Safety and Efficacy of State-of-the-Art Exoskeleton Technology to Improve Mobility in Parkinson's Disease
Phase: NA
Conditions: Parkinson Disease
Sponsor: Virginia Commonwealth University

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Date: Tuesday, March 1, 2022 5:23:59 PM
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ID: MS4_HM20020066
  
Study Identification
1. * Select the Principal Investigator:
Mark Baron
2. * Study Title:
Safety and Efficacy of State-of-the-Art Exoskeleton Technology to Improve Mobility in Parkinson೦s Disease
3. * Is this a student or trainee project in which activities will be carried out by that individual under your
supervision (for example, dissertation or degree-required projects):
  Yes
No
4. * Please select the primary department or center that this study is being conducted under:
Neurology
5. Select the VCU IRB numbers assigned to studies that are:
      1. Associated with this study
      2. Research registries this study will utilize
      3. Previously submitted versions of this study (closed, withdrawn, auto-withdrawn studies)
ID
Title
PI
HM14555 Parkinson's Disease and Movement Disorders Center Data Registry Brian Berman
6. Select all individuals who are permitted to edit the IRB protocol and should be copied on communications
(study staff will be entered later).  These individuals will be referred to as protocol editors:
Last Name
First Name
E-Mail
Phone
Mobile
Baron
Mark
msbaron@vcu.edu
8048289350
 
Blackwell
GinaMari
blackwellgg@vcu.edu
 
 
7. * Select one of the following that applies to the project (selection will branch to new pages):
Note: VCU IRB offers guidance for many types of studies, including secondary data analysis studies, internet
research, registries, EFIC, HUD, and Emergency Use protocols.
See https://research.vcu.edu/human_research/guidance.htm 
Research Project or Clinical Investigation [*most exempt, expedited, and full board research studies]
Exception from Informed Consent (EFIC) for Planned Emergency Research
Humanitarian Use of Device for Treatment or Diagnosis
Humanitarian Use of Device for Clinical Investigation
Emergency Use of Investigational Drug, Biologic or Device
Treatment Use (Expanded Access to Investigational Product for Treatment Use)
Center or Institute Administrative Grant Review
Request for Not Human Subject Research Determination (i.e. request a letter confirming that IRB review is not
required)
ID: MS4_HM20020066
  
Federal Regulations
1. * Is this a FDA regulated study?
FDA regulated research includes all clinical investigations involving a test article and a human subject(s) that
has been submitted for approval to the FDA or may be submitted in the future. 
Check Yes if
೦    the study involves an IND/IDE, abbreviated IDE, IND/IDE exemption, HUD, expanded access, or is
otherwise subject to 21 CFR 56, 
೦    the study involves a test article being administered or dispensed to subjects NOT according to a
clinicians೦ medical judgment but rather, per the study protocol, OR
೦    the study does not involve a test article but intends to provide safety or efficacy data to the FDA.
 
  Yes  No

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View: SF2 - IRB Panel Setup
View: SF2 - Review Setup
2. * Indicate the FDA regulated product(s) this study involves:

Drug

Medical Device

Biologic

Dietary Supplement

Food/Food Additive

Color Additive

Electronic Products for Human Use (radiation producing)

Other
3. * Is this study supported by the Department of Defense (DoD):
  Yes
No
4. * Check if any of the following funding sources apply to this research (including Direct and/or Indirect
funding):

Department of Education

Department of Justice

Environmental Protection Agency

None of the above
ID: MS4_HM20020066
  
IRB Panel Setup
1. * To which IRB is this study being submitted for review?
VCU IRB
WCG IRB
NCI Central IRB
Advarra IRB
Other IRB
2. * Is this study transitioning to review by another IRB?
Yes - transitioning from VCU IRB to an external IRB (WCG, CIRB, Other)
Yes - transitioning from an external IRB (WCG, CIRB, Other) to VCU IRB
No or not applicable
ID: MS4_HM20020066
  
Review Setup
1. * Select which study type best describes the majority of the study. Your response will help determine which
IRB panel should review this.
Bio-Medical Research
Social/Behavioral/Education (SBE) Research
2. * Which option(s) best describe the way(s) this study೦s procedures will be conducted? (Select all that apply.)
This information may be used by the IRB in triaging studies during an emergency.
In-person interactions / interventions with participants
3. * Would it be possible to convert in-person activities in your study to remote if there is an approved
contingency protocol? 
No, not possible to convert to remote activities
 
4. * Does this study involve greater than minimal risk:
  Yes  No
5. * Review type requested: (subject to IRB approval):
Full Board

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View: SF2 - Initial Setup Complete
View: SF2 - Background, Rationale and Goals
Expedited
Exempt
 
6. Is this study initiated by a VCU investigator or a sponsor:
VCU Investigator initiated
Sponsor or industry initiated
 
 
The IRB has determined that the selected types of anticipated individual and social benefit apply to this study
 
The below information is read-only to investigators, and the categories are set by the IRB during review. All
categories will appear blank until the IRB has made a determination. If a category is not checked, it does not
apply to this study. This information may be used by the IRB in triaging studies during an emergency
situation.
Possible or minimal direct benefit to individual participants
Scientific benefit
 
  
 
ID: MS4_HM20020066
  
Initial Setup Complete
Protocol Progress:
? INITIAL SETUP
? BACKGROUND, RATIONALE & GOALS
? RESEARCH PLAN
? CONSENT PLAN
? RISKS, PRIVACY & CONFIDENTIALITY
? POPULATIONS WITH SPECIAL CONSIDERATIONS
? INSTITUTIONAL REQUIREMENTS
? DOCUMENTS
Click Continue below to go to the next section
 
ID: MS4_HM20020066
  
Background, Rationale and Goals
1. * Describe the study's background and what is currently known from the scientific literature, including
citations, or upload a citation list in document upload.  Use lay language whenever possible.
The extent of disability in late stage PD limits the effectiveness of medicines and physical treatment interventions.
When patients become dependent on walkers for mobility or have progressed to the point of being wheelchair or bed
bound, there is essentially no evidence for interventions to support recovery, much the less maintain current function.1
Typical therapy paradigms at this stage are compensatory and focus on caregiver training with reduced patient
autonomy.2,3,4 Robotic-assist gait training (RAGT) has been extensively applied as a remarkable therapeutic modality,
such that it is enabling highly motivated people with devastating neurologic injuries and disorders associated with near
complete motor loss to regain independent ambulation. Currently, RAGT is targeted to a highly restricted population,
including those with spinal cord injuries, strokes, and multiple sclerosis.5 RAGT has evolved from treadmill-based
training to over ground walking by means of portable robotic exoskeletons. Further, lightweight assisted devices
intended for daily wear are being developed by multiple technology companies. These devices are designed to provide
a passive force to assist in mobilizing the legs and to give the additional force necessary to, for example, complete a
full step, aid climbing stairs or traverse a curb. Despite the remarkable potential for this cutting-edge technology to
transform the lives of people with PD and other parkinsonisms, these devices are not being adequately investigated in
this population. FDA approval has not yet been obtained for these over ground exoskeleton devices in our proposed
population. We are, therefore, effectively the frontrunners in advancing the use of portable exoskeletons for PD and
other movement disorders.
To date, RAGT has only been investigated in PD subjects using limited treadmill-based systems and these studies
have only focused on those with retained independent ambulation. One such study determined that the Hocoma
Lokomat೦ treadmill-based system was safe and well tolerated in patients with Hoehn & Yahr (H&Y) stages II and III
when operated 3 times per week for 30 minutes per day at 2.2 ೦ 2.5 km/h. Participants experienced improvements in
Tinetti Walking, Tinetti Balance, UPDRS Part III, and Geriatric Depression Scale (GDS); however, no effect was noted
on 10-meter Walking Test (10MWT) or PDQ39.6 More recent case studies reported improved FOG following Hocoma
Lokomat೦ training, but these studies again were focused on treadmill-based RAGT in patients who remained
independent for ambulation.7
Studies in other patient populations have demonstrated training effects with treadmill based RAGT systems that
typically lack carryover upon follow-up assessment.8 In comparison to RAGT treadmill systems which can perform

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View: SF2 - Study Population
walking 100% passively, the increased intensity, salience, and variability in training environments afforded by over
ground exoskeleton units are anticipated to yield appreciable greater therapeutic results. Patients will be able to
negotiate an environment, rather than a closed course of a treadmill system, for greater engagement with changing
scenery and stimulation. We recognize the importance of patient engagement and motivation as it pertains to motor
control theory and neural plasticity.9 These features are crucial in retraining or maintaining a skill such as walking.
Ultimately, due to the lighter weight of these portable exoskeleton devices, patients can be expected to use the devices
for regular wear outside of the therapy environment. Home use is expected to not only produce better outcomes of
mobility but also provide the greatest benefit to quality of life by improving or maintaining participation in family-based
and community activities.
2. * Describe the study hypothesis and/or research questions.  Use lay language whenever possible.
Is the wearable exoskeleton assistive technology safe for people with debilitating movement disorders to use on a daily
basis?
What is the potential efficacy of wearable exoskeleton assistive technology and will it be transformative for day to day
functioning of those with debilitating movement disorders?
3. * Describe the study's specific aims or goals.  Use lay language whenever possible.
Aim 1. To establish the safety of a portable exoskeleton for walking training in persons with PD.
We will measure safety as it pertains to the absence of or limited adverse events with training. We will assess via
tracking of adverse events throughout training, including the number of "prevented" or "near falls" requiring physical
assistance by the investigative training team.
Aim 2. To assess the efficacy of a portable exoskeleton for gait mobility and postural stability in persons with PD.
Intervention efficacy will be measured through comparative analysis of pre-, post- and durability assessments of
mobility and impairment. We will assess walking capacity and benefit (and safety) to management of freezing of gait
(FOG) with the Six Minute Walk Test (6MWT), and Ten-Meter Walk Test (TMWT), balance and postural stability with the
Berg Balance Scale (BBS), disease severity with the Examination, part III of the Unified Parkinson೦s Disease Rating
Scale (UPDRS), and impact on quality of life and activities of daily living, through the Parkinson೦s Disease
Questionnaire (PDQ39) and the Parkinson೦s Disease Carer Questionnaire (PD-Carer). During measure of the 6MWT
and TMWT, both aided by the exoskeleton and unaided (i.e. standard), additional data points will be collected through
use of the APDM Mobility Lab wearable sensor system. Six sensors will be placed on specific landmarks to capture
truncal and appendicular movement. Our team proposes the use of the following measures to best track proficiency of
exoskeleton device use and net effect on FOG: cadence, gait cycle duration, gait speed, double support time, stance
time, step duration, stride length, swing phase, toe out angle, stride length variability, arm swing velocity, arm swing
range of motion, and anticipatory postural adjustment via APA duration, first step duration, and first step range of
motion. These anticipatory postural adjustment measures are specific to initiation of gait, a critical event impacted by
FOG. Additionally, measures of truncal sway will further strengthen our assessment of postural stability relative to
dynamic walking.
At end of training, the 6MWT will be compared with and without the exoskeleton towards our goal of establishing an
indication for long-term studies assessing in-home use. The 6MWT will be adminstered with standard instructions while
also scoring FOG based on the criteria in the UPDRS items 3.10 (Gait) and 3.11 (Freezing of Gait) during 6MWT with
and without the exoskeleton.
4. * Describe the scientific benefit or importance of the knowledge to be gained:
We expect that mobile exoskeleton devices will provide a tremendous advancement for walking and bending
assistance for people with PD and other movement disorders, permitting them to maintain a more normal lifestyle and
quality of life. Portable exoskeleton devices can be expected to afford major advantages over current usage and
dependence on walkers in those with advancing symptoms. For those however dependent on walkers for postural
stability, the addition of an exoskeleton device will permit more effective ambulation at appreciable quicker speeds. For
drastically lower cost than motorized wheelchairs, personal exoskeleton devices will circumvent or delay the need of
motorized wheelchair dependence and associated deterioration and shorting of life in those with debilitating movement
disorders.
While PD is itself a devastating condition, atypical forms of parkinsonism do not respond to medications and current
therapies offer only modest benefits and so portable exoskeletons can provide people with these conditions new hope
to maintain functional mobility. A longer term goal of this work will be to continue to modify these devices to be
costumed for the individual.
5. * Describe any potential for direct benefits to participants in this study:
Patients may have increased mobility and/or other secondary benefits after completing the trial.
6. * Describe any potential for direct social impact in this study . For example, any engagement with specific
communities to respond to community-identified needs, or ways the study will strengthen the well-being of
the specific communities if applicable:
n/a
7. Upload a supporting citation list if applicable:
 
ID: MS4_HM20020066
  
Study Population
1. * Provide the maximum number of individuals that
  1. May participate in any study interaction or intervention (Including screening, consenting, and study
activities)
      AND/OR
  2. You obtain any data/specimens about (regardless of identifiability) 
 at VCU and at other sites under the VCU IRB's oversight. See the help text for additional guidance.
90 
2. If this is a multi-Center Project, what is the maximum anticipated number of subjects across all sites?

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View: SF2 - Background, Rationale & Goals Section Complete
View: SF2 - Study Procedures
3. * Provide justification for the sample size by explaining how you arrived at the expected number of
participants and why this number is adequate for answering the research questions:
An overarching goal of this pilot study is to obtain estimates of the means and variances of all study measures to
facilitate a power analysis for future extramurally funded clinical trials. van Belle proposed that a minimum of 12
observations should be used to calculate confidence intervals based on the t-statistic with n ೦ 1 degrees of
freedom.17 This rule is based on the fact that the half-width confidence interval for the mean decreases rapidly up to n
= 12, at which point the decrease is less dramatic and the half-width curve begins to asymptotically decrease. Thus,
the proposed sample size of 12 per H&Y group (3 groups of H&Y) should be adequate to provide means and variance
for planning of future studies.
We also expect to enroll 1 caregiver for each participant enrolled.
We proposed up to 90 participants because we included persons who signed the consent but were ineligible to
participate and those that started the protocol but dropped out.
4. * List the study inclusion criteria:
Parkinson's Participant
1) age 21 years or older,
2) PD confirmed by a movement disorder specialist using UK Brain Bank Criteria,
3) H&Y stage II, III, IV, or V.
Caregiver participant
1) Willing to complete questionnaire
5. * List the study exclusion criteria:
Parkinson's Participant
1) neurological, musculoskeletal, or other disorders unrelated to PD contributing to impairment of gait, stance, balance
or coordination,
2) history of implantable cardiac device or ablative surgery,
3) moderate to severe cognitive impairment / dementia (Montreal Cognitive Assessment < 17/30), impairing the ability
to follow simple commands during assessments and intervention sessions,
4) uncontrolled orthostatic hypotension,
5) feeding tube or associated port placement (PEG/J-PEG),
6) body height less than 5೦1೦ or greater than 6೦3೦ and
7) body weight greater than 250 pounds.
Caregiver participant
1) Unwilling to complete questionnaire
6. * Will individuals with limited English proficiency be included in or excluded  from this research?
Included
Excluded - safety concerns if participants are unable to communicate with the study team
Excluded - instruments/measures only validated in English
Excluded - no prospect of direct benefit to individual participants
Excluded - minimal risk study
Excluded - lack of budget/resources for translation and interpretation [provide an explanation in next question]
Excluded - other reason [provide an explanation in next question]
7. Justify the inclusion and exclusion criteria if you are either targeting, or excluding, a particular segment of the
population / community. Provide a description of the group/organization/community and provide a rationale.
Due to the ongoing COVID-19 pandemic we have experienced difficulties in recruiting individuals with late stage
Parkinson's disease. We intend to continue in our attempts to recruit H&Y Stage V subjects; however, we are
understanding of the personal decision to minimize exposure risk and decline participation in the study. The potential
benefit of the device could also be extended to early disease staging, such as H&Y Stage II subjects. Potential
subjects with Parkinson's disease are reporting greater inactivity due to changes in access to exercise-related services.
We propose the inclusion of H&Y Stage II subjects to provide otherwise unavailable exercise-related intervention with
documented medical benefit in this population.
For participants exhibiting moderate to severe cognitive impairment may still participant if scoring < 17/30 on the
Montreal Cognitive Assessment if a legally authorized representative (LAR) approves participation. The subject must
be able to follow commands associated with the listed outcome measures and follow instructions during walking
intervention.
 
