Screening Device for Autism Spectrum Disorders Using High Stimulation Rate ABR With Continuous Loop Averaging Deconvolution
Conditions: Autism Spectrum Disorder
Sponsor: Intelligent Hearing Systems

 
 
Title:  
Screening for Autism Spectrum Disorders Using Auditory Brainstem 
Responses 
 
Number: NCT03971578 
 
Date: Aug 8, 2019 
 
 
Project Funded by NIH NIDCD SBIR Grant R43DC018430-01 to Intelligent 
Hearing Systems Corp.  
 
Grant Title:  
Screening Device for Autism Spectrum Disorders using High Stimulation 
Rate ABR with Continuous Loop Averaging Deconvolution  
 

 
 
1) 
Protocol Title 
High stimulation rate ABR in ASD and non-ASD children 
 
2) 
Objectives* 
The purpose of this proposal is to develop and assess the feasibility of an 
automated auditory brainstem response (ABR) based neurological 
screening device and software module that will provide early detection of 
increased risk for autism spectrum disorder (ASD) and other neurological 
conditions (e.g., speech impairment or sudden infant death syndrome 
(SIDS)). Recordings will be obtained at a range of stimulation rates from 
19 to 250/second to determine the optimal rate to be used for newborn 
screening.  
 
3) 
Background* 
ASD is characterized by persistent deficits in communication and social 
interaction across multiple contexts and restricted, repetitive patterns of behavior, 
interests, or activities. Symptoms cause clinically significant impairments in 
social, occupational, or other important areas of current functioning. The term 
“spectrum” refers to the wide range of symptoms, skills, and levels of impairment 
or disability that children with ASD can have. Some children are mildly impaired 
by their symptoms, while others are severely disabled.  
 
The incidence rate of ASD is 1:59. Based on 3.94 million births in the United 
States in 2016, 66,780 new cases of ASD will be diagnosed from that birth cohort 
alone. Although the incidence rate of hearing loss is 3:1000, over 5 times smaller 
than ASD, universal hearing screening has been instituted in most states for more 
than 20 years. Approximately 2 million babies per year are currently screened 
with ABR technology, one million with Intelligent Hearing Systems (IHS) 
equipment alone. Current screening protocols use moderate auditory stimulation 
levels, 35 dB nHL, to focus on hearing sensitivity. The typical testing time is 
approximately 7 minutes plus electrode and insert earphone placement time. The 
new system tested in this study will add a supra-threshold testing level required 
for neurological evaluation, and will introduce only an additional minute to the 
screening process. These additions will capitalize on the initial prep-time and cost 
of disposables used for hearing screening, while providing important information 
on the newborn’s neurological status at almost no additional cost. Not screening 
for neurological conditions at this stage represents an enormous loss of 
opportunity to provide early diagnosis and intervention to these infants. 
Substantially improved outcomes can be achieved through early diagnosis and 
intervention.  
 
The practice of early screening and identification of ASD is encouraged by the 
nation’s Healthy People 2020 objectives and the American Academy of 
Pediatrics. Although ASD symptoms are present in the early developmental 
period and can be recognized in the first two years of life, the median age of ASD 
diagnosis still remains older than 4 years and has not decreased in recent years 

 
 
(Brett et al., 2016). Recommendations from the Autism and Developmental 
Disabilities Monitoring Network (ADDM) include enhancing strategies to address 
the need for decreasing the age when children receive their first evaluation for and 
a diagnosis of ASD and are enrolled in community-based support systems (Baio, 
2014). Given that about 46% of children with ASD have average to above average 
intellectual ability (Baio, 2014), early intervention provides a significant 
opportunity to improve the outcomes of these individuals in particular, as well as 
those with more severe intellectual disabilities.  
 
