Clinical Evaluation of a Device for Treatment of Lymphedema of the Upper Extremity
Phase: NA
Conditions: Lymphedema, Lymphedema Arm, Lymphedema of Upper Arm
Sponsor: Carilion Clinic

Carilion Clinic Human Research Protections Program, 213 S. Jefferson St., Suite 830, Roanoke, VA 24011
 
 
 
 
NEW APPROVAL                       
                    
PI: Ralph Brown, MD
CC - Carilion New River Valley Medical Center
 
Re:   IRB Approval for Protocol #IRB-22-1780, Clinical Evaluation of a Device for Treatment of Lymphedema of the 
Upper Extremity
  
Approval Date:  03/05/2024
Expiration Date:  02/21/2025
The Carilion Clinic Institutional Review Board (IRB) has fully approved the above referenced study via the fully 
convened committee for one year (reviewed on 2/22/2024). This approval is limited to the activities conducted 
by the research team members as described in the approved version of the IRB Application (Version 1.4). 
Modifications may not be initiated without prior IRB review and approval except where necessary to eliminate 
apparent immediate hazards to human participants. 
 
Please note the study expiration date above. All research activities must cease the day before the 
Expiration Date if the study has not been reapproved by the IRB.
  
 If this study is expected to extend beyond one year, please submit a continuing review request at 
least 45 days prior to the expiration date.  HHS regulations at 45 CFR 46.109(e) require that continuing review 
of research be conducted by the IRB at intervals appropriate to the degree of risk but not less than once per year. 
The regulations make no provision for any grace period extending the conduct of the research beyond the Expiration 
Date. Once research activities have been completed, including analysis of all identifiable data, submit a Closure form 
at least 30 days prior to the Expiration Date. Please retain copies of all records pertaining to this study for a minimum 
of six (6) years from study closure.
 
This IRB determined that the study met the criteria for a Non-Significant Risk Device study.  
 
Clinicaltrials.gov: The study meets requirements to be registered on Clinicaltrials.gov. Please ensure you are 
familiar with all the requirements of Section 801 of the Food and Drug Administration Amendments Act 
(https://clinicaltrials.gov/ct2/manage-recs/fdaaa), as there are consequences for not registering, including potential 
fines.  You must register this clinical trial prior to enrollment of the first participant. Please contact 
research@carilionclinic.org  for assistance with the ClinicalTrials.gov Protocol Registration and Results System (PRS).
 
OBTAINING INFORMED CONSENT: Delegated research team members are responsible for obtaining written 
informed consent in the manner approved by the IRB.    

When obtaining CONSENT from subjects, the consent document must contain the Carilion Clinic 
IRB approval date in the footer of the document. Please always access the consent form from within 
the PRIS3M system to ensure the most recently approved version is being used. Please document the 
consent process within the research record after obtaining consent from subjects. 

As part of this approval, the IRB has issued a consent document(s) that includes the approval 
date. The consent document does not include an expiration date. The approval for the consent document 
will last the life of the study, or until it is amended; whichever comes first.  It is the responsibility of the 
principal investigator and the research study team to monitor the expiration date of the study for continuing 
review purposes. It is the responsibility of the principal investigator and the research study team to ensure 
that no participant is enrolled if the expiration date for the study's IRB continuing review has been 
exceeded.

Carilion Clinic Human Research Protections Program, 213 S. Jefferson St., Suite 830, Roanoke, VA 24011
 

Electronic consent (eConsent) has been approved for this study. Please provide both the IRB stamped 
eConsent and standard consent to HART with a copy of this letter in order for HART to begin the eConsent 
build in REDCap.

The Carilion IRB has granted a partial waiver of the requirement of informed consent for recruitment 
purposes only as outlined in 45 CFR 46.116(d). A partial waiver of consent for recruitment purposes 
permits researchers to obtain information or biospecimens to screen, recruit, or determine eligibility and 
interest of prospective subjects for a research study without informed consent.  This is applicable if (1) the 
information is obtained through oral or written communication with the subject or the subject's legally 
authorized representative, or (2) identifiable private information or identifiable biospecimens are obtained by 
accessing records or stored identifiable biospecimens. 
 
HIPAA WAIVER: 

The Carilion IRB has granted a partial Waiver of Authorization to use and access protected health 
information for the above-mentioned study for recruitment purposes only.
In conducting this study, you are required to follow the requirements described in INVESTIGATOR GUIDANCE: 
Investigator Obligations (HRP-800), found at the end of this letter and located on the Carilion Clinic IRB website 
at https://www.carilionclinic.org/irb/policies, including reporting requirements for Unanticipated Problems and privacy 
breaches. 
 
Please note that this letter conveys IRB approval only and does not grant Conflict of Interest clearance. It is 
the Principal Investigator and research team members’ responsibilities to ensure they have completed an Annual COI 
Disclosure or Transactional Disclosure and CITI COI training. Any potential or perceived conflict or any changes that 
result in a potential conflict must be disclosed to the Office of Integrity and Compliance within 30 days. Disclosure 
and conflict management, if applicable, must occur before any employee is permitted to engage in any human 
subjects research activities. The COI policy can be reviewed at https://www.carilionclinic.org/IRB-OIC-Research-COI-
Policy. 
Please note that this letter conveys IRB approval only and does not grant institutional approval. 
If your research involves any Carilion Clinic facilities, then separate arrangements must be made with the appropriate 
hospital or medical staff department or committees, along with the Carilion Clinic Department of Research & 
Development. 
Participant Compensation: Please contact the Research and Development Office at research@carilionclinic.org if 
you need to discuss setting up the payment method to your research participants. The Principal Investigator is 
ultimately responsible to assure proper accounting of payments made to subjects for fiscal accountability and federal 
tax purposes and to maintain privacy of the human subject. 
 Research Data Management and Storage: Please contact HART at hart@carilionclinic.org for data management 
and storage implementation questions.
Carilion Clinic operates under Federal-Wide Assurance FWA00000392. 
The Carilion Clinic Institutional Review Board would like to thank you for the opportunity to review this protocol.  
Please contact Eric Wines at 540-224-5885 or irb@carilionclinic.org if you have any questions regarding this letter.
 
Carilion Clinic Human Research Protections Program, 213 S. Jefferson St., Suite 830, Roanoke, VA 24011
HRP-800: INVESTIGATOR GUIDANCE: Investigator Obligations
1.            PURPOSE
1.1 This guidance describes the obligations of Principal Investigators conducting <Human Research> 
overseen by Carilion Clinic’s local IRB.
1.2 For research overseen by an IRB other than Carilion Clinic’s local IRB, investigators should follow 
the requirements of that IRB.

