Shear Wave Sonoelastography for the Noninvasive Evaluation of Hepatic Fibrosis in the Pediatric Population
Conditions: Sonoelastography, Elastography, Elastograms, Liver Fibrosis, Hepatic Fibrosis, Cirrhosis, Pediatrics
Sponsor: St. Louis University

 
PROTOCOL
Biomedical Research
Saint Louis University
Protocol # 25138
 Date Printed: 05/24/2019
Continuing Review
1
Personnel Information
6
Subject Population
10
Study Location
10
General Checklist
11
Funding
11
Expedited Paragraphs
12
Background, Purpose, Study Procedures
14
Radioisotopes or Radiation Machines
20
Devices
21
Drugs, Reagents, Chemicals, or Biologic Products
21
Other Levels Of Review
22
Subject Population
24
Subject Population
25
Risks
26
Benefits/Alternatives, Procedures to Maintain Confidentiality and Privacy
29
Potential Conflict of Interest
33
Informed Consent
34
Assent
35
HIPAA
36

 
PROTOCOL
Biomedical Research
Saint Louis University
Protocol # 25138
 Date Printed: 05/24/2019
Attachments
38
PI Obligations
41
Event History
42

Page 1 of 47
SLU eIRB
1
PROTOCOL
Biomedical Research
Saint Louis University
Protocol # 25138
Farmakis
------------------------------------------------------------------------------
Protocol Title:
Shear wave sonoelastography for the noninvasive evaluation of hepatic
fibrosis in the pediatric population
Protocol Status:
APPROVED
Date Submitted:
11/13/2018
Approval Period:
12/19/2018-01/05/2020
Important Note:
This Print View may not reflect all comments and contingencies for approval.
Please check the comments section of the online protocol.
Questions that appear to not have been answered may not have been required
for this submission. Please see the system application for more details.
* * * Continuing Review * * *
 
Continuing Review Request
 
WHAT TO UPLOAD WITH YOUR CONTINUING REVIEW APPLICATION
 
For studies where research activities are limited to data analysis, upload subject safety
information and publications (e.g., manuscripts, abstracts) since the last IRB approval, if
applicable.
 NOTE: if activities are limited to data analysis of de-identified/anonymous data (data that
can no longer be linked to subject identifiers directly or through use of a code with master
list kept), the study can likely be closed via the Final Report Form. See the SLU IRB
Guidance for Closure of Human Subjects Research Studies.
 
For all other studies, upload:
     •    Subject safety information including the most current Serious Adverse Event
          (SAE) cumulative table and data safety monitoring reports since the last IRB
          approval, if applicable.
     •    Any publications (e.g., manuscripts, abstracts) since the last IRB approval.
 
Any changes, updated and/or new study materials should be uploaded and questions 19 -
24 of this form should be completed.
 
 
   
  1. 
Please indicate the status of the study:
a)
The study has not started but will become active.
     
   
   
Please explain why the study has not started.
b)
X
The study is ACTIVE (please check the appropriate box below):
Study is open to accrual.
Study is on hold or halted.
        
      
      
Please explain what needs to occur before accrual can resume.
X
Study is permanently closed to accrual.
 
i.  
Y
Have all subjects completed all research related
activities/interventions?

Page 2 of 47
SLU eIRB
2
PROTOCOL
Biomedical Research
Saint Louis University
Protocol # 25138
Farmakis
Protocol Title:
Shear wave sonoelastography for the noninvasive evaluation of hepatic fibrosis in the
pediatric population
----------------------------------------------------------------------------------------------------
ii.  
N/A
Will the research only remain active for long-term follow-up of
subjects?
iii.  
Y
Are remaining research activities limited to data analysis only? (See
instructions above).
iv.  
N
For studies that are closed to subject accrual, do any subjects need
to be re-consented (to inform them about changes to study
procedures, study risks, study personnel, etc.)?
 
 
      For IRB office use: * may qualify for expedited review
 
c)
The study has expired and needs to be re-initiated.
        
      
      
Explain any research activities occurring during lapse in IRB approval.
 
   
  2. 
Date the study was initially approved by the IRB:
01/06/2015
 
   
  3. 
Approval date of previous continuing review:
12/05/2017
 
   
  4. 
Total number of participants/records/specimens you are approved to
enroll.
200
 
   
  5. 
Total number of subjects that have given consent (verbal or written) to
date.
181
 
   
  6. 
Total number of subjects that failed screening (if not applicable, state
N/A).
9
 
   
  7. 
Total number of participants accrued since the beginning of the project.
172
 
   
  8. 
For multi-center studies, number of subjects approved for accrual study-
wide (SLU site plus all other sites).
NA
 
   
  9.   For multi-center studies, number of subjects enrolled study-wide (SLU
site plus other sites).
NA
 
    
10.   
  
Number of withdrawals from the research and explanation/reasons for withdrawals.
None
 
    
11.          Description and number of:

Page 3 of 47
SLU eIRB
3
PROTOCOL
Biomedical Research
Saint Louis University
Protocol # 25138
Farmakis
Protocol Title:
Shear wave sonoelastography for the noninvasive evaluation of hepatic fibrosis in the
pediatric population
----------------------------------------------------------------------------------------------------
 
 
 a)       Reportable Protocol Deviations/Violations since the last approval date:
NA
 
 
 b)       Unanticipated Problems (UPs) since the last approval date:
NA
 
 
 c)       Serious Adverse Events (SAEs) since the last approval date:Note: Information here should be
consistent with the cumulative table, which should also be attached in section #16.
NA
  12.  
Have there been any complaints about the research during the last year?
N
     
        
If yes, please describe.
 
    
13.   
Briefly describe the progress of the study to date. Provide a status of participants in study, for
example, where is the most recently accrued participant in terms of timeline in the study? If
participants are in long-term follow-up, explain what this consists of in terms of data collection
and/or intervention. Provide any new information in regard to risks. Summarize or attach
publications or presentations.
There are 78 participants and 88 exams in the liver disease group. Within this group, 11 exams are
unusable due to using the linear probe; 5 exams are unusable because they were screen fails. A
total of 10 patients had two exams – of which 5 exams were repeated since they were initially done
with the linear probe and they returned for another curved exam; another 5 were repeated because
they had a second biopsy performed. A total of 72 exams in the liver group have usable data.
There are 93 control patients and 95 control exams. Within the control group, 12 exams were
unable to be used due to using the linear probe; 2 are unusable since they were screen fails. A
total of 2 patients had a repeat exam since they came back after initially having an exam with a
linear probe. A total of 79 exams in the control group have usable data.
Screen fails include those from patients who moved too much, who were too obese to obtain an
image, or in whom the liver biopsy was not performed.
 
    
14.   
Is there a Data Safety Monitoring (DSM) plan for this study?
Y
No
Yes, a copy of the DSM report(s) for the last approval period is attached.
Yes, but a copy of the DSM reports(s) for the last approval period is not attached. Please
explain below.
 
    
15.  
FDA Regulated Studies
 
             
  
Is this a Food and Drug Administration (FDA) Regulated Study, (i.e., involves drugs,
devices, biologics)? If yes, please answer the following questions:
N

Page 4 of 47
SLU eIRB
4
PROTOCOL
Biomedical Research
Saint Louis University
Protocol # 25138
Farmakis
Protocol Title:
Shear wave sonoelastography for the noninvasive evaluation of hepatic fibrosis in the
pediatric population
----------------------------------------------------------------------------------------------------
 
a)
Have there been any changes in the FDA status of any
drug or device used in the study?
       
       
       
 
    
If yes, please explain:
 
b)
Have any of the investigational drugs or devices used in
this study received FDA approval?
       
       
       
 
    
If yes, please explain:
 
c)
Have any new alternative drugs or devices been approved
for treatment of the study condition that may affect subjects
willingness to participate?
       
       
       
 
    
If yes, please explain:
 
       
       
       
 
    
Have current subjects been notified? Please explain:
 
d)
Has there been a change in the standard care that may be
considered as an alternative to the investigational drug or
device or that would affect the original study design?
       
       
       
 
    
If yes, please explain:
 
       
       
       
 
    
Have current subjects been notified? Please explain:
 
e)
Is there any new information that might affect the
risk/benefit ratio and the willingness of current study
subjects to participate or to continue to participate in the
research?
       
       
       
 
    
If yes, please explain:
 
       
       
       
 
    
Have current subjects been notified? Please explain:
 
f)
Does the study include an investigator's brochure (IB)?
       
       
 
   
If yes, what is the current version date?

Page 5 of 47
SLU eIRB
5
PROTOCOL
Biomedical Research
Saint Louis University
Protocol # 25138
Farmakis
Protocol Title:
Shear wave sonoelastography for the noninvasive evaluation of hepatic fibrosis in the
pediatric population
----------------------------------------------------------------------------------------------------
 
       
       
 
   
(If study has multiple IBs, attach current versions in Attachments
section (#16))
 
    
16.  
Provide a summary of any recent findings, literature, or other relevant information (especially
pertaining to risks), if applicable.
NA
 
 17.
Have there been any significant amendments or revisions to the
protocol during the past approval period? (Significant amendments
include changes in study design or risk level including those that
resulted in a change in consent).
N
  
     
If yes, please briefly summarize the changes:
 
   18.  Y
The consent materials attached to this eIRB application (including consent documents, assent
documents, recruitment statements or other materials used to obtain consent) are the
versions being used in the conduct of this study and all enrolled subjects have signed consent
forms on file, if required. (If the requirement to obtain consent was waived or if no participants
have enrolled since last continuing review, check N/A).
 NOTE: The IRB routinely monitors consent document usage and may request copies of
redacted participant consent forms.
 
   
19.
Are any changes (amendments) requested with this Continuing Review?
Yes, please complete the remainder of this form.
Y
No, form is complete. Please submit.
 
   
20.
Summarize the proposed changes to the protocol in lay terms, including the type of change AND
what the change involves.
 If this is a change in PI a new  Department Chair review is required. Please upload the signed
document in the Attachments section.
 
   
21.
Provide justification/explanation for the proposed changes.
 
 22.
Will currently accrued subjects need to be notified of changes?
  
     
If no, please justify why not.
  
     
If yes, please explain how AND when notification or re-consenting will occur.
 
 23.
Does the SLU IRB Protocol need to be modified?

Page 6 of 47
SLU eIRB
6
PROTOCOL
Biomedical Research
Saint Louis University
Protocol # 25138
Farmakis
Protocol Title:
Shear wave sonoelastography for the noninvasive evaluation of hepatic fibrosis in the
pediatric population
----------------------------------------------------------------------------------------------------
 
 24.
Are consent documents modified?
 
   
     
 
Proceed to the appropriate section(s) of the protocol and make your changes. Also make necessary changes in
the Consent Form(s), Assent Form(s), Recruitment Statement, Questionnaire, or other attachments, as
applicable. Upload any revised IRB materials. Please provide the entire revised document (not just revised
pages). Use track changes or highlight (in yellow) changes to documents being revised. Please upload a
tracked/highlighted copy of each revised document to be stamped upon IRB approval. NOTE: Upload a clean
copy (changes or highlights removed) of documents in file formats other than Microsoft Word (i.e., the IRB will
remove the tracked changes/highlights on uploaded Word documents).
 
NOTE: Protocol amendments must receive IRB review and approval before they are implemented, unless an
immediate change is necessary to eliminate an apparent hazard to the subjects.
 
Sponsored Studies: Remember to update the Sponsor's Protocol version number and date in the Funding section
of the protocol (this information will appear on the approval letter).
 
Expedited Paragraphs
---------------------------------------------------------------------------------------------
* * * Personnel Information * * *
Study Personnel Roles:
-Principal Investigator: accepts responsibility for study, must sign obligations, can edit protocol and submit to IRB
-Administrative Contact: additional study contact, may or may not also be member of research team, can
edit/prepare protocol and submit to IRB
-Key Personnel (Research Team): SLU member of research team, can view protocol (not edit)
-Non-SLU Collaborator: member of research team from another institution or organization outside of SLU, has no
access to system, must be provided with PDF of protocol. NOTE: SLUH/SSM employees who collaborate
regularly may obtain a guest SLU account if access to system is needed.
-Department Chair: Official Department Chair, may or may not also be a member of research team, can view the
protocol (not edit). NOTE: a proxy may be listed if the Chair is the PI.
IMPORTANT NOTE: Human Subjects Protection Training is mandatory for all research team personnel.
Principal Investigator (PI)   Mandatory
PI must be SLU affiliate.
Name of Principal Investigator
(Faculty, Staff or Student)
Degree (MD/PhD)
Title
Farmakis, Shannon
MD
Assistant Professor
Email
Phone
Fax
farmakis@slu.edu
314-577-5649
Department Name
 
 
Radiology
 
 

Page 7 of 47
SLU eIRB
7
PROTOCOL
Biomedical Research
Saint Louis University
Protocol # 25138
Farmakis
Protocol Title:
Shear wave sonoelastography for the noninvasive evaluation of hepatic fibrosis in the
pediatric population
----------------------------------------------------------------------------------------------------
Human Subjects Training Completed?
WARNING: Proof of training must show below or the application will be
returned. If your training information isn't showing, upload a copy in the
Attachments section.
Y
Research Experience              *?HELP?*
involvement with prior retrospective clinical research studies during residency and fellowship training and with
laboratory research while in medical school
Research Team Member Duties Picklist
1.
X Recruitment
2.
X Obtains consent
3.
X Determine Subject Eligibility for Accrual
4a.
Subject Physical Examinations
4b.
Follow-up Visits including physical
assessments
5.
X Perform study procedures or Specimen
Collection
6a.
Administer and/or Dispense Study Drugs,
Biologics or Devices (must be licensed)
6b.
Receive, Store, Manipulate or Account for
Study Drugs, Biologics or Devices
7.
Subject Randomization or Registry
8.
X Collection of Subject Data
9.
X Report Data (CRFs, e-CRFs, Spreadsheets)
10.
X Data Analysis
11a.
X Review Adverse Events
11b.
X Treat and Classify Adverse Events
12.
Other (Please insert explanation below.)
 
