Effect of Knee Pain on Walking Biomechanics
Phase: PHASE4
Conditions: Osteoarthritis, Knee
Sponsor: The Cleveland Clinic

9/2/2025 
Cover Page 
Project Title: Effect of Knee Pain on Walking Biomechanics 
NCT Number: NCT05670236 
 
 

 
PROTOCOL
Biomedical Research
Saint Louis University
Protocol # 32283
 Date Printed: 07/09/2024
Amendment
1
Personnel Information
2
Subject Population
12
Study Location
13
General Checklist
13
Funding
14
Expedited Paragraphs
15
Background, Purpose, Study Procedures
17
Radioisotopes or Radiation Machines
23
Devices
24
Drugs, Reagents, Chemicals, or Biologic Products
25
Other Levels Of Review
25
Subject Population
27
Subject Population
29
Risks
31
Benefits/Alternatives, Procedures to Maintain Confidentiality and Privacy
38
Potential Conflict of Interest
43
Informed Consent
44
Assent
45
HIPAA
46

 
PROTOCOL
Biomedical Research
Saint Louis University
Protocol # 32283
 Date Printed: 07/09/2024
Attachments
48
PI Obligations
51
Event History
52

Page 1 of 56
SLU eIRB
1
PROTOCOL
Biomedical Research
Saint Louis University
Protocol # 32283
Corrigan
------------------------------------------------------------------------------
Protocol Title:
Effect of knee pain on walking biomechanics
Protocol Status:
APPROVED
Date Submitted:
03/05/2024
Approval Period:
03/13/2024-12/20/2024
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.
* * * Amendment * * *
Amendment
 
Complete this form and with it, submit any affected IRB materials needing revision. Please provide the entire
revised documents (not just revised pages). 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.
 
The proposed changes associated with this Amendment are related to personnel only
(members added or removed from the research team). Subjects do not need to be
notified.
You have completed the Amendment form and can now submit the form.
 
1.
Number of accrued subjects
31
 
2.
Status of Study (check one):
X
Continuing to accrue study subjects.
Closed to accrual. Date closed:
 
3.
Special populations (mark as applicable):
Children (<18 years of age)
Prisoner population targeted or study participant became a prisoner
 
4.
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.
Updating healthy participant criteria.
Adding new recruitment strategy.
 
5.
Provide justification/explanation for the proposed changes.
Expanding definition of no pain to exclude only those with a meaningful amount of pain to increase
recruitment feasibility.
Adding another recruitment strategy because recruitment efforts have slowed down and want the project to
be complete in the award period.
 
6.
For sponsor amendments, when did the SLU site receive
X
N/A

Page 2 of 56
SLU eIRB
2
PROTOCOL
Biomedical Research
Saint Louis University
Protocol # 32283
Corrigan
Protocol Title:
Effect of knee pain on walking biomechanics
----------------------------------------------------------------------------------------------------
notification of changes?
 
7.
 Will currently accrued subjects need to be notified of changes?
N
If no, please justify why not.
Both changes only affect recruitment.
 If yes, please explain how AND when notification or re-consenting will occur.
 
8.
 Does the SLU IRB Protocol need to be modified?
Y
9.
 Are consent documents modified?
N
 
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, or other attachments, as
applicable. 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).
 
List of changed sections:
Personnel Information
Subject Population 8(a-g)
Subject Population 8(h-k)
Attachments (16)
---------------------------------------------------------------------------------------------
* * * 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

Page 3 of 56
SLU eIRB
3
PROTOCOL
Biomedical Research
Saint Louis University
Protocol # 32283
Corrigan
Protocol Title:
Effect of knee pain on walking biomechanics
----------------------------------------------------------------------------------------------------
PI must be SLU affiliate.
Name of Principal Investigator
(Faculty, Staff or Student)
Degree (MD/PhD)
Title
Corrigan, Patrick
DPT, PhD
Assistant Professor
Email
Phone
Fax
pcorrigan@slu.edu
314-977-8541
Department Name
 
 
Physical Therapy
 
 
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?*
Dr. Corrigan has been performing human subjects research for approximately 12 years. He has led and been
involved in numerous projects funded by NIH and foundations. He has contemporary training and experience that
spans from project inception to dissemination of findings.
Research Team Member Duties Picklist
1.
X Recruitment
2.
X Obtains consent
3.
X Determine Subject Eligibility for Accrual
4a.
X Subject Physical Examinations
4b.
X 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.
X 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.
X Other (Please insert explanation below.)
 
 
Dissemination of study findings.
UserID
CourseCompletionDate
Course
pcorrigan
08-23-2021
CITI Biomedical Research Basic
Training
pcorrigan
04-07-2022
COI - No further review needed
 
Administrative Contact
Name of Administrative Contact
Degree
Title
Price, Samantha
PT, DPT
PhD Student
Daradkeh, Sharf
MPT
PhD Student
 

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SLU eIRB
4
PROTOCOL
Biomedical Research
Saint Louis University
Protocol # 32283
Corrigan
Protocol Title:
Effect of knee pain on walking biomechanics
----------------------------------------------------------------------------------------------------
Key Personnel (Research Team)
Name of Key Personnel
(Research Team)
Degree
Title
Department Name
Neme, Jamil
MD
Assistant Professor
Family and Community
Medicine
Salsich, Gretchen
PhD, PT
Professor
Physical Therapy
Hanselman, Abby
BS
Graduate Student
Physical Therapy
Edamala, Aaron
Undergraduate Student
Student
Physical Therapy
Fennell, Kaila
BS
Medical Student
Student Affairs-Medical
School
Panjeton, Geoffrey
MD
SLUCare/SSM Faculty
Anesthesiology
Thompson, Megan
Undergraduate Student
Student
Physical Therapy
Moore, Hailey
Undergraduate Student
Student
Physical Therapy
Barnas, Patryk
Undergraduate Student
Student
Physical Therapy
Al-Zoubaidi, Lara
Undergraduate Student
Student
Student Affairs-Medical
School
Faber, Allison
BS
Graduate Student
Biomedical Engineering
Samanta, Justin
BS
Medical Student
Student Affairs-Medical
School
Monteiro, Swapnil
BS
Student
Physical Therapy
Laigo, Alexander Jo
Undergraduate Student
Student
Physical Therapy
Torres, Marisol
Undergraduate Student
Student
Physical Therapy
Haug, Jonathan
Undergraduate Student
Student
Physical Therapy
 
 
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
Sebelski, Chris
DPT, PhD
Associate Professor
Email
Phone
Fax
csebelsk@slu.edu
(314) 977-8724
Department Name
 
 
Physical Therapy
 
 
Is this individual also a member of the research team?
N

Page 5 of 56
SLU eIRB
5
PROTOCOL
Biomedical Research
Saint Louis University
Protocol # 32283
Corrigan
Protocol Title:
Effect of knee pain on walking biomechanics
----------------------------------------------------------------------------------------------------
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.)
 
 
UserID
CourseCompletionDate
Course
csebelsk
08-23-2009
CITI Biomedical Research Basic
Training
csebelsk
04-06-2022
COI - No further review needed
 
Research Team Roles
Name(s), Degree
Department
Experience
Duties
 Corrigan, Patrick, DPT, PhD
Physical Therapy
Dr. Corrigan has been
performing human subjects
research for approximately
12 years. He has led and
been involved in numerous
projects funded by NIH and
foundations. He has
contemporary training and
experience that spans from
project inception to
dissemination of findings.
 Recruitment, Obtains
consent, Determine
Subject Eligibility for
Accrual, Subject Physical
Examinations, Follow-up
Visits including physical
assessments, Perform
study procedures or
Specimen Collection,
Subject Randomization or
Registry, Collection of
Subject Data, Report Data
(CRFs, e-CRFs,
Spreadsheets), Data
Analysis, Review Adverse
Events, Treat and Classify
Adverse Events, Other
(Please insert explanation
below.) Dissemination of
study findings.
 Price, Samantha, PT, DPT
Physical Therapy
Dr. Price is a PhD student
who has been performing
human subjects research for
approximately 6 years. She
Recruitment, Obtains
consent, Determine
Subject Eligibility for
Accrual, Subject Physical

Page 6 of 56
SLU eIRB
6
PROTOCOL
Biomedical Research
Saint Louis University
Protocol # 32283
Corrigan
Protocol Title:
Effect of knee pain on walking biomechanics
----------------------------------------------------------------------------------------------------
has been involved in
numerous studies focusing
on lower extremity
musculoskeletal
biomechanics. Her training
spans from project inception
to dissemination of findings.
Examinations , Follow-up
Visits including physical
assessments, Perform
study procedures or
Specimen Collection,
Collection of Subject
Data, Data Analysis,
Other (Please insert
explanation below.)
Disseminating research
findings
 Daradkeh, Sharf, MPT
Physical Therapy
Sharf Daradkeh is a PhD
student who has been
performing human subject
research for approximately 4
years. He has been involved
in many studies focusing on
orthopedic injuries,
specifically biomechanics
and ACL rehab.
Recruitment, Obtains
consent, Determine
Subject Eligibility for
Accrual, Subject Physical
Examinations , Follow-up
Visits including physical
assessments, Perform
study procedures or
Specimen Collection,
Collection of Subject
Data, Report Data (CRFs,
e-CRFs, Spreadsheets),
Data Analysis, Other
(Please insert explanation
below.) Dissemination of
results
 Neme, Jamil, MD
Family and
Community Medicine
Dr. Neme has been involved
in research for the past 8
years. He has experience
conducting and collaborating
on retrospective and
prospective studies in
pediatric and adult
demographics.
Recruitment, Subject
Physical Examinations ,
Perform study procedures
or Specimen Collection,
Administer and/or
Dispense Study Drugs,
Biologics or Devices
(must be licensed),
Receive, Store,
Manipulate or Account for
Study Drugs, Biologics or
Devices  , Collection of
Subject Data, Review
Adverse Events, Treat
and Classify Adverse
Events
 Al-Zoubaidi, Lara,
Undergraduate Student
Student Affairs-
Medical School
Lara has been an
undergraduate research
assistant in Dr. Corrigan's
lab since February 2023.
Prior to joining the team, she
has no research experience.
Recruitment, Determine
Subject Eligibility for
Accrual, Subject Physical
Examinations , Follow-up
Visits including physical
assessments, Perform
study procedures or
Specimen Collection,
Collection of Subject
Data, Data Analysis,
Other (Please insert
explanation below.) Lara's
primary role on this study
is to assist with data

Page 7 of 56
SLU eIRB
7
PROTOCOL
Biomedical Research
Saint Louis University
Protocol # 32283
Corrigan
Protocol Title:
Effect of knee pain on walking biomechanics
----------------------------------------------------------------------------------------------------
is to assist with data
collection, processing,
and analysis. She may
also be asked to assist
with recruitment and
screening. For all tasks,
she will follow
standardized laboratory
procedures and be
supervised by more
senior lab members.
 Faber, Allison, BS
Biomedical
Engineering
Throughout Alli's
undergraduate and master's
training she has been
involved in research.
Recruitment, Obtains
consent, Determine
Subject Eligibility for
Accrual, Subject Physical
Examinations , Follow-up
Visits including physical
assessments, Perform
study procedures or
Specimen Collection,
Collection of Subject
Data, Data Analysis,
Other (Please insert
explanation below.)
Dissemination of results
 Samanta, Justin, BS
Student Affairs-
Medical School
Justin has been a research
assistant in Dr. Corrigan's
lab since August 2023. Prior
to joining the team, he has
little research experience.
All of Justin's study-related
responsibilities will be
overseen by Dr. Corrigan or
a PhD student. During data
collections, Justin will
directly assist Dr. Corrigan
or a PhD student in
performing study
procedures. For example,
operating computers used to
collect motion and force
data, handing Dr. Corrigan
or a PhD student equipment
or supplies, collecting
height, weight, and blood
pressure measurements.
Throughout data collection,
Justin may also be asked to
write down field notes or
values being measured. For
data analysis, Justin will
follow standard lab
procedures for processing
motion analysis data as well
as ultrasound data. Again,
as a member of our
Recruitment, Obtains
consent, Determine
Subject Eligibility for
Accrual, Subject Physical
Examinations , Follow-up
Visits including physical
assessments, Perform
study procedures or
Specimen Collection,
Collection of Subject
Data, Data Analysis,
Other (Please insert
explanation below.)
Justin's primary role on
this study is to assist with
data collection,
processing, and analysis.
He may also be asked to
assist with recruitment
and screening. For all
tasks, he will follow
standardized laboratory
procedures and be
supervised by more
senior lab members.