Carilion Clinic Human Research Protections Program, 213 S. Jefferson St., Suite 830, Roanoke, VA 24011
 
2.         GUIDANCE
2.1 Do not begin research until you have the IRB approval letter and obtained all other required 
approvals, such as R&D authorization, biosafety approval, and approvals of departments or divisions 
that require approval of the use of their resources.
2.1.1 If there are any questions about whether you are conducting research involving human 
subjects, submit form Human Subjects Research Determination and wait for the IRB’s 
determination before commencing the study.
2.2 Personally conduct or supervise the research.
2.3 Protect the rights, safety, and welfare of subjects involved in the research.
2.4 Conduct the research in accordance with the relevant current protocol approved by the IRB, and 
comply with all requirements and determinations of the IRB, as well as Federal, state, and local laws 
and regulations, and be guided by the principles contained in the Belmont Report.
2.5 Ensure the research protocol is consistent with the proposal for funding for extramural or 
intramural support
2.6 Employ sound study design in accordance with the standards of your discipline and design studies 
in a manner that minimizes risks to subjects.
2.7 Ensure that there are adequate resources to carry out the research safely. This includes, but is not 
limited to, sufficient investigator time and oversight of all research team members, appropriately 
qualified research team members, equipment, and space.
2.8 Education and training requirements are described in SOG 7.1 IRB Education and Training: 
INVESTIGATOR AND KEY STUDY PERSONNEL TRAINING.
2.9 Unless the IRB affirmatively approved a protocol to include the following populations, such 
subjects may not be enrolled:
2.9.1 Adults unable to consent
2.9.2 Children
2.9.3 Neonates of uncertain viability
2.9.4 Nonviable neonates
2.9.5 Pregnant women
2.9.6 Prisoners
2.9.7 Individuals unable to speak English
2.10 When consent, parental permission, or assent are required by the IRB, ensure that they are 
obtained utilizing the IRB stamped form and documented in accordance with the relevant current 
protocol as approved by the IRB prior to any study procedures bring performed.
2.11 Submit proposed modifications to the IRB prior to their implementation.
2.11.1Do not make modifications to the research without prior IRB review and approval 
unless necessary to eliminate apparent immediate hazards to subjects.
2.12 Submit Continuing Review or Annual Check-in, as described in the approval letter, in the time 
frame requested by the IRB.
2.13 Submit a study closure to end the IRB’s oversight;
2.13.1 When all the following apply:
2.13.1.1 The protocol is permanently closed to enrollment;
2.13.1.2 All subjects have completed all protocol related interventions and 
interactions;
2.13.1.3 No additional identifiable private information about the subjects is being 
obtained;
2.13.1.4 Analysis of private identifiable information is completed.
2.13.2 When a study has expired or been administratively closed due to a continuing review 
not being submitted before expiration
2.14 If research approval expires, immediately stop all research activities including analysis of 
identifiable data, and do not resume the research study until the Continuing Review has been approved 
by the IRB.
2.15 Promptly report to the IRB the information items listed in HRP-071 Prompt Reporting 
Requirements to the IRB and SOG 6.4 Non-Compliance.
2.16 Follow Carilion Clinic’s requirements to disclose financial interests.
2.16.1 Disclose conflicts of interest for all study team members on submission of an initial 
review.

Carilion Clinic Human Research Protections Program, 213 S. Jefferson St., Suite 830, Roanoke, VA 24011
 
2.16.2 Disclose changes to your conflicts of interest.
2.16.2.1 On submission of continuing review
2.16.2.2 Within 30 days of discovering or acquiring (e.g., through purchase, 
marriage, or inheritance) a new financial interest that would have required disclosure 
on initial review
2.17 Retain research records for the greater of:
2.17.1 At least three years after completion of the research.
2.17.2 If the study involves Protected Health Information, research records must be 
maintained for a minimum of six years after the completion of the research.
2.17.3 For drug studies conducted under an IND, two years following the date a marketing 
application is approved for the drug for the indication for which it is being investigated; or, 
if no application is to be filed or if the application is not approved for such indication, until 
two years after the investigation is discontinued and FDA is notified.
2.17.4 For device studies conducted under an IDE or abbreviated IDE, two years after the 
latter of the following two dates: The date on which the investigation is terminated or 
completed, or the date that the records are no longer required for purposes of supporting a 
premarket approval application or a notice of completion of a product development 
protocol.
2.17.5 The retention period required by the sponsor
2.17.6 The retention period required by local, state, or international law.
2.17.7 The retention period required by a site that is not part of Carilion Clinic.
2.18 Contact the Research & Development Department regarding the need for a contract and letter of 
indemnification if your study involves any funding or resources from an outside source, or if you will 
be sharing data outside of Carilion Clinic prior to publication. If it is determined that either a contract 
or letter of indemnification is needed, subjects cannot be enrolled until these documents are complete.
2.19 Maintain confidentiality of all information gained during the conduct of research at Carilion 
Clinic, including but not limited to information about patients, employees, physicians, and students.
2.20 Do not accept or provide payments to professionals in exchange for referrals of potential subjects 
(“finder’s fees”).
2.21 Do not accept payments designed to accelerate recruitment that were tied to the rate or timing of 
enrollment (“bonus payments”) without prior IRB approval.
2.22 Notify the IRB immediately if involved in any regulatory or misconduct litigation or investigation 
by the FDA, or if you are debarred by the US FDA from involvement in clinical research studies.
2.23 If unable to perform the duties as outlined above for an extended period of time, you will close 
the study or transfer the duties of PI to the sub-investigator or to another qualified individual.
 

Carilion IRB Application (Version 1.4)
1.0
General Information
*Please enter the full title of your study (#[%irb_number%]):
Clinical Evaluation of a Device for Treatment of Lymphedema of the Upper Extremity
 
 
*Please enter an abbreviated study title or key words you would like to use to reference the study: 
Upper extremity lymphedema
* This field allows you to enter an abbreviated version of the Study Title to quickly identify this 
study.
 
