IDENTIFICATION AND CLASSIFICATION OF CHILDHOOD SPEECH-SOUND ACQUISITION
DISORDERS OF UNKNOWN ORIGIN
RELEASE DATE: March 10, 2003
RFA: DC-03-004
National Institute on Deafness and Other Communication Disorders (NIDCD)
(http://www.nidcd.nih.gov)
CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER: 93.173
LETTER OF INTENT RECEIPT DATE: June 19, 2003
APPLICATION RECEIPT DATE: July 17, 2003
THIS RFA CONTAINS THE FOLLOWING INFORMATION
o Purpose of this RFA
o Research Objectives
o Mechanism(s) of Support
o Funds Available
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements
o Where to Send Inquiries
o Letter of Intent
o Submitting an Application
o Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations
PURPOSE OF THIS RFA
The National Institute on Deafness and Other Communication Disorders
(NIDCD) conducts and supports biomedical and behavioral research and
research training in normal and disordered processes of speech
production and perception. The purpose of this RFA is to solicit
applications from multidisciplinary teams to investigate the
identification and assessment of childhood speech-sound acquisition
disorders of unknown origin.
RESEARCH OBJECTIVES
Background
Speech-sound acquisition disorders are common childhood communication
disorders, with estimates ranging from 3% to as high as 10% in
preschool and school-age children. Children who exhibit speech sound
acquisition disorders produce speech sounds less accurately than their
same-age peers. They do so in the absence of coexisting conditions
such as congenital hearing loss or mental retardation. Using a
conservative prevalence estimate of 4%, at least 1.5 million children
under the age of nine demonstrate a clinically significant speech-sound
acquisition disorder of unknown origin. Research studies have linked
delayed and/or disordered speech in children to decreased overall
communication skills with consequences reported in psychosocial,
educational, and vocational development and success.
Historically, speech-sound acquisition disorders of unknown origin were
classified as "functional." More recently, these disorders have been
termed "developmental phonologic disorders," or
"phonologic/articulatory disorders," terms that highlight the links to
other domains of language. Evidence is mounting for the existence of
several etiological subtypes of speech sound acquisition disorders of
unknown origin in children. Recent reports from family and twin
studies have suggested a genetic component.
One childhood speech disorder of unknown origin has been characterized
as a disorder in speech motor planning and/or programming and is termed
"developmental apraxia of speech" or "childhood apraxia of speech."
Questions remain as to the validity of the construct of developmental
apraxia of speech and the precise criteria for its diagnosis. Its
behavioral and neurologic markers remain undetermined, as do the
factors which differentiate it from other subtypes of speech-sound
acquisition disorders.
Currently, there is a need for a widely accepted etiological
classification system to identify and classify childhood speech-sound
acquisition disorders. Empirical data and a coherent theory are
lacking and are still needed to better guide clinical management of all
children with such disorders.
Research Needs
NIDCD requests applications with potential significance and relevance
to the clinical assessment of children with speech-sound acquisition
disorders of unknown origin. Examples of research studies that would
be responsive to this RFA include (but are not limited to) the
following:
The identification of factors that place children at risk for
developing speech-sound acquisition disorders;
The exploration of genetic factors associated with the development of
speech-sound acquisition disorders;
The identification of appropriate techniques for the differential
diagnoses and classification of the subgroups of children with speech-
sound acquisition disorders;
The development, evaluation and standardization of evaluation
procedures for childhood speech-sound acquisition disorders based on
theoretical models;
The development of a taxonomy that can delineate the various subgroups
of children with speech-sound acquisition disorders;
The use of neuroimaging to characterize the various subtypes of
childhood speech-sound acquisition disorders;
Longitudinal studies that will provide detailed information about the
natural history and course of development of the various subtypes of
childhood speech-sound acquisition disorders.
MECHANISM OF SUPPORT
This RFA will use NIH Research Project Grant (R01) and the
Exploratory/Developmental Research Grant (R21) award mechanisms. As an
applicant, you will be solely responsible for planning, directing, and
executing the proposed project. This RFA is a one-time solicitation.
Future unsolicited, competing-continuation applications based on this
project will compete with all investigator-initiated applications and
will be reviewed according to the customary peer review procedures.
The anticipated award date is April 2004. Applications that are not
funded in the competition described in this RFA may be resubmitted as
NEW investigator-initiated applications using the standard receipt
dates for NEW applications described in the instructions to the PHS 398
application.
Use of R21 or R01 mechanism
Typically, the R21 is used for support of creative, novel, and/or high
risk/high payoff approaches that could produce innovative advances in
this field. This includes feasibility studies, protocol planning, and
the incorporation of new disciplines and technologies. The R21
provides the means to acquire the necessary preliminary information, to
attract talented new investigators from related disciplines, and to
foster the development of interdisciplinary, inter-institutional
collaborative efforts among investigators with diverse training and
expertise. R21 awards are non-renewable, and may not be used to
supplement an ongoing project. The R01 mechanism is recommended for
applications based on significant published and/or preliminary data.
Applicants are strongly encouraged to contact the scientific program
director listed below under INQUIRIES to discuss which mechanism (R21
or R01) would be most suitable for the proposed research project.
This RFA uses just-in-time concepts. It also uses the modular as well
as the non-modular budgeting formats (see
https://grants.nih.gov/grants/funding/modular/modular.htm).
Specifically, if you are submitting an application with direct costs in
each year of $250,000 or less, use the modular format. Otherwise
follow the instructions for non-modular research grant applications.
This program does not require cost sharing as defined in the current
NIH Grants Policy Statement at
https://grants.nih.gov/archive/grants/policy/nihgps_2001/part_i_1.htm.
FUNDS AVAILABLE
The NIDCD intends to commit approximately $1.5 million in FY 04 for
applications responding to this RFA. For R01s, an applicant may
request a project period of up to five years. Because of the
exploratory/developmental nature of the R21, applicants submitting an
R21 may only request a budget for direct costs of up to $125,000 per
year for a maximum of three years. Because the nature and scope of the
proposed research will vary from application to application, it is
anticipated that the size and duration of each award will also vary
within the defined parameters. Although the financial plans of the
NIDCD provide support for this program, awards pursuant to this RFA are
contingent upon the availability of funds and the receipt of a
sufficient number of meritorious applications.
ELIGIBLE INSTITUTIONS
You may submit an application if your institution has any of the
following characteristics:
o For-profit or non-profit organizations
o Public or private institutions, such as universities, colleges,
hospitals, and laboratories
o Units of State and local governments
o Eligible agencies of the Federal government
o Domestic or foreign
INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS
Any individual with the skills, knowledge, and resources necessary to
carry out the proposed research is invited to work with their
institution to develop an application for support. Individuals from
underrepresented racial and ethnic groups as well as individuals with
disabilities are always encouraged to apply for NIH programs.
SPECIAL REQUIREMENTS
Applications in response to this RFA must include children with speech-
sound acquisition disorders. The Principal Investigator may submit
only one application in response to this RFA. This RFA is intended to
provide information relevant to the clinical management of children
with speech sound acquisition disorders of unknown origin and not
disorders coexisting with conditions such as mental retardation,
pervasive developmental disorders, autism, etc. Whenever feasible,
participants from multicultural and with diverse dialectal backgrounds
should be included. Additionally, a multidisciplinary research
approach with expertise in speech-sound acquisition must be evident.
Applicants awarded grants in response to this RFA may be required to
come to the metro Washington DC area (or other location to be
determined by the NIDCD) annually to share their findings with other
recipients of the RFA, therefore annual travel for up to two
individuals from the research team should be included as part of the
overall requested budget.
WHERE TO SEND INQUIRIES
We encourage inquiries concerning this RFA and welcome the opportunity
to answer questions from potential applicants. Inquiries may fall into
three areas: scientific/research, peer review, and financial or grants
management issues:
o Direct your questions about scientific/research issues to:
Lana Shekim, Ph.D.
Program Director, Voice & Speech Program
Division of Extramural Research
National Institute on Deafness and Other Communication Disorders
6120 Executive Boulevard, EPS Room 400C, MSC 7180
Bethesda, MD 20892-7180
Telephone: 301-496-5061
Fax: 301-402-6251
Email: shekiml@nidcd.nih.gov
o Direct your questions about peer review issues to:
Craig Jordan, Ph.D.
Chief, Scientific Review Branch
Division of Extramural Research
National Institute on Deafness and Other Communication Disorders
6120 Executive Boulevard, EPS Room 400C, MSC 7180
Bethesda, MD 20892-7180
Telephone: 301-496-8683
Fax: 301-402-6250
Email: jordanc@nih.gov
o Direct your questions about financial or grants management matters
to:
Ms. Sara Stone
Chief, Grants Management Branch
Division of Extramural Research
National Institute on Deafness and Other Communication Disorders
6120 Executive Boulevard, EPS Room 400B, MSC 7180
Bethesda, MD 20892-7180
Telephone: (301) 402-0909
Fax: (301) 402-1758
Email: stones@nidcd.nih.gov
LETTER OF INTENT
Prospective applicants are asked to submit a letter of intent that
includes the following information:
o Descriptive title of the proposed research
o Name, address, and telephone number of the Principal Investigator
o Names of other key personnel
o Participating institutions
o Number and title of this RFA
Although a letter of intent is not required, is not binding, and does
not enter into the review of a subsequent application, the information
that it contains allows IC staff to estimate the potential review
workload and plan the review.
The letter of intent is to be sent by June 19th 2003 to:
Lana Shekim, Ph.D.
Program Director, Voice & Speech Program
Division of Extramural Research
National Institute on Deafness and Other Communication Disorders
6120 Executive Boulevard, EPS Room 400C, MSC 7180
Bethesda, MD 20892-7180
Telephone: 301-496-5061
Fax: 301-402-6251
Email: shekiml@nidcd.nih.gov
SUBMITTING AN APPLICATION
Applications must be prepared using the PHS 398 research grant
application instructions and forms (rev. 5/2001). The PHS 398 is
available at https://grants.nih.gov/grants/funding/phs398/phs398.html in
an interactive format. For further assistance contact GrantsInfo,
Telephone (301) 710-0267, Email: GrantsInfo@nih.gov.
ADDITIONAL R21 INSTRUCTIONS:
All application instructions in the PHS 398 research grant application
instructions and forms (rev. 5/2001) apply to the R21 with the
exception of the following modifications:
1. R21 applications may request up to five (5) $25,000 modules for a
maximum direct cost of $125,000 per year for up to a maximum of
three (3) years.
2. The Research Plan for the R21 application may not exceed 10
pages. All tables and figures (color and black and white) must
be included within the 10-page limit. However, to aid reviewers,
original color figures should be included in the appendices if
the data cannot be adequately evaluated when scanned/copied in
black and white (see APPLICATION SUBMISSION.) The R21
applications are limited to 5 publications in the appendix.
Appendix materials must be sent with two copies of the
application to the NIDCD SCIENTIFIC REVIEW BRANCH, DIVISION OF
EXTRAMURAL RESEARCH, whose address is below. Appendices should
not be sent to the Center for Scientific Review (CSR).
SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: Applications
requesting up to $250,000 per year in direct costs must be submitted in
a modular grant format. The modular grant format simplifies the
preparation of the budget in these applications by limiting the level
of budgetary detail. Applicants request direct costs in $25,000
modules. Section C of the research grant application instructions for
the PHS 398 (rev. 5/2001) at
https://grants.nih.gov/grants/funding/phs398/phs398.html includes step-
by-step guidance for preparing modular grants. Additional information
on modular grants is available at
https://grants.nih.gov/grants/funding/modular/modular.htm.
USING THE RFA LABEL: The RFA label available in the PHS 398 (rev.
5/2001) application form must be affixed to the bottom of the face page
of the application. Type the RFA number on the label. 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. In
addition, the RFA title and number must be typed on line 2 of the face
page of the application form and the YES box must be marked. The RFA
label is also available at:
https://grants.nih.gov/grants/funding/phs398/label-bk.pdf.
SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten
original of the application, including the Checklist, and three signed,
photocopies, in one package to:
Center For Scientific Review
National Institutes Of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710
Bethesda, MD 20817 (for express/courier service)
At the time of submission, two additional copies of the application and
any appendices must be sent to:
Craig Jordan, Ph.D.
Chief, Scientific Review Branch
Division of Extramural Research
National Institute on Deafness and Other Communication Disorders
6120 Executive Boulevard, EPS Room 400C, MSC 7180
Bethesda, MD 20892-7180
Telephone: 301-496-8683
Fax: 301-402-6250
Email: jordanc@nih.gov
APPLICATION PROCESSING: Applications must be received by the
application receipt date listed in the heading of this RFA. If an
application is received after that date, it will be returned to the
applicant without review.
Although there is no immediate acknowledgement of the receipt of an
application, applicants are generally notified of the review and
funding assignment within 8 weeks.
The Center for Scientific Review (CSR) will not accept any application
in response to this RFA that is essentially the same as one currently
pending initial review, unless the applicant withdraws the pending
application. However, when a previously unfunded application,
originally submitted as an investigator-initiated application, is to be
submitted in response to an RFA, it is to be prepared as a NEW
application. That is the application for the RFA must not include an
Introduction describing the changes and improvements made, and the text
must not be marked to indicate the changes. While the investigator may
still benefit from the previous review, the RFA application is not to
state explicitly how.
PEER REVIEW PROCESS
Upon receipt, applications will be reviewed for completeness by the CSR
and for responsiveness by the NIDCD. Incomplete applications will be
returned to the applicant without further consideration. In addition,
if an R01 application is not responsive to the RFA, NIH staff may
contact the applicant to determine whether to return the R01
application to the applicant or submit it for review in competition
with unsolicited applications at the next appropriate NIH review cycle.
R21 applications that are not responsive to this RFA will be returned.
Applications that are complete and responsive to the RFA will be
evaluated for scientific and technical merit by an appropriate peer
review group convened by the NIDCD, in accordance with the review
criteria stated below. As part of the initial merit review, all
applications will:
o Receive a written critique
o Undergo a process in which only those applications deemed to have the
highest scientific merit, generally the top half of the applications
under review, will be discussed and assigned a priority score
o Receive a second level review by the National Deafness and Other
Communication Disorders Advisory Council.
REVIEW CRITERIA
The goals of NIH-supported research are to advance our understanding of
biological systems, improve the control of disease, and enhance health.
In the written comments, reviewers will be asked to discuss the
following aspects of your application in order to judge the likelihood
that the proposed research will have a substantial impact on the
pursuit of these goals:
o Significance
o Approach
o Innovation
o Investigator
o Environment
The scientific review group will address and consider each of these
criteria in assigning your application's overall score, weighting them
as appropriate for each application. Your application does not need to
be strong in all categories to be judged likely to have major
scientific impact and thus deserve a high priority score. For example,
you may propose to carry out important work that by its nature is not
innovative but is essential to move a field forward.
(1) SIGNIFICANCE: Does your study address an important problem? If the
aims of your application are achieved, how do they advance scientific
knowledge? What will be the effect of these studies on the concepts or
methods that drive this field?
(2) APPROACH: Are the conceptual framework, design, methods, and
analyses adequately developed, well integrated, and appropriate to the
aims of the project? Do you acknowledge potential problem areas and
consider alternative tactics?
(3) INNOVATION: Does your project employ novel concepts, approaches or
methods? Are the aims original and innovative? Does your project
challenge existing paradigms or develop new methodologies or
technologies?
(4) INVESTIGATOR: Are you appropriately trained and well suited to
carry out this work? Is the work proposed appropriate to your
experience level as the principal investigator and to that of other
researchers (if any)?
(5) ENVIRONMENT: Does the scientific environment in which your work
will be done contribute to the probability of success? Do the proposed
experiments take advantage of unique features of the scientific
environment or employ useful collaborative arrangements? Is there
evidence of institutional support?
ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your
application will also be reviewed with respect to the following:
o PROTECTIONS: The adequacy of the proposed protection for humans,
animals, or the environment, to the extent they may be adversely
affected by the project proposed in the application.
o INCLUSION: The adequacy of plans to include subjects from both
genders, all racial and ethnic groups (and subgroups), and children as
appropriate for the scientific goals of the research. Plans for the
recruitment and retention of subjects will also be evaluated. (See
Inclusion Criteria included in the section on Federal Citations, below)
o BUDGET: The reasonableness of the proposed budget and the requested
period of support in relation to the proposed research.
o ADDITIONAL REVIEW CRITERIA:
For the R01 applications only, the potential impact on the clinical
management of children with speech-sound acquisition disorders.
For the R21 applications, the likelihood that the exploratory grant
will lead to an R01 submission.
PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of
human subjects and protections from research risk relating to their
participation in the proposed research will be assessed. (See criteria
included in the section on Federal Citations, below).
INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy
of plans to include subjects from both genders, all racial and ethnic
groups (and subgroups), and children as appropriate for the scientific
goals of the research. Plans for the recruitment and retention of
subjects will also be evaluated. (See Inclusion Criteria in the
sections on Federal Citations, below).
CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals
are to be used in the project, the five items described under Section f
of the PHS 398 research grant application instructions (rev. 5/2001)
will be assessed.
BUDGET: The reasonableness of the proposed budget and the requested
period of support in relation to the proposed research.
RECEIPT AND REVIEW SCHEDULE
Letter of Intent Receipt Date: June 19, 2003
Application Receipt Date: July 17, 2003
Peer Review Date: October/November 2003
Council Review: January 2004
Earliest Anticipated Start Date: April 2004
AWARD CRITERIA
Award criteria that will be used to make award decisions include:
o Scientific merit (as determined by peer review)
o Availability of funds
o Programmatic priorities.
REQUIRED FEDERAL CITATIONS
HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that
applications and proposals involving human subjects must be evaluated
with reference to the risks to the subjects, the adequacy of protection
against risks, the potential benefits of the research to the subjects
and others, and the importance of the knowledge gained or to be gained.
MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: Research
components involving Phase I and II clinical trials must include
provisions for assessment of patient eligibility and status, rigorous
data management, quality assurance, and auditing procedures. In
addition, it is NIH policy that all clinical trials require data and
safety monitoring, with the method and degree of monitoring being
commensurate with the risks (NIH Policy for Data Safety and Monitoring,
NIH Guide for Grants and Contracts, June 12, 1998:
https://grants.nih.gov/grants/guide/notice-files/not98-084.html).
INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the
policy of the NIH that women and members of minority groups and their
sub-populations must be included in all NIH-supported clinical research
projects unless a clear and compelling justification is provided
indicating that inclusion is inappropriate with respect to the health of
the subjects or the purpose of the research. This policy results from
the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43).
All investigators proposing clinical research should read the "NIH
Guidelines for Inclusion of Women and Minorities as Subjects in
Clinical Research - Amended, October, 2001," published in the NIH Guide
for Grants and Contracts on October 9, 2001
(https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines are available at
https://grants.nih.gov/grants/funding/women_min/guidelines_amended
_10_2001.htm. The amended policy incorporates: the use of an NIH
definition of clinical research; updated racial and ethnic categories
in compliance with the new OMB standards; clarification of language
governing NIH-defined Phase III clinical trials consistent with the new
PHS Form 398; and updated roles and responsibilities of NIH staff and
the extramural community. The policy continues to require for all NIH-
defined Phase III clinical trials that: a) all applications or
proposals and/or protocols must provide a description of plans to
conduct analyses, as appropriate, to address differences by sex/gender
and/or racial/ethnic groups, including subgroups if applicable; and b)
investigators must report annual accrual and progress in conducting
analyses, as appropriate, by sex/gender and/or racial/ethnic group
differences.
INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN
SUBJECTS: The NIH maintains a policy that children (i.e., individuals
under the age of 21) must be included in all human subjects research,
conducted or supported by the NIH, unless there are scientific and
ethical reasons not to include them. This policy applies to all initial
(Type 1) applications submitted for receipt dates after October 1, 1998.
All investigators proposing research involving human subjects should
read the "NIH Policy and Guidelines" on the inclusion of children as
participants in research involving human subjects that is available at
https://grants.nih.gov/grants/funding/children/children.htm.
REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH
policy requires education on the protection of human subject
participants for all investigators submitting NIH proposals for research
involving human subjects. You will find this policy announcement in the
NIH Guide for Grants and Contracts Announcement, dated June 5, 2000, at
https://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT:
The Office of Management and Budget (OMB) Circular A-110 has been
revised to provide public access to research data through the Freedom of
Information Act (FOIA) under some circumstances. Data that are (1)
first produced in a project that is supported in whole or in part with
Federal funds and (2) cited publicly and officially by a Federal agency
in support of an action that has the force and effect of law (i.e., a
regulation) may be accessed through FOIA. It is important for
applicants to understand the basic scope of this amendment. NIH has
provided guidance at
https://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this PA in a public
archive, which can provide protections for the data and manage the
distribution for an indefinite period of time. If so, the application
should include a description of the archiving plan in the study design
and include information about this in the budget justification section
of the application. In addition, applicants should think about how to
structure informed consent statements and other human subjects
procedures given the potential for wider use of data collected under
this award.
URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and
proposals for NIH funding must be self-contained within specified page
limitations. Unless otherwise specified in an NIH solicitation, Internet
addresses (URLs) should not be used to provide information necessary to
the review because reviewers are under no obligation to view the
Internet sites. Furthermore, we caution reviewers that their anonymity
may be compromised when they directly access an Internet site.
HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to
achieving the health promotion and disease prevention objectives of
"Healthy People 2010," a PHS-led national activity for setting priority
areas. This RFA is related to one or more of the priority areas.
Potential applicants may obtain a copy of "Healthy People 2010" at
http://www.health.gov/healthypeople.
AUTHORITY AND REGULATIONS: This program is described in the Catalog of
Federal Domestic Assistance No. 93.173, and is not subject to the
intergovernmental review requirements of Executive Order 12372 or
Health Systems Agency review. Awards are made under authorization of
Sections 301 and 405 of the Public Health Service Act as amended (42
USC 241 and 284) and administered under NIH grants policies described
at https://grants.nih.gov/grants/policy/policy.htm and under Federal
Regulations 42 CFR 52 and 45 CFR Parts 74 and 92.
The PHS strongly encourages all grant recipients to provide a smoke-
free workplace and discourage the use of all tobacco products. In
addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits
smoking in certain facilities (or in some cases, any portion of a
facility) in which regular or routine education, library, day care,
health care, or early childhood development services are provided to
children. This is consistent with the PHS mission to protect and
advance the physical and mental health of the American people.