Institutional Review Board

Use this form for proposing non-exempt research that involves human subjects. This form is a stand-alone
document, but you will need an internet connection in order to access supplemental forms from IRBNet and guidance
documents from a CMU IRB page. In addition, the form contains links to short Guidance statements at the end of the
document.

Always download the most recent version from IRBNet Library.

Please send reports of errors and problems and suggestions for improvement to cmuirb@cmich.edu

Application to Conduct Research Involving Human Subjects

Investigators
Title of Project Reliability and validity of functional vestibular assessments
Principal Investigator Jennifer K Sansom
Must be faculty member
Department Physical Therapy
College Health Professions
Mailing Address 1242 HPB
Phone 9897744366 E-mail sanso1jk@cmich.edu
Additional members of research team. Provide contact information for all other members of the research team
and Indicate whether they are faculty collaborators, postdoctoral fellows, or students supervised by the Principal
Investigator for an honors project, capstone project, thesis, or dissertation.
Lomond, Karen: role: Co-Prinicipal Investigator; department: Health Sciences; mailing address: 1179
HPB; phone: 9897742687; contact: lomon2k@cmich.edu
Balendra, Nilanthy, MEng: Research Lab Engineer, assist with research team training for equipment use,
participant recruitment, data collections, data analysis and reduction, results dissemination; contact:
balen1n@cmich.edu
Burkhardt, Zachary: Undergraduate student, responsibility= assist with recruitment, data collections, data
analysis & reduction, results dissemination; contact: burkh1zd@cmich.edu
Perez, Perla: Graduate DPT student, responsibility= assist with recruitment, data collections, data
analysis & reduction, results dissemination; contact: perez1pc@cmich.edu
Roberts, Alexandria: Graduate DPT student, responsibility= assist with recruitment, data collections, data
analysis & reduction, results dissemination; contact: rober5ad@cmich.edu
CITI training for members of the research team. All members of the research team must complete CITI training
(www.citiprogram.org). If you have questions about CITI training, visit cmich.edu/irb

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Abstract
Provide an abstract of the proposed research or teaching in language that can be understood by a non-scientist.
The abstract should summarize the objectives of this project and the procedures to be used, with an emphasis on
what will happen to research subjects. (Maximum 250 words for sections A-D combined)
Objective, Aim, or Purpose
The purpose of this project is to determine the test-retest reliability and construct validity of two
commonly used, functional assessments for vestibular function, Dynamic Visual Acuity (DVA) and Gaze
Stabilization Test (GST), in standing relative to performance when sitting.
Background
Falls are one of the most common causes of injury, often due to an underlying vestibular impairment.
Current objective assessment protocols require testing to be performed in a seated position. However,
falls typically occur from a standing position.
Significance
These results will determine test-retest reliability for DVA and GST in sitting and standing as well as
construct validity for assessment of vestibular function in standing.
Methods
We will test 25 young adults, 18-35 years old with no history of vestibular pathology. Participants will be
tested 3 times; testing sessions will occur within 7 days of each other. At each testing session, testing
protocols for the Sensory Organization Test, Head-Shake Sensory Organization Test, Static Visual
Acuity, Perception Time, DVA and GST using a Neurocom Balance Manager will be performed.
Additionally, cervical range of motion in the 3 cardinal planes, visual acuity testing using a Snellen chart,
and 3 overground walking trials will be performed.

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Supplemental information. The form fields in the following sections (shown as ) will expand to
accommodate responses. You may upload separate documents if you feel additional information about risks,
methodology, or literature references, would assist reviewers in evaluating your application. Uploaded responses
should be keyed to specific questions in the following sections.

Criterion 1. Risks are Minimized

Research Procedures
a. Rationale and study design.
RATIONALE
Falls are one of the most common causes of injury in people 65 and older. Greater than
one-third of individuals in this population fall each year 1 with 30% of them experiencing a
subsequent injury related to the fall (Berry and Miller, 2008; Tinetti and Kumar, 2010). Most falls
occur due to a slip/trip, loss of balance, and/or an episode of vertigo/dizziness (Pi, Hu, Zhang, et
al., 2015). In addition to injuries, there is a significant increase in death rates in the elderly who
experience falls (CDC, 2016). The costs associated with treating injuries resulting from falls has
increased from $20 billion in 2006 to approximately $34 billion in 2013 (Stevens, Corso,
Finkelstein et al., 2006).
The ability to maintain one’s postural control during upright, dynamic activities, such as walking, is
critically important for the prevention of falls. During normal walking, a small amount of head
movement accompanies displacement of the body vertically, laterally, and rotationally. In order to
keep gaze stabilized, compensatory eye movements (vestibulo-ocular reflex) occur in response to
movements of the head (Cromwell, Newton, & Carlton, 2001; Cromwell, Aadland-Monahan,
Nelson, et al., 2001). These compensatory eye movements are one of the key reasons people
are able to maintain upright postural control while standing in one place and when moving
dynamically through the environment.

Current practice for Assessment of the Vestibulo-occular Reflex in Sitting

Current practice for objective assessment of the vestibular ocular reflex (VOR) is
performed in the static sitting posture (Goebel, Tungsiripat, Sinks, et al., 2007; Herdman Tusa,
Blatt, et al., 1998; Schubert, Herdman, and Tusa, 2002). While testing in sitting promotes postural
control and isolates movement to the head during testing (i.e., reducing the number of degrees of
freedom for movement), most falls occur from a standing posture and during dynamic movement.
The standing position affords more opportunities to use small, compensatory body movements to
maintain control and prevent falling (Marigold and Patla, 2002). Therefore, determining VOR
function in standing using accepted assessment tests and determination of reliability and validity
for these assessments compared to sitting is necessary in order to gain a better understanding of
VOR function while in the standing posture.
Falls occur in standing and often during dynamic activities
The ability to maintain postural control is dependent on the capacity for effective
integration of information from 3 sensory systems: visual, vestibular, and somatosensory. In
healthy people, the central nervous system dynamically adapts to changing conditions by
selectively altering its’ reliance on incoming information from various sensory inputs to provide the
most reliable information for maintaining postural control (Carver, Kiemel, and Jeka, 2006;
Pinsault and Vuillerme, 2010). These dynamic adaptations inform the postural control strategies
selected when environmental conditions change and is therefore one of the most critical factors
for successful postural control, an essential element for performance of daily activities and
maintenance of mobility (Winter, 1995). When a person has an impairment in functioning of one
or more of the multisensory systems responsible for adaptation of integration of sensory
information, the individual will use alternative strategies to try to maintain postural control during
balance activities. However, sometimes these alternative postural control strategies are not
effective in keeping the center of mass within the person’s limits of stability and they fall.