The system developed will serve to provide an objective measure of neurological 
function that can be used for screening purposes at any age to determine the 
transmission rate and synchrony of neurological pathways. Of particular interest 
is the reported link between ABR peak latency delays and ASD (Dabbous, 2012; 
Fujikawa-Brooks et al., 2010; Kwon et al., 2007; Maziade et al., 2000; Miron et 
al., 2015; Rosenhall et al., 2003; Roth et al., 2012; Russo et al., 2010; Tas et al., 
2007; Thivierge et al., 1990; Wong et al., 1991). Although evoked potentials can 
be acquired using visual and somatosensory stimulation; auditory stimulation 
provides an ideal method as it requires no patient participation and is painless. 
Tests using ABR can be conducted in a minimally invasive procedure by only 
applying three surface scalp electrodes and sound stimulation while an infant is in 
natural sleep. Newborn hearing screening is currently routinely conducted 
universally across the United States and in many developed countries around the 
world using the same ABR technology. Expanding hearing screening to 
neurological screening could be accomplished with minimal cost and test time 
using the proposed techniques.  
 
Significant latency differences in the peak components of ABRs have been 
identified in children with ASD compared to aged matched normal children 
(Dabbous, 2012; Fujikawa-Brooks et al., 2010; Kwon et al., 2007; Maziade et al., 
2000; Rosenhall et al., 2003; Roth et al., 2012; Russo et al., 2010; Tas et al., 2007; 
Thivierge et al., 1990; Wong et al., 1991). Studies have also shown that prolonged 
ABRs occurred in infants who later had social engagement problems (Geva et al., 
2011) and repetitive behaviors (Cohen et al., 2013). More recently, Miron et al. 
(2015) showed that prolonged ABR occurred in young infants later diagnosed 
with ASD and that this prolongation, especially in wave V, was capable of 
accurately classifying ASD. Although the sensitivity (84% & 80%) and 
specificity (56% & 70%) measures for Cohen et al. (2013) and Miron et al. 
(2015), respectively, are encouraging, the resulting high false positive rate would 
be of concern for any screening tool. It is important to point out that these values 
were derived primarily from testing at-risk infants and that a broader study 
including a large number of well-babies is required to fully develop latency norms 
and new specificity and sensitivity measures.  
 
There are several options to improve test sensitivity and specificity. 
Choosing the proper cut-off value for absolute and interpeak latency 
difference between normal and ASD infants are critical for optimizing any 

 
 
screening tool. In addition to abnormalities in ABR latencies, studies have 
shown that ABR amplitudes are also abnormal in some children with ASD 
(Coutinho et al., 2002; N. Russo et al., 2009). Miron et al. (2015), 
hypothesize that predicting ASD based on both ABR amplitude and 
latency may be even more accurate than predicting based solely on ABR 
latency. Furthermore, the use of higher stimulation rates may provide an 
additional way to differentiate normal versus ASD infants. 
 
4) 
Inclusion and Exclusion Criteria* 
Subjects will be children between the ages of 1.5 and 5.5 years.  Our target 
age group is 3.5 to 4.5 years of age but younger or older children may be 
included as well. Parents must be able to communicate effectively in 
English to participate in the study.  
 
A formal ASD diagnosis (i.e., community diagnosis or educational 
eligibility diagnosis) is required for children to be part of the ASD group.  
Children in the control group will not have a diagnosis of ASD or any 
other developmental disability.  Control children will be age and gender 
matched with the ASD subjects. All children will be screened to insure 
that they do not have hearing problems, a history of middle ear infections, 
or a current ear infection. All children will be given an Otoacoustic 
Emissions (OAE) hearing screening test prior to ABR testing to confirm 
that their peripheral auditory system is normal. 
 
Exclusion criteria for all subjects include:  hearing problems, history of 
middle ear infections or current ear infection, and other abnormalities or 
impairments that could impact neurological functioning such as seizures, 
comorbid syndromes or diseases, sensory disorders, craniofacial 
abnormalities, other developmental or physical disabilities, or having a 
sibling with ASD or another developmental disability. 
 
5) 
Procedures Involved* 
Data collection is anticipated to occur from September 2019 through May 2021. 
 
Phone Screen: 
Parents/guardians who call to inquire about the study will be screened over the 
phone to determine if they meet the inclusion criteria.  Subjects who meet 
inclusion criteria will be invited to come to the lab. The Phone Intake Form is 
attached. 
 
Lab Session:   
All assessments will be completed during one lab visit.  A second visit may be 
needed if testing cannot be completed during the initial visit.  The lab session will 
include some or all of the following assessments: 
 
 

 
 
Informed Consent: 
The study will be described to the parent/guardian and informed consent will be 
obtained. The Informed Consent document is attached. 
 