Page 8 of 56
SLU eIRB
8
PROTOCOL
Biomedical Research
Saint Louis University
Protocol # 32283
Corrigan
Protocol Title:
Effect of knee pain on walking biomechanics
----------------------------------------------------------------------------------------------------
research team, Justin will
work closely with other
members of the research
team and bring items to be
addressed to team
meetings.
 Monteiro, Swapnil, BS
Physical Therapy
Swapnil has been a
research assistant on Dr.
Corrigan's team since
August 2023. He has no
prior research experience.
Swapnil's primary role on
this study will be calling or
emailing individuals who do
not qualify for the study.
Notifying those who are
screened but do not qualify
is a courtesy service. Drs.
Corrigan and Price will train
and supervise Swapnil
throughout the study.
Recruitment, Determine
Subject Eligibility for
Accrual
 Laigo, Alexander Jo,
Undergraduate Student
Physical Therapy
Alex has been an
undergraduate research
assistant in Dr. Corrigan's
Lab since September 2023.
He has no prior research
experience.
Alex's study-related
responsibilities will be
overseen by Dr. Corrigan or
a PhD student. During data
collections, Alex will directly
assist Dr. Corrigan or a PhD
student in performing study
procedures. For example,
operating computers used to
collect motion and force
data, handing Dr. Corrigan
or a PhD student equipment
or supplies, collecting
height, weight, and blood
pressure measurements.
Throughout data collection,
Alex may also be asked to
write down field notes or
values being measured. For
data analysis, Alex will
follow standard lab
procedures for processing
motion analysis data as well
as ultrasound data. Again,
as a member of our
research team, Alex will
work closely with other
members of the research
Recruitment, Determine
Subject Eligibility for
Accrual, Subject Physical
Examinations , Follow-up
Visits including physical
assessments, Perform
study procedures or
Specimen Collection,
Collection of Subject
Data, Data Analysis,
Other (Please insert
explanation below.) Alex's
primary role on this study
is to assist with data
collection, processing,
and analysis. He may also
be asked to assist with
recruitment and
screening. For all tasks,
he will follow standardized
laboratory procedures and
be supervised by more
senior lab members.

Page 9 of 56
SLU eIRB
9
PROTOCOL
Biomedical Research
Saint Louis University
Protocol # 32283
Corrigan
Protocol Title:
Effect of knee pain on walking biomechanics
----------------------------------------------------------------------------------------------------
team and bring items to be
addressed to team
meetings.
 Torres, Marisol, Undergraduate
Student
Physical Therapy
Marisol has been an
undergraduate research
assistant in Dr. Corrigan's
Lab since September 2023.
She has no prior research
experience.
Marisol's study-related
responsibilities will be
overseen by Dr. Corrigan or
a PhD student. During data
collections, Marisol will
directly assist Dr. Corrigan
or a PhD student in
performing study
procedures. For example,
operating computers used to
collect motion and force
data, handing Dr. Corrigan
or a PhD student equipment
or supplies, collecting
height, weight, and blood
pressure measurements.
Throughout data collection,
Marisol may also be asked
to write down field notes or
values being measured. For
data analysis, Marisol will
follow standard lab
procedures for processing
motion analysis data as well
as ultrasound data. Again,
as a member of our
research team, Marisol will
work closely with other
members of the research
team and bring items to be
addressed to team
meetings.
Recruitment, Determine
Subject Eligibility for
Accrual, Subject Physical
Examinations , Follow-up
Visits including physical
assessments, Perform
study procedures or
Specimen Collection,
Data Analysis, Other
(Please insert explanation
below.) Marisol's primary
role on this study is to
assist with data collection,
processing, and analysis.
She may also be asked to
assist with recruitment
and screening. For all
tasks, she will follow
standardized laboratory
procedures and be
supervised by more
senior lab members.
 Haug, Jonathan, Undergraduate
Student
Physical Therapy
Jonathan has been an
undergraduate research
assistant in Dr. Corrigan's
Lab since October 2023. He
has no prior research
experience.
All of Jonathan's study-
related responsibilities will
be overseen by Dr. Corrigan
or a PhD student. During
data collections, Jonathan
will directly assist Dr.
Corrigan or a PhD student in
performing study
Recruitment, Determine
Subject Eligibility for
Accrual, Subject Physical
Examinations , Perform
study procedures or
Specimen Collection,
Collection of Subject
Data, Data Analysis,
Other (Please insert
explanation below.)
Jonathan's primary role
on this study is to assist
with data collection,
processing, and analysis.
He may also be asked to

Page 10 of 56
SLU eIRB
10
PROTOCOL
Biomedical Research
Saint Louis University
Protocol # 32283
Corrigan
Protocol Title:
Effect of knee pain on walking biomechanics
----------------------------------------------------------------------------------------------------
procedures. For example,
operating computers used to
collect motion and force
data, handing Dr. Corrigan
or a PhD student equipment
or supplies, collecting
height, weight, and blood
pressure measurements.
Throughout data collection,
Jonathan may also be asked
to write down field notes or
values being measured. For
data analysis, Jonathan will
follow standard lab
procedures for processing
motion analysis data as well
as ultrasound data. Again,
as a member of our
research team, Jonathan will
work closely with other
members of the research
team and bring items to be
addressed to team
meetings.
assist with recruitment
and screening. For all
tasks, he will follow
standardized laboratory
procedures and be
supervised by more
senior lab members.
 Salsich, Gretchen, PhD, PT
Physical Therapy
Dr. Salsich has been an
active researcher at SLU for
the past 20+ years. She has
expertise in lower extremity
musculoskeletal
biomechanics and has rich
experiences performing
human-subjects research
projects at SLU with funding
from NIH, foundations, as
well as other sources.
Other (Please insert
explanation below.) Dr.
Salsich serves as a
faculty research mentor to
Dr. Corrigan for the grants
associated with this
project.
 Hanselman, Abby, BS
Physical Therapy
Abby has been a research
assistant in Dr. Corrigan's
lab since January 2022.
During her undergraduate
studies, she completed
coursework related to
research methods and
design.
Recruitment, Determine
Subject Eligibility for
Accrual, Subject Physical
Examinations , Follow-up
Visits including physical
assessments, Perform
study procedures or
Specimen Collection,
Collection of Subject
Data, Data Analysis,
Other (Please insert
explanation below.)
Dissemination of results
 Edamala, Aaron, Undergraduate
Student
Physical Therapy
Aaron has been a research
assistant in Dr. Corrigan's
lab since August 2022. Prior
to joining the team, he had
no research experience.
Recruitment, Determine
Subject Eligibility for
Accrual, Subject Physical
Examinations , Follow-up
Visits including physical
assessments, Perform
study procedures or
Specimen Collection,
Collection of Subject

Page 11 of 56
SLU eIRB
11
PROTOCOL
Biomedical Research
Saint Louis University
Protocol # 32283
Corrigan
Protocol Title:
Effect of knee pain on walking biomechanics
----------------------------------------------------------------------------------------------------
Collection of Subject
Data, Data Analysis,
Other (Please insert
explanation below.)
Aaron's primary role on
this study is to assist with
data collection,
processing, and analysis.
He may also be asked to
assist with recruitment
and screening. For all
tasks, he will follow
standardized laboratory
procedures and be
supervised by more
senior lab members.
 Fennell, Kaila, BS
Student Affairs-
Medical School
Kaila has been a research
assistant in Dr. Corrigan's
lab since February 2023.
Prior to joining the team, she
conducted behavioral
research during her
undergraduate studies.
Perform study procedures
or Specimen Collection,
Collection of Subject
Data, Data Analysis,
Other (Please insert
explanation below.)
Dissemination of results
 Panjeton, Geoffrey, MD
Anesthesiology
Dr. Panjeton is an
anesthesiologist with
particular interests in pain.
He has been involved in
various research projects
throughout his medical
training. His involvement in
the current project
represents a new
collaboration. During data
collections, he will only be
involved with performing
knee injections. Once data
is processed, he will be
involved with analysis and
dissemination.
Administer and/or
Dispense Study Drugs,
Biologics or Devices
(must be licensed),
Receive, Store,
Manipulate or Account for
Study Drugs, Biologics or
Devices  , Data Analysis,
Treat and Classify
Adverse Events, Other
(Please insert explanation
below.) Dissemination of
research findings.
 Thompson, Megan,
Undergraduate Student
Physical Therapy
Megan has been an
undergraduate research
assistant in Dr. Corrigan's
lab since August 2022. Prior
to joining the lab, she had
no research experience.
Recruitment, Determine
Subject Eligibility for
Accrual, Subject Physical
Examinations , Follow-up
Visits including physical
assessments, Perform
study procedures or
Specimen Collection,
Collection of Subject
Data, Data Analysis,
Other (Please insert
explanation below.)
Megan's primary role on
this study is to assist with
data collection,
processing, and analysis.
She may also be asked to
assist with recruitment