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Falls typically occur from a standing position or during dynamic activities such as walking
or turning (Pi et al., 2015). However, assessment of vestibular function, one of the 3 sensory
systems responsible for maintenance of postural control is performed in the sitting posture. While
the sitting position provides better control for the amount of incoming somatosensory information,
it does not provide an accurate representation of the sensory integration strategies that the
individual employs when attempting to maintain postural control. Therefore, our clinical insights
are significantly restricted, limiting our ability to design and implement effective treatment
strategies.
Summary
While testing the VOR in standing and during dynamic activities is challenging due to the
increase in incoming somatosensory information afforded by the standing position, assessments
performed in this position are not only warranted, but necessary for design and implementation of
more effective treatment strategies for people who are at risk or experience falls. However, before
we can recommend testing of VOR function in standing, we must first determine its’ reliability and
validity within an unimpaired population relative to their sitting performance.
STUDY DESIGN: Prospective, repeated-measures.
Research studies that have examined reliability and validity of the DVA and GST
assessments for VOR function have been performed in sitting postures and for movement of the
head in only 2 planes: horizontal (yaw: shaking head “no”) and vertical (pitch: shaking head
“yes”). We plan to build on this research by also testing DVA and GST in standing and including
assessment of VOR during head movement in the lateral direction (roll: ear-to-shoulder, side-to-
side) – an important head movement that is necessary for performance of safe, independent
functional mobility like walking. To determine how people integrate sensory information from the
vestibular system while maintaining postural control in sitting and standing, participants will be
tested using computerized dynamic posturography. The Neurocom Balance Manager
(NeuroCom, a division of Natus, Clackamas, OR), is a computerized dynamic posturography
system that we will use to objectively assess performance of the vestibular sensory system during
two common testing procedures: DVA and GST. Data will be collected during 3, 2-hour testing
sessions spaced 7 days apart. Sessions will be spaced 7 days apart and order of testing
randomized to facilitate decreased learning effect on test performance.
b. Methodology.
TESTING PROCEDURES
Participants
We will recruit 25 participants, 18-35 years old, male and female genders. Inclusion criteria will
include: individuals who are 18-35 years old with no history of back or neck pain and no history of
concussion. Exclusion criteria will include individuals presenting with neurological, cardiovascular,
or psychiatric disorders, vestibular impairment, pathologies of the lower extremities, systemic
infection, known problems with alcoholism, tumor or suspected carcinoma, surgery in the
previous three months, history of back or neck surgery, fracture of spinal vertebrae, suspected
pregnancy, or structural spinal deformity. A sample size of 22 was determined assuming a 5%
significance level and power of 80%. Given that this study requires testing at 3 separate sessions,
recruiting for 25 participants will allow us to over-recruit in the event that some subjects may
choose not to attend all testing sessions.

Procedures
Participants will be tested on 3 separate visits; testing sessions will occur within 7 days of each
other. At the first testing session, we will obtain signed informed consent from each participant.
The informed consent forms will be approved according to guidelines of the Central Michigan
University Institutional Review Board (IRB). Prior to initiation of balance testing, participants will
complete 2 forms: 1) a general health and activity questionnaire and 2) Tampa Scale for
Kinesiophobia. The Tampa Scale for Kinesiophobia is a commonly used instrument in kinesiology

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and physical therapy. We will also take a series of anthropometric measurements, including:
participant height, weight, full leg length, and head circumference.
At each of the 3 testing sessions, we will measure cervical range of motion for bilateral
lateral sidebending (roll), bilateral rotation (yaw), and flexion/extension (pitch) in seated and
standing. We will also measure visual acuity in sitting and standing using a Snellen chart.

Participants will be instructed to wear comfortable clothing with sport shorts and sports bra (for
females) and, if needed, glasses or contacts. Shoes and socks will be removed during the testing
session. Participants will complete static balance assessments and functional vestibular testing
will be performed using the Neurocom Balance Manager (Clackamas, OR, USA). Static balance
assessments include the Sensory Organization Test (SOT) and Head-Shake Sensory
Organization Test (HS-SOT). Each test will be performed per the manufacturer’s instructions. The
SOT will take approximately 15 minutes to complete; the HS-SOT will take approximately 10
minutes to complete.

For vestibular testing, participants will be positioned 10 feet from the Neurocom video monitor.
The monitor will be placed at eye-level. Position of testing will be randomized for start of
vestibular testing in either sitting or standing. In sitting, a standard-sized chair will be used and
positioned so the participant’s head will be 10 feet from the monitor, hands in lap, knees and hips
at 90 degrees, and feet flat on floor. In standing, participants will stand 10 feet from monitor with
hands at sides and head upright. For both positions, the order of testing will progress as follows:
Static Visual Acuity (SVA)/Perception Time Test (PTT), DVA, and GST. Participants will perform
all three testing conditions in either the sitting or standing position, and then repeat testing in the
second position. To minimize impact of fatigue, participants will be given 1-2 minute rest breaks
between each testing condition or as requested.

Neurocom Balance Manager:

Testing protocols using the Neurocom Balance Manager will include: SOT, HS-SOT,
SVA, PTT, DVA, and GST. The SOT must occur, per the manufacturer, before HS-SOT. SVA and
PTT must occur, per the manufacturer, before DVA or GST testing because their results depend
on SVA and PTT performance. However, whether testing begins with SOT or SVA/PTT will be
randomly determined. The testing protocols and rationale for each of these tests:

Sensory Organization Test

The SOT will identify how individuals use their visual, somatosensory, and vestibular systems to
maintain balance within the variety of environments we encounter in daily life. The SOT protocol
systematically adjusts sensory information to isolate vestibular balance control and test the
adaptive responses of the central nervous system. The SOT is comprised of 6 sensory
conditions: 1) All sensory systems available, 2) Vision absent (eyes closed), 3) Vision altered
(surround sway), 4) Somatosensory altered (tilting of support surface), 5) Vision absent +
Somatosensory altered, (eyes closed + tilting of support surface) 6) Vision and Somatosensory
altered (surround sway + tilting of support surface). Participants will stand within a visual surround
on a support surface comprised of bilateral force plates. Participants will wear 6 OPAL inertial
movement sensors at the bilateral ankles, bilateral wrists, umbilicus, and 5th lumbar/1st sacral
vertebral level of the lower back for measurement of postural sway during each trial. The visual
surround has an adjustable-height computer monitor. All participants will also wear a safety
harness around their pelvis and trunk to prevent falls from loss of balance. Participants will be
tested without shoes or socks. Dependent on testing condition, the visual surround and/or support
surface may move to directly follow the participant’s anteroposterior body sway. No practice trials
will be permitted. Data from the SOT includes: raw and composite equilibrium scores for postural
sway.