 
No training data is available.
 
Administrative Contact
Name of Administrative Contact
Degree
Title
Kitchell, Robin
Administrative Assistant
Hardy, Anna
RN, MPH
Research Nurse
 
Key Personnel (Research Team)
Name of Key Personnel
(Research Team)
Degree
Title
Department Name
Tao, Ting
MD
Assistant Professor
Radiology
Teckman, Jeffrey
MD
Professor
Pediatrics
Jain, Ajay
M.D.
Assistant Professor
Pediatrics
Guzman, Miguel
M.D.
Assistant Professor
Pathology
Caudill, Karen
M.D.
Assistant Professor
Radiology

Page 8 of 47
SLU eIRB
8
PROTOCOL
Biomedical Research
Saint Louis University
Protocol # 25138
Farmakis
Protocol Title:
Shear wave sonoelastography for the noninvasive evaluation of hepatic fibrosis in the
pediatric population
----------------------------------------------------------------------------------------------------
 
 
Department Chair  Mandatory
The official Department Chair should be listed here. If the Department Chair is the PI, a proxy may be listed.
Name of Department Chair
Degree
Title
Brown, Jeffrey
MD
Professor
Email
Phone
Fax
jjbrown@slu.edu
(314) 268-5780
Department Name
 
 
Radiology
 
 
Is this individual also a member of the research team?
N
Human Subjects Training Completed?
WARNING: Proof of training must show below or the application will be
returned. If your training information isn't showing, upload a copy in the
Attachments section.
Research Experience      *?HELP?*
Research Team Member Duties Picklist
1.
Recruitment
2.
Obtains consent
3.
Determine Subject Eligibility for Accrual
4a.
Subject Physical Examinations
4b.
Follow-up Visits including physical
assessments
5.
Perform study procedures or Specimen
Collection
6a.
Administer and/or Dispense Study Drugs,
Biologics or Devices (must be licensed)
6b.
Receive, Store, Manipulate or Account for
Study Drugs, Biologics or Devices
7.
Subject Randomization or Registry
8.
Collection of Subject Data
9.
Report Data (CRFs, e-CRFs, Spreadsheets)
10.
Data Analysis
11a.
Review Adverse Events
11b.
Treat and Classify Adverse Events
12.
Other (Please insert explanation below.)
 
 
No training data is available.
 
Research Team Roles
Name(s), Degree
Department
Experience
Duties
 Farmakis, Shannon, MD
Radiology
involvement with prior
retrospective clinical
research studies during
residency and fellowship
training and with laboratory
research while in medical
school
 Recruitment, Obtains
consent, Determine
Subject Eligibility for
Accrual, Perform study
procedures or Specimen
Collection, Collection of
Subject Data, Report Data
(CRFs, e-CRFs,
Spreadsheets), Data
Analysis, Review Adverse

Page 9 of 47
SLU eIRB
9
PROTOCOL
Biomedical Research
Saint Louis University
Protocol # 25138
Farmakis
Protocol Title:
Shear wave sonoelastography for the noninvasive evaluation of hepatic fibrosis in the
pediatric population
----------------------------------------------------------------------------------------------------
Analysis, Review Adverse
Events, Treat and Classify
Adverse Events
 Hardy, Anna, RN, MPH
Radiology
Anna has been involved with
clinical and retrospective
research in the past and she
will be supervised by Dr.
Farmakis.
Recruitment, Obtains
consent, Subject
Randomization or
Registry, Collection of
Subject Data, Data
Analysis
 Tao, Ting, MD
Radiology
8 years of bench research, 4
years experience with
retrospective clinical studies
while in residency training
Recruitment, Obtains
consent, Determine
Subject Eligibility for
Accrual, Perform study
procedures or Specimen
Collection, Collection of
Subject Data, Report Data
(CRFs, e-CRFs,
Spreadsheets), Data
Analysis
 Teckman, Jeffrey, MD
Pediatrics
>20 years experience as
both PI and Co-I with
multiple clinical trials
Recruitment, Obtains
consent, Determine
Subject Eligibility for
Accrual, Report Data
(CRFs, e-CRFs,
Spreadsheets), Data
Analysis, Review Adverse
Events, Treat and Classify
Adverse Events
 Jain, Ajay, M.D.
Pediatrics
PI and Co-I in multiple
clinical trials
Recruitment, Obtains
consent, Determine
Subject Eligibility for
Accrual, Perform study
procedures or Specimen
Collection, Collection of
Subject Data, Report Data
(CRFs, e-CRFs,
Spreadsheets), Data
Analysis, Review Adverse
Events, Treat and Classify
Adverse Events
 Guzman, Miguel, M.D.
Pathology
Currently involved in a
clinical trial with Harbor-
UCLA Medical Center (NIH
grant support).
Prior research experience in
clinical translation research
in anatomic pathology,
pediatric pathology and
neuropathology.
Bench research experience
with different techniques in
anatomic pathology
including histochemistry,
immunohistochemistry and
electron microscopy.
Other (Please insert
explanation below.)
histopathologic evaluation
of subject specimen

Page 10 of 47
SLU eIRB
10
PROTOCOL
Biomedical Research
Saint Louis University
Protocol # 25138
Farmakis
Protocol Title:
Shear wave sonoelastography for the noninvasive evaluation of hepatic fibrosis in the
pediatric population
----------------------------------------------------------------------------------------------------
 Caudill, Karen, M.D.
Radiology
involvement with research
during training
Recruitment, Obtains
consent, Determine
Subject Eligibility for
Accrual, Perform study
procedures or Specimen
Collection, Collection of
Subject Data, Report Data
(CRFs, e-CRFs,
Spreadsheets), Data
Analysis
---------------------------------------------------------------------------------------------
* * * Subject Population * * *
 
Subject Population(s) Checklist
 
Select All That Apply :
Adults
X
Cognitively Impaired Subjects
Employees (specifically targeted)
Fetuses
X
Minors (under 18)
Neonates
Non English Speaking Subjects
Pregnant Women
Prisoners
Students (specifically targeted)
Terminally Ill Subjects
Wards of the State
Other (any population that is not specified above)
       
---------------------------------------------------------------------------------------------
* * * Study Location * * *
 
Study Location(s) Checklist
      
Indicate where the study will be conducted. Select all that apply:
X
Saint Louis University, Medical Center Campus
Saint Louis University, Frost Campus
Saint Louis University, Madrid Campus
Saint Louis University, SLUCare Practice Locations
SSM STL (DePaul Hospital, St. Mary's Health Center, St. Joseph (St. Charles, Wentzville, Lake Saint
Louis), St. Clare)
X
Cardinal Glennon Children's Medical Center
Saint Louis University Hospital (SSM Health- SLU Hospital)
SLU-SSM Cancer Center Research Alliance Sites

Page 11 of 47
SLU eIRB
11
PROTOCOL
Biomedical Research
Saint Louis University
Protocol # 25138
Farmakis
Protocol Title:
Shear wave sonoelastography for the noninvasive evaluation of hepatic fibrosis in the
pediatric population
----------------------------------------------------------------------------------------------------
Other (In the box below, list any off-campus institutions or locations and describe the activities being
conducted there. Please provide letters of cooperation and/or IRB approvals from each location to
document support/approval of the study. You may provide such documentation as it becomes available, but
you may not begin work at those sites until documentation of support is provided to the IRB.)  Please refer
to the  Guidance for involving non-SLU institutions in human subject research.
      
---------------------------------------------------------------------------------------------
* * * General Checklist * * *
 
General Checklist
      
Select All That Apply :
Collection of Specimens
Data collection via e-mail or the Internet
Deception/Incomplete Disclosure
Dietary Supplements, Vitamins, and Other Food Agents
X
FDA Approved Device
FDA approved  drugs, reagents, other chemicals administered to subjects (even if they are not being
studied), or biologic products
Genetic Testing
HIV Testing
Human blood, cells, tissues, or body fluids
International Research or Research on International Populations
Investigational drugs, reagents, chemicals, or biologic products
Investigational Device
Investigator Initiated Study     *?HELP?*
X
Medical Records
Photography, Video, or Voice-Recording Subjects
Questionnaires and/or tests
Radioisotopes/radiation-producing machines, even if standard of care
rDNA/Gene Transfer Therapy
Registry(ies)
Specimens to be stored for future research projects (must be in consent form)
X
Study of existing data or specimens
X
University Indemnified Study (SLU is responsible for liability coverage)    *?HELP?*
Other (clarify in text box to the right)
Single Use. Provide a brief summary and justification for the Single Use Therapy. Note: This application will
refer to research. For Single Use applications it is understood that 'research' will mean 'therapy'.
       
---------------------------------------------------------------------------------------------
* * * Funding * * *

Page 12 of 47
SLU eIRB
12
PROTOCOL
Biomedical Research
Saint Louis University
Protocol # 25138
Farmakis
Protocol Title:
Shear wave sonoelastography for the noninvasive evaluation of hepatic fibrosis in the
pediatric population
----------------------------------------------------------------------------------------------------
 
Funding Checklist
 
NONE
 
 
Funding - Saint Louis University
What type of Saint Louis University funding?
SLU eRS #
Grant submitted to President's Research Fund
8878
Liver Center grant--Grant submitted
N/A
 
Funding - Industry Sponsor
Sponsor Name
Sponsor's Protocol Version Date
GE Healthcare Ltd.
 
 
Funding - Other
Name of Other Funding source
SLU eRS #
Cardinal Glennon Foundation--Grant application in
process
N/A
 
  
  
NOTE:   Applicable grant application, contract or subcontract, investigator's brochure, and sponsor's
protocol (for all industry sponsored clinical trials) must be attached. You will be prompted for these in
section #16 (Attachments).
---------------------------------------------------------------------------------------------
* * * Expedited Paragraphs * * *
To request an Expedited Review, check the appropriate category(ies) below. Provide justification for your request
for Expedited Review.
 
To qualify for expedited review, research activities must (1) present no more than minimal risk to human subjects,
and (2) involve only procedures listed in one or more of the categories below.
 

Page 13 of 47
SLU eIRB
13
PROTOCOL
Biomedical Research
Saint Louis University
Protocol # 25138
Farmakis
Protocol Title:
Shear wave sonoelastography for the noninvasive evaluation of hepatic fibrosis in the
pediatric population
----------------------------------------------------------------------------------------------------
 
 
1.
Clinical studies of drugs and medical devices only when condition (a) or (b) is met.
 
a) 
Research on drugs for which an investigational new drug application (21 CFR Part 31, 32) is not
required. (Note: Research on marketed drugs that significantly increases the risks or decreases the
acceptability of the risks associated with the use of the product is not eligible for expedited review.)
 
        
    
 b)
Research on medical devices for which
(i) 
An investigational device exemption application (21 CFR Part 812) is not required; or
       
       
       
     
(ii) 
The medical device is cleared/approved for marketing and the medical device is being used in
accordance with its cleared/approved labeling.
 
2.
Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows:
 
a) 
From healthy, nonpregnant adults who weigh at least 110 pounds. For these subjects, the amounts
drawn may not exceed 550 ml in an 8-week period and collection may not occur more frequently
than 2 times per week; or
 
     
     
   
      
From other adults and children, considering the age, weight, and health of the subjects, the
collection procedure, the amount of blood to be collected, and the frequency with which it will be
collected. For these subjects, the amount drawn may not exceed the lesser of 50 ml or 3 ml per
kg in an 8-week period and collection may not occur more frequently than 2 times per week.
    
Children are "persons who have not attained the legal age for consent to treatments or
procedures involved in the research, under the applicable law of the jurisdiction in which
the research will be conducted."
 
3.
Prospective collection of biological specimens for research purposes by non-invasive means.
 
  
  
  
EXAMPLES: (a) hair and nail clippings in a nondisfiguring manner; (b) deciduous teeth at time of exfoliation or
if routine patient care indicates a need for extraction; (c) permanent teeth if routine patient care indicates a
need for extraction; (d) excreta and external secretions (including sweat); (e) uncannulated saliva collected
either in an unstimulated fashion or stimulated by chewing gumbase or wax or by applying a dilute citric
solution to the tongue; (f) placenta removed at delivery; (g) amniotic fluid obtained at the time of rupture of the
membrane prior to or during labor; (h) supra-and subgingival dental plaque and calculus, provided the
collection procedure is not more invasive than routine prophylactic scaling of the teeth and the process is
accomplished in accordance with accepted prophylactic techniques; (i) mucosal and skin cells collected by
buccal scraping or swab, skin swab, or mouth washings; (j) sputum collected after saline mist nebulization.
 