ID: MS4_HM20020066
  
Background, Rationale & Goals Section Complete
Protocol Progress:
? INITIAL SETUP
? BACKGROUND, RATIONALE & GOALS
? RESEARCH PLAN
? CONSENT PLAN
? RISKS, PRIVACY & CONFIDENTIALITY
? POPULATIONS WITH SPECIAL CONSIDERATIONS
? INSTITUTIONAL REQUIREMENTS
? DOCUMENTS
Click Continue below to go to the next section
ID: MS4_HM20020066

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Study Procedures
 
1. * Describe the study hypothesis and/or research questions.  Use lay language whenever possible.
Is the wearable exoskeleton assistive technology safe for people with debilitating movement disorders to use on a daily
basis?
What is the potential efficacy of wearable exoskeleton assistive technology and will it be transformative for day to day
functioning of those with debilitating movement disorders?
2. * Describe the study's specific aims or goals.  Use lay language whenever possible.
Aim 1. To establish the safety of a portable exoskeleton for walking training in persons with PD.
We will measure safety as it pertains to the absence of or limited adverse events with training. We will assess via
tracking of adverse events throughout training, including the number of "prevented" or "near falls" requiring physical
assistance by the investigative training team.
Aim 2. To assess the efficacy of a portable exoskeleton for gait mobility and postural stability in persons with PD.
Intervention efficacy will be measured through comparative analysis of pre-, post- and durability assessments of
mobility and impairment. We will assess walking capacity and benefit (and safety) to management of freezing of gait
(FOG) with the Six Minute Walk Test (6MWT), and Ten-Meter Walk Test (TMWT), balance and postural stability with the
Berg Balance Scale (BBS), disease severity with the Examination, part III of the Unified Parkinson೦s Disease Rating
Scale (UPDRS), and impact on quality of life and activities of daily living, through the Parkinson೦s Disease
Questionnaire (PDQ39) and the Parkinson೦s Disease Carer Questionnaire (PD-Carer). During measure of the 6MWT
and TMWT, both aided by the exoskeleton and unaided (i.e. standard), additional data points will be collected through
use of the APDM Mobility Lab wearable sensor system. Six sensors will be placed on specific landmarks to capture
truncal and appendicular movement. Our team proposes the use of the following measures to best track proficiency of
exoskeleton device use and net effect on FOG: cadence, gait cycle duration, gait speed, double support time, stance
time, step duration, stride length, swing phase, toe out angle, stride length variability, arm swing velocity, arm swing
range of motion, and anticipatory postural adjustment via APA duration, first step duration, and first step range of
motion. These anticipatory postural adjustment measures are specific to initiation of gait, a critical event impacted by
FOG. Additionally, measures of truncal sway will further strengthen our assessment of postural stability relative to
dynamic walking.
At end of training, the 6MWT will be compared with and without the exoskeleton towards our goal of establishing an
indication for long-term studies assessing in-home use. The 6MWT will be adminstered with standard instructions while
also scoring FOG based on the criteria in the UPDRS items 3.10 (Gait) and 3.11 (Freezing of Gait) during 6MWT with
and without the exoskeleton.
3. * Choose all types of recruitment materials that may be used and upload them below:

E-mail invitations

Phone Solicitation scripts (i.e. cold calls or random-digit-dialing)

Flyers, Mailed Letters or Newspaper/TV/Radio Ads

TelegRAM announcements

Website text

Study-specific web sites (provide the design and text)

Social Media

EPIC MyChart Patient Portal research study descriptions

Psychology Research Participant Pool (SONA) study descriptions

Scripts for announcements made to groups

Other recruitment material

No recruitment materials
4. * Describe the study procedures/methods for identifying and recruiting participants. Address the following
three aspects of recruitment in your response. 
1. Identification of potentially eligible participants or secondary data/specimens of interest.
     - What database(s) will be queried to identify secondary data/specimens
     - How potential participants' contact information will be obtained
2. Recruitment procedures to invite participation in the study (when applicable):
     - How each of the written or verbal recruitment materials and reminders (selected above) will be used
     - Who will contact or respond to potential participants
     - Locations where recruitment procedures will take place
     - The timing and frequency of recruitment attempts
3. Eligibility screening prior to consent and how those activities will be carried out (when applicable)
See the help text for additional guidance.
RECRUITMENT PROCESS:
HOW WILL POTENTIAL PARTICIPANTS BE IDENTIFIED AND THEIR CONTACT INFORMATION OBTAINED?
WHAT AND HOW WRITTEN OR VERBAL RECRUITMENT MATERIALS BE USED?
1) Screening during clinic visits (or in advance of clinic visits) at the Parkinson's Movement Disorder Center will be

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accomplished by screening clinic schedules and looking at the Cerner electronic medical records to confirm patient's
Parkinson's disease (PD) diagnosis.
This will be conducted by study staff. Patients with PD related gait disturbances will be informed of the study by their
provider. If interested, they will be put in touch with the study staff directly or handed a post-card/flier described in #2.
2) Post-card/flier announcements will be available for review in clinic exam rooms. If the patient is interested, they can
contact the study staff using the contact information on the card.
3) Post-card/flier announcements of the study will also be made available to local support groups and at local PD
community events. If the patient is interested, they can contact the study staff using the contact information on the
card.
4) The PMDC Research registry for PD patients interested in being contacted about research opportunities will be
screened by the study coordinator.
5) The organizers of local support groups will be contacted and asked if they would be willing to allow study staff to
speak to the groups. If allowed, study staff will inform the groups of the study (using the scripts for announcements
made to groups). Post-card/flier announcements will be left with the groups and members can contact the study staff if
interested.
Caregivers will be recruited after the PD participant has agreed to participate and is found to be eligible to participate in
the study.
NOTE - A POST-CARD/FLIER WILL BE UPLOADED AFTER IRB APPROVAL WITH AN AMENDMENT.
All prospective participants will be called (i.e., identified by provider or from registry), or they will call the study
coordinator (using information on post-card/flier). The study coordinator will inform them of the study and then ask if
they are willing to participate. If yes, they will be asked the screening questions (see pre-screen phone script in
documents). Pre-screen phone scripts will be destroyed immediately after determining eligibility. If they are eligible to
participate and agreeable, they will be scheduled for an initial visit when the full consent will be explained, questions
answered, and consent signed. Participants will receive a signed copy of the consent at that time. Participants will be
verbally reminded (by phone or in person) when their next visit will occur.
If they do not meet the eligibility criteria, their name will be kept with a generic "did not meet eligibility criteria" so as not
to be contacted again for the same study.
TIMING AND FREQUENCY OF RECRUITMENT ACTIVITIES
Recruitment will start once IRB approval is established. Frequency of recruitment activities will occur when patients are
attending the PMDC clinic on a weekly basis. Support groups meet at most, monthly.
WHERE AND HOW RECRUITMENT PROCEDURES WILL BE COMPLETED
Recruitment will occur at the VCU Parkinson೦s and Movement Disorder Clinic on the 4th floor of the NOW building at
Short Pump. Study staff will be available on clinic days to speak with potential participants identified by the patient೦s
provider as interested in learning more about the study.
WHO WILL RECRUIT OR RESPOND TO POTENTIAL PARTICIPANTS?
The study coordinator and PIs will respond to potential participants.
ALL screening procedures described above are performed for the purpose of screening, recruiting or determining the
eligibility of prospective subjects for this study.
5. * Does this study have a separate protocol document (i.e. a multisite or sponsor's protocol) that contains a
detailed description of the study's methodology?
  Yes
No
6. * Since a separate protocol document is not uploaded, describe the proposed research using language
understandable to those IRB committee members whose expertise is not scientific. The description must
include:
1. A statement explaining the study design
2. A detailed description of all the procedures that will be followed to carry out the study, preferably in
sequential order, and in sufficient detail that the study's methods could be replicated
3. A description of all research measures/tests/interventions that will be used (if applicable)
See the help text for additional guidance
PD Participants:
3 hours are required for each the pre-, post-, and durability assessments in order to collect outcome measures, a 10
meter WT, a 6MWT, the BBS, disease severity with the Examination, part III of the UPDRS, and PDQ39. For visually
impaired, either the caregiver or a member of the research staff will read the PDQ39 to the participant then answers
will be documented. Additionally, the pre-assessment visit will also include consent review, the MoCA (or blind MoCA
which will be given to visually impaired participants that may not be able to see what's on paper but are still able to see
enough to walk) and medical history including height, weight and BP and an additional 6MWT with the device on to
allow the patient to get familiar with the device prior to treatment. Safety will be ensured through use of a gait belt and
two supervising staff providing lateral support as necessary. A harness system has been considered as it could
potentially influence movement patterns and/or incite anxiousness, both of which have been observed when using
body weight-supported systems in patients with PD. Two spotters will provide necessary anterior or posterior
assistance in the case of a loss of balance. If a subject is unable to ambulate one length of the measured 6MWT (10
meters) while wearing the exoskeleton without physical assistance, a harness may be used during the training
intervention. Post-intervention assessments will be completed within 1 week of the final study visit. Durability
assessments will be completed between 4-6 weeks following the final study visit. All assessments and testing will be
restricted to the patient೦s best on time.
Subjects will participate in a total of 10 sessions, twice per week for 5 weeks, with the Keeogo೦ device and the APDM
Mobility Lab wearable sensor system. (The APDM Mobility Lab wearable sensor system is an FDA approved device
that measures to best track proficiency of exoskeleton device use and net effect on FOG: cadence, gait cycle duration,
gait speed, double support time, stance time, step duration, stride length, swing phase, toe out angle, stride length
variability, arm swing velocity, arm swing range of motion, and anticipatory postural adjustment via APA duration, first
step duration, and first step range of motion. These anticipatory postural adjustment measures are specific to initiation
of gait, a critical event impacted by FOG. Additionally, measures of truncal sway will further strengthen our assessment

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of postural stability relative to dynamic walking.) A goal of 30 minutes total walking time is desired within each session.
Participants will be able to rest, as needed. Completing 30 minutes of walking may require multiple walking trials within
sessions due to fatigue. If a subject is unable to complete 30 minutes of walking within an allotted one-hour session,
the total walking time will be recorded. The first six minutes of walking with the Keeogo೦ device will be completed per
the instructions of the 6MWT, in order to longitudinally measure proficiency with the device. Use of an assistive device
will be allowed, though not required. Subjects may opt to utilize a platform rolling walker, rolling walker, bilateral
Lofstrand crutches or a unilateral device, such as a cane or Lofstrand crutch. Assistive device of choice will be
consistent with baseline and maintained throughout the intervention. Patients who are functionally non-ambulatory at
baseline will utilize a rolling walker or platform rolling walker with the exoskeleton. One-hour sessions will allow for
safety with setup and management of the exoskeleton. There are no restrictions or specific instructions necessary to
users during the remainder of the session beyond the first six minutes of walking each session.
Caregiver:
The caregiver will be asked to complete the PD-Carer survey 3 times, once each at the PD participants pre-, post-, and
durability assessments. They will be allowed to complete the survey in a private space. No identifying information will
be collected from the caregiver. They will be given the same generic code as the PD participant.
7. * The IRB only reviews research activities, so indicate which of the study activities are:
  - Being performed exclusively for research purposes (i.e. they would not otherwise be done apart from this
study) VERSUS.
  - Alterations of routine activities/procedures (e.g. the study is altering the timing, frequency, method,
location, amount, etc.) VERSUS.
  - Being done for other purposes and whose data/results will be used secondarily in the study (e.g. standard
medical or psychological tests, routine education practices, quality improvement initiatives, etc.).
All procedures are performed exclusively for research purposes.
8. If applicable, describe alternatives (research or non-research) that are available to potential participants if they
choose not to participate in this study:
9. Upload any supporting tables or documents (e.g. protocol documents, figures/tables, data collection forms,
study communications/reminders):
Upload ALL instruments/guides that will be used or that participants will experience (i.e. see, hear, complete),
including measures, scripts/questions to guide interviews, surveys, questionnaires, observational guides,
etc,:
Upload ALL recruitment and screening materials, including such as ads, flyers, telephone or in-person scripts,
letters, email invitations, TelegRAM announcements, and postcard reminders, screening scripts, screening
forms, and screening measures:
ID: MS4_HM20020066
  
Project Details
1. * Select all of the following types of interventions that apply to this study (selections will branch):

Social/Behavioral interventions or experimentation / Tasks / Environmental manipulations

Deception (misleading participants through false or incomplete information)

Drug(s) / Biologics / Supplement(s) / Other Compounds (investigational products or products whose
administration is dictated by the study protocol and not per the physician's clinical judgment)

Placebos

Safety and/or effectiveness evaluation of Bio-Medical Device(s), including in-vitro diagnostic
devices/assays, mobile medical apps, software functions, and HUDs used in clinical investigations

Washout Periods

Expanded Access - Treatment Use of an Investigational Product

Medical or Surgical Procedures (eg: physical exam, clinical procedures, scans, etc)

Specimen/biological sample collection

None of the Above
2. * Select all of the following types of interactions that apply to this study (selections will branch):

Surveys / Questionnaires /Written responses to questions (including data entry)

Active Internet data collection (i.e. using the internet to interact or intervene directly with research participants)

Interviews / Focus Groups / Verbal responses to questions

Audio / Video recording or photographing participants

Observations

Passive Internet data collection (i.e. passively observing online behavior)

Educational Settings/Assessments/Procedures

None of the Above
3. * Select all types of recordings that will be made:

Audio

Video

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
Photographs
4. * Describe the purpose of the recordings, who will be recorded and when such recordings will occur:
Photographs and video's of walking may be used for the purposes of education, presentation of findings, and future
data analysis. Photographs and video will be taken only from the neck down in order to maintain privacy for the
participant.
5. * Select all types of secondary information and/or specimens that apply to this study (selections will branch):
See the help text for definitions.

Individually Identifiable Health Information (PHI or RHI)

Secondary data/specimens NOT from a research registry or repository

Information/specimens from a research registry or repository (Usage Protocol)

Information/specimens originally collected for a previous research study

Publicly available information/specimens

Government-generated or collected information that was or will be obtained for nonresearch activities [only
applicable to research conducted by or on behalf of a Federal department or agency]

No secondary data/specimens will be used
 
ID: MS4_HM20020066
  
Bio-Medical Device Details
1. * Select the type of device :

Marketed Device (including 510k device) used as indicated

Marketed but new indication or intended use

Mobile application or software function with regulatory discretion

Mobile application or software function without regulatory discretion

Investigational device

Humanitarian Use Device (HUD)
2. * List devices this study will involve:
Device
ManufacturerDevice Risk
IDE
IDE Holder
Keeogo Dermoskeleton
b-temia Inc.
Not Designated / Not
Required
IDE
Exempt
VCU Sponsor-
Investigator
APDM Mobility Lab wearable sensor
system
ERT
Not Designated / Not
Required
n/a
Not Required
3. * Describe how the device will be stored and controlled.
The devices will be stored in its lock-bearing case, in a locked closet at NOW.
4. A. For each device listed above, upload documentation of the approved use(s) (operation manual, instructions
for use, etc.) or a detailed description of the design, use, and risks of the device.
B1. If 'Investigational Medical Device' or 'New Use for Marketed Medical Device' was selected above AND the
device qualifies for IDE exemption under under 21 CFR 812.2(c), upload one of the following documents for
each applicable device:
   - A document explaining how the device's use in this study meets one of the categories for IND exemption
under 21 CFR 812.2(c).
   - External sponsor's protocol including IDE exemption information
   - Communication from the external sponsor verifying the IDE exemption
   - Communication from the FDA with verification of IDE exemption
B2. Upload at least one of the following documents for each Significant Risk medical device:
   - External sponsor's protocol including IDE number
   - Communication from the external sponsor verifying the IDE number
   - VCU sponsor-investigator's FDA IDE protocol including IDE number
   - Communication from the FDA with verification of the IDE number
B3. Upload at least one of the following documents for each Non-Significant Risk medical device:
   - External sponsor's protocol including a justification regarding the risk of the device (significant vs. non-
significant)
   - Communication from the sponsor holding the IDE, which provides a justification regarding the risk of the
device (significant vs. non-significant) according to 21 CFR 812.3(m).
 
Document Name
Document
VersionDate
Modified
Uploaded
By
Type
Approved
View Consent_exoskeleton
Consent_exoskeleton_01202022a.pdf
0.17
1/26/2022
2:55 PM
Mark Baron Consent/Assent/Information
Sheet
Yes
View Consent_exoskeleton_large_print Consent_exoskeleton_large_print_version_01202022.pdf 0.05
1/26/2022
2:55 PM
GinaMari
Blackwell
Consent/Assent/Information
Sheet
Yes

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Document Name
Document
VersionDate
Modified
Uploaded
By
Type
Approved
View Consent_SO
Consent_exoskeleton_SO_v1.1.pdf
0.08
1/26/2022
2:55 PM
GinaMari
Blackwell
Consent/Assent/Information
Sheet
Yes
View PROC not activated
PROC neurology not activated.pdf
0.01
1/20/2022
11:45 AM
GinaMari
Blackwell
Ancillary Committee
Approval
Not
Applicable
View VCU Informed Consent
Evaluation Tool
ICEval.doc
0.01
2/23/2021
3:13 PM
GinaMari
Blackwell
Consent/Assent/Information
Sheet
Not
Applicable
View MoCA - blind
MoCA-Test-BLIND - 04-2020.pdf
0.01
2/1/2021
3:52 PM
GinaMari
Blackwell
Research Measure
Yes
View NSR Device APDM
APDM CE 510k exempt.pdf
0.01
11/10/2020
3:18 PM
GinaMari
Blackwell
Other
Not
Applicable
View APDM User Manual
APDM MobilityLab_UserGuide.pdf
0.01
10/25/2020
5:14 PM
GinaMari
Blackwell
Other
Not
Applicable
View Keeogo User Manual
IFU-006-EN v1.1 Keeogo_ User Manual
(USA)_approved.pdf
0.02
10/14/2020
5:49 PM
GinaMari
Blackwell
Drug/Device Brochure
Not
Applicable
View User Manual
IFU-003-EN v1.2_Keeogo_ Clinician
Manual_approved.pdf
0.02
10/14/2020
5:48 PM
GinaMari
Blackwell
Drug/Device Brochure
Not
Applicable
View Article for NSR device
Keeogo in MS open label.pdf
0.01
9/23/2020
10:49 AM
GinaMari
Blackwell
Other
Not
Applicable
View Pre-screen phone script
prescreen phone script_exoskeleton2.docx
0.02
9/21/2020
3:59 PM
GinaMari
Blackwell
Recruitment/Advertising
Yes
View Consent from HM14555
PMDC registry-May 2019-clean.pdf
0.01
9/16/2020
11:09 AM
GinaMari
Blackwell
Other
Not
Applicable
View Support Group Script
Script for Support Groups 9.16.20.docx
0.01
9/16/2020
10:42 AM
GinaMari
Blackwell
Recruitment/Advertising
Yes
View Demographics exoskeleton
Demographics exoskeleton.docx
0.01
8/17/2020
4:38 PM
Mark Baron Research Measure
Yes
View References
References.docx
0.01
8/13/2020
3:44 PM
GinaMari
Blackwell
Other
Not
Applicable
View PDQ-Carer
FINAL_PDQ-C_English_UK.pdf
0.01
8/11/2020
1:12 PM
GinaMari
Blackwell
Research Measure
Yes
View MoCA
MoCA.pdf
0.01
8/10/2020
5:23 PM
GinaMari
Blackwell
Research Measure
Yes
View UPDRS-Part III
MDS-UPDRS_Part III.pdf
0.01
8/10/2020
5:20 PM
GinaMari
Blackwell
Research Measure
Yes
View PDQ-39
PDQ39.pdf
0.01
8/10/2020
5:02 PM
GinaMari
Blackwell
Research Measure
Yes
View Berg Balance Scale
BBS short form.pdf
0.01
8/10/2020
4:54 PM
GinaMari
Blackwell
Research Measure
Yes
View Hand Biosketch
Hand Biosketch.pdf
0.01
8/10/2020
4:51 PM
GinaMari
Blackwell
CV/Biosketch
No
View Baron Biosketch
Baron Biosketch.pdf
0.01
8/10/2020
4:51 PM
GinaMari
Blackwell
CV/Biosketch
Yes
View IDE Exemption
Keeogo_No IDE Req'd.pdf
0.01
8/10/2020
4:42 PM
GinaMari
Blackwell
FDA Regulatory Document Not
Applicable
 
ID: MS4_HM20020066
  
Secondary Data/Specimen Details
1. * Describe the source(s) and nature of the information/specimens being obtained. This response should:
  a. Identify where the data/specimens will come from (e.g., another researcher's registry, pathology lab,
commercial source, medical records, etc.); and
  b. List what types of specimens will be obtained (when applicable); and/or
  c. List all data elements that will be obtained (when applicable). A data collection form or other
documentation may be uploaded and referenced here.
The VCU PMDC research registry is a database of individuals seen at the VCU Parkinson೦s and Movement Disorders
Center who have already consented to be contacted about future research studies. The Data Registry includes
information from routine clinical evaluations, including appropriate scales relevant to the clinical diagnosis, neurology
examination and history notes, neuropsychology examination and history notes and cognitive and effective
assessments, physical therapy examination and history notes and mobility ratings, speech therapy examination and
history notes, and sleep specialty evaluations and examination and history notes.