Head-Shake Sensory Organization Test

Static balance will also be assessed with the Head-Shake Sensory Organization Test (HS-SOT).
The testing protocol for the HS-SOT is performed using the Neurocom Balance Manager. The
HS-SOT is an enhancement of the SOT and can only be performed after the SOT. It assesses an

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individual’s ability to effectively use vestibular inputs for balance while simultaneously moving the
head. For testing, individuals will repeat SOT condition 2 (vision absent) and condition 5 (vision
absent + somatosensory altered) while wearing a head movement monitor and performing
continuous, rhythmic head movements about a specified yaw (left-right), pitch (up-down), or roll
(side to side) movement axes. For each condition of the HS-SOT, one practice trial will be
permitted, followed by up to 5 scored trials. Participants will wear 6 OPAL inertial movement
sensors at bilateral ankles, bilateral wrists, umbilicus, and the 5th lumbar/1st sacral vertebral level
of the lower back for measurement of postural sway during each trial. Additionally, all participants
will wear a safety harness around their pelvis and trunk to prevent falls in case of balance loss.
Participants will be tested without shoes or socks. Data from the HS-SOT includes: raw and
composite equilibrium scores for postural sway.

Static Visual Acuity Measurement

Static visual acuity (SVA) determines the minimum angle of resolution for visual acuity
(logMAR) of an optotype of unchanging size while the head is maintained in a static position. SVA
will be measured by instructing participants to identify orientation of an optotype (letter E). Testing
will start at 0.0 logMAR optotype. The optotype will appear in the center of a circle on a 15-inch
computer screen for 1.0 second. Once the optotype appears, participants will be asked to report
its’ orientation (up, down, right, left, or unknown). The participant’s response will be recorded on a
computer by the researcher. Each optotype size will be presented a maximum of five times. If a
participant responds incorrectly to three of five possible optotype presentations, its size will
increase one level until correctly identified for three of five possible presentations. If a participant
correctly identifies three of five possible optotype presentations at a given level, optotype size will
decrease by one level until the optotype is too small for reliable identification of its’ orientation.
Determination of SVA value is dependent on number of correct and incorrect optotype
identifications. When three of five optotype identifications are correct, logMAR level is advanced
and all incorrect responses zeroed. This process will be repeated until three of five identifications
for an optotype are incorrect (or unknown) at a given logMAR level. Upon reaching this point, the
assigned logMAR value will increase by 0.02 times the number of incorrect (or unknown) choices
for the final logMAR value. For example: if test begins at an acuity level of 20/25 (=0.1 logMAR)
and participant identifies three optotypes correctly, level will change to 20/20 (0.0 logMAR). If
three of the subsequent five optotypes are incorrectly identified, logMAR level of 0.0 will increase
by multiplying three errors by 0.02 for a final SVA value of 0.06.

Perception Time Test

The Perception Time Test (PTT) will be performed in a manner similar to determination of
SVA. PTT determines the target presentation time necessary for an individual to identify an
object’s orientation. However, instead of optotype size progressively increasing or decreasing
dependent on correct or incorrect identification, the test progresses for shorter or longer intervals
of time while optotype size is maintained at the smallest identifiable visual acuity perceived by the
participant during SVA testing. Recording of responses and verification of test end point will be
determined in same manner as SVA.

Dynamic Visual Acuity Test

Dynamic Visual Acuity (DVA) quantifies visual acuity during movement. For DVA, head
movements in three planes will be tested in standing and sitting: yaw, pitch, and roll. A head-
mounted rate sensor will be calibrated and positioned at the apex of a participant’s head and held
in place with a headband. This sensor detects head speed and displacement, allowing active
monitoring during testing. For testing movement in the yaw direction, participants will be asked to
move their head 20 degrees in the horizontal plane to each side (right and left; 40 degrees total)
with smooth transition and movement between sides. The rate at which participants are asked to
move their head will remain at a constant 85 degrees/second for yaw, 60 degrees/second for
pitch, and 40 degrees/second for roll directions. Practice for head movement and optotype
identification will be allowed before data collection for each of the three directions.

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During DVA testing, optotype size will start at the 0.0 logMAR visual acuity level. To begin, the
video screen will display a center circle in which the optotype is presented; two bars at bottom of
the screen will show desired range of head movement and velocity. Once a participant starts
moving their head, range of head movement and velocity bars will disappear, but the participant
will be instructed to continue head movements until an optotype appears on the screen. Once
optotype appears, the participant will stop moving their head and verbalize direction of optotype, if
known. Participant’s response will be recorded on the Neurocom computer. After entry of
participant’s response, the next trial will began.

Similar to the SVA test, optotype size will change depending on participant’s performance. Once
three consecutive incorrectly identified optotypes are recorded, optotype size will increase, or,
conversely decrease following three consecutive correctly identified optotypes. DVA logMAR
score will be calculated by counting total number of errors made and subtracting this from
corresponding SVA. This process will be repeated for head movements in all 3 planes.

Gaze Stabilization Test

Testing procedures for Gaze Stabilization Test (GST) in the yaw, pitch, and roll movement
directions are similar to DVA testing, except that optotype size is fixed at 0.3 logMAR above each
participant’s SVA level and velocity of head movement will become the varying factor. Practice
will be performed for each direction prior to data collection. If optotype direction for 3-5
presentations at a specific velocity are correctly identified, head movement velocity will increase.
Conversely, if optotype direction of 3-5 presentations are incorrectly identified, velocity will
decrease. Maximum velocity at which a participant moves their head while correctly identifying
optotypes will be recorded. Velocities will be tested from 10-150 degrees/second.

Vicon Motion Capture System:

At each of the 3 testing session, participants will also perform 3 trials of normal speed
walking across a 15-foot flat space while wearing reflective markers on 45 anatomical landmarks.
Movements will be recorded by a 12-camera Vicon Motion Capture System. This kinematic data
will be used to determine phase relationships between the head, trunk, and pelvis during
performance of an upright, dynamic activity. Before placing the wireless electrodes on
participants’ skin, we will clean the skin with a prep pad to remove any excess oils or residues.
Retro-reflective markers will be placed on the following anatomical landmarks: right anterior and
posterior head, left anterior and posterior head, seventh cervical spinous process, 10 th thoracic
spinous process, bilateral acromioclavicular joints, bilateral mid-biceps muscle bellies, bilateral
elbow lateral epicondyles, bilateral mid-forearm muscle bellies (ventral surface), bilateral ulnar
styloid processes, bilateral radial styloid processes, fifth lumbar/first sacral spinous process,
bilateral anterior superior iliac spines, bilateral posterior superior iliac spines, bilateral greater
trochanters, bilateral mid-thigh (ventral surface), bilateral femoral lateral epicondyles, bilateral
femoral medial epicondyles, bilateral mid-fibulas (lateral surface), bilateral distal 1/3 tibias (ventral
surface), bilateral ankle medial malleoli, bilateral ankle lateral malleoli, bilateral calcanei, bilateral
head 1st metatarsal phalangeals, bilateral head 5th metatarsal phalangeals. The retro-reflective
markers will be held in place by a latex-free, double-sided, adhesive collar.

c. Duration of an individual subject’s participation and duration of the entire study.