Page 12 of 56
SLU eIRB
12
PROTOCOL
Biomedical Research
Saint Louis University
Protocol # 32283
Corrigan
Protocol Title:
Effect of knee pain on walking biomechanics
----------------------------------------------------------------------------------------------------
assist with recruitment
and screening. For all
tasks, she will follow
standardized laboratory
procedures and be
supervised by more
senior lab members.
 Moore, Hailey, Undergraduate
Student
Physical Therapy
Hailey has been an
undergraduate research
assistant in Dr. Corrigan's
lab since January 2023.
Prior to joining the lab, she
has no research experience.
Recruitment, Determine
Subject Eligibility for
Accrual, Subject Physical
Examinations , Follow-up
Visits including physical
assessments, Perform
study procedures or
Specimen Collection,
Collection of Subject
Data, Data Analysis,
Other (Please insert
explanation below.)
Hailey's primary role on
this study is to assist with
data collection,
processing, and analysis.
She may also be asked to
assist with recruitment
and screening. For all
tasks, she will follow
standardized laboratory
procedures and be
supervised by more
senior lab members.
 Barnas, Patryk, Undergraduate
Student
Physical Therapy
Patryk has been an
undergraduate research
assistant in Dr. Corrigan's
lab since January 2023.
Prior to joining the lab, he
has no research experience.
Recruitment, Determine
Subject Eligibility for
Accrual, Subject Physical
Examinations , Follow-up
Visits including physical
assessments, Perform
study procedures or
Specimen Collection,
Collection of Subject
Data, Data Analysis,
Other (Please insert
explanation below.)
Patryk's primary role on
this study is to assist with
data collection,
processing, and analysis.
He may also be asked to
assist with recruitment
and screening. For all
tasks, he will follow
standardized laboratory
procedures and be
supervised by more
senior lab members.
---------------------------------------------------------------------------------------------

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Biomedical Research
Saint Louis University
Protocol # 32283
Corrigan
Protocol Title:
Effect of knee pain on walking biomechanics
----------------------------------------------------------------------------------------------------
* * * Subject Population * * *
 
Subject Population(s) Checklist
 
Select All That Apply :
X
Adults
Cognitively Impaired Subjects
Employees (specifically targeted)
Fetuses
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
X
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)
Cardinal Glennon Children's Medical Center
Saint Louis University Hospital (SSM Health- SLU Hospital)
SLU-SSM Cancer Center Research Alliance Sites
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

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PROTOCOL
Biomedical Research
Saint Louis University
Protocol # 32283
Corrigan
Protocol Title:
Effect of knee pain on walking biomechanics
----------------------------------------------------------------------------------------------------
      
Select All That Apply :
Collection of Specimens
X
Data collection via e-mail or the Internet
Deception/Incomplete Disclosure
Dietary Supplements, Vitamins, and Other Food Agents
X
FDA Approved Device
X
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
X
Investigator Initiated Study     *?HELP?*
Medical Records
X
Photography, Video, or Voice-Recording Subjects
X
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)
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 * * *
 
Funding Checklist
 
NONE
 
Funding - Grants/Contracts
Funding Type
Funded By
Private Agency/Foundation
628
Private Agency/Foundation
628

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Biomedical Research
Saint Louis University
Protocol # 32283
Corrigan
Protocol Title:
Effect of knee pain on walking biomechanics
----------------------------------------------------------------------------------------------------
 
 
 
 
 
  
  
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.
 
 
 
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.

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Biomedical Research
Saint Louis University
Protocol # 32283
Corrigan
Protocol Title:
Effect of knee pain on walking biomechanics
----------------------------------------------------------------------------------------------------
    
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
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.)
 
8.
 [FOR IRB use only]. Continuing review of research previously approved by a convened IRB only
when condition (a), (b), or (c) is met.

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Biomedical Research
Saint Louis University
Protocol # 32283
Corrigan
Protocol Title:
Effect of knee pain on walking biomechanics
----------------------------------------------------------------------------------------------------
 
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.
 
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.
---------------------------------------------------------------------------------------------
* * * Background, Purpose, Study Procedures * * *
Title
Effect of knee pain on walking biomechanics
 
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?*
Osteoarthritis (OA) affects one in eight adults and is a leading cause of disability. Knee OA is
particularly prevalent and accounts for an ~83% of the total burden of OA. In many cases, knee
OA begins as unilateral disease; yet, up to 90% of those with unilateral knee OA develop
bilateral knee OA within 10 years. This is concerning because bilateral KOA is associated with
greater functional decline, worse pain, lower quality of life, and higher healthcare costs. To this
end, a critical need exists to determine why knee OA commonly progresses from a unilateral to
a bilateral disease.
Knee pain may hasten the progression from unilateral to bilateral knee OA if it influences knee
joint loads during walking. Those with unilateral knee OA seem to unload their arthritic knee
while walking. Although unloading the arthritic knee likely relieves pain, it may shift load to the
contralateral knee and increase the risk of bilateral knee OA. However, the speculation that
unilateral knee pain influences contralateral knee joint loads while walking remains largely
unsubstantiated. Because walking is commonly recommended for managing symptoms of knee
OA, it is important to evaluate the effects of unilateral knee pain on contralateral knee loads
during walking. Moreover, since walking mechanics are constantly changing with speed,
gradient, and fatigue, it is critical to capture the effect of pain on loading during different types of

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Biomedical Research
Saint Louis University
Protocol # 32283
Corrigan
Protocol Title:
Effect of knee pain on walking biomechanics
----------------------------------------------------------------------------------------------------
gradient, and fatigue, it is critical to capture the effect of pain on loading during different types of
walking.
Specific Aims as well as Significance Sections for both grants can be reviewed for more
information.
References can be found in the attached bibliography or the grant proposals.
 
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.
Knee osteoarthritis (OA) is a highly prevalent disease that often results in pain and disability.
Emerging evidence shows that nearly every person with OA in one knee will develop OA in
their other knee within 10 years. This progression is concerning because people with OA in
both knees have worse pain, function, and quality of life. The purpose of the current study is to
determine if pain in one knee influences loading of the other knee during different types of
walking (i.e., varying speeds, gradients, and durations). This project is important because it
may lay foundational knowledge that is critical for developing treatments that reduce the
likelihood of knee OA progression.
 
     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).
Aim 1. Evaluate the effects of unilateral knee pain on contralateral patellofemoral (PF) and
tibiofemoral (TF) compartment loads in those with unilateral symptomatic knee OA during
level, inclined, and declined walking at comfortable, fast, and slow speeds.
Hypothesis 1.1. Contralateral PF and TF contact forces will be greater during painful walking
compared to nonpainful walking.
Hypothesis 1.2. The effect of knee pain on PF and TF contact forces will be greater for inclined
and declined walking compared to level walking.
Aim 2. Determine if the presence of unilateral knee pain affects contralateral PF and TF
compartment loads during a prolonged walk in those with unilateral symptomatic knee OA.
Hypothesis 2.1. Cumulative loading of the contralateral PF and TF compartments will be
greater
during a painful 30-minute walk compared to a nonpainful 30-minute walk.
Hypothesis 2.2. Variability of PF and TF contact forces will be greater during a painful 30-
minute walk compared to a nonpainful 30-minute walk.
Aim 3. Describe mechanical changes for the hips, knees, and ankles during prolonged walking
in those with unilateral symptomatic knee OA.
Hypothesis 3.1. Increased in unilateral knee pain will be associated with decreases in (a) knee
work on the painful side, and increases in (b) knee work on the non-painful side, (c) ankle work
on both sides, and (d) hip work on both sides.

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Biomedical Research
Saint Louis University
Protocol # 32283
Corrigan
Protocol Title:
Effect of knee pain on walking biomechanics
----------------------------------------------------------------------------------------------------
 
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.
This biomechanical study will use a repeated measures design to evaluate the effects of
unilateral knee pain on contralateral knee joint loading during different types of walking. Thirty
adults with unilateral symptomatic knee osteoarthritis will complete four, 1.5-hour study visits.
The first and third visits will include level, inclined, and declined walking at comfortable, fast,
and slow speeds. The second and fourth visits will include a 30-minute walk. There will be at
least two days between visits. The only difference between each pair of visits is that one visit
will involve walking with unilateral knee pain (painful walking) and the other visit will involve
walking without unilateral knee pain (nonpainful walking). Individuals will be recruited based on
the presence of unilateral knee pain so the painful walking will be representative of their typical
walking. For the visits with nonpainful walking, the third and fourth visits, pain will be alleviated
by performing an intraarticular injection with a local anesthetic (lidocaine). All walking will be
performed in a three-dimensional motion capture environment on a split-belt treadmill that is
instrumented with force plates.
A cohort of 30 healthy controls will complete the different walking conditions at two, 1.5-hour
study visits. The healthy control group will not receive intraarticular knee injections. The
purpose of this cohort is to better understand how walking mechanics in individuals with
unilateral knee osteoarthritis compare to similar individuals without knee osteoarthritis.
 
  
  
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
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

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Biomedical Research
Saint Louis University
Protocol # 32283
Corrigan
Protocol Title:
Effect of knee pain on walking biomechanics
----------------------------------------------------------------------------------------------------
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).
Potential participants will fill out a screening form in the REDCap Database designated for
screening. This database will be monitored by the research team. If an individual is eligible, a
member of the research team will call or email (based on preference reported on screening
form) to schedule the participant for their first visit. If ineligible, a member of the research team
will call or email the potential participant to notify them that they do not qualify for the study. If
follow-up information is needed to determine eligibility, a member of the research team will call
the potential participant to discuss and clarify any responses on the screening form.
Overview for those with knee osteoarthritis: Participants will be asked to complete four 1.5-hour
visits where they fill out questionnaires and surveys, complete a clinical examination, and walk
on a treadmill for approximately 30 minutes. At the third and fourth visits, participants will
receive a knee injection prior to walking on the treadmill.
Overview for healthy participants: Participants will be asked to complete two 1.5-hour visits
where they fill out questionnaires and surveys, complete a clinical examination, and walk on a
treadmill for approximately 30 minutes.
Questionnaires and surveys: Demographics (age, sex, gender, race, ethnicity, and occupation)
as well as a general and knee-specific medical history will be collected at the first visit. Medical
history will include questions about past orthopedic injuries and any other medical conditions.
Knee-specific medical history will include surveys and questionnaires about knee pain, function,
quality of life, and treatments. In addition to these, participants will also complete
questionnaires about their physical activity and comfort with treadmill walking at the first visit.
The only questionnaires that will be repeated at the other three visits are the ones for assessing
knee pain.
Specific questionnaires included in this study are 1) the Physical Activity and Sedentary
Behavior Questionnaire (PASB-Q), 2) the Visual Analog Scale (for pain and treadmill comfort),
3) the Knee Injury and Osteoarthritis Outcome Score (KOOS) 4) PROMIS Scale – Pain
Intensity 5) PROMIS Scale – Pain Interference 6) Intermittent and Constant Pain Score
(ICOAP) questionnaire. Demographics and medical history questions are not a part of any
particular questionnaire or survey.
Clinical examination: At each visit, participants will be asked to complete a clinical examination.
- Height and body mass will be measured with a stadiometer and digital scale, respectively.
- Blood pressure will be measured with a blood pressure cuff and stethoscope with participant
in seated position.
- Pain sensitivity will be assessed with mechanical algometry at the knee and wrist. This will
involve a researcher slowly applying pressure to the kneecap as well as the wrist with a device
that has a rubber tip on the end. Once pain is perceived, participants will report it and the
researcher will stop applying pressure. Throughout this assessment participants will be sitting
with their knees bent to 90 degrees and feet flat on the floor. When assessing the wrist,
participants will have their arm resting on a treatment table.
- Anatomic structures will be examined with ultrasound imaging. First, ultrasound gel will be
applied to obtain an image. Researchers will then examine structures around your knee joint as
well as structures that play a role in how the knee joint functions (e.g., calf, quadriceps, and
hamstrings musculotendinous structures).
Walking Evaluation:
Speed determination and treadmill familiarization. At the first visit, participants will walk on a
treadmill prior to performing the experimental walking conditions. The purposes of this walk are
to determine a comfortable speed for level, inclined, and declined walking, and to familiarize the
participant to walking on a treadmill. The speed of the treadmill will be set to 0.8 m/s at the
beginning of the walk and modified based on feedback until a comfortable speed is determined.
Familiarization will be completed when the participant feels comfortable and shows no outward