4.
Collection of data through non-invasive procedures (not involving general anesthesia or sedation)
routinely employed in clinical practice, excluding procedures involving X-rays or microwaves. Where
medical devices are employed, they must be cleared/approved for marketing. (Studies intended to
evaluate the safety and effectiveness of the medical device are not generally eligible for expedited

Page 14 of 47
SLU eIRB
14
PROTOCOL
Biomedical Research
Saint Louis University
Protocol # 25138
Farmakis
Protocol Title:
Shear wave sonoelastography for the noninvasive evaluation of hepatic fibrosis in the
pediatric population
----------------------------------------------------------------------------------------------------
review, including studies of cleared medical devices for new indications.)
 
  
  
  
EXAMPLES: (a) physical sensors that are applied either to the surface of the body or at a distance and do not
involve input of significant amounts of energy into the subject or an invasion of the subjects' privacy; (b)
weighing or testing sensory acuity; (c) magnetic resonance imaging; (d) electrocardiography,
electroencephalography, thermography, detection of naturally occurring radioactivity, electroretinography,
ultrasound, diagnostic infrared imaging, doppler blood flow, and echocardiology; (e) moderate exercise,
muscular strength testing, body composition assessment, and flexibility testing where appropriate given the
age, weight and health of the individual.
 
5.
Research involving materials (data, documents, records, or specimens) that have been collected, or
will be collected solely for nonresearch purposes (such as medical treatment or diagnosis). (NOTE:
Some research in this category may be exempt from the HHS regulations for the protection of human
subjects. 45CFR 46.101(b)(4). This listing refers only to research that is not exempt.)
 
6.
Collection of data from voice, video, digital, or image recordings made for research purposes.
 
7.
Research on individual or group characteristics or behavior (including, but not limited to, research on
perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and
social behavior) or research employing survey, interview, oral history, focus group, program
evaluation, human factors evaluation, or quality assurance methodologies. (NOTE: Some research in
this category may be exempt from the HHS regulations for the protection of human subjects. 45 CFR
46.101(b)(2) and (b)(3). This listing refers only to research that is not exempt.)
 
X
8.
 [FOR IRB use only]. Continuing review of research previously approved by a convened IRB only
when condition (a), (b), or (c) is met.
 
a)
Previously approved research where
(i)
The research is permanently closed to the enrollment of new subjects;
(ii)
All subjects have completed all research-related interventions; and
(iii)
The research remains active only for the long term follow-up of subjects.
 
b)
Previously approved research where no subjects have been enrolled and no additional
risks have been identified.
 
X c)
Previously approved research where the remaining research activities are limited to data
analysis.
 
9.
 [FOR IRB use only]. Continuing review or research not conducted under an investigational new drug
application or investigational drug exemption where expedited categories two (2) through eight (8) do
not apply but the IRB  has determined and documented at a convened meeting that the research
involves no greater than minimal risk and no additional risks have been identified.
---------------------------------------------------------------------------------------------

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SLU eIRB
15
PROTOCOL
Biomedical Research
Saint Louis University
Protocol # 25138
Farmakis
Protocol Title:
Shear wave sonoelastography for the noninvasive evaluation of hepatic fibrosis in the
pediatric population
----------------------------------------------------------------------------------------------------
* * * Background, Purpose, Study Procedures * * *
Title
Shear wave sonoelastography for the noninvasive evaluation of hepatic fibrosis in the pediatric population
 
Complete Sections 1 - 16. In sections that allow reference to sponsor protocol or grant, clearly state section and
page numbers. Any information that is different or specific to the local site should be in the SLU application.
Specify N/A as appropriate.
1. Background
 
     Page numbers from a sponsor's protocol/grant may be referenced in 1a and 1b.
 
  
  
a)  
Provide an introduction and background information. Describe past experimental and/or clinical
findings leading to the formulation of the study, if applicable. Investigator Initiated studies must
cite references in the response provided or attach a bibliography.     *?HELP?*
The evaluation of pediatric liver disease continues to be a major focus of research both in well-
characterized liver diseases and in liver fibrosis secondary to obesity.  The degree of fibrosis is
generally well-accepted as both a measurement of disease severity and a prognostic indicator.
Unfortunately, the current gold standard to assess fibrosis remains a liver biopsy, which, in
addition to anesthesia risks and sampling errors, can result in profound hemorrhage, infections,
and even mortality. Standard and reliable noninvasive biomarkers of hepatic fibrosis in the
pediatric population are greatly needed.  Sonoelastography has emerged as a method of
evaluating liver disease.  Three methods of quantitative sonoelastography are currently in use.
Transient elastography is an M-mode based sonographic technique in which a mechanical
vibrator creates a low-frequency wave causing shear stress in the tissue at a fixed depth in the
target tissue.  It has gained widespread use in evaluation of liver fibrosis in the adult population
(Fibroscan); however, its use has great limitations in the pediatric population as it does not use
real-time ultrasonography (B mode) and has a fixed depth in which the measurement is taken.
The lack of real-time imaging makes it impossible to accurately select an area for appropriate
sampling, and the fixed depth is not appropriate for very young children with smaller livers.
Also, the shock wave that is administered has not been tailored for use in young children.
Furthermore, this technique is very unreliable in patients that are obese or who have ascites.
Other methods of sonoelastography include Acoustic Radiation Force Impulse Imaging (ARFI)
and Shear Wave Elastography (SWE).  The latter is also known as supersonic shear wave
imaging.  Both of these techniques use real-time ultrasonography and administer focused high-
intensity, short-duration (acoustic radiation) pulses to produce shear waves in the target tissue.
Neither technique is limited by the presence of ascites as the shear waves propagate through
the fluid.  ARFI uses a single pushing beam to generate the shear waves, and the propagation
of those shear waves are monitored using conventional pulse-echo ultrasound at various off-
axis lateral locations.  The speed of the shear wave in the tissue is determined by collecting the
displacement through time.  This principle of elastography is based on the Young modulus
using the formula: E=3ρѴ2 (E elasticity’s modulus, Ѵ speed, ρ density of the tissue).  The
degree of tissue displacement is then used to create an elastogram.  Limitations of ARFI
include a small selected region of interest (ROI) (10 mm x 5 mm), it is a 1-dimensional
technique, and it is unable to provide a corresponding elasticity map of the tissue.  The latter
also prevents retrospective evaluations of the tissue elasticity.
SWE is the newest elastography technique.  It works by generating a localized radiation force
that travels faster down the acoustic axis than the shear wave speed producing tiny, almost
simultaneous, displacements in the tissues at all positions along the acoustic axis.  The
generated shear wave is shaped like a cone or fan, known as the Mach cone.  An ultrafast

Page 16 of 47
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16
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Biomedical Research
Saint Louis University
Protocol # 25138
Farmakis
Protocol Title:
Shear wave sonoelastography for the noninvasive evaluation of hepatic fibrosis in the
pediatric population
----------------------------------------------------------------------------------------------------
sonography is then performed which provides a side-by-side greyscale image and color-coded
elasticity map of the tissue in the ROI.  The ROI is displayed in real time B-mode imaging and,
thus, represents a 2-dimensional technique.  Advantages include a larger, fan-shaped ROI (up
to 50mm x 50mm), and the acquisition of a quantitative map of liver tissue stiffness with
corresponding greyscale ultrasound image.  As a result, simultaneous viewing of the selected
region of interest provides better anatomic detail with a corresponding color map of the tissue
elasticity which may result in more accurate scoring of the stage of fibrosis.  The presence of a
color map also allows for retrospective analysis.
Only a few studies have begun to use ARFI to analyze liver fibrosis in the pediatric population.
Studies using SWE for evaluation of liver fibrosis are also limited and all but one have been
performed in adults; however, early studies have shown it to be an accurate method for liver
fibrosis staging.   Tutar, et al safely performed a study using SWE in pediatric patients in
Turkey.  No dedicated pediatric studies have been performed in the United States, as the
technology was just recently approved for use in adults by the FDA.  The use of this device in
pediatrics represents an off-label use.   That being said, SWE has safety considerations that
are similar to Doppler mode which is a standard ultrasound technology performed in pediatric
patients of all ages.   While it has a higher thermal index than routine B-mode ultrasound, it is
measured to be within the safety limits set by the American Institute of Ultrasound in Medicine
(AIUM).
 
Please save frequently
 
  
  
b)  
Describe any animal experimentation and findings leading to the formulation of the study, if
there is no supporting human data.
N/A
 
2. Purpose of the study
 
  
  
a)  
Provide a brief lay summary of the project in <200 words. The lay summary should be readily
understandable to the general public.
Background: Pediatric liver disease continues to remain a major focus of research. This has
taken on greater relevance with the rise in pediatric obesity which, in addition to several other
well-characterized liver diseases, causes liver fibrosis. The degree of fibrosis is well-accepted
as both a measurement of disease severity and a prognostic indicator.  Unfortunately, the
current gold standard to assess fibrosis remains a liver biopsy, which, in addition to anesthesia
risks and sampling errors, can result in profound hemorrhage, infections, and even mortality.
Thus, there is a great need for reliable, non-invasive biomarkers of hepatic fibrosis.
Sonoelastography has emerged as a method of evaluating liver disease.
Specific Aims: To perform shear wave elastography (SWE) on pediatric patients with known
liver disease who undergo a liver biopsy in order to determine the accuracy of SWE in
evaluating the various stages of liver fibrosis using the METAVIR histopathologic scale.  We will
also perform SWE on patients without liver disease to establish baseline measurements in a
normal liver.
Potential Impact: SWE may represent an accurate, reliable, and noninvasive method of staging
liver fibrosis in pediatric patients and may obviate the need for performing liver biopsies in
evaluating liver disease in these patients.
 

Page 17 of 47
SLU eIRB
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PROTOCOL
Biomedical Research
Saint Louis University
Protocol # 25138
Farmakis
Protocol Title:
Shear wave sonoelastography for the noninvasive evaluation of hepatic fibrosis in the
pediatric population
----------------------------------------------------------------------------------------------------
     Page numbers from a sponsor's protocol/grant may be referenced in 2b and 2c.
 
  
  
b)  
List your research objectives (specific aims & hypotheses of the study).
Hypothesis: We hypothesize that shear wave sonoelastography (SWE) measurements will
correlate with the histopathologic assessment of liver fibrosis in pediatric patients.
Specific Aims: To perform SWE on pediatric patients with known liver disease who undergo a
liver biopsy within one month of the ultrasound exam in order to determine the accuracy of
SWE in evaluating the various stages of liver fibrosis using the METAVIR histopathologic scale.
As a control, we will perform SWE on patients without liver disease to establish baseline
measurements in a normal liver.
 
Please save frequently
 
  
  
c)  
Describe the study design (e.g., single/double blind, parallel, crossover, control, experimental,
observational, etc.). If the study is investigator-initiated, a timeline for individual subject
recruitment, follow-up, and analysis for the study is required. Also, indicate if the subjects will be
randomized.
The study design is a prospective single blind control experiment.  Subject recruitment will be
ongoing as patients who undergo routine liver biopsy in order to evaluate their liver disease will
also undergo an ultrasound with sonoelastography.  The minimum number of patients required
in the test group in order to determine accuracy of the research test is 100.  Study recruitment
for patients without liver disease will be stopped once 100 patients are enrolled.  An additional 8
months will be required for study analysis.
 
  
  
d)  
If subjects will be given placebo, please justify placebo use.    *?HELP?*
N/A
 
3. Study Procedures
 
    a)
N
Is this project a multicenter study (i.e., same project is conducted elsewhere by a
different investigator) OR does this study involve conduct of research at multiple sites?
      
Is SLU acting as a coordinating center for other sites OR is the SLU PI a direct recipient
of a federal grant for this research? If yes, complete and attach the  Supplemental
Application for Coordinating Center Activities.
      
Will the SLU site be participating in all parts/procedures/arms of the study?
   
    
    
If No, explain what SLU will NOT participate in:
 
Please save frequently
 
Page numbers from a sponsor's protocol/grant may be referenced in 3b, 3c, and 3d.
 