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View: SF2 - Compensation
This database will be screened by appropriate study staff to identify potential participants and call them on the phone
to discuss the study.
The study staff will also screen the PMDC clinic schedule for potential participants. If a potential participant (someone
with gait and balance problems) is found on the clinic schedule, the study staff will confirm their diagnosis in Cerner
(the clinic's electronic medical record), and then notify the potential participant's provider. The provider will inform the
potential participant about the study and provide them with the contact information of the study staff. The potential
participant will be able contact the study staff. Any individual recruited in this manner will be fully consented, if they are
interested in participating. Study staff will not keep any information about daily clinic schedules, they will only confirm
whether the potential patient has a diagnosis of Parkinson's disease or not.  
2. * Describe whether any agreement exists between you and data/specimen provider that states you will never
have access to the ability to identify the participants (i.e. access to identifiers or the code key) and that you
will not attempt to re-identify individuals.
Registry:
The identifiers that will be obtained are the names and contact information of prospective participants. This will be
provided by the study staff member that is maintaining the PMDC registry of patients who have consented to be
contacted for future research studies. We will not have to re-enter the PMDC registry for this study after recruitment
efforts are complete. There are NO needs for code access to the registry. A separate coding system will be initiated
specifically for this study and only persons who meet the eligibility criteria and agree to the initial screen will receive a
code. Names of persons who are not interested or do not meet the eligibility criteria will kept in a separate spreadsheet
that will be destroyed at the end of the recruitment period.
Clinic Patients and Cerner:
Once patients are identified by screening clinic schedules for people with gait and balance problems and confirmed
Parkinson's diagnosis (via Cerner electronic medical records), the potential patient's healthcare provider will ask their
patient if they would like to hear more about this study. The healthcare provider will give the patient the contact
information for the study staff (post card). Study staff will not keep any information about daily clinic schedules or
Cerner. There is no need to retain any information from Cerner.
3. * When the information/specimens were originally collected, did individuals provide consent for secondary
research use of their data/specimens (i.e. consent to another research study or to a research registry)?
  Yes
No
4. * Provide name(s) of the registry/repository being accessed.
Parkinson's Disease Center Data Registry.
5. * Site having responsibility for the management of this registry/repository:
VCU
Non-VCU
6. If the registry / repository is located at VCU, provide the IRB number for the registry / repository.
HM14555
7. * Is the original consent form that participants signed upon entry into the registry /repository available?
  Yes
No
8. If YES, the original consent is available, upload it for the IRB to reference
 
 
ID: MS4_HM20020066
  
Costs to Participants
1. * Select all categories of costs that participants or their insurance companies will be responsible for:

Participants will have no costs associated with this study

Study related procedures that would be done under standard of care

Study related procedures not associated with standard of care

Administration of drugs / devices

Study drugs or devices

Other
 
ID: MS4_HM20020066
  
Compensation
It is recommended that investigators consult with VCU Procurement Services before proposing a compensation plan
(monetary or non-monetary) to the IRB to ensure the plan will comply with VCU policies. Refer to WPP XVII-2 for the IRB೦s

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View: SF2 - Research Plan Complete
View: SF2 - Consent Process
guidelines about compensating research participants.
1. * Describe any compensation that will be provided including:
   1. total monetary amount
   2. type (e.g.,  gift card, cash, check, merchandise, drawing, extra class credit)
   3. how it will be disbursed
   4. how you arrived at this amount
Participants will not be compensated in this study.
2. If compensation will be pro-rated, explain the payment schedule.
3. * Will Social Security Numbers be collected for compensation purposes only?
  Yes
No
 
ID: MS4_HM20020066
  
Contingency Plan
This page will be used by the IRB in the event that an institution-wide emergency situation arises that requires
contingency plans. 
A contingency plan describes the alternative procedures that a study would want to use in case of an emergency that
prevented normal study activities from occurring. It is a form of adaptive protocol. It enables the VCU IRB to quickly
approve alternative study activities along with criteria for when those activities would or would not be put into effect.
For example, in 2020, some studies had a COVID-19 Contingency Protocol approved that described alternative
remote procedures that they would switch to whenever the University restricted in-person research activities.
In all studies, investigators are strongly encouraged to plan prospectively and build flexibilities into their regular
protocols (regardless of whether an emergency situation exists) as well as think about what they would do in an
emergency situation. For example, windows for timed study visits, ranges instead of exact values, flexibilities in
inclusion criteria, etc. Flexibility and adaptations that are built into the protocol will reduce the number of changes
that have to be submitted to the IRB and should reduce the number of incidents of deviations and noncompliance by
investigators.
Further instructions and smartform questions on this page will be released from the IRB in the event of such an
institution-wide emergency situation.
 
ID: MS4_HM20020066
  
Research Complete
Protocol Progress:
? INITIAL SETUP
? BACKGROUND, RATIONALE & GOALS
? RESEARCH PLAN
? CONSENT PLAN
? RISKS, PRIVACY & CONFIDENTIALITY
? POPULATIONS WITH SPECIAL CONSIDERATIONS
? INSTITUTIONAL REQUIREMENTS
? DOCUMENTS
Click Continue below to go to the next section
 
ID: MS4_HM20020066
  
Consent Process
1. * List all consent groups:
 
Group
Types
Waivers
Roles
Roles
-
Other
Electronic
SignaturesConsent
Coercion
Decision Re-
Consent
View Partial
waiver for
pre-screens
from
registry
None of the
Above (select
waiver below)
Waiver of
All
Consent
or Some
Elements
in Consent
Form
Principal
Investigator
Co/Sub-
Investigator
Research
Coordinator
 
Not using
electronic
signature
platforms
Registry
participants
who appear to
meet basic
inclusion
criteria will be
contacted and
offered
participation in
this study.
Those
interested will
Sitting down
beside the
participant
instead of
standing over
them
If obtaining
consent /
assent in a
clinical setting,
letting patients
sit instead of
Indefinite
 

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Group
Types
Waivers
Roles
Roles
-
Other
Electronic
SignaturesConsent
Coercion
Decision Re-
Consent
be scheduled
for a study
screening visit,
at which time
they will go
through the
informed
consent
process with
study staff and
will either
choose to sign
the form or
not.
lie down (if
they are able
to)
Other
protection(s)
not listed here
೦ describe
below
View Clinic
patients
None of the
Above (select
waiver below)
Waiver of
All
Consent
or Some
Elements
in Consent
Form
Principal
Investigator
Co/Sub-
Investigator
Research
Coordinator
 
Not using
electronic
signature
platforms
If a potential
participant is
found in the
clinic schedule
and
confirmation of
diagnosis is
confirmed by
reviewing the
patient's
electronic
medical
records, the
study staff will
notify the
potential
participants
provider. The
provider will
inform the
potential
participant
about the
study and
provide them
with the
contact
information of
the study staff.
The potential
participant will
be able
contact the
study staff.
Sitting down
beside the
participant
instead of
standing over
them
If obtaining
consent /
assent in a
clinical setting,
letting patients
sit instead of
lie down (if
they are able
to)
Other
protection(s)
not listed here
೦ describe
below
They will
be allowed
to take as
much time
as needed
to read the
ICF, ask
questions,
and make
a decision.
If they wish
to take the
informed
consent
form (ICF)
home to
think about
it, they may
do that and
return at a
later date
to enroll in
the study.
 
View Caregivers
of PD
Patient
Participants
Signed Consent
by Participant
No
Waivers
Requested
Principal
Investigator
Co/Sub-
Investigator
Research
Coordinator
 
Not using
electronic
signature
platforms
Informed
consent will be
obtained at the
start of the visit
before any
study
procedures are
done. The
consent
process will
occur in a
private exam
room.
After each
study visit, the
patient will be
asked to
continue in the
study by
confirming
their next visit.
Participants
will be
informed of
their right to
withdraw from
the study at
any time
without
prejudice. If a
new consent is
approved after
a participant
starts the
study but
Sitting down
beside the
participant
instead of
standing over
them
If obtaining
consent /
assent in a
clinical setting,
letting patients
sit instead of
lie down (if
they are able
to)
Other
protection(s)
not listed here
೦ describe
below
The
caregiver
will have
until the
first
treatment
visit of the
PD patient
to decide if
they want
to
participate.
n/a

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Group
Types
Waivers
Roles
Roles
-
Other
Electronic
SignaturesConsent
Coercion
Decision Re-
Consent
before they
finish the
study, they will
be consented
again with the
most current
consent form.
View Assent for
Decisionally
Impaired
Adult
Signed Assent
by Child or
Decisionally
Impaired Adult
Signed
Parent/Guardian
Permission or
Legally
Authorized
Representative
Consent
No
Waivers
Requested
Co/Sub-
Investigator
Research
Coordinator
 
Not using
electronic
signature
platforms
Consent will
be obtained
from the
Legally
Authorized
Representative
of participants
and assent will
be obtained by
the participant.
Information
about the
study will be
provided in
oral and
written form to
the
participants,
prior to any
study
activities.
Consent
conversations
will occur in a
private room.
Visually
impaired
participants
will be given a
large print
version of the
consent.
After each
study visit, the
patient will be
asked to
continue in the
study by
confirming
their next visit.
Participants
will be
informed of
their right to
withdraw from
the study at
any time
without
prejudice. If a
new consent is
approved after
a participant
starts the
study but
before they
finish the
study, they will
be consented
again with the
most current
consent form.
Having a 3rd
person
(family/friends,
another study
team member,
etc.) present
during the
consent /
assent
discussion
Having an
independent
advocate (e.g.
advocate for
decisionally
impaired
adults, wards)
present during
the consent /
assent
discussion
Sitting down
beside the
participant
instead of
standing over
them
If obtaining
consent /
assent in a
clinical setting,
letting patients
sit instead of
lie down (if
they are able
to)
Other
protection(s)
not listed here
೦ describe
below
Potential
participants
will be
allowed to
take as
much time
as they
need to
decide.
They will
be allowed
to take the
consent
form home
to review.
n/a
View Potential
PD Patient
Participants
Signed Consent
by Participant
No
Waivers
Requested
Principal
Investigator
Co/Sub-
Investigator
Research
Coordinator
Medical or
Psychological
Responsible
Investigator
 
Not using
electronic
signature
platforms
Informed
consent will be
obtained at the
start of the visit
before any
study
procedures are
done. The
consent
process will
occur in a
private exam
room. Visually
impaired
participants
will be given a
Sitting down
beside the
participant
instead of
standing over
them
If obtaining
consent /
assent in a
clinical setting,
letting patients
sit instead of
lie down (if
they are able
to)
Other
They will
be allowed
to take as
much time
as needed
to read the
ICF, ask
questions,
and make
a decision.
If they wish
to take the
informed
consent
form (ICF)
home to
n/a

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View: SF2 - Waiver of Some or All Elements of Consent
 
Group
Types
Waivers
Roles
Roles
-
Other
Electronic
SignaturesConsent
Coercion
Decision Re-
Consent
large print
version of the
consent.
After each
study visit, the
patient will be
asked to
continue in the
study by
confirming
their next visit.
Participants
will be
informed of
their right to
withdraw from
the study at
any time
without
prejudice. If a
new consent is
approved after
a participant
starts the
study but
before they
finish the
study, they will
be consented
again with the
most current
consent form.
protection(s)
not listed here
೦ describe
below
think about
it, they may
do that and
return at a
later date
to enroll in
the study.
2. Upload any consent / assent documents:
 
ID: MS4_HM20020066
  
Waiver of Some or All Elements of Consent
Consent groups that require a waiver of some or all elements of consent:
Group
Types
Waivers
Roles
Roles
-
Other
Consent
Decision
Status
Change
Partial
waiver for
pre-
screens
from
registry
None of
the
Above
(select
waiver
below)
Waiver of All
Consent or
Some
Elements in
Consent
Form
Principal
Investigator
Co/Sub-
Investigator
Research
Coordinator
 
Registry participants who appear
to meet basic inclusion criteria will
be contacted and offered
participation in this study. Those
interested will be scheduled for a
study screening visit, at which
time they will go through the
informed consent process with
study staff and will either choose
to sign the form or not.
Indefinite
 
Clinic
patients
None of
the
Above
(select
waiver
below)
Waiver of All
Consent or
Some
Elements in
Consent
Form
Principal
Investigator
Co/Sub-
Investigator
Research
Coordinator
 
If a potential participant is found in
the clinic schedule and
confirmation of diagnosis is
confirmed by reviewing the
patient's electronic medical
records, the study staff will notify
the potential participants provider.
The provider will inform the
potential participant about the
study and provide them with the
contact information of the study
staff. The potential participant will
be able contact the study staff.
They will be allowed to
take as much time as
needed to read the ICF,
ask questions, and
make a decision. If they
wish to take the
informed consent form
(ICF) home to think
about it, they may do
that and return at a later
date to enroll in the
study.
 
1. * For each group listed at the top of this page, describe which elements of informed consent you are waiving
or altering.
  - To request a waiver or alteration of SOME elements of informed consent, describe each of the elements that
you wish to waive. See the help text for a list of elements, and copy/paste the descriptions of the elements (not
just the element numbers) into this response.
  - To waive ALL elements of informed consent, state "All elements of informed consent" in this response. 
Individuals have previously provided written informed consent to be contacted about possible participation in other
research studies. We are requesting a waiver of all elements of consent only to screen individuals in the registry and
approach them for this study. Any individual recruited in this manner will be fully consented, if they are interested in
participating.

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We are also requesting a waiver of some of the elements of consent for individuals who are screened from the clinic
schedule. If a potential participant is found in the clinic schedule, the study staff will confirm their diagnosis in Cerner
(electronic medical record), and then notify the potential participant's provider. The provider will inform the potential
participant about the study and provide them with the contact information of the study staff. The potential participant will
be able contact the study staff. Any individual recruited in this manner will be fully consented, if they are interested in
participating. Study staff will not keep any information about daily clinic schedules. 
2. * Will you be waiving parental permission for wards of the state (and/or a Legally Authorized Representative's
consent) in any of the consent groups at the top of this page:
  Yes
No
3. * Is this study conducted by or subject to the approval of State or Local Government and designed to study,
evaluate, or otherwise examine public benefit or service programs:
  Yes
No
4. * Explain how the research involves no more than minimal risk to the participants (Alternative question
phrasing: How do the risk(s) of the research activity for which consent is being waived compare to the risks a
person might reasonably experience in normal everyday life?)::
The "pre-screen from registry" waiver will allow us to contact people with Parkinson's disease who have already
provided consent to be contacted about research studies.
The "clinic schedule" partial waiver is no more than minimal risk because we are asking the potential participant's
provider to speak to the patient first to reduce coercion. Study staff will not keep any information about daily clinic
schedules.
5. * Explain how the research could not practicably be carried out without the waiver or alteration (Alternative
question phrasing: Why would obtaining consent from participants make the study not achievable or not
viable?):
Our past experience has taught us that using our registry for recruitment, and screening clinic schedules (with
confirmation of diagnosis via Cerner) and then asking providers to ask identified patients if they are interested in
hearing more about the study are the most effective and expeditious ways to reach interested individuals.
Confirming diagnosis via Cerner electronic medical records of potential patients screened from the clinic schedules is
important so as to not falsely raise hope of participation in a study they do not qualify for, and not wasting patients time
and cost of travel to the study site. This also improves efficiency of the research team.
6. * Explain why this study can only be carried out using identifiable or de-identified information/biospecimens. 
- Studies with Department of Justice funding may state "Not applicable."
(Alternative question phrasing: Why would it be impossible to conduct the study using only anonymous
information/biospecimens?). 
All direct and indirect identifying information that would enable the investigator to know the subject೦s identity will be
removed or replaced with a number, letter, symbol, or combination thereof. Again, all video's will be scrubbed of
identifiable images such as tattoo's and faces. 
7. * Explain how the waiver or alteration will not adversely affect the rights or welfare of the participants 
(Alternative question phrasing: Will this consent waiver violate any of the participant's rights or adversely
affect their welfare - why or why not?):
The individuals from the registry have already provided consent to be contacted about research. Only their contact
information and name will be shared with the staff of this study so that we may contact them.
Individuals screened from weekly clinic schedules whose diagnosis was confirmed via their electronic medical record
will be asked by their healthcare provider if they would like to hear more about the study. They can decline to speak
with study staff or decline to participate in research without prejudice.
Study staff will not keep any information about daily clinic schedules.
Those interested will come in for a visit, where they will provide written informed consent for this protocol.
8. * Explain how participants will be provided with additional pertinent information after participation. If this will
not be provided, explain why not:
If either registry participants or screened clinic schedule participants (with diagnosis confirmed via electronic medical
record by study staff) are interested, they will come in for a study visit where they will go through the full written
informed consent process. Should any pertinent information arise after their participation has been completed, they will
be contacted by phone or by mail with the relevant information updates.
 