Head Circumference: 
The circumference of the child’s head will be measured using a measuring tape. 
 
OAE:   
In order to make sure that the subject has normal hearing, an Otoacoustic 
Emissions (OAE) measurement will be conducted. OAEs are a routine 
audiometric test conducted to measure cochlear function. OAEs will be recorded 
using the SmartDPOAE system on the Duet Platform (Intelligent Hearing 
Systems Corp).  The OAE procedure involves placing a small probe in the ear, 
similar to an insert earphone, presenting soft sounds to the ear at 65 and 55 dB 
SPL and measuring the acoustical output from the ear. The OAE system provides 
a pass or refer output based on the measurements. Children with passing OAE 
results will be retained for the ABR portion of the study.  
 
ABR: 
Neurological function will be assessed using ABR.  ABRs will be recorded using 
the SmartEP system on the Duet Platform (Intelligent Hearing Systems Corp).  
Various stimulation rates (19-250/sec) using a 75 dB nHL100 µsec click will be 
used to compare ABR peak latency and amplitude differences between children 
with ASD and control children.  The ABR procedure involves placing 4 small 
electrodes (Ambu Neuroline 720) on the subject’s head (right and left mastoids, 
high and low forehead) and inserting earphones in both ears. Prior to placing the 
electrodes, a disposable electrode prep pad (70% isopropyl alcohol, purified 
water, and pumice) will be used to gently clean the skin at the electrode site.  
Click sound stimuli of a moderate level (75 dB nHL) are presented at various 
stimulation rates. This intensity level is routinely used for hearing assessment and 
is considered safe for short duration stimuli. ABR data will be recorded and peaks 
identified and measured. A flyer describing the SmartDPOAE and SmartEP 
systems is attached. 
 
ASRS 
All children, including controls, will be evaluated using the Autism Spectrum 
Rating Scale (ASRS) questionnaire to verify ASD symptomology in the ASD 
children and lack of symptomology in the control children. The ASRS will be 
completed by the child’s parent or guardian. A sample of the ASRS questionnaire 
is attached. 
 
ASQ-3:   
The Ages and Stages Questionnaire, Third Edition (ASQ-3) will be used to 
evaluate the child’s development in the areas of communication, gross motor, fine 
motor, problem solving, and personal-social. The ASQ-3 will be completed by the 
child’s parent or guardian.  A sample of the ASQ questionnaire is attached. 

 
 
 
Family Information Form: 
The Family Information Form contains questions regarding birth indicators (e.g., 
birth weight, gestational age, birth complications), demographic information (e.g., 
race, ethnicity, parent education, parent occupation, family income), and siblings.  
The Family Information Form will be completed by the child’s parent or 
guardian. The Family Information Form is attached. 
 
6) 
Data and Specimen Banking* 
At the close of the study period, when all final data have been entered, a 
final read-only data set will be generated to document the data used for 
publication as well as for potential use in future research. 
 
7) 
Data Management* 
Paper forms will be used to collect consent and demographic/family history 
information as well as for the ASRS and ASQ assessments. Paper forms will be 
scanned and stored on a secure, encrypted cloud-based system (i.e., Box) and the 
forms will be physically stored in a locked file cabinet.   
 
A unique subject identifier will be assigned and used for all OAE and ABR data 
acquisition.  OAE and ABR data will be recorded on the data acquisition system, 
stored electronically identified by subject number only, and backed up daily to a 
secure computer at the University of Miami. A deidentified database (records will 
be identified by subject numbers only, names will not be included) containing all 
study data will be created and will be accessible only to authorized study 
personnel. Identifying information will not be included in the analyses nor 
released to non-study personnel.  Deidentified raw OAE and ABR data will be 
transferred using a secured Box account to Dr. Savio at Intelligent Hearing 
Systems for review to assure that the data meet the required quality for the study. 
 
Data analysis plan: 
The following statistical analyses will be performed: 
1) Analysis of variance and t-tests will be conducted to determine if there are 
significant differences between the ASD and control groups, sex and ear on ABR 
peak latency and amplitude. 
2) Sensitivity and specificity measures will also be conducted using Receiver 
Operating Characteristic (ROC) curves and d-prime measures.  The optimal 
stimulation rate for ASD detection will be determined using these measures. 
 