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Biomedical Research
Saint Louis University
Protocol # 32283
Corrigan
Protocol Title:
Effect of knee pain on walking biomechanics
----------------------------------------------------------------------------------------------------
signs of being uncomfortable.
Setup. For each walking evaluation, 59 motion capture markers (small plastic balls) will be
attached to the participant's pelvis, legs, and feet. At the first visit, markers will be placed after
the familiarization walk to provide a 10- to 15-minute break from walking. For the other three
visits, markers will be placed at the beginning of the visit since walking speed and
familiarization will carry over from the first visit.
Once all markers are attached, participants will be asked to stand as still as possible for up to
30 seconds and perform dynamic hip trials. For dynamic hip trials, participants will be asked to
flex, extend, abduct, and circumduct their hip to approximately 20 degrees. After both of these
tasks are quality checked with the motion capture system, 26 markers will be removed, leaving
33 markers for tracking motion during the walking.
Intra-articular knee injections. Once the 26 markers are removed, participants will either begin
the walking on the treadmill (visits 1 and 2) or receive an intraarticular knee injection and then
proceed to walking on the treadmill (visits 3 and 4). If the participant is in the healthy control
group, they will never receive a knee injection. If the participant is in the OA group, they will
receive a knee injection at their third and fourth visits.
For the injections, 10 mL of 1% lidocaine hydrochloride will be put into the arthritic knee using a
lateral approach. All injections will be sterile and ultrasound-guided to ensure safety and proper
placement of drug within the knee joint. Within 5 minutes of the injection, the participant will
experience numbness and likely significant decreases in pain. Dr. Jamil Neme and Dr. Geoffrey
Panjeton, licensed physicians in the School of Medicine at Saint Louis University, will perform
all knee injections and monitor the participant for 15 minutes after the injections.
Walking analysis for those with knee osteoarthritis. At the first and third visits, participants will
be asked to complete level, inclined, and declined walking at comfortable, fast, and slow
speeds in a randomized order. The only difference between the first and third visits is that an
injection of lidocaine hydrochloride will be received during the third visit before walking.  Each
type of walking will be performed for two minutes then immediately followed by two minutes of
rest. For the inclined and declined walking, the treadmill will be set to 8.3% grade (4.8 degrees).
This is the maximum gradient for public and business ramps set by the Americans with
Disabilities Act, and is therefore representative of gradients that individuals with knee
osteoarthritis are exposed to regularly. For the fast and slow walking at each of the gradients,
the speed will be increased or decreased 20% of the comfortable walking speed determined
during the familiarization walk.
In addition to the first and third visits, which involve nine types of walking, participants will walk
for 30-minutes continuously at their second and fourth visits. The only difference between the
two 30-minute walks is that an injection of lidocaine hydrochloride will be received during the
fourth visit before walking. For these walks, participants will walk at their comfortable speed and
0% grade.
During the 30-minute walks individuals will have a functional near-infrared spectroscopy
(fNIRS) cap placed on their head to monitor hemodynamic response in the cortex of the brain.
fNIRS utilizes light-emitting diodes and receptors to measure blood oxygenation in the cerebral
cortex (the outer portion of the brain). This is similar to how a pulse oximeter measures blood
oxygenation in a finger. The overall safety of fNIRS is well established as minimal risk with a
similar risk profile to conventional electroencephalography (EEG).
Pain with walking. For those with knee osteoarthritis, they will be asked to report the severity of
their knee pain on a 0-to-10 scale after each type of walking and for every 5 minutes of walking
during the 30 minute walks.
Walking analysis for healthy participants. Participants will complete the same types of walking
that the participants with knee osteoarthritis complete. In other words, at the first visit

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Biomedical Research
Saint Louis University
Protocol # 32283
Corrigan
Protocol Title:
Effect of knee pain on walking biomechanics
----------------------------------------------------------------------------------------------------
participants will be asked to complete level, inclined, and declined walking at comfortable, fast,
and slow speeds, and at the second visit participants will be asked to walk for 30 consecutive
minutes. During the 30 minute walk fNIRS will be used as described for the knee OA cohort.
Perceived exertion with walking.  All participants will be asked to report their perceived level of
exertion  after each type of walking and for every 5 minutes of walking during the 30 minute
walk.
 
  
  
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.
We will use descriptive statistics (e.g., means, medians, standard deviations, interquartile
ranges) to describe each measurement, including those related to demographics, pain,
structure, and biomechanics (movement and loading). Hypothesis testing will be completed
using between and within group comparisons. Effect sizes, 95% confidence intervals, and
metrics of significance will be calculated and used for interpretation. The smallest unit that will
be reported are group level measures.
 
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
condition/disease/situation being studied.
There are numerous treatments for knee osteoarthritis, but none of them are considered the
standard of care. Usual care for knee osteoarthritis depends on the healthcare team as well as
the stage of disease. In early phases of disease, typical treatments include aerobic exercise,

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Biomedical Research
Saint Louis University
Protocol # 32283
Corrigan
Protocol Title:
Effect of knee pain on walking biomechanics
----------------------------------------------------------------------------------------------------
strengthening, stretching, modalities (e.g., laser therapy, heat/ice, ultrasound, electrical
stimulation, vibration), weight loss programs, walking programs, acupuncture, bracing and
orthotics, and over-the-counter medications and supplements. In middle phases of disease,
these treatments are typically supplemented with prescription medications and injectable
therapies (e.g., platelet rich plasma, hyaluronic acid, corticosteriods). In late phases of disease,
surgical procedures are strongly considered, such as joint realignment or replacement
surgeries.
 
   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).
Y
 
    
  
   
If yes, please describe and include whether there are plans to share findings with study
participants.
This study involves ultrasound imaging of the knee and anatomic structures around the knee.
We expect to see structural changes that are common in individuals with knee osteoarthritis
(e.g., joint space narrowing, calcifications, meniscal extrusion), but there is also a possibility for
incidental findings. Both expected and incidental findings will be shared with participants. If the
sonographer is concerned about any findings on imaging, the research team will ask the
participant to reach out to their doctor for further examination and provide the participant with
the images on a USB flash drive.
 
    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 after the IRB staff has drafted the informed consent radiation exposure
risk statement, or verified the statement that was drafted by the research team (as noted below*).  For more
information on how to submit for radiation safety review, see RSC  instructions or contact the Radiation Safety
Officer at 977-6895.

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Biomedical Research
Saint Louis University
Protocol # 32283
Corrigan
Protocol Title:
Effect of knee pain on walking biomechanics
----------------------------------------------------------------------------------------------------
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.)
 
 
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 appropriate Informed Consent Radiation
Exposure Risk Statement template language must be inserted 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. Per IRB Guidelines, the language will either be drafted by the IRB staff or
drafted by the research team and then verified by IRB staff prior to submission to the RSC for review. 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

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Biomedical Research
Saint Louis University
Protocol # 32283
Corrigan
Protocol Title:
Effect of knee pain on walking biomechanics
----------------------------------------------------------------------------------------------------
Device Name
Manufacturer
Provide IDE #. Documentation
of IDE # required unless
imprinted on sponsor protocol
(attach in section #16).
LOGIQ E10 Ultrasound System
GE Medical Systems Ultrasound
and Primary Care Diagnostics, LLC
---------------------------------------------------------------------------------------------
* * * 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
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).
 
FDA Approved Drugs, Reagents, Chemicals, Biologic Product
Drug Name
Manufacturer
Source (e.g., Pharmacy,
Sponsor, etc.)
Dosage
Lidocaine Hydrochloride
Hospira, Inc.
McKesson Corp.
1%, 10 mg/mL
 
d)
Please list in the space below all dietary supplements, vitamins, minerals, or foods to be administered to
subjects during this study.
 
 
 
---------------------------------------------------------------------------------------------
* * * Other Levels Of Review * * *
7. Other Levels Of Review
 

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PROTOCOL
Biomedical Research
Saint Louis University
Protocol # 32283
Corrigan
Protocol Title:
Effect of knee pain on walking biomechanics
----------------------------------------------------------------------------------------------------
  
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 <a
href=https://www.slu.edu/research/faculty-resources/research-integrity-safety/documents/irb-protocols-
requiring-rsc-review-instructions-for-coordinators.pdf target=_blank > instructions or contact the
Radiation Safety Officer at 977-6895.
X
Not Applicable
Yes, study involves radioactive materials
 
 
  
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
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@ssmhealth.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 SLUH South Campus and the infusion center at the
DOB) and medical record access, requires Research Business Review (RBR) and approval 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 Clinical

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Biomedical Research
Saint Louis University
Protocol # 32283
Corrigan
Protocol Title:
Effect of knee pain on walking biomechanics
----------------------------------------------------------------------------------------------------
complete the SSM RBR form at any time, the form should not be submitted until the IRB and the Clinical
Trials Office (CTO) have approved the study. Please contact the Research Compliance Office at 577-
8113 or sluh-research@ssmhealth.com or the 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.
X
Not Applicable
Yes, study requires RBR review
 
 
6.
&nbsp&nbsp&nbspDoes 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).
Participants must be at least 45 years old to qualify.
 
b)  
Number of evaluable subjects to be accrued at SLU or SLU site (this includes all
sites under the direction of the SLU PI).
60 (30 in Knee OA cohort;
30 in Control cohort)
 

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Biomedical Research
Saint Louis University
Protocol # 32283
Corrigan
Protocol Title:
Effect of knee pain on walking biomechanics
----------------------------------------------------------------------------------------------------
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?*
60
 
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.
N/A, no vulnerable populations will be included in this study.
 
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?*
Minors will not be included because knee OA is rare in minors and because the clinical definition of knee
OA used in this study requires participants to be at least 45 years old.
 