ID: MS4_HM20020066
  
Consent Plan Complete
Protocol Progress:
? INITIAL SETUP
? BACKGROUND, RATIONALE & GOALS
? RESEARCH PLAN
? CONSENT PLAN
? RISKS, PRIVACY & CONFIDENTIALITY
? POPULATIONS WITH SPECIAL CONSIDERATIONS
? INSTITUTIONAL REQUIREMENTS
? DOCUMENTS
Click Continue below to go to the next section

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ID: MS4_HM20020066
  
Risks, Discomforts, Potential Harms and Monitoring
1. * Describe the risks of each research procedure to participants or others. For each identified risk, provide an
assessment of the anticipated seriousness and likelihood of the risk. Some examples of possible risks include
but are not limited to:
Physical risks (e.g. bodily harms or discomforts, side effects, etc.)
Psychological risks (e.g. emotional, mental, or spiritual harms or discomforts, changes to thoughts,
beliefs, or behaviors, etc.)
Research data risks (e.g. loss of confidentiality and privacy)
Social or legal risks (e.g. impacts on relationships or reputation, legal or criminal justice actions for self
or others, etc.)
Financial risks (e.g. impacts on income, employability, or insurability, loss of services, etc.)
Other risks (e.g. unforeseeable risks of experimental procedures, risks related to particular study
designs (randomization, washout, placebo, withholding care/services, deception), etc.)
See the help text for additional guidance.
PD participant
-loss of confidentiality and privacy,
-skin irritation,
-musculoskeletal injury,
-falls,
-fatigue,
-episodes of symptomatic orthostasis, or
-frustration with the intervention.
Caregiver
-loss of confidentiality and privacy,
-some survey questions may make the participant uncomfortable.
2. * Describe how each of the risks/harms/discomforts identified above will be minimized:
To minimize the risk of loss of confidentiality and privacy, data will be de-identified per protocol described in prior
sections. Data on the computer will only be accessible on VCU's password protected computers and secure/encrypted
databases.
PD Participant
During the first session a device fitting will occur to insure appropriate fitting and will be checked periodically to make
sure device is still comfortable and not hurting the patient. The patient will wear a gait belt and someone will be walking
the the patient at all times to prevent falls. Patients will be allowed to take additional breaks if necessary.
Caregiver
Participants will be allowed to skip questions.
3. * Describe any potential risks or harms to a community or a specific population based on study findings (e.g.
information that could be stigmatizing or derogatory):
There are no potential risks or harms to a community or a specific population based on study findings.
4. Where appropriate, discuss provisions for ensuring necessary medical, professional, or psychological
intervention in the event of adverse events to the subjects:
In the case of adverse event during device training, medical oversight is available by the team at NOW.
5. * Describe criteria for when the investigator would withdraw an individual participant from the study; such as
safety or toxicity concerns, emotional distress, inability to comply with the protocol, etc.:
If the patient gets injured, too frustrated, or the investigator determines that it is unsafe for the patient to continue, the
investigator will withdraw the patient from the study.
6. * Summarize any pre-specified criteria that would trigger the investigator/sponsor/monitoring committee to
stop or change the study protocol due to safety concerns:
None 
Data and Safety Monitoring
Data and safety monitoring is a system for checking the study೦s data at regular intervals over the study
period to identify and address issues that could affect the safety of research participants. This requirement is
in accordance with 45 CFR 46.111.
The purpose of data and safety monitoring plan is to set forth study team procedures for
monitoring/addressing:
- Participant safety (physical, psychological, etc.)
- Data validity
- Early stopping (termination) based upon changes in risks and benefits.
7. * Indicate if this study will have a Data Safety Monitoring Board (DSMB) or a Data Safety Monitoring Plan
(DSMP): [Required for all greater than minimal risk studies]

DSMB

DSMP

No DSMB/DSMP [Note: This response is not applicable for greater than minimal risk studies]

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8. * Describe your Data Safety Monitoring Plan for monitoring the study೦s data to ensure the safety of
participants. This plan should include (but is not limited to) the following elements:
1. Who will monitor data
2. What data and/or processes will be reviewed
3. When and how frequently monitoring will occur
4. What report/documentation will be submitted to the IRB at the time of continuing reviews
See the help text for additional guidance.
An independent study monitor will oversee the conduct of the trial in order to assure that all staff members are
adhering to the protocol, standard operating procedures, tenets of good clinical practice, and all local and federal
research regulations.
Our strict adherence to the inclusion and exclusion criteria, and also to the other aspects of the protocol will help
ensure participant safety. Dr. Baron will provide medical oversight to assess and grade all adverse events. He will refer
as needed to appropriate medical providers to manage any adverse events that may occur.
Monitoring will occur after 25% of participants complete the study. Monitoring will occur again after 50%, 75% and
100% participants complete the study.
The study PI will report adverse events to the IRB as appropriate and per VCU IRB policy.
At the time of continuing review, the IRB will receive a report containing enrollment data, patient safety data, adverse
event summaries.
 
ID: MS4_HM20020066
  
Privacy
Privacy refers to an individual೦s right to control how others view, record, or obtain information about them. When
privacy is violated it can involve such things as
Being asked personal questions in a public setting;
Being publicly identified as having a particular characteristic or diagnosis;
Being seen entering a place that might be stigmatizing;
Being photographed, videotaped or observed without consent;
Disclosure of personal information to unauthorized people
Privacy is not the same as confidentiality because privacy protections apply to people, and confidentiality
protections apply to data. Confidentiality protections should be described on the Data Confidentiality page of this
form, not here.
Instructions for this page:
Select all the applicable ways that the research team will protect participants' privacy throughout the course of the
study. Not all will be applicable to every study. 
To elaborate on any response, also click the ೦Other Protections೦ checkbox to provide further explanation in the last
free-text question.
Read the entire page before filling out the form.
1. * Protections when conducting one-on-one in-person interventions or interactions (for groups see Q2 below):

Conducting study activities in locations that maximize privacy (limited people around, closing doors,
drawing drapes around beds, monitoring voice volume, etc.)

Verifying identity before discussing personal information.

Asking the participant if they are comfortable answering questions in that location

Asking the participant if they are comfortable with having other people present (if any)

Moving away from other people when conducting activities in public spaces or offering a private space

Offering other options of ways to respond to sensitive questions (i.e. pointing, clicking, or writing) if
uncomfortable verbally responding

Using generic signs on research rooms and spaces, particularly for research on stigmatizing or sensitive topics

Other protections not listed in this question ೦ describe below

N/A ೦ study has no in-person interventions or interactions with participants
 
2. * Protections when conducting group interventions or interactions:

Conducting study activities in locations that maximize privacy (limited people passing by, closing doors,
monitoring voice volume, etc.)

Moving to a more private area to answer questions or to discuss concerns

Discussing privacy with the participants and the importance of not talking outside the group about what other
people say during the group session

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
Allowing participants to use a pseudonym or limiting use of individuals೦ names during the group activity

Asking everyone in a public group setting (e.g. classrooms, workshops) to turn something in (blank or filled) so
participants do not have to self-identify when turning in materials

Collecting paper forms in a closed box or envelope rather than passing to others or leaving in an open area

Limiting participant identifiers that would be visible on paper documents (i.e. using study IDs instead of direct
identifiers)

Allowing people to distance themselves from other participants during group activities

Offering other options of ways to respond to sensitive questions (i.e. pointing, clicking, or writing instead of
speaking)

Using generic signs on research rooms and spaces, particularly for research on stigmatizing or sensitive topics

Ensuring non-participating individuals are not captured on recordings or in photos

Other protections not listed in this question ೦ describe below

N/A ೦ study has no group interventions or interactions
 
3. * Protections when conducting remote interventions or interactions (e.g. phone, text, email, video-conference,
tele-health, online, etc.):

Conducting study activities in locations where study staff can maximize their own privacy (limited
people around, closing doors, monitoring voice volume, etc.)

Leaving/sending generic messages that avoid using study and participant identifiers, such as names,
study titles, clinics, study topics, etc.

Obtaining permission prior to sending text messages

Advising the participant to move to a location where they are comfortable answering questions and will
not be overheard

Advising online participants to complete the activity at a time and location where they will be comfortable
answering questions

Ensuring non-participating individuals are not captured on recordings or in photos

Offering other options of ways to complete the activity (i.e. online, paper, phone) if more privacy is desired

Offering a way to save and return later to the online activity if privacy is compromised

Other protections not listed in this question ೦ describe below

N/A ೦ study has no remote interventions or interactions with participants
 
4. * Protections when mailing study materials to/from participants:

Obtaining permission to mail study materials

Confirming/verifying the accuracy of addresses before mailing items

Ensuring the participant is able to personally receive mailed materials and has a way to protect their
own privacy if they do not want others to know they are receiving research communications (i.e.
notifying participants of when to expect it)

Using return address labels and document headers that avoid study identifiers, such as study names,
clinics, study topics, etc.

Avoiding or limiting use of participant identifiers and health information on mailed documents (i.e. using
study IDs instead of direct identifiers)

Providing a return mailing address label or pre-addressed envelope to ensure returned items are sent to
the correct address

Communicating receipt of mail from participants and/or asking them to notify you when they mail it to
ensure study documents are not lost in transfer

Offering other options of ways to complete the activity (i.e. by phone or online) if desired

Other protections not listed in this question ೦ describe below

N/A ೦ not mailing any materials to/from participants
 
5. * Protections when analyzing or disseminating study data *Applicable to all studies*:

Working only in locations where the study team can ensure privacy (not working in close proximity to
non-study personnel, closing doors, closing/putting away documents/files before leaving, etc.)

Securing physical materials only in locations that ensure privacy (access limited to authorized study
personnel)

Only sharing data/specimens in accordance with the Sharing Plan outlined in this smartform

Obtaining explicit parental permission before disseminating or sharing recordings or photos of children

Blurring/redacting/hiding faces and other identifiable features/marks (tattoos, scars, birthmarks,
distinctive voice, etc.) in recordings or photos prior to disseminating or sharing

Only publishing or presenting aggregate results or findings (i.e. no individual-level information)

Taking additional steps to protect participant identities when publishing or presenting individual-level information,
quotations, results, images ೦ describe below

Other protections not listed in this question ೦ describe below

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6. Describe any other way(s) that the research team will protect participants' privacy. See the help text for
additional guidance.
Potential participants will be recruited out of our clinic at the Parkinson's and Movement Disorders Clinic, physical
therapy patients or support groups. Most of the participants will already be patients.
Potential participants will be informed that their decision to participate in this study will have no impact on their clinical
care. The informed consent process will occur in a private room where the individual will be able to ask questions.
Study procedures will be conducted at the VCUHealth Neuroscience, Orthopaedics and Wellness Center in the
physical therapy gym space. Study procedures that are confidential in nature will occur in a private setting.
No PHI will be attached to the data when it is published/disseminated.
 
ID: MS4_HM20020066
  
Data Confidentiality and Storage
Confidentiality refers to the way private, identifiable information about a participant or defined community is
maintained and shared. It describes how the study೦s research materials (data, specimens, records, etc.) are
protected from unauthorized access.
Instructions for this page:
Select all the ways that the research team will keep the study materials and data confidential throughout the course
of the study. Not all will be applicable to every study. 
To elaborate on any response, also click the ೦Other Protections೦ checkbox to provide further explanation in the last
free-text question.
Read the entire page before filling out the form.
1. * Protections for paper research materials:

Maintaining control of paper documents at all times, including when at an off-campus location

Limiting or avoiding use of participant identifiers on paper documents (i.e. using study IDs instead of
direct identifiers)

Storing paper documents in a secure location accessible only to authorized study personnel

Promptly transcribing, scanning, or abstracting data from paper into electronic platforms with
destruction of the paper copy

Proper destruction of paper records (and obtaining prior permission when required) in accordance with
VCU Records Management policies

Other protection not listed in this question ೦ describe below

N/A ೦ no paper research materials
2. * Protections for research specimens:

Maintaining control of specimens at all times, including when at an off-campus location

Storing specimens in a secure location accessible only to authorized study personnel

Labeling specimens with subject ID or other coded information instead of direct identifiers

Final destruction of specimens will be devoid of any identifiable information

Other protection not listed in this question ೦ describe below

N/A ೦ no research specimens
3. * Protections for electronic files/data - See https://ts.vcu.edu/about-us/information-security/data-management-
system/

*Required for all studies* Use VCU-approved methods of data storage, transmission, and transfer (see
https://dms.vcu.edu)

Remotely accessing VCU network storage to store data when at off-campus locations

Ensuring unauthorized individuals who might share a device do not have access to study materials (e.g.
individual logins, separate accounts)

Using VCU-approved data collection tools and apps (e.g. REDCap) and storing exported analysis files in
VCU-approved storage locations (see https://dms.vcu.edu)

When using non-VCU-approved electronic data collection tools, storage locations, data transfer
platforms, and mobile apps (e.g. Dropbox, Box, Survey Monkey, Fitbits, novel apps):
೦ consulting with VCU Information Security on proper data management (see
https://ts.vcu.edu/askit/essential-computing/information-security/);
೦ advising participants about the terms of use and privacy policies of those sites/apps;
೦ limiting or avoiding use of identifiers; and
೦ removing data promptly from the external location after transferring it to a VCU storage location

De-identifying the research data by replacing subjects೦ names with assigned subject IDs

Storing the study೦s linkage key in a password-protected and VCU-approved storage location (see
https://dms.vcu.edu)

When analyzing particularly sensitive information, using computers that are unconnected from the
internet.

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
Proper destruction of electronic records (and obtaining prior permission when required) in accordance
with VCU Records Management policies

Other protection not listed in this question ೦ describe below
4. * Protections for computers and research devices/apps that are provided to participants for use in the study:

Transferring data promptly from the device/app to a VCU storage location

Setting strong passwords on computers and research devices (when applicable)

When providing devices or mobile apps to children, informing parents about the settings and how to manage
them (if applicable), internet access, and any other installed apps on the device

Other protection not listed in this question ೦ describe below

N/A ೦ no computers or devices/apps being provided for participant use
5. * Protections for email/online communications

Only using VCU/VCU Health email addresses for study-related communications

Only using VCU/VCU Health೦approved methods of teleconferencing or video conferencing (e.g. Zoom)
(for studies involving HIPAA, contact VCU or VCU Health Information Security [as appropriate] about
HIPAA-compliant systems)

Other protection not listed in this question ೦ describe below

N/A ೦ no email/online communications
6. Specify any other places where this study೦s paper and electronic research data and/or physical specimens
will be stored and any other ways they will be secured from improper use and disclosure. 
See the help text for additional guidance.
Upon enrollment, subjects shall be assigned a study identification number. This number will be used to identify all of
their paper and electronic data on the Case Report Forms (CRFs). The key that matches participants PHI to their study
number will be stored in a separate locked cabinet from the data and accessible only to the investigators.
We will utilize a combination of electronic and paper CRFs. Paper CRFs will be stored in a locked cabinet in a locked
office within the research suite at NOW. Upon completion of the study, the paper CRFs will be stored in the locked file
cabinets in a locked office until they can be destroyed as allowed by the FDA and IRB. Electronic CRFs will be
completed using REDCap.
7. * If research data that contains any of the 18 HIPAA identifiers will be released to person(s) or group(s) outside
of the VCU study team or the PI's department, identify the data recipient(s) along with their VCU department or
other institutional or organizational affiliation(s).
Any data that is shared with groups/persons outside VCU will not contain any HIPAA identifiers.
8. * Select all identifiers that will be collected as part of this study (including for recruitment, data gathering, data
analysis, etc.), even if the data will eventually be anonymized:

Names

Geographic Locators Below State Level

Social Security Numbers

Dates (year alone is not an identifier)

Ages over 89 (age under 89 is not an identifier)

Phone Numbers

Facsimile Numbers

E-mail Addresses

Medical Record Numbers

Device Identifiers

Biometric Identifiers

Web URLs

IP Addresses

Account Numbers

Health Plan Numbers

Full Face Photos or Comparable Images

License/Certification Numbers

Vehicle ID Numbers

Other Unique Identifier

No Identifiers

Employee V#
9.   * If the study will code (i.e. de-identify) the research data by replacing subjects೦ names with assigned
subject IDs, explain the following aspects of the coding process:

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View: SF2 - Sharing Plan
- The process for how subject IDs will be generated/assigned (e.g. random, sequential)
- Whether there will be a key that links the subject ID with direct identifiers.
If a key will be created, describe
- The place where the key will be stored
- The role(s) of all individuals who will have access to the key
- When the key will be destroyed
See the help text for guidance.  
1. Sequential numbers
2. A key that matches number to name, DOB, MRN, and contact information will be made
3. The key will be kept in a separate location from the CRFs in a locked cabinet inside a locked office in the research
suite at the NOW building
4. Only Gina Blackwell and Dr. Robert Hand will have access
5. Key will be destroyed when final data analysis is complete
6. Before any future research use or share of the research data generated under this study, all identifiers will be
removed from all research data generated under this study (paper and electronic) and all key code will be destroyed so
that no one (not even the VCU study team) can re-identify subjects from the remaining research data.
ID: MS4_HM20020066
  
Data Retention
1. * Select all of the ways that individually identifiable information obtained during pre-screening and/or
screening will be handled for individuals who DO NOT qualify for the study:

Immediately destroy the information and identifiers (no data collected)

Immediately destroy the identifiers connected with the data (anonymization)

Store until the end of study & then destroy

Use as "screening failure" data by members of the study team

Provide to others outside of the research team (with the participant's permission)

Request permission from participant to maintain and use the identifiable information

Other

N/A - study does not require screening procedures
2. * Will participants be able to withdraw their data (paper, electronic, or specimens) from the study (e.g. ask that
it be destroyed or returned) if they no longer wish to participate? (FDA-regulated studies should select No -
see help text)
  Yes
No
3. * What will happen to the research materials (e.g. data, specimens, documents, etc.) when the research has
been completed?
Stored indefinitely with identifiers removed
Stored indefinitely with identifiers attached
Destroyed at the end of study once the minimum time required for data retention has been met per VCU Data
Retention Policy and/or sponsor retention requirements
Destroyed when notified by sponsor but not less than the minimum time required for data retention per VCU
Data Retention Policy
Other
4. * Will audio/video recordings and full face photographs be destroyed?
  Yes
No
5. If yes, describe at what point and how recordings will be destroyed:
6. If no, explain why the recordings need to be maintained:
Full-face videos and photographs will not be recorded. The below the neck videos and photographs will be stored on
VCU's encrypted server.
 