 
2.0
Add departments
2.1 Add the departments of all Key Study Personnel that will be involved with the design, conduct, or reporting on this project:
Is 
Primary? Department Name
CC - Carilion - Other
CC - External - VTCSOM
CC - External- Virginia Tech Blacksburg
 
3.0
Assign key study personnel(KSP) access to the study  
3.1 
 Please add a Principal Investigator for the study: 
*
Name
Role
Training Record
Brown, Ralph Jr, MD
Principal Investigator
 View Training Record
3.2 
 
Please add the Research Staff, if applicable:
A) Additional Investigators 
Name
Role
Training Record
Molotkova, Evgeniya, MD 
Candidate
Sub-Investigator
 View Training Record
Muelenaer, Andre
Sub-Investigator
 View Training Record
Newberry, Tara
Sub-Investigator
 View Training Record
B) Research Support Staff 
Name
Role
Training Record

Fielder, Annette
Other
 View Training Record
Spivey, Cara
Research Coordinator
 View Training Record
3.3 
Please add a Study Contact:
*
Name
Role
Training Record
Molotkova, Evgeniya, MD 
Candidate
Study Contact
 View Training Record
Spivey, Cara
Study Contact
 View Training Record
The Study Contact(s) will receive all important system notifications along with the Principal Investigator. (e.g. The 
project contact(s) are typically either the Study Coordinator or the Principal Investigator themselves).  
4.0  
Key Study Personnel (KSP) Info
4.1  Provide the following information below for each Carilion Clinic research team member: You will be asked to provide information about 
members of the research team that are outside Carilion at a later time.
Click "add another entry" to respond to this item.
 
*CITI Training in Human Subjects Research Biomedical Researchers and GCP (for FDA-
regulated and NIH-funded) will be verified for each team member before the 
application will be reviewed by the IRB. Detailed instructions for Carilion's CITI 
training requirements can be found at  https://www.carilionclinic.org/irb/education
.  Please ask all team members to ensure their Carilion email address is added to their 
CITI account profile so that their CITI training is pulled into this system. This feed 
occurs on a nightly basis.
       Entry 1       
Research team member 
name:
Molotkova, Evgeniya, MD Candidate
Degree:
BS
Status:
VTCSOM Medical Student
If other, specify:
Email address:
emolotkova3@vt.edu
Phone number:
6784353316
Alternate phone number 
(optional):
Affiliation:
VTCSOM
If other, specify:
Research Duties (check 
all that apply):
PI: Ultimately responsible for the study including conduct 
by all study team members
Identification of potential subjects

Contacting potential subjects
Screening of subjects, including assessing eligibility criteria
Obtain Informed Consent
Randomization
Conduct of study procedures that result in research data
Prepare or dispense study drug/device
Research specimen collection/shipping
Adverse Event documenting and reporting
Data entry
Data Analysis - Identifiable
Data Analysis - De-identified
Regulatory document maintenance
Other (specify):
       Entry 2       
Research team member 
name:
Muelenaer, Andre
Degree:
MD
Status:
Physician
If other, specify:
Email address:
andrem1@vt.edu
Phone number:
Alternate phone number 
(optional):
Affiliation:
VT
If other, specify:
Research Duties (check 
all that apply):
PI: Ultimately responsible for the study including conduct 
by all study team members
Identification of potential subjects
Contacting potential subjects
Screening of subjects, including assessing eligibility criteria
Obtain Informed Consent
Randomization
Conduct of study procedures that result in research data
Prepare or dispense study drug/device
Research specimen collection/shipping
Adverse Event documenting and reporting
Data entry
Data Analysis - Identifiable
Data Analysis - De-identified
Regulatory document maintenance
Other (specify):
Training research staff, physical contact with subjects in case 
of an emergency

       Entry 3       
Research team member 
name:
Newberry, Tara
Degree:
Status:
Carilion Staff/Employee
If other, specify:
Email address:
tanewberry@carilionclinic.org
Phone number:
Alternate phone number 
(optional):
Affiliation:
Carilion Clinic
If other, specify:
Research Duties (check 
all that apply):
PI: Ultimately responsible for the study including conduct 
by all study team members
Identification of potential subjects
Contacting potential subjects
Screening of subjects, including assessing eligibility criteria
Obtain Informed Consent
Randomization
Conduct of study procedures that result in research data
Prepare or dispense study drug/device
Research specimen collection/shipping
Adverse Event documenting and reporting
Data entry
Data Analysis - Identifiable
Data Analysis - De-identified
Regulatory document maintenance
Other (specify):
Training research staff, physical contact with subjects in case 
of an emergency
       Entry 4       
Research team member 
name:
Spivey, Cara
Degree:
MS
Status:
Other:
If other, specify:
Clinical Research Coordinator
Email address:
crspivey@carilionclinic.org

Phone number:
Alternate phone number 
(optional):
Affiliation:
Carilion Clinic
If other, specify:
Research Duties (check 
all that apply):
PI: Ultimately responsible for the study including conduct 
by all study team members
Identification of potential subjects
Contacting potential subjects
Screening of subjects, including assessing eligibility criteria
Obtain Informed Consent
Randomization
Conduct of study procedures that result in research data
Prepare or dispense study drug/device
Research specimen collection/shipping
Adverse Event documenting and reporting
Data entry
Data Analysis - Identifiable
Data Analysis - De-identified
Regulatory document maintenance
Other (specify):
Study contact
       Entry 5       
Research team member 
name:
Brown, Ralph Jr, MD
Degree:
MD
Status:
Physician
If other, specify:
Email address:
rdbrown@carilionclinic.org
Phone number:
Alternate phone number 
(optional):
Affiliation:
Carilion Clinic
If other, specify:
Research Duties (check 
all that apply):
PI: Ultimately responsible for the study including conduct 
by all study team members
Identification of potential subjects
Contacting potential subjects
Screening of subjects, including assessing eligibility criteria
Obtain Informed Consent

Randomization
Conduct of study procedures that result in research data
Prepare or dispense study drug/device
Research specimen collection/shipping
Adverse Event documenting and reporting
Data entry
Data Analysis - Identifiable
Data Analysis - De-identified
Regulatory document maintenance
Other (specify):
       Entry 6       
Research team member 
name:
Fielder, Annette
Degree:
Status:
Carilion Staff/Employee
If other, specify:
Occupational Therapist
Email address:
alfielder@carilionclinic.org
Phone number:
Alternate phone number 
(optional):
Affiliation:
Carilion Clinic
If other, specify:
Research Duties (check 
all that apply):
PI: Ultimately responsible for the study including conduct 
by all study team members
Identification of potential subjects
Contacting potential subjects
Screening of subjects, including assessing eligibility criteria
Obtain Informed Consent
Randomization
Conduct of study procedures that result in research data
Prepare or dispense study drug/device
Research specimen collection/shipping
Adverse Event documenting and reporting
Data entry
Data Analysis - Identifiable
Data Analysis - De-identified
Regulatory document maintenance
Other (specify):