Factor: Click stimulation rate (five levels): 19, 39, 61, 120, and 250 per second.  
The three lower rate levels were selected to replicate previous research. The upper 
levels were selected to obtain ABRs with discernible peaks while challenging the 
neural transmission of the auditory system. 
 
Dependent Variables: Absolute peak latencies and amplitudes.  
 

 
 
Data and Safety Monitoring (DSM) Plan: 
This study was designated as a clinical trial by NIH.  It is registered on 
clinicaltrials.gov and a data and safety monitoring plan was developed. This is a 
case-control study involving the recording of data routinely used for hearing 
assessment using non-invasive techniques; therefore, it is considered low risk. As 
such, it does not warrant a formal DSM board.  However, an independent 
monitor, Dr. Jorge Bohoquez, was assigned and will review all study activities.  
Dr. Bohoquez is a professor of Biomedical Engineering at the University of 
Miami and has no conflict of interest with the PI, Intelligent Hearing Systems or 
the primary investigators at the Department of Psychology of the University of 
Miami.  Dr. Bohoquez has extensive experience with ABR acquisition at high 
stimulation rates and has conducted independent research validating the data 
acquisition methods used in this study.  As such, he is qualified to independently 
review the study overall and specifically the validity and quality of the ABR data 
being acquired.  Dr. Bohoquez will have full access to the study records and data 
for review as needed.  Dr. Bohoquez will review all data capture, storage, 
verification, and disposition activities quarterly.  A quarterly DSM report will be 
generated and will contain the following information: (a) study recruitment 
progress; (b) study retention and reasons for drop-out; (c) protocol and data 
completeness; (d) data analysis; and (e) data quality. The Data and Safety 
Monitoring Plan that was submitted to and approved by NIH is attached. 
 
8) 
Risks to Subjects* 
The potential risks to the subjects are minimal. The OAE and ABR equipment and 
procedures to be used have been used in previous studies with human subjects, 
with no adverse effects. The equipment is specifically designed to protect subjects 
from possible electric shock originating from the test equipment to the subjects 
and from exposure to high sound intensity levels. The device to be used has been 
approved by the US FDA and has passed all required IEC60601 safety tests from 
independent, accredited testing laboratories. The proposed testing methods have 
also been previously used in human clinical and research studies.  There are no 
known side effects, risks or complications associated with the OAE and ABR 
assessments.  Possible adverse events (AEs) may include a skin rash associated 
with the recording electrodes.  These can be identified by skin redness or rash at 
the time that the electrode is removed.  No serious adverse events (SAEs) are 
anticipated as the ABR and OAE procedures are routinely used for hearing 
evaluation throughout the world.   
 
Any AE or SAE during data acquisition at the University of Miami will be 
reported by the University of Miami Site Director (IRB PI), Dr. Christine 
Delgado, immediately to 1) the PI at Intelligent Hearing Systems, 2) the IRB 
board, 3) the study team, and 4) Independent Data Safety Monitor.  The PI at 
Intelligent Hearing Systems will report the event within 48 hours to 5) NIH-
NIDCD Staff and 6) Office of Human Research Protection.   
 

 
 
Any adverse event associated with the data recording equipment will be handled 
as a device complaint by the manufacturer (Intelligent Hearing Systems) through 
their complaint and reporting procedure QOP-85-02-WI2 (attached).  Personnel 
using the equipment will contact IHS immediately at 1-800-447-9783 to report 
any concerns, issues or problems during the data recording process.  The timeline 
for reporting any SAEs is outlined in the reporting procedure as mandated by the 
FDA. 
 
All AEs will be reported to the Office for Human Research Protections (OHRP) 
in a report containing the following information: 
Name of the institution: University of Miami 
Title of the research project: Screening Device for Autism Spectrum Disorders 
using High Stimulation Rate ABR with Continuous Loop Averaging 
Deconvolution 
Grant proposal:  1R43DC018430-01 
Grant Principal Investigator: Rafael E. Delgado 
Principal Investigator on IRB Protocol: Christine Delgado 
Number of the research project assigned by the IRB: ___________ [TBD] 
Explain in detail the problem that occurred 
Actions the institution is taking or plans to take to address the problem: (e.g., 
revise the protocol, suspend subject enrollment, terminate the research, revise the 
informed consent document, inform enrolled subjects, increase monitoring of 
subjects, etc.). 
 