ID: MS4_HM20020066
  
Sharing Plan
This page addresses times when investigators may be required to share information about participants or may desire
to share their research information/specimens with the aim of advancing science. This page creates a plan for when
and how information/specimens could be shared.

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Try to anticipate all reasonably foreseeable sharing so that the consent document can also reflect that information.
However, it is acceptable to amend this page later and explain either how re-consent of previously and currently
enrolled participants will occur or why re-consent should not be required.
The IRB reviews this page against the consent document (if one exists) to demonstrate the ethical principle of
Respect for Persons by confirming that plans for sharing do not go against what participants would understand
about the use of their data/specimens.
The IRB also ensures there are adequate protections for the privacy of participants and the confidentiality of
participants' data/specimens when data is shared with others.
1. * Is it likely investigators could discover information about child/elder abuse or neglect that would require
mandatory reporting by the investigators or staff?
The Code of Virginia requires that most medical personnel and all employees of institutions of higher
education report suspected child/elder abuse or neglect.
  Yes
No
2. *  Is it likely investigators could discover a previously unknown reportable disease or condition that would
require mandatory reporting by the investigators or staff (i.e., HIV , coronavirus, hepatitis, etc.)?
  Yes  No
3. * Will the sponsor or investigator obtain a Certificate of Confidentiality for this study?
Certificates of Confidentiality  (CoC) are issued by the National Institutes of Health (NIH), the FDA and CDC to
protect identifiable research information from forced disclosure. All human subject research studies
regardless of funding can qualify to receive a CoC. A CoC is automatically issued for research that was
ongoing on December 13, 2016. or initiated after that date. For more information, see
https://humansubjects.nih.gov/coc/
No - Will not obtain CoC for this study
Yes - CoC has been obtained or issued automatically
Yes - CoC request is pending
4. * Select the way(s) that information or biospecimens (including DNA) may be used by the VCU PI or VCU study
team for other future research projects (i.e. analyses beyond/apart from the aims of this study)?
See help text for definitions.

Will use directly identifiable information or specimens.
(‘Directly identifiable’ means that identifiers like name, medical record number, social security number, etc. are
included in/attached to the dataset/specimens. Maintaining identifiable data for future research is treated as a
registry by the VCU IRB. The IRB must approve the new research use in an amendment to this study or as part
of a new study before the project is initiated. You will be asked more questions about this on a later page)

Will use de-identified or indirectly identifiable information or specimens.
(‘De-identified’ means that a linkage/key code exists that links identifiers to data/specimens. When the
researcher holds both the data and the key, the VCU IRB considers the subjects to be readily identifiable.
Maintaining identifiable data for future research uses is treated by the IRB as a registry. The IRB must approve
the new research use in an amendment to this study or as part of a new study before the project is initiated. You
will be asked more questions about this on a later page)

Will use anonymized information or specimens.
(‘Anonymized’ means that 1) no linkage/key codes exist that link identifiers to data/specimens; and 2) subjects
cannot be readily identified, i.e. no direct or indirect identifiers or identifiable combinations of variables. The VCU
IRB considers uses of anonymized data/specimens to not be human subject research.)

Will use aggregate results (summary-level results), not individual-level information or specimens.
(The VCU IRB considers uses of aggregate data to not be human subject research because there are no
individual subjects.)

Will contribute to an existing registry or repository
(You will be asked more questions about this on a later page.)

Will not use information/specimens for purposes beyond this study.

Not sure and will submit an amendment when known

Other use(s) of individual-level information in a way not listed above
5. * Select the way(s) the VCU PI/study team may share information or biospecimens (including DNA) with other
researchers who are not on this study team (i.e. for analyses beyond/apart from the aims of this study). 
See help text for definitions.

Will share directly identifiable information or specimens with other researchers.

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(‘Directly identifiable’ means that identifiers like name, medical record number, social security number, etc. are
included in/attached to the dataset/specimens. Maintaining identifiable data for future research uses is treated
by the VCU IRB as a registry. The data recipient’s use of identifiable data would require them to obtain IRB
review. You will be asked more questions about this on a later page.)

Will share de-identified or indirectly identifiable information or specimens with other researchers.
(‘De-identified’ means that a linkage/key code exists that links identifiers to data/specimens. The VCU
researcher maintains the key but does not share it with any other researchers. The recipient’s use of de-
identified data/specimens may not be human subject research if there is documentation that the key will never
be shared with the recipient, but they should check with their own IRB about review requirements. You will be
asked more questions about this on a later page.)

Will share anonymized information or specimens with other researchers.
(‘Anonymized’ means that 1) no linkage/key codes exist that link identifiers to data/specimens; and 2) subjects
cannot be readily identified (i.e. no direct or indirect identifiers or identifiable combinations of variables). The
VCU IRB considers uses of anonymized data/specimens by other researchers to not be human subject
research, but the recipient should check with their own IRB about review requirements.)

Will only share aggregate results (summary-level results), not individual-level information or specimens.
(The VCU IRB considers uses of aggregate data to not be human subject research because there are no
individual subjects. The data recipient should check with their own IRB about review requirements.)

Will contribute to an existing registry or repository (You will be asked more questions about this on a later page.)

Will submit data to an NIH genomic data repository (You will be asked more questions about this on a later
page.)

Will not share information/specimens with other researchers.

Not sure and will submit an amendment when known

Other sharing of individual-level information with other researchers
6. * Since you responded in a question above that you may use or share anonymous, individual level data,
indicate why the proposed use or sharing of anonymous data/specimens is not inconsistent with what
participants would have reasonably understood from the consent document about the uses of their
information. (Select all that apply.)

The consent form states that after identifiers are removed, information or specimens could be used for
future research studies without additional informed consent from the subject (this is a new element of
consent included in consent templates as of May 2018)

The consent form or exempt information sheet is silent about whether/how information or specimens could be
used for future research studies.

The information or specimens were/will be obtained under a waiver of informed consent, waiver of HIPAA
authorization, or an exempt study that did not use an information sheet.

Other reason why anonymous use/sharing is not inconsistent with the consent document
7. * The Principal Investigator certifies that prior to releasing an anonymized dataset or anonymized specimens
the following conditions will all be met:
 - all 18 HIPAA identifiers (including all dates) will be removed;
  - all indirectly identifiable data elements (unusual, rare, uncommon data) will be removed, grouped,
suppressed, or otherwise transformed to no longer be readily identifiable;
  - a different subject ID will be assigned than the one used for the main study and a linkage key will not be
kept; and
  - the PI will review the dataset/specimens to confirm that the remaining information could not be used alone
or in combination with any other information to re-identify the participants represented in the data.
See help text for more information.
Yes
No
8. * The Principal Investigator certifies that after the study has been closed with the VCU IRB, the following
conditions will be met whenever individual level research information and/or specimens are used or shared:
  - The identities of participants who are represented in the dataset/specimens will not be readily ascertainable
or otherwise re-identifiable by the recipient;
  - If a linkage/code key is created, it will be maintained at VCU and not shared with the recipient under any
circumstances;
  - The PI will have no knowledge that the remaining information could be used alone or in combination with
any other information to identify the individuals represented in the data; and
  - The PI agrees to abide by this sharing plan even after the study has been closed with the VCU IRB.
Yes
No

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View: SF2 - Pertinent Results and Incidental Findings
View: SF2 - Risk Benefit Complete
View: SF2 - Populations with Special Considerations
N/A - No sharing will occur
 
ID: MS4_HM20020066
  
Pertinent Results and Incidental Findings
1. * Is it likely investigators could discover a participant's previously unknown condition (e.g. pregnancy,
disease, suicidal thoughts, wrong paternity, genetic results, or other findings that may be of importance to
health or well-being) or if a participant is engaging in illegal or reportable activities:
  Yes
No
 
ID: MS4_HM20020066
  
Risk Benefit Complete
Protocol Progress:
? INITIAL SETUP
? BACKGROUND, RATIONALE & GOALS
? RESEARCH PLAN
? CONSENT PLAN
? RISKS, PRIVACY & CONFIDENTIALITY
? POPULATIONS WITH SPECIAL CONSIDERATIONS
? INSTITUTIONAL REQUIREMENTS
? DOCUMENTS
Click Continue below to go to the next section
 
ID: MS4_HM20020066
  
Populations with Special Considerations
1. * Check all participant groups that will be either
  a) Specifically included in this study or
  b) Discernable in the research data/specimens.
  (Selections will branch)

Children

Emancipated minors

Wards of the State

Pregnant women or fetuses

Neonates or Post-delivery Materials

Prisoners

Decisionally Impaired Adults

VCU / VCUHS students or trainees

VCU / VCU Health System employees

Individuals with limited English proficiency

Active military personnel

Student populations in K-12 educational settings or other learning environments

Members of a federally recognized American Indian and Alaska Native tribe

None of the Above
 
2. Additional considerations for VCU/VCU Health System employees:
* Describe how the study will minimize the possibility of coercion to participate.
We will not directly solicit employees. However, if someone we encounter in clinic or via the registry or is a caregiver of
a participant that happens to work for VCU, we will not exclude them on this basis.
Subjects exhibiting moderate to severe cognitive impairment may still participant if scoring < 17/30 on the Montreal
Cognitive Assessment if a legally authorized representative (LAR) approves participation. The subject must be able to

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View: SF2 - Decisionally Impaired Adults
View: SF2 - Populations with Special Considerations Section Complete
View: SF2 - Study Funding
follow commands associated with the listed outcome measures and follow instructions during walking
intervention.         
          
          
ID: MS4_HM20020066
  
Decisionally Impaired Adults
1. * Choose the nature of the decisional impairment participants will have:
Temporarily Incompetent to Give Consent
Permanently Incompetent to Give Consent
Unknown
2. * Explain why this population is necessary for the conduct of the study.
Parkinson's disease is a neurodegenerative disease that can cause dementia. The further a persons progression of the
disease, the more likely they are to develop dementia. Since the study is enrolling persons with advanced PD (H&Y 4
& 5) we anticipate that some of our patients will have dementia.
3. * Describe methods for determining whether participants are capable of providing consent or assent.
Most of the participants that will be in the study are clinically familiar with the investigator. The investigator and study
coordinator will determine if a participant is competent to provide consent during the consenting process. If an
individual is able to explain the study and the required involvement upon questioning, they will be deemed competent.
We will use the VCU Informed Consent Evaluation Tool to verify the individuals ability to explain the study.
4. * If a participant is capable of exercising some judgment concerning the nature of the study, describe how
assent will be obtained.
Decisionally impaired adults will be given the opportunity to provide assent. The research study will be explained in
basic terms and each individual will be asked whether or not he/she wishes to participate in research, particularly if
he/she can comprehend and appreciate what it means to be a volunteer.
5. Describe, if applicable, how the individuals' ability to give consent will be assessed throughout the study and
how consent will be obtained when appropriate.
There are multiple visits over the course of up to 14 weeks. We do not expect an individuals ability to consent to
change in such a short period of time. After each study visit, the study team will verbally ask the individual if they can
briefly explain what is expected of them at the next study visit and if they are willing to continue. 
6. * Describe how and when consent will be obtained from participants' legally authorized representative (LAR).
Consent will be obtained from legally authorized representative (LAR) when an adult is not capable of providing
informed consent. Consent will be obtained at the beginning of the initial visit before any research activity occurs. LARs
will be expected to be at every visit since they will most likely also be the participants caregiver and transportation.
Since they will be at visits, they can also confirm participants the continued participation.  
 
ID: MS4_HM20020066
  
Populations with Special Considerations Section Complete
Protocol Progress:
? INITIAL SETUP
? BACKGROUND, RATIONALE & GOALS
? RESEARCH PLAN
? CONSENT PLAN
? RISKS, PRIVACY & CONFIDENTIALITY
? POPULATIONS WITH SPECIAL CONSIDERATIONS
? INSTITUTIONAL REQUIREMENTS
? DOCUMENTS
Click Continue below to go to the next section
ID: MS4_HM20020066
  
Study Funding
1. * Have you applied for funding:
  Yes
No
2. Is this study already funded:
  Yes
No
3. * Select all funding sources for this study (pending or awarded):

Industry

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View: SF2 - Types of Sites

Direct Federal

Indirect Federal

State/Local Government

Non-Profit - Sponsored Project

Non-Profit - Gift

Internal Grant

Investigator/Departmental Funds

None

Other
4. Select all related funding proposals that have been submitted through the Office of Sponsored Programs
(OSP):
RAMS-SPOT ID# (FP/PT/PD#)
Direct Sponsor
PI Title
Status
Start
End
There are no items to display
 
ID: MS4_HM20020066
  
Types of Sites
VCU Site Information
1. * Select all VCU sites that will be utilized in this study:

Children's Hospital of Richmond at VCU

Clinical Research Services Unit (CRSU)

Massey Cancer Center

VCU Health Community Memorial Hospital

VCU Health Tappahannock Hospital

VCU Medical Center

Other VCU Health Location

VCU Monroe Park Campus

VCU Qatar

Other VCU Site
 
Non-VCU Site Information 
Non-VCU sites should be selected whenever any of the following situations apply:
   a) Non-VCU sites that will be collaborating on a VCU-led study
   b) Non-VCU sites that will be deferring to the VCU IRB for IRB review
   c) Non-VCU sites where VCU investigators will be overseeing study interventions or interactions
   d) Non-VCU sites/locations where VCU investigators will conduct study activities
2. * Select any of the following non-VCU sites utilized in this study:

McGuire VAMC

Foreign Sites

Other Non-VCU Sites

No Non-VCU Sites
3. * Is this a multi-center study being led by VCU?
  Yes  No
4. For Non-VCU Sites: For each site or institution listed as "Site Engaged -- Requests to Rely on VCU IRB
Review," upload:
- Completed Local Context Form for Relying on VCU's IRB
- Site specific informed consent form(s)  and HIPAA authorization(s), if applicable
For Foreign Sites: For each Cultural Consultant upload a CV/Biosketch that includes a clear description of
cultural expertise:
 
Document Name
Document
VersionDate
Modified
Uploaded
By
Type
Approved
View Consent_exoskeleton
Consent_exoskeleton_01202022a.pdf
0.17
1/26/2022
2:55 PM
Mark Baron Consent/Assent/Information
Sheet
Yes

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View: SF2 - Personnel
 
Document Name
Document
VersionDate
Modified
Uploaded
By
Type
Approved
View Consent_exoskeleton_large_print Consent_exoskeleton_large_print_version_01202022.pdf 0.05
1/26/2022
2:55 PM
GinaMari
Blackwell
Consent/Assent/Information
Sheet
Yes
View Consent_SO
Consent_exoskeleton_SO_v1.1.pdf
0.08
1/26/2022
2:55 PM
GinaMari
Blackwell
Consent/Assent/Information
Sheet
Yes
View PROC not activated
PROC neurology not activated.pdf
0.01
1/20/2022
11:45 AM
GinaMari
Blackwell
Ancillary Committee
Approval
Not
Applicable
View VCU Informed Consent
Evaluation Tool
ICEval.doc
0.01
2/23/2021
3:13 PM
GinaMari
Blackwell
Consent/Assent/Information
Sheet
Not
Applicable
View MoCA - blind
MoCA-Test-BLIND - 04-2020.pdf
0.01
2/1/2021
3:52 PM
GinaMari
Blackwell
Research Measure
Yes
View NSR Device APDM
APDM CE 510k exempt.pdf
0.01
11/10/2020
3:18 PM
GinaMari
Blackwell
Other
Not
Applicable
View APDM User Manual
APDM MobilityLab_UserGuide.pdf
0.01
10/25/2020
5:14 PM
GinaMari
Blackwell
Other
Not
Applicable
View Keeogo User Manual
IFU-006-EN v1.1 Keeogo_ User Manual
(USA)_approved.pdf
0.02
10/14/2020
5:49 PM
GinaMari
Blackwell
Drug/Device Brochure
Not
Applicable
View User Manual
IFU-003-EN v1.2_Keeogo_ Clinician
Manual_approved.pdf
0.02
10/14/2020
5:48 PM
GinaMari
Blackwell
Drug/Device Brochure
Not
Applicable
View Article for NSR device
Keeogo in MS open label.pdf
0.01
9/23/2020
10:49 AM
GinaMari
Blackwell
Other
Not
Applicable
View Pre-screen phone script
prescreen phone script_exoskeleton2.docx
0.02
9/21/2020
3:59 PM
GinaMari
Blackwell
Recruitment/Advertising
Yes
View Consent from HM14555
PMDC registry-May 2019-clean.pdf
0.01
9/16/2020
11:09 AM
GinaMari
Blackwell
Other
Not
Applicable
View Support Group Script
Script for Support Groups 9.16.20.docx
0.01
9/16/2020
10:42 AM
GinaMari
Blackwell
Recruitment/Advertising
Yes
View Demographics exoskeleton
Demographics exoskeleton.docx
0.01
8/17/2020
4:38 PM
Mark Baron Research Measure
Yes
View References
References.docx
0.01
8/13/2020
3:44 PM
GinaMari
Blackwell
Other
Not
Applicable
View PDQ-Carer
FINAL_PDQ-C_English_UK.pdf
0.01
8/11/2020
1:12 PM
GinaMari
Blackwell
Research Measure
Yes
View MoCA
MoCA.pdf
0.01
8/10/2020
5:23 PM
GinaMari
Blackwell
Research Measure
Yes
View UPDRS-Part III
MDS-UPDRS_Part III.pdf
0.01
8/10/2020
5:20 PM
GinaMari
Blackwell
Research Measure
Yes
View PDQ-39
PDQ39.pdf
0.01
8/10/2020
5:02 PM
GinaMari
Blackwell
Research Measure
Yes
View Berg Balance Scale
BBS short form.pdf
0.01
8/10/2020
4:54 PM
GinaMari
Blackwell
Research Measure
Yes
View Hand Biosketch
Hand Biosketch.pdf
0.01
8/10/2020
4:51 PM
GinaMari
Blackwell
CV/Biosketch
No
View Baron Biosketch
Baron Biosketch.pdf
0.01
8/10/2020
4:51 PM
GinaMari
Blackwell
CV/Biosketch
Yes
View IDE Exemption
Keeogo_No IDE Req'd.pdf
0.01
8/10/2020
4:42 PM
GinaMari
Blackwell
FDA Regulatory Document Not
Applicable
ID: MS4_HM20020066
  
Personnel
1. * List all VCU/VCUHS personnel who are key study personnel.
Key personnel are defined as including:
     - Conflict of interest investigators, including
     - the PI
     - the Lead Student/Trainee Investigator,
     - medically/Psychologically responsible investigator(s)
     - FDA Form 1572 investigators, and
     - Other personnel whose roles are essential to the conduct of the research.

