
RFA may be subjected to a triage by an NINDS peer review
group to determine relative scientific merit among the
applications.  The NINDS will administratively withdraw
those applications judged to be noncompetitive for award
and will notify the applicant Principal Investigator and
institutional business official.
 
Those applications judged to be competitive for award will
be further reviewed for scientific and technical merit by
an initial review group convened by the Division of
Extramural Activities, NINDS, during June/July 1991.  A
final level of review will be by the National Advisory
Neurological Disorders and Stroke Council in September 1991.
 
Review Criteria
 
Application for Research Center Grant.  The factors to be
considered in the evaluation of the merit and promise of
each application will include an assessment of the
likelihood that the proposed center would be capable of
achieving significant biomedical research on the
restoration of neural function after traumatic injury to
the CNS; the extent and promise of the integrative aspects
of the proposed center; the importance of the proposed
activities to the objectives of this RFA; the training,
experience, and research competence of the applicant
investigator and potential collaborators; the commitment of
the Center Director and senior investigators to communicate
and collaborate within the center and share information
with colleagues in the centers program; the suitability of
the resources and facilities; availability of a population
of head and spinal cord injured patients; facilities and
personnel to follow and analyze epidemiological data on CNS
injured patients; capacity to provide technical experience
to junior and senior investigators in methodologies
relevant to CNS injury, as well as planned or projected
access to additional techniques or collaborations; and the
appropriateness of the requested budget to the work
proposed.
 
Application for Feasibility Grant.  The factors to be
considered in the evaluation of the merit and promise of
each application will focus on the potential for the
applicant institution to develop into a full clinical
research center; potential access to appropriate patient
populations; arrangements to augment or establish
biostatistical or epidemiological capabilities; presence of
facilities for basic, applied, or clinical research, with
the potential to develop other areas; plans for future
development in innovative areas of research and recruitment
of needed personnel; planned collaborations to strengthen
existing facilities; plans for further development of
existing research personnel and exchange of ideas and
techniques; and feasibility of the planned research within
the time and budget requested.
 
METHOD OF APPLYING
 
Letter of Intent
 
The NINDS urges applicants to submit a letter of intent
that  includes: the name and address of the Principal
Investigator, the names and addresses of co-investigators
who will be responsible for the research projects and
required components within the center, a descriptive title
of each research project and each required component for
which support will be requested, and the identification of
any collaborating institutions.  Letters should specify
whether the application will be for the research center
(P50) or for the feasibility grant (P20) mechanism.  A
letter of intent is not binding, does not enter into the
review of a subsequent application, and is not a
precondition for an award.  The information provided will
be used by NINDS staff in planning for the review of
applications to estimate the potential workload and to
avoid possible conflict of interest.  The letters should be
RECEIVED NO LATER THAN MARCH 1, 1991, and sent to Dr. Mary
Ellen Michel at the address below.
 
Format of Applications
 
All applicants will submit applications on form PHS 398 (rev. 10/88),
the application form for the traditional research project
grant.  This form is available in an applicant
institution's office of sponsored research or business
office.
 
Applicants for both the research center grant (P50) and the
feasibility grant (P20) should use the application format
as described in the NINDS pamphlet, "Application
Guidelines: Program Project and Clinical Research Center
Grants" (revised October 1989), which may be obtained from
Dr. Mary Ellen Michel at the address below.
 
To identify the application as a response to this RFA,
check "yes" on item 2 of page 1 of the application and
enter the title "NINDS: HEAD, SPINAL CORD INJURY CLINICAL
RESEARCH CENTERS" and the RFA number NS-91-02.  The RFA
label available in the 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 review.
 
Application Procedure
 
Send or deliver the completed application and four (4)
signed, exact photocopies to:
 
Division of Research Grants
Westwood Building, Room 240
National Institutes of Health
Bethesda, MD  20892**
 
In addition, send two (2) exact photocopies to Dr. Mary
Ellen Michel at the address below.
 
This RFA is a one-time solicitation with a SPECIFIED
DEADLINE OF APRIL 26, 1991.  An application not received by
close of business on this date will be ineligible for
consideration.  The review for scientific and technical
merit of applications judged responsive to the RFA will
take place in June/July 1991.  THERE WILL BE NO SITE
VISITS.  Review by National Advisory Neurological Disorders
and Stroke Council will be in September 1991.
Awards will be made on or before September 30, 1991.
 
INQUIRIES
 
Inquiries regarding this announcement may be directed to:
 
Dr. Mary Ellen Michel
Division of Stroke and Trauma
National Institute of Neurological Disorders and Stroke
Federal Building, Room 8A13
Bethesda, MD  20892
Telephone:  (301) 496-4226
 
The program to which the intended grants relate is
described in the Catalog of Federal Domestic Assistance,
entry numbers 93.853, "Clinical Research Related
Neurological Disorders" and 93.854, "Biological Basis
Research in the Neurosciences".  Grants will be awarded
under the authority of the Public Health Service Act, Title
IV, Section 301 (Public Law 78-410, as amended; 42 USC 241),
and administered under PHS grant policies and Federal
Regulations 42 CFR Part 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.