Semantic Learning Deficits in School Age Children With Developmental Language Disorder
Phase: NA
Conditions: Developmental Language Disorder
Sponsor: San Diego State University

Semantic Learning Deficits in School Age Children with Developmental Language Disorder 
NCT04508699 
May 1, 2020 

Graduate and Research Affairs
Division of Research Affairs San
Diego Statue University 5500
Campanile Drive San Diego, CA
92182-1933 Phone 619-594-6622
irb@sdsu.edu
Expedited Approval
01-May-2020
Principal Investigator:
Abel, Alyson
Department:
Speech, Language and Hearing Sciences
Protocol Number:
HS-2020-0108
Title: Semantic learning deficits in school age children with developmental language disorder
Dear Alyson,
The above referenced protocol was reviewed and approved on 01-May-2020 under expedited
procedures in accordance with SDSU's Federal Wide Assurance (FWA) with the Department of
Health and Human Services as well as federal requirements pertaining to human subjects
protections within the Code of Federal Regulations (45 CFR 46) and relevant subparts. This
approval applies to the conditions and procedures described in your protocol. As the study was
reviewed under expedited review procedures at 45 CFR 46.110, annual continuing review is not
required.
Approval by the IRB does not necessarily constitute authorization to initiate the conduct of a
human subjects research study. Principal Investigators are responsible for assuring final
approval from other applicable school, department, center, or institute review committee(s) or
boards has been obtained. If any of these other committees require changes to the
IRB-approved protocol and informed consent/assent document(s), the changes must be
submitted to and approved by the SDSU IRB prior to beginning the research study.
Important:
Research is to be conducted according to the proposal approved by the IRB.
1.
Changes to the protocol or related documents are to be reviewed and approved before any
changes are implemented unless those changes are to ensure the safety of the research
participants. In the event that changes are enacted for the safety of research participants without
prior IRB approval, you must promptly notify the IRB within 5 days.
2.
Unanticipated problems, protocol deviations or adverse events are to be reported to the IRB within
5 days of occurence. Serious adverse events (e.g. life-threatening, death, hospitalization,
significant disability or incapacity) must be reported within 48 hours of the event.
3.
Participants are to receive a copy of the consent form, unless the IRB waives the requirement to
obtain informed consent per 45 CFR 46.116(d).
4.
Regulatory requirements as well as California State University Executive Order 1031, require that
IRB records be maintained for the duration of the activity and at least an additional three years
after completion. https://www.calstate.edu/recordsretention/documents/RSP.pdf Important: If your
5.

research study is funded, the funding agency may have more stringent record retention
requirements.
All CITI Human Subjects training for all study team members must be kept current to be in
compliance.
6.
For questions related to this correspondence, please contact the Human Research Protection Program
office at 619-594-6622 or at irb@sdsu.edu.
Sincerely,
THE CALIFORNIA STATE UNIVERSITY - BAKERSFIELD - CHANNEL ISLANDS - CHICO - DOMINGUEZ HILLS - EAST
BAY - FRESNO - FULLERTON - HUMBOLDT - LONG BEACH - LOS ANGELES MARITIME ACADEMY - MONTEREY
BAY - NORTHRIDGE - POMONA - SACRAMENTO - SAN BERNARDINO - SAN DIEGO - SAN FRANSICSO - SAN JOSE -
SAN LUIS OBISPO - SAN MARCOS - SONOMA - STANISLAUS

STUDY TEAM INFORMATION
Contact Information for this Protocol Submission
Principal Investigator:
Abel, Alyson
 Academic Status:
Faculty
 Department:
 Work Phone:
619-594-4694
Alternate Phone:
678-592-8755
Alternate Email Address:(SDSU email on file)
alyson.abel@sdsu.edu
Funding Details
 Is your study funded?
Yes 
No
HRPP | INITIAL APPLICATION
Updated By: Alyson Abel @ 30-Apr-2020 09:05:11 PM
*
*
*
*

STUDY PERSONNEL
Personnel - Review(Add Personnel - Review)
Personnel - Review
Name
Abel, Alyson
Primary Investigator
Start Date
27-Apr-2020
End Date
Role
PI
CITI Human Subjects Training Complete
 Please Upload Training Completion Report
This individual will be involved with the administration of informed consent.
*

STUDY PERSONNEL CONTINUED
Non-SDSU Affiliated or Undergraduate Study Personnel
Use the table below to list study team members who do not have InfoEd accounts
Full Name
Email
Start Date
End Date
Upload
CITI
Training
Certificates
Role
This
individual
will be
involved
with the
administration
of informed
consent.
 