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View: SF2 - Conflict of Interest
Note: Individuals who are not key personnel are not required to be listed here, but PIs still bear the
responsibility to document the delegation of responsibilities in the study records.
PIs may elect to use the Study Roster activity button in RAMS-IRB (available after approval) as an alternative
way to document study staff involvement and delegation of responsibilities. Personnel changes made to the
non-key personnel listed in the separate Study Roster activity do not require an amendment.
 
Name
Roles
Roles -
Other
ResponsibilitiesResponsibilities
- Other
QualificationsQualifications
- Other
COI
Investigator
View Mark
Baron
Principal
Investigator
Medical or
Psychological
Responsible
Investigator
 
Data Collection -
Direct Observation
Participant
Consent
Data Collection -
Lab
Data Collection -
Clinical
Participant
Identification
Study Design
Participant
Recruitment
Intervention
Services
Clinical Services
Data Collection -
Interviews/Surveys
 
Experience -
Research
Experience -
Related Skills
Experience -
Clinical
Education
and/or
Professional
Preparation
 
yes
View GinaMari
Blackwell
Other
Study
Coordinator
Project
Coordination
Participant
Consent
Regulatory
Management
Data Management
Participant
Identification
Data Entry
Data Coding
Participant
Recruitment
Data Collection -
Interviews/Surveys
 
Experience -
Research
Experience -
Related Skills
Education
and/or
Professional
Preparation
 
no
View Ronald
Elswick
Other
Biostatistician Data Analysis
Data Management
Study Design
 
Education
and/or
Professional
Preparation
 
no
2. Identify all independent investigators and key personnel at non-VCU sites who will be engaged in this study
AND who DO NOT have IRB approval for this study from their own institution.
 NameRoles
Roles
-
Other
ResponsibilitiesResponsibilities
- Other
QualificationsQualifications
- Other
COI
Investigator
There are no items to display
3. If independent investigators or community engaged investigators are listed above,describe the human subjects
training these individuals will complete and the process that will be used to ensure that all persons assisting
with the research are adequately informed about the protocol and their research related duties and functions: 
The staff of the Parkinson೦s and Movement Disorders Center engaged in this research work very closely in their
respective roles. They communicate about clinical and research related topics and issues at scheduled weekly
meetings. Prior to participating, all engaged personnel will participate in a meeting to review the protocol. Special
meetings will be held as necessary to update all staff on any changes to the protocol.
4. * Upload a CV or Biosketch for the PI, Medically/Psychologically Responsible Investigators and the lead
Student/Trainee Investigators. Do not upload CVs or Biosketches for other individuals.
 
ID: MS4_HM20020066
  
Conflict of Interest
The PI should ask the questions on this page of all research personnel who are engaged in the research, including
subrecipient investigators and personnel. 

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1. * To the best of your knowledge, do you (as PI) or any other engaged individual have a financial interest
related to this study?
Financial interest include utilizing your licensed intellectual property in the study; serving as a paid
consultant, or advisory board member, or officer/director with a related entity; and equity or business
ownership in a company that is related to this project
  Yes  No
2. * To the best of your knowledge, do you (as PI) or any other engaged individual have a non-financial interest
related to this study?
Non-financial Interests could include such things as:
- utilizing your unlicensed intellectual property in the study,
- serving as an unpaid advisory board member or officer/director with a related entity, and
- equity or business ownership in a company that has yet to make a profit and is related to this project
- conflict of time/effort,
- personal and professional relationships/affiliations,
- intellectual passions or personal beliefs
- other factors that could create bias in the study
  Yes  No
3. Describe any institutional conflict of interest that you or any member of the research team are aware of that
pertains to this research:
 An institutional conflict of interest is a situation in which financial interests of the University or University
leadership may affect research activities at VCU.
none
 
ID: MS4_HM20020066
  
Other VCU Requirements
This page asks questions on behalf of other ancillary offices, committees and departments at VCU regarding
institutional requirements that could apply to this research. In some cases, these requirements could also
impact the consent process or other aspects of the IRB's review.
Based upon answers provided earlier in this form, certain ancillary sections below may not have questions
displayed if those requirements are not applicable to this study.
1. Cost Coverage Analysis
         Information on coverage analysis requirements and processes can be found through VCU೦s Clinical
Research Compliance Program at https://research.vcu.edu/human-research/clinical-research/vcu-clinical-research-
coverage-analysis/ 
 
1. * VCU requires that all clinical research studies be evaluated to determine if a Coverage Analysis is
required. Has your study been evaluated by an institutionally designated Coverage Analysis Specialist?
Yes
No
Not Applicable
 
2. ClinicalTrials.gov Program & OnCore
For guidance, see https://cctr.vcu.edu/support/consultation/clinical-trials-gov/ or email CCTRCTGOV@vcu.edu
1. * Is this a Clinical Trial?
  Yes  No 
2. * ThePI acknowledges awareness of the following requirements for posting clinical trial consent forms:
 
  - Each clinical trial under the 2018 Common Rule that is conducted or supported by a Federal
department or agency must post one IRB-approved consent form that was used to enroll subjects on a
publicly available Federal website [45 CFR 46.116(h)].
  - When engaged in multi-site research, the VCU PI is responsible for confirming with the lead site who
is responsible for posting the informed consent form.
  - When VCU is the lead site, the VCU PI is responsible for posting the informed consent form (unless
the federal department or agency will post it).
  Yes  No 
3. Community Engagement
For more information, see https://community.vcu.edu/
1. * Is this a community engaged research study? (See help text for definitions)
  Yes
No
 
4. Family Educational Rights and Privacy Act (FERPA) Requirements
For guidance, see  https://rar.vcu.edu/records/family-educational-rights-and-privacy-act/

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1. * Does this study involve obtaining information from VCU students' educational records (see help
text)?
  Yes
No
5. Research Data Privacy Requirements
Contact the VCU Research Data Privacy Office with questions: https://research.vcu.edu/integrity-and-
compliance/compliance/research-data-privacy/
1. * Does this study involve the VCU site (regardless of the IRB of record), or any sites under the VCU
IRB'೦s oversight, obtaining data in, or from, a foreign country? 
  Yes  No   
 
6. Information Security
For guidance, see https://ts.vcu.edu/askit/essential-computing/information-security/
1. * Using the VCU Data Classification Tool, please determine the appropriate data classification category
for the data that will be collected or used in this research.
Note: if the data falls into Category 1, a data security management plan is required by University
Information Security Office.
See help text for information on accessing the VCU Data Classification Tool, and for information on
creating a data security management plan at https://dms.vcu.edu.
Category 1: all data that require breach notifications in the event of improper release, including
personally identifiable information covered by HIPAA and Commonwealth of Virginia regulations.
Category 2: all proprietary data that if improperly released has the potential to cause harm to the
institution, its mission or its reputation that do not require breach notifications.
2. * I confirm use of the VCU Data Classification Tool at https://go.vcu.edu/dataclassification in determining
the data classification category selected in Question 1:
  Yes
No
3. * The PI is aware that if the study೦s data is classified as Category 1, a Data Management Plan must be
created. See https://ts.vcu.edu/askit/essential-computing/information-security/data-management-system/
  Yes  No  
 
4. * I confirm that any use of external technology has been submitted to Information Security in the
study೦s Data Management Plan. If this study uses any technology platforms, apps, services, etc. that
are maintained external to VCU or hosted by another institution and are NOT currently listed in the DMS
system as an approved service for the storage, processing, or transmission of VCU data, I am required
to have VCU Information Security conduct a security review of that technology. I may contact
infosec@vcu.edu with questions.
I also confirm that if the study involves use of external technology and VCUHS HIPAA data, I must also
seek security review from the VCUHS Data Governance group (contact Mary Harmon at
mary.harmon@vcuhealth.org):
  Yes  No
7. Massey Cancer Center Protocol Review and Monitoring Committee (PRMC)
For guidance, see https://www.massey.vcu.edu/research/protocol-review/
1. * Does this study involve any of the following?
- Research involving patients with cancer, their families or their health care providers
- Research involving cancer screening, diagnosis or prevention
- Secondary data collected from cancer patients or their medical records
- Cancer-related surveys (e.g., attitudes about risk, prevention and treatment) of the general population
  Yes
No
8. VCU ONETRAC Protocol Review Oversight Committees (PROCs) For guidance, see https://onetrac.vcu.edu/
1. * Does this study involve research with any of the following?
- VCU Health System patients
- VCU Health System facilities
- VCU Health System data   Yes
No
   
9. VCU Health Department of Patient Centered Services
 

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1. * Does your study involve a satisfaction survey  administered to VCUHS patients (*See Help Text):
Yes
No
Not Applicable
10. VCU Faculty-Held IND or IDE
For guidance, see http://go.vcu.edu/indide
1. * The PI has reviewed and agreed to comply with the VCU policy "Reporting Sponsor-Investigator
Investigational New Drug Applications (IND) or Investigational Device Exemptions (IDE).
  Yes
No
11. VCU Health System locations
1. * Will research activities occur in patient care areas of the VCU Health System (including at CHoR,
Community Memorial Hospital, Tappahannock Hospital, VCU Medical Center and Massey Cancer
Center)?
  Yes
No
2. * The PI has reviewed and agreed to comply with the  VCU Health System Research in Patient Care
Areas policy (https://research.vcu.edu/compliance_program/vcuhs_policies.htm):
  Yes
No
12. VCUHS Department of Pathology
Learn more about requesting and establishing an account with Pathology here:  See
https://pathology.vcu.edu/research-services/
1. * I have contacted VCUHS Department of Pathology to determine feasibility if my study involves the
following: 
- Storage of Microbiology isolates
- New instrumentation provided by clinical trial/study sponsor, or 
- Non-routine specimen processing (examples include but aren೦t limited to the following: addition of
reagents to samples/aliquots, buffy coat processing, DNA sample processing)
N/A - my study does not involve any of the listed processes.
2. * If my study involves specimen retrieval from the Pathology laboratory, I have established a process
with Pathology to deidentify and retrieve specimens.
N/A - my study won't involve specimen retrieval from Pathology
 
 
13. VCU Institutional Biosafety Committee (IBC)
To contact the Biosafety Office see their website at:  https://research.vcu.edu/integrity-and-
compliance/compliance/regulatory-committees/
1. * Does this project involve any of the following hazardous biological agents (೦biohazardous agents೦)
that have NOT been FDA approved? These may include, but are not limited to, any of the following. If
you are unsure, please contact the Biosafety Office:
       - Any functional recombinant viruses (especially viruses that may integrate into the patients೦
genome).
       - Expression or administration of biological toxins.
       - Live pathogenic or potentially pathogenic organisms of plants or animals (bacteria, fungi, wild-
type viruses, parasites, etc.), that are, or potentially may be, in experimental products.
       - Introduction or expression of rDNA or synthetic nucleic acids
       - Use of a product (e.g., monoclonal antibodies, recombinant cytokines) produced from virally
infected mammalian cells.
       - Use of a product (purified growth factors, cytokines) produced from mammals or their cells.
  Yes  No
 
 
14. VCU Radiation Safety Committee (RSC)
To contact the Radiation Safety Section see their website at: https://research.vcu.edu/integrity-and-
compliance/compliance/regulatory-committees/ 
1. * Does this study involve radiation exposure and/or scans involving radiation (e.g.: PET, MRA, CT, DXA,
nuclear medicine, etc.)?
  Yes
No
           

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View: SF2 - HIPAA
View: SF2 - Partial Waiver of Authorization
15. VCU Scientific Review Committee (SRC)
For guidance, see https://cctr.vcu.edu/support/consultation/scientific-review-committee/
1. * Has this human subjects protocol (not the grant application) already been reviewed by the funder of a
sponsored project (e.g. a federal, state or non-profit funding sponsor)?
  Yes
No
Based upon your responses, this study will be routed to the VCU Scientific Review Committee (SRC)
when it is submitted. After SRC review is completed, the IRB will receive the study.
16. Upload any documents requested in the questions above:
ID: MS4_HM20020066
  
HIPAA
In order for VCUHS to meet HIPAA regulations regarding accounting of disclosures, data retention, and data destruction
requirements for PHI data obtained without patient authorization, members of the study team (including principal investigators)
are directed to consult with VCU Informatics to obtain any VCUHS data. This does not include obtaining data for which the
study team has patient authorization. [VCU Health System Authority and Affiliates Policy COMP-014] 
For data requests, including preparatory to research and research with decedents, submit a request for the desired PHI, or for
a consultation on alternate methods to obtain the data, at https://informatics.vcu.edu.
HIPAA Privacy Board Requirements
       For guidance, see https://www.vcuhealth.org/our-story/who-we-are/compliance-services/compliance-services
1. * Select the source of the Individually Identifiable Health Information. See help text for definitions.

PHI associated with or derived from (i.e. obtained from or entered into) VCU Health medical records or
VCU Dental Care records

Research Health Information (RHI) created or received by a study and kept solely in study records (e.g. self
reported or the result of research tests and not entered into health records)

PHI associated with or derived from (i.e. obtained from or entered into) a non-VCU HIPAA covered entity೦s
health records
2. * Summarize the types of health information that will be obtained or used in this research. Do not describe
only the identifiers that you will collect or use during the study.
We will collect: name, DOB, contact information (phone and email), medical record numbers, and medical history
related to PD diagnosis (date of Parkinson೦s diagnosis, medication list, medical history, gait impairments).
3. * Describe the source(s) of the protected health information (e.g. Informatics or which clinical databases):
Most information will be collected directly from patients. Outpatient records from neurology may be reviewed to confirm
PD diagnosis during screening.
4. * Does the PI certify that this study's access to and use of the protected health information is limited to the
minimum amount necessary to be able to effectively conduct the research?
  Yes  No 
5. * Select all pathways this research will employ to use or access PHI  (selections will branch):

De-Identified Data (none of the 18 identifiers are recorded or associated with the research data)

Limited Data Set

Waiver of Authorization

Partial Waiver of Authorization (temporary waiver for recruitment purposes and/or waiver of some
elements of Authorization)

Signed Authorization Combined with Consent Form

Signed Authorization as Stand-Alone Form
 
 
ID: MS4_HM20020066
  
Partial Waiver of Authorization
1. * Select the purpose for requesting the partial waiver of authorization:

Identify possible participants to recruit for the study

Waive some elements of authorization (such as signature)
2. * Explain how the partial waiver of authorization poses no greater than minimal risk to participants' privacy:
(Alternative question phrasing: How do the risk(s) of this use of identifiable health information compare to the
risks to privacy a person might reasonably experience in normal everyday life?).
Partial waiver is for recruiting only. One method of recruitment will to review records in the PMDC registry to determine

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View: SF2 - Institutional Requirements Complete
View: SF2 - Documents
which participants interested in being contacted for research opportunities also meet the basic inclusion/exclusion
criteria for this study. Registry study staff will record only the basic contact information to transmit to our study staff to
enable us to contact them, explain the study, and determine if they wish to be scheduled for a screening visit. Informed
consent will be obtained at that screening visit prior to any further assessments.
3. * If you selected "Identify possible participants to recruit" above,  describe when will the 18 HIPAA identifiers
be destroyed for those who do not eventually enroll in the study?

Following Participant Contact

Upon Reaching Study Accrual Objectives

Other
 
4. * Other than the PI and research personnel identified in this research application, who else will have access to
the Protected Health Information?
No one.
5. * Explain why the study cannot practicably be conducted without the partial waiver of authorization:
(Alternative question phrasing: Why is this partial waiver necessary to make the study achievable or viable?)
Recruitment in prior studies at the VCU Parkinson's Movement Disorder Clinic (PMDC) has proven that targeting our
registry and clinic populations is the most successful means of recruiting for clinical trials.
6. * In applying for a partial waiver of authorization, the PI agrees to the following:
A)  The identifiers used for this research study will not be used for any other purpose or disclosed to any
other person or entity (aside from members of the research team identified in this application), except as
required by law.
B)  If at any time I want to reuse this information for other purposes or disclose the information to other
individuals, I will seek approval from the IRB/Privacy Board.
C)  I will comply with VCU HIPAA policies and procedures and to the use and disclosure restrictions described
above. 
D)  I assume responsibility for all uses and disclosures of the PHI by members of my study team.
  Yes
No
 
ID: MS4_HM20020066
  
Institutional Requirements Complete
Protocol Progress:
? INITIAL SETUP
? BACKGROUND, RATIONALE & GOALS
? RESEARCH PLAN
? CONSENT PLAN
? RISKS, PRIVACY & CONFIDENTIALITY
? POPULATIONS WITH SPECIAL CONSIDERATIONS
? INSTITUTIONAL REQUIREMENTS
? DOCUMENTS
Click Continue below to go to the next section
 
ID: MS4_HM20020066
  
Documents
1. Upload any documents that the VCU IRB will need to conduct a review of this submission:
A list of potential documents is given in the help text.
NOTE: The delete function should only be used if an incorrect document is uploaded or added to the system AND that
document has not been reviewed and approved by the IRB. Do NOT delete documents that the IRB previously
reviewed and approved.
Once you have uploaded a document to RAMS-IRB, any changes to that document (i.e. different versions of
the same document) should be added to the IRB submission by using the Update button. To provide updated
documents, follow these steps:
  - Click the Update button located to the left of the document to be updated.
  - In the Add Document window, click the Choose File or Browse button, select the file you are adding, and
click on the Open button.
  - Click OK to close the Add Document window, and the system will upload the revised document. RAMS-IRB
will automatically provide a version number for the document.
To access previous versions of a document in RAMS-IRB you must use the History link associated with the
document.
- Click the View or Update button located to the left of the document you wish to access.
- In the Add/View Document window, click the "History" hyperlink located to the right of the file name.

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View: SF2 - Documents Complete
- A separate window will open that shows all versions of the document that have been added to RAMS-IRB.
Click on any file name to download and view the document.
 