Participants will be tested on 3 separate days/times. Each testing session will be 7 days apart. Each
session will take 2 hours to complete. Therefore, in total, participants will be tested 6 hours, distributed
over 21 days.
The goal is to complete active testing of participants within 9 months of study initiation. Plan is to begin
active testing of participants in May 2018. If able to begin testing in May 2018, active testing will be
completed by end of February 2019.
If plan for testing of participants maintained, anticipate that data reduction, processing, and analyses will
be completed by December 2021.

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d. If this study involves drugs or biologics, complete Form H. ☐ X NA
e. If this study involves medical devices, complete Form I. ☐ X NA
Note: The Principal Investigator is responsible for determining that all equipment used in the study is safe.
Data/Statistical Analysis Plan
a. Information or data that will be obtained from or about participants. Include copies of all surveys, interview
scripts, and data collection forms with this submission.
• Consent (Adult Consent form): Written description of study process that includes the study’s
purpose, procedures, risks and benefits, confidentiality, compensation, as well as contact
information. The participants will sign the form.
• Visual Acuity, Anthropometric measurements, & Cervical Range of Motion data collection form:
Data collection sheet for each participant that will contain their visual acuity score based on
testing with a Snellen eye chart, anthropometric measurements, and cervical range of motion.
• Anthropometric measurement will be performed in standing for the following: overall height,
weight, full leg length (greater trochanter to floor), foot length, hip diameter, abdominal
circumference, and full arm length.
• Cervical range of motion measurements will be performed in sitting and standing for the following
movements: flexion, extension, right lateral sidebending, left lateral sidebending, right rotation, left
rotation.
• Background & Activity information (Questionnaire): General information related to participant's
injury history, activity levels, and exercise habits that may impact their balance performance. All
participants will complete this questionnaire at their first testing session. The information provided
on this form will be important for describing our sample as well as identifying any potential
participants who do not qualify for study participation.
• Fear of movement (Tampa Scale for Kinesiophobia): Commonly used intake form to assess an
individual’s fear of performing physical activities. It has 2 subscales to delineate reasons for
underlying fear of movement: 1) somatic focus and 2) activity avoidance. All participants will
complete this form at the beginning the first testing session.
• Neurocom data collection form: Data collection sheet for each participant that will contain notes,
as appropriate, indicating any challenges or unique observations specific to an individual’s testing
session.
• Vicon data collection form: Data collection sheet for each participant that will contain notes, as
appropriate, incating any challenges or unique observations specific to an individual’s testing
session.
b. Sample size calculation is required for all studies involving vulnerable populations and studies that involve
more than minimal risk. Guidance is available. Is there a sample size/power calculation? ☐ Yes ☐ No
If yes, describe the calculation and scientific rationale.
c. Plans for analysis of data, including statistical analysis if applicable.
Raw data from the Neurocom Balance Manager will be used to calculate basic descriptive statistics within
and between-subjects, including: mean, standard deviation, and coefficient of variation in sitting vs.
standing for head movements in 3 directions (yaw, pitch, roll). Basic descriptive statistics will be
calculated for the following dependent variables:
• Static Visual Acuity logMAR
• Dynamic Visual Acuity logMAR
• Gaze Stabilization logMAR

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• Perception Time (seconds) and logMAR
• Gaze Stabilization Test head velocity (degrees/second)
Dependent variables will be assessed for normality of distribution. If variable(s) are found to be non-
normally distributed, the transformation technique described by Templeton (2011) will be used. Paired
samples t-tests will be used to examine results between sitting and standing postures. Mixed-model, 2x3
repeated measures ANOVAs (Posture x Head movement direction) will be used to determine if significant
differences exist between head movement directions (i.e., yaw vs. pitch vs. roll) in sitting and standing
postures.
Test-retest reliability will be examined through calculation of intraclass correlation coefficients. Construct
validity for standing SVA, PTT, DVA, and GST dependent variables will be examined relative to results
obtained in sitting. Significance will be set at p<.05.
Research Locations
a. All locations where research procedures will be performed.
Research testing for this research study will occur in rooms 1304 (Neurocom) and 1356 (Vicon) of the
Health Professions Building on the main campus of Central Michigan University, Mount Pleasant, MI.

b. Will the local investigator be the lead investigator on a Multicenter Study or will CMU ☐ Yes ☐X No
serve as the Coordinating Center for a Multicenter Study? If Yes, Complete Form L.

c. If research will be conducted outside of Central Michigan University, identify any site-specific ☐ NA
regulations or customs affecting the project, including any local scientific and ethical review
structure, approvals, or authorizations. Complete Form M for International Research.

d. If doing online research, provide the URL where data collection will occur. ☐XNA
Indicate whether an IP address tracking function will be active or turned off.

Risks to Participants
List the reasonably foreseeable risks, discomforts, hazards, or inconveniences associated with the research.
Consider physical, psychological, social, legal, and economic risks to individuals and, if applicable, to communities.
Estimate the likelihood, magnitude, and duration of each risk. For greater than minimal risk studies, describe steps
that will be taken to mitigate each risk.
During testing with the Neurocom Balance Manager, participants will be permitted practice prior to
initiation of some testing protocols (i.e., HS-SOT, DVA, GST). Practice will not be allowed for the other
testing protocls (i.e., SOT, SVA, PTT) due to characteristics being tested.
For testing with the Vicon Motion Capture system, participants will receive verbal instruction and
permitted up to 2 practice walking trials prior to initiation of testing.
A potential, foreseeable risk is that participants may experience a fall or near-fall during the balance tests
(i.e., SOT, HS-SOT, DVA, GST). In order to minimize the risk of falling for participants, a support harness
will be worn by each participant during testing in the Neurocom Balance Manager and a member of our
research team will be positioned behind each participant during all testing (in and outside of Neurocom
Balance Manager unit) in order to provide assist as needed. We will also have a chair positioned near the
participant at all times when standing to facilitate opportunities for seated rests as team and/or participant
deems appropriate.
A potential discomfort that participants may experience is neck soreness during and/or after a testing visit
due to movement of the head in the yaw, pitch, and roll directions during DVA, GST, and HS-SOT testing
conditions. If a participant reports neck discomfort during testing, we will instruct them to rest in sitting,
closely monitoring their status for increase in complaints. If participant reports increased neck discomfort
despite rest, we will end the testing session. However, if participant reports decreased or resolution of

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neck discomfort, we will proceed with the testing session while continuing to closely monitor the
participant’s status. A similar process will be used if a participant reports onset of neck discomfort after
participating in a testing session and there is no other potential precipitating cause (e.g., involvement in
motor vehicle accident, etc.).
For all testing, there is no greater risk for individuals participating in this research study than they would
encounter in everyday life or during the performance of balance tests commonly used in Physical Therapy
evaluation. However, the anticipated knowledge gained could be of benefit for patient populations
including those with falls, at risk for falls, vestibular pathologies, concussions, or other balance
impairments.
Investigators’ Qualifications Relevant to Protecting Research Participants
Role of each investigator, including assistants and students, in this research as well as their qualifications for
conducting the research and obtaining informed consent. For greater than minimal risk studies, discuss time
commitment of investigators to the study.
1) Jennifer Sansom, PT, MPT, MS, PhD is an Assistant Professor in the Doctoral Program in Physical
Therapy at Central Michigan University. She has been a practicing physical therapist for the past 16 years
working in hospitals, general practice outpatient clinics, subacute rehab facilities, and home health where
she has had the opportunity to work with patient populations ranging from children with developmental
disabilities to adults following orthopaedic surgeries to geriatric patients with Parkinson's and Stroke. She
has received employee and patient recognition of her abilities as a physical therapist over the past 16
years of practice. During her graduate work, Jennifer worked under the guidance of Dr. Beverly Ulrich in
the Developmental Neuromotor Control Lab at the University of Michigan. Prior to attending the University
of Michigan, she attended Northern Michigan University where she received both her Bachelor of Science
in Sports Science and Master's in Exercise Science. Her Master's in Physical Therapy was awarded from
the College of St. Catherine (now St. Catherine University) in St. Paul, MN in 2002. Role: Principal
Investigator – oversee and conduct all recruitment, testing, data processing, data analyses, and training
for research assistants.
2) Karen Lomond, PhD is an Associate Professor in the Health Sciences Program within the College of
Health Professions here at CMU. She has a PhD in Biomechanics and has conducted several research
experiments examining movement coordination in persons with and without chronic musculoskeletal
disorders, including LBP. Role: Co-Principal Investigator – assist with recruitment, testing, data
processing and analyses, and training of research assistants.
3) Training Procedures and Supervision for Assistants (Burkhardt, Perez, and Roberts): All staff and
students assisting with this research project have undergone CITI training for research conduct and
practices. Additionally, all student assistants listed on this project have undergone considerable training
for the proper use and care of lab equipment (see below). Roles – assist with participant recruitment,
testing, and data processing.
4) Nilanthy Balandra, MEng , has undergone extensive training both during her education and since
coming to work at the Motion Analysis Center within the College of Health Professions in April 2014. She
is highly skilled in the use of all equipment that will be used in this research project (and more).
Additionally, she is responsible for conducting all student training for use and care of equipment within the
Motion Analysis Center (rooms 1356 & 1356A in the Health Professions Building). Role – assist with
testing, data processing and analyses, and training of assistants.
Upon receipt of IRB approval for this research project, the principal investigators will conduct and oversee
all staff and student training specific to the research study procedures outlined within this proposal prior to
initiating any testing with human participants. All testing sessions will be overseen by the principal
investigators.
Resources to Protect Participants
Availability of psychological, social or medical services, including counseling or social support services ☐ NA
that may be required as a consequence of participating in the research.
Anticipated physical risk to participants is minimal during both Neurocom Balance Manager

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and walking task testing conditions. In case of physical injury during testing, we will assist the
participant in obtaining emergency care. A hard-wired phone and cell phone are available
within the testing space for calling emergency services if needed.
No social or psychological risk is anticipated for individuals participating in this research study.

Criterion 2. Risks Are Reasonable in Relation to Potential Benefits

Potential Benefits to Individuals Participating in the Research
Compensation is NOT generally considered a benefit.
The primary potential benefits to individuals who choose to participate in this research study are the
experience of participating and knowledge that their participation has the potential to be of benefit for
helping others. Most people enjoy adding to the body of knowledge that their participation provides.
Potential Benefits to Society or Value of the Knowledge to be Gained
The anticipated knowledge gained could be of benefit for patient populations with balance impairments
who are at risk for falls or have a history of falls. This information could facilitate design, development,
and implementation of therapeutic interventions for individuals with balance impairments and/or
individuals at risk for falls/history of falls who have impaired proprioception and/or motor control.

Criterion 3. Selection of Participants is Equitable

Target Population
Describe the target population from which you intend to recruit participants; list inclusion and exclusion criteria.
Inclusion criteria will include: individuals who are 18-35 years old with no history of back or neck pain and
no history of concussion.
Exclusion criteria will include: individuals presenting with neurological, cardiovascular, or psychiatric
disorders, vestibular impairment, pathologies of the lower extremities, systemic infection, known problems
with alcoholism, tumor or suspected carcinoma, surgery in the previous three months, history of back or
neck surgery, fracture of spinal vertebrae, suspected pregnancy, or structural spinal deformity.
Recruitment
How will participants will be recruited for this study and how will recruitment materials be distributed?
Potential study participants will be recruited via word-of-mouth; flyers to be posted in the community (e.g.,
grocery stores, libraries) and approved public posting areas around campus by members of the research
team. Study flyers will be posted in areas accessible by diverse members of the local and university
communities.
Attach copies of any proposed flyers, posters, pamphlets, advertisements, e-mail invitations (in any format) and
any scripts for on-air advertisements or phone calls. All printed material must contain the CMU logo and be
approved by the IRB prior to use. (Guidance on Snowball Sampling and Posting Recruitment Materials)
Vulnerable Participants
If the research involves children, pregnant women, or decisionally-impaired persons, download and ☐XNA
complete Form A, C, or D as appropriate.

Recruiting Students
Will you recruit CMU students for this study? If yes, describe the recruitment process. ☐ Yes ☐XNo
Guidance is available.

Recruiting Participants in Hospitals or Healthcare Facilities

If you intend to recruit patients in a hospital or healthcare facility, the study must be introduced to ☐XNA
patients by a member of their healthcare team. How will you describe the study to the healthcare

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staff?

Compensation
Will you offer compensation (including extra course credit) to participants? If Yes, ☐X Yes ☐ No
complete Form F. This information may be shared with university auditors.

Criterion 4. Informed Consent Will Be Sought

and
Criterion 5. Informed Consent Will Be Documented
Which of the Following Conditions Apply to this Research?
Check all that apply.
Fully informed consent will be obtained – either in writing or orally - from all participants before
a. ☐
any research procedures begin. Proceed to Informed Consent Process below.
Fully informed consent will not be obtained from all participants prior to their participation.
b. ☐ This includes deception, withholding information, and secondary subjects. Complete Form E1
and Form E2 proceed to Withdrawal of Participants below.
c. ☐ Children will be research participants. Complete Form A.
Decisionally-impaired persons will be research participants. Complete Form D and proceed to
d. ☐
Withdrawal of Participants below.
Informed consent will be obtained from participants, but no signed consent form will be used.
This includes oral consent and implied consent (e.g., completing a survey). Proceed to Informed
e. ☐
Consent Process below and complete Form E2 to request a waiver of documentation of
consent.

Informed Consent Process

Consult the Elements of Informed Consent for what should be included in any informed consent process.
a. Will there be a waiting period between informing a prospective participant about the research and obtaining
consent? ☐ Yes ☐XNo If Yes, how long?
b. How will information be presented to participants (eg, consent form, orally, information sheet). Attach a copy
of each document that will be presented to participants.
Participants will be fully informed (verbal and written consent) of the nature and expectations associated
with participation in this research study when they present for the first testing session within the Health
Professions Building (HPB 1304). At the testing session, participants will also be asked to complete an
activity questionnaire and Tampa Scale for Kinesiophobia.
The PIs will encourage questions and/or concerns to be expressed by participants throughout testing.
The PIs will also make it clear to the participant that they may withdraw their participation from this study
at any time without repercussion or ill-will for the visit.
c. Describe the circumstances under which consent will be obtained, including where the process will take place
and who will obtain consent.
Participants will be fully informed (verbal and written consent) of the nature and expectations associated
with participation in this research study when they present for the first testing session in the Health
Professions Building (HPB 1304).
A member of the research team will obtain consent from all participants. The PIs have obtained consent
from participants in numerous other research studies. Populations have included adults with nonspecific

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chronic low back pain, healthy adults, athletes, parents of typically developing infants, parents of infants
with Down syndrome, and assent from 5-8 year old children with myelomeningocele (consent from
parent/guardian).
d. If participants do not understand English, how will translation be provided? ☐ NA
If a potential participant is not fluent in English, we will:
1) Ask the potential participant to come to the testing session with a reliable friend and/or
family member who is fluent in English. (Once a potential participant's language has been
identified, we will recruit an English-speaking individual who speaks the potential participant's
native language to contact them with our request to come accompanied by an English-
speaking friend/family member.)
2) If the potential participant does not have an associate who is fluent in English, we will make
every attempt to recruit an English-speaking individual who speaks the potential participant's
native language to be present throught the participant's testing session. If a translator can not
be recruited, we will not be able to include the interested individual because effective
communication is important for safety and test performances.
e. How will you determine whether the participants or their legally authorized representatives understand the
information presented? Guidance
Participant understanding of the information presented will be determined by the individual obtaining
consent (consenter) first providing a verbal description of the research study as outlined within the
consent form to the potential participant. The verbal description will be followed by an opportunity for the
potential participant to read and review the consent form independently with the consenter nearby
throughout to answer any questions in a timely manner. Once the potential participant has indicated
completion of review of the consent form, the consenter will verbally ask the potential participant
questions to determine if they understand the nature of the study and procedures involved in testing as
described within the consent form. Again, the potential participant will be queried if they have any
questions and/or provide clarification as necessary. Once the consenter is satisfied that the potential
participant understands the nature of the study and testing procedures, the potential participant will be
asked to sign the consent form. A copy of the consent form will be provided to the participant before they
leave the testing session for their reference and records.
The study team will encourage questions and/or concerns to be expressed by participants at any time
during their participation.
If a potential participant requests, we will provide a copy of the consent form prior to the testing session
for their review.
Members of the study team will make it clear to the participant that they may withdraw their participation
at any time without repercussion or ill-will for the visit.
f. What steps will be taken to minimize the possibility of coercion or undue influence?
To minimize the possibility of coercion and undue influence, the consenter will assess participant
understanding and agreement to participate in research study by verbally asking the potential participant
questions to determine if they understand the nature of the study and procedures involved in testing as
described within the consent form. Again, the potential participant will be queried if they have any
questions and/or provide clarification as necessary. Once the consenter is satisfied that the potential
participant understands the nature of the study and testing procedures as well as desire to participate, the
potential participant will be asked to sign the consent form.
The study team will encourage questions and/or concerns to be expressed by participants at any time
during their participation. If any member of the study team is concerned that a participant is not willingly
participating or fully understanding what their participation entails, we will attempt to determine
participant's appropriateness for continued participation through questionning of study purpose and
procedures.

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g. If participants cannot read the consent form, how will their consent be documented? ☐ NA
For potential participants who cannot read the consent form, due to literacy or language
problems, we will communicate the need for them to present to the initial testing session with
a reliable friend/family member who can communicate effectively with study team members.
We will then use the same process for obtaining consent as outlined above in Criterion 4d, but
will rely on the questions/responses provided by the interpreter to determine if the potential
participant has an adequate understanding of the research study to provide informed consent.

Withdrawal of Participants
a. Under what circumstances can participants be withdrawn by the investigator from the research without their
consent? Guidance
A participant may be withdrawn from the research study without their consent in the following situations:
the participant does not present for a scheduled testing session; the participant experiences difficulty
during a testing session that places them at risk of injury during current and/or subsequent testing
session; the participant has difficulty or is unable to follow directions necessary to participate in a testing
session.
b. What procedures will be followed when participants are withdrawn by an investigator or withdraw
voluntarily? Guidance
If a researcher withdraws a participant without their consent or a participant withdrawals voluntarily, the
reason(s) for the withdrawal, if known, will be documented and maintained with the individual’s informed
consent form. The same procedures for maintenance and destruction of the informed consent will be
followed for documentation of participant withdrawal.
Financial Interest in Research
Do any members of the research team or any members of their immediate families have any financial interest in
the sponsor of this research and/or in the results of this research? ☐ Yes ☐XNo If Yes, complete IRB Form N.

Criterion 6. Data Will Be Monitored for Safety

Unanticipated Problems
Who will monitor the data during the course of the research for signals of new risks, unanticipated problems, or
threats to safety of research participants?
All members of the research team will be responsible for monitoring data during the course of this
research study and notifying the principal investigator(s) of any emerging results that may indicate a
possible increase in risk for participants and/or occurrence of an unanticipated risk and/or potential
problem(s). Additionally, the principal investigator, Jennifer Sansom, will perform checks of the data after
testing has been completed for every 5 participants to ensure protocol adherence along with data quality
and integrity.
Stopping Rules
Under what circumstances would it be necessary to stop the research prematurely? (This is NOT the same as
withdrawing individual participants.) Guidance is available.
This research study will be stopped prematurely for safety or efficacy concerns, or if we are unable to
recruit a sufficient number of participants within 9 months of study initiation.
Safety concerns indicating that the study needs to be stopped include: 1) more than 3 participants report
onset of unremitting dizziness or vertigo during or after testing of vestibular function; 2) more than 3
participants report onset of unremitting neck pain during or after testing of vestibular function.
Efficacy concern indicating that the study needs to be stopped include: data after testing for first 10
participants has been completed shows no association between tests performed in sitting and standing.

