Subject: NIH GUIDE - RFA DC-92-03 - V20(46) 12/13/91
From: Dot Baker <[email-masked]>
To: [email-masked]
Cc: [email-masked], [email-masked], [email-masked]
Date: Tue, 17 Dec 91 10:21 EST

Hi Paul,
  Please post this to the NIH Listserver as:
     RFADC-92-03.911213
                       Dottie
 ---------------------------- Text of forwarded message -----------------------
 
$$XID RFA DC9203 DC-92-03 P1O1 *****************************************
 
TREATMENT AND REHABILITATION OF ADULT APHASIA
 
RFA:  DC-92-03
 
P.T. 34; K.W. 0715050, 0715055, 0710085, 0404000, 0710030
 
National Institute on Deafness and Other Communication Disorders
 
Letter of Intent Receipt Date:  February 3, 1992
Application Receipt Date:  February 19, 1992
 
PURPOSE
 
The National Institute on Deafness and Other Communication Disorders
(NIDCD), through the Division of Communication Sciences and
Disorders, invites individual research grant (R01) applications
focused on treatment and rehabilitation of adult aphasia.
 
BACKGROUND
 
Aphasia is a language disorder involving total or partial impairment
of the capacity to understand or produce spoken language, as well as
impairments of the ability to read or write, all secondary to
neurological insult or disease.  Most aphasic individuals receive
some form of treatment for these language deficits.  Previous
research has indicated that treatment efforts are effective with some
subgroups of aphasia, while other aphasic individuals remain severely
impaired despite long-term treatment.  Further research is needed
into issues associated with treatment of aphasia and the development
and refinement of effective treatment protocols.  This Request for
Applications (RFA) encourages applications for research projects that
address treatment issues and rehabilitation of adult aphasia.  This
would exclude studies on treatment trials directed at improving
general outcome of the neurological disorder or disease.
 
RESEARCH GOALS AND SCOPE
 
Our understanding of behavioral, linguistic, and neurological
correlates of adult aphasia continues to expand.  In addition, a
number of recent advances have occurred in the area of treatment of
adult aphasia.  Research has indicated that some profoundly aphasic
patients can learn a computerized technique for exchanging
information by manipulating visual symbols.  Results of
pharmacological treatment have shown promise in the amelioration of
selective disorders of aphasia, such as impairments of speech
initiation, through the use of the dopamine agonist bromocriptine.
Efficacy of specific therapeutic techniques has been demonstrated,
among them, the elimination of perseverative intrusions of earlier
utterances.  Additional intervention strategies currently being
tested include treatment protocols targeted directly at theoretically
defined language components that are found to be impaired.  A limited
number of such studies conducted to date have demonstrated measurable
improvement among individual aphasic patients many years following
onset of their aphasia.
 
In general, however, research into the development of treatment
protocols and the efficacy of those treatments remains limited.
Techniques and commercially available treatment plans have found
their way into the clinical arena often with little attention to
usefulness with specific subgroups, evidences of efficacy, or
attempts to merge theoretical constructs with clinical procedures.
It remains unclear why treatment is effective for some but
ineffective for other aphasic individuals.  Theories of treatment
need to be developed in order to place therapeutic efforts on
scientific foundations.  Efforts should be increased to match patient
characteristics to treatment paradigms and ascertain the proper level
of description, because only with adequate description of those
characteristics can selection and specification of treatment occur.
Approaches to the remediation of language disorders require objective
and reliable information about the nature and stability of patients'
symptoms.  Assessment instruments that provide such information are
needed in light of new research findings that have clarified symptom
and deficit relationships.  Existing assessment procedures must be
revised and improved in order to bring them into line with current
understanding of the relationship of patients' symptoms to underlying
language deficits.
 
Proposed research programs would benefit from a number of
interdisciplinary approaches.  For example, interdisciplinary models
of the treatment process might include speech-language pathology,
neuropsychology, pharmacology, and computer sciences.  There is a
need to coordinate efforts of researchers in all areas of cognitive
science and rehabilitation.  Cognitive neurolinguistic approaches and
theories regarding the basis of language should be utilized and
pursued.  Social science methodologies are needed to examine
psychosocial aspects of aphasia.  Documentation of changes and
improvements resulting from treatment and not other variables is
required from all professionals providing treatment to individuals
with adult aphasia.
 
Applications in response to this RFA may  utilize single subject or
group designs and address the above issues, the following specific
topics, or other related areas:
 
o  Demonstration of the efficacy and efficiency of existing
intervention strategies for aphasia treatment.
 
o  Development and validation of novel, innovative, theory-based
techniques of treatment.
 
o  Assessment of short- and long-term effects of specific treatments.
 
o  Identifications of aphasia subgroups or subtypes most responsive
to specific treatments.
 
o  Characterization of patients with successful responses to
treatment.
 
o  Identification of the treatment variables most important in
predicting outcome, for example, the effects of intensity and
duration of treatment on improvement.
 
o  Identification of factors that contribute to or limit
generalization (carry-over) of language skills.
 
o  Evaluation of recovery from aphasia, with and without treatment,
and processes whereby recovery is maximized.
 
o  Assessment of impact of specific language ability training on
other language skills, for example, the effects of language
production training on comprehension skills.
 
o  Determination of most effective focus of treatment: deficit vs.
strength oriented.
 
o  Exploration of the use of neuroradiographic techniques pre- and
post-treatment in documenting brain reorganization.
 
o  Examination of the use of pharmacotherapy in the treatment of
aphasia.
 
o  Development and evaluation of alternative and augmentative
communication systems for adults with language deficits.
 
o  Investigation of social and psychological factors that have the
potential to affect treatment outcome.
 
ELIGIBILITY
 
The following organizations are eligible to apply:  foreign and
domestic, non-profit institutions of higher education; other
non-profit and for-profit organizations, State and local governments
and their agencies, and authorized Federal agencies.
 
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.  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., 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
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.
 
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 and 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.
 
MECHANISM OF SUPPORT
 
The support mechanism for this program will be the individual
research project grant (R01) mechanism.  Three to five years of
support may be requested; however, the number of years to be awarded
will be recommended at review.  Budgets must be carefully justified.
This is a one-time request for applications, with plans to set aside
$750,000 total costs in FY 1992.  Awards will be made by September
30, 1992.  Funding for these grants beyond the initial period will be
subject to competitive renewal.
 
REVIEW PROCEDURES AND CRITERIA
 
Applications will be evaluated by NIDCD staff to determine
responsiveness to the RFA.  Non-responsive applications will be
returned to the applicant, or, if appropriate, referred to another
NIH institute according to DRG referral guidelines.  Responsive
applications will be evaluated for scientific/technical merit by a
review committee convened by the Scientific Review Branch of NIDCD
solely for this purpose.  A second level review will be made by the
National Deafness and Other Communication Disorders Advisory Council.
 
The Special Review Committee will use the following criteria in
evaluating the applications:
 
o  the scientific merit of the project including:  the originality
and feasibility of the approach, the adequacy of the experimental
design, and relevance of the proposed project to the overall goals
and objectives of the RFA;
 
o  qualifications, experience, and proposed responsibilities of the
investigators and the ability to devote the required time and effort
to the program;
 
o  adequacy of resources and facilities to support the various
components of the project;
 
o  demonstration of availability of patient populations;
 
o  adequacy of the means proposed for protecting against risks to
human subjects;
 
o  plans for the inclusion of underrepresented minorities and women
as part of any clinical study population.  For projects that do not
include these groups, a clear rationale for not including them must
be provided; and
 
o  appropriateness of the budget.
 
METHOD OF APPLYING
 
Applicants are requested to submit a letter of intent to the NIDCD on
or before February 3, 1992, that includes a descriptive title of the
proposed research, the names of investigators who may be involved,
and any collaborating participants outside the applicant institution.
The NIDCD requests such letters only for planning purposes and to
provide an indication of the number and scope of applications to be
received and, therefore, will not acknowledge their receipt.  A
letter of intent is not binding, it will not enter into the review of
any application subsequently submitted, nor is it a necessary
requirement.
 
A letter of intent is to be sent by February 3, 1992, to:
 
Judith A. Cooper, Ph.D.
Deputy Director, 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) 496-5061
FAX:  (301)402-6251
 
Applications must be submitted on form PHS 398 (rev. 10/88) using the
instructions included in the application kit.  These kits are
available from the NIDCD Program Administrator address cited above
and from the Division of Research Grants, National Institutes of
Health, Westwood Building, Room 449, Bethesda, MD  20892, telephone
301/496-7441.
 
On page 1 of form PHS 398, check "yes" in item 2 and type:
"DC-92-03, Treatment and Rehabilitation of Adult Aphasia."
 
The RFA label available in the 10/88 revision 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 review.
 
The receipt date for applications is February 19, 1992.  Applications
received after February 19, 1992 will be returned to the applicant.
Send the original and five copies of the application to:
 
Division of Research Grants
National Institutes of Health
Westwood Building, Room 240
Bethesda, MD  20892-4500**
 
To expedite the review, send one copy of the application to:
 
Chief, Scientific Review Branch
National Institute on Deafness and Other Communication Disorders
National Institutes of Health
Executive Plaza South, Room 400-B
6120 Executive Boulevard
Rockville, MD  20892
Telephone:  (301) 496-8683
 
INQUIRIES
 
Written and telephone inquiries concerning the objectives and scope
of the RFA and inquiries about whether or not specific proposed
research would be responsive, are encouraged.  The opportunity to
clarify any issues or questions from potential applicants is
welcomed.
 
For further information, contact:
 
Judith A. Cooper, Ph.D.
Deputy Director, 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) 496-5061
FAX:  (301) 402-6251
 
For budgetary and fiscal questions, contact:
 
Sharon Hunt
Grants Management Officer
National Institute on Deafness and Other Communication Disorders
Executive Plaza South, Room 400-B
6120 Executive Boulevard
Rockville, MD  20892
Telephone:  (301) 496-0909
 
AUTHORITY AND REGULATIONS
 
This program is described in the Catalog of Federal Domestic
Assistance No. 93.855.  Awards will be made under the authority of
the Public Health Service Act, 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.  The program
is not subject to the intergovernmental review requirements of
Executive Order 12372 or Health Systems Agency review.