Document Name
Document
VersionDate
Modified
Uploaded
By
Type
Approved
View Consent_exoskeleton
Consent_exoskeleton_01202022a.pdf
0.17
1/26/2022
2:55 PM
Mark Baron Consent/Assent/Information
Sheet
Yes
View Consent_exoskeleton_large_print Consent_exoskeleton_large_print_version_01202022.pdf 0.05
1/26/2022
2:55 PM
GinaMari
Blackwell
Consent/Assent/Information
Sheet
Yes
View Consent_SO
Consent_exoskeleton_SO_v1.1.pdf
0.08
1/26/2022
2:55 PM
GinaMari
Blackwell
Consent/Assent/Information
Sheet
Yes
View PROC not activated
PROC neurology not activated.pdf
0.01
1/20/2022
11:45 AM
GinaMari
Blackwell
Ancillary Committee
Approval
Not
Applicable
View VCU Informed Consent
Evaluation Tool
ICEval.doc
0.01
2/23/2021
3:13 PM
GinaMari
Blackwell
Consent/Assent/Information
Sheet
Not
Applicable
View MoCA - blind
MoCA-Test-BLIND - 04-2020.pdf
0.01
2/1/2021
3:52 PM
GinaMari
Blackwell
Research Measure
Yes
View NSR Device APDM
APDM CE 510k exempt.pdf
0.01
11/10/2020
3:18 PM
GinaMari
Blackwell
Other
Not
Applicable
View APDM User Manual
APDM MobilityLab_UserGuide.pdf
0.01
10/25/2020
5:14 PM
GinaMari
Blackwell
Other
Not
Applicable
View Keeogo User Manual
IFU-006-EN v1.1 Keeogo_ User Manual
(USA)_approved.pdf
0.02
10/14/2020
5:49 PM
GinaMari
Blackwell
Drug/Device Brochure
Not
Applicable
View User Manual
IFU-003-EN v1.2_Keeogo_ Clinician
Manual_approved.pdf
0.02
10/14/2020
5:48 PM
GinaMari
Blackwell
Drug/Device Brochure
Not
Applicable
View Article for NSR device
Keeogo in MS open label.pdf
0.01
9/23/2020
10:49 AM
GinaMari
Blackwell
Other
Not
Applicable
View Pre-screen phone script
prescreen phone script_exoskeleton2.docx
0.02
9/21/2020
3:59 PM
GinaMari
Blackwell
Recruitment/Advertising
Yes
View Consent from HM14555
PMDC registry-May 2019-clean.pdf
0.01
9/16/2020
11:09 AM
GinaMari
Blackwell
Other
Not
Applicable
View Support Group Script
Script for Support Groups 9.16.20.docx
0.01
9/16/2020
10:42 AM
GinaMari
Blackwell
Recruitment/Advertising
Yes
View Demographics exoskeleton
Demographics exoskeleton.docx
0.01
8/17/2020
4:38 PM
Mark Baron Research Measure
Yes
View References
References.docx
0.01
8/13/2020
3:44 PM
GinaMari
Blackwell
Other
Not
Applicable
View PDQ-Carer
FINAL_PDQ-C_English_UK.pdf
0.01
8/11/2020
1:12 PM
GinaMari
Blackwell
Research Measure
Yes
View MoCA
MoCA.pdf
0.01
8/10/2020
5:23 PM
GinaMari
Blackwell
Research Measure
Yes
View UPDRS-Part III
MDS-UPDRS_Part III.pdf
0.01
8/10/2020
5:20 PM
GinaMari
Blackwell
Research Measure
Yes
View PDQ-39
PDQ39.pdf
0.01
8/10/2020
5:02 PM
GinaMari
Blackwell
Research Measure
Yes
View Berg Balance Scale
BBS short form.pdf
0.01
8/10/2020
4:54 PM
GinaMari
Blackwell
Research Measure
Yes
View Hand Biosketch
Hand Biosketch.pdf
0.01
8/10/2020
4:51 PM
GinaMari
Blackwell
CV/Biosketch
No
View Baron Biosketch
Baron Biosketch.pdf
0.01
8/10/2020
4:51 PM
GinaMari
Blackwell
CV/Biosketch
Yes
View IDE Exemption
Keeogo_No IDE Req'd.pdf
0.01
8/10/2020
4:42 PM
GinaMari
Blackwell
FDA Regulatory Document Not
Applicable
ID: MS4_HM20020066
  
Documents Complete
Protocol Progress:
? INITIAL SETUP
? BACKGROUND, RATIONALE & GOALS
? RESEARCH PLAN
? CONSENT PLAN
? RISKS, PRIVACY & CONFIDENTIALITY
? POPULATIONS WITH SPECIAL CONSIDERATIONS

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View: Copy of Bio-Med Devices
View: Copy of Bio-Med Devices
? INSTITUTIONAL REQUIREMENTS
? DOCUMENTS
End of Application
Click Continue below to exit and submit this project
 
ID: MS4_HM20020066
  
Bio-Medical Devices
1. * Name:
Keeogo Dermoskeleton  
2. * Manufacturer:
b-temia Inc.
3. * What risk has the sponsor or sponsor-investigator designated the device:
Not Designated / Not Required
4. * Indicate the device's IDE number if a protocol was submitted to the FDA for any investigational device or new
use of a marketed device (regardless of what the FDA's determination was).
Or, if a protocol was not submitted to the FDA:
- Enter "Abbreviated IDE" if the sponsor or sponsor-investigator has designated the device as a Non-
Significant Risk device
- Enter "IDE Exempt" if the sponsor or sponsor-investigator has determined that the device qualifies for IDE
exemption
- Enter "Regulatory Discretion" for a mobile application with regulatory discretion
- Enter the FDA-provided HDE number if a HUD is being used in a clinical investigation for the HDE-approved
indication(s).
IDE Exempt
5. * Select who holds the Investigational Device Exemption (FDA-granted IDE or Abbreviated IDE) for the device:
 
External to VCU Sponsor or Investigator
VCU Sponsor-Investigator
VCU Sponsor who is not the Investigator
Not Required
6. If someone other than the PI is the sponsor for the IDE, name the entity or individual who will be the IDE
sponsor.
 
ID: MS4_HM20020066
  
Bio-Medical Devices
1. * Name:
APDM Mobility Lab wearable sensor system 
2. * Manufacturer:
ERT
3. * What risk has the sponsor or sponsor-investigator designated the device:
Not Designated / Not Required
4. * Indicate the device's IDE number if a protocol was submitted to the FDA for any investigational device or new
use of a marketed device (regardless of what the FDA's determination was).
Or, if a protocol was not submitted to the FDA:
- Enter "Abbreviated IDE" if the sponsor or sponsor-investigator has designated the device as a Non-
Significant Risk device
- Enter "IDE Exempt" if the sponsor or sponsor-investigator has determined that the device qualifies for IDE
exemption
- Enter "Regulatory Discretion" for a mobile application with regulatory discretion
- Enter the FDA-provided HDE number if a HUD is being used in a clinical investigation for the HDE-approved
indication(s).
n/a
5. * Select who holds the Investigational Device Exemption (FDA-granted IDE or Abbreviated IDE) for the device:

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View: SF_IRB_Summary_Document
View: SF_IRB_Summary_Document
View: SF_IRB_Summary_Document
View: SF_IRB_Summary_Document
View: SF_IRB_Summary_Document
 
External to VCU Sponsor or Investigator
VCU Sponsor-Investigator
VCU Sponsor who is not the Investigator
Not Required
6. If someone other than the PI is the sponsor for the IDE, name the entity or individual who will be the IDE
sponsor.
 
ID: MS4_HM20020066
Add Document
1. * Document Name:
Consent_exoskeleton
2. * Type:
Consent/Assent/Information Sheet
3. * File:

Consent_exoskeleton_01202022a.pdf(0.17)
ID: MS4_HM20020066
Add Document
1. * Document Name:
Consent_exoskeleton_large_print
2. * Type:
Consent/Assent/Information Sheet
3. * File:

Consent_exoskeleton_large_print_version_01202022.pdf(0.05)
ID: MS4_HM20020066
Add Document
1. * Document Name:
Consent_SO
2. * Type:
Consent/Assent/Information Sheet
3. * File:

Consent_exoskeleton_SO_v1.1.pdf(0.08)
ID: MS4_HM20020066
Add Document
1. * Document Name:
PROC not activated
2. * Type:
Ancillary Committee Approval
3. * File:

PROC neurology not activated.pdf(0.01)
ID: MS4_HM20020066
Add Document

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View: SF_IRB_Summary_Document
View: SF_IRB_Summary_Document
View: SF_IRB_Summary_Document
View: SF_IRB_Summary_Document
View: SF_IRB_Summary_Document
1. * Document Name:
VCU Informed Consent Evaluation Tool
2. * Type:
Consent/Assent/Information Sheet
3. * File:
ICEval.doc(0.01)
ID: MS4_HM20020066
Add Document
1. * Document Name:
MoCA - blind
2. * Type:
Research Measure
3. * File:

MoCA-Test-BLIND - 04-2020.pdf(0.01)
ID: MS4_HM20020066
Add Document
1. * Document Name:
NSR Device APDM
2. * Type:
Other
3. * File:

APDM CE 510k exempt.pdf(0.01)
ID: MS4_HM20020066
Add Document
1. * Document Name:
APDM User Manual
2. * Type:
Other
3. * File:

APDM MobilityLab_UserGuide.pdf(0.01)
ID: MS4_HM20020066
Add Document
1. * Document Name:
Keeogo User Manual
2. * Type:
Drug/Device Brochure
3. * File:

IFU-006-EN v1.1 Keeogo_ User Manual (USA)_approved.pdf(0.02)
ID: MS4_HM20020066
Add Document
1. * Document Name:
User Manual
2. * Type:
Drug/Device Brochure
3. * File:

IFU-003-EN v1.2_Keeogo_ Clinician Manual_approved.pdf(0.02)

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View: SF_IRB_Summary_Document
View: SF_IRB_Summary_Document
View: SF_IRB_Summary_Document
View: SF_IRB_Summary_Document
View: SF_IRB_Summary_Document
View: SF_IRB_Summary_Document
ID: MS4_HM20020066
Add Document
1. * Document Name:
Article for NSR device
2. * Type:
Other
3. * File:

Keeogo in MS open label.pdf(0.01)
ID: MS4_HM20020066
Add Document
1. * Document Name:
Pre-screen phone script
2. * Type:
Recruitment/Advertising
3. * File:
prescreen phone script_exoskeleton2.docx(0.02)
ID: MS4_HM20020066
Add Document
1. * Document Name:
Consent from HM14555
2. * Type:
Other
3. * File:

PMDC registry-May 2019-clean.pdf(0.01)
ID: MS4_HM20020066
Add Document
1. * Document Name:
Support Group Script
2. * Type:
Recruitment/Advertising
3. * File:
Script for Support Groups 9.16.20.docx(0.01)
ID: MS4_HM20020066
Add Document
1. * Document Name:
Demographics exoskeleton
2. * Type:
Research Measure
3. * File:
Demographics exoskeleton.docx(0.01)
ID: MS4_HM20020066
Add Document

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View: SF_IRB_Summary_Document
View: SF_IRB_Summary_Document
View: SF_IRB_Summary_Document
View: SF_IRB_Summary_Document
View: SF_IRB_Summary_Document
1. * Document Name:
References
2. * Type:
Other
3. * File:
References.docx(0.01)
ID: MS4_HM20020066
Add Document
1. * Document Name:
PDQ-Carer
2. * Type:
Research Measure
3. * File:

FINAL_PDQ-C_English_UK.pdf(0.01)
ID: MS4_HM20020066
Add Document
1. * Document Name:
MoCA
2. * Type:
Research Measure
3. * File:

MoCA.pdf(0.01)
ID: MS4_HM20020066
Add Document
1. * Document Name:
UPDRS-Part III
2. * Type:
Research Measure
3. * File:

MDS-UPDRS_Part III.pdf(0.01)
ID: MS4_HM20020066
Add Document
1. * Document Name:
PDQ-39
2. * Type:
Research Measure
3. * File:

PDQ39.pdf(0.01)
ID: MS4_HM20020066
Add Document
1. * Document Name:
Berg Balance Scale
2. * Type:
Research Measure
3. * File:

BBS short form.pdf(0.01)

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View: SF_IRB_Summary_Document
View: SF_IRB_Summary_Document
View: SF_IRB_Summary_Document
View: SF_IRB_ConsentPlan_Groups
ID: MS4_HM20020066
Add Document
1. * Document Name:
Hand Biosketch
2. * Type:
CV/Biosketch
3. * File:

Hand Biosketch.pdf(0.01)
ID: MS4_HM20020066
Add Document
1. * Document Name:
Baron Biosketch
2. * Type:
CV/Biosketch
3. * File:

Baron Biosketch.pdf(0.01)
ID: MS4_HM20020066
Add Document
1. * Document Name:
IDE Exemption
2. * Type:
FDA Regulatory Document
3. * File:

Keeogo_No IDE Req'd.pdf(0.01)
ID: MS4_HM20020066
  
Consent Groups
1. * Enter a descriptive name for this consent / assent group:
Partial waiver for pre-screens from registry
2. * Select all that apply to this consent / assent group:
 
Name

Signed Consent by Participant

Signed Parent/Guardian Permission or Legally Authorized Representative Consent

Signed Assent by Child or Decisionally Impaired Adult

Verbal Assent by Child or Decisionally Impaired Adult

Short Form Consent (limited applicability)

None of the Above (select waiver below)
3. * Select all electronic signature platforms that apply to this consent / assent group:

Not using electronic signature platforms

DocuSign Part 11 (FDA regulated studies)

DocuSign (standard platform for non-FDA regulated studies)

REDCap e-Consent

Other electronic signature platform

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4. If Other is selected, explain:
5. * Select any waivers that apply to this consent / assent group:
 

No Waivers Requested

Waiver of All Consent or Some Elements in Consent Form

Waiver of Parental Permission or Legally Authorized Representative Consent

Waiver of All Assent by Child or Decisionally Impaired Adult

Waiver of Signature on Consent/Permission Forms (waiver of documentation of consent)

Exception from Informed Consent (for emergency research only)
6. * Select all study team role(s) that will obtain consent / assent from this group:
 

Principal Investigator

Co/Sub-Investigator

Medical or Psychological Responsible Investigator

Lead Student/Trainee Investigator (leading their own project)

Research Coordinator

Research Nurse

Consultant

Research Assistant

Pharmacist

Statistician

Regulatory Coordinator

Trainee/Student(working on project)

Other

N/A: Requesting Waiver of Consent
7. * Describe the consent procedures used for this group. Address each point below:
        - When and where consent will occur
        - What will be covered during the consent discussion 
        - How the consent discussion will occur (e.g. in-person, phone, video conference)
        - How you will reconfirm consent on an ongoing basis, if applicable
Registry participants who appear to meet basic inclusion criteria will be contacted and offered participation in this study.
Those interested will be scheduled for a study screening visit, at which time they will go through the informed consent
process with study staff and will either choose to sign the form or not.
8. Select the processes for minimizing any potential perception of undue influence to participate, particularly
when there is a pre-existing relationship between the participant and the researcher (e.g. treatment
provider/patient; instructor/student; supervisor/employee, etc.):

Having a 3rd person (family/friends, another study team member, etc.) present during the consent / assent
discussion

Having an independent advocate (e.g. advocate for decisionally impaired adults, wards) present during the
consent / assent discussion

Removing physical symbols of authority like white coats or police badges

Sitting down beside the participant instead of standing over them

If obtaining consent / assent in a clinical setting, letting patients sit instead of lie down (if they are able
to)

Moving to a more neutral location like a conference room

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View: SF_IRB_ConsentPlan_Groups

Obtaining consent / assent after other services/interactions have been completed (e.g. after school or the clinic
visit)

Having a mandatory wait period for the participant to go home and think before they sign consent /assent

Sharing the consent / assent discussion between two people (i.e. a clinician might be the best person to explain
study procedures and risks, but then they could step out and let a research assistant finish the consent process)

Other protection(s) not listed here ೦ describe below

N/A: Requesting Waiver of Consent
9. * Describe the other ways the study team will minimize any potential perception of undue influence to
participate:
Participants will be told verbally and in writing on the ICF that participation is voluntary and that they may decline
without prejudice to their ongoing care.
10. * How much time will participants be given to make a decision:
Indefinite
11. If applicable, describe the procedures for consenting children upon entering adulthood or participants who
are no longer decisionally impaired:
 
ID: MS4_HM20020066
  
Consent Groups
1. * Enter a descriptive name for this consent / assent group:
Clinic patients
2. * Select all that apply to this consent / assent group:
 
Name

Signed Consent by Participant

Signed Parent/Guardian Permission or Legally Authorized Representative Consent

Signed Assent by Child or Decisionally Impaired Adult

Verbal Assent by Child or Decisionally Impaired Adult

Short Form Consent (limited applicability)

None of the Above (select waiver below)
3. * Select all electronic signature platforms that apply to this consent / assent group:

Not using electronic signature platforms

DocuSign Part 11 (FDA regulated studies)

DocuSign (standard platform for non-FDA regulated studies)

REDCap e-Consent

Other electronic signature platform
4. If Other is selected, explain:
5. * Select any waivers that apply to this consent / assent group:
 

No Waivers Requested

Waiver of All Consent or Some Elements in Consent Form

Waiver of Parental Permission or Legally Authorized Representative Consent

Waiver of All Assent by Child or Decisionally Impaired Adult

Waiver of Signature on Consent/Permission Forms (waiver of documentation of consent)

Exception from Informed Consent (for emergency research only)
6. * Select all study team role(s) that will obtain consent / assent from this group:

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
Principal Investigator

Co/Sub-Investigator

Medical or Psychological Responsible Investigator

Lead Student/Trainee Investigator (leading their own project)

Research Coordinator

Research Nurse

Consultant

Research Assistant

Pharmacist

Statistician

Regulatory Coordinator

Trainee/Student(working on project)