Criterion 7. Participants’ Privacy Will Be Protected and Confidentiality of

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Data Will Be Maintained

Definition of Privacy Definition of Confidentiality
Privacy
Discuss procedures to protect participants’ privacy interests throughout the research activities (recruitment,
consenting, participating, and follow-up).
Recruitment:
Potential study participants will be recruited via word-of-mouth; flyers to be posted in the community (e.g.,
grocery stores, libraries), and approved public posting areas around campus by members of the research
team. Use of word-of-mouth will generate potential interest in participation. Since this typically involves
individuals who are not members of the research team, we will not have contact with potentially interested
individuals. Additionally, study flyers will be posted in areas accessible by diverse members of the local
and university communities. Therefore, members of the research team will not typically be in direct
contact with potential participants during initial exposure to recruitment strategies.
When an individual contacts one of the research team requesting additional information via phone or
email, we will enter their contact information on a password-protected excel spreadsheet kept on the lab
network drive that is only accessible by members of the research study team. All members of the
research team have completed CITI training for human research protection.
Consenting and Participating:
Participants will interact with study team members during testing sessions in the Health Professions
Building (HPB 1304 & HPB 1356).
In addition to the consent form, participants will be asked to complete an activity questionnaire and
Tampa Scale for Kinesiophobia at the first testing session. No other information about or from participants
will be requested by study team members.
The activity questionnaire will provide general information related to participant's injury history, activity
levels, and exercise habits that may impact their balance performance. All participants will complete this
questionnaire at their testing session.
The Tampa Scale for Kinesiophobia assesses fear-avoidance beliefs and is commonly used in physical
therapy for individuals with balance impairments or lower limb injuries. All participants will complete this
scale at the beginning of the testing session to examine movement behaviors.
For scheduling of the 2nd and 3rd testing sessions, the PI (Jennifer Sansom) will correspond directly with
the participant via their private email. The PI will pass along requests for reservation of study equipment
and space to research team using an anonymous study designator. Once participant’s participation in
study completed, all email correspondence related to their involvement in the proposed research study
will be deleted.
Plans for securing sensitive data should be developed in collaboration with your College Director of IT.
Confidentiality of Education Records Containing Identifiers
Will you use information in school records containing personal identifiers? If Yes,
☐ Yes ☐XNo
complete Form SchRec and attach a letter authorizing you to access the records.

Confidentiality of Medical Records Containing Identifiers

Will you use information in medical records containing personal identifiers? If Yes, ☐ Yes ☐XNo
complete Form MedRec, and attach a letter authorizing you to access the records.

Identifiable Data from Other Records or from Direct Interaction with Subjects
Will your data contain personal identifiers? If Yes, answer the following questions. ☐XYes ☐ No

a. Where and how will data with personal identifiers be stored? How will data be transported from the point of
collection to the storage location?

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The consent form will be the only document directly linking an individual with their participation in this
research study. Signed consent forms will be maintained by storage of forms with identifiable participant
information within a locked storage cabinet in a locked office with restricted access (PI office; PI access
only). After a participant signs their informed consent form at the initiation of the first testing session in
HPB 1304 or 1356, the PI, Jennifer Sansom, will personally transport the form from HBP 1304 or 1356 to
her faculty office and place into a study-desginated 3-ring binder for storage in a cabinet for 5 years after
conclusion of the study.
At first testing session, each participant will be assigned a unique, de-identified code. The code uses only
numbers and letters. The letters used will identify the research study the data is associated with, but not
the specific participant.
Data processing of de-identified, raw data will occur on a restricted lab-specific network drive that requires
use of individual ID plus password protection for access.
b. How long will the data be stored? (In general, data should be kept for 3 years after completion of the project
unless participant safety warrants deidentification or destruction sooner.)
Consent forms with participant identification will be saved for 3 years after completion of the project. After
3 years, the consent forms will be destroyed by shredding.
De-identified data will be deleted from our restricted, lab-specific network drive 3 years after completion of
manuscripts associated with the project.
c. Who will have access to the stored data?
Research personnel who work on this research project have all completed CITI training. They will conduct
all of their work related to this research project within the designated lab space (Health Professions
Building Biomechanics Lab-1304 1356A), on designated lab computers within a lab-specific network
computer drive. When research personnel leave the project, their access rights to the following will be
terminated: lab space where data collections take place, lab computers within the lab space, and lab
network drive. Additionally, security software (firewall, anti-virus, anti-intrusion) is installed and regularly
updated on all servers, workstations, laptops, and other devices used in the project. The data collected
will not be of a sensitive nature, but we will adhere to the above protocol for participant confidentiality.
d. Who is responsible for receiving or transmitting data?
The principal investigators are solely responsible for receiving or transmitting any data associated with
this research project. Any data that is received or transmitted will be de-identified as described above.
e. How will data be secured (eg, training, authorization of access, password protection, encryption, physical
controls, certificates of confidentiality, and separation of identifiers and data) during storage, use, and
transmission.
All de-identified data will be secured on a researcher-specific (Sansom), password-protected, network
drive. All personnel who work on this research project will have completed CITI training and/or certificate
of confidentiality. In order for personnel to have access to the researcher-specific network drive, the
principal investigator (Jennifer Sansom) is required to provide permission; she can revoke access for
anyone at any time.
f. If participants withdraw voluntarily or are withdrawn by an investigator, will any of their data already
accumulated be used?
☐XYes How will the data will be used? As able, raw, de-identified data that can be salvaged will be
used in statistical analyses to describe research study sample and results.
☐ No What will you do with the data?

Future Use of Deidentified Data or Biospecimens <<Either a or b must be True>>

a. Identifiers will be removed from the identifiable private information or identifiable ☐ XYes ☐ No
biospecimens and that, after such removal, the information or biospecimens could be

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used for future research studies or distributed to another investigator for future
research studies without additional informed consent from the subject or the legally
authorized representative.
b. Information or biospecimens collected as part of the research, even if identifiers are ☐ Yes ☐ No
removed, will not be used or distributed for future research studies.

Future Use of Identifiable Data or Biospecimens New Regulation

Do you intend to store identifiable data for future use? If yes, complete Form J. ☐ Yes ☐ No

Additional Determinations
Community Involvement in Research
a. Describe the community and discuss how or whether you will obtain permission or ☐ XNA
authorization from leaders of the community to conduct this research.

☐ Yes ☐ XNo
b. Are you a member of this community?
c. Discuss how or whether members of the community participated in any phase of ☐ XNA
planning the research or plan to participate in carrying out the research.

d. Discuss how or whether you intend to share the results with the community. ☐ XNA

Project Funding
a. Is this project supported by any source of funding, either internal (such as a faculty ☐XYes ☐ No
research award) or external (eg, grant or contract)? If Yes, Submit a copy of any grant
application or contract proposal related to this application.
b. Is this project being submitted as part of an application for funding to a federal agency? ☐ Yes ☐XNo

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Assurance of Principal Investigator

Complete EITHER Section A or Section B.
A. Complete this Section if Students Will Not Function Independently in Conducting this Research.
Electronic signature. My checking of the box below is representation of my signature and is
legally valid and binding as if I had signed the document with ink on paper in accordance with
Michigan’s Uniform Electronic Transactions Act (UETA) and the Electronic Signatures in Global
and National Commerce Act (E-SIGN) of 2000.
As the Principal Investigator, I assure that:
• I will conduct this study as described in this application and accompanying documents.
• I will report immediately to the CMU Institutional Review Board any changes in the
procedure; injury to a research participant; or any problems that involve risk or the
☐ possibility of risk to participants or others.
NAME Jennifer K. Sansom Date 02/19/2018

B. Complete this section if Students Will Have a Major Role in Conducting this Research.
Electronic signature. My checking of the box below is representation of my signature and is
legally valid and binding as if I had signed the document with ink on paper in accordance with
Michigan’s Uniform Electronic Transactions Act (UETA) and the Electronic Signatures in Global
and National Commerce Act (E-SIGN) of 2000.
As the Principal Investigator and Faculty Supervisor for the research proposed in this application,
I assure that:
• The student(s) is/are sufficiently knowledgeable about the regulations and policies
governing research with human subject, and has/have sufficient training and experience,
to conduct this particular study according to the approved protocol.
• I have reviewed the application and all associated materials with the student(s).
• I will meet with the student investigator(s) as necessary to monitor study progress.
• I will assist and advise the student(s) in reporting immediately to the CMU Institutional
Review Board any changes in the procedure; injury to a research participant; or any
☐ problems that involve risk or the possibility of risk to participants or others.
NAME Date

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Guidance
Regulatory Criteria for IRB Approval of Research (45 CFR 46.111)
In order to approve research the IRB shall determine that all of the following criteria are satisfied:
Criterion 1. Risks to subjects are minimized: (i) By using procedures which are consistent with sound research
design and which do not unnecessarily expose subjects to risk, and (ii) whenever appropriate, by using procedures
already being performed on the subjects for diagnostic or treatment purposes. Return
Criterion 2. Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the
importance of the knowledge that may reasonably be expected to result. In evaluating risks and benefits, the IRB
should consider only those risks and benefits that may result from the research (as distinguished from risks and
benefits of therapies subjects would receive even if not participating in the research). Return
Criterion 3. Selection of subjects is equitable. In making this assessment the IRB should take into account the
purposes of the research and the setting in which the research will be conducted and should be particularly
cognizant of the special problems of research involving vulnerable populations, such as children, prisoners,
pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons. Return
Criterion 4. Informed consent will be sought from each prospective subject or the subject's legally authorized
representative, in accordance with, and to the extent required by §46.116. Return
Criterion 5. Informed consent will be appropriately documented, in accordance with, and to the extent required by
§46.117. Return
Criterion 6. When appropriate, the research plan makes adequate provision for monitoring the data collected to
ensure the safety of subjects. Return
Criterion 7. When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain
the confidentiality of data. Return
Duration of Study
How long will the study last? A few days, weeks, months? Return
Data to be Collected
“Data” includes all information collected in the conduct of the research, such as, but not limited to: consents,
surveys, interview notes, audio or video recordings, photographs, notes of observations, and field notes. Return
Risks to Participants
Minimal risk is the probability and magnitude of harm or discomfort anticipated in the research are not greater
than those ordinarily encountered in daily life or during the performance of routine physical or psychological
examinations or tests.
You can estimate likelihood (or probability) of a risk as very low, low, medium, or high; if actuarial data are
available you can give actual percentages. Similarly, you can express the magnitude of risk as small, medium, and
large. You can cite references or your own research experience. Return
Posting Recruitment Materials
This guidance applies to both physical and electronic postings. Investigator is responsible for securing approval to
mount recruitment materials in various venues. Recruitment posters on campus must be approved by the
administrative office responsible for the building or website. Posters in private venues (eg, physician’s office, a
clinic, or a gym) must be approved by an authorized person, either in writing or by signing a copy of the
recruitment flyer, or by the investigator’s statement that they obtained verbal approval. Posters on public bulletin
boards do not generally need approval. Return
Recruiting Students
IRB Policy on Recruiting Students: When CMU students and/or employees are being recruited as potential subjects,
researchers must ensure that there are additional safeguards for these subjects. The voluntary nature of their
participation must be primary and without undue influence on their decision. Researchers must emphasize to

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participants that neither their academic status or grades, or their employment, will be affected by their
participation decision. To minimize coercion, investigators should avoid, whenever possible, the use of their
students and employees in procedures that are neither therapeutic nor diagnostic. In these latter situations,
investigators should solicit subjects through means such as bulletin board notices, flyers, advertisements in
newspapers, and announcements in classes or laboratories other than their own. When entering a classroom to
recruit students and conduct research (e.g. administer a survey), investigators must do so at the end of the class
period to allow non-participating students the option of leaving the classroom, thereby alleviating pressure to
participate. Return
Psychology Faculty may use a standard description of recruiting students through the SONA system.
Determining Whether a Person Understands the Research
There are various ways to assess whether a potential participant understands the research and what they are
consenting to. Return
• Teach Back. Tell me in your own words: what the purpose of this research is; what the risks of being in
this study are; how long you will be in this study..
• True/False Quiz. Can you leave the study at any time? Will you receive any money for participating in this
study?
• Short Questions. Do you have any questions about the information on the first page of the Consent Form?
What kind of personal information will we collect from you? Who can your answer questions after this
study starts? How can you complain about something that happened to you in this study?
Coercion and Undue Influence
Coercion occurs when an overt or implicit threat of harm is intentionally presented by one person to another in
order to obtain compliance. For example, an investigator might tell a prospective subject that he or she will lose
access to needed health services if he or she does not participate in the research.
Undue influence, by contrast, often occurs through an offer of an excessive or inappropriate reward or other
overture in order to obtain compliance. For example, an investigator might promise psychology students extra
credit if they participate in the research. If that is the only way a student can earn extra credit, then the
investigator is unduly influencing potential subjects. If, however, she offers comparable non-research alternatives
for earning extra credit, the possibility of undue influence is minimized. Return
Withdrawal of Participants
Examples: Participant does not follow instructions; participant fails to appear for a scheduled research session;
investigator determines it is in best interest of participant not to continue. These should be documented. Return
Examples of procedures that might be followed: debriefing participants; interview to determine reasons for
withdrawing; request to use data accumulated so far; request permission to contact participants for follow-up
questions. Return
Privacy & Confidentiality
Privacy Having control over the extent, timing, and circumstances of sharing oneself (physically, behaviorally, or
intellectually) with others.
Confidentiality Methods used to ensure that information obtained by researchers about their subjects is not
improperly divulged. Return
Definition of Community
For purposes of this question, you may consider the term “community” to be broadly defined and encompass any
group that self-identifies as a community (including ethnic, religious, occupational, social, or special interest group
or group defined by a disease or physical condition), arrangements with local community organizations and
advisory boards, and/or formalized community partnerships.
Developing and strengthening partnerships between the university and the communities it serves is integral to the
university’s mission and an Imperative of CMU’s Strategic Plan 2017-2022. Return

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