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 (labeled a-c): a) who you are recruiting for this study (e.g., your patients/students/colleagues,
those in existing database or registry, the general public), and b) how you are recruiting (flyers,
advertisements, direct call/mailing, membership networks, in-person recruitment in clinic, classroom, public
locations, etc.). For secondary data analysis or specimen studies, state how you have access to materials.
Importantly: do not contact participants prior to obtaining IRB approval for your study.
c) Also indicate whether or not you plan to obtain personal/private information or biospecimens for the
purpose of screening, recruiting, or determining eligibility of prospective subjects prior to obtaining informed
consent and how (obtained by communicating with prospective subjects or obtained by accessing records
or stored biospecimens). Note: if you are accessing medical records other than those of your own patients
or those in your immediate department, you will need to submit a <a href=
https://www.slu.edu/research/faculty-resources/research-integrity-safety/institutional-review-board-
irb/irb_assets/prep_to_research_form.doc target=_blank>HIPAA Preparatory to Research form and submit
to the SLU Privacy Officer PRIOR to accessing records.
Please refer to the <a href=https://www.slu.edu/research/faculty-resources/research-integrity-
safety/institutional-review-board-irb/irb_assets/guidelines_subject_recruitment.doc target=_blank>SLU IRB
Recruitment Guidelines when designing recruitment strategies and upload recruitment materials to the
Attachments page for IRB review. You are expected to obtain permission for individuals/organizations that
assist with recruitment, and whenever possible, those assisting should share your materials with potential
participants on your behalf rather than providing you with private contact information.
A) Patients as well as individuals from the St. Louis metropolitan area will be recruited for this study.
B) Potential participants will be recruited through advertisements, flyers, press releases, and word-of-
mouth. Advertisements will be broadcasted through social media platforms, including Facebook and
Instagram. Flyers will be distributed to local physician groups, foundations, health and wellness programs,

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Biomedical Research
Saint Louis University
Protocol # 32283
Corrigan
Protocol Title:
Effect of knee pain on walking biomechanics
----------------------------------------------------------------------------------------------------
Instagram. Flyers will be distributed to local physician groups, foundations, health and wellness programs,
fitness centers, community centers, and local businesses. Press releases will be performed by SLU
Marketing and Communication (MarCom) services. Word-of-mouth recruitment will occur through personal
interactions with St. Louis community members. Dr. Corrigan will also ask his physician colleagues to send
out "Dear Patient" letters describing the study.
We will also utilize Washington University's Volunteer for Health (VFH) Recruitment Enhancement
Core (REC) to assist with recruiting participants. This will be limited to posting on their social media
platforms (i.e., Facebook, Instagram, and “X” formally Twitter) and posting to their website.
For all recruitment strategies, potential participants will be directed to fill out the Screening Form on
REDCap as the first point of contact with the research team.
C) Individuals who are interested in participating in the study will fill out the online screening form. This
screening form will be hosted by a database designed in Research Electronic Data Capture (REDCap) - a
secure web-based, HIPAA-compliant and FDA-approved tool for collecting and analyzing data. In addition
to answering questions that determine study eligibility (see inclusion/exclusion criteria), potential
participants will be asked to provide their name, email address, phone number, and mailing address. The
collection of this private information is necessary for bookkeeping, quality assurance, and mailing
compensation to those who participate and opt to receive their payment by mail.  No study-specific code
numbers will appear in this database. Rather, screenings will be auto-numbered in the order they are
received (1,2,3, etc.) then for those who enroll, records will be developed in the 'Master List' and 'Project
Data' REDCap databases.
---------------------------------------------------------------------------------------------
* * * 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 for Knee OA Cohort:
- at least 45 years old
- one knee that elicits at least 3 out of 10 pain with walking
- one knee with stiffness that lasts 0-30 minutes after periods of inactivity
- one knee with pain for at least the past 3 months
* Note -- same knee for items 2-4 above*
Inclusion for Healthy Cohort:
-at least 45 years old
- no lower body pain (greater than 1 out of 10 with walking) or injury within the past 6 months
 
 
  
Identify exclusion criteria.
Exclusions for Both Cohorts:
- history of knee replacement surgery
- opiate use within the past 3 months
- narcotic use within the past 3 months
- known medical condition that affects walking mechanics (besides knee OA for the Knee OA Cohort)
- known medical condition that affects pain perception
- inability to walk for 30 minutes without using an assistive device
- body weight greater than 300 pounds

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Biomedical Research
Saint Louis University
Protocol # 32283
Corrigan
Protocol Title:
Effect of knee pain on walking biomechanics
----------------------------------------------------------------------------------------------------
- known allergy to adhesives
- high risk for a cardiovascular event (modified 2020 PAR-Q+)
-currently pregnant
Additional exclusions for Knee OA Cohort:
- anticoagulant use within the past 3 months
- intraarticular knee injection within the past 3 months
- known history of hypersensitivity to local anesthetics of the amide type
- history of lower body pain or injury, besides knee osteoarthritis, within the past 6 months
- Opposite knee has pain of greater than 1 out of 10 with walking
- Opposite knee has stiffness that lasts more than 30 minutes after periods of inactivity
 
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.
Each participant in the Knee OA Cohort who completes the study will receive $100.00. Each participant in
the Healthy Cohort (i.e., control group without knee OA) who completes the study will receive $50.00.
Participants in the Healthy Cohort receive $50.00 less than those in the Knee OA Cohort because they
complete two fewer visits (i.e., two visits compared to four visits). If participants do not complete the entire
study, they will receive $25.00 for each completed visit. Participants will be paid in the amount owed to
them with a single Amazon.com gift card at the end of their participation. Depending on the participant's
preference, the gift card will either be transferred electronically via email or mailed to them. Regardless of
the method of payment, gift cards will be sent to each participant within 4 weeks of their final visit.
All participants will also receive a parking voucher at each visit. Parking vouchers will allow participants to
park in the visitor parking garage adjacent to the Allied Health Professions Building at no cost to them.
 
j)
Describe who will cover study related costs. Explain any costs that will be charged to the subject.
Participants will not be responsible for any study costs. All research costs will be covered by the Academy
of Orthopaedic Physical Therapy, the Rheumatology Research Foundation, Dr. Corrigan's faculty startup
funds, or the Department of Physical Therapy and Athletic Training.
 
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 time each participant in the Knee OA Cohort may spend on this research study is approximately 6
hours over a 2-week period. (Four 1.5-hour visits with at least 2 days between visits)
The time each participant in the Healthy Cohort  (i.e., control group without knee OA) may spend on this
research study is approximately 3 hours over a 1-week period. (Two 1.5-hour visits with at least 2 days
between visits)
It is expected that all visits will take approximately 1.5 hours, regardless of cohort allocation. In certain
circumstances (e.g., equipment failure/malfunction) visits may last longer. No visit will last longer than 1.5
hours without agreement from the participant.
Anticipated Timeline:
- Subject Recruitment/Data Collections- September 2022-December 2023 (4 participants/month)
- Data Processing- September 2022-December 2023 (for each data collection, processing is expected to
be completed within 1 week)
- Data Analyses- September 2023- January 2024
- Dissemination of Findings- Preliminary findings may be presented at professional conferences starting
Fall of 2022. Peer-reviewed manuscripts will be prepared and submitted for publication within 12 months of
the final data collection.
- Secondary analyses - Deidentified data will be leveraged indefinitely for answering additional research
questions and providing preliminary data in future grant proposals.

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Biomedical Research
Saint Louis University
Protocol # 32283
Corrigan
Protocol Title:
Effect of knee pain on walking biomechanics
----------------------------------------------------------------------------------------------------
 
---------------------------------------------------------------------------------------------
* * * 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.
 
 
 
 
 
    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.
Adverse reactions for Lidocaine hydrochloride are provided below. For more information please see
information and safety documents attached is section 16.
ADVERSE REACTIONS
Systemic
Adverse experiences following the administration of lidocaine HCl are similar in nature to those
observed with other amide local anesthetic agents. These adverse experiences are, in general, dose-
related and may result from high plasma levels caused by excessive dosage, rapid absorption or
inadvertent intravascular injection, or may result from a hypersensitivity, idiosyncrasy or diminished
tolerance on the part of the patient. Serious adverse experiences are generally systemic in nature.
The following types are those most commonly reported:
Central Nervous System
CNS manifestations are excitatory and/or depressant and may be characterized by lightheadedness,
nervousness, apprehension, euphoria, confusion, dizziness, drowsiness, tinnitus, blurred or double
vision, vomiting, sensations of heat, cold or numbness, twitching, tremors, convulsions,
unconsciousness, respiratory depression and arrest. The excitatory manifestations may be very brief
or may not occur at all, in which case the first manifestation of toxicity may be drowsiness merging into
unconsciousness and respiratory arrest.

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Biomedical Research
Saint Louis University
Protocol # 32283
Corrigan
Protocol Title:
Effect of knee pain on walking biomechanics
----------------------------------------------------------------------------------------------------
Drowsiness following the administration of lidocaine HCl is usually an early sign of a high blood level
of the drug and may occur as a consequence of rapid absorption.
Cardiovascular System
Cardiovascular manifestations are usually depressant and are characterized by bradycardia,
hypotension, and cardiovascular collapse, which may lead to cardiac arrest.
Allergic
Allergic reactions are characterized by cutaneous lesions, urticaria, edema or anaphylactoid reactions.
Allergic reactions may occur as a result of sensitivity either to local anesthetic agents or to the
methylparaben used as a preservative in the multiple dose vials. Allergic reactions, including
anaphylactic reactions, may occur as a result of sensitivity to lidocaine, but are infrequent. If allergic
reactions do occur, they should be managed by conventional means. The detection of sensitivity by
skin testing is of doubtful value.
There have been no reports of cross sensitivity between lidocaine hydrochloride and procainamide or
between lidocaine hydrochloride and quinidine.
Neurologic
The incidences of adverse reactions associated with the use of local anesthetics may be related to the
total dose of local anesthetic administered and are also dependent upon the particular drug used, the
route of administration and the physical status of the patient. In a prospective review of 10,440
patients who received lidocaine HCl for spinal anesthesia, the incidences of adverse reactions were
reported to be about 3 percent each for positional headaches, hypotension and backache; 2 percent
for shivering; and less than 1 percent each for peripheral nerve symptoms, nausea, respiratory
inadequacy and double vision. Many of these observations may be related to local anesthetic
techniques, with or without a contribution from the local anesthetic.
In the practice of caudal or lumbar epidural block, occasional unintentional penetration of the
subarachnoid space by the catheter may occur. Subsequent adverse effects may depend partially on
the amount of drug administered subdurally. These may include spinal block of varying magnitude
(including total spinal block), hypotension secondary to spinal block, loss of bladder and bowel control,
and loss of perineal sensation and sexual function. Persistent motor, sensory and/or autonomic
(sphincter control) deficit of some lower spinal segments with slow recovery (several months) or
incomplete recovery have been reported in rare instances when caudal or lumbar epidural block has
been attempted. Backache and headache have also been noted following use of these anesthetic
procedures.
There have been reported cases of permanent injury to extraocular muscles requiring surgical repair
following retrobulbar administration.
Hematologic
Methemoglobinemia.
 
