Subject: RFANR/AG-91-01.910118 l/l8/9l NIH Guide
From: Dot Baker <[email-masked]>
To: [email-masked]
Date: Wed, 16 Jan 91 15:14 EST

Hi Paul,
  The sixth and last for today from the l/l8/9l NIH Guide.  Please post
as:  RFANR/AG-91-01.910118.
   Thanks.  Have a nice evening.
                                Dottie
 ---------------------------- Text of forwarded message -----------------------
 
MANAGEMENT OF ALZHEIMER'S DISEASE SYMPTOMS
 
RFA AVAILABLE:  NR/AG-91-01
 
P.T. 34; K.W. 0715180, 0785035, 0404000
 
National Center for Nursing Research
National Institute on Aging
 
Letter of Intent Receipt Date:  April 8, 1991
Application Receipt Date:  May 20, 1991
 
PURPOSE
 
The National Center for Nursing Research (NCNR) and the
National Institute on Aging (NIA)
invite applications for R01 research applications
for preliminary investigations that will lead to large-
scale clinical studies on the assessment and
nonpharmacological management of secondary symptoms
exhibited by patients with Alzheimer's disease and related
disorders (AD).
The Alzheimer's Association is cooperating with NCNR and NIA in
this Request for Applications (RFA).
 
BACKGROUND INFORMATION
 
The NCNR is interested in
studies relevant to the diagnosis and treatment of human
responses to actual and potential health problems.  As
such, nursing investigations focus on fundamental
biological and behavioral processes relevant to assessment
and management of patient care.  An inter-disciplinary
approach holds great promise to the understanding of this
complex disease.  Within this context, nursing research
can make a significant contribution to the scientific
knowledge base necessary to the care and management of
patients with health problems related to Alzheimer's
disease and related disorders.
 
The overall focus of the NIA's
efforts in Alzheimer's disease is to develop the knowledge
base to prevent and treat the biological course and to
manage and interrupt the behavioral manifestations of the
age-associated dementias.  The treatment and management
work is addressed to the patient and his/her behavior, and
the goal is no less than the alteration of the clinical
course.
 
Estimates indicate that 4 million Americans presently
suffer from AD.  The
impact of AD on patients, families, and society is severe
and is anticipated to grow as older persons, the group
most at risk for AD, continue to increase in number.
Although it may not yet be possible to prevent, treat, or
permanently alter the course of the underlying disease,
interventions can be developed and systematically tested
that reduce the patient's secondary symptoms and preserve
function.  In addition to cognitive symptoms, non-
cognitive secondary symptoms are frequently seen across
the course of Alzheimer's disease and present significant
management problems.  These symptoms of special concern
may include, but are not limited to, wandering, disturbed
sleep, pacing, agitation, feeding and dressing
difficulties, incontinence and toileting difficulties,
screaming and other vocalizations, aggression and
violence, and inappropriate sexual behavior.  These
symptoms not only contribute to decisions to
institutionalize affected individuals, but also lead to
the use of chemical and physical restraints.
 
While there exists a great deal of clinical and anecdotal
information about methods that can effectively deal with
individual symptoms, little data exist that have been
obtained with the rigor of design and procedures of the
controlled clinical trial.  Therefore, applications are
solicited for preliminary investigations and feasibility
studies that will lay the groundwork for the development
of rigorously controlled clinical trials to test
interventions for the management of the secondary
symptoms.
 
These preliminary studies may address any of the
scientific assessment, design, methodological, and
intervention problems to facilitate the launch of large-
scale clinical trials.  For example, satisfactory
assessment techniques and instruments for addressing the
previously noted problematic symptoms are needed.  Studies
are needed of strategies for enhancing AD patients' self-
care abilities.  Delineation of appropriate interventions
for an individual symptom or cluster of symptoms and
methods for implementing the interventions must be
identified.    In particular, attention is needed to the
affected person's past daily practices and preferences in
order to adjust care to such characteristics.  Although
the primary focus is on nonpharmacologic interventions,
research is also needed that addresses the multimodal
treatment approaches including, but not limited to,
pharmacological interventions for managing symptoms.
Studies addressing only pharmacological interventions are
not acceptable.
 
Information on the acceptability, safety, and rationale
for the effectiveness of interventions must be obtained
prior to undertaking any large-scale trial.  Carefully
developed interventions for testing in controlled clinical
trials in long-term care institutions are needed.
Procedures for maintaining interventions across the
duration of the trial, using existing nursing home staff,
are not clear.  Therefore, behavioral, environmental,
social, or organizational interventions, individually or
in combinations, may be proposed and examined.  Applicants
are encouraged to consider collaborative efforts with
sites that have established AD research programs, such as
the Alzheimer's Disease Centers currently funded by the
National Institute on Aging in locations throughout the
United States.
 