Other

N/A: Requesting Waiver of Consent
7. * Describe the consent procedures used for this group. Address each point below:
        - When and where consent will occur
        - What will be covered during the consent discussion 
        - How the consent discussion will occur (e.g. in-person, phone, video conference)
        - How you will reconfirm consent on an ongoing basis, if applicable
If a potential participant is found in the clinic schedule and confirmation of diagnosis is confirmed by reviewing the
patient's electronic medical records, the study staff will notify the potential participants provider. The provider will inform
the potential participant about the study and provide them with the contact information of the study staff. The potential
participant will be able contact the study staff.
8. Select the processes for minimizing any potential perception of undue influence to participate, particularly
when there is a pre-existing relationship between the participant and the researcher (e.g. treatment
provider/patient; instructor/student; supervisor/employee, etc.):

Having a 3rd person (family/friends, another study team member, etc.) present during the consent / assent
discussion

Having an independent advocate (e.g. advocate for decisionally impaired adults, wards) present during the
consent / assent discussion

Removing physical symbols of authority like white coats or police badges

Sitting down beside the participant instead of standing over them

If obtaining consent / assent in a clinical setting, letting patients sit instead of lie down (if they are able
to)

Moving to a more neutral location like a conference room

Obtaining consent / assent after other services/interactions have been completed (e.g. after school or the clinic
visit)

Having a mandatory wait period for the participant to go home and think before they sign consent /assent

Sharing the consent / assent discussion between two people (i.e. a clinician might be the best person to explain
study procedures and risks, but then they could step out and let a research assistant finish the consent process)

Other protection(s) not listed here ೦ describe below

N/A: Requesting Waiver of Consent
9. * Describe the other ways the study team will minimize any potential perception of undue influence to
participate:
Participants will be told verbally and in writing on the ICF that participation is voluntary and that they may decline
without prejudice to their ongoing care.
10. * How much time will participants be given to make a decision:
They will be allowed to take as much time as needed to read the ICF, ask questions, and make a decision. If they wish
to take the informed consent form (ICF) home to think about it, they may do that and return at a later date to enroll in
the study.
11. If applicable, describe the procedures for consenting children upon entering adulthood or participants who
are no longer decisionally impaired:

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View: SF_IRB_ConsentPlan_Groups
 
ID: MS4_HM20020066
  
Consent Groups
1. * Enter a descriptive name for this consent / assent group:
Caregivers of PD Patient Participants
2. * Select all that apply to this consent / assent group:
 
Name

Signed Consent by Participant

Signed Parent/Guardian Permission or Legally Authorized Representative Consent

Signed Assent by Child or Decisionally Impaired Adult

Verbal Assent by Child or Decisionally Impaired Adult

Short Form Consent (limited applicability)

None of the Above (select waiver below)
3. * Select all electronic signature platforms that apply to this consent / assent group:

Not using electronic signature platforms

DocuSign Part 11 (FDA regulated studies)

DocuSign (standard platform for non-FDA regulated studies)

REDCap e-Consent

Other electronic signature platform
4. If Other is selected, explain:
5. * Select any waivers that apply to this consent / assent group:
 

No Waivers Requested

Waiver of All Consent or Some Elements in Consent Form

Waiver of Parental Permission or Legally Authorized Representative Consent

Waiver of All Assent by Child or Decisionally Impaired Adult

Waiver of Signature on Consent/Permission Forms (waiver of documentation of consent)

Exception from Informed Consent (for emergency research only)
6. * Select all study team role(s) that will obtain consent / assent from this group:
 

Principal Investigator

Co/Sub-Investigator

Medical or Psychological Responsible Investigator

Lead Student/Trainee Investigator (leading their own project)

Research Coordinator

Research Nurse

Consultant

Research Assistant

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
Pharmacist

Statistician

Regulatory Coordinator

Trainee/Student(working on project)

Other

N/A: Requesting Waiver of Consent
7. * Describe the consent procedures used for this group. Address each point below:
        - When and where consent will occur
        - What will be covered during the consent discussion 
        - How the consent discussion will occur (e.g. in-person, phone, video conference)
        - How you will reconfirm consent on an ongoing basis, if applicable
Informed consent will be obtained at the start of the visit before any study procedures are done. The consent process
will occur in a private exam room.
After each study visit, the patient will be asked to continue in the study by confirming their next visit. Participants will be
informed of their right to withdraw from the study at any time without prejudice. If a new consent is approved after a
participant starts the study but before they finish the study, they will be consented again with the most current consent
form.
8. Select the processes for minimizing any potential perception of undue influence to participate, particularly
when there is a pre-existing relationship between the participant and the researcher (e.g. treatment
provider/patient; instructor/student; supervisor/employee, etc.):

Having a 3rd person (family/friends, another study team member, etc.) present during the consent / assent
discussion

Having an independent advocate (e.g. advocate for decisionally impaired adults, wards) present during the
consent / assent discussion

Removing physical symbols of authority like white coats or police badges

Sitting down beside the participant instead of standing over them

If obtaining consent / assent in a clinical setting, letting patients sit instead of lie down (if they are able
to)

Moving to a more neutral location like a conference room

Obtaining consent / assent after other services/interactions have been completed (e.g. after school or the clinic
visit)

Having a mandatory wait period for the participant to go home and think before they sign consent /assent

Sharing the consent / assent discussion between two people (i.e. a clinician might be the best person to explain
study procedures and risks, but then they could step out and let a research assistant finish the consent process)

Other protection(s) not listed here ೦ describe below

N/A: Requesting Waiver of Consent
9. * Describe the other ways the study team will minimize any potential perception of undue influence to
participate:
The consent will clearly state that their participation is voluntary, and that they may decline participation without
prejudice. As a caregiver, they will also be informed that their participation is not required for the PD patient to take part
in the study.
10. * How much time will participants be given to make a decision:
The caregiver will have until the first treatment visit of the PD patient to decide if they want to participate.
11. If applicable, describe the procedures for consenting children upon entering adulthood or participants who
are no longer decisionally impaired:
n/a
 
ID: MS4_HM20020066
  
Consent Groups
1. * Enter a descriptive name for this consent / assent group:
Assent for Decisionally Impaired Adult
2. * Select all that apply to this consent / assent group:
 
Name

Signed Consent by Participant

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Name

Signed Parent/Guardian Permission or Legally Authorized Representative Consent

Signed Assent by Child or Decisionally Impaired Adult

Verbal Assent by Child or Decisionally Impaired Adult

Short Form Consent (limited applicability)

None of the Above (select waiver below)
3. * Select all electronic signature platforms that apply to this consent / assent group:

Not using electronic signature platforms

DocuSign Part 11 (FDA regulated studies)

DocuSign (standard platform for non-FDA regulated studies)

REDCap e-Consent

Other electronic signature platform
4. If Other is selected, explain:
5. * Select any waivers that apply to this consent / assent group:
 

No Waivers Requested

Waiver of All Consent or Some Elements in Consent Form

Waiver of Parental Permission or Legally Authorized Representative Consent

Waiver of All Assent by Child or Decisionally Impaired Adult

Waiver of Signature on Consent/Permission Forms (waiver of documentation of consent)

Exception from Informed Consent (for emergency research only)
6. * Select all study team role(s) that will obtain consent / assent from this group:
 

Principal Investigator

Co/Sub-Investigator

Medical or Psychological Responsible Investigator

Lead Student/Trainee Investigator (leading their own project)

Research Coordinator

Research Nurse

Consultant

Research Assistant

Pharmacist

Statistician

Regulatory Coordinator

Trainee/Student(working on project)

Other

N/A: Requesting Waiver of Consent

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View: SF_IRB_ConsentPlan_Groups
7. * Describe the consent procedures used for this group. Address each point below:
        - When and where consent will occur
        - What will be covered during the consent discussion 
        - How the consent discussion will occur (e.g. in-person, phone, video conference)
        - How you will reconfirm consent on an ongoing basis, if applicable
Consent will be obtained from the Legally Authorized Representative of participants and assent will be obtained by the
participant. Information about the study will be provided in oral and written form to the participants, prior to any study
activities. Consent conversations will occur in a private room. Visually impaired participants will be given a large print
version of the consent.
After each study visit, the patient will be asked to continue in the study by confirming their next visit. Participants will be
informed of their right to withdraw from the study at any time without prejudice. If a new consent is approved after a
participant starts the study but before they finish the study, they will be consented again with the most current consent
form.
8. Select the processes for minimizing any potential perception of undue influence to participate, particularly
when there is a pre-existing relationship between the participant and the researcher (e.g. treatment
provider/patient; instructor/student; supervisor/employee, etc.):

Having a 3rd person (family/friends, another study team member, etc.) present during the consent /
assent discussion

Having an independent advocate (e.g. advocate for decisionally impaired adults, wards) present during
the consent / assent discussion

Removing physical symbols of authority like white coats or police badges

Sitting down beside the participant instead of standing over them

If obtaining consent / assent in a clinical setting, letting patients sit instead of lie down (if they are able
to)

Moving to a more neutral location like a conference room

Obtaining consent / assent after other services/interactions have been completed (e.g. after school or the clinic
visit)

Having a mandatory wait period for the participant to go home and think before they sign consent /assent

Sharing the consent / assent discussion between two people (i.e. a clinician might be the best person to explain
study procedures and risks, but then they could step out and let a research assistant finish the consent process)

Other protection(s) not listed here ೦ describe below

N/A: Requesting Waiver of Consent
9. * Describe the other ways the study team will minimize any potential perception of undue influence to
participate:
Potential participants will be informed it is their decision to participate and not a requirement to receive clinical care.
10. * How much time will participants be given to make a decision:
Potential participants will be allowed to take as much time as they need to decide. They will be allowed to take the
consent form home to review.
11. If applicable, describe the procedures for consenting children upon entering adulthood or participants who
are no longer decisionally impaired:
n/a
 
ID: MS4_HM20020066
  
Consent Groups
1. * Enter a descriptive name for this consent / assent group:
Potential PD Patient Participants
2. * Select all that apply to this consent / assent group:
 
Name

Signed Consent by Participant

Signed Parent/Guardian Permission or Legally Authorized Representative Consent

Signed Assent by Child or Decisionally Impaired Adult

Verbal Assent by Child or Decisionally Impaired Adult

Short Form Consent (limited applicability)

None of the Above (select waiver below)
3. * Select all electronic signature platforms that apply to this consent / assent group:

Not using electronic signature platforms

DocuSign Part 11 (FDA regulated studies)

DocuSign (standard platform for non-FDA regulated studies)

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
REDCap e-Consent

Other electronic signature platform
4. If Other is selected, explain:
5. * Select any waivers that apply to this consent / assent group:
 

No Waivers Requested

Waiver of All Consent or Some Elements in Consent Form

Waiver of Parental Permission or Legally Authorized Representative Consent

Waiver of All Assent by Child or Decisionally Impaired Adult

Waiver of Signature on Consent/Permission Forms (waiver of documentation of consent)

Exception from Informed Consent (for emergency research only)
6. * Select all study team role(s) that will obtain consent / assent from this group:
 

Principal Investigator

Co/Sub-Investigator

Medical or Psychological Responsible Investigator

Lead Student/Trainee Investigator (leading their own project)

Research Coordinator

Research Nurse

Consultant

Research Assistant

Pharmacist

Statistician

Regulatory Coordinator

Trainee/Student(working on project)

Other

N/A: Requesting Waiver of Consent
7. * Describe the consent procedures used for this group. Address each point below:
        - When and where consent will occur
        - What will be covered during the consent discussion 
        - How the consent discussion will occur (e.g. in-person, phone, video conference)
        - How you will reconfirm consent on an ongoing basis, if applicable
Informed consent will be obtained at the start of the visit before any study procedures are done. The consent process
will occur in a private exam room. Visually impaired participants will be given a large print version of the consent.
After each study visit, the patient will be asked to continue in the study by confirming their next visit. Participants will be
informed of their right to withdraw from the study at any time without prejudice. If a new consent is approved after a
participant starts the study but before they finish the study, they will be consented again with the most current consent
form.
8. Select the processes for minimizing any potential perception of undue influence to participate, particularly
when there is a pre-existing relationship between the participant and the researcher (e.g. treatment
provider/patient; instructor/student; supervisor/employee, etc.):

Having a 3rd person (family/friends, another study team member, etc.) present during the consent / assent
discussion

Having an independent advocate (e.g. advocate for decisionally impaired adults, wards) present during the
consent / assent discussion

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View: Personnel

Removing physical symbols of authority like white coats or police badges

Sitting down beside the participant instead of standing over them

If obtaining consent / assent in a clinical setting, letting patients sit instead of lie down (if they are able
to)

Moving to a more neutral location like a conference room

Obtaining consent / assent after other services/interactions have been completed (e.g. after school or the clinic
visit)

Having a mandatory wait period for the participant to go home and think before they sign consent /assent

Sharing the consent / assent discussion between two people (i.e. a clinician might be the best person to explain
study procedures and risks, but then they could step out and let a research assistant finish the consent process)

Other protection(s) not listed here ೦ describe below

N/A: Requesting Waiver of Consent
9. * Describe the other ways the study team will minimize any potential perception of undue influence to
participate:
The consent will clearly state that participation is voluntary, and that they may decline participation without prejudice to
their ongoing care.
10. * How much time will participants be given to make a decision:
They will be allowed to take as much time as needed to read the ICF, ask questions, and make a decision. If they wish
to take the informed consent form (ICF) home to think about it, they may do that and return at a later date to enroll in
the study.
11. If applicable, describe the procedures for consenting children upon entering adulthood or participants who
are no longer decisionally impaired:
n/a
 
ID: MS4_HM20020066
  
Personnel
1. * Name:
Mark Baron
2. * Is this individual a 'COI Investigator'?
Conflict of Interest (COI) Investigator - any individual who has a level of independence and responsibility
comparable to that of the PI for the design, conduct, or reporting of research.
Anyone designated as a COI Investigator must have a current Financial Interest Report (FIR) in the Activity and
Interest Reporting System (AIRS) (https://airs.research.vcu.edu).
  Yes
No
3. * Roles:
 

Principal Investigator

Co/Sub-Investigator

Medical or Psychological Responsible Investigator

Lead Student/Trainee Investigator (leading their own project)

Research Coordinator

Research Nurse

Consultant

Research Assistant

Pharmacist

Statistician

Regulatory Coordinator

Trainee/Student(working on project)

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View: Personnel
 

Other
4. * Study related responsibilities:
 

Study Design

Data Collection - Lab

Data Collection - Clinical

Data Collection - Interviews/Surveys

Data Collection - Direct Observation

Clinical Services

Intervention Services

Data Entry

Data Coding

Data Management

Data Analysis

Project Coordination

Participant Identification

Participant Recruitment

Participant Consent

Regulatory Management

Other
5. * The PI certifies that if this individual will conduct any clinical activities as part of this study, the individual is
appropriately credentialed and privileged to practice within the institution where the research will be
conducted:
Yes
6. * Qualifications to carry out study related responsibilities: (you may select multiple answers)
 

Education and/or Professional Preparation

Experience - Research

Experience - Clinical

Experience - Related Skills

Trainee

Student

Other
7. Additional or Emergency Phone:
 
ID: MS4_HM20020066
  

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Personnel
1. * Name:
GinaMari Blackwell
2. * Is this individual a 'COI Investigator'?
Conflict of Interest (COI) Investigator - any individual who has a level of independence and responsibility
comparable to that of the PI for the design, conduct, or reporting of research.
Anyone designated as a COI Investigator must have a current Financial Interest Report (FIR) in the Activity and
Interest Reporting System (AIRS) (https://airs.research.vcu.edu).
  Yes
No
3. * Roles:
 

Principal Investigator

Co/Sub-Investigator

Medical or Psychological Responsible Investigator

Lead Student/Trainee Investigator (leading their own project)

Research Coordinator

Research Nurse

Consultant

Research Assistant

Pharmacist

Statistician

Regulatory Coordinator

Trainee/Student(working on project)

Other
4. * If other role is selected, explain:
Study Coordinator
5. * Study related responsibilities:
 

Study Design

Data Collection - Lab

Data Collection - Clinical

Data Collection - Interviews/Surveys

Data Collection - Direct Observation

Clinical Services

Intervention Services

Data Entry

Data Coding

Data Management

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View: Personnel
 

Data Analysis

Project Coordination

Participant Identification

Participant Recruitment

Participant Consent

Regulatory Management

Other
6. * The PI certifies that if this individual will conduct any clinical activities as part of this study, the individual is
appropriately credentialed and privileged to practice within the institution where the research will be
conducted:
Individual has no clinical responsibilities
7. * Qualifications to carry out study related responsibilities: (you may select multiple answers)
 

Education and/or Professional Preparation

Experience - Research

Experience - Clinical

Experience - Related Skills

Trainee

Student

Other
8. Additional or Emergency Phone:
 
ID: MS4_HM20020066
  
Personnel
1. * Name:
Ronald Elswick
2. * Is this individual a 'COI Investigator'?
Conflict of Interest (COI) Investigator - any individual who has a level of independence and responsibility
comparable to that of the PI for the design, conduct, or reporting of research.
Anyone designated as a COI Investigator must have a current Financial Interest Report (FIR) in the Activity and
Interest Reporting System (AIRS) (https://airs.research.vcu.edu).
  Yes
No
3. * Roles:
 

Principal Investigator

Co/Sub-Investigator

Medical or Psychological Responsible Investigator

Lead Student/Trainee Investigator (leading their own project)

Research Coordinator

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
Research Nurse

Consultant

Research Assistant

Pharmacist

Statistician

Regulatory Coordinator

Trainee/Student(working on project)

Other
4. * If other role is selected, explain:
Biostatistician
5. * Study related responsibilities:
 

Study Design

Data Collection - Lab

Data Collection - Clinical

Data Collection - Interviews/Surveys

Data Collection - Direct Observation

Clinical Services

Intervention Services

Data Entry

Data Coding

Data Management

Data Analysis

Project Coordination

Participant Identification

Participant Recruitment

Participant Consent

Regulatory Management

Other
6. * The PI certifies that if this individual will conduct any clinical activities as part of this study, the individual is
appropriately credentialed and privileged to practice within the institution where the research will be
conducted:
Individual has no clinical responsibilities
7. * Qualifications to carry out study related responsibilities: (you may select multiple answers)
 

Education and/or Professional Preparation

Experience - Research

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
Experience - Clinical

Experience - Related Skills

Trainee

Student

Other
8. Additional or Emergency Phone: