A Pilot Study of Auricular Microstimulation to Determine if it Improves Vagal Modulation
Phase: NA
Conditions: Functional Gastrointestinal Disorders
Sponsor: Virginia Commonwealth University

STUDY TEAM NOTE: The following document, while in a non-
standard format, is the protocol document for this study. At the 
time of submission, our institution did not require a separate 
protocol document and the IRB application was permitted to be 
used as the acting protocol document.   

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HM20025635
View: SF - Study Identification
Date: Tuesday, April 23, 2024 11:33:33 AM
ID: HM20025635
HM20025635 - Gisela Chelimsky
A pilot study of auricular microstimulation to determine if it improves vagal modulation
  
Study Identification
1. * Select the Principal Investigator:
Gisela Chelimsky
2. * Study Title:
A pilot study of auricular microstimulation to determine if it improves vagal modulation
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:
Peds - Gastroenterology
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 Previously submitted versions of this study (closed, withdrawn, auto-withdrawn studies)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
HM20025242 Pediatric POTS: does a periaqueductal gray – vagus nerve interface malfunction explain
the natural history with its numerous co-morbidities?
Gisela
Chelimsky
HM20025299 Patient Registry for the Autonomics Center
Gisela
Chelimsky
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
Andaya
Andrea-Kayle
andayaa@vcu.edu
8048283793
 
Chelimsky
Gisela
grotewoldcg@vcu.edu
 
 
Chelimsky
Thomas
chelimskyt@vcu.edu
 
 
Dave
Bhakti
badave@vcu.edu
 
 
Lessard
Margaret
mklessard@vcu.edu
8046283093
 
Maxwell
Madison
maxwellme@vcu.edu
 
 
Minter
Sabrina
scminter@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
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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)
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HM20025635
View: SF2 - Federal Regulations
ID: HM20025635
HM20025635 - Gisela Chelimsky
A pilot study of auricular microstimulation to determine if it improves vagal modulation
  
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
•    the study involves an IND/IDE, abbreviated IDE, IND/IDE exemption, HUD, expanded access, or is otherwise
subject to 21 CFR 56, 
•    the study involves a test article being administered or dispensed to subjects NOT according to a clinicians’
medical judgment but rather, per the study protocol, OR
•    the study does not involve a test article but intends to provide safety or efficacy data to the FDA.
 
  Yes
No
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)

Tobacco Product

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
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HM20025635
View: SF2 - IRB Panel Setup
ID: HM20025635
HM20025635 - Gisela Chelimsky
A pilot study of auricular microstimulation to determine if it improves vagal modulation
  
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
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HM20025635
View: SF2 - Review Setup
ID: HM20025635
HM20025635 - Gisela Chelimsky
A pilot study of auricular microstimulation to determine if it improves vagal modulation
  
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 study’s 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

Remote interactions / interventions with participants

Secondary data/specimen analyses with or without contact with study 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
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.
Scientific benefit
 
  
 
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HM20025635
View: SF2 - Initial Setup Complete
ID: HM20025635
HM20025635 - Gisela Chelimsky
A pilot study of auricular microstimulation to determine if it improves vagal modulation
  
Initial Setup Complete
Protocol Progress:
❶ INITIAL SETUP
② BACKGROUND, RATIONALE & GOALS
③ RESEARCH PLAN
④ CONSENT PLAN
⑤ RISKS, PRIVACY & CONFIDENTIALITY
⑥ POPULATIONS WITH SPECIAL CONSIDERATIONS
⑦ INSTITUTIONAL REQUIREMENTS
⑧ DOCUMENTS
Click Continue below to go to the next section
 
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HM20025635
View: SF2 - Background, Rationale and Goals
ID: HM20025635
HM20025635 - Gisela Chelimsky
A pilot study of auricular microstimulation to determine if it improves vagal modulation
  
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 aim of this proposal is to determine if utilizing an affordable tool like microstimulation utilizing a TENs unit and
applying the stimulation to the ear though an ear clip does improve vagal modulation. This can be easily done at home
by utilizing the microstimulation for 2 hours a day and measuring vagal modulation before and after. Previous research
investigating this had participants use the unit for 2 hours as well. (Chelimsky et al., 2019), however the data from this
study was inconclusive, and therefore this study aims to demonstrate effectiveness of the unit usage on heart rate
variability (HRV).
Although functional gastrointestinal disorders (FGID) affect 10%-20% of children and adolescents. 1-3 the
pathophysiology remains unknown. The multiple current hypotheses include visceral hypersensitivity, altered brain-gut
connections, dysbiosis, genetic and epigenetic factors, and increased gut permeability among others. 4 Since the
vagus nerve links the brain to the gut, many studies of adult subjects have evaluated the cardiovagal modulation in this
group of disorders. The cardiovagal modulation can be measured by heart rate variability (HRV). HRV evaluates the
heart rate fluctuation over a period of time. HRV is considered a reliable tool to look at parasympathetic function,
baroreflex function, and parasympathetic to sympathetic balance.5, 6 High-frequency (hf) HRV is a marker of vagal
modulation. The low-frequency (lf) HRV probably reflects cardiac autonomic outflow from the baroreflex or
parasympathetic regulation, rather than sympathetic modulation, although this is still being discussed.6, 7
A meta-analysis of adult subjects with irritable bowel syndrome (IBS) showed decreased cardiovagal modulation.8 One
study compared children aged 7-10 years of age with functional abdominal pain or IBS to healthy subjects. They found
no difference in cardiovagal and cardiac sympathetic modulation.9 However, a study of young adolescents with
different chronic pain syndromes, including chronic abdominal pain, showed decreased cardiovagal modulation.10
These findings are similar to those in many adult syndromes with chronic pain, such as chronic pelvic pain,11 complex
regional pain syndrome,12 fibromyalgia,13 and chronic neck pain.14
Although future research would aim to investigate vagal modulation in those specifically with FGID, for preliminary data
purposes we are testing the unit's effects on heart rate variability regardless of having/not having an FGID diagnosis.
1Hyams JS, Davis P, Sylvester FA, Zeiter DK, Justinich CJ, Lerer T. Dyspepsia in children and adolescents: a
prospective study. J Pediatr Gastroenterol Nutr. 2000; 30: 413- 418.
2Apley J, Naish N. Recurrent abdominal pains: a field survey of 1,000 school children. Arch Dis Child. 1958; 33: 165-
170.
3Boey C, Yap SB, Goh KL. The prevalence of recurrent abdominal pain in 11-to 16-year-old Malaysian schoolchildren.
J Paediatr Child Health. 2000; 36: 114- 116.
4Enck P, Aziz Q, Barbara G, et al. Irritable bowel syndrome. Nat Rev Dis Prim. 2016; 2: 16014.
5Riganello F, Garbarino S, Sannita WG. Heart Rate Variability, Homeostasis, and Brain Function. J Psychophysiol.
2012; 26: 178– 203.
6Goldstein DS, Bentho O, Park M-Y, Sharabi Y. LF power of heart rate variability is not a measure of cardiac
sympathetic tone but may be a measure of modulation of cardiac autonomic outflows by baroreflexes. Exp Physiol.
2011; 96: 1255– 1261.
7Reyes del Paso GA, Langewitz W, Mulder LJ, van Roon A, Duschek S. The utility of low frequency heart rate
variability as an index of sympathetic cardiac tone: A review with emphasis on a reanalysis of previous studies.
Psychophysiol. 2013; 50: 477– 487.
8Liu Q, Wang EM, Yan XJ, Chen SL. Autonomic functioning in irritable bowel syndrome measured by heart rate
variability: A meta-analysis. J Dig Dis. 2013; 14: 638- 646.
9Jarrett M, Heitkemper M, Czyzewski D, Zeltzer L, Shulman RJ. Autonomic nervous system function in young children
with functional abdominal pain or irritable bowel syndrome. Journal of Pain. 2012; 13: 477- 484.
10Evans S, Seidman L, Tsao J, Lung K, Zeltzer L, Naliboff B. Heat rate variability as a biomarker for autonomic
nervous system response differences between children with chronic pain and healthy control children. J Pain Res.
2013; 6: 449- 457.
11Williams DP, Chelimsky G, McCabe NP, et al. Effects of chronic pelvic pain on heart rate variability in women. J Urol.
2015; 194: 1289- 1294.
12Terkelsen AJ, Molgaard H, Hansen J, Finnerup NB, Kroner K, Jensen TS. Heart rate variability in complex regional
pain syndrome during rest and mental and orthostatic stress. Anesthesiology. 2012; 116: 133- 146.
13Mork PJ, Nilsson J, Loras HW, Riva R, Lundberg U, Westgaard RH. Heart rate variability in fibromyalgia patients
and healthy controls during non-REM and REM sleep: a case-control study. Scand J Rheumatol. 2013; 42: 505- 508.
14Kang JH, Chen HS, Chen SC, Jaw FS. Disability in patients with chronic neck pain: heart rate variability analysis
and cluster analysis. Clin J Pain. 2012; 28: 797- 803.
Chelimsky, G., Rausch, S., Bierer, D., Feng, M., Simpson, P., Awe, E., & Chelimsky, T. (2019). Cardiovagal modulation
in pediatric functional gastrointestinal disorders. Neurogastroenterology and motility : the official journal of the
European Gastrointestinal Motility Society, 31(5), e13564. https://doi.org/10.1111/nmo.13564
2. * Describe the study hypothesis and/or research questions.  Use lay language whenever possible.
The overarching hypothesis of this proposal is that auricular vagal micro-stimulation improves vagal modulation.
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Based on prior experience, in more than half the subjects, we expect high-frequency heart rate variability (hfHRV) to
improve by 10% from baseline to week 4.
3. * Describe the study's specific aims or goals.  Use lay language whenever possible.
To determine if the auricular microstimulator produces the expected increase in HRV.
4. * Describe the scientific benefit or importance of the knowledge to be gained:
Potential conclusions would include that the vagal stimulator inhibits the neuroinflammatory cascade and that neuro-
inflammation plays a major role in pediatric FGID, a currently open question.
5. * Describe any potential for direct benefits to participants in this study:
The TENS unit has the potential to decrease symptoms in participants with FGID. We cannot guarantee this will help,
hence why we are doing the study.
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:
If this auricular TENS unit device produces the expected results, it will:
1) provide a portable, affordable tool to decrease symptoms in FGID
2) corroborate that increasing vagal modulation improves symptoms in FGID
7. Upload a supporting citation list if applicable:
 
Document
Name
Document
VersionDate
Modified
Uploaded
By
Type
Approved
View FGID
Assent/Parental
Permission
TENS FGID Assent
V10.pdf
0.23
4/23/2024
11:25 AM
Madison
Maxwell
Consent/Assent/Information
Sheet
Yes
View Healthy Control
Assent/Parental
Permission
TENS HC Assent
V10.pdf
0.23
4/23/2024
11:25 AM
Madison
Maxwell
Consent/Assent/Information
Sheet
Yes
View Healthy Control
Consent
TENS HC Consent
V10.pdf
0.22
4/23/2024
11:24 AM
Madison
Maxwell
Consent/Assent/Information
Sheet
Yes
View FGID Consent
TENS FGID
Consent V10.pdf
0.22
4/23/2024
11:24 AM
Madison
Maxwell
Consent/Assent/Information
Sheet
Yes
View Best Practice
Alert MyChart
Message Script
Best Practice Alert
MyChart Message
Script V2.docx
0.03
3/13/2024
3:52 PM
Madison
Maxwell
Recruitment/Advertising
Yes
View Flyer
TENS Flyer
(Undesigned
Language Only)
V4.docx
0.07
3/13/2024
3:51 PM
Madison
Maxwell
Recruitment/Advertising
Yes
View REDCap Study
Interest &
Screening
Form
Study Interest &
Screening Form
V3.pdf
0.04
3/13/2024
3:51 PM
Madison
Maxwell
Recruitment/Advertising
Yes
View Daily Recording
Diary
Daily Recording
Diary V6.pdf
0.06
3/13/2024
3:51 PM
Madison
Maxwell
Research Measure
Yes
View In-Person
Recruitment
Script
TENS In Person
Recruitment Script
V5.docx
0.12
3/13/2024
3:46 PM
Madison
Maxwell
Recruitment/Advertising
Yes
View Phone
Recruitment
Script
TENS Phone
Recruitment Script
V7.docx
0.15
3/13/2024
3:46 PM
Madison
Maxwell
Recruitment/Advertising
Yes
View Eligible Interest
Form
Submission
Follow-Up
Email
Recruitment
Script
TENS Eligible
Interest Form
Submission Follow-
Up Email
Recruitment Script
V3.docx
0.06
3/13/2024
3:44 PM
Madison
Maxwell
Recruitment/Advertising
Yes
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Document
Name
Document
VersionDate
Modified
Uploaded
By
Type
Approved
View Participant
TENS
Instructions
TENS Unit
Instructions V6.docx
0.11
1/9/2024
1:31 PM
Madison
Maxwell
Other
Yes
View Screen Fail
Contact
Information
Screen Fail Contact
Information.pdf
0.01
12/6/2023
3:22 PM
Madison
Maxwell
Recruitment/Advertising
Yes
View Heart Rate
Variability
Measurements
HRV Measurements
for both study visits
(V2).pdf
0.02
8/23/2023
11:31 AM
Madison
Maxwell
Research Measure
Yes
View TENS Unit
Manual
TENS Unit Manual
(Microcurrent
Model).pdf
0.02
8/17/2023
9:07 AM
Madison
Maxwell
Drug/Device Brochure
Yes
View TENS Unit
Photo
TENS Unit Photo
(Microcurrent
Model).png
0.02
8/17/2023
9:07 AM
Madison
Maxwell
Other
Yes
View Symptom
Questionnaire
GI Symptom
Questionnaire
(V1).pdf
0.01
4/13/2023
3:11 PM
Madison
Maxwell
Research Measure
Yes
View Ear Clip Info
TENS Unit Ear Clip
Information.docx
0.01
1/20/2023
2:09 PM
Madison
Maxwell
Drug/Device Brochure
Yes
View IDE Documents TENS
Documentation of
NSR
determination.docx
0.02
11/29/2022
9:41 AM
Madison
Maxwell
Other
Yes
View TENS Unit Ear
Clip
TENS Ear Clip.jpg
0.01
11/18/2022
12:35 PM
Madison
Maxwell
Other
Yes
View PROC Approval TENS PROC
Approval.pdf
0.01
10/21/2022
12:45 PM
Madison
Maxwell
Ancillary Committee
Approval
Not
Applicable
View M. Maxwell
Trainings (All
Merged)
M Maxwell CITI,
Bioraft, MERT
Trainings
(Merged).pdf
0.01
10/20/2022
11:55 AM
Madison
Maxwell
Other
Not
Applicable
View B. Dave CITI
Trainings (All
Merged)
B Dave CITI
Trainings
(Merged).pdf
0.01
10/20/2022
11:51 AM
Madison
Maxwell
Other
Not
Applicable
View G. Chelimsky
CITI Trainings
(All Merged)
G Chelimsky CITI
Trainings
(Merged).pdf
0.01
10/20/2022
11:49 AM
Madison
Maxwell
Other
Not
Applicable
View T. Chelimsky
CV
T Chelimsky CV
Signed.pdf
0.01
10/20/2022
11:43 AM
Madison
Maxwell
CV/Biosketch
Yes
View Basic
Participant
Information
BasicInformation.pdf 0.01
10/18/2022
3:38 PM
Madison
Maxwell
Research Measure
Yes
View Screening
Form
ScreeningForm.pdf 0.01
10/18/2022
3:37 PM
Madison
Maxwell
Research Measure
Yes
View G. Chelimsky
CV
G Chelimsky
CV.docx
0.01
9/12/2022
4:52 PM
Bhakti Dave CV/Biosketch
Yes
  
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HM20025635
View: SF2 - Study Population
ID: HM20025635
HM20025635 - Gisela Chelimsky
A pilot study of auricular microstimulation to determine if it improves vagal modulation
  
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.
100 
2. If this is a multi-Center Project, what is the maximum anticipated number of subjects across all sites?
Not multi-center
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:
Our power estimates show that 28 or more measurements/surveys are needed to have a confidence level of 95% that
the actual change in HRV d/t TENS unit use is within ±5% of our measurements of HRV. We estimate about a 30%
compliance rate, so we arrived at 100 to account for dropouts and screen fails. We are not aiming to recruit an equal
number of FGIDs/non-FGID, because our main aim is to figure out if the TENS unit improves vagal modulation in
general, not to compare the degree of variability between FGID and non-FGID subjects.
4. * List the study inclusion criteria:
Female
12 – 21 years old
Either diagnosed OR not diagnosed with chronic idiopathic nausea, functional abdominal pain, dyspepsia and/or
irritable bowel syndrome.
English speaking
5. * List the study exclusion criteria:
Patients who are unable to stand upright during the heart rate variability recording
Patients with a known bleeding disorder
Patients with swollen, infected, inflamed, or other skin eruptions on outer ear
Patients with epilepsy
Patients with any implanted cardiac pacemaker or defibrillator
Patients with serious arterial circulatory problems in the lower limbs
Patients with abdominal or inguinal hernia
Patients who are pregnant
Any unstable medical condition, such as renal disease, uncontrolled diabetes, etc.
Requires new medication during the 4 weeks of the study that may affect the gastrointestinal symptoms, vagal
modulation or immune response.
Practices over 1 hour of aerobic activity a day
Daily practice of abdominal breathing (yoga)
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
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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.
The sex restriction is because there is a disproportionate representation of females having functional disorders. Having
male participants in the study may lower the study's external validity and findings may not be generalizable to females
with a male population included.
The TENS unit uses an ear clip and we do not want to disrupt the healing process for ear problems.
We want to exclude people with the conditions listed above (bleeding disorders, epilepsy, circulatory problems, hernias,
pregnancy, any other unstable condition) because it will skew the data by decreasing the ability to properly assess
heart rate variability without confounding variables.
We do not know how the presence of cardiac pacemaker or defibrillators will alter our data nor do we have solid
research on the safety of using TENS with these devices, so we are excluding this population.
We are excluding those who start a medication during the 4 weeks of the study that may affect the gastrointestinal
symptoms, vagal modulation or immune response because we do not know how this will alter our data or interact with
the TENS unit.
Participants who engage in over 1 hour of aerobic exercise or daily practice of yoga will be excluded because we will
not be able to pinpoint whether HRV changes are due to the use of the TENS unit or the exercise/yoga.
  
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HM20025635
View: SF2 - Background, Rationale & Goals Section Complete
ID: HM20025635
HM20025635 - Gisela Chelimsky
A pilot study of auricular microstimulation to determine if it improves vagal modulation
  
Background, Rationale & Goals Section Complete
Protocol Progress:
❶ INITIAL SETUP
❷ BACKGROUND, RATIONALE & GOALS
③ RESEARCH PLAN
④ CONSENT PLAN
⑤ RISKS, PRIVACY & CONFIDENTIALITY
⑥ POPULATIONS WITH SPECIAL CONSIDERATIONS
⑦ INSTITUTIONAL REQUIREMENTS
⑧ DOCUMENTS
Click Continue below to go to the next section
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HM20025635
View: SF2 - Study Procedures
ID: HM20025635
HM20025635 - Gisela Chelimsky
A pilot study of auricular microstimulation to determine if it improves vagal modulation
  
Study Procedures
  
1. * Describe the study hypothesis and/or research questions.  Use lay language whenever possible.
The overarching hypothesis of this proposal is that auricular vagal micro-stimulation improves vagal modulation.
Based on prior experience, in more than half the subjects, we expect high-frequency heart rate variability (hfHRV) to
improve by 10% from baseline to week 4.
2. * Describe the study's specific aims or goals.  Use lay language whenever possible.
To determine if the auricular microstimulator produces the expected increase in HRV.
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 document

No recruitment materials
4. * If Other was selected above, describe the recruitment document that will be used:
Scripts for individual participants
5. * Describe the study procedures/methods for identifying and recruiting participants. Address all of 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 VCU Informatics or VCU IRDS will be used for cohort identification (when applicable, see help text)
    - 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, approach, 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.
1.
- Potential participants can contact the study team phone number or email on the study flyer to express interest in their
study. The design and formatting of study flyers are subject to change, but all language will remain the same as in the
current IRB-approved version.
- Potential participants can scan a QR code on the study flyer to complete a REDCap Study Interest & Screening Form
that includes a brief eligibility assessment survey and the option to submit their contact information for study team
follow-up if answers to the survey indicate eligibility criteria are met. Otherwise, they will be shown a message that
notifies them that they are ineligible and thanking them for their time, and an opportunity to submit their contact
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information to be contacted regarding other studies that may be a better fit for their characteristics.
- Participants who are consented to the Registry for the Autonomics Center (HM20025299) and have consented to
receiving information about future research studies for which they may be eligible will be contacted via email, phone, or
in-person to assess interest in participation with the appropriate script. The design and formatting of email messages
are subject to change, but all language will remain the same as in the current IRB-approved script. Potential
participants can choose to answer screening questions verbally with a study team member during phone recruitment
attempts- if this method is used, a REDCap Study Interest & Screening Form will be filled out by the study team on
their behalf for documentation purposes. Study staff will administer screening questions verbally during in-person
recruitment attempts. Otherwise, potential participants will fill out the REDCap Study Interest & Screening Form on
their own and will be followed up with via the preferred contact method to schedule the first in-person study visit.
- Potential participants may be approached in-person at their clinic visit by a research team member. The PI/clinical
staff will not be consenting patients, but they may ask a patient if it is okay if a coordinator talks to them while they are
at their appointment if they express interest. Potential participants will answer screening questions verbally with a study
team member - a REDCap Study Interest & Screening Form will be filled out by the study team on their behalf for
documentation purposes. Eligible participants will be followed up with via the preferred contact method to schedule the
first in-person study visit if they would like to proceed with participation.
- EPIC "best practice alerts" (BPA) will be used to notify the study team of potentially eligible participants. This alert will
appear if the potential participant meets pre-designated parameters based on the eligibility criteria (e.g., age, sex, ICD-
10 codes for diagnoses, medications being taken, etc.). Study team members will receive a message in their InBasket
when a potential participant is identified. The study team will then send a MyChart message to the potential participant
using the TENS Best Practice Alert MyChart Message Script that includes the REDCap Study Interest & Screening
Form link and study team contact information. If interested, they will fill out the REDCap Study Interest & Screening
Form at their own discretion and will be followed up with via the preferred contact method to schedule the first in-
person study visit if they would like to proceed with participation.
- Potential participant contact information will be stored in a secure REDcap database regardless of recruitment
method.
2.
-Study flyers will be posted in VCU/VCUHealth clinics. Study flyers will also be given to clinical staff to directly hand to
potential participants. PI/clinical staff will simply be distributing flyers and will not be answering study related questions
(unless it is a clinical/health related question beyond the coordinator’s credentials/knowledge) or consent patients. The
flyer may also be distributed through the TelegRAM announcements or the VCU Clinical Research Facebook page.
The flyer may also be sent via department faculty & staff email messages as permitted.
-Approved coordinators will respond/initiate calls or emails from/to potential participants or approach them in person to
schedule an informed consent discussion. PI/clinical staff will only answer clinical/health related questions in relation to
participation beyond the coordinator’s credentials/knowledge.
- For in-person recruitment attempts, the coordinator will view the GI clinic schedule on Epic to see when a potential
participant’s appointment time is and to review basic eligibility criteria before approaching. A coordinator will approach
a patient during their visit to the Gastroenterology Clinic in the private clinic room either before or after their
appointment and introduce the study/assess eligibility using the In-Person Recruitment Script. If the potential
participant is interested in participating, but is unable to complete an informed consent discussion during the visit, the
researcher may collect consent at the study baseline visit in the clinic or pediatric research unit prior to starting study
procedures. Only potential participant screening question answers and contact information will be stored on REDcap
before the consent discussion. Recruitment discussions with children under 18 will be held with at least one
parents/legal guardian present. If recruitment attempts fail for that participant, their contact information will be deleted
upon study closure.
- In-person recruitment efforts will be held on all days the PI's clinic is being held. Study staff will be notified upon
receiving Study Interest & Screening Form submissions, emails, or phone calls, and will respond to these submissions,
emails, or phone calls via preferred contact method within 7 business days. Potential participants who submitted an
interest form, sent an email, or made a phone call to our study team may be contacted up to 3 times by email or phone
call, once a week.
- During any recruitment discussions, potential participants may be emailed or handed a copy of the consent form for
review if requested.
3.
- Eligibility screening will be done via chart review by a study team member, via a REDCap Study Interest & Screening
form submission, or via verbal administration of the items on the REDCap Study Interest & Screening Form by a study
team member.
6. * 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
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7. * 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. The schedule and frequency of when and how procedures will be conducted (e.g. in person, online, phone,
paper, etc.)
 4. A description of all research measures/tests/interventions that will be used, including analyses/tests
conducted on specimens/biological samples (if applicable)
See the help text for additional guidance
1.
This study is a clinical trial involving a TENS unit with an IDE.
2.
Week 0 Visit (Baseline): After the signing of the ICF, participants will take a pregnancy test. All other screening
questions will have been answered previously in the REDCap Study Interest and Screening Form. If the pregnancy test
is negative, the participant will be marked as eligible and assigned a Study ID. Participants will complete the GI
Symptom Questionnaire on REDCap via a computer or tablet handed to the participant. Heart rate variability (HRV) will
then be collected using a digital HRV device. These devices are commonly used to measure HRV, and this study will
not be altering the use of that device for research purposes. To measure HRV, electrode leads connected to the device
will be placed on the participant's chest and stomach while they are laying down. HRV will be measured for 15 minutes
of supine time and 5 minutes of standing time. Participants will then be hooked up to the TENS microcurrent unit (the
unit has a pulse rate from 0.1 - 150 Hz, a pulse width of 2 - 200 mS, and an adjustable pulse amplitude of 0-0.7 mA
peak at 1000 ohms- the unit will be set at a pulse rate of 50 and a pulse width of 5ms. The mA will be turned up just
until the participant can feel it, and then back down to where they can just not feel it, so specific mA strengths may vary
between each participant and session), and heart rate variability will be measured again (supine) for another 30
minutes. The unit will be disconnected and HRV will then again be measured for 15 minutes of supine time and 5
minutes of standing time. The HRV device will continuously measure and the electrodes will not be taken off/the
machine will not be turned off in between physical positions and conditions since it gives us information on HRV during
episodes of position change. Measurement times, including the start time, time when the participant changes physical
position, and end time will be recorded in REDcap. Upon completion of the study visit, HRV data from the device will
be exported into software-compatible files on a VCU managed computer. They will then be stored on a VCU managed
drive with their Study ID and name of the visit (baseline/follow up) as the title of the file for later use in Kubios, an HRV
analysis software. The files generated by the HRV measurement devices include information such as the measurement
start and end times and the participants' interbeat intervals (IBI/RR)/ECG during the measurement. Files with this
information will only be stored in Kubios and/or the VCU drive until analysis is complete. Following the completion of
the HRV measurement, the participant will receive a printout of instructions and a physical demonstration on how to
use the unit by an approved study team member and instructed to use it at a consistent time each day for 2 hours daily
over 4 weeks. The participant doesn't have to hold the unit the entire time, as long as their ear clip is connected to
them and that clip is connected to the machine, they have the freedom to set down the unit near them, hold it, put it in
a pocket, or use the belt clip on the device. The ear clip connects to the unit by a cord. The participant will be asked to
complete the TENS Microcurrent Unit Daily Recording Diary to document when the device was used and where on
their ear, as well as the times of starting/ending sessions. Participants will be emailed daily via REDcap survey
distribution for completion. The study coordinator will contact the patient 2 times over the 4 weeks to check in for
adverse events that would be promptly recorded and reported and to remind them to keep using the device, but a
coordinator contact will be on the instructions printout should they need to report any AEs/device issues prior to the
check-in. Problems may also be reported on the daily recording diary, upon which study team members will receive a
notification. The next visit will be scheduled, and payment will be processed.
Week 4 Visit: The participant and parent(s)/guardian(s) if applicable, will return to the FGID clinic or PRU and complete
heart rate variability measuring using the same procedures as at baseline, return their TENS microcurrent unit,
complete the same symptom questionnaire, and return their daily recording diaries if done on paper. Payment will be
processed.
3.
Tests: Heart Rate Variability assessment, pregnancy test during screening
Interventions: TENS microcurrent unit usage
Measures: Daily recording diary, GI symptom questionnaire
8. * The IRB only reviews research activities, so indicate for each of the study activities described in the question
above or in the protocol which 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.).
    See the help text for additional guidance
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All research activities are being performed exclusively for research purposes.
9. If applicable, describe alternatives (research or non-research) that are available to potential participants if they
choose not to participate in this study:
No alternatives will be available to potential participants. Participants will be notified that declining to participate will not
impact their clinical care and that their participation is totally voluntary.
10. 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:
 
Document
Name
Document
VersionDate
Modified
Uploaded
By
Type
Approved
View FGID
Assent/Parental
Permission
TENS FGID Assent
V10.pdf
0.23
4/23/2024
11:25 AM
Madison
Maxwell
Consent/Assent/Information
Sheet
Yes
View Healthy Control
Assent/Parental
Permission
TENS HC Assent
V10.pdf
0.23
4/23/2024
11:25 AM
Madison
Maxwell
Consent/Assent/Information
Sheet
Yes
View Healthy Control
Consent
TENS HC Consent
V10.pdf
0.22
4/23/2024
11:24 AM
Madison
Maxwell
Consent/Assent/Information
Sheet
Yes
View FGID Consent
TENS FGID
Consent V10.pdf
0.22
4/23/2024
11:24 AM
Madison
Maxwell
Consent/Assent/Information
Sheet
Yes
View Best Practice
Alert MyChart
Message Script
Best Practice Alert
MyChart Message
Script V2.docx
0.03
3/13/2024
3:52 PM
Madison
Maxwell
Recruitment/Advertising
Yes
View Flyer
TENS Flyer
(Undesigned
Language Only)
V4.docx
0.07
3/13/2024
3:51 PM
Madison
Maxwell
Recruitment/Advertising
Yes
View REDCap Study
Interest &
Screening
Form
Study Interest &
Screening Form
V3.pdf
0.04
3/13/2024
3:51 PM
Madison
Maxwell
Recruitment/Advertising
Yes
View Daily Recording
Diary
Daily Recording
Diary V6.pdf
0.06
3/13/2024
3:51 PM
Madison
Maxwell
Research Measure
Yes
View In-Person
Recruitment
Script
TENS In Person
Recruitment Script
V5.docx
0.12
3/13/2024
3:46 PM
Madison
Maxwell
Recruitment/Advertising
Yes
View Phone
Recruitment
Script
TENS Phone
Recruitment Script
V7.docx
0.15
3/13/2024
3:46 PM
Madison
Maxwell
Recruitment/Advertising
Yes
View Eligible Interest
Form
Submission
Follow-Up
Email
Recruitment
Script
TENS Eligible
Interest Form
Submission Follow-
Up Email
Recruitment Script
V3.docx
0.06
3/13/2024
3:44 PM
Madison
Maxwell
Recruitment/Advertising
Yes
View Participant
TENS
Instructions
TENS Unit
Instructions V6.docx
0.11
1/9/2024
1:31 PM
Madison
Maxwell
Other
Yes
View Screen Fail
Contact
Information
Screen Fail Contact
Information.pdf
0.01
12/6/2023
3:22 PM
Madison
Maxwell
Recruitment/Advertising
Yes
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Document
Name
Document
VersionDate
Modified
Uploaded
By
Type
Approved
View Heart Rate
Variability
Measurements
HRV Measurements
for both study visits
(V2).pdf
0.02
8/23/2023
11:31 AM
Madison
Maxwell
Research Measure
Yes
View TENS Unit
Manual
TENS Unit Manual
(Microcurrent
Model).pdf
0.02
8/17/2023
9:07 AM
Madison
Maxwell
Drug/Device Brochure
Yes
View TENS Unit
Photo
TENS Unit Photo
(Microcurrent
Model).png
0.02
8/17/2023
9:07 AM
Madison
Maxwell
Other
Yes
View Symptom
Questionnaire
GI Symptom
Questionnaire
(V1).pdf
0.01
4/13/2023
3:11 PM
Madison
Maxwell
Research Measure
Yes
View Ear Clip Info
TENS Unit Ear Clip
Information.docx
0.01
1/20/2023
2:09 PM
Madison
Maxwell
Drug/Device Brochure
Yes
View IDE Documents TENS
Documentation of
NSR
determination.docx
0.02
11/29/2022
9:41 AM
Madison
Maxwell
Other
Yes
View TENS Unit Ear
Clip
TENS Ear Clip.jpg
0.01
11/18/2022
12:35 PM
Madison
Maxwell
Other
Yes
View PROC Approval TENS PROC
Approval.pdf
0.01
10/21/2022
12:45 PM
Madison
Maxwell
Ancillary Committee
Approval
Not
Applicable
View M. Maxwell
Trainings (All
Merged)
M Maxwell CITI,
Bioraft, MERT
Trainings
(Merged).pdf
0.01
10/20/2022
11:55 AM
Madison
Maxwell
Other
Not
Applicable
View B. Dave CITI
Trainings (All
Merged)
B Dave CITI
Trainings
(Merged).pdf
0.01
10/20/2022
11:51 AM
Madison
Maxwell
Other
Not
Applicable
View G. Chelimsky
CITI Trainings
(All Merged)
G Chelimsky CITI
Trainings
(Merged).pdf
0.01
10/20/2022
11:49 AM
Madison
Maxwell
Other
Not
Applicable
View T. Chelimsky
CV
T Chelimsky CV
Signed.pdf
0.01
10/20/2022
11:43 AM
Madison
Maxwell
CV/Biosketch
Yes
View Basic
Participant
Information
BasicInformation.pdf 0.01
10/18/2022
3:38 PM
Madison
Maxwell
Research Measure
Yes
View Screening
Form
ScreeningForm.pdf 0.01
10/18/2022
3:37 PM
Madison
Maxwell
Research Measure
Yes
View G. Chelimsky
CV
G Chelimsky
CV.docx
0.01
9/12/2022
4:52 PM
Bhakti Dave CV/Biosketch
Yes
4/23/24, 11:33 AM
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HM20025635
View: SF2 - Project Details
ID: HM20025635
HM20025635 - Gisela Chelimsky
A pilot study of auricular microstimulation to determine if it improves vagal modulation
  
Project Details
An intervention includes both physical procedures by which information or biospecimens are gathered (e.g., venipuncture) and
manipulations of the subject or the subject's environment that are performed for research purposes.
An interaction includes communication or interpersonal contact between investigator and subject. It may include in-person,
online, written, or verbal communications.
Secondary information/biospecimens are information or biospecimens that have been or will be collected for some other
“primary” or “initial” activity and that will be used secondarily in the research study.
 
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)

IV contrast administration for research-related imaging (will branch to the Drugs page)

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 and methods of data collection 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 collect data, including online surveys, data
collection via Zoom, apps, etc.)

Passive Internet data collection (i.e. passively observing online behavior, bots)

Interviews / Focus Groups / Verbal responses to questions

Audio / Video recording or photographing participants

Observations

Educational Settings/Assessments/Procedures

None of the Above
3. * 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)

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]
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
No secondary data/specimens will be used
 
4/23/24, 11:33 AM
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HM20025635
View: SF2 - Bio-Medical Device Details
ID: HM20025635
HM20025635 - Gisela Chelimsky
A pilot study of auricular microstimulation to determine if it improves vagal modulation
  
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
Manufacturer
Device Risk
IDE
IDE Holder
Digital TENS Unit
InTENSity
Non-Significant Risk
Abbreviated IDE
VCU Sponsor-Investigator
3. * Describe how the device will be stored and controlled.
The device will be stored in a locked room and cabinet with the CRC, the device will be given to the participant after
eligibility and consent has been confirmed and the participant has completed their Week 0 HRV measurement session.
No identifiable information is stored on the device.
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 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 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 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 FGID
Assent/Parental
Permission
TENS FGID Assent
V10.pdf
0.23
4/23/2024
11:25 AM
Madison
Maxwell
Consent/Assent/Information
Sheet
Yes
View Healthy Control
Assent/Parental
Permission
TENS HC Assent
V10.pdf
0.23
4/23/2024
11:25 AM
Madison
Maxwell
Consent/Assent/Information
Sheet
Yes
View Healthy Control
Consent
TENS HC Consent
V10.pdf
0.22
4/23/2024
11:24 AM
Madison
Maxwell
Consent/Assent/Information
Sheet
Yes
View FGID Consent
TENS FGID
Consent V10.pdf
0.22
4/23/2024
11:24 AM
Madison
Maxwell
Consent/Assent/Information
Sheet
Yes
4/23/24, 11:33 AM
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Document
Name
Document
VersionDate
Modified
Uploaded
By
Type
Approved
View Best Practice
Alert MyChart
Message Script
Best Practice Alert
MyChart Message
Script V2.docx
0.03
3/13/2024
3:52 PM
Madison
Maxwell
Recruitment/Advertising
Yes
View Flyer
TENS Flyer
(Undesigned
Language Only)
V4.docx
0.07
3/13/2024
3:51 PM
Madison
Maxwell
Recruitment/Advertising
Yes
View REDCap Study
Interest &
Screening
Form
Study Interest &
Screening Form
V3.pdf
0.04
3/13/2024
3:51 PM
Madison
Maxwell
Recruitment/Advertising
Yes
View Daily Recording
Diary
Daily Recording
Diary V6.pdf
0.06
3/13/2024
3:51 PM
Madison
Maxwell
Research Measure
Yes
View In-Person
Recruitment
Script
TENS In Person
Recruitment Script
V5.docx
0.12
3/13/2024
3:46 PM
Madison
Maxwell
Recruitment/Advertising
Yes
View Phone
Recruitment
Script
TENS Phone
Recruitment Script
V7.docx
0.15
3/13/2024
3:46 PM
Madison
Maxwell
Recruitment/Advertising
Yes
View Eligible Interest
Form
Submission
Follow-Up
Email
Recruitment
Script
TENS Eligible
Interest Form
Submission Follow-
Up Email
Recruitment Script
V3.docx
0.06
3/13/2024
3:44 PM
Madison
Maxwell
Recruitment/Advertising
Yes
View Participant
TENS
Instructions
TENS Unit
Instructions V6.docx
0.11
1/9/2024
1:31 PM
Madison
Maxwell
Other
Yes
View Screen Fail
Contact
Information
Screen Fail Contact
Information.pdf
0.01
12/6/2023
3:22 PM
Madison
Maxwell
Recruitment/Advertising
Yes
View Heart Rate
Variability
Measurements
HRV Measurements
for both study visits
(V2).pdf
0.02
8/23/2023
11:31 AM
Madison
Maxwell
Research Measure
Yes
View TENS Unit
Manual
TENS Unit Manual
(Microcurrent
Model).pdf
0.02
8/17/2023
9:07 AM
Madison
Maxwell
Drug/Device Brochure
Yes
View TENS Unit
Photo
TENS Unit Photo
(Microcurrent
Model).png
0.02
8/17/2023
9:07 AM
Madison
Maxwell
Other
Yes
View Symptom
Questionnaire
GI Symptom
Questionnaire
(V1).pdf
0.01
4/13/2023
3:11 PM
Madison
Maxwell
Research Measure
Yes
View Ear Clip Info
TENS Unit Ear Clip
Information.docx
0.01
1/20/2023
2:09 PM
Madison
Maxwell
Drug/Device Brochure
Yes
View IDE Documents TENS
Documentation of
NSR
determination.docx
0.02
11/29/2022
9:41 AM
Madison
Maxwell
Other
Yes
View TENS Unit Ear
Clip
TENS Ear Clip.jpg
0.01
11/18/2022
12:35 PM
Madison
Maxwell
Other
Yes
View PROC Approval TENS PROC
Approval.pdf
0.01
10/21/2022
12:45 PM
Madison
Maxwell
Ancillary Committee
Approval
Not
Applicable
View M. Maxwell
Trainings (All
M Maxwell CITI,
Bioraft, MERT
0.01
10/20/2022
11:55 AM
Madison
Maxwell
Other
Not
Applicable
4/23/24, 11:33 AM
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Document
Name
Document
VersionDate
Modified
Uploaded
By
Type
Approved
Merged)
Trainings
(Merged).pdf
View B. Dave CITI
Trainings (All
Merged)
B Dave CITI
Trainings
(Merged).pdf
0.01
10/20/2022
11:51 AM
Madison
Maxwell
Other
Not
Applicable
View G. Chelimsky
CITI Trainings
(All Merged)
G Chelimsky CITI
Trainings
(Merged).pdf
0.01
10/20/2022
11:49 AM
Madison
Maxwell
Other
Not
Applicable
View T. Chelimsky
CV
T Chelimsky CV
Signed.pdf
0.01
10/20/2022
11:43 AM
Madison
Maxwell
CV/Biosketch
Yes
View Basic
Participant
Information
BasicInformation.pdf 0.01
10/18/2022
3:38 PM
Madison
Maxwell
Research Measure
Yes
View Screening
Form
ScreeningForm.pdf 0.01
10/18/2022
3:37 PM
Madison
Maxwell
Research Measure
Yes
View G. Chelimsky
CV
G Chelimsky
CV.docx
0.01
9/12/2022
4:52 PM
Bhakti Dave CV/Biosketch
Yes
  
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HM20025635
View: SF2 - Sample Collection Details
ID: HM20025635
HM20025635 - Gisela Chelimsky
A pilot study of auricular microstimulation to determine if it improves vagal modulation
  
Sample Collection Details
1. * Select all of the types of samples that will be collected as part of this study.

Amniotic Fluid

Blood

Buccal Smears

Saliva

Tissue

Urine

Stool

Other
2. * In order to collect urine, will an indwelling catheter be placed solely for the research study:
  Yes
No
3. * Describe how the sample will be collected and the collection schedule. For each type of sample, include
information about
- The procedures that will be followed to collect the sample
- The role(s) of the individuals who will collect the sample
- The volume/size range of the sample
- The timing and frequency of sample collection
- Participants will be given a non-labeled specimen cup to urinate in privately. They will hand the cup to an approved
study staff member who will conduct a dipstick pregnancy test using good practice. The sample will be immediately
disposed of when the test is done and only the result will be recorded on the participant's screening form.
- Approved and trained study staff will be able to collect the sample (except PI)
- 6.5oz specimen cups will be used but only about 3oz of urine is needed to perform the test, so it will vary from
participant to participant.
- One sample will be taken after consent at the beginning of the study for screening purposes.
4. * Will genetic testing or genetic analyses be conducted on any of the samples:
  Yes
No
  
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HM20025635
View: SF2 - Active Internet Data Collection
ID: HM20025635
HM20025635 - Gisela Chelimsky
A pilot study of auricular microstimulation to determine if it improves vagal modulation
  
Active Internet Data Collection
1. * Describe the platform/technology chosen for collecting the data and transmitting data securely over the
internet. If proposing a non-VCU approved platform, give the rationale for selecting the technology instead of
a VCU-approved platform.
REDcap
2. * Describe how data will be linked or unlinked to identifiers including email addresses, names, and/or IP
address.
REDCap Study Interest & Screening Forms will contain names, phone numbers, and emails if this information is
provided by the potential participant.
REDcap daily diary forms will be linked to a separate form with identifying/contact information (name, email, phone
number) in the participant's REDcap record. None of the daily recording diary response forms require the input of
personal information, but we ask for their initials for consistency and tracking. Symptom questionnaire will be linked in
the same way.
3. * How will you protect your data collection from fraudulent responses:
The REDCap Study Interest & Screening Form will have a reCAPTCHA test enabled to protect the form link from
fraudulent responses.
Daily recording diaries will be sent out individually to each participant. Each daily form will have a unique access URL,
and once it is completed the answers cannot be changed. Participants will be encouraged to give honest answers on
the form, and even if they did not use it we still would like that information to take into account. Symptom
questionnaires will be given to the participant via a REDCap survey at their in-person visits via a VCU-managed
computer or with the survey link opened on a tablet. These questions are not particularly sensitive or difficult to answer,
so we will communicate the importance of honesty, but no survey questions are required.
4. * Is there an alternative method for completion of the data collection other than the internet?
  Yes
No
5. * If yes, describe the alternative(s).
Participants can choose to take home paper printouts of the daily diary REDcap form that they can write on and return
to study staff at the final in-person visit. They may also choose to be verbally administered questionnaire items by
study staff if requested.
6. * Describe how individuals will be able to skip or not answer particular questions.  If any questions are
mandatory, provide justification.
We will encourage participants to fill out their diaries accurately, honestly, and consistently. Participants may skip any
questions they would like, but because the diary and symptom questionnaires are so short, objective, simple, and do
not cover any particularly sensitive material, we will encourage them not to skip if possible.
7. If not including children, describe any procedures used to verify that research participants are adults.
Including children
 
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HM20025635
View: SF2 - Secondary Data/Specimen Details
ID: HM20025635
HM20025635 - Gisela Chelimsky
A pilot study of auricular microstimulation to determine if it improves vagal modulation
  
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.
a. Epic
b. N/A
c. Name, MRN, medications to confirm eligibility on an ongoing basis (medication information is not recorded, only
monitored). Name/MRN stored in REDcap separate from research data.  
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.
No agreement exists.
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
 
  
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HM20025635
View: SF2 - Costs to Participants
ID: HM20025635
HM20025635 - Gisela Chelimsky
A pilot study of auricular microstimulation to determine if it improves vagal modulation
  
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
 
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HM20025635
View: SF2 - Compensation
ID: HM20025635
HM20025635 - Gisela Chelimsky
A pilot study of auricular microstimulation to determine if it improves vagal modulation
  
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 IRB’s
guidelines about compensating research participants.
1. * Describe any compensation that will be provided including:
   1. total monetary amount
   2. type (e.g., gift card, research pre-paid card, cash, check, merchandise, drawing, extra class credit)
   3. how it will be disbursed
   4. how you arrived at this amount
   5. What identifiers and tax forms will be required for compensation purposes (i.e. W-9 form, SSN, V#,
addresses, etc.)
1. $100 total. $25 for the first visit and $75 for the second visit.
2. Mailed check
3. Participants will fill out a W-9 form that will be given to the business office for check processing.
4. With the current budget and the time it takes to complete the research procedures we believe this is a fair amount of
compensation.
5. W-9 form that includes full name, address, and SSN. No one except the CRC and the business office will have
access to these forms. These elements are all required to process checks.
2. If compensation will be pro-rated, explain the payment schedule.
Participants will receive a $25 mailed check after the completion of the Week 0 (Baseline) Visit and a $75 mailed check
after the completion of the Week 4 Visit.
 
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HM20025635
View: SF2 - Contingency Plan
ID: HM20025635
HM20025635 - Gisela Chelimsky
A pilot study of auricular microstimulation to determine if it improves vagal modulation
  
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.
 
  
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HM20025635
View: SF2 - Research Plan Complete
ID: HM20025635
HM20025635 - Gisela Chelimsky
A pilot study of auricular microstimulation to determine if it improves vagal modulation
  
Research Complete
Protocol Progress:
❶ INITIAL SETUP
❷ BACKGROUND, RATIONALE & GOALS
❸ RESEARCH PLAN
④ CONSENT PLAN
⑤ RISKS, PRIVACY & CONFIDENTIALITY
⑥ POPULATIONS WITH SPECIAL CONSIDERATIONS
⑦ INSTITUTIONAL REQUIREMENTS
⑧ DOCUMENTS
Click Continue below to go to the next section
 
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HM20025635
View: SF2 - Consent Process
ID: HM20025635
HM20025635 - Gisela Chelimsky
A pilot study of auricular microstimulation to determine if it improves vagal modulation
  
Consent Process
1. * List all consent groups:
 
Group Types
Waivers
Roles
Roles
-
Other
Electronic
SignaturesConsent
Coercion
DecisionRe-
Consent
View Children
(12-17)
Signed Assent
by Child or
Decisionally
Impaired Adult
Signed
Parent/Guardian
Permission or
Legally
Authorized
Representative
Consent
No
Waivers
Requested
Research
Coordinator
Research
Assistant
 
Not using
electronic
signature
platforms
- Consent will occur
at the FGID clinic
appointment either
before or after the
visit or while they are
waiting for the
physician or at the
PRU with
parent(s)/guardian(s)
present
- Study procedures,
rights as a
participant, risks and
discomforts, data
privacy, and
compensation will be
discussed with
parent(s) present.
- In-person
- We will encourage
participants/parents
to reach out to us
with any questions
or concerns about
the study or if they
would like to stop
participating and will
be following up with
them multiple times
throughout the study
where we can
address any needs.
Having a 3rd
person
(family/friends,
another study
team member,
etc.) present
during the
consent /
assent
discussion
Sitting down
beside the
participant
instead of
standing over
them
Until they
are outside
the age
range thus
not
meeting
inclusion
criteria
We will
contact the
participant
using
recorded
contact
information
via phone,
letter, or
email to
communicate
that we need
to meet with
them for
them to re-
consent.
View Adults
(18)
Signed Consent
by Participant
No
Waivers
Requested
Research
Coordinator
Research
Assistant
 
Not using
electronic
signature
platforms
- Consent will occur
at the FGID clinic
appointment either
before or after the
visit or while they are
waiting for the
physician or at the
PRU.
- Study procedures,
rights as a
participant, risks and
discomforts, data
privacy, and
compensation will be
discussed.
- In-person
- We will encourage
participants to reach
out to us with any
questions or
concerns about the
study or if they
would like to stop
participating and will
be following up with
them multiple times
throughout the study
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)
Until they
are outside
of the age
range, thus
not
meeting
inclusion
criteria
N/A
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Group Types
Waivers
Roles
Roles
-
Other
Electronic
SignaturesConsent
Coercion
DecisionRe-
Consent
where we can
address any needs.
2. Upload any consent / assent documents:
 
Document
Name
Document
VersionDate
Modified
Uploaded
By
Type
Approved
View FGID
Assent/Parental
Permission
TENS FGID Assent
V10.pdf
0.23
4/23/2024
11:25 AM
Madison
Maxwell
Consent/Assent/Information
Sheet
Yes
View Healthy Control
Assent/Parental
Permission
TENS HC Assent
V10.pdf
0.23
4/23/2024
11:25 AM
Madison
Maxwell
Consent/Assent/Information
Sheet
Yes
View Healthy Control
Consent
TENS HC Consent
V10.pdf
0.22
4/23/2024
11:24 AM
Madison
Maxwell
Consent/Assent/Information
Sheet
Yes
View FGID Consent
TENS FGID
Consent V10.pdf
0.22
4/23/2024
11:24 AM
Madison
Maxwell
Consent/Assent/Information
Sheet
Yes
View Best Practice
Alert MyChart
Message Script
Best Practice Alert
MyChart Message
Script V2.docx
0.03
3/13/2024
3:52 PM
Madison
Maxwell
Recruitment/Advertising
Yes
View Flyer
TENS Flyer
(Undesigned
Language Only)
V4.docx
0.07
3/13/2024
3:51 PM
Madison
Maxwell
Recruitment/Advertising
Yes
View REDCap Study
Interest &
Screening
Form
Study Interest &
Screening Form
V3.pdf
0.04
3/13/2024
3:51 PM
Madison
Maxwell
Recruitment/Advertising
Yes
View Daily Recording
Diary
Daily Recording
Diary V6.pdf
0.06
3/13/2024
3:51 PM
Madison
Maxwell
Research Measure
Yes
View In-Person
Recruitment
Script
TENS In Person
Recruitment Script
V5.docx
0.12
3/13/2024
3:46 PM
Madison
Maxwell
Recruitment/Advertising
Yes
View Phone
Recruitment
Script
TENS Phone
Recruitment Script
V7.docx
0.15
3/13/2024
3:46 PM
Madison
Maxwell
Recruitment/Advertising
Yes
View Eligible Interest
Form
Submission
Follow-Up
Email
Recruitment
Script
TENS Eligible
Interest Form
Submission Follow-
Up Email
Recruitment Script
V3.docx
0.06
3/13/2024
3:44 PM
Madison
Maxwell
Recruitment/Advertising
Yes
View Participant
TENS
Instructions
TENS Unit
Instructions V6.docx
0.11
1/9/2024
1:31 PM
Madison
Maxwell
Other
Yes
View Screen Fail
Contact
Information
Screen Fail Contact
Information.pdf
0.01
12/6/2023
3:22 PM
Madison
Maxwell
Recruitment/Advertising
Yes
View Heart Rate
Variability
Measurements
HRV Measurements
for both study visits
(V2).pdf
0.02
8/23/2023
11:31 AM
Madison
Maxwell
Research Measure
Yes
View TENS Unit
Manual
TENS Unit Manual
(Microcurrent
Model).pdf
0.02
8/17/2023
9:07 AM
Madison
Maxwell
Drug/Device Brochure
Yes
4/23/24, 11:33 AM
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Document
Name
Document
VersionDate
Modified
Uploaded
By
Type
Approved
View TENS Unit
Photo
TENS Unit Photo
(Microcurrent
Model).png
0.02
8/17/2023
9:07 AM
Madison
Maxwell
Other
Yes
View Symptom
Questionnaire
GI Symptom
Questionnaire
(V1).pdf
0.01
4/13/2023
3:11 PM
Madison
Maxwell
Research Measure
Yes
View Ear Clip Info
TENS Unit Ear Clip
Information.docx
0.01
1/20/2023
2:09 PM
Madison
Maxwell
Drug/Device Brochure
Yes
View IDE Documents TENS
Documentation of
NSR
determination.docx
0.02
11/29/2022
9:41 AM
Madison
Maxwell
Other
Yes
View TENS Unit Ear
Clip
TENS Ear Clip.jpg
0.01
11/18/2022
12:35 PM
Madison
Maxwell
Other
Yes
View PROC Approval TENS PROC
Approval.pdf
0.01
10/21/2022
12:45 PM
Madison
Maxwell
Ancillary Committee
Approval
Not
Applicable
View M. Maxwell
Trainings (All
Merged)
M Maxwell CITI,
Bioraft, MERT
Trainings
(Merged).pdf
0.01
10/20/2022
11:55 AM
Madison
Maxwell
Other
Not
Applicable
View B. Dave CITI
Trainings (All
Merged)
B Dave CITI
Trainings
(Merged).pdf
0.01
10/20/2022
11:51 AM
Madison
Maxwell
Other
Not
Applicable
View G. Chelimsky
CITI Trainings
(All Merged)
G Chelimsky CITI
Trainings
(Merged).pdf
0.01
10/20/2022
11:49 AM
Madison
Maxwell
Other
Not
Applicable
View T. Chelimsky
CV
T Chelimsky CV
Signed.pdf
0.01
10/20/2022
11:43 AM
Madison
Maxwell
CV/Biosketch
Yes
View Basic
Participant
Information
BasicInformation.pdf 0.01
10/18/2022
3:38 PM
Madison
Maxwell
Research Measure
Yes
View Screening
Form
ScreeningForm.pdf 0.01
10/18/2022
3:37 PM
Madison
Maxwell
Research Measure
Yes
View G. Chelimsky
CV
G Chelimsky
CV.docx
0.01
9/12/2022
4:52 PM
Bhakti Dave CV/Biosketch
Yes
  
4/23/24, 11:33 AM
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HM20025635
View: SF2 - Consent Plan Complete
ID: HM20025635
HM20025635 - Gisela Chelimsky
A pilot study of auricular microstimulation to determine if it improves vagal modulation
  
Consent Plan Complete
Protocol Progress:
❶ INITIAL SETUP
❷ BACKGROUND, RATIONALE & GOALS
❸ RESEARCH PLAN
❹ CONSENT PLAN
⑤ RISKS, PRIVACY & CONFIDENTIALITY
⑥ POPULATIONS WITH SPECIAL CONSIDERATIONS
⑦ INSTITUTIONAL REQUIREMENTS
⑧ DOCUMENTS
Click Continue below to go to the next section
 
4/23/24, 11:33 AM
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HM20025635
View: SF2 - Risks, Discomforts, Potential Harms and Monitoring
ID: HM20025635
HM20025635 - Gisela Chelimsky
A pilot study of auricular microstimulation to determine if it improves vagal modulation
  
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.
Physical risks: It is possible that participants may develop skin irritation or scab(s) in/on the ear from using the TENS
unit. The TENS unit ear clip may become uncomfortable or annoying to wear. Participants may possibly have a skin
reaction from electrodes placed during heart monitoring.
Psychological risks: None
Research data risks: Loss of confidentiality
Social/Legal risks: None
Financial risks: None
Other risks: None
2. * Describe how each of the risks/harms/discomforts identified above will be minimized:
Physical risks: Participants will be advised to rotate between clipping the unit to their tragus or conchae on their ears
for each session to avoid irritation, scabbing, and discomfort. Skin will be properly cleaned and dried before electrode
placement during the HRV measurements to avoid reactions and silicone pads will be used which are generally not
reactive in most people.
Research data risks: All data will be kept in a secure REDcap/OnCore/OneDrive database only accessible to approved
study team members.
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):
None
4. Where appropriate, discuss provisions for ensuring necessary medical, professional, or psychological
intervention in the event of adverse events to the subjects:
Dr. Gisela Chelimsky will monitor the health of all patients in this study per standard clinical practice.
If needed, we will contact emergency personnel to assist with emergency episodes that could occur.
We will clearly tell the participant about all risks during the consent discussion. When CRCs are checking in on the
participant during the weeks of using the TENS unit, they will ask the participant if they are experiencing any ear
irritation. If severe irritation or scabbing occurs, we will instruct the participant to discontinue the use of the unit.
If the subject experiences a medical emergency during the Week 0 or 4 in-person visits, the VCU Public Safety
emergency response process will be activated. In a situation that calls for an advanced medical response, this process
includes the following steps:
a. VCU public safety working with a 911 dispatcher to direct emergency personnel to the
building
b. Emergency vehicle transporting to VCU emergency department
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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 participant is not able to wear the TENS unit due to physical discomfort, severe irritation/scabbing, or they cannot
commit to using the unit for 2 hours a day for the duration of the study, they will be withdrawn from the study.
Should the participant require new medication during the duration of the study that may affect gastrointestinal
symptoms, vagal modulation or immune response, or their HRV measurement indicates an abnormality, the PI may
withdraw the participant. The Epic build of this study will send the study team an alert for new medications for FGID
participants. New medication usage will be assessed on a case-by-case basis by the PI and they will make a decision
on whether to keep or withdraw the participant. All participants will also be asked to detail the start or plans to start a
new medication.
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:
The stopping points for the study include the request to stop by the patient as well as the inability to recruit participants
or unexpected adverse events that might result in stopping the study.  
Data and Safety Monitoring
Data and safety monitoring is a system for checking the study’s 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]
8. * Describe the composition and affiliations of the DSMB:
Henry J. Rozycki, M.D., CHRI
Brad McQuilkin, M.D., CHoR
9. * Describe the frequency or schedule for DSMB review of data:
Before study kickoff, then every 6 months
10. * Describe what data (blinded or unblinded) the DSMB will review.:
Protocol before study kickoff. Blinded adverse events/safety issues, serious non-compliance, vagal modulation data
(when data is available/members have bandwidth to review for any concerning trends) every 6 months.
 
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HM20025635
View: SF2 - Privacy
ID: HM20025635
HM20025635 - Gisela Chelimsky
A pilot study of auricular microstimulation to determine if it improves vagal modulation
  
Privacy
Privacy refers to an individual’s 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. The options listed include some of the most common best practices. Not all will be applicable to every study. 
**The IRB will expect studies to operationalize all selected checkboxes into the conduct of the research.
To elaborate on any response, also click the “Other Protections” 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 – describe below

N/A – 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

Allowing participants to use a pseudonym or limiting use of individuals’ 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
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
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 – describe below

N/A – 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 - incorporate this instruction into your study materials

Advising online participants to complete the activity at a time and location where they will be comfortable
answering questions - incorporate this instruction into your study materials

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 – describe below

N/A – 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 – describe below

N/A – 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)

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 – describe below
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
Other protections not listed in this question – describe below
 
6. Describe any other way(s) that the research team will protect participants' privacy. See the help text for
additional guidance.
We will be using a secure REDcap database and OnCore to store data. The eligibility screening form/consent form will
have the participants' name and will be stored in a binder in a locked cabinet separate from the participant's study data,
which will only have a study ID on it. REDcap data forms will be stored in a separate form than the forms with
participants' name and eligibility information. The heart rate variability assessment will be in a private room. The HRV
measurements will be stored with no identifiers. The data collection diaries will have no identifiable information on
them. The TENS unit poses no privacy risks as it does not collect data or personal information.
  
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HM20025635
View: SF2 - Data Confidentiality and Storage
ID: HM20025635
HM20025635 - Gisela Chelimsky
A pilot study of auricular microstimulation to determine if it improves vagal modulation
  
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 study’s 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 “Other Protections” 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 – describe below

N/A – 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 in accordance with VCU policies and specimen containers will be
devoid of any identifiable information

Other protection not listed in this question – describe below

N/A – 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, multi-site data
collection platforms):
• consulting with VCU Information Security on proper data management (see
https://ts.vcu.edu/askit/essential-computing/information-security/);
• advising participants about the terms of use and privacy policies of those sites/apps;
• limiting or avoiding use of identifiers; and
• removing data promptly from the external location after transferring it to a VCU storage location

De-identifying the research data by replacing subjects’ names with assigned subject IDs

Storing the study’s 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 – describe below
4. * Protections for computers and research devices/apps that are provided to participants for use in the study
and taken out of the lab (i.e., giving participants a phone or iPad to take home, wearable trackers, apps, etc.):

Transferring data promptly from the device/app given to the participant to a VCU storage location

Setting strong passwords on computers and research devices (when applicable) that leave VCU with
participants

Device/app set up by VCU Information Security

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 – describe the device/app and protection below

N/A – no computers or devices/apps being provided for participant use outside the lab
5. * Protections for email/online communications

Only using VCU/VCU Health email addresses for study-related communications

Only using VCU/VCU Health–approved 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 – describe below

N/A – no email/online communications
6. Specify any other places where this study’s 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.
Paper diary documents will be copied into the corresponding REDcap forms for the participant and immediately
shredded upon entry and verification.
Pregnancy test strips and urine samples will be immediately disposed of after reading.
The TENS unit does not record or store data.
7. * If research data/specimens will be sent/released to person(s) or group(s) outside of the VCU study team or
the PI’s department for the conduct of this protocol (not for future sharing),
1) identify the data/specimen recipient(s) along with their VCU department or other institutional or
organizational affiliation(s).
2) give a description of what identifiers and/or codes will accompany the data/specimens.
If data/specimens are not being sent/released outside of the VCU study team or the PI’s department, state that:
N/A
8. * Select all identifiers that will be collected at any time 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
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
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 subjects’ names and/or other identifiers
with assigned subject IDs, explain the following aspects of the coding process:
- 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 there will be no linkage key, state
that.
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.  
Study IDs will be generated sequentially in REDcap. A key with participant identifiers will be stored in a separate form
in REDcap. Only approved research personnel will be able to access this key. This key will be stored until the study is
closed. Some participants will give us permission to use their contact information to contact them for future studies. We
will not keep the code key or any link to the data from this study upon its closing, but we will be keeping a separate,
unlinked list of names and contact info for those who consent to contact for future studies.
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HM20025635
View: SF2 - Data Retention
ID: HM20025635
HM20025635 - Gisela Chelimsky
A pilot study of auricular microstimulation to determine if it improves vagal modulation
  
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:

N/A - study does not require screening procedures

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
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
 
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HM20025635
View: SF2 - Sharing Plan
ID: HM20025635
HM20025635 - Gisela Chelimsky
A pilot study of auricular microstimulation to determine if it improves vagal modulation
  
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.
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. VCU IRB studies 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
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the new research use in an amendment to this study or as part of a new study before the project is initiated.
VCU IRB studies 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
(VCU IRB studies 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.
(‘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. VCU IRB studies 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. VCU IRB
studies 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 (VCU IRB studies will be asked more questions about this on
a later page.)

Will submit data to an NIH genomic data repository (VCU IRB studies will be asked more questions about this on
a later page.)

Will not share information/specimens with other researchers.
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
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
N/A - No sharing will occur
 
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HM20025635
View: SF2 - Pertinent Results and Incidental Findings
ID: HM20025635
HM20025635 - Gisela Chelimsky
A pilot study of auricular microstimulation to determine if it improves vagal modulation
  
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
2. * Describe what possible pertinent results or incidental findings stemming from research-only procedures may
be discovered.
Pregnancy (collected only for screening).
Arrhythmia on HRV measurement
3. * Explain what actions or procedures research personnel should take to inform the PI of such a discovery :
Pregnancy findings will not constitute contacting the PI and the participant will not be able to participate further in the
study since we are not aware of the long-term effects of using a TENS unit while pregnant.
Upon review of the HRV measurements, the PI will contact participants/parents and engage in proper referral
procedures if there is evidence of arrhythmia.
4. * Will findings be disclosed to participants and/or any other person/group outside of the study team?
  Yes
No
5. * Describe a communication plan addressing:
1. What criteria will be used to determine which pertinent and/or incidental findings will be communicated,
including the following for health related findings:
    --- The reliability of the tests/images, such as being done in a CLIA-certified lab,
    --- Whether the meaning and significance of the findings are known,
    --- Whether the findings reveal a significant risk of a serious health condition,
    --- Whether there is an accepted treatment for the health condition revealed by the findings, and
    --- The risks both of knowing and not knowing the findings, including risks to family members from genetic
testing results.
2. What information will be provided during the consent process about the plans for communicating pertinent
and/or incidental findings;
3. Whether the participants will be given the option of refusing communication of some or all types of
pertinent and/or incidental findings to themselves, their family members, and/or any other individuals or
groups; and
4. To whom and by whom the findings will be communicated, when, and how. 
Pregnancy findings:
1. -Pregnancy tests are generally reliable. We will be using a urine test purchased through a trusted clinical
manufacturer.
-the meaning and significance of a positive pregnancy test is known, the participant will no longer be eligible to
participate in the study.
-the findings of a positive pregnancy test does not reveal a significant risk of a serious health condition
-there are resources and treatment for taking a pregnancy to term or not.
-the risk of a positive pregnancy test could cause potential mental and emotional issues, as well as health concerns to
the participants if they have other conditions. the risk of not knowing is that participation in the study and using the
TENS unit may cause harm to an embryo/fetus. We do not have solid information on the risks of TENS units on
pregnant people.
2. If a participant has a positive pregnancy test, we will only be telling the participant whether they are a child or an
adult, which we note in the ICFs.
3. Participants will not have the option to refuse communications for safety reasons. If we identify a situation that
requires mandatory reporting (ie child abuse in the context of the pregnancy), we will follow the normal procedures for
mandatory reporting.
4. Positive pregnancy tests will be verbally communicated to the adult or child participant by a member of the study
team, preferably the PI. The study doctor will be notified so they are aware of the participant's ineligibility to continue
with the study. If the parent asks why their child is ineligible, we will tell them that we have many different criteria and
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can only tell them/the participant if they are eligible or not, and not the reason why.
Arrhythmia findings:
1. - HRV measurement is generally reliable. HRV measurement will be conducted by study team members will
sufficient training to operate the devices. HRV measurements done by a coordinator will be reviewed by the PI for
evidence of arrhythmia during the data analysis portion of the study.
- The full meaning and significance of an arrhythmia cannot be concluded with a single test. Proper referral will be
given, and it will be the responsibility of the participant and/or their parents to seek specialized testing/care to further
analyze.
- Arrhythmia findings may reveal a significant risk of a serious health condition, but further testing and analysis is
needed for conclusive results.
- There are a variety of accepted treatments for arrhythmia such as medications, therapies such as vagal maneuvers,
cardioversion, catheter procedures or heart surgery.
- The risk of knowing the findings is that participants and/or parents could become distressed upon learning the finding.
- The risk of not knowing the finding is that we would not be able to properly measure HRV which is essential to
answering our research questions.
2. Participants will be told during the consent discussion that the investigator will contact them/their parents upon the
instance of abnormal findings.
3. Participants will not have the option to refuse communications for safety reasons.
4. Abnormal HRV measurements will be communicated by the PI verbally or by phone/email to the participant and/or
their parents upon review of the measurements. The participant will be withdrawn from the study by the study staff if
this finding is revealed during their participation, but analysis of these measurements will not happen immediately upon
collection, so this is an unlikely occurrence.
 
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HM20025635
View: SF2 - Risk Benefit Complete
ID: HM20025635
HM20025635 - Gisela Chelimsky
A pilot study of auricular microstimulation to determine if it improves vagal modulation
  
Risk Benefit Complete
Protocol Progress:
❶ INITIAL SETUP
❷ BACKGROUND, RATIONALE & GOALS
❸ RESEARCH PLAN
❹ CONSENT PLAN
❺ RISKS, PRIVACY & CONFIDENTIALITY
⑥ POPULATIONS WITH SPECIAL CONSIDERATIONS
⑦ INSTITUTIONAL REQUIREMENTS
⑧ DOCUMENTS
Click Continue below to go to the next section
 
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HM20025635
View: SF2 - Populations with Special Considerations
ID: HM20025635
HM20025635 - Gisela Chelimsky
A pilot study of auricular microstimulation to determine if it improves vagal modulation
  
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
 
          
          
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HM20025635
View: SF2 - Children
ID: HM20025635
HM20025635 - Gisela Chelimsky
A pilot study of auricular microstimulation to determine if it improves vagal modulation
  
Children
1. * Check all that apply to the study:

45 CFR
46.404
Research involving no greater than minimal risk to children, with adequate provisions for
soliciting the assent of the children and permission of their parents or guardians, as set forth
in Sec. 46.408

45 CFR
46.405
Research involving greater than minimal risk but presenting the prospect of direct benefit to individual
participants

45 CFR
46.406
Research involving greater than minimal risk and no prospect of direct benefit to individual
participants, but likely to yield generalizable knowledge about the participant’s disorder or condition

45 CFR
46.407
Research not otherwise approvable which presents an opportunity to understand, prevent or alleviate
a serious problem affecting the health or welfare of children. (Research in this category must be
reviewed and approved by the Secretary of the Department of Health & Human Services)
2. If multiple categories are selected above, explain which study groups are covered by each selected category
(e.g. treatment vs. control groups):
N/A
3. * Describe how you plan to obtain permission of parents or legal guardians. If you have indicated this study
will fall into categories 406 or 407, please describe here how you will obtain permission from both parents.
Parents will provide informed consent for their child's participation by signing the consent form. Any questions will be
answered. A copy of the informed consent will be given to the parents for their records.
4. * Describe how children will be assented to participate in the study (i.e. what will the study team do during the
assent process to ensure the child understands what the research involves).
Children will provide informed assent by signing the form. The form will use lay language so the participant knows what
the study procedures entail. Any questions will be answered. The study will be explained in a developmentally and age
appropriate manner by using "smaller" words to describe the procedures after it is read verbatim. For example, the
section in the consent that describes the TENS units sending electrical signals and communications to the brain will be
read that way, but will then be elaborated in more age-appropriate language. Study staff would say something like "and
by that, we mean the TENS units help your brain talk to the other parts of your body more clearly, and they work by
sending a little bit of electricity through your skin. It is not something that will hurt you- you might just feel like someone
is tapping your skin a little bit or you may feel a little twitch". Study staff will ask the child if they feel worried or scared
about anything we talked about, and will encourage them to ask questions and let them know they are safe to tell us
anything they are thinking during the discussion.
 
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HM20025635
View: SF2 - Populations with Special Considerations Section Complete
ID: HM20025635
HM20025635 - Gisela Chelimsky
A pilot study of auricular microstimulation to determine if it improves vagal modulation
  
Populations with Special Considerations Section Complete
Protocol Progress:
❶ INITIAL SETUP
❷ BACKGROUND, RATIONALE & GOALS
❸ RESEARCH PLAN
❹ CONSENT PLAN
❺ RISKS, PRIVACY & CONFIDENTIALITY
❻ POPULATIONS WITH SPECIAL CONSIDERATIONS
⑦ INSTITUTIONAL REQUIREMENTS
⑧ DOCUMENTS
Click Continue below to go to the next section
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HM20025635
View: SF2 - Study Funding
ID: HM20025635
HM20025635 - Gisela Chelimsky
A pilot study of auricular microstimulation to determine if it improves vagal modulation
  
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

Direct Federal

Indirect Federal

State/Local Government

Non-Profit - Sponsored Project

Non-Profit - Gift

Internal Grant

Investigator/Departmental Funds

None

Other
4. * In addition to providing funding support, what is the funding source’s role in this study? Select all that apply:

Solely providing funding support

Providing resources (e.g. study drug, device)

Providing guidance to the researcher but does NOT make decisions about study design

Study design/Creation of the study protocol

Collaborator in the research (helps design and/or conduct the study) [list the funder as a site on the Types of
Sites page]

Data or sample analysis regardless of identifiability
5. Select all related funding proposals and contracts that have been submitted through the Division of
Sponsored Programs (DSP):
RAMS-SPOT ID# (FP/PT/PD#)
Direct Sponsor
PI Title
Status
Start
End
There are no items to display
 
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HM20025635
View: SF2 - Types of Sites
ID: HM20025635
HM20025635 - Gisela Chelimsky
A pilot study of auricular microstimulation to determine if it improves vagal modulation
  
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 (i.e. involved in conducting the research,
including being involved in the study interpretation or analysis of data and/or authorship of presentations or
manuscripts related to the research.)  
   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 FGID
Assent/Parental
Permission
TENS FGID Assent
V10.pdf
0.23
4/23/2024
11:25 AM
Madison
Maxwell
Consent/Assent/Information
Sheet
Yes
View Healthy Control
Assent/Parental
Permission
TENS HC Assent
V10.pdf
0.23
4/23/2024
11:25 AM
Madison
Maxwell
Consent/Assent/Information
Sheet
Yes
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Document
Name
Document
VersionDate
Modified
Uploaded
By
Type
Approved
View Healthy Control
Consent
TENS HC Consent
V10.pdf
0.22
4/23/2024
11:24 AM
Madison
Maxwell
Consent/Assent/Information
Sheet
Yes
View FGID Consent
TENS FGID
Consent V10.pdf
0.22
4/23/2024
11:24 AM
Madison
Maxwell
Consent/Assent/Information
Sheet
Yes
View Best Practice
Alert MyChart
Message Script
Best Practice Alert
MyChart Message
Script V2.docx
0.03
3/13/2024
3:52 PM
Madison
Maxwell
Recruitment/Advertising
Yes
View Flyer
TENS Flyer
(Undesigned
Language Only)
V4.docx
0.07
3/13/2024
3:51 PM
Madison
Maxwell
Recruitment/Advertising
Yes
View REDCap Study
Interest &
Screening
Form
Study Interest &
Screening Form
V3.pdf
0.04
3/13/2024
3:51 PM
Madison
Maxwell
Recruitment/Advertising
Yes
View Daily Recording
Diary
Daily Recording
Diary V6.pdf
0.06
3/13/2024
3:51 PM
Madison
Maxwell
Research Measure
Yes
View In-Person
Recruitment
Script
TENS In Person
Recruitment Script
V5.docx
0.12
3/13/2024
3:46 PM
Madison
Maxwell
Recruitment/Advertising
Yes
View Phone
Recruitment
Script
TENS Phone
Recruitment Script
V7.docx
0.15
3/13/2024
3:46 PM
Madison
Maxwell
Recruitment/Advertising
Yes
View Eligible Interest
Form
Submission
Follow-Up
Email
Recruitment
Script
TENS Eligible
Interest Form
Submission Follow-
Up Email
Recruitment Script
V3.docx
0.06
3/13/2024
3:44 PM
Madison
Maxwell
Recruitment/Advertising
Yes
View Participant
TENS
Instructions
TENS Unit
Instructions V6.docx
0.11
1/9/2024
1:31 PM
Madison
Maxwell
Other
Yes
View Screen Fail
Contact
Information
Screen Fail Contact
Information.pdf
0.01
12/6/2023
3:22 PM
Madison
Maxwell
Recruitment/Advertising
Yes
View Heart Rate
Variability
Measurements
HRV Measurements
for both study visits
(V2).pdf
0.02
8/23/2023
11:31 AM
Madison
Maxwell
Research Measure
Yes
View TENS Unit
Manual
TENS Unit Manual
(Microcurrent
Model).pdf
0.02
8/17/2023
9:07 AM
Madison
Maxwell
Drug/Device Brochure
Yes
View TENS Unit
Photo
TENS Unit Photo
(Microcurrent
Model).png
0.02
8/17/2023
9:07 AM
Madison
Maxwell
Other
Yes
View Symptom
Questionnaire
GI Symptom
Questionnaire
(V1).pdf
0.01
4/13/2023
3:11 PM
Madison
Maxwell
Research Measure
Yes
View Ear Clip Info
TENS Unit Ear Clip
Information.docx
0.01
1/20/2023
2:09 PM
Madison
Maxwell
Drug/Device Brochure
Yes
View IDE Documents TENS
Documentation of
NSR
determination.docx
0.02
11/29/2022
9:41 AM
Madison
Maxwell
Other
Yes
View TENS Unit Ear
Clip
TENS Ear Clip.jpg
0.01
11/18/2022
12:35 PM
Madison
Maxwell
Other
Yes
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Document
Name
Document
VersionDate
Modified
Uploaded
By
Type
Approved
View PROC Approval TENS PROC
Approval.pdf
0.01
10/21/2022
12:45 PM
Madison
Maxwell
Ancillary Committee
Approval
Not
Applicable
View M. Maxwell
Trainings (All
Merged)
M Maxwell CITI,
Bioraft, MERT
Trainings
(Merged).pdf
0.01
10/20/2022
11:55 AM
Madison
Maxwell
Other
Not
Applicable
View B. Dave CITI
Trainings (All
Merged)
B Dave CITI
Trainings
(Merged).pdf
0.01
10/20/2022
11:51 AM
Madison
Maxwell
Other
Not
Applicable
View G. Chelimsky
CITI Trainings
(All Merged)
G Chelimsky CITI
Trainings
(Merged).pdf
0.01
10/20/2022
11:49 AM
Madison
Maxwell
Other
Not
Applicable
View T. Chelimsky
CV
T Chelimsky CV
Signed.pdf
0.01
10/20/2022
11:43 AM
Madison
Maxwell
CV/Biosketch
Yes
View Basic
Participant
Information
BasicInformation.pdf 0.01
10/18/2022
3:38 PM
Madison
Maxwell
Research Measure
Yes
View Screening
Form
ScreeningForm.pdf 0.01
10/18/2022
3:37 PM
Madison
Maxwell
Research Measure
Yes
View G. Chelimsky
CV
G Chelimsky
CV.docx
0.01
9/12/2022
4:52 PM
Bhakti Dave CV/Biosketch
Yes
 
 
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HM20025635
View: SF2 - Personnel
ID: HM20025635
HM20025635 - Gisela Chelimsky
A pilot study of auricular microstimulation to determine if it improves vagal modulation
  
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.
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 Gisela
Chelimsky
Principal
Investigator
 
Data Analysis
Project
Coordination
Data Collection -
Direct Observation
Data Management
Data Collection -
Clinical
Participant
Identification
Data Entry
Study Design
Clinical Services
 
Experience -
Research
Experience -
Related Skills
Experience -
Clinical
Education
and/or
Professional
Preparation
 
yes
View Thomas
Chelimsky
Co/Sub-
Investigator
 
Data Analysis
Project
Coordination
Data Collection -
Direct Observation
Data Collection -
Clinical
Participant
Identification
Study Design
Clinical Services
 
Experience -
Research
Experience -
Related Skills
Experience -
Clinical
Education
and/or
Professional
Preparation
 
yes
View Madison
Maxwell
Research
Coordinator
 
Data Analysis
Project
Coordination
Data Collection -
Direct Observation
Participant
Consent
Data Management
 
Experience -
Research
Experience -
Related Skills
Education
and/or
Professional
Preparation
 
yes
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Name
Roles
Roles
-
Other
ResponsibilitiesResponsibilities
- Other
QualificationsQualifications
- Other
COI
Investigator
Data Collection -
Clinical
Participant
Identification
Data Entry
Study Design
Data Coding
Participant
Recruitment
View Bhakti
Dave
Research
Coordinator
 
Data Analysis
Project
Coordination
Data Collection -
Direct Observation
Participant
Consent
Data Management
Data Collection -
Clinical
Participant
Identification
Data Entry
Study Design
Data Coding
Participant
Recruitment
 
Experience -
Research
Experience -
Related Skills
Experience -
Clinical
Education
and/or
Professional
Preparation
 
yes
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: 
N/A
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.
 
Document
Name
Document
VersionDate
Modified
Uploaded
By
Type
Approved
View FGID
Assent/Parental
Permission
TENS FGID Assent
V10.pdf
0.23
4/23/2024
11:25 AM
Madison
Maxwell
Consent/Assent/Information
Sheet
Yes
View Healthy Control
Assent/Parental
Permission
TENS HC Assent
V10.pdf
0.23
4/23/2024
11:25 AM
Madison
Maxwell
Consent/Assent/Information
Sheet
Yes
View Healthy Control
Consent
TENS HC Consent
V10.pdf
0.22
4/23/2024
11:24 AM
Madison
Maxwell
Consent/Assent/Information
Sheet
Yes
View FGID Consent
TENS FGID
Consent V10.pdf
0.22
4/23/2024
11:24 AM
Madison
Maxwell
Consent/Assent/Information
Sheet
Yes
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Document
Name
Document
VersionDate
Modified
Uploaded
By
Type
Approved
View Best Practice
Alert MyChart
Message Script
Best Practice Alert
MyChart Message
Script V2.docx
0.03
3/13/2024
3:52 PM
Madison
Maxwell
Recruitment/Advertising
Yes
View Flyer
TENS Flyer
(Undesigned
Language Only)
V4.docx
0.07
3/13/2024
3:51 PM
Madison
Maxwell
Recruitment/Advertising
Yes
View REDCap Study
Interest &
Screening
Form
Study Interest &
Screening Form
V3.pdf
0.04
3/13/2024
3:51 PM
Madison
Maxwell
Recruitment/Advertising
Yes
View Daily Recording
Diary
Daily Recording
Diary V6.pdf
0.06
3/13/2024
3:51 PM
Madison
Maxwell
Research Measure
Yes
View In-Person
Recruitment
Script
TENS In Person
Recruitment Script
V5.docx
0.12
3/13/2024
3:46 PM
Madison
Maxwell
Recruitment/Advertising
Yes
View Phone
Recruitment
Script
TENS Phone
Recruitment Script
V7.docx
0.15
3/13/2024
3:46 PM
Madison
Maxwell
Recruitment/Advertising
Yes
View Eligible Interest
Form
Submission
Follow-Up
Email
Recruitment
Script
TENS Eligible
Interest Form
Submission Follow-
Up Email
Recruitment Script
V3.docx
0.06
3/13/2024
3:44 PM
Madison
Maxwell
Recruitment/Advertising
Yes
View Participant
TENS
Instructions
TENS Unit
Instructions V6.docx
0.11
1/9/2024
1:31 PM
Madison
Maxwell
Other
Yes
View Screen Fail
Contact
Information
Screen Fail Contact
Information.pdf
0.01
12/6/2023
3:22 PM
Madison
Maxwell
Recruitment/Advertising
Yes
View Heart Rate
Variability
Measurements
HRV Measurements
for both study visits
(V2).pdf
0.02
8/23/2023
11:31 AM
Madison
Maxwell
Research Measure
Yes
View TENS Unit
Manual
TENS Unit Manual
(Microcurrent
Model).pdf
0.02
8/17/2023
9:07 AM
Madison
Maxwell
Drug/Device Brochure
Yes
View TENS Unit
Photo
TENS Unit Photo
(Microcurrent
Model).png
0.02
8/17/2023
9:07 AM
Madison
Maxwell
Other
Yes
View Symptom
Questionnaire
GI Symptom
Questionnaire
(V1).pdf
0.01
4/13/2023
3:11 PM
Madison
Maxwell
Research Measure
Yes
View Ear Clip Info
TENS Unit Ear Clip
Information.docx
0.01
1/20/2023
2:09 PM
Madison
Maxwell
Drug/Device Brochure
Yes
View IDE Documents TENS
Documentation of
NSR
determination.docx
0.02
11/29/2022
9:41 AM
Madison
Maxwell
Other
Yes
View TENS Unit Ear
Clip
TENS Ear Clip.jpg
0.01
11/18/2022
12:35 PM
Madison
Maxwell
Other
Yes
View PROC Approval TENS PROC
Approval.pdf
0.01
10/21/2022
12:45 PM
Madison
Maxwell
Ancillary Committee
Approval
Not
Applicable
View M. Maxwell
Trainings (All
M Maxwell CITI,
Bioraft, MERT
0.01
10/20/2022
11:55 AM
Madison
Maxwell
Other
Not
Applicable
4/23/24, 11:33 AM
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Document
Name
Document
VersionDate
Modified
Uploaded
By
Type
Approved
Merged)
Trainings
(Merged).pdf
View B. Dave CITI
Trainings (All
Merged)
B Dave CITI
Trainings
(Merged).pdf
0.01
10/20/2022
11:51 AM
Madison
Maxwell
Other
Not
Applicable
View G. Chelimsky
CITI Trainings
(All Merged)
G Chelimsky CITI
Trainings
(Merged).pdf
0.01
10/20/2022
11:49 AM
Madison
Maxwell
Other
Not
Applicable
View T. Chelimsky
CV
T Chelimsky CV
Signed.pdf
0.01
10/20/2022
11:43 AM
Madison
Maxwell
CV/Biosketch
Yes
View Basic
Participant
Information
BasicInformation.pdf 0.01
10/18/2022
3:38 PM
Madison
Maxwell
Research Measure
Yes
View Screening
Form
ScreeningForm.pdf 0.01
10/18/2022
3:37 PM
Madison
Maxwell
Research Measure
Yes
View G. Chelimsky
CV
G Chelimsky
CV.docx
0.01
9/12/2022
4:52 PM
Bhakti Dave CV/Biosketch
Yes
  
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HM20025635
View: SF2 - Conflict of Interest
ID: HM20025635
HM20025635 - Gisela Chelimsky
A pilot study of auricular microstimulation to determine if it improves vagal modulation
  
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. 
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.
N/A
  
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HM20025635
View: SF2 - Other VCU Requirementsv2
ID: HM20025635
HM20025635 - Gisela Chelimsky
A pilot study of auricular microstimulation to determine if it improves vagal modulation
  
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 VCU’s 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/
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/
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1. * Does this study involve the VCU site (regardless of the IRB of record), or any sites under the VCU
IRB'’s 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 study’s data is classified as Category 1, a Data Management Plan must be
submitted to and approved by VCU Information Security prior to IRB approval. 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
study’s 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
N/A - not using external technology
7. Massey Cancer Center Protocol Review and Monitoring Committee (PRMC)
For guidance, see https://www.masseycancercenter.org/research/~/link.aspx?
_id=ee49e95faa8b44d09b6e89d8e3b48b57&_z=z
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
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- VCU Health System facilities
- VCU Health System data   Yes
No
 
 If Yes, upload documentation of approval or review by the PROC or PRMC in this study’s topic area. If
you do not have PROC or PRMC approval, please visit onetrac.vcu.edu for additional information and
to submit your project for review.
 
9. VCU Health Department of Patient Centered Services
 
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 https://research.vcu.edu/human-research/regulatory-affairs/.
Questions related to if you need an IND or IDE for your study should be emailed to: indide@vcu.edu. Please submit a
copy of your FDA 
submission prior to submitting to the FDA to https://redcap.vcu.edu/surveys/?s=NR7K7LR4JW.
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 am aware that I may need to establish a research account with VCUHS Department of Pathology for
specimen processing:
  Yes
No
2. * 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 aren’t limited to the following: addition of
reagents to samples/aliquots, buffy coat processing, DNA sample processing)
Yes
No
N/A - my study does not involve any of the listed processes.
3. * If my study involves specimen retrieval from the Pathology laboratory, I have established a process
with Pathology to deidentify and retrieve specimens.
Yes
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No
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 (“biohazardous agents”)
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 patients’
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
           
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:
 
Document
Name
Document
VersionDate
Modified
Uploaded
By
Type
Approved
View FGID
Assent/Parental
Permission
TENS FGID Assent
V10.pdf
0.23
4/23/2024
11:25 AM
Madison
Maxwell
Consent/Assent/Information
Sheet
Yes
View Healthy Control
Assent/Parental
Permission
TENS HC Assent
V10.pdf
0.23
4/23/2024
11:25 AM
Madison
Maxwell
Consent/Assent/Information
Sheet
Yes
View Healthy Control
Consent
TENS HC Consent
V10.pdf
0.22
4/23/2024
11:24 AM
Madison
Maxwell
Consent/Assent/Information
Sheet
Yes
4/23/24, 11:33 AM
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Document
Name
Document
VersionDate
Modified
Uploaded
By
Type
Approved
View FGID Consent
TENS FGID
Consent V10.pdf
0.22
4/23/2024
11:24 AM
Madison
Maxwell
Consent/Assent/Information
Sheet
Yes
View Best Practice
Alert MyChart
Message Script
Best Practice Alert
MyChart Message
Script V2.docx
0.03
3/13/2024
3:52 PM
Madison
Maxwell
Recruitment/Advertising
Yes
View Flyer
TENS Flyer
(Undesigned
Language Only)
V4.docx
0.07
3/13/2024
3:51 PM
Madison
Maxwell
Recruitment/Advertising
Yes
View REDCap Study
Interest &
Screening
Form
Study Interest &
Screening Form
V3.pdf
0.04
3/13/2024
3:51 PM
Madison
Maxwell
Recruitment/Advertising
Yes
View Daily Recording
Diary
Daily Recording
Diary V6.pdf
0.06
3/13/2024
3:51 PM
Madison
Maxwell
Research Measure
Yes
View In-Person
Recruitment
Script
TENS In Person
Recruitment Script
V5.docx
0.12
3/13/2024
3:46 PM
Madison
Maxwell
Recruitment/Advertising
Yes
View Phone
Recruitment
Script
TENS Phone
Recruitment Script
V7.docx
0.15
3/13/2024
3:46 PM
Madison
Maxwell
Recruitment/Advertising
Yes
View Eligible Interest
Form
Submission
Follow-Up
Email
Recruitment
Script
TENS Eligible
Interest Form
Submission Follow-
Up Email
Recruitment Script
V3.docx
0.06
3/13/2024
3:44 PM
Madison
Maxwell
Recruitment/Advertising
Yes
View Participant
TENS
Instructions
TENS Unit
Instructions V6.docx
0.11
1/9/2024
1:31 PM
Madison
Maxwell
Other
Yes
View Screen Fail
Contact
Information
Screen Fail Contact
Information.pdf
0.01
12/6/2023
3:22 PM
Madison
Maxwell
Recruitment/Advertising
Yes
View Heart Rate
Variability
Measurements
HRV Measurements
for both study visits
(V2).pdf
0.02
8/23/2023
11:31 AM
Madison
Maxwell
Research Measure
Yes
View TENS Unit
Manual
TENS Unit Manual
(Microcurrent
Model).pdf
0.02
8/17/2023
9:07 AM
Madison
Maxwell
Drug/Device Brochure
Yes
View TENS Unit
Photo
TENS Unit Photo
(Microcurrent
Model).png
0.02
8/17/2023
9:07 AM
Madison
Maxwell
Other
Yes
View Symptom
Questionnaire
GI Symptom
Questionnaire
(V1).pdf
0.01
4/13/2023
3:11 PM
Madison
Maxwell
Research Measure
Yes
View Ear Clip Info
TENS Unit Ear Clip
Information.docx
0.01
1/20/2023
2:09 PM
Madison
Maxwell
Drug/Device Brochure
Yes
View IDE Documents TENS
Documentation of
NSR
determination.docx
0.02
11/29/2022
9:41 AM
Madison
Maxwell
Other
Yes
View TENS Unit Ear
Clip
TENS Ear Clip.jpg
0.01
11/18/2022
12:35 PM
Madison
Maxwell
Other
Yes
View PROC Approval TENS PROC
Approval.pdf
0.01
10/21/2022
12:45 PM
Madison
Maxwell
Ancillary Committee
Approval
Not
Applicable
4/23/24, 11:33 AM
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Document
Name
Document
VersionDate
Modified
Uploaded
By
Type
Approved
View M. Maxwell
Trainings (All
Merged)
M Maxwell CITI,
Bioraft, MERT
Trainings
(Merged).pdf
0.01
10/20/2022
11:55 AM
Madison
Maxwell
Other
Not
Applicable
View B. Dave CITI
Trainings (All
Merged)
B Dave CITI
Trainings
(Merged).pdf
0.01
10/20/2022
11:51 AM
Madison
Maxwell
Other
Not
Applicable
View G. Chelimsky
CITI Trainings
(All Merged)
G Chelimsky CITI
Trainings
(Merged).pdf
0.01
10/20/2022
11:49 AM
Madison
Maxwell
Other
Not
Applicable
View T. Chelimsky
CV
T Chelimsky CV
Signed.pdf
0.01
10/20/2022
11:43 AM
Madison
Maxwell
CV/Biosketch
Yes
View Basic
Participant
Information
BasicInformation.pdf 0.01
10/18/2022
3:38 PM
Madison
Maxwell
Research Measure
Yes
View Screening
Form
ScreeningForm.pdf 0.01
10/18/2022
3:37 PM
Madison
Maxwell
Research Measure
Yes
View G. Chelimsky
CV
G Chelimsky
CV.docx
0.01
9/12/2022
4:52 PM
Bhakti Dave CV/Biosketch
Yes
 
 
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View: SF2 - HIPAA
ID: HM20025635
HM20025635 - Gisela Chelimsky
A pilot study of auricular microstimulation to determine if it improves vagal modulation
  
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 entity’s 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.
PHI: Name, MRN, medications (to confirm eligibility on an ongoing basis)
RHI: Screening questions, pregnancy test (screening purposes only), HRV recording data, daily recording diary entries
3. * Describe the source(s) of the protected health information (e.g. Informatics or which clinical databases):
EPIC, via information submitted on the secure REDCap eligibility screening survey
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
 
 
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HM20025635
View: SF2 - Partial Waiver of Authorization
ID: HM20025635
HM20025635 - Gisela Chelimsky
A pilot study of auricular microstimulation to determine if it improves vagal modulation
  
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?).
This waiver requests access to the electronic medical record so study staff can briefly review eligibility criteria and send
recruitment messages or approach patients referred via the Best Practice Alert or patients who are scheduled for a
clinical visit at the PI's clinic. Those potential participants who are consented to the Registry for the Autonomics Center
have already provided consent for the study team to access their full medical record. The privacy risks are similar than
those experienced in everyday life as names, phone numbers and emails are often collected and used without
additional authorization for recruitment & advertising purposes both in and outside the context of research. Chart
review for any patients will only include items directly related to eligibility criteria, and that information will only be
recorded upon a voluntary completion of the screening questions by the potential participant. Any personal information,
like contact information, would also be stored on a secure REDcap database which has strict access requirements (ie
can only view if manually added to the project with identifier viewing permissions, must be on a VPN to access,
password protected) that are similar to protections in place for EMR information storage. None of this information
would ever be shared with unauthorized individuals who do not have a key role in the study.
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?)
Recruiting only patients who are under the care of the PI will create bias in the sample and gives scarce opportunity to
identify non-FGID group participants (since this is the PI's primary patient population). Using the BPA and MyChart
allows for more widespread recruitment across a more diverse population.
Attempting to recruit at different VCUHS clinics in-person for a more varied sample would also disrupt clinical flow for
these departments who are not set up to accommodate research recruitment efforts.
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
  
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HM20025635
View: SF2 - Institutional Requirements Complete
ID: HM20025635
HM20025635 - Gisela Chelimsky
A pilot study of auricular microstimulation to determine if it improves vagal modulation
  
Institutional Requirements Complete
Protocol Progress:
❶ INITIAL SETUP
❷ BACKGROUND, RATIONALE & GOALS
❸ RESEARCH PLAN
❹ CONSENT PLAN
❺ RISKS, PRIVACY & CONFIDENTIALITY
❻ POPULATIONS WITH SPECIAL CONSIDERATIONS
❼ INSTITUTIONAL REQUIREMENTS
⑧ DOCUMENTS
Click Continue below to go to the next section
 
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HM20025635
View: SF2 - Documents
ID: HM20025635
HM20025635 - Gisela Chelimsky
A pilot study of auricular microstimulation to determine if it improves vagal modulation
  
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.
- 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 FGID
Assent/Parental
Permission
TENS FGID Assent
V10.pdf
0.23
4/23/2024
11:25 AM
Madison
Maxwell
Consent/Assent/Information
Sheet
Yes
View Healthy Control
Assent/Parental
Permission
TENS HC Assent
V10.pdf
0.23
4/23/2024
11:25 AM
Madison
Maxwell
Consent/Assent/Information
Sheet
Yes
View Healthy Control
Consent
TENS HC Consent
V10.pdf
0.22
4/23/2024
11:24 AM
Madison
Maxwell
Consent/Assent/Information
Sheet
Yes
View FGID Consent
TENS FGID
Consent V10.pdf
0.22
4/23/2024
11:24 AM
Madison
Maxwell
Consent/Assent/Information
Sheet
Yes
View Best Practice
Alert MyChart
Message Script
Best Practice Alert
MyChart Message
Script V2.docx
0.03
3/13/2024
3:52 PM
Madison
Maxwell
Recruitment/Advertising
Yes
View Flyer
TENS Flyer
(Undesigned
Language Only)
V4.docx
0.07
3/13/2024
3:51 PM
Madison
Maxwell
Recruitment/Advertising
Yes
View REDCap Study
Interest &
Screening
Form
Study Interest &
Screening Form
V3.pdf
0.04
3/13/2024
3:51 PM
Madison
Maxwell
Recruitment/Advertising
Yes
View Daily Recording
Diary
Daily Recording
Diary V6.pdf
0.06
3/13/2024
3:51 PM
Madison
Maxwell
Research Measure
Yes
View In-Person
Recruitment
Script
TENS In Person
Recruitment Script
V5.docx
0.12
3/13/2024
3:46 PM
Madison
Maxwell
Recruitment/Advertising
Yes
View Phone
Recruitment
Script
TENS Phone
Recruitment Script
V7.docx
0.15
3/13/2024
3:46 PM
Madison
Maxwell
Recruitment/Advertising
Yes
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Document
Name
Document
VersionDate
Modified
Uploaded
By
Type
Approved
View Eligible Interest
Form
Submission
Follow-Up
Email
Recruitment
Script
TENS Eligible
Interest Form
Submission Follow-
Up Email
Recruitment Script
V3.docx
0.06
3/13/2024
3:44 PM
Madison
Maxwell
Recruitment/Advertising
Yes
View Participant
TENS
Instructions
TENS Unit
Instructions V6.docx
0.11
1/9/2024
1:31 PM
Madison
Maxwell
Other
Yes
View Screen Fail
Contact
Information
Screen Fail Contact
Information.pdf
0.01
12/6/2023
3:22 PM
Madison
Maxwell
Recruitment/Advertising
Yes
View Heart Rate
Variability
Measurements
HRV Measurements
for both study visits
(V2).pdf
0.02
8/23/2023
11:31 AM
Madison
Maxwell
Research Measure
Yes
View TENS Unit
Manual
TENS Unit Manual
(Microcurrent
Model).pdf
0.02
8/17/2023
9:07 AM
Madison
Maxwell
Drug/Device Brochure
Yes
View TENS Unit
Photo
TENS Unit Photo
(Microcurrent
Model).png
0.02
8/17/2023
9:07 AM
Madison
Maxwell
Other
Yes
View Symptom
Questionnaire
GI Symptom
Questionnaire
(V1).pdf
0.01
4/13/2023
3:11 PM
Madison
Maxwell
Research Measure
Yes
View Ear Clip Info
TENS Unit Ear Clip
Information.docx
0.01
1/20/2023
2:09 PM
Madison
Maxwell
Drug/Device Brochure
Yes
View IDE Documents TENS
Documentation of
NSR
determination.docx
0.02
11/29/2022
9:41 AM
Madison
Maxwell
Other
Yes
View TENS Unit Ear
Clip
TENS Ear Clip.jpg
0.01
11/18/2022
12:35 PM
Madison
Maxwell
Other
Yes
View PROC Approval TENS PROC
Approval.pdf
0.01
10/21/2022
12:45 PM
Madison
Maxwell
Ancillary Committee
Approval
Not
Applicable
View M. Maxwell
Trainings (All
Merged)
M Maxwell CITI,
Bioraft, MERT
Trainings
(Merged).pdf
0.01
10/20/2022
11:55 AM
Madison
Maxwell
Other
Not
Applicable
View B. Dave CITI
Trainings (All
Merged)
B Dave CITI
Trainings
(Merged).pdf
0.01
10/20/2022
11:51 AM
Madison
Maxwell
Other
Not
Applicable
View G. Chelimsky
CITI Trainings
(All Merged)
G Chelimsky CITI
Trainings
(Merged).pdf
0.01
10/20/2022
11:49 AM
Madison
Maxwell
Other
Not
Applicable
View T. Chelimsky
CV
T Chelimsky CV
Signed.pdf
0.01
10/20/2022
11:43 AM
Madison
Maxwell
CV/Biosketch
Yes
View Basic
Participant
Information
BasicInformation.pdf 0.01
10/18/2022
3:38 PM
Madison
Maxwell
Research Measure
Yes
View Screening
Form
ScreeningForm.pdf 0.01
10/18/2022
3:37 PM
Madison
Maxwell
Research Measure
Yes
View G. Chelimsky
CV
G Chelimsky
CV.docx
0.01
9/12/2022
4:52 PM
Bhakti Dave CV/Biosketch
Yes
 
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HM20025635
View: SF2 - Documents Complete
ID: HM20025635
HM20025635 - Gisela Chelimsky
A pilot study of auricular microstimulation to determine if it improves vagal modulation
  
Documents Complete
Protocol Progress:
❶ INITIAL SETUP
❷ BACKGROUND, RATIONALE & GOALS
❸ RESEARCH PLAN
❹ CONSENT PLAN
❺ RISKS, PRIVACY & CONFIDENTIALITY
❻ POPULATIONS WITH SPECIAL CONSIDERATIONS
❼ INSTITUTIONAL REQUIREMENTS
❽ DOCUMENTS
End of Application
Click Continue below to exit and submit this project
 
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HM20025635
View: Copy of Bio-Med Devices
ID: HM20025635
  
Bio-Medical Devices
1. * Name:
Digital TENS Unit 
2. * Manufacturer:
InTENSity
3. * What risk has the sponsor or sponsor-investigator designated the device:
Non-Significant Risk
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).
Abbreviated IDE
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.
 
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View: SF_IRB_Summary_Document
ID: HM20025635
Add Document
1. * Document Name:
FGID Assent/Parental Permission
2. * Type:
Consent/Assent/Information Sheet
3. * File:

TENS FGID Assent V10.pdf(0.23)
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View: SF_IRB_Summary_Document
ID: HM20025635
Add Document
1. * Document Name:
Healthy Control Assent/Parental Permission
2. * Type:
Consent/Assent/Information Sheet
3. * File:

TENS HC Assent V10.pdf(0.23)
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View: SF_IRB_Summary_Document
ID: HM20025635
Add Document
1. * Document Name:
Healthy Control Consent
2. * Type:
Consent/Assent/Information Sheet
3. * File:

TENS HC Consent V10.pdf(0.22)
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View: SF_IRB_Summary_Document
ID: HM20025635
Add Document
1. * Document Name:
FGID Consent
2. * Type:
Consent/Assent/Information Sheet
3. * File:

TENS FGID Consent V10.pdf(0.22)
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View: SF_IRB_Summary_Document
ID: HM20025635
Add Document
1. * Document Name:
Best Practice Alert MyChart Message Script
2. * Type:
Recruitment/Advertising
3. * File:
Best Practice Alert MyChart Message Script V2.docx(0.03)
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View: SF_IRB_Summary_Document
ID: HM20025635
Add Document
1. * Document Name:
Flyer
2. * Type:
Recruitment/Advertising
3. * File:
TENS Flyer (Undesigned Language Only) V4.docx(0.07)
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View: SF_IRB_Summary_Document
ID: HM20025635
Add Document
1. * Document Name:
REDCap Study Interest & Screening Form
2. * Type:
Recruitment/Advertising
3. * File:

Study Interest & Screening Form V3.pdf(0.04)
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View: SF_IRB_Summary_Document
ID: HM20025635
Add Document
1. * Document Name:
Daily Recording Diary
2. * Type:
Research Measure
3. * File:

Daily Recording Diary V6.pdf(0.06)
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View: SF_IRB_Summary_Document
ID: HM20025635
Add Document
1. * Document Name:
In-Person Recruitment Script
2. * Type:
Recruitment/Advertising
3. * File:
TENS In Person Recruitment Script V5.docx(0.12)
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View: SF_IRB_Summary_Document
ID: HM20025635
Add Document
1. * Document Name:
Phone Recruitment Script
2. * Type:
Recruitment/Advertising
3. * File:
TENS Phone Recruitment Script V7.docx(0.15)
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View: SF_IRB_Summary_Document
ID: HM20025635
Add Document
1. * Document Name:
Eligible Interest Form Submission Follow-Up Email Recruitment Script
2. * Type:
Recruitment/Advertising
3. * File:
TENS Eligible Interest Form Submission Follow-Up Email Recruitment Script V3.docx(0.06)
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View: SF_IRB_Summary_Document
ID: HM20025635
Add Document
1. * Document Name:
Participant TENS Instructions
2. * Type:
Other
3. * File:
TENS Unit Instructions V6.docx(0.11)
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View: SF_IRB_Summary_Document
ID: HM20025635
Add Document
1. * Document Name:
Screen Fail Contact Information
2. * Type:
Recruitment/Advertising
3. * File:

Screen Fail Contact Information.pdf(0.01)
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View: SF_IRB_Summary_Document
ID: HM20025635
Add Document
1. * Document Name:
Heart Rate Variability Measurements
2. * Type:
Research Measure
3. * File:

HRV Measurements for both study visits (V2).pdf(0.02)
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View: SF_IRB_Summary_Document
ID: HM20025635
Add Document
1. * Document Name:
TENS Unit Manual
2. * Type:
Drug/Device Brochure
3. * File:

TENS Unit Manual (Microcurrent Model).pdf(0.02)
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View: SF_IRB_Summary_Document
ID: HM20025635
Add Document
1. * Document Name:
TENS Unit Photo
2. * Type:
Other
3. * File:

TENS Unit Photo (Microcurrent Model).png(0.02)
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View: SF_IRB_Summary_Document
ID: HM20025635
Add Document
1. * Document Name:
Symptom Questionnaire
2. * Type:
Research Measure
3. * File:

GI Symptom Questionnaire (V1).pdf(0.01)
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HM20025635
View: SF_IRB_Summary_Document
ID: HM20025635
Add Document
1. * Document Name:
Ear Clip Info
2. * Type:
Drug/Device Brochure
3. * File:
TENS Unit Ear Clip Information.docx(0.01)
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HM20025635
View: SF_IRB_Summary_Document
ID: HM20025635
Add Document
1. * Document Name:
IDE Documents
2. * Type:
Other
3. * File:
TENS Documentation of NSR determination.docx(0.02)
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View: SF_IRB_Summary_Document
ID: HM20025635
Add Document
1. * Document Name:
TENS Unit Ear Clip
2. * Type:
Other
3. * File:

TENS Ear Clip.jpg(0.01)
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View: SF_IRB_Summary_Document
ID: HM20025635
Add Document
1. * Document Name:
PROC Approval
2. * Type:
Ancillary Committee Approval
3. * File:

TENS PROC Approval.pdf(0.01)
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View: SF_IRB_Summary_Document
ID: HM20025635
Add Document
1. * Document Name:
M. Maxwell Trainings (All Merged)
2. * Type:
Other
3. * File:

M Maxwell CITI, Bioraft, MERT Trainings (Merged).pdf(0.01)
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View: SF_IRB_Summary_Document
ID: HM20025635
Add Document
1. * Document Name:
B. Dave CITI Trainings (All Merged)
2. * Type:
Other
3. * File:

B Dave CITI Trainings (Merged).pdf(0.01)
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HM20025635
View: SF_IRB_Summary_Document
ID: HM20025635
Add Document
1. * Document Name:
G. Chelimsky CITI Trainings (All Merged)
2. * Type:
Other
3. * File:

G Chelimsky CITI Trainings (Merged).pdf(0.01)
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View: SF_IRB_Summary_Document
ID: HM20025635
Add Document
1. * Document Name:
T. Chelimsky CV
2. * Type:
CV/Biosketch
3. * File:

T Chelimsky CV Signed.pdf(0.01)
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View: SF_IRB_Summary_Document
ID: HM20025635
Add Document
1. * Document Name:
Basic Participant Information
2. * Type:
Research Measure
3. * File:

BasicInformation.pdf(0.01)
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View: SF_IRB_Summary_Document
ID: HM20025635
Add Document
1. * Document Name:
Screening Form
2. * Type:
Research Measure
3. * File:

ScreeningForm.pdf(0.01)
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View: SF_IRB_Summary_Document
ID: HM20025635
Add Document
1. * Document Name:
G. Chelimsky CV
2. * Type:
CV/Biosketch
3. * File:
G Chelimsky CV.docx(0.01)
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HM20025635
View: SF_IRB_ConsentPlan_Groups
ID: HM20025635
  
Consent Groups
1. * Enter a descriptive name for this consent / assent group:
Children (12-17)
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/Other Indication of 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

iMedConsent (Veterans Affairs studies)

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
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
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
- Consent will occur at the FGID clinic appointment either before or after the visit or while they are waiting for the
physician or at the PRU with parent(s)/guardian(s) present
- Study procedures, rights as a participant, risks and discomforts, data privacy, and compensation will be discussed
with parent(s) present.
- In-person
- We will encourage participants/parents to reach out to us with any questions or concerns about the study or if they
would like to stop participating and will be following up with them multiple times throughout the study where we can
address any needs.
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 – describe below

N/A: Requesting Waiver of Consent
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9. * Describe the other ways the study team will minimize any potential perception of undue influence to
participate:
We will ensure participants understand their participation is voluntary. Questions and concerns will be answered from
the child and parent(s)/guardian(s). No staff involved in the patient's clinical care or the PI will be present for the
discussion.
10. * How much time will participants be given to make a decision:
Until they are outside the age range thus not meeting inclusion criteria
11. If applicable, describe the procedures for consenting children upon entering adulthood or participants who
are no longer decisionally impaired:
We will contact the participant using recorded contact information via phone, letter, or email to communicate that we
need to meet with them for them to re-consent.
 
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HM20025635
View: SF_IRB_ConsentPlan_Groups
ID: HM20025635
  
Consent Groups
1. * Enter a descriptive name for this consent / assent group:
Adults (18)
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/Other Indication of 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

iMedConsent (Veterans Affairs studies)

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
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
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
- Consent will occur at the FGID clinic appointment either before or after the visit or while they are waiting for the
physician or at the PRU.
- Study procedures, rights as a participant, risks and discomforts, data privacy, and compensation will be discussed.
- In-person
- We will encourage participants to reach out to us with any questions or concerns about the study or if they would like
to stop participating and will be following up with them multiple times throughout the study where we can address any
needs.
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 – describe below

N/A: Requesting Waiver of Consent
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9. * Describe the other ways the study team will minimize any potential perception of undue influence to
participate:
Participants will be given ample time to consider their participation and have any questions answered about the
research activities. No staff involved in clinical care or the PI of the study will be present during the discussion.
10. * How much time will participants be given to make a decision:
Until they are outside of the age range, thus not meeting inclusion criteria
11. If applicable, describe the procedures for consenting children upon entering adulthood or participants who
are no longer decisionally impaired:
N/A
 
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HM20025635
View: Personnel
ID: HM20025635
  
Personnel
1. * Name:
Gisela Chelimsky
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. * Study related responsibilities:
 

Study Design

Data Collection - Lab

Data Collection - Clinical
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
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:
 
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HM20025635
View: Personnel
ID: HM20025635
  
Personnel
1. * Name:
Thomas Chelimsky
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. * Study related responsibilities:
 

Study Design

Data Collection - Lab

Data Collection - Clinical
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
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:
 
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HM20025635
View: Personnel
ID: HM20025635
  
Personnel
1. * Name:
Madison Maxwell
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. * Study related responsibilities:
 

Study Design

Data Collection - Lab

Data Collection - Clinical
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
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:
Individual has no clinical responsibilities
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:
 
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HM20025635
View: Personnel
ID: HM20025635
  
Personnel
1. * Name:
Bhakti Dave
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. * Study related responsibilities:
 

Study Design

Data Collection - Lab

Data Collection - Clinical
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
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:
Individual has no clinical responsibilities
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:
 
4/23/24, 11:33 AM
HM20025635
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