In addition to these research goals, naturalistic/field/
qualitative research is needed to examine the onset,
pattern and progress of the behavioral changes that occur
during the clinical course of Alzheimer's disease.
Careful scientific observations of the longitudinal,
natural history are critical to understanding the
disease progression and for relating the behavioral
changes to brain degeneration.  The research in an
observational setting, either institutional or
noninstitutional, should accrue a representative sample
to develop clear, rigorous descriptions,
characterizations, and understandings of the behavioral
clinical course that can be ultimately related to
biological changes.
 
Applications are invited for support of projects to
address issues including, but not limited to:
 
o  the identification of underlying factors in research
subjects that result in behavioral symptoms and methods
to address these factors.
 
o  the development of preliminary work and early
investigations that will lead to the nonpharmacologic
management and treatment of the secondary symptoms
exhibited by patients with AD.
 
o  provision of a rigorous scientific base that will lead
to controlled clinical trials in institutional or
noninstitutional settings by delineating approaches for
the management of symptoms, the duration of change, and
the procedures required to maintain the change, if
possible.
 
o  development of instruments to assess behavioral
problems and monitor changes.
 
o  careful scientific observations of the natural history/
clinical course of the behavioral changes that
occur during the progression of Alzheimer's disease.
 
MECHANISM OF SUPPORT
 
It is anticipated that ten to fifteen R01 applications
will be funded.  This support level is dependent on the
receipt of a sufficient number of applications of high
scientific merit.  Up to $75,000 in direct costs will be
allocated for each award for each funding year, not to
exceed three years.  The anticipated award date will be
September 30, 1991.  Although this program is accommodated
in the financial plans of the NCNR and NIA, the award of
grants pursuant to this Request for Applications (RFA) is also
contingent upon the
availability of funds for this purpose.
 
Applications may be submitted by for-profit or nonprofit
organizations, public or 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.
 
SPECIAL REQUIREMENTS
 
Applications submitted to the NIH will be reviewed
according to normal NIH peer review procedures.  Principal
Investigators may submit their applications and summary
statements to the Alzheimer's Association for funding
consideration.  The Alzheimer's Association may fund
selected applications at a maximum level of $45,000 total
costs each year with a 10 percent ceiling on indirect
costs, for a maximum of three years.  The Alzheimer's
Association project start dates for funding may not
coincide with the NCNR or NIA award dates.  Applicants may
not receive funding from both NIH and the Alzheimer's
Association for the same application.
 
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 should be
provided.
 
The composition of the proposed study population must be
described in terms of gender and racial/ethnic group,
together with a rationale for its choice.  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 are urged to assess carefully the feasibility
of including the broadest possible representation of
minority groups.  However, NIH recognize 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 includes
human biomedical and behavioral studies of etiology,
epidemiology, prevention (and preventive strategies),
diagnosis, or treatment of disease, 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.
 
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 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.
 
REVIEW PROCEDURES AND CRITERIA
 
Review Procedure
 
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 scientific intent identified in the RFA
or to the timeframe and budget guidelines, NIH staff will
return it to Division of Research Grants (DRG) for review with
other unsolicited grant
applications received during the next available NIH review
cycle.
 
Applications may be subjected to triage by a peer review
group to determine their scientific merit relative to
other applications received in response to this RFA.
Criteria for triage will be the same as the review
criteria listed below.  The NIH will administratively
withdraw from competition those applications judged to be
noncompetitive and notify the applicant and institutional
official.
 
Those applications judged to be complete, responsive, and
competitive will be evaluated in accordance with the
criteria stated below for scientific/technical merit by an
appropriate peer review group convened by the NCNR and
NIA.  The second level of review will be provided by the
NCNR and NIA National Advisory Councils.
 
Review Criteria
 
Applications will be reviewed in accord with the usual NIH
peer review criteria:
 
o  scientific and technical 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; and
 
o  where an application involves activities that could
have an adverse effect upon humans, animals, or the
environment, the adequacy of the proposed means for
protecting against or minimizing such effects.
 
o  appropriate inclusion of women and minorities in study
population.
 
METHOD OF APPLYING
 
The regular research grant application form PHS-398
(revised 10/88 or 9/89) must be used to apply for
these grants.  These forms are available at most
institutional business offices or from the Office of
Grants Inquiries, Division of Research Grants, National
Institutes of Health, 5333 Westbard Avenue, Bethesda, MD
20892 (telephone 301-496-7441).
 
The RFA label available in the 10/88-9/89 revision of
application form PHS 398 must be affixed to the bottom of
the face page.  Failure to use this label could delay
processing of your application.  On Item 2 on the face
page of the application, enter "Management of Alzheimer's
Disease Symptoms, NR/AG-91-01" in the provided space.
 
Submit a signed original of the application, including the
Checklist, and four (4) signed, exact 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, send two (2) additional copies
of the application to:
 
John C. Chah, PhD
National Center for Nursing Research
Building 31, Room 5B19
9000 Rockville Pike
Bethesda, MD  20892
 
Applications must be received by May 20, 1991.  If an
application is received after that date, it will be
submitted to the DRG for the
next regular grant cycle without benefit of this RFA.
 
If the application submitted in response to this RFA is
substantially similar to a research grant application already
submitted to the NIH for review, but has not yet been 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.
 
LETTER OF INTENT
 
Prospective applicants are asked to submit by April 8,
1991, a letter of intent that includes a descriptive title
of the proposed research, the name, address, and telephone
number of the Principal Investigator, the names of other
key personnel, the participating institution(s), and the
number and title of the RFA in response to which the
application is being submitted.
 
Although a letter of intent is not required, is not
binding, and does not enter into the review of subsequent
applications, the information which it contains is
extremely helpful in planning for the review of
applications.  It allows ICD staff to estimate the
potential review workload and to avoid possible conflict
of interest in the review.  The letter of intent should be
sent to:
 
John C. Chah, PhD
National Center for Nursing Research
Building 31, Room 5B19
9000 Rockville Pike
Bethesda, MD  20892
 
INQUIRIES
 
Written or telephone inquiries concerning this RFA are
encouraged and should be directed to either of the
following individuals.  The program staff welcome the
opportunity to clarify any issues or questions from
potential applicants.
 
Mary D. Lucas, PhD, RN         Teresa S. Radebaugh, Sc.D.
Chief, Acute & Chronic         Chief, Dementias of Aging
    Illness Branch             Neuroscience and
National Center for Nursing      Neuropsychology of Aging
    Research                   National Institute on Aging
Building 31, Room 5B03         Building 31, Room 5C21
Bethesda, MD  20892            Bethesda,  MD 20892
Telephone:  (301) 496-0523     Telephone:  (301) 496-9350
 
SCHEDULE
 
Letter of Intent:                         April 8, 1991
Application Receipt Date:                 May 20, 1991
Initial Review:                           June/July 1991
Secondary Review:                         September 1991
Anticipated Award Date:                   September 30, 1991
Other institutes and agencies are also interested in
research dealing with Alzheimer's disease and related
disorders, including:
 
The National Institute on Aging is developing a request
for cooperative agreement applications for "Special Care
Units for Alzheimer's Disease".
The program contacts are Marcia G. Ory,
PhD, Behavioral and Social Research Program, NIA, Building
31, Room 5C32, NIH, Bethesda, MD 20892, phone (301) 496-
3136 and Neil Buckholtz, PhD, Neuroscience and
Neuropsychology of Aging, NIA, Building 31, Room 5C35,
NIH, Bethesda, MD 20892, phone (301) 496-9350.
 
This RFA is in addition to the
ongoing program announcement on "Alzheimer's Disease and
Related Disorders:  Issues in Caregiving," published in
the NIH Guide for Grants and Contracts, Vol. 18, No. 6,
February 24, 1989, sponsored by the National Institute on
Aging, National Center for Nursing Research, National
Institute of Mental Health, and the National Center for
Health Services Research (now the Agency for Health Care
Policy Research).
 
The National Institute of Mental Health (NIMH) is interested in
research dealing with the behavioral and emotional
consequences of Alzheimer's disease and related disorders.
The scope of NIMH interest is delineated in the
announcement "Alzheimer's Disease Treatment and Family
Stress."  For more information concerning research
interests of the NIMH, contact Enid Light, PhD, NIMH, Room
11C-03, 5600 Fishers Lane, Rockville, MD 20857, phone
(301) 443-1185.
 
The National Institute of Neurological Disease and Stroke
program contact for Alzheimer's disease related research
is Dr. Eugene J. Oliver, NINDS, Federal Building, Room
806, Bethesda, MD 20892, phone (301) 496-1431.
 
This program is described in the Catalog of Federal
Domestic Assistance No. 93.336, Nursing Research, and No.
93.866.  Awards are 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 grant 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,
April 6, 1988.