  
  
b)  
Describe all the procedures, from screening through end-of-study, that the human subject must
undergo in the research project, including study visits, drug treatments, randomization and the

Page 18 of 47
SLU eIRB
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Biomedical Research
Saint Louis University
Protocol # 25138
Farmakis
Protocol Title:
Shear wave sonoelastography for the noninvasive evaluation of hepatic fibrosis in the
pediatric population
----------------------------------------------------------------------------------------------------
procedures that are part of standard of care. Specify which procedures are for research and
which are standard of care. Please note: The box below is for text only. If you would like to add
tables, charts, etc., attach those files in the Attachment section (#16).
Any pediatric patient (0-18 years of age) with known liver disease in whom a liver biopsy is to
be performed as standard of care to assess the degree of fibrosis will also undergo an
abdominal ultrasound to evaluate the liver.  The ultrasound is also standard of care.  Informed
consent will then be obtained from the patient's parent or guardian with verbal assent from the
patient for the perfomance of a shear wave sonoelastography exam as part of the research
study.   The research portion of the ultrasound exam will be performed at the same time as the
standard of care ultrasound exam.  The ultrasound must be performed within 1 month of the
liver biopsy.  No additional visits or treatments are required of the patients beyond what they
would normally have as part of their routine treatment or medical care following the liver biopsy.
Following the liver biopsy and ultrasound exam, the patients involvement in the study is
complete.  The patient's electronic medical record will be reviewed for pertinent clinical
information including history, laboratory values, and liver biopsy results.
Underlying diagnoses include but are not limited to biliary atresia, congenital fibrosis-
cholestasis, Alagille syndrome, Caroli’s disease, choledochal cyst, alpha-1-antitrypsin
deficiency, progressive familial intrahepatic cholestasis (PFIC), viral hepatitis, glycogenosis,
fructosemia, Wilson disease, cystic fibrosis, autosomal recessive polycystic kidney disease
(ARPCKD), mesenterico-caval shunt, post liver transplant, and nonalcoholic steatohepatitis
(NASH).
In addition, any pediatric patient (0-18 years of age) undergoing evaluation with an abdominal
ultrasound as standard of care for evaluation for a diagnosis other than liver disease and in
whom the US shows a normal liver, gallbladder, pancreas, spleen, and biliary tree will then be
asked to enroll  in the research study by undergoing shear wave elastography.  Following
completion of the exam, the patient's involvement in the study will be complete.  No additional
follow up appointments or study visits are required.  Liver biopsies are not to be performed in
this group of patients.
The biopsy will be obtained as random sample, preferably from the right lobe of the liver, by the
pediatric gastroenterologists as this is the area that the sonoelastography measurements will
also be obtained.  This should reduce sampling error and result discordance.  The liver biopsy
must be obtained within 1 month of the ultrasound exam.
Histolopathologic evaluation will be performed using the Ishak and METAVIR classification
systems by pathologists blinded to elastography results.  These classifications systems are part
of the standard of care evaluation of the biopsy material.  Only the liver biopsy results in the
patient's chart will be reviewed as part of the study.
Ishak:
0: No fibrosis
1: Fibrous expansion of some portal areas, with or without short fibrous septa
2: Fibrous expansion of most portal areas, with or without short fibrous septa
3:  Fibrous expansion of most portal areas with occasional portal to portal (P-P) bridging
4:  Fibrous expansion of portal areas with marked bridging [portal to portal (P-P) as well as
portal to central (P-C)]
5:  Marked bridging (P-P and/or P-C) with occasional nodules (incomplete cirrhosis)
6.  Cirrhosis, probably or definite
METAVIR:
F0: no portal fibrosis
F1: portal fibrosis without septa
F2: portal fibrosis with few septa
F3: portal fibrosis with numerous septa but non cirrhosis
F4: cirrhosis

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Biomedical Research
Saint Louis University
Protocol # 25138
Farmakis
Protocol Title:
Shear wave sonoelastography for the noninvasive evaluation of hepatic fibrosis in the
pediatric population
----------------------------------------------------------------------------------------------------
Shear wave ultrasound—Using 2 probes (C1-6 which is a low frequency curved probe and L9
which is a high-frequency linear probe) on the the GE Logiq E9, the selected area of interest
(ROI) will be in the right lobe of the liver or in a portion of a transplant liver.  The ROI will be an
area away from vessels and bile ducts using an intercostal or subcostal approach.  Ten
separate acquisitions will be obtained on each patient by the attending radiologist and
sonographer who are blinded to the results of the liver biopsy.  The mean value will be used.
 
  
  
c)  
If the proposed study is a clinical trial where a drug, vaccine, device or other treatment is
compared to a placebo group or comparison treatment group, what are the guidelines or
endpoints by which early decisions regarding efficacy or lack of efficacy can be made? For
example, it may be reasonable to stop enrollment on a study when efficacy has already been
clearly demonstrated, to avoid unnecessary enrollments of additional subjects. Alternatively, it
may be reasonable to stop enrollment when it is clear that efficacy will never be demonstrated,
given the statistical power of the study as designed. Describe the guidelines that are in place to
assist in making these determinations, if relevant to the proposed study.
N/A
 
  
  
d)  
Describe how data analysis will be performed (statistical tests, methods of evaluating data) and
indicate the smallest group/unit for which separate reporting will occur. For studies involving a
questionnaire, if data and reliability information are available, please describe or provide
references. For full board, unfunded studies describe sample size determination and power
analysis. If none, please justify.
The results of the SWE using the velocity measurements displayed on the elastography map
with a quantitative color map that is expressed in kPa (kiloPascals) will be correlated with the
stage of fibrosis using the METAVIR scale from the liver biopsy results in order to determine the
accuracy of SWE in evaluating the various degrees of liver fibrosis.  The statistical analysis will
include Receiver Operating Characteristic curves as well as scatter plots and box plots.  The
mean and median values as well as a range of the SWE measurements will be correlated with
the individual METAVIR stages of fibrosis (F0-F4), and a p value will be calculated for each
stage to assess the accuracy of SWE based on individual fibrosis stages.  Further statistical
analysis will also be performed to compare results of SWE and histopathology in subgroups of
liver disease patients, such as those with NASH compared to those without.  Scatter plots will
be used to compare the SWE results in normal patients to those with liver disease.
 
Please save frequently
 
  
  
e)  
State if deception (including incomplete disclosure of study purpose/procedures) will be used. If
so, describe the nature of the deception and provide a rationale for its use. Also, describe
debriefing procedures or justify a waiver of the requirement to debrief. NOTE: for studies using
deception, an alteration of consent must be justified in the Informed Consent section of the
protocol (#13) and the debriefing script/statement must be uploaded in the Attachments section
(#16).  See IRB Deception Guidelines.
 
    f) 
Is there an accepted standard of care and/or standard practice at SLU for the
condition/disease/situation being studied? This information will assist in comparing
the risk/benefit ratio of study procedures relevant to usual care that would be
received outside of the research context. *?HELP?*
Y
 
    
  
   
If yes, please describe the standard of care and standard practice at SLU for the

Page 20 of 47
SLU eIRB
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Biomedical Research
Saint Louis University
Protocol # 25138
Farmakis
Protocol Title:
Shear wave sonoelastography for the noninvasive evaluation of hepatic fibrosis in the
pediatric population
----------------------------------------------------------------------------------------------------
condition/disease/situation being studied.
The current standard of care for evaluation of pediatric patients with liver disease includes
routine abdominal ultrasounds and liver biopsy in order to determine the stage of fibrosis.
 
   g) 
Does this study involve any diagnostic imaging, labwork or genetic testing that could
result in clinical discovery (diagnoses, genetic mutations, etc.)? Note that this could
include discovery that is expected (related to the research) or incidental (not related
to research aims, but possible, like a mass/shadow found in imaging despite not
looking for it).
N
 
    
  
   
If yes, please describe and include whether there are plans to share findings with study
participants.
 
    h) 
Is this study subject to the NIH Genomic Data Sharing Policy?
The NIH GDS policy applies to all NIH-funded research that generates large-scale
human genomic data as well as the use of these data for subsequent research and
includes: genome-wide association studies (GWAS), single nucleotide
polymorphisms (SNP) arrays, and genome sequence, transcriptomic,
metagenomics, epigenomic and gene expression data, irrespective of NIH funding
mechanism. Click here for more specific examples.
N
 
---------------------------------------------------------------------------------------------
* * * Radioisotopes or Radiation Machines * * *
You have not selected the Radioisotopes option in the General Checklist. If you would like to add Radioisotopes
information, please select the option to enable this section.
 
4.  Radioisotopes or Radiation Machines
 
In this section, investigators must enter all radiation usage associated with the protocol.
 
Important: Protocols that involve non-standard of care radioactive materials (which includes the terms
"radioisotopes", "radionuclides", "radiopharmaceuticals", and "nuclear medicine studies", e.g., "PET", "MUGA",
"Zevalin", and/or specific radionuclides such as "F-18", "Tc-99m", "Th-201", "I-131", "Ra-233", "Y-90", etc.) will
receive review by the Radiation Safety Officer (RSO) and/or Radiation Safety Committee (RSC). In these cases,
submission to the RSO/RSC should occur first, even before submission to IRB. For more information on how to
submit for radiation safety review, see RSC  instructions or contact the Radiation Safety Officer at 977-6895.
 
(1) It is the responsibility of the PI to assure the accuracy and completeness of the data submitted in this section,
consistent with guidelines provided below. (2) For projects requiring radiation procedures, please refer to this
guidance.
 
 
a) 
If applicable, list and quantify the radiographic diagnostic and therapeutic procedures associated with
this protocol by clicking "Add" and adding to Table 1 below. (Includes X-ray, fluoroscopy, CT,
radioactive materials, nuclear medicine, PET-CT, radiation oncology, accelerator, Cyber Knife
procedures, etc.)

Page 21 of 47
SLU eIRB
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Biomedical Research
Saint Louis University
Protocol # 25138
Farmakis
Protocol Title:
Shear wave sonoelastography for the noninvasive evaluation of hepatic fibrosis in the
pediatric population
----------------------------------------------------------------------------------------------------
 
 
b)
 Total estimated research radiation dose * :
 
     
* Calculate from the table above by adding the Effective Dose Subtotals for all procedures.
 
 
 
NOTE: Informed Consent Radiation Exposure Risk Statement- The applicant must insert the appropriate
Informed Consent Radiation Exposure Risk Statement template language into the SLU IRB Informed Consent,
inclusive of applying the total estimated research radiation dose specified in item b) from the table above, as
instructed in the SLU IRB Informed Consent Template. Contact the IRB Office at 977-7744 or irb@slu.edu with
any questions.
 
 
---------------------------------------------------------------------------------------------
* * * Devices * * *
5. Devices
 
 a) Please list in the space below all investigational devices to be used on subjects during this study.
 
 
 b) Please list in the space below all FDA approved devices to be used on subjects during this study.
 
FDA Approved Devices
Device Name
Manufacturer
Provide IDE #. Documentation
of IDE # required unless
imprinted on sponsor protocol
(attach in section #16).
Logiq E9 Diagnostic Ultrasound
System
GE
Nonsignificant risk.  The device
has FDA approval for use in
adults and now in children as
well
---------------------------------------------------------------------------------------------
* * * Drugs, Reagents, Chemicals, or Biologic Products * * *
6. Drugs, Reagents, Chemicals, Biologic Products, or Dietary Supplements, Vitamins, and Other Food Agents
Pilot
Phase I
Phase II

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SLU eIRB
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Biomedical Research
Saint Louis University
Protocol # 25138
Farmakis
Protocol Title:
Shear wave sonoelastography for the noninvasive evaluation of hepatic fibrosis in the
pediatric population
----------------------------------------------------------------------------------------------------
Phase III
Phase IV
Not Phased
 
List placebo if it is considered a drug (contains more than inactive ingredients). For example, normal saline
is considered a drug that should be listed, whereas placebo tablets are usually inert ingredients that do not
need to be listed.
 
b)
Please list in the space below all investigational drugs, reagents or chemicals to be administered to
subjects during this study. Attach all applicable Investigator Brochures in section #16 (Attachments).
 
 
c)
Please list in the space below all FDA approved drugs, reagents, chemicals to be administered to subjects
during this study. Attach all applicable package inserts in section #16 (Attachments).
 
 
d)
Please list in the space below all dietary supplements, vitamins, minerals, or foods to be administered to
subjects during this study.
 
 
Please read the  IND Statements.
 
---------------------------------------------------------------------------------------------
* * * Other Levels Of Review * * *
7. Other Levels Of Review
 
  
1. University Radiation Safety
  
Protocols that involve non-standard of care radioactive materials (which includes the terms
"radioisotopes", "radionuclides", "radiopharmaceuticals", and "nuclear medicine studies", e.g., "PET",
"MUGA", "Zevalin", and/or specific radionuclides such as "F-18", "Tc-99m", "Th-201", "I-131", "Ra-223",
"Y-90", etc.) will receive review by the Radiation Safety Officer (RSO) and/or Radiation Safety
Committee (RSC). For information on how to submit for radiation safety review, see RSC  instructions or
contact the Radiation Safety Officer at 977-6895.
X
Not Applicable
Yes, study involves radioactive materials (per instructions, submit to RSC before IRB)
 
 
  
2. Institutional Biosafety
  
Experiments involving the deliberate transfer of Recombinant or Synthetic Nucleic Acid Molecules (e.g.,
Gene Transfer), or DNA or RNA derived from Recombinant or Synthetic Nucleic Acid Molecules, or
Microorganisms containing Recombinant or Synthetic Nucleic Acid Molecules and/or infectious agents
(including select agents and toxins as defined by CDC and/or Animal and Plant Health Inspection
Service (APHIS)) into one or more human research participants must be reviewed by the SLU Biological
Safety Officer. Most of these protocols also require review and approval by the SLU Institutional
Biosafety Committee (IBC). Please contact the SLU Biological Safety Officer at 977-6888 for more

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Biomedical Research
Saint Louis University
Protocol # 25138
Farmakis
Protocol Title:
Shear wave sonoelastography for the noninvasive evaluation of hepatic fibrosis in the
pediatric population
----------------------------------------------------------------------------------------------------
information.
X
Not Applicable
Yes, study requires Institutional Biosafety review
 
 
  
3. Pharmacy, Therapeutics, Nutrition, and Transfusion (PTNT) Committee
  
Saint Louis University Hospital requires that all research involving the administration of medications
within the hospital (including outpatient areas such as the Emergency Department, Outpatient Center,
Saint Louis University Hospital-South Campus, etc.) be reviewed and approved by the Pharmacy,
Therapeutics, Nutrition, and Transfusion (PTNT) Committee and that study drugs are received, stored,
prepared, and dispensed by the Hospital's Department of Pharmacy Services. Please contact the
Investigational Drug Services Clinical Pharmacist at 268-7156 or SLUH-IDS@ssmsluh.com for more
information.
X
Not Applicable
Yes, study requires PTNT review
 
 
  
4. Saint Louis University Hospital
  
All research involving Saint Louis University Hospital, including the Emergency Department, inpatient or
outpatient services (including outpatient surgery at ABI and the infusion center at DOB) and medical
record access, requires approval from the Saint Louis University Hospital Research Review Committee
prior to study initiation. This process is designed to facilitate compliance with state and federal
regulations as they pertain to research in hospitals and clinical research billing. Documents should be
submitted as soon as possible, or at the latest, concurrently with IRB submission. Please contact the
Research Compliance Office at 577-8113 or sluh-research@ssmhealth.com of the SLU Clinical Trials
Office (CTO) at 977-6335 or clinical-trials-office@health.slu.edu for more information.
X
Not Applicable
Yes, study requires Saint Louis University Hospital review
 
 
  
5. SSMSL
  
All research involving SSMSL locations (including Cardinal Glennon), including inpatient or outpatient
services and medical record access, requires approval from the SSM STL or SSM Cardinal Glennon
Research Business Review (RBR) prior to study initiation. This process is designed to facilitate
compliance with state and federal regulations as they pertain to research in hospitals and clinical
research billing. While researchers can begin to complete the SSM RBR form at any time, the form
should not be submitted until the IRB and the CTO have approved the study. Please contact the SSMSL
Office at 989-2058 or Marcy.Young@ssmhealth.com for more information.
Not Applicable
X
Yes, study requires RBR review
 
 

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Biomedical Research
Saint Louis University
Protocol # 25138
Farmakis
Protocol Title:
Shear wave sonoelastography for the noninvasive evaluation of hepatic fibrosis in the
pediatric population
----------------------------------------------------------------------------------------------------
6.
 Does this project require registration on ClinicalTrials.gov, and/or is this project subject to
the NIH GCP Training Requirement? (Select "Yes" if either apply)
Registration may be required if any of the following apply: 1) The project meets the
FDAAA definition of an "Applicable Clinical Trial", which requires registration on
ClinicalTrials.gov. 2) As of January 1, 2017, a new NIH policy mandated biomedical and
behavioral "Clinical Trials" to be registered on ClinicalTrials.gov. In addition, NIH policies
require personnel on NIH "Clinical Trials" to take GCP training every three years. 3)
Registering may be required for Journal Publication (ICMJE). Please review relevant
definitions here. Contact the CTO at clinical-trials-office@slu.edu with questions about
registering on ClinicalTrials.gov and refer to the training page of the IRB website for
information on NIH GCP Training requirements.
Y
 
 
---------------------------------------------------------------------------------------------
* * * Subject Population * * *
8.  Subject Population - In the space below, please detail the participants that you are requesting to recruit
(include description of each group requested)
a)
Expected age range of subjects. (For example ≥ 18 yrs to 90 yrs).
0-18 years
 
b)  
Number of evaluable subjects to be accrued at SLU or SLU site (this includes all
sites under the direction of the SLU PI).
200
 
Exceeding the number listed here is a protocol violation. Prior IRB approval is required if additional
participants are to be accrued. If applicable, this number should be consistent with your power analysis
described in 3d.
 
c)  
Number of evaluable subjects to be accrued study wide.  *?HELP?*
200
 
d)
If including vulnerable populations (minors, pregnant women and fetuses, neonates, non-English speaking,
economically or educationally disadvantaged, prisoners, adults temporarily or permanently unable to
consent for themselves): 1) provide the rationale for the importance of including this population in the
research, and 2) specify the measures being taken to minimize risks to potentially vulnerable subjects.
Click on hyperlinks to access SLU Guidelines containing additional considerations and strategies for
mitigating risks.
The study is specifically designed to evaluate the effectiveness of shear wave elastography in determining
liver fibrosis in pediatric patients.  The shear wave elastography exam has no risks as it is a noninvasive
and non-radiation based imaging test.  There are no risks to the patients.  Routine ultrasound exams and
liver biopsies being performed in these patients is part of standard of care treatment.
 
e)
If women, minorities, or minors are not included, a clear compelling rationale must be provided unless not
applicable. Examples for not including minors: disease does not occur in children; drug or device would
interfere with normal growth and development; etc. If federally funded reference appropriate section of the
sponsors protocol/grant.  *?HELP?*

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Biomedical Research
Saint Louis University
Protocol # 25138
Farmakis
Protocol Title:
Shear wave sonoelastography for the noninvasive evaluation of hepatic fibrosis in the
pediatric population
----------------------------------------------------------------------------------------------------
If minors are of age of assent but are mentally unable to provide consent, parental consent will be
obtained.  The minor will be made aware of the study to the best of our ability and the decision will be left
up to the parents at that point.  Parents will be clearly be made aware that the age of the child would
normally require their assent but because of the education level of their child the assent is not obtained.
 
f) 
If any specifically targeted subjects are students, employees, or laboratory personnel, specify the measures
being taken to minimize the risks and the chance of harm to these potentially vulnerable subjects. See SLU
Guidelines for additional considerations and strategies for mitigating risks.
 
g)
Describe how potential subjects will be identified for recruitment (e.g., chart review, referral from individual's
treating physician, those individuals answering an ad). How will potential participants learn about the
research, and how will they be recruited (e.g., flyer, e-mail, web posting, telephone, etc.)? Upload
recruitment materials in the Attachment Section (#16). Important to remember: potential subjects cannot be
contacted before IRB approval. NOTE: The use of SLU owned websites in an approved SLU format (e.g.,
Cancer Center website, etc.) are always approved methods of recruitment.
Potential subjects with known liver disease will be recruited by the pediatric gastroenterologists as these
patients would be undergoing ultrasound evaluation and liver biopsy as part of standard of care treatment.
These patients would be presented with a recruitment statement form during their clinic visit.  During their
exam in radiology, explanation of the procedure would be performed by the radiologist who would then
obtain consent from the parent and informed assent from the child.  Potential control patients will be
recruited by giving them a recruitment statement and copy of the consent form as they check-in to the
radiology department for an abdominal exam ordered by a physician as part of standard clinical care.  The
form will inform them that they may be asked to participate in the study following the exam.  If deemed
eligible by the radiologist, the radiologist will then obtain consent from the parent and informed assent from
the child.  Recruitment will also  occur  via  flyers  posted  in  the  radiology  department  and  GI  clinics.
---------------------------------------------------------------------------------------------
* * * Subject Population * * *
8. Subject Population (continued)
Page numbers from a sponsor's protocol/grant may be referenced in 8h.
 
h)
Inclusion and Exclusion Criteria.
 
 
  
Identify inclusion criteria.
Inclusion criteria:
Test population: Any pediatric patient (0-18 years of age) with known liver disease with plans to
undergo a liver biopsy within 1 month of ultrasound exam.  Underlying diagnoses include but are not
limited to biliary atresia, congenital fibrosis-cholestasis, Alagille syndrome, Caroli’s disease,
choledochal cyst, alpha-1-antitrypsin deficiency, progressive familial intrahepatic cholestasis (PFIC),
viral hepatitis, glycogenosis, fructosemia, Wilson disease, cystic fibrosis, autosomal recessive
polycystic kidney disease (ARPCKD), mesenterico-caval shunt, post liver transplant, and nonalcoholic
steatohepatitis (NASH).  Written informed consent from parent or legal guardian. Informed assent from
the child.
Control population: Any pediatric patient (0-18 years of age) undergoing an abdominal ultrasound for
reasons other than liver disease and in whom the US shows a normal liver, gallbladder, pancreas,
spleen, and biliary tree.  Written informed consent from parent or legal guardian. Informed assent from
the child.  In addition, the patients that have undergone biopsy and have shown no histologic evidence

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Biomedical Research
Saint Louis University
Protocol # 25138
Farmakis
Protocol Title:
Shear wave sonoelastography for the noninvasive evaluation of hepatic fibrosis in the
pediatric population
----------------------------------------------------------------------------------------------------
of fibrosis will also serve as a control population.  The elastography measurements of these patients
will be compared to those obtained in the pediatric patients without a history of liver disease in whom
the ultrasound exam of the abdomen was found to be normal.
 
 
  
Identify exclusion criteria.
Exclusion criteria: Inconclusive biopsy results. Patient not cooperative for the ultrasound exam. Failure
to give informed consent.  No biopsy results within allotted time frame.  Poor acoustic window in which
to perform sonoelastography.
 
i)
Compensation. Explain the amount and schedule of compensation, if any, that will be paid for participation
in the study. Include provisions for prorating payment.
No compensation will be provided for participation in the study for the initial study group unless patients
were asked to come back in for an additional ultrasound because original data was unusable. In that case,
they will receive $50 for their visit if they live within 40 miles and $100 if they live
further out to cover the cost of the additional travel and additional time required to Cardinal Glennon for the
ultrasound exam visit required for participation.
 
j)
Describe who will cover study related costs. Explain any costs that will be charged to the subject.
Study related costs will be covered by intramural and possible extramural funding.  The patient will not be
charged for any costs related to the shear wave elastography exam.  Costs of patient office visits, liver
biopsy, and routine ultrasound exams will be paid by the patient or insurance company as these are
considered standard of care treatment methods.
 
k)
Estimate the probable duration of the entire study including data analysis and publication. This estimate
should include the total time each subject is to be involved and the duration the data about the subject is to
be collected. If the study is  Investigator-initiated, a timeline  for individual subject recruitment, follow-up,
total time for subject accrual, and data analysis for the study is required.
The total recruitment process for control patients is estimated to take one year.  The total recruitment
process for test subjects is expected to take 18 months.  The data analysis is expected to take 3 months.
 
---------------------------------------------------------------------------------------------
* * * Risks * * *
9. Risks
     
There is no research that can be considered totally risk free (e.g., a potential risk of breach of
confidentiality). Therefore, when describing the risk, the lowest level of risk is "no more than minimal risk".
 
 
Page numbers from a sponsor's protocol/grant may be referenced in 9.1, 9.2, 9.3, and 9.4.
 
 
 
 
    1.
Use of investigational devices. Please include the clinical adverse events (AEs) associated with each
of the devices with an indication of frequency, severity and reversibility. This information can often be
found in the Investigator(s) brochure. NOTE: Include any likely adverse effects associated with
procedures that subjects may experience while in the study.

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PROTOCOL
Biomedical Research
Saint Louis University
Protocol # 25138
Farmakis
Protocol Title:
Shear wave sonoelastography for the noninvasive evaluation of hepatic fibrosis in the
pediatric population
----------------------------------------------------------------------------------------------------
 
 
 
 
 
    2.
Use of investigational drugs. Please include the clinical AEs associated with each of the drugs with an
indication of frequency, severity and reversibility. This information can often be found in the
Investigator(s) brochure. NOTE: Include any likely adverse effects associated with placebos or
washout periods that subjects may experience while in the study.
 
 
 
 
 
    3.
Use of FDA approved drugs, reagents, chemicals, or biologic products.  Please include the clinical AEs
associated with each of the drugs with an indication of frequency, severity and reversibility. This
information can often be found in the package insert provided by the manufacturer. NOTE: Include any
likely adverse effects associated with placebos or washout periods that subjects may experience while
in the study.
 
 
 
 
 
    4.
Use of FDA approved devices. Please include the clinical adverse events (AEs) associated with each
of the devices with an indication of frequency, severity and reversibility. This information can often be
found in the Investigator(s) brochure. NOTE: Include any likely adverse effects associated with
procedures that subjects may experience while in the study.
no more than minimal risk
 
 
 
 
 
    5.
Describe any risks related to performing study procedures. Please include all investigational, non-
investigational, and non-invasive procedures (e.g., surgery, blood draws, treadmill tests).
loss of confidentiality
 
 
 
 
 
    6.
Describe any risks related to the use of radioisotopes/radiation-producing machines (e.g., X-rays, CT
scans, fluoroscopy).
 
 
 
 
 
    7.
Describe why this investigational compound/drug/device/procedure's risks/benefits are potentially
better than standard of care or other common alternatives. Any standard treatment that is being
withheld must be disclosed and the information must be included in the consent form. *?HELP?*
N/A
 
 
 
 
 
    8.
Describe any psychological, social, or legal risks the subject may experience.   *?HELP?*
no more than minimal risk

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Biomedical Research
Saint Louis University
Protocol # 25138
Farmakis
Protocol Title:
Shear wave sonoelastography for the noninvasive evaluation of hepatic fibrosis in the
pediatric population
----------------------------------------------------------------------------------------------------
 
Page numbers from a sponsor's protocol/grant may be referenced in 9.9 and 9.10.
 
 
 
 
  
9.
Special Precautions. Describe the planned procedures for protecting against or minimizing potential
risks. If appropriate, include the standards for termination of the participation of the individual subject.
Discuss plans for ensuring necessary medical or professional intervention in the event of adverse
effects to the subjects.
The shear wave sonoelastography exam will be terminated on a patient if the patient is uncooperative.
The loss of confidentiality will be minimized by having the recorded data on an encrypted USB device
which is password protected.  The physical data will be kept in a locked file cabinet in a locked office
to which only the PI has access.
 
 
 
 
  
10.
Reproductive Risks.
 
 
 
    
   
a.
Please list the pregnancy category of any drugs or N/A.
N/A
 
           b. Please describe any reproductive risk associated with any part of the research study. Include any data
from other studies (animal or human).
N/A
 
11.
Data Safety Monitoring
 
 
 
 
          
Federal regulations require that when appropriate, the research protocol makes adequate provisions
for monitoring the data to ensure the safety of participants. Monitoring should be commensurate with
risks and with the size and complexity of the research, and could range from no plan needed to an
independent data safety monitoring board. Please refer to  SLU Guidelines for Data and Safety
Monitoring as you complete the questions below.
 
a.
Is there a Data Monitoring Committee (DMC) or Board (DSMB)?
N/A
 
 
 
 
 
          
If yes, please provide the following information (labeled a-g): a)  the composition of the board
(degrees/qualifications of members),  b)  whether the board is independent from the sponsor and
research team or not,  c)  frequency of meetings and issuance of reports to sites,  d)  assurance that
the board is reviewing aggregate safety data and making recommendations regarding study
continuance,  e)  provisions for ad hoc meetings if needed,  f)  who is reviewing SAEs in real time (MD
or DO), and  g)  stopping/halting rules (if any exist).
A DSM charter can be referenced for all items except for "f) who is reviewing SAEs in real time."
 
 
 
 
 
          
If no, please justify why not.

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Biomedical Research
Saint Louis University
Protocol # 25138
Farmakis
Protocol Title:
Shear wave sonoelastography for the noninvasive evaluation of hepatic fibrosis in the
pediatric population
----------------------------------------------------------------------------------------------------
 
     
b.
  Is there a Data Safety Monitoring Plan (DSMP)?
N/A
 
 
 
 
 
          
Note, if all relevant plan information is included in DSMB question above, select 'Yes' and state "see
above" in the answer box.
 
 
 
 
 
          
If yes, provide details (labeled a-e) including: a) what types of data or events are captured and how are
they documented, b)  who is monitoring data, their independence/affiliation with the research and their
degrees/qualifications, c)  frequency of aggregate data review, d)  who is reviewing SAEs in real time
(MD or DO), and  e)  stopping/halting rules (if any exist).
 
 
 
 
 
          
If no, please justify why not.
 
   
12.
In case of international research (research outside of the U.S. or research on international
populations (non-U.S.)), describe qualifications/preparations that enable you to evaluate cultural
appropriateness and estimate/minimize risks to subjects. Include whether research is sensitive given
cultural norms.
 
 
 
 
    a.
State any local laws/regulations governing Human Subjects Research in the country(ies) you will
conduct the research and attach any relevant approvals. If none, state N/A.
 
 
 
 
    b.
Will there be language barriers and if so, how will they be addressed?
 Note: If materials are to be distributed to subjects in their native language, please follow  SLU's
Guidance For Studies Involving Non-English Speaking Subjects.
 
          NOTE: Export control laws include the transfer of technical information and data, as well as information
and technology to foreign nationals. If this study has international components, contact the  SLU Export
Control Officer for direction on whether export control policies apply.
 
---------------------------------------------------------------------------------------------
* * * Benefits/Alternatives, Procedures to Maintain Confidentiality and Privacy * * *
10. Benefits/Alternatives
a)
Benefits. Describe the potential benefit(s) to be gained by the subjects and how the results of the study
may benefit future subjects and/or society in general.  Indicate if there is no direct benefit to the
participants.

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Biomedical Research
Saint Louis University
Protocol # 25138
Farmakis
Protocol Title:
Shear wave sonoelastography for the noninvasive evaluation of hepatic fibrosis in the
pediatric population
----------------------------------------------------------------------------------------------------
participants.
There is no potential benefit to the subjects.  The results of the study may benefit future subjects and/or
society in general as if shear wave sonoelastography is found to be an accurate method of evaluating the
degree of liver fibrosis in pediatric patients, it may reduce or obviate the need for liver biopsies in patients
with liver disease.  In addition, if the number of required liver biopsies in these patients is reduced or
eliminated, the risks associated with performing sedation in these patients is also reduced or eliminated.
 
b)
Alternatives. Describe any alternative treatments and procedures available to the subjects should they
choose not to participate in the study. If no such alternatives exist, please state that the alternative is
nonparticipation. For some studies, such as record reviews, a description of alternatives would not be
applicable.
Nonparticipation
 
11. Procedures to Maintain Confidentiality and Privacy
        
Federal regulations require that research materials be kept for a minimum of three (3) years and HIPAA
documents be kept for a minimum of six (6) years after the closure of the study. For FDA-regulated or
sponsored projects, the PI may be required to keep the data and documents for a longer time period.
 
Confidentiality
 
         To determine whether adequate provisions for confidentiality of data are in place, the IRB must ensure that
research materials are stored in appropriate locations throughout the study (during collection,
transport/transmission, analysis and long term storage). Research information must be protected using
appropriate safeguards based on identifiability of the data and risk associated with the study (See SLU IRB
Confidentiality Guidelines).
     
For the questions below, please use the following definitions:
 Anonymous/De-identified: data contain no identifiers, including code numbers that investigators can link to
individual identities;
 Coded: data in which (1) identifying information, such as name or social security number, has been
replaced with a number, letter, symbol, or combination thereof (i.e., the code), and (2) a key to decipher the
code exists enabling linkage of data to identifying information (e.g., a master list), and (3) the key (master
list) is kept separately from coded data; AND/OR
 Identifiable: data that includes personal identifiers (e.g., name, social security number), such that
information could be readily connected to respective individuals.
 
 
a)
Electronic (Computer) Data
 
     
Click "Add" to enter data security information for each type of electronic data that will be created in the
study: anonymous/de-identified, coded, and/or identifiable (see definitions above).

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Biomedical Research
Saint Louis University
Protocol # 25138
Farmakis
Protocol Title:
Shear wave sonoelastography for the noninvasive evaluation of hepatic fibrosis in the
pediatric population
----------------------------------------------------------------------------------------------------
 To properly address this question, there should only be one listing of each type of data in the table.
Depending on your project, you could have up to three types of data. See the SLU ITS Sensitive Data Guide
for acceptable data security methods.
 
Not Applicable, No Electronic (Computer) Data
X
Study IRB-approved Prior to New Question (Question N/A- Grandfathered)
 
b)
Hardcopy (Paper) Data
 
     
Click "Add" to enter information for each type of hardcopy (paper) data that will be created in the study:
anonymous/de-identified, coded, and/or identifiable (see definitions above).
 To properly address this question, there should only be one listing of each type of data in the table.
Depending on your project, you could have up to three types of data.
 
Not Applicable, No Hardcopy (Paper) Data
X
Study IRB-approved Prior to New Question (Question N/A- Grandfathered)
 
 
c)
If a master list is used in this study (linking study codes to subject identifiers), explain: a) how and where
you will secure the master list, b) how long it will be kept/when it will be destroyed, and c) provide a sample
of the code.
USB devices used at SSM Cardinal Glennon Children's Medical Center are encrypted devices which are
password protected.  Anyone trying to access the information on the drive without the correct password will
not be able to see what information the device contains.  In addition, the data on the device will be
accessed through the username/password secured SSM network.  The data obtained from the patient's
medical record will be kept on a data collection sheet which will then be kept in a locked cabinet in a
locked office.  The information that will be obtained from the patient's medical record includes birthdate,
current age, gender, height, weight, BMI, history of known liver disease, labs (total bilirubin, AST, ALT,
GGTP, cytokeratin-18), liver biopsy results, and reports of abdominal ultrasounds.
 
d)
If data or specimens are being shared outside of the research team, indicate who will receive the material,
specifically what they will receive (data or specimens), and if an agreement has been signed to cover the
transfer. Note: unless covered under a Clinical Trial or other agreement, the transfer of data or specimens
to an external entity will require an agreement. For the transfer of materials (specimens), a Materials
Transfer Agreement (MTA) is used; for the transfer of data, a Data Use or Data Transfer Agreement is
used. Please contact the Research Innovation Group at 314-925-3027 for assistance.
N/A
 
 
e)
If samples or data will be provided to SLU from an outside source, indicate whether you will  have access
to identifiers, and if so, how identifiable information is protected. Note: unless covered under another
agreement (e.g., Clinical Trial Agreement or subcontract), the transfer of data or specimens from an
external entity to SLU may require an agreement. For the transfer of materials (specimens), a Materials
Transfer Agreement (MTA) may be required; for the transfer of data, a Data Use or Data Transfer
Agreement may be required. Please contact the Research Innovation Group at 314-925-3027 for

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Biomedical Research
Saint Louis University
Protocol # 25138
Farmakis
Protocol Title:
Shear wave sonoelastography for the noninvasive evaluation of hepatic fibrosis in the
pediatric population
----------------------------------------------------------------------------------------------------
assistance.
N/A
 
f)
If data will be collected via e-mail or the Internet, how will anonymity or confidentiality be affected?
Describe how  data will be recorded (i.e., will internet protocol (IP) addresses and/or e-mail addresses be
removed from data?).
 
g)
If you will be audio/video recording or photographing subjects, provide a rationale as voiceprints and
images of faces/unique body markings are considered identifiers.  Describe confidentiality procedures,
including any restricted access to images and/or the final disposition of the recordings/photos (destruction,
archiving, etc.).
 
h)
Describe any study-specific (non standard of care) information or documentation that will be put in the
participants' medical records for this research (e.g., study visit notes, lab results, etc.). If none, state "not
applicable". NOTE: documentation of research in Epic should be done in accordance with the SLUCare
Epic Research Charting Policy and Clinical Workflow: Documenting Research Encounters in Epic.
N/A
 
i)
Are there any information security requirements identified in the project's
RFP/Award Notice/Contract? This could include data security, technical
safeguards, security controls, NIST, FISMA, CFR, etc.
 If yes, SLU ITS approval is required. Contact InfoSecurityTeam@slu.edu to start
the approval process.
N
 
Privacy
 
 
Privacy refers to persons having control over the sharing of oneself with others.
 
j)   Please indicate how participant privacy will be protected in this study (select all that apply):
 
X
Discussion of health related and/or personal information in a private room/area
 
X
Research interactions/interventions are conducted in a private room/area
 
Use of drapes or other privacy measures
 
Collection of sensitive/identifiable information is limited to the minimum necessary to achieve
the aims of the research
 
X
Access to study information is limited to the minimum amount of persons necessary to achieve
the aims of the research (e.g., access restricted to research team members only)

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Biomedical Research
Saint Louis University
Protocol # 25138
Farmakis
Protocol Title:
Shear wave sonoelastography for the noninvasive evaluation of hepatic fibrosis in the
pediatric population
----------------------------------------------------------------------------------------------------
 
X
Consideration of parental inclusion/absence for studies involving minors
 
Other (please explain):
       
 
 
---------------------------------------------------------------------------------------------
* * * Potential Conflict of Interest * * *
12. Potential Conflict of Interest
  
    
Indicate whether you, your spouse or dependent children,  have, or anticipate having, any income
from or financial interest in a sponsor, device or drug manufacturer of this protocol, or a company
that owns/licenses the technology being studied. Please remember that you are responding for you
and any other investigator participating in the study. Financial Interest includes but is not limited to:
consulting; speaking or other fees; honoraria; gifts; licensing revenues; equity interests (including
stock, stock options, warrants, partnership and other equitable ownership interests). For questions
regarding Conflict of Interest consult the  Conflict of Interest in Research Policy.
 
Check one of the following (please remember that you are responding for yourself, your spouse, dependent
children and any investigator, investigator's spouse and dependent children participating in the study):
 
1)
X
No equity interest and/or Financial Interest less than or equal to $5K
2)
Any equity interest and/or Financial Interest  exceeding $5K but not exceeding $25K in the past
year or expected in the current year
3)
Financial Interest  exceeding $25K in the past year or expected in the current year
 
Check all those that apply:
 
         
Consulting
         
Speaking Fees or Honoraria
         
Gifts
         
Licensing agreement or royalty income
         
Equity interests, (including stock, stock options, warrants, partnership or equitable ownership
interests), or serving on a scientific advisory board or board of directors
         
Other fees/compensation
 
 
       
If you have marked #2 or #3, please contact coi@slu.edu to initiate review of this study and provide the
following information:
 
1. 
A Conflict of Interest Management Plan.

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Biomedical Research
Saint Louis University
Protocol # 25138
Farmakis
Protocol Title:
Shear wave sonoelastography for the noninvasive evaluation of hepatic fibrosis in the
pediatric population
----------------------------------------------------------------------------------------------------
            
has been approved for all investigators for this study
            
is pending
            
has not been initiated
 
2. 
Describe who has, and briefly explain, the conflict of interest and indicate specific amounts for
each subcategory checked:
      
 
  Note to Investigator(s) Reporting a Potential Conflict of Interest
 
  Investigator(s) must have:
 
1.
Current, up-to-date Conflict of Interest Disclosure Form  on file with the SLU Conflict of Interest
in Research Committee (COIRC) that describes any financial relationship indicated above.
 
                  
.
This information must be disclosed on the SLU confidential Conflict of Interest
Disclosure Form and reviewed by the COIRC before accruing research subjects in this
study. If your current Disclosure Form does not contain this information, you are
required to submit an updated Disclosure Form to the COIRC.
 
2.
You may not begin your study until your disclosure form has been reviewed and any required
management plan has been approved by the COIRC for this study. To initiate COIRC review of
your study, please contact coi@slu.edu.
---------------------------------------------------------------------------------------------
* * * Informed Consent * * *
13. Informed Consent
 
Federal regulations require that informed consent be obtained from individuals prior to their participation in
research unless the IRB grants a waiver of consent. Answer the questions, below, then click Add to provide
the necessary consent documents and information regarding subject consent. Multiple consents/waivers
may be added, but they must be uploaded one at a time.
 
NOTE: You may refer to the SLU IRB Guidance for Obtaining Informed Consent for considerations
regarding the consent/assent process.
 
State N/A if not applicable.
 
  
  1)
How is consent being obtained? When and where will the discussion take place? If the study involves
a Non-English Speaking participant/population, please include details about plans for translated
consent materials and interpreters to be used (see SLU Guidelines for Involving Non-English
Speaking Subjects for more details).
Consent will be obtained by any of the four pediatric radiologists on the IRB proposal who will
discuss the research study and explain the shear wave elastography exam with the parent/guardian
and child while in the ultrasound exam room in the radiology department while they are there for
their routine abdominal ultrasound or prior to a scheduled liver biopsy in the endoscopy suite, patient

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Biomedical Research
Saint Louis University
Protocol # 25138
Farmakis
Protocol Title:
Shear wave sonoelastography for the noninvasive evaluation of hepatic fibrosis in the
pediatric population
----------------------------------------------------------------------------------------------------
their routine abdominal ultrasound or prior to a scheduled liver biopsy in the endoscopy suite, patient
room, or radiology department.
 
  
  2)
If the study involves adults unable to consent for themselves (whether diminished capacity to consent
is temporary, permanent, progressive or fluctuating), please address the following: a) how is capacity
to provide consent being assessed (initially and throughout study, if applicable); b) if unable to
provide consent, how is LAR being determined (See SLU LAR Guidelines); c) if unable to provide
consent, will assent be obtained and if not, why not?; d) if unable to provide assent, will dissent be
honored and if not, why not? Note: participants initially unable to provide consent for themselves are
expected to be given an opportunity to provide consent once capacity is gained. See SLU Guidelines
for Adults Unable to Provide Consent for additional detail.
In patients that are old enough for assent but are cognitively impaired to a point of being unable to
give assent we would allow the parents or guardians to make the decision about participation.  We
will make every effort to assent the patient to best of their ability.
Note: Any assent documents which will be used per the Adults Unable to Provide Consent guidance, should be
appropriately named and uploaded using the Add button and the Consent drop down menu selection.
 
Informed Consent
Title
Consent Type
Attached Date
Approved_CR2017_Addendum
Consent
Consent
12/06/2017
 Approved_CR2017_Control
Consent FDA app...
Consent
12/06/2017
Approved_CR2017_Test patients
Consent F...
Consent
12/06/2017
---------------------------------------------------------------------------------------------
* * * Assent * * *
14. Assent
     
Complete this section if your study includes minors. The Assent Form Template provides
guidelines for writing assent documents.
 
     
 1.
Will minors be asked to give assent, then consent once they reach adulthood? If not, please justify. If
not capable to provide assent initially, please address whether assent will be obtained as the minor
gains capacity. Note: children who reach the age of adulthood during participation should be given
the opportunity to provide consent as parent/guardian consent no longer applies. If obtaining consent
would be impracticable (e.g., this is a registry with data/specimen obtained long ago), a waiver of
consent should be added for IRB review. See SLU Guidelines for Research Involving Minors for
additional detail.
Yes, unless they are developmentally delayed and are unable to give assent, then it will be left up to
the parent/guardian for the decision to participate, but we will still go over the assent with the patient
and make every effort to inform them to best of our ability.

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Biomedical Research
Saint Louis University
Protocol # 25138
Farmakis
Protocol Title:
Shear wave sonoelastography for the noninvasive evaluation of hepatic fibrosis in the
pediatric population
----------------------------------------------------------------------------------------------------
 
     
 2.
If minors are asked to assent and do not wish to participate, will they still be accrued in the study? If
yes, justify.
No
 
     
 3.
How will the minor's ability to give assent be assessed? (Consider the age and maturity of the minors
as well as their physical or mental condition). If capacity is fluctuating, please explain how capacity
will be assessed throughout the study.
Research team members involved in consenting are pediatric health care providers with training in
childhood development. Comprehension and willingness will be based on the researchers
interaction with the adolescent. Parental input will be considered but will not supersede the
investigator’s analysis of the child’s willingness to participate.
 
  
Note:  For studies that require a discussion about reproductive risks, note that the conversation with the
minor should take place separately from the parents. Also, if a minor will reach adulthood (18 in Missouri)
during the course of the study, they will need to be asked to consent as an adult at that time to continue in
the study.
 
Assent Documents
Title
Upload assent document
Attached Date
Approved_
CR2017_Assent_CHILDREN_Clinic.
..
Approved_CR2017_Assent_CHILDR
EN_Clinical normal control
12/06/2017
Approved_CR2017_Assent_CHILDR
EN_Clinical
Approved_CR2017_Assent_CHILDR
EN_Clinical_
12/06/2017
 
Approved_CR2017_Assent_ADOLE
SCENTS_Clin..
Approved_CR2017_Assent_ADOLE
SCENTS_Clinical
12/06/2017
 
Approved_CR2017_Assent_ADOLE
SCENTS_Clin.
Approved_CR2017_Assent_ADOLE
SCENTS_Clinical normal control
12/06/2017
---------------------------------------------------------------------------------------------
* * * HIPAA * * *
15. HIPAA
 
    
 
Studies that access, receive or collect protected health information (PHI) are subject to HIPAA regulations.
PHI is health information with one or more personal identifiers.   For more information visit the  IRB HIPAA
page or refer to the SLU IRB HIPAA Guidance.
 
    1. Will health information be accessed, received or collected?

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PROTOCOL
Biomedical Research
Saint Louis University
Protocol # 25138
Farmakis
Protocol Title:
Shear wave sonoelastography for the noninvasive evaluation of hepatic fibrosis in the
pediatric population
----------------------------------------------------------------------------------------------------
No health information. HIPAA does not apply.
X
Yes (continue to question 2).
 
    2. Which personal identifiers will be received or collected/recorded?
No identifiers.  I certify that no identifiers from the list below will be received or collected and
linked to health information. (Skip remainder of page).
Limited identifiers will be received or collected/recorded (study will likely require a data use
agreement). Select Data Use Agreement- INTERNAL or Data Use Agreement- EXTERNAL as
appropriate, below.
City/State/Zip codes
Person-specific dates (e.g., date of birth, dates of service, admission/discharge dates,
etc.)
Age (if subjects are 90+ years)
At least one direct identifier will be received or collected/recorded.
X
Names
Social Security numbers
Telephone numbers
X
Linkable code or any other unique identifying number (note this does not mean the unique
code assigned by the Investigator(s) to code the research data)
All geographic subdivisions smaller than a State, including street address, city, county,
precinct, zip code, and their equivalent geocodes, except for the initial three digits of a zip
code, if, according to the current publicly available data from the Bureau of the Census:
(1) The geographic unit formed by combining all zip codes with the same three initial digits
contains more than 20,000 people; and (2) The initial three digits of a zip code for all such
geographic units containing 20,000 or fewer people is changed to 000
X
All elements of dates (except year) for dates directly related to an individual, including
birth date, admission date, discharge date, date of death; and all ages over 89 and all
elements of dates (including year) indicative of such age, except that such ages and
elements may be aggregated into a single category of age 90 or older
Fax numbers
Electronic mail addresses
X
Medical record numbers
Health plan beneficiary numbers
Account numbers
Certificate/license numbers
Vehicle identifiers and serial numbers, including license plate numbers
Device identifiers and serial numbers
Web Universal Resource Locations (URLs)
Internet Protocol (IP) address numbers
Biometric identifiers, including finger and voice prints
Full face photographic images and any comparable images
 
    
  
If you are receiving or collecting/recording health information and at least one personal identifier, please
continue to complete the sections, below.
 

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SLU eIRB
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PROTOCOL
Biomedical Research
Saint Louis University
Protocol # 25138
Farmakis
Protocol Title:
Shear wave sonoelastography for the noninvasive evaluation of hepatic fibrosis in the
pediatric population
----------------------------------------------------------------------------------------------------
    3. Sources of Protected Health Information:
X
Hospital/medical records for in or out patients
X
Physician/clinic records
X
Laboratory, pathology and/or radiology results
Biological samples
X
Interviews or questionnaires/health histories
Mental health records
Data previously collected for research purposes
Billing records
Other
       
     
      
     
Please describe:
 
    4. If data will be shared outside the research team and the study involves PHI indicate how the research
team will share the information.
 
X
Not applicable (continue to question 5).
Only linkable code that can link data to the identity of the subject. A code access agreement or
business associate agreement may be needed when data are shared with other non-SLU
entities. If necessary, the agreement can be added and uploaded in item #5, below.
Limited identifiers: Zip codes, dates of birth, or other dates only. The study qualifies as a Limited
Data Set. A data use agreement may be needed when data are shared with other non-SLU
entities.  If necessary, the agreement can be added and uploaded in item #5, below, using DUA-
external option.
With unlimited identifiers. The consent document and HIPAA Authorization form must describe
how the information will be disclosed.
 
    5. HIPAA Documentation is required for this study.  Use the table below to add HIPAA Documents for
your study.
 
 
HIPAA Documents
HIPAA Documents
Title
Attached Date
HIPAA Authorization
Approved_Version 2 HIPAA
authorization
01/22/2015
---------------------------------------------------------------------------------------------
* * * Attachments * * *
16. Attachments
In this section, please upload additional documents associated with your protocol. Failure to attach files

Page 39 of 47
SLU eIRB
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PROTOCOL
Biomedical Research
Saint Louis University
Protocol # 25138
Farmakis
Protocol Title:
Shear wave sonoelastography for the noninvasive evaluation of hepatic fibrosis in the
pediatric population
----------------------------------------------------------------------------------------------------
associated with the protocol may result in the protocol being returned to you.
 
  Possible documents for this protocol could include:
 •
Bibliography
 •
Cooperating Institution's IRB Approval
 •
Data Collection Sheet
 •
Debriefing Script
 •
Device Information/Documentation
 •
Grant Proposal/Sub-Contract
 •
Human Subjects Training Certificate/Proof of Training
 •
Information Sheet/Brochure
 •
Interview/Focus Group Questions
 •
Investigator's Brochure
 •
Letter of Agreement/Cooperation
 •
IND Application Letter
 •
Package Insert
 •
Patient Diary Form
 •
Questionnaire/Survey
 •
Recruitment Material (e.g., flyers, ads, e-mail text)
 •
Safety Information (DSM Information)
 •
Scientific/PPC Review or Department Chair Review
 •
Sponsor's Protocol
 •
Sponsor's Protocol Amendment
 •
Study Design Chart/Table
 •
Other files associated with the protocol (most standard formats accepted: pdf, jpg, tiff, mp3, wmv,
etc.)
       
To update or revise any attachments, please delete the existing attachment and upload the revised
document to replace it.
 
Document Type
Document Name
Attached Date
Submitted Date
Bibliography
Bibliography IRB
10/30/2014
11/14/2014
Human Subjects Training
Certificate/Proof of
Training
CITI certificate
10/30/2014
11/14/2014
Device
Information/Documentatio
n
K142160 LOGIQ E9 R5
Clearance Letter
11/04/2014
11/14/2014
Letter of
Agreement/Cooperation
Logiq E9 brochure
11/05/2014
11/14/2014
Device
Information/Documentatio
n
LOGIQ E9 Shear Wave
USA Sell Sheet
11/05/2014
11/14/2014

Page 40 of 47
SLU eIRB
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PROTOCOL
Biomedical Research
Saint Louis University
Protocol # 25138
Farmakis
Protocol Title:
Shear wave sonoelastography for the noninvasive evaluation of hepatic fibrosis in the
pediatric population
----------------------------------------------------------------------------------------------------
Device
Information/Documentatio
n
LOGIQ E9 Timeline-USA
11/05/2014
11/14/2014
Human Subjects Training
Certificate/Proof of
Training
Tao CITI FCOI
11/07/2014
11/14/2014
Human Subjects Training
Certificate/Proof of
Training
Tao CITI SLU
11/07/2014
11/14/2014
Human Subjects Training
Certificate/Proof of
Training
Tao CITI training
11/07/2014
11/14/2014
Device
Information/Documentatio
n
Device Nonsignificant
Risk Justification
12/16/2014
12/16/2014
Data Collection Sheet
Approved_Data collection
sheet
01/22/2015
01/22/2015
Recruitment Material
(e.g., flyers, ads, e-mail
text)
Approved_SWE
model_recruitment_state
ment for test population
01/22/2015
01/22/2015
Recruitment Material
(e.g., flyers, ads, e-mail
text)
Approved_SWE normal
model_recruitment_state
ment
01/22/2015
01/22/2015
Committee Approvals
SSM RBR Approval
Letter Farmakis SLU
#25138
03/05/2015
03/27/2015
Recruitment Material
(e.g., flyers, ads, e-mail
text)
Approved_Flyer for SWE
04/02/2015
04/02/2015
Other
Highlighted K152195
LOGIQ S8 R3 510k
Clearance Letter
12/18/2015
12/18/2015
Other
K152195 LOGIQ S8 R3
510k Clearance Letter
12/18/2015
12/18/2015
Other
Approved_SWE
Clarification Letter
01/08/2016
01/08/2016
Publications (e.g.,
manuscripts, abstracts)
SPR 2017 meeting
submission FINAL
12/09/2016
12/09/2016
Publications (e.g.,
manuscripts, abstracts)
SPR 2017 Figure 1
12/09/2016
12/09/2016
Publications (e.g.,
manuscripts, abstracts)
SPR 2017 Figure 2
12/09/2016
12/09/2016
Publications (e.g.,
manuscripts, abstracts)
SPR 2017 Table 1
12/09/2016
12/09/2016
Human Subjects Training
Certificate/Proof of
Training
A Hardy CITI COI desc
10/06/2017
10/06/2017

Page 41 of 47
SLU eIRB
41
PROTOCOL
Biomedical Research
Saint Louis University
Protocol # 25138
Farmakis
Protocol Title:
Shear wave sonoelastography for the noninvasive evaluation of hepatic fibrosis in the
pediatric population
----------------------------------------------------------------------------------------------------
Human Subjects Training
Certificate/Proof of
Training
A Hardy CITI IRB desc
10/06/2017
10/06/2017
---------------------------------------------------------------------------------------------
* * * PI Obligations * * *
 
PI Obligations
 
By clicking the box  below you indicate that you accept responsibility for and will follow the ethical guidelines set
forth by the Belmont Report, Declaration of Helsinki, the Nuremberg Code, and the Ethical Principles of the
American Psychological Association (if applicable) for the research described. It also indicates that you have the
requisite funding, credentials, training, and any necessary hospital privileges, if needed, to carry out all
procedures and treatments involved in the protocol.
 
Clicking the box  also affirms that the activities involving human subjects will not begin without prior review and
approval by the Institutional Review Board, and that all activities will be performed in accordance with state and
federal regulations and Saint Louis University's assurance with the Department of Health and Human Services.
The PI assures that if members of the SLU research team access protected health information (PHI) from a
covered entity in order to seek consent/authorization for research or to conduct research, such access is
necessary for the research, is solely for that purpose, and the information will not be removed from the covered
entity without IRB authorization or approved waiver. PI further assures that the SLU research team will comply
with the terms of a Data Use Agreement to PHI (if any).
 
1)
Have you completed the annual Conflict of Interest in Research Disclosure Form?
Y
You can only select N/A if you are not currently listed on any externally
funded research projects nor listed on any proposals
for externally funded research support.
 
NOTE: An annual disclosure must be completed by all faculty, staff and students involved in the design,
conduct or reporting of externally funded research applications and awards.
 
2)
Have your financial interests changed significantly since you completed the annual
disclosure form?
N
 
The PRINCIPAL INVESTIGATOR certifies that he/she has read the University's Conflict of Interest Research
Policy and has checked the appropriate box in the 'Potential Conflict of Interest' section of the application. In
addition, the PRINCIPAL INVESTIGATOR certifies that, to the best of his/her knowledge, no person working on
this project at SLU has a conflict of interest or if a conflict of interest does exist, that an appropriate management
plan is in place.

Page 42 of 47
SLU eIRB
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PROTOCOL
Biomedical Research
Saint Louis University
Protocol # 25138
Farmakis
Protocol Title:
Shear wave sonoelastography for the noninvasive evaluation of hepatic fibrosis in the
pediatric population
----------------------------------------------------------------------------------------------------
 
According to the Saint Louis University Conflict of Interest in Research Policy, as PI, it is your responsibility to
inform co-investigators, staff, or students involved in the design, conduct, or reporting of externally sponsored
research of their requirement to complete a Conflict of Interest in Research Disclosure Form.
 
X
I accept this responsibility.
 
 
X
The Principal Investigator has read and agrees to the above certifications and will abide
by the above obligations.
---------------------------------------------------------------------------------------------
* * * Event History * * *
Event History
Date
Status
View Attachments
Letters
12/19/2018
CONTINUING REVIEW 4
FORM APPROVED
Y
N
12/14/2018
CONTINUING REVIEW 4
FORM REVIEWER(S)
ASSIGNED
12/07/2018
CONTINUING REVIEW 4
FORM PANEL
REASSIGNED
11/24/2018
CONTINUING REVIEW 4
FORM PANEL
REASSIGNED
11/13/2018
CONTINUING REVIEW 4
FORM SUBMITTED
Y
11/12/2018
CONTINUING REVIEW 4
FORM CREATED
07/23/2018
AMENDMENT 10 FORM
DELETED
06/22/2018
AMENDMENT 10 FORM
CREATED
12/06/2017
CONTINUING REVIEW 3
FORM APPROVED
Y
N
11/27/2017
CONTINUING REVIEW 3
FORM REVIEWER(S)
ASSIGNED
11/21/2017
CONTINUING REVIEW 3
FORM PANEL
MANAGER REVIEW
11/20/2017
CONTINUING REVIEW 3
FORM PANEL
REASSIGNED

Page 43 of 47
SLU eIRB
43
PROTOCOL
Biomedical Research
Saint Louis University
Protocol # 25138
Farmakis
Protocol Title:
Shear wave sonoelastography for the noninvasive evaluation of hepatic fibrosis in the
pediatric population
----------------------------------------------------------------------------------------------------
11/08/2017
CONTINUING REVIEW 3
FORM SUBMITTED
Y
11/08/2017
CONTINUING REVIEW 3
FORM CREATED
10/11/2017
AMENDMENT 9 FORM
APPROVED
Y
N
10/11/2017
AMENDMENT 9 FORM
REVIEWER(S)
ASSIGNED
10/06/2017
AMENDMENT 9 FORM
RESUBMITTED
Y
10/04/2017
AMENDMENT 9 FORM
RETURNED
10/04/2017
AMENDMENT 9 FORM
PANEL REASSIGNED
10/03/2017
AMENDMENT 9 FORM
SUBMITTED
Y
09/18/2017
AMENDMENT 9 FORM
CREATED
03/03/2017
AMENDMENT 8 FORM
DELETED
03/03/2017
AMENDMENT 8 FORM
CREATED
12/21/2016
CONTINUING REVIEW 2
FORM APPROVED
Y
N
12/09/2016
CONTINUING REVIEW 2
FORM REVIEWER(S)
ASSIGNED
12/09/2016
CONTINUING REVIEW 2
FORM PANEL
MANAGER REVIEW
12/09/2016
CONTINUING REVIEW 2
FORM PANEL
REASSIGNED
12/09/2016
CONTINUING REVIEW 2
FORM RESUBMITTED
Y
12/08/2016
CONTINUING REVIEW 2
FORM RETURNED
12/08/2016
CONTINUING REVIEW 2
FORM PANEL
REASSIGNED
12/08/2016
CONTINUING REVIEW 2
FORM PANEL
MANAGER REVIEW
12/08/2016
CONTINUING REVIEW 2
FORM PANEL
REASSIGNED
12/08/2016
CONTINUING REVIEW 2
FORM SUBMITTED
Y

Page 44 of 47
SLU eIRB
44
PROTOCOL
Biomedical Research
Saint Louis University
Protocol # 25138
Farmakis
Protocol Title:
Shear wave sonoelastography for the noninvasive evaluation of hepatic fibrosis in the
pediatric population
----------------------------------------------------------------------------------------------------
12/08/2016
CONTINUING REVIEW 2
FORM CREATED
07/29/2016
AMENDMENT 7 FORM
APPROVED
Y
N
07/27/2016
AMENDMENT 7 FORM
REVIEWER(S)
ASSIGNED
07/21/2016
AMENDMENT 7 FORM
PANEL REASSIGNED
07/18/2016
AMENDMENT 7 FORM
SUBMITTED
Y
07/18/2016
AMENDMENT 7 FORM
CREATED
06/10/2016
AMENDMENT 6 FORM
APPROVED
Y
Y
05/27/2016
AMENDMENT 6 FORM
REVIEWER(S)
ASSIGNED
05/26/2016
AMENDMENT 6 FORM
PANEL MANAGER
REVIEW
05/19/2016
AMENDMENT 6 FORM
PANEL REASSIGNED
05/11/2016
AMENDMENT 6 FORM
SUBMITTED
Y
05/03/2016
AMENDMENT 6 FORM
CREATED
01/08/2016
AMENDMENT 5 FORM
APPROVED
Y
Y
01/07/2016
AMENDMENT 5 FORM
REVIEWER(S)
ASSIGNED
12/18/2015
AMENDMENT 5 FORM
PANEL REASSIGNED
12/18/2015
REPORT 1 FORM
APPROVED
Y
Y
12/18/2015
AMENDMENT 5 FORM
SUBMITTED
Y
12/18/2015
AMENDMENT 5 FORM
CREATED
12/17/2015
REPORT 1 FORM
REVIEWER(S)
ASSIGNED
12/17/2015
REPORT 1 FORM
PANEL REASSIGNED
12/17/2015
REPORT 1 FORM
SUBMITTED
Y

Page 45 of 47
SLU eIRB
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PROTOCOL
Biomedical Research
Saint Louis University
Protocol # 25138
Farmakis
Protocol Title:
Shear wave sonoelastography for the noninvasive evaluation of hepatic fibrosis in the
pediatric population
----------------------------------------------------------------------------------------------------
12/17/2015
REPORT 1 FORM
CREATED
12/16/2015
CONTINUING REVIEW 1
FORM APPROVED
Y
Y
12/04/2015
CONTINUING REVIEW 1
FORM REVIEWER(S)
ASSIGNED
12/03/2015
CONTINUING REVIEW 1
FORM PANEL
MANAGER REVIEW
11/18/2015
CONTINUING REVIEW 1
FORM PANEL
REASSIGNED
11/09/2015
CONTINUING REVIEW 1
FORM SUBMITTED
Y
11/09/2015
CONTINUING REVIEW 1
FORM CREATED
08/28/2015
AMENDMENT 4 FORM
APPROVED
Y
Y
08/28/2015
AMENDMENT 4 FORM
UNDO APPROVED
08/28/2015
AMENDMENT 4 FORM
APPROVED
Y
Y
08/28/2015
AMENDMENT 4 FORM
REVIEWER(S)
ASSIGNED
08/27/2015
AMENDMENT 4 FORM
RESUBMITTED
Y
08/27/2015
AMENDMENT 4 FORM
RETURNED
08/19/2015
AMENDMENT 4 FORM
SUBMITTED
Y
08/17/2015
AMENDMENT 4 FORM
CREATED
07/01/2015
AMENDMENT 3 FORM
APPROVED
Y
Y
06/30/2015
AMENDMENT 3 FORM
REVIEWER(S)
ASSIGNED
06/26/2015
AMENDMENT 3 FORM
SUBMITTED
Y
06/26/2015
AMENDMENT 3 FORM
CREATED
04/02/2015
AMENDMENT 2 FORM
APPROVED
Y
Y
04/01/2015
AMENDMENT 2 FORM
REVIEWER(S)
ASSIGNED

Page 46 of 47
SLU eIRB
46
PROTOCOL
Biomedical Research
Saint Louis University
Protocol # 25138
Farmakis
Protocol Title:
Shear wave sonoelastography for the noninvasive evaluation of hepatic fibrosis in the
pediatric population
----------------------------------------------------------------------------------------------------
03/31/2015
AMENDMENT 2 FORM
RESUBMITTED
Y
03/31/2015
AMENDMENT 2 FORM
RETURNED
03/27/2015
AMENDMENT 2 FORM
SUBMITTED
Y
03/27/2015
AMENDMENT 2 FORM
CREATED
01/28/2015
AMENDMENT 1 FORM
APPROVED
Y
Y
01/27/2015
AMENDMENT 1 FORM
REVIEWER(S)
ASSIGNED
01/27/2015
AMENDMENT 1 FORM
PANEL REASSIGNED
01/27/2015
AMENDMENT 1 FORM
SUBMITTED
Y
01/27/2015
AMENDMENT 1 FORM
CREATED
01/22/2015
NEW FORM APPROVED
Y
Y
01/21/2015
NEW FORM
REVIEWER(S)
ASSIGNED
01/14/2015
NEW FORM
SUBMITTED (CYCLE 3)
Y
01/08/2015
NEW FORM
CONTINGENT
12/19/2014
NEW FORM
REVIEWER(S)
ASSIGNED
12/17/2014
NEW FORM PANEL
MANAGER REVIEW
12/17/2014
NEW FORM PANEL
REASSIGNED
12/16/2014
NEW FORM
SUBMITTED (CYCLE 2)
Y
12/15/2014
NEW FORM
SUBMITTED (CYCLE 1)
Y
12/08/2014
NEW FORM
CONTINGENT
11/17/2014
NEW FORM
REVIEWER(S)
ASSIGNED
11/14/2014
NEW FORM PANEL
ASSIGNED
11/14/2014
NEW FORM
SUBMITTED
Y

Page 47 of 47
SLU eIRB
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PROTOCOL
Biomedical Research
Saint Louis University
Protocol # 25138
Farmakis
Protocol Title:
Shear wave sonoelastography for the noninvasive evaluation of hepatic fibrosis in the
pediatric population
----------------------------------------------------------------------------------------------------
11/14/2014
NEW FORM
PREREVIEWED
11/14/2014
NEW FORM
PREAPPROVAL
11/14/2014
NEW FORM
PREAPPROVAL
10/21/2014
NEW FORM CREATED