A PDF file containing the report will be emailed to: IRPT.OS@hhs.gov 
 
9) 
Potential Benefits to Subjects* 
A benefit to subjects will be obtaining information as to their current hearing 
status.  Subjects will be provided with information pertaining to the OAE test 
results based on automated interpretation from the recording system.  Subjects not 
passing the initial OAE screening will be informed of the test result and advised 
to consult their pediatrician and/or the Florida Diagnostic and Learning Resources 
System (FDLRS) for potential follow up.  Additionally, control subjects with 
deviant scores on the ASRS or ASQ may be advised to consult their pediatrician 
and/or the Florida Diagnostic and Learning Resources System (FDLRS) for 
potential follow up.  No other specific information will be provided to subjects.  A 
final study report with summary data will be made available to participants upon 
requests and the results will also be posted at clinicaltrials.gov.   
 
10) Vulnerable Populations* 
 
The primary aim of the study is to develop an improved method to screen 
children for ASD.  As such, the use of children as subjects is critical in the 
assessment of the feasibility of the proposed techniques. Parents will be 
given the alternative to not participate in the study. 
 

 
 
11) Setting 
Data collection will be conducted on the second and third floors of the 
Department of Psychology, Flipse Building at the University of Miami. 
Address:  5665 Ponce de Leon Blvd., Coral Gables, FL  33146. 
 
12) Resources Available 
Dr. Christine Delgado (Research Assistant Professor, Department of 
Psychology) is the Director of the Children’s Registry and Information 
System (CHRIS) project.  Her research focuses on the identification of 
early risk factors for children with disabilities and the tracking of 
outcomes of preschool children with disabilities.  
 
Dr. Elizabeth Simpson (Assistant Professor, Department of Psychology) conducts 
research on understanding infant social cognitive development, including the 
ultimate and proximate mechanisms that shape individual differences in social 
perception. She longitudinally studies human and nonhuman primate infant 
development, including studies of imitation and face perception.  
 
Dr. Anibal Gutierrez (Research Associate Professor, Department of 
Psychology) is an Associate Director of the Center for Autism and Related 
Disabilities (CARD). He is also a Board Certified Behavior Analyst with 
experience in the assessment and treatment of problem behavior and in the 
development of adaptive skills for individuals with autism. His research 
focuses on early intervention, variables related to treatment effectiveness 
for individuals with autism, and the use of technology to bring about 
behavior change. 
 
Dr. Guillermo Savio (Research Scientist, Intelligent Hearing Systems 
Corporation) has published extensively in the field of auditory evoked 
potentials and has extensive experience recording data from pediatric 
populations.  He will train the research assistant in recording techniques 
and will be available for assistance as needed.  He will also review and 
analyze all raw OAE and ABR data to assure quality. 
 
Oren Miron (Research Associate, Biomedical Informatics, Harvard 
University) has conducted several studies on the prediction of autism risk 
in newborns using ABR.   
 
Dr. Jorge Bohorquez (Associate Professor in Practice, Biomedical 
Engineering Department) has experience with the development of methods 
and equipment for neurophysiology and neuro-monitoring and objective 
hearing assessment.  Dr. Bohorquez will serve as the independent monitor 
for this study. 
 
The research assistant (TBD) will be trained by study personnel to conduct 
the sessions. 

 
 
 
Each research team member will complete the required CITI training 
courses.   
 
13) Prior Approvals 
A Data and Safety Monitoring Plan was submitted to and approved by 
NIH. 
 
14) Recruitment Methods 
Recruitment will take place through the Center for Autism and Related 
Disabilities (CARD) and through other means such as by posting or distributing 
flyers at various child-friendly establishments in our community (e.g., preschools, 
museums, pediatrician’s offices, retail businesses). The recruitment flyers are 
attached.  Parents may contact the study investigators at their convenience, at 
which point the study will be described in detail and information regarding 
potential participants will be obtained.  This prescreening will allow the 
researchers to determine whether the family is eligible to participate.  Only 
children who meet the inclusion criteria for the study will be invited to schedule a 
lab session.    
 