Cristy
Sotomayor
csotomayor@sdsu.edu
27-Apr-2020
31-May-2022
Other Study Personnel
Yes
Ashlie
Pankonin
apankonin3092@sdsu.edu
27-Apr-2020
31-May-2022
Other Study Personnel
Yes

HUMAN SUBJECTS RESEARCH QUESTIONNAIRE
HS or NHSR?
The following items do not fall under the purview and authority of the IRB:
 Scholarly and journalistic activities (e.g. biography, literary criticism, legal research, and historical scholarship;
 Public health surveillance activities for the purposes of identifying, monitoring, assessing, or investigating
potential public health signals, onsets of disease outbreaks or conditions of public health importance; or
 The collection and analysis of information, biospecimens or records by or for a criminal justice agency for
activities authorized by law or court order for criminal justice or criminal investigative purposes
If your project solely involves one or more of the three bullet items above, check “no” to the answer to Question 1
below:
 1. Does your project involve a systematic investigation and is intended to develop or contribute to
generalizable knowledge (e.g. publication, presentation at a conference, or thesis)?
Yes 
No
 2. Does your research involve obtaining data from or about living individuals through interaction with them, or
through an intervention?
Yes 
No
Identifiable Information
 3. Will any study team member receive, possess, or have access to any of the following identifiers listed below
Yes 
No
Name
Geographic subdivision smaller than a state unless
according to currently publically available data from the
Census Bureau the geographic unit formed consents more
than 20,000 people.
Telephone Numbers
E-Mail addresses
Social Security Numbers
Medical Record Numbers
Health Plan Beneficiary numbers
Account Numbers
All elements of date (except for year) directly related to
an individual (e.g. birth date, admission date, discharge
date, date of death), all ages over 89, and elements of
dates (including year) indicative of age, except such as
ages and elements may be aggregated into a single
category of age 90 or older
Certificate / license number
Vehicle identifiers (e.g. serial number, VIN, license
plate number)
Device identifiers & serial numbers
Biometric Identifiers including voice and fingerprints
Full face photographic images and any comparable
images
Video and voice recordings
Any other unique indentifying number, characteristic or
code
Access to the key to the code allowing you to link the
data to the identity of study participants
HRPP Questionnaire Cont...
4. Is your project a clinical trial?
NIH defines a clinical trial as: "A research study in which one or more human subjects are prospectively assigned
to one or more interventions (which may include placebo or other control) to evaluate the effects of those
interventions on health-related biomedical or behavioral outcomes." Interventions include drugs, medical
devices, procedures, vaccines, as well as noninvasive approaches such as surveys, education, and interviews.
Yes 
No
5. Cancer Related Research
 Does your study involve cancer patients under current treatment or with evidence of current disease; target
cancer survivors, or participants which may be at high risk for cancer?
Yes 
No
 Does your study involve participants from a healthy population but are at a high risk for cancer or is cancer a
study outcome?
Yes 
No
*
*
*
*
*
*

IDENTIFIERS
Select any PHI identifiers you will be accessing (i.e., using), recording (i.e. collecting), or disclosing (i.e. sharing outside
of SDSU) among the following:
 Use the "+" symbol to add additional rows and select applicable PHI Identifiers
 PHI Identifier
Accessing
Recording
Disclosing
 
Names
Telephone numbers
E-mail addresses
Any other unique identifying number, characteristic, or code
Access to the key to the code allowing you to link the data
*
*