 
 
 
 
    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.
During a diagnostic ultrasound examination, high frequency sound waves penetrate and interact with
tissue in and around the area of anatomy to be imaged. Typical values of Center Frequency and
Transmit Repetition Rate for these sound pulses are, respectively, from 1 to 20 MHz and from 1000 to
30000 pulses per second (1 KHz to 30 KHz).
Only a small portion of the sound energy of each pulse is reflected all the way back to the probe for
use in constructing the image while the remainder is dissipated within the tissue. Although the

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Biomedical Research
Saint Louis University
Protocol # 32283
Corrigan
Protocol Title:
Effect of knee pain on walking biomechanics
----------------------------------------------------------------------------------------------------
generation of biological effects (aka bioeffects) is intentional with therapeutic ultrasound, it is generally
undesired in diagnostic applications and may be harmful in some conditions.
The interaction of sound energy with tissue at sufficiently high levels can produce bioeffects of either a
mechanical or thermal nature. Mechanical bioeffects are primarily related to the pressure amplitude of
individual pulses. Thermal bioeffects are primarily related to absorbed energy, and therefore
contributing factors are the amplitude and length of the pulses, as well as the spatial distribution and
repetition rate of the acoustic pulse stream, and the overall dwell times of the exam.
The American Institute of Ultrasound in Medicine (AIUM) has published the following statement on the
Safety of Research Using Diagnostic Ultrasound: "Diagnostic ultrasound has been in use since the
late 1950s. There are no confirmed adverse biological effects on patients resulting from this use.
Although no hazard has been identified that would preclude the prudent and conservative use of
diagnostic ultrasound in research, experience from normal diagnostic practice may not be relevant to
potential extended exposure times and altered exposure conditions in research. It is therefore
considered appropriate to make the following recommendation: When examinations are carried out for
purposes of research, ultrasound exposures should be as low as reasonably achievable (ALARA)
within the goals of the study. In addition, informed consent, using a form approved by an Institutional
Review board, should be obtained from the patient. Informed consent forms should include information
about the anticipated exposure conditions and how these compare with normal diagnostic practice.
Repetitive and prolonged exposures on a single patient should be justified and consistent with prudent
and conservative use."
 
 
 
 
 
    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).
The following are potential risks associated with participating in this study.
1. Local discomfort, infection, and/or nerve damage during injections (Knee OA Cohort only)
2. Discomfort or lightheadedness from prolonged standing during preparation phase of motion
analysis
3. Slipping or falling while walking on the treadmill
4. Loss of privacy during data collection
5. Increased knee pain (Knee OA Cohort only)
6. Skin irritation when removing motion capture markers (i.e., reflective plastic balls)
7. Soreness and/or stiffness in lower body joints and muscles
8. Loss of confidentiality
9. Side effects and/or adverse reactions to the study drug, lidocaine hydrochloride.
10. Discomfort with the functional near-infrared spectroscopy (fNIRS) cap.
 
 
 
 
 
    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?*
This study is not intended to provide treatment to participants. Furthermore, this study should not
prevent participants from receiving treatments for their condition.

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Biomedical Research
Saint Louis University
Protocol # 32283
Corrigan
Protocol Title:
Effect of knee pain on walking biomechanics
----------------------------------------------------------------------------------------------------
 
 
 
 
 
    8.
Describe any psychological, social, or legal risks the subject may experience.   *?HELP?*
There is a risk of loss of confidentiality.
 
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.
Protection against the potential risks are as follows:
1.  Local discomfort, infection, and/or nerve damage during injections. (Knee OA Cohort only)  Local
discomfort during and immediately following the injections is expected to be minimal and resolve
within 2-3 minutes, similar to receiving a flu shot. Discomfort will be monitored by Dr. Neme for 15
minutes post-injection and then by Dr. Corrigan for the remainder of each visit. Infection is very
uncommon with knee injections. In order to reduce the likelihood of infection, we will use sterile
procedures, which includes using sterile needles and syringes and preparing the skin with an
antiseptic (e.g., betadine). Nerve damage is also possible, yet we will use ultrasound imaging to guide
the injection into the knee joint, making the possibility of nerve damage highly unlikely. If signs or
symptoms of infection or nerve damage occur, the participant will be recommended to seek medical
attention.
2. Discomfort or lightheadedness from prolonged standing during preparation phase of motion
analysis. To minimize this risk, participants will be instructed to occasionally bend their knees and shift
their body weight. If a participant becomes lightheaded, proper medical care will be provided including
lying down and monitoring vital signs. If additional medical care is necessary an ambulance will be
summoned.
3. Slipping or falling while walking on the treadmill. Participants will be educated on the use of the
treadmill prior to walking. Safety will be ensured by gradually increasing the speed of the treadmill and
discussing comfort level. Participants will also wear a fall-safety harness while walking on the treadmill
and be instructed to remain within arms-reach of the hand rail. If a participant slips or falls, study staff
will stop the treadmill immediately, assess the severity of the slip/fall, and determine if other injuries
occurred that require medical attention. First-aid will be provided by study staff as needed. If further
immediate attention is needed,  an ambulance will be summoned. Regardless of the severity, study
staff will follow-up with the participant the following day to ensure appropriate care was received and
to determine next steps in study participation.
4. Loss of privacy during data collection. The research lab is accessible to faculty, staff, and students
within the Department of Physical Therapy and Athletic Training. It is possible that individuals not
directly involved in this study will access the lab during testing. To minimize this risk, signs will be
posted outside the lab requesting privacy during testing.
5. Increased knee pain. (Knee OA Cohort only) It is highly likely that participants in the Knee OA
Cohort will experience fluctuating pain throughout the study, as this is a typical presentation of knee
OA and the protocol is designed to change pain severity. Study staff will closely monitor pain severity
throughout the study. If a participant's pain increases to a point where they request to stop walking,
testing will be stopped immediately and the participant will not perform any remaining physical
tests/procedures. Regardless of pain severity, at the end of each visit, participants will be offered a
bag of ice for short-term pain relief.

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Biomedical Research
Saint Louis University
Protocol # 32283
Corrigan
Protocol Title:
Effect of knee pain on walking biomechanics
----------------------------------------------------------------------------------------------------
6. Skin irritation when removing motion capture markers (i.e., reflective plastic balls). Irritation is
generally caused by minor reactions to adhesive or when leg hair is pulled out with the adhesive. This
process is comparable to removing a band-aid in a hairy location of the body. In Dr. Corrigan's
experience, very few people experience irritation that last longer than a few minutes. If a participant
experiences lasting irritation, study staff will recommend over-the-counter ointments and determine
appropriateness of continued participation.
7. Soreness and/or stiffness in lower body joints and muscles. The study protocol involves walking at
different speeds, gradients, and durations. These different types of walking may be unfamiliar to
participants and cause soreness and/or stiffness throughout the body, particularly after testing has
been completed. This is normal physiologic response to exercise. To reduce the likelihood of
excessive soreness or stiffness, participants will be given 2-minute breaks between the different
walking conditions. Furthermore, there will be a minimum of 2 days between visits so the likelihood of
soreness or stiffness during testing is unlikely. However, if a participant experiences soreness/stiffness
that is disabling and either lasts longer or is more severe than expected, study staff will recommend
they seek medical attention prior to continuing participation in the study.
8. Loss of confidentiality. In order to protect your information, Dr. Corrigan and the research team will
assign you with a subject identifier (unique code), store your personal information (name, date of birth,
phone number, email address, and mail address) separate from study data, and only use secure
means for collecting, analyzing, and storing your data. Furthermore, after 10 years, your personal
information will be destroyed, leaving only de-identified data.
Throughout the study, Research Electronic Data Capture (REDCap) will be used for collecting,
managing, and storing your study record. REDCap is a secure web-based tool that is HIPAA
compliant and FDA approved. Other than REDCap, raw data files from motion capture and ultrasound
imaging will be stored on secure Saint Louis University managed devices with encryption and servers
hosted by Saint Louis University’s Information Technology Services.
9. Side effect to lidocaine hydrochloride. Researchers will be using a drug called Lidocaine
Hydrochloride to numb the participants knee joint. Although it is unclear how often side effects occur, it
is recommended for individuals to seek medical attention if they experience any of the following:
Bluish-colored lips, fingernails, or palms blurred or double vision; chest pain or discomfort; cold,
clammy, or pale skin; confusion; continuing ringing or buzzing or other unexplained noise in the ears;
cough; dark urine; difficulty breathing; difficulty swallowing; dizziness or lightheadedness; dizziness,
faintness, or lightheadedness when getting up suddenly from a lying or sitting position; drowsiness;
fast heartbeat; fever; headache; hearing loss; hives, itching, skin rash; irregular heartbeat; irregular,
fast or slow, or shallow breathing; loss of consciousness; puffiness or swelling of the eyelids or around
the eyes, face, lips, or tongue; rapid or slow heart rate; seizures; slow or irregular heartbeat; sore
throat; sweating; tightness in the chest; tremor; twitching; unusual bleeding or bruising; unusual
tiredness or weakness. There is also the possibility of other side effects. During the study, researchers
will monitor the participants closely for any side effects. If any occur, researchers will help them seek
immediate medical advice and attention.
10. Discomfort with fNIRS cap. The cap is designed to be snug and the diodes can exert some
pressure on the scalp. This improves data quality. The research team will attempt to minimize
discomfort by adjusting diode pressures and measuring head size. Although we expect to be able to
make adjustments to the cap to minimize discomforts, if a participant reports continued discomfort,
fNIRS will not be completed.
Participants may be withdrawn from the research study. Potential reasons for withdrawal include:
1) knee pain worsens to a point where alternative treatment is medically indicated
2) A side effect or medical condition occurs that may place the participant at risk of further
complications
3) Inability to participate as instructed
4) Inability to keep scheduled appointments
5) Cancellation of the research study by sponsor or regulatory agency.

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Biomedical Research
Saint Louis University
Protocol # 32283
Corrigan
Protocol Title:
Effect of knee pain on walking biomechanics
----------------------------------------------------------------------------------------------------
Participant safety will be closely monitored by the study staff throughout the project. Participants will
be advised to contact Dr. Corrigan if they wish to discuss any issues that arise outside of data
collection visits. Dr. Corrigan will follow all protocols and procedures for managing and reporting
unanticipated problems and adverse events.
 
 
 
 
  
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
 
 
 
 
 
          
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.
SAEs are highly unlikely for this research project. All of the research methodologies used in this study
are minimal risk. Furthermore, knee injections with lidocaine hydrochloride are routinely performed in
clinical practice with minimal risk.
 
     
b.
  Is there a Data Safety Monitoring Plan (DSMP)?
Y
 

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Biomedical Research
Saint Louis University
Protocol # 32283
Corrigan
Protocol Title:
Effect of knee pain on walking biomechanics
----------------------------------------------------------------------------------------------------
 
 
 
 
          
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).
a) adverse events and unanticipated problems will be captured during study visits and when a
participant directly contacts either Dr. Corrigan or SLU's IRB. They will be documented by submitting
adverse event and/or unanticipated problem documents in SLU's IRB portal. Additionally, forms will be
de-identified and uploaded into the participants record in the project's REDCap database.
b) As the principal investigator, Dr. Corrigan will be the primary individual responsible for data
monitoring. Dr. Gretchen Salsich, will monitor adverse events and unanticipated problems alongside
Dr. Corrigan. Dr. Salsich is ideal for this role because she is Dr. Corrigan's faculty research mentor
and experienced in conducting biomechanical research at SLU.
c) Drs. Corrigan and Salsich will perform aggregate data review on a monthly basis.
d) SAEs are highly unlikely, but in this situation Drs. Corrigan, Salsich, and Neme will review in real
time.
e) No stopping or halting rules exist. If a SAE occurs, Dr. Corrigan will work with Dr. Salsich, Dr.
Neme, and the SLU IRB to generate stopping and halting rules.
 
 
 
 
 
          
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.
 
&nbsp&nbsp&nbsp&nbsp&nbsp&nbsp&nbsp&nbsp&nbsp&nbspNOTE: Export control laws include the transfer of
technical information and data, as well as information
&nbsp&nbsp&nbsp&nbsp&nbsp&nbsp&nbsp&nbsp&nbsp&nbspand technology to foreign nationals. If this study
has international components, contact the  SLU Export
&nbsp&nbsp&nbsp&nbsp&nbsp&nbsp&nbsp&nbsp&nbsp&nbspControl Officer for direction on whether export
control policies apply.

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Biomedical Research
Saint Louis University
Protocol # 32283
Corrigan
Protocol Title:
Effect of knee pain on walking biomechanics
----------------------------------------------------------------------------------------------------
 
---------------------------------------------------------------------------------------------
* * * 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.
Participants may not benefit from participating in this research study. Participants' condition may get better,
stay the same, or worsen.
Even though participants may not benefit from participating in this study, findings from the current study
are likely to inform future research that leads to improved outcomes for persons with knee OA.
 
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.
The alternative to participation is nonparticipation. No other treatments or procedures will be offered to
individuals who chose not to participate.
 
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.
 
 

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Biomedical Research
Saint Louis University
Protocol # 32283
Corrigan
Protocol Title:
Effect of knee pain on walking biomechanics
----------------------------------------------------------------------------------------------------
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).
 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
Study IRB-approved Prior to New Question (Question N/A- Grandfathered)
 
Electronic Data

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Biomedical Research
Saint Louis University
Protocol # 32283
Corrigan
Protocol Title:
Effect of knee pain on walking biomechanics
----------------------------------------------------------------------------------------------------
Type of Data
Storage Location
Data Transmission
Outside of SLU
Supplemental information
related to above items
can be entered here or
leave blank:
Coded
SLU ITS managed device
(computer, tablet, etc.)
with encryption; SLU ITS
network storage (T: drive
(shared drive), U: drive
(personal drive));
Collection or Storage of
data in SLU REDCap
Not Applicable, I will not
be sending/sharing
electronic data outside of
SLU
The master list REDCap
database will be coded,
including only the code
number and the
screening number.
Survey/Questionnaire
data will be collected
directly in the project's
REDCap database.
Motion capture data files
will be collected on SLU
ITS managed devices
with encryption, then
backed up on ITS
networks (T and/or U
drives). After determined
from motion capture data
files, measures will be
recorded and in the
project's REDCap
database.
Ultrasound data will be
collected with the
ultrasound scanner. At
the end of each visit,
ultrasound data will be
transferred to a SLU ITS
managed device with
encryption and backed up
on ITS networks (T
and/or U drives). After
imaging processing,
measures will be recoded
in the project's REDCap
database.
Identifiable
Collection or Storage of
data in SLU REDCap
Not Applicable, I will not
be sending/sharing
electronic data outside of
SLU
The screening REDCap
database will include
questions for determining
eligibility as well as name,
phone number and/or
email, and mailing
address.
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).

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Biomedical Research
Saint Louis University
Protocol # 32283
Corrigan
Protocol Title:
Effect of knee pain on walking biomechanics
----------------------------------------------------------------------------------------------------
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
Study IRB-approved Prior to New Question (Question N/A- Grandfathered)
 
Hardcopy Data
Type of Data
Storage Location
Transported Data
Security
Supplemental information
related to above items
can be entered here or
leave blank:
Identifiable
SLU Locked Cabinet;
SLU Locked Room/Office
N/A
Consent forms will be the
only hardcopy documents
for the study.
 
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.
This study will use three separate REDCap databases. One will be a screening database, which includes a
screening number (145), subject identifiers (name, phone, email, mailing address), and questions for
screening (see attached screening form). The second will be a project database, which includes the code
number (e.g., KP05), and the participants data. The third will be a master list database, which will simply
pair the screening and code numbers (i.e., Data for KP05 is from Screen 145). In this way, subject
identifiers are never connected with the code number and data, and all three database would be required
to decipher an individuals data. Three years after the study is completed, the master list database will be
destroyed, effectively removing the link between participant identities and study data. As for the screening
database, individual records will be destroyed three years after the study is completed for all entries except
those who enrolled and consented to be contacted for future research.
 
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.
De-identified data will be shared with the following personnel:
David Felson: Boston University School of Medicine
Tuhina Neogi: Boston University School of Medicine
Cara Lewis: Boston University
Michael LaValley: Boston University
Irene Davis: Harvard University
Joshua Stefanik; Northeastern University
 
 

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Biomedical Research
Saint Louis University
Protocol # 32283
Corrigan
Protocol Title:
Effect of knee pain on walking biomechanics
----------------------------------------------------------------------------------------------------
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
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?).
The internet will be used by potential participants who fill out the REDCap screening form. Additionally,
during data collection visits, a member of the research team will use the internet to login to their REDCap
account, access the appropriate project and record, then the participant will answer questionnaires/surveys
directly into their own record. Loss of confidentiality or anonymity is unlikely by using SLU's secure
REDCap database only.
 
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.).
Photos and/or videos of study tasks and procedures will be obtained for educational and dissemination
purposes. Photos and videos will only be obtained from participants who consent. No videos or photos will
include the participant's face. If the participant has unique body markings, photos and/or videos will not be
taken. All video and photos will be stored without code or screening numbers to maintain confidentiality
and privacy. Additionally, all videos and photos will be stored on secure SLU ITS Servers (T and/or U
Drives).
 
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):

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Biomedical Research
Saint Louis University
Protocol # 32283
Corrigan
Protocol Title:
Effect of knee pain on walking biomechanics
----------------------------------------------------------------------------------------------------
 
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
 
X
Use of drapes or other privacy measures
 
X
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)
 
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

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Biomedical Research
Saint Louis University
Protocol # 32283
Corrigan
Protocol Title:
Effect of knee pain on walking biomechanics
----------------------------------------------------------------------------------------------------
         
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.
            
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

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Biomedical Research
Saint Louis University
Protocol # 32283
Corrigan
Protocol Title:
Effect of knee pain on walking biomechanics
----------------------------------------------------------------------------------------------------
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).
The consenting process will be completed by Dr. Corrigan or a member of the research team at the
potential participant's first visit in a semi-private office located within the private lab space. As part of
this process, Dr. Corrigan or a member of the research team will re-screen the potential participant
to ensure eligibility, go through the entire consent form, and answer any questions. After Dr.
Corrigan or a member of the research team has fielded their questions, the potential participant
decides whether or not they will participate. If the potential participant decides to participate in the
study, they will be asked to sign the consent form. A signed copy of the consent form will be
provided to the participant. If the potential participant decides not to participate in the study, they will
not sign the consent form or complete any study procedures.
 
  
  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.
N/A
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_Informed Consent --
Version 5 -- Clean
Consent
03/01/2023
Approved_CR2023_Informed
Consent_v5_clean
Consent
12/19/2023
---------------------------------------------------------------------------------------------
* * * Assent * * *
14. Assent
     
Complete this section if your study includes minors. The Assent Form Templates (For
children and For adolescents) provide guidelines for writing the assent document.
 

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PROTOCOL
Biomedical Research
Saint Louis University
Protocol # 32283
Corrigan
Protocol Title:
Effect of knee pain on walking biomechanics
----------------------------------------------------------------------------------------------------
     
 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.
 
     
 2.
If minors are asked to assent and do not wish to participate, will they still be accrued in the study? If
yes, justify.
 
     
 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.
 
  
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.
 
---------------------------------------------------------------------------------------------
* * * 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 refer to the SLU IRB
HIPAA Guidance.
 
    1. Will health information be accessed, received or collected?
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)
X
At least one direct identifier will be received or collected/recorded.
X
Names

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PROTOCOL
Biomedical Research
Saint Louis University
Protocol # 32283
Corrigan
Protocol Title:
Effect of knee pain on walking biomechanics
----------------------------------------------------------------------------------------------------
Social Security numbers
X
Telephone numbers
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)
X
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
X
Electronic mail addresses
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.
 
    3. Sources of Protected Health Information:
Hospital/medical records for in or out patients
Physician/clinic records
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

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PROTOCOL
Biomedical Research
Saint Louis University
Protocol # 32283
Corrigan
Protocol Title:
Effect of knee pain on walking biomechanics
----------------------------------------------------------------------------------------------------
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_HIPAA Authorization
Form - Version 2 - Clean
03/03/2022
---------------------------------------------------------------------------------------------
* * * Attachments * * *
16. Attachments
In this section, please upload additional documents associated with your protocol. Failure to attach files
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

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PROTOCOL
Biomedical Research
Saint Louis University
Protocol # 32283
Corrigan
Protocol Title:
Effect of knee pain on walking biomechanics
----------------------------------------------------------------------------------------------------
 •
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
Grant Proposal/Sub-
Contract
AOPT Funded Grant
Proposal
12/06/2021
12/07/2021
Grant Proposal/Sub-
Contract
RRF Funded Grant
Proposal
12/06/2021
12/07/2021
Package Insert
Lidocaine Package Slip
12/07/2021
12/09/2021
Human Subjects Training
Certificate/Proof of
Training
Patrick Corrigan CITI
Training Certificate
12/07/2021
12/09/2021
Bibliography
Bibliography
12/08/2021
12/09/2021
Device
Information/Documentatio
n
User Manual for
Ultrasound Scanner
12/08/2021
12/09/2021
Safety Information (DSM
Information)
Safety Information for
Lidocaine HCl
12/08/2021
12/09/2021
Scientific/PPC Review or
Department Chair Review
Scientific Pre-Review
Form
12/09/2021
12/09/2021
Human Subjects Training
Certificate/Proof of
Training
Patrick Corrigan CITI
Completion Report
12/09/2021
12/09/2021
Device
Information/Documentatio
n
K211488
01/26/2022
02/15/2022
Grant Proposal/Sub-
Contract
AOPT Approved Deferral
and Change of Institution
02/15/2022
02/15/2022
Grant Proposal/Sub-
Contract
AOPT Grant Agreement
02/15/2022
02/15/2022
Grant Proposal/Sub-
Contract
AOPT NOA
02/15/2022
02/15/2022

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SLU eIRB
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Biomedical Research
Saint Louis University
Protocol # 32283
Corrigan
Protocol Title:
Effect of knee pain on walking biomechanics
----------------------------------------------------------------------------------------------------
Grant Proposal/Sub-
Contract
RRF Approved Change of
Institution
02/15/2022
02/15/2022
Grant Proposal/Sub-
Contract
RRF Approved Deferral
02/15/2022
02/15/2022
Grant Proposal/Sub-
Contract
RRF Deferral Approval
02/15/2022
02/15/2022
Grant Proposal/Sub-
Contract
RRF NOA
02/15/2022
02/15/2022
Questionnaire/Survey
Approved_Study
Questionnaires
03/03/2022
03/03/2022
Questionnaire/Survey
Approved_Demographics
Form
03/03/2022
03/03/2022
Recruitment Material
(e.g., flyers, ads, e-mail
text)
Approved_Recruitment
Conversation/Statement
03/03/2022
03/03/2022
Recruitment Material
(e.g., flyers, ads, e-mail
text)
Approved_ScreeningFor
m
03/03/2022
03/03/2022
Human Subjects Training
Certificate/Proof of
Training
Aaron CITI training
certificate
08/31/2022
09/02/2022
Questionnaire/Survey
Approved_Demographics
_EffectOfKneePainO
10/21/2022
10/21/2022
Questionnaire/Survey
Approved_GeneralMedica
lHistory_EffectOf
10/21/2022
10/21/2022
Questionnaire/Survey
Approved_KneeSpecificS
urvey_EffectOfKnee
10/21/2022
10/21/2022
Questionnaire/Survey
Approved_LeftKoos_Effec
tOfKneePainOnWal
10/21/2022
10/21/2022
Questionnaire/Survey
Approved_PASBQ_Effect
OfKneePainOnWalkin
10/21/2022
10/21/2022
Questionnaire/Survey
Approved_PreviousMusc
uloskeletalInjurie
10/21/2022
10/21/2022
Questionnaire/Survey
Approved_RightKoos_Eff
ectOfKneePainOnWa
10/21/2022
10/21/2022
Questionnaire/Survey
Approved_Screening form 10/21/2022
10/21/2022
Questionnaire/Survey
Approved_Study
Description screening
instructions
10/21/2022
10/21/2022
Questionnaire/Survey
Approved_TreadmillComf
ort_EffectOfKneeP
10/21/2022
10/21/2022
Questionnaire/Survey
Approved_VasScale_Effe
ctOfKneePainOnWal
10/21/2022
10/21/2022
Recruitment Material
(e.g., flyers, ads, e-mail
text)
Approved_Facebook_Ad
10/21/2022
10/21/2022
Recruitment Material
(e.g., flyers, ads, e-mail
text)
Approved_Injection Study
Flyer - final
10/21/2022
10/21/2022

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SLU eIRB
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PROTOCOL
Biomedical Research
Saint Louis University
Protocol # 32283
Corrigan
Protocol Title:
Effect of knee pain on walking biomechanics
----------------------------------------------------------------------------------------------------
Human Subjects Training
Certificate/Proof of
Training
Kaila Fennell Citi Training
Certificate
01/20/2023
02/08/2023
Package Insert
fNIRS Package Insert
02/25/2023
02/25/2023
Questionnaire/Survey
Approved_ICOAPQuestio
nnaire_EffectOfKne
03/01/2023
03/01/2023
Questionnaire/Survey
Approved_PROMISScale
V10PainIntensity3a_
03/01/2023
03/01/2023
Questionnaire/Survey
Approved_PROMISSFV1
0PainInterference6b_
03/01/2023
03/01/2023
Recruitment Material
(e.g., flyers, ads, e-mail
text)
Approved_Dear patient
letter_PC
03/01/2023
03/01/2023
Human Subjects Training
Certificate/Proof of
Training
Megan_CITI_Cert
04/25/2023
04/25/2023
Human Subjects Training
Certificate/Proof of
Training
Lara_CITI_Cert
04/25/2023
04/25/2023
Human Subjects Training
Certificate/Proof of
Training
Patryk _CITI_Cert
04/25/2023
04/25/2023
Human Subjects Training
Certificate/Proof of
Training
Hailey_CITI_Cert
04/25/2023
04/25/2023
Recruitment Material
(e.g., flyers, ads, e-mail
text)
Approved_HealthyParticip
ant_Flyer
05/03/2023
05/03/2023
Recruitment Material
(e.g., flyers, ads, e-mail
text)
Approved_32283_Press_
Release
07/05/2023
07/05/2023
Safety Information (DSM
Information)
Data Safety Monitoring
Report
12/13/2023
12/13/2023
Human Subjects Training
Certificate/Proof of
Training
Sharf_CITI_Cert
01/23/2024
03/05/2024
---------------------------------------------------------------------------------------------
* * * 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.

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PROTOCOL
Biomedical Research
Saint Louis University
Protocol # 32283
Corrigan
Protocol Title:
Effect of knee pain on walking biomechanics
----------------------------------------------------------------------------------------------------
 
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.
 
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

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PROTOCOL
Biomedical Research
Saint Louis University
Protocol # 32283
Corrigan
Protocol Title:
Effect of knee pain on walking biomechanics
----------------------------------------------------------------------------------------------------
Date
Status
View Attachments
Letters
04/29/2024
REPORT 1 FORM
APPROVED
Y
Y
04/22/2024
REPORT 1 FORM
REVIEWER(S)
ASSIGNED
04/22/2024
REPORT 1 FORM
REVIEWER(S)
ASSIGNED
04/11/2024
REPORT 1 FORM
SUBMITTED
Y
04/09/2024
REPORT 1 FORM
CREATED
03/21/2024
AMENDMENT 7 FORM
APPROVED
Y
Y
03/13/2024
AMENDMENT 7 FORM
REVIEWER(S)
ASSIGNED
03/12/2024
AMENDMENT 7 FORM
PANEL REASSIGNED
03/12/2024
AMENDMENT 7 FORM
PANEL MANAGER
REVIEW
03/12/2024
AMENDMENT 7 FORM
PANEL REASSIGNED
03/05/2024
AMENDMENT 7 FORM
SUBMITTED
Y
01/18/2024
AMENDMENT 7 FORM
CREATED
12/19/2023
CONTINUING REVIEW 2
FORM APPROVED
Y
Y
12/11/2023
CONTINUING REVIEW 2
FORM SUBMITTED
(CYCLE 1)
Y
11/27/2023
CONTINUING REVIEW 2
FORM REVIEWER(S)
ASSIGNED
11/27/2023
CONTINUING REVIEW 2
FORM PANEL
MANAGER REVIEW
11/27/2023
CONTINUING REVIEW 2
FORM PANEL
REASSIGNED
11/24/2023
CONTINUING REVIEW 2
FORM SUBMITTED
Y
11/18/2023
CONTINUING REVIEW 2
FORM CREATED
11/15/2023
AMENDMENT 6 FORM
APPROVED
Y
Y

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Biomedical Research
Saint Louis University
Protocol # 32283
Corrigan
Protocol Title:
Effect of knee pain on walking biomechanics
----------------------------------------------------------------------------------------------------
11/15/2023
AMENDMENT 6 FORM
REVIEWER(S)
ASSIGNED
11/13/2023
AMENDMENT 6 FORM
SUBMITTED (CYCLE 1)
Y
10/26/2023
AMENDMENT 6 FORM
PANEL MANAGER
REVIEW
10/25/2023
AMENDMENT 6 FORM
SUBMITTED
Y
08/29/2023
AMENDMENT 6 FORM
CREATED
07/05/2023
AMENDMENT 5 FORM
APPROVED
Y
Y
06/30/2023
AMENDMENT 5 FORM
REVIEWER(S)
ASSIGNED
06/30/2023
AMENDMENT 5 FORM
SUBMITTED
Y
06/30/2023
AMENDMENT 5 FORM
CREATED
05/03/2023
AMENDMENT 4 FORM
APPROVED
Y
Y
05/01/2023
AMENDMENT 4 FORM
REVIEWER(S)
ASSIGNED
05/01/2023
AMENDMENT 4 FORM
PANEL REASSIGNED
04/25/2023
AMENDMENT 4 FORM
SUBMITTED
Y
04/24/2023
AMENDMENT 4 FORM
CREATED
03/01/2023
AMENDMENT 3 FORM
APPROVED
Y
Y
02/25/2023
AMENDMENT 3 FORM
SUBMITTED (CYCLE 1)
Y
02/14/2023
AMENDMENT 3 FORM
REVIEWER(S)
ASSIGNED
02/14/2023
AMENDMENT 3 FORM
PANEL REASSIGNED
02/08/2023
AMENDMENT 3 FORM
SUBMITTED
Y
12/06/2022
AMENDMENT 3 FORM
CREATED
11/30/2022
CONTINUING REVIEW 1
FORM APPROVED
Y
Y

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Biomedical Research
Saint Louis University
Protocol # 32283
Corrigan
Protocol Title:
Effect of knee pain on walking biomechanics
----------------------------------------------------------------------------------------------------
11/29/2022
CONTINUING REVIEW 1
FORM REVIEWER(S)
ASSIGNED
11/29/2022
CONTINUING REVIEW 1
FORM PANEL
REASSIGNED
11/29/2022
CONTINUING REVIEW 1
FORM SUBMITTED
Y
11/23/2022
CONTINUING REVIEW 1
FORM CREATED
11/21/2022
AMENDMENT 2 FORM
APPROVED
Y
Y
11/07/2022
AMENDMENT 2 FORM
REVIEWER(S)
ASSIGNED
11/04/2022
AMENDMENT 2 FORM
PANEL REASSIGNED
11/04/2022
AMENDMENT 2 FORM
PANEL REASSIGNED
11/03/2022
AMENDMENT 2 FORM
SUBMITTED
Y
11/02/2022
AMENDMENT 2 FORM
CREATED
10/21/2022
AMENDMENT 1 FORM
APPROVED
Y
Y
10/21/2022
AMENDMENT 1 FORM
REVIEWER(S)
ASSIGNED
10/10/2022
AMENDMENT 1 FORM
SUBMITTED (CYCLE 1)
Y
10/06/2022
AMENDMENT 1 FORM
CONTINGENT
09/27/2022
AMENDMENT 1 FORM
REVIEWER(S)
ASSIGNED
09/26/2022
AMENDMENT 1 FORM
PANEL REASSIGNED
09/02/2022
AMENDMENT 1 FORM
SUBMITTED
Y
08/16/2022
AMENDMENT 1 FORM
CREATED
03/03/2022
NEW FORM APPROVED
Y
Y
03/02/2022
NEW FORM
REVIEWER(S)
ASSIGNED
02/15/2022
NEW FORM
SUBMITTED (CYCLE 1)
Y
12/22/2021
NEW FORM
CONTINGENT

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PROTOCOL
Biomedical Research
Saint Louis University
Protocol # 32283
Corrigan
Protocol Title:
Effect of knee pain on walking biomechanics
----------------------------------------------------------------------------------------------------
12/13/2021
NEW FORM
REVIEWER(S)
ASSIGNED
12/13/2021
NEW FORM PANEL
MANAGER REVIEW
12/09/2021
NEW FORM PANEL
ASSIGNED
12/09/2021
NEW FORM
RESUBMITTED
Y
12/07/2021
NEW FORM RETURNED
12/07/2021
NEW FORM
SUBMITTED
Y
12/07/2021
NEW FORM
PREREVIEWED
12/06/2021
NEW FORM
PREAPPROVAL
10/05/2021
NEW FORM CREATED