Participants will be compensated $50 at the completion of the study.  
Partial compensation will be made for participants who begin but do not 
complete the study.  Participants will be paid through ClinCard (a 
reloadable debit card for research studies) or through check.  The ClinCard 
is the preferred method of paying research participants for their 
participation, and is managed by the Office of Research Administration 
(ORA).  Participants will complete and sign a payment form, with their 
full name, date of birth, and address, in order to receive payment for 
participation.  This information will not be linked to any of the study data 
and will only be used for payment purposes.   
 
15) Local Number of Subjects 
100 children 1.5-5.5 years of age will be recruited to participate in the 
study, including 50 children with ASD and 50 age and gender-matched 
controls.  Additional subjects will be recruited as needed to achieve a 
complete age and gender matched control group and to accommodate for 
subjects who did not fully complete the session.   
 
16) Confidentiality 
Paper forms used to collect consent and demographic/family history information 
as well as for the ASRS and ASQ assessments will be scanned and stored on a 
secure, encrypted cloud-based system (i.e., Box) and the forms will be physically 
stored in a locked file cabinet.  OAE and ABR data will be recorded on the data 
acquisition system, stored electronically identified by subject number only, and 
backed up daily to a secure computer at the University of Miami. Deidentified 
raw OAE and ABR data will be transferred using a secured Box account to Dr. 

 
 
Savio at Intelligent Hearing Systems for review to assure that the data meet the 
required quality for the study. A deidentified database (records will be identified 
by subject numbers only, names will not be included) containing all study data 
will be created and will be accessible only to authorized study personnel. 
Identifying information will not be included in the analyses nor released to non-
study personnel.  All local computers or cloud-based storage systems (e.g., Box) 
used will require a password to gain access. If requested, data will be provided to 
NIH and authorized University of Miami employees or other agents for the 
purposes of official audits or reviews. 
 
17) Provisions to Protect the Privacy Interests of Subjects 
The confidentiality practices described above will be conducted to protect the 
privacy interest of subjects.  Any persons collecting or assessing participant data 
will have completed CITI certifications and will be included on the IRB protocol. 
 
18) Consent Process 
When the family arrives for the session, a trained member of the research 
team will give the parents an overview of the entire study, as well as 
detailed descriptions of what the visit will entail, and will answer any 
questions.  Parents will provide consent in order for their children to 
participate. 
 
 
 

 
 
INFORMED CONSENT FORM 
 
STUDY INFORMATION: 
Title:  How Children With and Without Autism Process Sounds 
Principal Investigator:  Christine Delgado, Ph.D. 
Department:  Psychology 
Phone Number:  305-284-3371 
Email Address:  cdelgado@umiami.edu 
Study Contact Email:  UMChildDevelopment@miami.edu 
Sponsor:  This research study is supported by a grant (1R43DC018430-01) from the 
National Institutes of Health (NIH), National Institute on Deafness and Other 
Communication Disorders (NIDCD) to Intelligent Hearing Systems.  
 
PURPOSE:  The goal of this study is to measure brain responses in children while they 
listen to click sounds. The ways in which children’s brains respond to these sounds may 
be linked to developmental disorders, such as autism.   
 
ELIGIBILITY:  We will study children with autism and children without autism. Your 
child must be healthy and between the ages of 1.5 and 5.5 years old. 
 
PROCEDURE:  During your visit, you will be asked to provide us with information 
about your child and your family.  You will also be asked questions about your child’s 
development.  We will measure the size of your child’s head using a measuring tape.  We 
will also conduct two tests on your child that are very similar to the hearing test your 
child most likely received in the hospital shortly after he/she was born. First, we will give 
your child a routine hearing test that involves placing earphones in his/her ears.  If your 
child’s hearing is normal, we will conduct another test. This second test involves placing 
earphones in your child’s ears and small stickers called “electrodes” on your child’s head.  
Sounds will be played through the earphones and the electrodes will measure brain 
activity in response to those sounds.  Both tests are painless and require that the child be 
quiet and lie still. If you choose, your child can watch a silent video or participate in 
some other quiet/calm activity during this time. You will be with your child for the entire 
duration of your visit.  The study is designed to be completed in one session, but if this is 
not possible you may be asked to return for a second session. The two tests should take 
no more than 30 minutes and the total session should take about 90 minutes. 
 
RISKS: The risks of being in this study are minimal.  The equipment and procedures 
have been used in previous studies with human children and adults with no negative 
effects. The devices that will be used on your child have been tested for safety and are 
approved by the U.S. Food and Drug Administration (FDA).  There are no known side 
effects, risks, or complications associated with these tests.  Rarely a skin rash or irritation 
may occur where the stickers were placed on the skin.   
 
BENEFITS: Test results pertaining to the hearing status of your child will be provided to 
you.  The overall findings of the study will provide information about brain activity in 
children with autism that may be used to develop and improve screening tests for 

 
 
newborns.  If we can find out that a child is at risk for autism or another developmental 
disability when they are first born, then this may lead to better support for these children.  
If you would like, after the study is finished, we will share with you our findings. 
 
COSTS: You may have transportation costs for being in this study. You will not receive 
compensation for transportation in this study. 
 
PAYMENT TO PARTICIPANT: If you agree to be in this research study, we will pay 
you $50.00 at the completion of the study for your time and effort. We will give you a 
partial payment for an incomplete visit if you do not return to complete the study. 
 
CONFIDENTIALITY: Data collected for this study will be accessed and analyzed by 
collaborators at the University of Miami, Harvard University, and Intelligent Hearing 
Systems.  The NIH is funding this study and may, therefore, request to review and obtain 
copies of your records. Your records may also be reviewed for audit purposes by 
authorized University of Miami employees or other agents who will be bound by the 
same provisions of confidentiality.  Any data from the study provided to other entities or 
presented/published will be in aggregate/summary form and will not include any 
identifying information.  Paper forms will be stored in a locked file cabinet and electronic 
information and data will be stored in a secure, encrypted data storage platform that is 
password protected.  Data analyses will be conducted using a de-identified database (i.e., 
all names and identifying information will be removed).   
 
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as 
required by U.S. law. This web site will not include information that can identify you or 
your child. At most, the web site will include a summary of the results. You can search 
this web site at any time. 
SHARING INFORMATION: Families who participate in our study may be interested in 
participating in other research projects at the University of Miami.  Please indicate 
below if you would like for us to provide your contact information to researchers 
conducting other studies that you and/or your child may be eligible to participate in.   
 [   ]  Yes, I give permission to share my contact information. 
[   ]  No, I do not wish to share my contact information. 
RIGHT TO WITHDRAW: Your participation is voluntary. That means you can decide 
that you do not want you or your child to be in the study. Once you begin, you can 
request to stop any procedure at any time. You can decline to answer or skip any question 
you do not wish to answer. No consequences will result from either declining or 
discontinuing participation. Upon request, we will give you a copy of this consent form. 
QUESTIONS: Ask us questions now or at any time during your visit(s). Talk to the 
research team if you have questions, problems, concerns, or complaints, want more 
information, want to offer a suggestion, think you or your child has been injured, or 

 
 
would like a copy of the results.  You can contact Dr. Christine Delgado at 305-284-3371 
or by email at cdelgado@umiami.edu. 
 
This research has been reviewed and approved by an Institutional Review Board (“IRB”).  
The Human Subject Research Office (HSRO) provides administrative support to the 
University of Miami’s IRBs.  Please call the HSRO at 305-243-3195 if you are a 
participant in any research being conducted at UM and: 
• Your questions, concerns, or complaints are not being answered by the 
research team 
• You cannot reach the research team 
• You want to talk to someone besides the research team 
• You have questions about your rights as a research participant 
• You want to get information or provide input about this research 
 
PARTICIPANT’S (PARENT’S) STATEMENT/SIGNATURE: 
• I have read this form and the research study has been explained to me. 
• I have been given the chance to ask questions, and my questions have been 
answered. If I have more questions, I have been told who to call. 
• I agree to my child being in the research study described above. 
• I will receive a copy of this consent form after I sign it, upon request. 
 
 
_______________________________________________ 
 
Printed Name of Child 
 
 
_______________________________________________ 
 
Printed Name of Parent/Legally Authorized Representative 
 
 
_______________________________________________ 
 
__________________ 
Signature of Parent/Legally Authorized Representative 
 
Date 
 
 
 
_______________________________________________ 
 
Printed Name of Person Obtaining Consent 
 
 
_______________________________________________ 
 
__________________ 
Signature of Person Obtaining Consent 
 
 
Date