BASIC STUDY INFORMATION
Investigator(s) Experience
 List relevant experience of all study team members as it pertains to this research.
Dr. Alyson Abel developed the research skills that allow her to collect, process, analyze and interpret behavioral and
EEG data through her doctoral and postdoctoral training. Dr. Abel received her PhD in Child Language from the
University of Kansas in 2012 and a postdoctoral training in EEG research at the University of Texas at Dallas in 2014.
She also holds a degree in clinical speech-language pathology. Dr. Abel is an expert in child language development
and disorders and EEG analyses of on-line language processing. She has years of experience testing children from
infancy through adolescence and adults. As director of the Language Learning Lab in the School of Speech,
Language, and Hearing Sciences, Dr. Abel has access to equipment and software necessary to complete this
research.
Conflict of Interest
 Does anyone on the research team have a conflict of interest (significant financial interest, financial
relationship, governance or administrative affiliation with any entity that is providing funds for or which has rights
to intellectual property resulting from this study.) SDSU COI
Yes 
No
Background & Significance
 Discuss relevant background information and literature reviewed to provide the rationale for the proposed
research.
Semantic knowledge, or knowledge of a word’s meaning, has strong ties to reading comprehension and long-term
academic outcomes, particularly in the school years. Children with developmental language disorder (DLD),
language impairment in the absence of any causal factors, often show deficits in semantic knowledge and
acquisition. It is generally accepted that these deficits are driven by difficulty with the process of adding meaning to
a new word with repeated exposures to the word, or configuration. What is unknown is what underlies deficits in
configuration and whether these deficits vary across the DLD profile. The goal of this project is to elucidate the
semantic learning deficits in DLD. Toward this goal, this project uses a combined electroencephalogram (EEG) -
behavioral methods approach to examine the cognitive and linguistic processes engaged during semantic learning
in school-age children with and without DLD. The inclusion of EEG will allow for a real-time examination of
semantic learning and associated cognitive and linguistic processes. 10-12 year old children with and without DLD
will complete a behavioral assessment battery and semantic learning task while their EEG is collected. Behavioral
data will be analyzed for semantic learning group differences (Aim 1) and the types of errors that children make when
they are unable to retrieve a correct meaning (Aim 2). EEG data will be analyzed in two ways. The event-related
potential (ERP) analysis will examine changes in semantic processing, indexed by the N400, during learning (Aim
1). Time frequency analysis of the EEG will examine the engagement of neural processes associated with lexical
retrieval (theta) and attention/inhibition (alpha) during learning (Aim 1). Behavioral and EEG methods will be
combined to examine individual differences related to semantic learning outcomes and fine-grained differences in
N400 learning effects across groups (Aim 2). Taken together, findings will inform our understanding of the nature of
the semantic learning deficits in school-aged children with DLD. This understanding is prerequisite for targeted
intervention that would help these children learn how to learn.
 Please provide a list of references to support the information found in the background and significance section.
Ouellette, G.P. (2006). What's meaning got to do with it: The role of vocabulary in word reading and reading
comprehension. Journal of Educational Psychology, 98(3), 554. Milton, J., & Treffers-Daller, J. (2013). Vocabulary
size revisited: the link between vocabulary size and academic achievement. Applied Linguistics Review, 4(1),
151-172. Bishop, D.V., Snowling, M.J., Thompson, P.A., Greenhalgh, T., Consortium, C., Adams, C., . . . Bellair, J.
(2017). Phase 2 of CATALISE: A multinational and multidisciplinary Delphi consensus study of problems with
language development: Terminology. Journal of Child Psychology and Psychiatry, 58(10), 1068-1080. Watkins, R.V.,
& Rice, M.L. (1994). Specific Language Impairments in Children: ERIC. Leonard, L.B. (1998). Children with Specific
Language Impairment. Cambridge, MA: MIT Press. Gray, S. (2003). Word learning by preschoolers with specific
language impairment. Journal of Speech, Language, and Hearing Research, 46, 56-67. Gray, S. (2004). Word
learning by preschoolers with Specific Language Impairment: Predictors and poor learners. Journal of Speech,
Language, and Hearing Research, 47, 1117-1132. Gray, S. (2005). Word learning by preschoolers with Specific
Language Impairment: Effect of phonological or semantic cues. Journal of Speech, Language, and Hearing
Research, 48, 1452-1467. Windfuhr, K.L., Faragher, B., & Conti-Ramsden, G. (2002). Lexical learning skills in young
children with specific language impairment (SLI). International Journal of Language & Communication Disorders,
37(4), 415-432.
Study Abstract
Briefly complete the following Study Abstract components:
 1. Purpose/objective:
Children with developmental language disorder (DLD) have deficits in semantic learning, or learning the meaning of
new words. However, the nature of the deficit remains elusive. Understanding why children with DLD fall short in
semantic learning is prerequisite for targeted intervention that would help these children learn how to learn.
 2. Methods:
This study will use brain processing measures in conjunction with traditional behavioral measures to evaluate the
process of semantic learning in real-time
 3. Subjects
10-12 year old children, both those with typical language development and those with DLD, will serve as participants
for this research. DLD is defined as impairment with language and no other deficit (e.g. neurological impairment,
intellectual deficit, ADHD, autism, etc.) affecting language abilities.
 4. Planned analyses:
Data analyzed will include behavioral performance on a semantic learning task (percent correct and analysis of
incorrect responses) and EEG data time-locked to the novel word being learned. To compare behavioral semantic
learning performance, behavioral data will be subjected to a one-way ANOVA to evaluate a possible effect of group
(DLD, TL) on accuracy and the error analysis. To evaluate changes in brain processing of the novel word during
*
*
*
*
*
*
*
*

learning and potential group differences in neural processing, a 2 group (DLD, TL) x 3 presentation (1st sentence,
2nd sentence, 3rd sentence in the set) ANOVA will be run on the EEG data.
 5. Potential benefits:
There are no direct benefits to the participants. Researchers will learn more about the nature of the semantic
learning deficits in children with DLD.
 6. Potential risks:
Participants will be exposed to very minimal risks. Due to the length of the assessments and semantic learning task,
participants may experience some boredom and stress, which will not exceed the levels they experience in everyday
life and breaks will be provided to alleviate any fatigue or boredom participants may experience. The EEG cap may
be a little stressful for some participants and may seem itchy or uncomfortable. The risks and inconveniences
associated with the assessments are reasonable in relation to the anticipated benefits discussed above.
 7. Risk management procedures:
Participants will be informed about the procedure and the minimal risk. If at any time the participant does not feel
comfortable with the EEG process, the experiment will be terminated. To help alleviate fatigue or boredom, breaks
will be provided throughout the assessment session. To maintain confidentiality, a code number will replace
participants’ names on all of the information collected from them. All data will be marked with a participant code
number only. Research records will be kept confidential to the extent allowed by law and stored in a locked filing
cabinet at the Language Learning Lab and only personnel associated with this research will have access.
Research Design and Methods
 Specify aims of the research that include the hypotheses to be tested, research questions to answer, data to be
gathered and tested.
The central hypothesis of this research is that children with DLD engage cognitive and linguistic processes at different
points during configuration compared to their typical peers, resulting in poorer semantic learning outcomes. Aim 1.
To investigate the cognitive and linguistic processes underlying configuration in children with DLD and typical
language (TL) peers. Aim 2. To investigate individual differences in configuration in children with DLD and TL peers.
Toward these aims, we will administer a series of behavioral assessments to establish language status and a semantic
learning task, during which we will collect EEG. See below for details.
 Use this space to provide a detailed list of every step you will take to test your hypothesis. Beginning with
recruitment strategy, data collection , to analysis of research results.
Participant Recruitment: The PI has experience recruiting children with DLD and has established relationships with
community agencies and professionals who work with these children, including local speech-language clinics, school
districts, and literacy centers. Participants, both DLD and TL, will be recruited from these and other
locations/professionals by way of flyers and in-person recruitment, when possible. General procedures: All
participants will be screened over the phone or via email for language history, handedness, medication use and
history of neurological disorders or dysfunction. Upon arriving at the lab, participants will complete a behavioral test
battery including nonverbal cognition, receptive and expressive vocabulary, general language and verbal working
memory measures. For the EEG task, an electrode cap, similar to a lycra swimcap, will be placed on the participant’s
head. The EEG caps used in the PI's lab are designed for research conducted with infants, children, adolescents,
and adults. The EEG cap is being used as described for use with children according to the instructions for use
document provided by the manufacturer. The researcher will apply a small amount of saline solution to each
electrode (total: 64 on the scalp, another two above and below the left eye). The solution enables the small sponge
in each electrode to expand and make contact with the scalp. When this contact is made, the measured impedance
(measurement of resistance) decreases, and the impedance values can be observed on a computer monitor visible to
the researcher. When the impedance level is decreased on most electrodes, the experiment can begin. Participants
will be seated in an electrically-shielded room in the Language Learning Lab. The electrode cap will collect
electrical activity from the brain as participants complete the semantic learning task, as described below. Participants
will silently listen to naturally-paced sentences presented in sets of 3 sentences. The last word of each sentence will
be a nonsense word. After each set of 3, the participant will be asked to provide the meaning of the nonsense word,
if possible. An experimenter, sitting in the room but out of sight of the participant so as not to distract them, will write
down the word provided by the participant. The participant will be asked to sit as still as possible while the stimuli are
being presented, with the exception of when they are asked to define the nonsense word. Participants will be given
breaks as needed. Following completion of the semantic learning task, participants will complete a word recognition
task where they hear 200 nonsense words one at a time and push a button to indicate whether they've heard it before
or not. Data analyzed will include behavioral performance on the semantic learning task (percent correct and
incorrect responses for error analysis) and EEG data time-locked to the nonsense word in each sentence. To compare
behavioral semantic learning performance and errors, behavioral data will be subjected to a one-way ANOVA to
evaluate a possible effect of group (TL, DLD). To evaluate changes in brain processing of the novel word during
learning and potential group differences in neural processing, a 2 group (TL, DLD) x 3 presentation (1st sentence,
2nd sentence, 3rd sentence in the set) ANOVA will be run on the EEG data.
*
*
*
*
*

PARTICIPANT INFORMATION
Study Population
Instructions: Enter the total number of adults and children you wish to recruit for your study. If you plan on recruiting
members of a vulnerable population, indicate using the check boxes below and enter the total number expected
for that category.
ADULTS (18+)
0
Cognitively Impaired
Prisoners
Pregnant Women
Other
Children
60
Cognitively Impaired
Prisoner/Detainee
Pregnant Women
Other
 Population:
language impaired
30
TOTAL:
60
 Describe how the number of subjects was determined ( e.g. statistical significance).
A priori power analyses were conducted with G*Power using preliminary data to determine sample sizes needed for
the proposed project. For the behavioral data, the semantic learning accuracy analysis requires 16 participants/group
for power=0.95, f=0.6, α=0.05, the error analysis requires 14 participants/group for power=0.95, f=0.6, α=0.05, and
the regression requires 24 participants/group for power=0.95, f2=0.35 α=0.05. The ERP analysis requires 18
participants/group for power=0.95, f=0.6, α=0.05. The time frequency analysis requires 12 participants/group for
power=0.95, f=0.6, α=0.05. This is consistent with evidence that time frequency analysis is more robust to noise than
ERP requiring fewer trials and participants. Therefore, a targeted sample of 25 participants/group should easily
provide at least power=0.8 for all proposed variables.
 List the criteria for inclusion and exclusion of subjects in this study.
Participant exclusion criteria include: neurological disorders (i.e., ASD, ADHD), significant neurological history (i.e.,
head injury, epilepsy), left handedness, medication other than over-the-counter allergy medications, and/or
nonverbal IQ less than 70, as measured by the Wechsler Intelligence Scale for Children. Performance on a
standardized language omnibus assessment (Clinical Evaluation of Language Fundamentals-5 Core Language
Scale; CELF) will be used to classify children as DLD if they earn a standard score of < 80, else they will be classified
as TL. The use of a standard score of 80 on the CELF as a cut point for identification of DLD is supported by good
sensitivity (0.97) and specificity (0.97). The use of this validated cut score is the best assurance that children will be
correctly identified for their respective groups. DLD and TL groups will be equivalent on age, nonverbal cognition,
handedness, and gender, as measured by parental responses to a questionnaire administered during participant
intake.
If applicable, provide a rationale to support subject exclusion for populations who might benefit from
participation in the research.
This age range was selected, in part, because the rate of vocabulary growth in children with DLD further decreases
relative to TL peers around age 10.
Subject Recruitment
How will you contact potential subjects for recruitment?
Record Review
In-Person
Classroom
Flyer
Third Party Referral
Paid Advertisements
Telephone
Email
Letter
Electronic Participant Pool Recruitment
Other
Please upload a copy of any recruitment language that will be used to introduce this study to potential participants.
Subject Screening
What instrument(s) will you use to determine subject eligibility?
*
*
*
*

Survey/Screening/Checklist
Phone Screen
Health Records
Other
N/A
Survey/Screening/Checklist Detail
Mail
In-Person
Online
Other
SONA
 Are you going to obtain informed consent prior to participant screening?
Yes 
No
 Explain how consent will be obtained prior to screening.
Consent will be obtained via phone or email, per parent request, following a script which has been uploaded.
Please upload instrument
Phone Screen Detail
 Are you going to obtain documentation of informed consent prior to participant screening?
Yes 
No
 Explain how documented consent will be obtained prior to screening?
Consent will be obtained via phone or email, per parent request, following a script which has been uploaded.
Please upload phone screen or phone script
Subject Involvement Expectations
 Describe the tasks in the order that the subject will be asked to complete them. If tasks vary by group, please
indicate the group in the description.
Name
of Task
Brief Description
Time to
Complete
 
Visit 1
Demographic questionnaire, Edinburgh Handedness Inventory, Wechsler
Intelligence Scale for Children, Clinical Evaluation of Language Fundamentals,
Nonword Recognition Task, Flanker Inhibitory Control and Attention task
0-5 hours
Visit 2
EEG cap application, semantic learning task, word recognition task
0-5 hours
Research Interviews/Surveys/Questionnaires/Focus Groups
 List all measures used for this study and provide rationale for its use. inidicate if the measure is validated or
published:
Measure
Availability
Validation
 
Demographic questionnaire
Privately Available
PI Developed
Edinburgh Handedness Inventory
Publicly Available
Peer Approved
Wechsler Intelligence Scale for Children
Publicly Available
Peer Approved
Clinical Evaluation of Language fundamentals
Publicly Available
Peer Approved
Nonword Repetition Task
Publicly Available
Peer Approved
Flanker inhibitory control and attention
Publicly Available
Peer Approved
Semantic learning task
Privately Available
PI Developed
Word recognition task
Privately Available
PI Developed
Please upload measures
Research Setting
 Identify the location and describe the setting, include any safety/privacy concerns to study participants
The study will be conducted at Dr. Abel’ Language Learning Lab (6505 Alvarado Rd, Suite 100). This laboratory is
equipped to administer behavioral measures and collect and record EEG data. The laboratory is typically locked and
only accessible to laboratory personnel.
 Will the researcher(s) be traveling to another country to conduct the research?
*
*
*
*
*
*
*
*

Yes 
No
Payment/Incentives to Participants
What form of payment/incentive will be provided?
Payment/Incentives to Participants Details
(Check all that apply):
Reimbursement
Compensation
Drawing
Small Gift
Cash/Check
Gift Card
Other
None
 Describe each type of payment/incentive checked above.
Participants will be reimbursed with cash at a rate of $15/hour of participation
If applicable, please provide a schedule for any prorated payments or incentives.
The prorated rate is $15/hour of participation, even if participation isn't completed.
*

CONSENT PROCESS AND PROCEDURES
Informed Consent
How will you obtain informed consent? (Click HERE for Informed Consent Templates and Guidance)
Please Select
Comprehensive written
Request for alteration or waiver of informed consent
requirement
Short form
Request for waiver of documentation (Signature not
Required)
Comprehensive oral
Pre-existing consents(s) covers this activity
Legally authorized representative consent
Broad Consent
Minors and Cognitively Impaired Persons Detail
(Check all that apply)
Documentation of Assent
Request for waiver of documentation of assent
Request for waiver or alteration of informed
consent/parental permission/legally authorized
representative consent
Request for waiver or alteration of assent
Parental permission or other Legally Authorized
Representative in addition to assent
 Will your assent be translated into a foreign language?
Yes 
No
 If the child attains the age of majority during study participation, how will you obtain consent?
N/A
*
*

RISK/BENEFIT/DATA MANAGEMENT
Potential Benefits
Are potential benefits specific to the participant (check all that apply)
Indirect
Direct
N/A
Are potential benefits specific to society (check all that apply)
Indirect
Direct
 Describe benefits indicated above.
There are little to no direct benefits to participants. Participation in this study will advance knowledge about brain
representations of semantic learning, particularly differences between TD children and children with DLD.
Information gained from this study will inform theories of DLD and potential techniques for semantic learning
intervention with these children.
Risk Assessment and Data Storage Safety Measures/ Risk Management
 Select the level of risk:
Minimal Risk
Minimal Risk: That the probability and magnitude of harm or discomfort anticipated in the research are not greater
in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or
psychological examinations or tests.
Greater than Minimal Risk: That the probability and magnitude of harm or discomfort anticipated in the research
are greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine
physical or psychological examinations or tests.
 Describe risks other than loss of privacy and breach of confidentiality associated with the minimal or greater
than minimal risk research, as indicated above.
Participants will be exposed to very minimal risks. Due to the length of the assessments and semantic learning task,
participants may experience some boredom and stress, which will not exceed the levels they experience in everyday
life and breaks will be provided to alleviate any fatigue or boredom participants may experience. The EEG cap may
be a little stressful for some participants and may seem itchy or uncomfortable. The risks and inconveniences
associated with the assessments are reasonable in relation to the anticipated benefits discussed above.
 What procedures are researchers using to protect personal identifiers and human subject research data,
remember use of passwords, encryption of data stored, and who will have permission to access the data?
Participants will be informed about the procedure and the minimal risk. If at any time the participant does not feel
comfortable with the EEG process, the experiment will be terminated. To help alleviate fatigue or boredom, breaks
will be provided throughout the assessment session. To maintain confidentiality, a code number will replace
participants’ names on all of the information collected from them. All data will be marked with a participant code
number only. Research records will be kept confidential to the extent allowed by law and stored in a locked filing
cabinet at the Language Learning Lab and only personnel associated with this research will have access.
Data Safety Monitoring Plan (DSMP)
 Will any of the data be released outside of the research study team? (other than to publisher)
Yes 
No
 Please explain:
For the purpose of replication, deidentified data may be provided upon request to collaborators and other
investigators.
 Will data be provided to a repository as part of a data sharing agreement?
Yes 
No
 Will the project require a certificate of confidentiality?
Yes 
No
As Data is/ are Collected
Confidential (Data contains at least one of the 18 listed HIPAA personal identifiers)
Coded and key is linked to the code (or linked to personal identifier(s)) (Code is used on individual data and
researchers maintain a key to personal identifier(s))
Anonymous/ or Coded With No Key or/ De-Identified (Personal identifiers were never associated with the data
or/ personal identifiers are separated from coded data with no key to link to identifiers or / data had personal
identifiers then researchers stripped the data of all personal identifiers as an aggregate before analysis)
Coded Details
 Will the information remain coded for the duration of the research?
Yes 
No
*
*
*
*
*
*
*
*
*

Data Storage
 How long will data be stored? (Hover over Help Icon for more information)
Data will be stored for 10 years
 When will data be de-identified or destroyed?
Data will be de-identified upon collection.
*
*

OFFICE USE ONLY
Post-Approval Tracking
q_1
Yes
q_2
Yes
q_3
Yes
Division of Research Affairs
Human Research Protection Program
Gateway Center, Rm 3505
San Diego State University
5250 Campanile Dr., MC 1933 San Diego, CA 92182
PHONE: 619-594-6622 
FAX: 619-594-4109
Email: irb@mail.sdsu.edu
Institution Home
Human Research Protection Program Website
Division of Research Affairs Website

Appendix 1
EForm Name: HRPP | INITIAL APPLICATION
Page:
Study Personnel
Section:
Personnel - Review
Question:
Please Upload Training Completion Report
File Name:
citiCompletionReport_RCR1_2019.pdf

 
Completion Date 22-Sep-2019
Expiration Date 21-Sep-2022
Record ID
32125896
This is to certify that:
Alyson Abel Mills
Has completed the following CITI Program course: 
Responsible Conduct of Research (RCR)
(Curriculum Group)
Research Involving Human Subjects
(Course Learner Group)
1 - Basic Course
(Stage)
Under requirements set by:
San Diego State University
Verify at www.citiprogram.org/verify/?w209491e0-bf04-43fe-9ae1-10f568d051d7-32125896 

Appendix 2
EForm Name: HRPP | INITIAL APPLICATION
Page:
Study Personnel Continued
Section:
Non-SDSU Affiliated or Undergraduate Study Personnel
Question:
Upload CITI Training Certificates
File Name:
CITI Research Involving Human Subjects_Sotomayor.pdf

 
Completion Date 30-Jun-2017
Expiration Date 29-Jun-2020
Record ID
23668863
This is to certify that:
Cristy Sotomayor
Has completed the following CITI Program course: 
Responsible Conduct of Research (RCR)
(Curriculum Group)
Research Involving Human Subjects
(Course Learner Group)
1 - Basic Course
(Stage)
Under requirements set by:
San Diego State University
Verify at www.citiprogram.org/verify/?wc7b1c7ae-92df-45b6-b95e-649e78260ad4-23668863 

Appendix 3
EForm Name: HRPP | INITIAL APPLICATION
Page:
Study Personnel Continued
Section:
Non-SDSU Affiliated or Undergraduate Study Personnel
Question:
Upload CITI Training Certificates
File Name:
SDSU RCR citi Completion Report - Ashlie Pankonin.pdf

COLLABORATIVE INSTITUTIONAL TRAINING INITIATIVE (CITI PROGRAM)
COMPLETION REPORT - PART 1 OF 2
COURSEWORK REQUIREMENTS*
* NOTE: Scores on this Requirements Report reflect quiz completions at the time all requirements for the course were met. See list below for details.
See separate Transcript Report for more recent quiz scores, including those on optional (supplemental) course elements.
•  Name:
Ashlie Pankonin (ID: 6426979)
•  Institution Affiliation:
San Diego State University (ID: 3235)
•  Institution Email:
apankonin3092@sdsu.edu
•  Institution Unit:
Speech Language and Hearing Sciences
•  Phone:
4024290258
•  Curriculum Group:
Responsible Conduct of Research (RCR)
•  Course Learner Group: Faculty, Staff and Students
•  Stage:
Stage 1 - Basic Course
•  Record ID:
32556699
•  Completion Date:
27-Jul-2019
•  Expiration Date:
26-Jul-2022
•  Minimum Passing:
80
•  Reported Score*:
100
REQUIRED AND ELECTIVE MODULES ONLY
DATE COMPLETED
SCORE
Authorship (RCR-Basic) (ID: 16597) 
27-Jul-2019
5/5 (100%) 
Collaborative Research (RCR-Basic) (ID: 16598) 
27-Jul-2019
5/5 (100%) 
Data Management (RCR-Basic) (ID: 16600) 
27-Jul-2019
5/5 (100%) 
Mentoring (RCR-Basic) (ID: 16602) 
27-Jul-2019
5/5 (100%) 
Peer Review (RCR-Basic) (ID: 16603) 
27-Jul-2019
5/5 (100%) 
Research Misconduct (RCR-Basic) (ID: 16604) 
27-Jul-2019
5/5 (100%) 
Plagiarism (RCR-Basic) (ID: 15156) 
27-Jul-2019
5/5 (100%) 
For this Report to be valid, the learner identified above must have had a valid affiliation with the CITI Program subscribing institution
identified above or have been a paid Independent Learner.
Verify at: www.citiprogram.org/verify/?kc65181d7-8f11-41b5-bbff-d87c89f7fe96-32556699
Collaborative Institutional Training Initiative (CITI Program)
Email: support@citiprogram.org
Phone: 888-529-5929
Web: https://www.citiprogram.org

COLLABORATIVE INSTITUTIONAL TRAINING INITIATIVE (CITI PROGRAM)
COMPLETION REPORT - PART 2 OF 2
COURSEWORK TRANSCRIPT** 
** NOTE: Scores on this Transcript Report reflect the most current quiz completions, including quizzes on optional (supplemental) elements of the
course. See list below for details. See separate Requirements Report for the reported scores at the time all requirements for the course were met.
•  Name:
Ashlie Pankonin (ID: 6426979)
•  Institution Affiliation:
San Diego State University (ID: 3235)
•  Institution Email:
apankonin3092@sdsu.edu
•  Institution Unit:
Speech Language and Hearing Sciences
•  Phone:
4024290258
•  Curriculum Group:
Responsible Conduct of Research (RCR)
•  Course Learner Group: Faculty, Staff and Students
•  Stage:
Stage 1 - Basic Course
•  Record ID:
32556699
•  Report Date:
27-Jul-2019
•  Current Score**:
100
REQUIRED, ELECTIVE, AND SUPPLEMENTAL MODULES
MOST RECENT
SCORE
Plagiarism (RCR-Basic) (ID: 15156)
27-Jul-2019 
5/5 (100%) 
Authorship (RCR-Basic) (ID: 16597)
27-Jul-2019 
5/5 (100%) 
Collaborative Research (RCR-Basic) (ID: 16598)
27-Jul-2019 
5/5 (100%) 
Data Management (RCR-Basic) (ID: 16600)
27-Jul-2019 
5/5 (100%) 
Mentoring (RCR-Basic) (ID: 16602)
27-Jul-2019 
5/5 (100%) 
Peer Review (RCR-Basic) (ID: 16603)
27-Jul-2019 
5/5 (100%) 
Research Misconduct (RCR-Basic) (ID: 16604)
27-Jul-2019 
5/5 (100%) 
For this Report to be valid, the learner identified above must have had a valid affiliation with the CITI Program subscribing institution
identified above or have been a paid Independent Learner.
Verify at: www.citiprogram.org/verify/?kc65181d7-8f11-41b5-bbff-d87c89f7fe96-32556699
Collaborative Institutional Training Initiative (CITI Program)
Email: support@citiprogram.org
Phone: 888-529-5929
Web: https://www.citiprogram.org