5.0  
Application Type
5.1  Select the application type:
Human Subject Research Study 
Determination of Human Subjects Research (including QA/QI Determination) 
Establishing a prospective Data or Specimens Research Repository 
Humanitarian Use Device (non-research use) 
Expanded Access or Compassionate Use 
Single Patient Emergency Use 
Preparatory to Research Application 
IRB Grant Review ONLY for preliminary approval if required by funder 
Requesting Carilion Clinic RELY on another IRB of Record (WIRB, CIRB, VT, UVA, Advarra 
etc.) 
Conversion of a paper application due for Continuing Review or Annual Check-In 
Please ensure the PI has completed and submitted the R&D Application Department 
Level Review Form (eCRAF), and that the PI's Department Chair or signatory has 
signed off on the R&D Department Level Review eCRAF Form BEFORE you proceed any 
further with this IRB application. Please read the below bullet points carefully and 
acknowledge your understanding.
The R&D Application Department Level Review eCRAF Form must be submitted 
by the PI and signed off by Department Chair or signatory through RedCap
 BEFORE you may proceed with this IRB application.
The R&D Application Department Level Review eCRAF Form serves a major 
function for section and department level review and may result in this study 
not being permitted due to resources, scientific validity, or other reasons.  
You 
 submit a copy of the signed R&D Application Department Level Review 
must
eCRAF Form with this IRB application in the supplemental document section.
Failure to complete the steps in the above order will result in a significant delay 
in the IRB's review of this study. 
Acknowledged 
6.0  
Funding Information and Outside Services
6.1  Select the applicable funding source(s).
None (no money, equipment, supplies, and/or services will be provided by external source)
No monetary funding BUT equipment, supplies, and/or services will be provided
Federal Government
Foundation or Non-profit
Industry/Commercial Sponsor
State or Local Government
Investigator or Departmental/Unit Funds
Carilion RAP Grant
Other
Please specify:
VTCSOM Research Domain funding
6.2  Select services from all areas 
 of the Research Team members’ affiliations that are necessary to conduct the work.
outside

Research and Development (R&D) will contact you to arrange a Feasibility Meeting based on your responses 
below.  This will ensure roles, responsibilities, and costs associated with this project are understood by all 
parties. Final sign-off from leadership in the additional service areas, as well as contracts, may be required.
Animals
Basic Science Laboratory Services
Center for Simulation, Research & Patient Safety (CSRPS)
Department of Medicine
Department of Pediatrics
Department of Psychiatry
Department of Surgery
Emergency Department
Hazardous Materials
Health Analytics Research Team (HART), including Epic Data Extraction, Statistics Services, 
Carilion RedCap, Epic Research Access
Human Resources
Jefferson College
Nuclear Medicine
Nursing
Pathology
Pharmacy
Physical Therapy
Radiology
Recombinant DNA/RNA
Respiratory
Solstas Lab
Technology Services Group (TSG)
Other
None
6.3  You have selected that HART services are needed for this research.  Specify the resources needed.
Epic Data Extract
Statistics Support (biostatisticians)
Carilion REDCap (Data management)
Epic Research Access for Chart Review
TriNetX Identifiable Patient List/Data Set
SPARC Carilion Secure Research Environment
Note: If you have not yet discussed this project with the HART team, please contact 
them at HART@carilionclinic.org before proceeding any further with this application. 
This will ensure that your request for this project is feasible.
7.0  
Regulatory Compliance
7.1  How many studies is the PI currently responsible for?
1
7.2  Does the PI have protected or dedicated time available to conduct this research?
 Yes  
 No
7.3  Has any member of the research team ever received a FDA 483, “Warning Letter”, Notice of Disqualification, or other 
warning or disciplinary action from an agency or licensing authority?

  Yes  
  No
7.4  Has this study been disapproved or terminated by another IRB?
  Yes  
  No
8.0  
Conflict of Interest
8.1  A Conflict of Interest, per the Carilion Clinic Organizational Policy, is a situation in which an Investigator’s and/or their Family 
Member’s financial, professional, or other personal consideration may directly or indirectly affect, or reasonably appear to affect, the 
Investigator’s professional judgement in performing their Institutional Responsibilities. A Conflict of Interest may be actual, apparent, 
or potential. Any research team member listed on the IRB application is considered to be an Investigator. It is the Principal Investigator’
s responsibility to query all Carilion research team members on this study to ensure they have honestly completed their Annual COI 
Disclosure and that it is current. The Principal Investigator should be notified by the study team member if the study team member has 
disclosed any related interests. Carilion Clinic’s Conflicts of Interest in Research Policy can be found here.
 
If this study has any external funding or support, have all Carilion research team 
members filed an Annual COI Disclosure through Carilion Clinic’s Office of 
Organizational Integrity and Compliance via the COI-Smart online disclosure system? 
Yes 
No 
N/A - this study does not have any external funding or support 
 An Annual COI disclosure must be completed for ALL Carilion research team 
members. Please contact the Carilion Clinic Office of Organizational 
Integrity & Compliance immediately at researchcompliance@carilionclinic.
 in order to ensure you can submit a disclosure through 
  
org
COISmart.
If new Carilion study team members are added to this study in the future, 
you must contact 
. If the new team 
researchcompliance@carilionclinic.org
member needs to submit an Annual COI disclosure, this must occur before 
the new team member is permitted to conduct any work on this research 
study.
 
 
Do any Carilion research team members or their family members have a 
Conflict of Interest or related outside interest with the sponsor/funding 
agency of this study?
 Yes  
 No
Please email researchcompliance@carilionclinic.org 
and irb@carilionclinic.org immediately to ensure this 
Conflict of Interest or Outside Interest has been 
appropriately managed. Please note that the IRB may 
require additional management conditions for this study.  
It is the Principal Investigator and conflicted employee's responsibilities to ensure the 
conflict or any changes that result in a potential conflict are disclosed to the Office of 
Integrity and Compliance who will refer it to the Carilion Clinic's Research Conflict of 

Interest Commitee for appropriate management when necessary. Disclosure and 
management must occur before the conflicted employee is permitted to engage in any 
research activities. Any employee who violates the Conflict of Interest policy is subject 
to disciplinary actions, up to and including termination.
 
 
9.0  
Collaboration
9.1  Is this research project a collaboration between Carilion Clinic and another institution (including, but not limited 
to Fralin Biomedical Research Institute at VTC, VTCSOM, VT, UVA)?
 Yes  
 No
9.2  Please provide the name(s) of the collaborating institution(s) and the name(s) and contact information of the lead PI(s) at that 
institution.
This research project is a collaboration between Carilion Clinic, VTCSOM, and VT. 
VTCSOM:
- Evgeniya Molotkova (BS, emolotkova3@vt.edu, 678-435-3316)
VT:
- Dr. Andre Muelenaer (MD, andrem1@vt.edu)
- Dr. Christopher Arena (PhD, topher3@vt.edu)
- Seth Jarvis (BS, sethjarvis@vt.edu)
- Selah Wangler (Undergraduate student, wanglers@vt.edu)
- Leah Thomas (BS, MS student, leahrebecca@vt.edu)
- Jennifer Rechani (Undergraduate student, jennifer0605@vt.edu)
9.3  Is Carilion acting as one site of a multicenter study?
  Yes  
  No
9.7  Are any members of the research team listed on 
 IRB application under the jurisdiction of another institution's IRB?
this
 Yes  
 No
Please state specifically which external personnel are under the jurisdiction of another IRB, their role on 
this research study and the type of interaction they will have with the subjects, the name of the 
institution's IRB(s), and an explanation as to why they are listed on this IRB application.
VTCSOM:
- Evgeniya Molotkova (BS, emolotkova3@vt.edu, 678-435-3316) Research duties are those listed 
in this IRB application. This individual is listed on this IRB application because this research 
project is being done as part of the research requirement for graduation from VTCSOM.
VT:
- Dr. Andre Muelenaer (MD, andrem1@vt.edu) Research duties are those listed in this IRB 
application. Dr. Muelenaer was an instrumental part in the development of the medical device to 
be tested and played an important role in advocating for its translation to the clinical realm.
- Dr. Christopher Arena (PhD, topher3@vt.edu) Research duties are as follows: provide the 
device, prepare the device,
ensure proper training of the study personnel, and post-processing of de-identified data, including 
none of the 18 HIPAA identifiers.
- Seth Jarvis (BS, sethjarvis@vt.edu) Research duties are as follows: provide the device, prepare 
the device,
ensure proper training of the study personnel, and post-processing of de-identified data, including 
none of the 18 HIPAA identifiers. Seth built the device from the ground up, with help from both 
Dr. Muelenaer and Dr. Arena.
- Leah Thomas (BS, 
) Research duties are as follows: provide the device, 
leahrebecca@vt.edu
prepare the device,

ensure proper training of the study personnel, and post-processing of de-identified data, including 
none of the 18 HIPAA identifiers. Leah built the device from the ground up, with help from both 
Dr. Muelenaer and Dr. Arena.
- Selah Wangler (Undergraduate student, 
) Research duties are as follows: 
wanglers@vt.edu
conduct of study procedures that result in research data, prepare or dispense study drug/device, 
adverse event documenting and reporting, data entry, data analysis (identified and de-identified) 
- Jennifer Rechani (Undergraduate student, 
) Research duties are as 
jennifer0605@vt.edu
follows: conduct of study procedures that result in research data, prepare or dispense study drug
/device, adverse event documenting and reporting, data entry, data analysis (identified and de-
identified) 
Dr. Muelenaer, Tara Newberry (listed on this application), and Leah Thomas (VT collaborator) will 
train the entire research team, including Selah Wangler and Jennifer Rechani, on how to interact 
with patients and conduct study procedures that result in research data as well as document and 
report adverse events. This training will be logged and signed by one of the aforementioned 
trainers. 
9.8  Are you requesting that Carilion Clinic serve as the IRB of record for the other participating institutions or organizations?
For more information on IRB reliance requests, please visit the Carilion Clinic IRB website or contact the 
IRB Office.
  Yes  
  No
9.11  Describe any plans for initial and ongoing training of the other sites on important aspects of the protocol.
The research team will complete training requirements set forth by Carilion Clinic standards. The 
principal investigator will work with members of the research team to accomplish this and provide 
continuing education and protocol training through lab meetings or via secure and encrypted 
Carilion Clinic email.
Dr. Muelenaer, Tara Newberry (listed on this application), and Leah Thomas (VT collaborator) will 
train the entire research team, including Selah Wangler and Jennifer Rechani, on how to interact 
with patients and conduct study procedures that result in research data as well as document and 
report adverse events. This training will be logged and signed by one of the aforementioned 
trainers. 
9.12  Describe the plan to manage communication of information at the other sites that is relevant to the conduct of the research 
and the protection of human subjects, such as reporting of unexpected problems, protocol modifications, and interim results 
for all sites to the Carilion Clinic IRB.
For FDA-regulated clinical trials, the plan must include the plan for reporting serious adverse events or 
serious adverse device effects, significant new risk information, and any other reports mandated by 
regulation or policy.
The principal investigator will be involved in all aspects of this study and will be responsible for reporting any 
adverse events or protocol modifications to the Carilion Clinic IRB. This information will be shared with the rest 
of the research team during research meetings or using secure, encrypted Carilion Clinic email in the interim. 
9.13  Describe the Carilion Clinic investigator's plan for oversight of research activities at other sites including verification of 
Institutional approvals, data safety monitoring, and ensuring data quality and integrity.
For FDA-regulated clinical trials, the plan must include the use of trained and qualified monitors to oversee 
the progress of the research.
All research activities will be conducted in a Carilion Clinic facility.
9.14  Will identifiable data or specimens be transferred, transmitted, or shared outside of Carilion?

For example, transfer of data or specimens from Carilion Clinic to an external collaborator (including VT, 
VTCRI, UVA, etc.).
 Yes  
 No
9.15  Provide information about the types of specimens and/or data, including specific datapoints, that will be shared 
and the methods of storage of the data at the collaborating site.  Include a description of the process for 
shipping the specimens and/or transmitting the data to the collaborator, including the method of encryption if 
sharing data electronically.
Data sharing will only occur with those delegated in section 9.2. Data will be stored and shared within RedCap. 
Carilion Clinic's REDCap software will be used as the central location for data collection. REDCap provides a 
secure, web-based application designed to support data management and collection for research/QA/QI studies. 
Carilion's REDCap servers are securely housed on site in a limited access data center, and all data are stored on 
Carilion's firewall protected network.
10.0  
Human Subjects Research Description
10.1  In the opinion of the Principal Investigator, does this research impart minimal risk or greater than minimal risk to 
subjects? 
As defined by regulation, minimal risk means that the probability and magnitude of harm or discomfort 
anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily 
life or during the performance of routine physical or psychological examinations or tests.  Please note that 
the IRB makes the final determination of risk level and may ask you to change this based on their decision.
 
If this is a Conversion of a Paper Application, select the risk level that has been determined already by the 
IRB  at most recent review per the most recent approval letter (expedited review = minimal risk, full board 
review = greater than minimal risk).
Minimal Risk 
Greater than minimal 
10.2  Does the research offer the prospect of direct benefits to the individual subjects?
  Yes  
  No
10.3  Select ALL the types of research activities that will be involved in your human subject research subject, or select None.
Drugs, biologics or other FDA-regulated products (other than devices)
Medical devices
Review of data/records (i.e. prospective clinical data collection from medical records, 
reviewing previously collected data)
Biospecimen collection (i.e. blood, tissue, urine, saliva)
Analysis of existing specimens from patients and/or bank or repository
Human genetic analysis or Recombinant DNA, or Gene Therapy
Invasive medical procedures (i.e. lumbar puncture, biopsy, endoscopy, surgery, etc.)
Non-invasive medical procedures routinely employed in medical practice (i.e., physical 
measurements, EKG, EEG, moderate exercise, etc.)
Imaging (i.e., x-ray, CT, DEXA, MRI, ultrasound, etc.), Use of Therapeutic or Diagnostic 
Radiation, Radioactive Drugs
Task-based activities or games, or Psychometric Testing
Surveys, questionnaires, focus groups, or interviews
Examination of educational practices, instructional techniques, curricula or classroom 
management
Observations of public behavior
Interventions or procedures involving deception
Use of Internet

Audio or Video recording
International Research
NONE OF THE ABOVE
10.4  Briefly describe the proposed research in language that can be understood by a non-scientist.
This description should summarize the objectives of the research and the procedures to be used, with an 
emphasis on what will happen to the subjects. If this is an application for the establishment of a research 
repository, summarize the objectives of the repository and how data/specimens will be used in the future. 
Lymphedema is a painful and disfiguring condition related to the buildup of protein-rich fluid in 
the body’s tissues. The goal of this research study is to determine the safety and efficacy of a novel, 
proprietary device in the treatment of upper extremity lymphedema. This device has been previously studied on 
healthy people that do not have a diagnosis of lymphedema. It was found that using the device on them does 
not cause significant changes to their vital signs or level of pain. Side effects are reported sometimes; however, 
these are to be expected and are also frequently reported when people receive the standard of care for their 
lymphedema. 
Patients who have diagnosed lymphedema will be approached to participate in this study as part of their care. 
Patients will wear this device for approximately 40 minutes and then have certain measurements taken before 
and after doing so. These measurements include the size of their arm, how much pain/discomfort they are 
currently in, and if they experienced any side effects. After getting treatment with the device, they will receive the 
standard of care treatment for their lymphedema from their provider. After the standard of care has concluded, 
the previously mentioned measurements will be repeated. This data will be put together and analyzed to look for 
differences in arm size before and after treatment with the device as well as to look for the prevalence of side 
effects.
 
10.5  Provide background information about the research question(s.)  Explain why the research is needed and include the 
relevance of this research to the contribution of this field of study.
Please include the current state of knowledge about your project topic by summarizing 
and synthesizing the available research (including published data) to provide 
justification for the study. Include a reference list of literature cited to support the 
protocol statement, either in your response below or as a supplemental document as 
part of the application packet.
Lymphedema is a chronic condition characterized by the buildup of protein-rich fluid in the body’s tissues, 
leading to bothersome swelling. There are several causes of lymphedema, but it typically arises due to damage or 
dysfunction of the lymphatic system, which is composed of lymph drainage vessels and lymphatic fluid itself. 
Lymphatic drainage includes lymphatic capillaries, lymphatic trunks, and lymph nodes, creating one large 
lymphatic drainage network that is tightly controlled and highly associated with the circulatory system. 
Hydrostatic and oncotic forces push lymph out from the body’s veins and arteries and into the body’s tissues, 
where it is absorbed by lymphatic vessels and eventually recycled back into systemic circulation. Lymphatic fluid 
itself is very similar in composition to blood plasma, and it typically contains high levels of triglycerides, white 
blood cells, and bacterial debris. (Sleigh and Manna, 2022). 
Lymphedema can be subdivided into primary and secondary causes. Primary lymphedema is due to underlying 
genetic mutations, often leading to the malformation and malfunctioning of the lymphatic system. Secondary 
lymphedema is caused by some sort of external damage or injury to the lymphatic system. Most cases of 
lymphedema are secondary lymphedema, most widely seen in the oncologic population, where invasive surgery 
to remove tumors or diseased lymph nodes disrupts lymphatic flow. In fact, it is estimated that approximately 1 
in 5 women who survive breast cancer will go on to develop lymphedema. While the underlying etiology of 
lymphedema may vary, all lymphedema is staged in the same fashion, falling anywhere from Stage 0 to Stage 3. 
Stage 0 represents an “at-risk” state, where an individual has risk factors associated with the development of 
lymphedema, and Stage 3 represents a stage of lymphostatic elephantiasis (Sleigh and Manna, 2022).
Lymphedema in and of itself can be uncomfortable, if not downright painful. However, it also predisposes 
patients to developing secondary vascular, inflammatory, and infectious conditions as it progresses and becomes 
increasingly severe. Additionally, it may undermine patients’ body image and self-esteem and affect their daily 
lives and personal relationships. Currently, once lymphedema develops, there is no definitive cure, only symptom 
management. The standard of care entails using a combination of outpatient decongestive lymphedema therapy 

1.  
1.  
2.  
3.  
and manual lymph drainage alongside stringent home care characterized by the use of compression garments and 
therapist-taught manual lymph drainage techniques. However, oftentimes home care is not enough to control 
lymphedema between therapist appointments.
In recent years, medical devices have been developed to improve home care and lymphedema outcomes. There 
are many different types of lymphedema pumps currently available on the market. Unfortunately, across the 
board, they can be bulky, noisy, expensive, and require long periods of immobility while treatment takes place. 
There is a definitive need for new lymphedema technology that can improve patients’ symptoms while being 
easier and more enjoyable to use than previous products. This study aims to evaluate a new, proprietary device 
designed at Virginia Tech through Carilion Innovations to address the problem of upper extremity lymphedema. 
A previously conducted safety study has demonstrated that this device does not cause significant changes in vital 
signs or pain. Additionally, the overwhelming majority of side effects associated with the use of this device are 
those expected with the standard of care. Being able to assess the efficacy and safety of this device in patients 
with lymphedema over the course of this study would provide a promising alternative to current lymphedema 
home care modalities that can improve lymphedema patient outcomes.
References:
Sleigh BC, Manna B. Lymphedema. [Updated 2022 Sep 18]. In: StatPearls [Internet]. Treasure Island 
(FL): StatPearls Publishing; 2022 Jan-.
10.6  State the research hypothesis or the question that the research will answer.
List the research objectives and expected outcomes. A primary outcome or objective must be identified. After 
the statement of the primary objective, secondary objectives may be listed. Objectives should be simple and 
specific.
Research Question: How can we utilize new technology in the treatment of lymphedema?
Hypothesis: Use of a recently developed, proprietary device will reduce lymphedema in the outpatient clinic 
setting.
Objectives:
Implement a new, proprietary device in the treatment of lymphedema.
Assess the safety and tolerability of the aforementioned device.
Assess pre- and post-treatment pain metrics and change in upper extremity circumference and induration 
for treatment with the proprietary device and the standard of care.
10.7  State how qualitative and/or quantitative data will be analyzed in order to answer the research questions.
Include an analysis from a statistician (or someone familiar with statistical methods) that either indicates the 
power calculation for the sample size necessary to meet the primary study outcome or objective OR a 
statement from the statistician indicating reasons why a power calculation is waived or not necessary for this 
study.  Also include the statistical test(s) that will be used to analyze your primary study objective (t-test, chi-
square, etc.).  Secondary outcomes may be listed as descriptive.  
 
If this is a proof of concept or feasibility study that includes limited efficacy testing, please provide a 
description on how your design will determine if an intervention should be recommended for broader 
efficacy testing.  If a study is meant to be solely descriptive, then the primary outcome or objective must be 
limited in scope.  As such, the study results apply only to the sample being studied, and conclusions cannot be 
drawn about the larger population. 
section helps the IRB confirm the data being collected are relevant to 
This is required for ALL studies, as this 
the study aims and planned analysis. 
Power Calculation
1. The most conservative approach of sample size calculation without counting for replication.
The sample size calculation for this study was based on paired samples t-test for testing the pre- and post-
treatment outcomes. With an estimated effect size of 0.3, it will require a total sample of 90 patients with 0.8 
power at 5% significance level using two-tailed test. The power calculation was performed using R4.2
(https://cran.r-project.org/).

2. Assuming a correlation of 0.5 (strong correlation between replicated measures)
The sample size calculation for this study was based on paired samples t-test for testing the pre- and post-
treatment outcomes with 4 replicated measures. With an estimated effect size of 0.3 and a correlation of 0.5 
between replicated measures, it will require a total sample of 57 patients at 5% significance level using two tailed 
test. The power calculation was performed using R4.2(https://cran.r-project.org/).
3. Assuming a correlation of 0.25 (moderate correlation between replicated measures)
The sample size calculation for this study was based on paired samples t-test for testing the pre- and post-
treatment outcomes with 4 replicated measures. With an estimated effect size of 0.3 and a correlation of 0.25 
between replicated measures, it will require a total sample of 40 patients at 5% significance level using two tailed 
test. The power calculation was performed using R4.2(https://cran.r-project.org/).
Plan for Statistical Analysis
All data obtained in this research study will be analyzed using a paired t-test.
Feasibility Study
Since this is the first time that the proprietary device will be used on patients and not on healthy volunteers, we 
are primarily aiming to establish safety, first and foremost, and efficacy, to ensure that the device works like it is 
supposed to do so. Because of these two factors, we plan on enrolling only 15 patients in this feasibility/pilot 
study, which is less than what was indicated to us through the power analysis. 
10.8  Statistical Review
Name of statistician or person 
who prepared the statistical 
plan:
Department/Institution:
Date statistical review was 
conducted:
Ahmed N. Al-qaffas
HART
12/19/2022
*Note: The statistician or individual that prepared the statistical plan must also be included on the study 
team if they meet the definition of key research personnel (ex: significantly involved in the study design, 
conduct, or reporting of the research).
If a statistical review has not been submitted, explain why:
11.0  
Subject Population
11.1  Please select the population(s) being 
 in this research study. (select all that apply)
targeted, or likely to be included
Medical Chart Review of patients only (no in-person contact)
Normal Adults/Healthy Volunteers
In-Patient Population
Out-Patient Population
Patients in emergency situations
Terminally ill patients
Employees/Staff
Students
Children/Minors (anyone younger than 18 years of age in the state of Virginia. For research 
conducted outside of the state of Virginia, age of majority is dependent on state/local law)
Prisoners
Pregnant Women
Fetuses
Neonates of uncertain viability and/or nonviable neonates
Adults with Impaired Decision-Making Capacity
Persons with Limited-English proficiency (LEP) or Non-English Speakers
Individuals of Childbearing Potential

11.2  Please indicate the total number of subjects anticipated to be enrolled at this site/by this investigator.
For the purposes of the IRB, a subject is enrolled once they have provided consent to participate, or for 
studies approved with a waiver of consent, once data has been collected on the subject.
15
11.3  If the research involves multiple subject groups or cohorts at this site, provide the anticipated number of subjects in each of 
group or cohort (e.g., control/experimental, adults/children, etc.).
This research does not involve multiple subject groups or cohorts.
11.4  Provide the age range for the proposed subject population (e.g., 0-5 years old):
18 and older
11.5  Specify the inclusion criteria for each of the subject groups to be included in the research.
If there are multiple different groups being recruited with different eligibility criteria, 
instead add an Eligibility Criteria checklist for each group as a supplemental document 
after you complete this application. Please make note of this in the Inclusion Criteria 
below.
Order 
Number
Criteria
1 
Patients 18 year of age or older
 
2 
Clinical diagnosis of lymphedema
 
3 
Receiving current, once weekly, lymphedema treatment by PT/OT
 
4 
Participants must have the ability to provide consent for themselves
 
11.6  Specify the exclusion criteria for each of the subject groups to be included in the research.
If there are multiple different groups being recruited with different eligibility criteria, 
instead add an Eligibility Criteria checklist for each group as a supplemental document 
after you complete this application. Please make note of this in the Exclusion Criteria 
below.
Order 
Number
Criteria
1 
Active infection
 
2 
Active cancer (not in remission) 
3 
Diagnosis of/past medical history of deep venous thrombosis or pulmonary embolism
 
4 
Active phlebitis
 
5 
Diagnosis of congestive heart failure
 
6 
Previous severe trauma (i.e. requiring extensive corrective surgery)
 

7 
History of vascular surgery
 
8 
Lesions of the skin or weeping skin in the treatment area
 
11.7  
(such as a family member or colleague of the 
Is information being obtained about individuals other than the “target subjects” 
subject), making the other individuals “secondary subjects”?
  Yes  
  No
12.0  
Informed Consent for Adult Subjects
12.1  How do you plan to obtain consent from ADULT subjects or their Legally Authorized Representative?
Check all that apply:
Written consent document with signature (ie: obtaining signature from subject or Legally 
Authorized Representative)
Waiver of written documentation of consent (ie: consent will be obtained through verbal 
confirmation from the subject or Legally Authorized Representative rather than through a 
signed document)
Waiver of informed consent for minimal risk research (ie: typically appropriate only when the 
study does not involve any interaction or intervention with subjects)
Waiver or alteration of the elements of informed consent (ie: research involving deception)
Waiver of the informed consent document and process for PLANNED EMERGENCY RESEARCH. 
Contact the IRB before submission.
No adults are being enrolled; this study is only enrolling children. (You will answer questions 
about the assent and parental permission process later.)
You must attach all consent forms, consent scripts, and information sheets in the Initial Submission Packet.
12.2  Is it expected that surrogate consent will need to be obtained from Legally Authorized Representatives (LARs) for some or 
all adult subjects?
  Yes  
  No
12.3  If the research includes more than one subject group or you have selected multiple responses above due to the inclusion of 
multiple subject groups, please specify the requested consent method for each group, or state N/A.
N/A
12.4  How will written consent be documented?
Click the Help bubble to the right for more information about requirements for 
eConsent before selecting this option.
Traditional signed written consent form on paper document
eConsent: signed via an REDCap or other electronic or web-based form
Short Form Method (for non-English speaking subjects only)
Other
12.5  Describe the 
 of obtaining consent and 
 the process, including the following:
process
documenting
Circumstances under which consent will be obtained, including how the potential participant will first be 
approached;
Where the consent process will take place  (ex: in person in a private clinic room, over the phone, through WebEx, 
etc.);
When the consent process will take place and how long participants will be given to decide;

1.  
2.  
3.  
4.  
5.  
6.  
7.  
1.  
2.  
3.  
If eConsent is being utilized, describe how you will first contact the potential participants and provide the consent 
form to them to review;
Steps that will be taken to ensure voluntary participant and to minimize the possibility of coercion or undue 
influence;
Any cultural considerations (ex: tribal or group permission requirements, age of majority, technological 
implications, etc.);
If any participants do not speak English, whether a translator with witness will be used, whether translated materials will be 
used, whether the consent process changes based on the language;
If multiple participant groups or consent procedures are to be included, these need to be clearly delineated;
how participants will be provided with a copy of their signed consent;
Describe the method you will use to document the consent 
 
PROCESS within each participants' research record
/medical record (state which). This should include a process note or checklist that will document all the components 
listed above, the start and end time of the discussion, and is 
 to the signed and dated consent form (if 
in addition
applicable).
For example, describe it consent will take place in the research office, in a private conference room, in the 
doctor’s office, in a group setting, over the phone, etc.
GENERAL
The occupational therapist (OT) listed at the beginning of this application will identify 
potential participants (based on established inclusion and exclusion criteria) from their 
patient pool. All consenting procedures will be completed by the Carilion Affiliated or 
VTCSOM IRB approved team members.
The occupational therapist will verbally bring up this research study during a patient's 
regularly scheduled treatment visit, which is typically about an hour long. Lymphedema is 
treated with a combination of massage and compression, giving the OT leeway to talk to a 
patient while they are delivering hands-on treatment. They will give a brief explanation of 
what will happen to the patient and how it will/will not impact their care. Only the 
occupational therapist will initially approach potential subjects.
If a patient expresses interest in participating in the study, the OT will give them an 
unsigned copy of the consent document to take home and read over. The OT will confirm 
their contact information and the best time to reach out to them. Then, the OT will reach 
out to a designated IRB approved research team member.
This encounter will be documented as a research note in Epic by a designated IRB 
approved research team member.
Two to three days after the initial contact has been made, a designated IRB approved 
research team member will attempt to contact the patient via phone call, limiting the 
number of attempts to three. There will be no voicemail left. If the designated IRB 
approved research team member cannot reach the patient during this time, they will not 
be included in the research study.
If the designated IRB approved research team member is able to successfully make 
contact with the patient, they will first confirm the patient’s identity by asking them to 
state their name and date of birth. This will create a passcode based on known information 
(first two letters of legal first name followed by first two letters of legal last name followed 
by last 2 digits of birth year). Each section of the consent form will be reviewed in detail 
before consent is obtained. The designated IRB approved research team member will ask 
the patient if they have any questions about the study. 
After the patient has expressed interest in the study and agreed to participate, they will be 
allowed to choose whether they would like to undergo consent in person, at their next 
regularly scheduled office visit or remotely, via eConsent.
IN PERSON
Upon arriving to their next regularly scheduled office visit, the patient will be brought back 
to a private treatment room by a designated IRB approved research team member.
An IRB Research team member will review the each section of the consent in detail with 
the participantThe patient will be asked if they have any further questions about the 
research study.
A number of teach-back and open-ended questions will be used to assess patient 
understanding regarding the research study and what is/is not expected of them. Once all 
applicable questions have been answered/addressed, the patient will physically sign a two 
paper copies of the consent form (one for the research team and one for themselves)

4.  
5.  
6.  
1.  
2.  
3.  
4.  
5.  
6.  
7.  
8.  
9.  
The participant will immediately receive their signed copy of the consent form.
A summary of the conversation, any pertinent questions that were addressed during the 
encounter, and the signed consent form will be recorded in a research note in Epic. 
Specifically, the following points will be recorded in the research note:
The method that was used to discuss the study with the potential subject 
(discussion happened in person)
The questions that the potential subject asked
The time the potential subject was given to make their decision
How long the conversation lasted
Research tasks will only be completed after the informed consent document is signed.
eCONSENT
The eConsent process will take place over the phone. The patient will be asked whether 
they would prefer to get the link to the eConsent form emailed or texted to them.
Once communication modalities have been confirmed, the designated IRB approved 
research team member will have to state the following: “Carilion Clinic cannot control the 
security of email or text messages once we send them, therefore we need your permission 
to text or email you the link to the eConsent form for the study we discussed. Please be 
aware that while the email title will not include your lymphedema, the body of the email 
will contain the link to the study. Someone else accessing your email/text messages could 
click on the link and read the consent, and therefore learn about your lymphedema, which 
you may consider to be of a private or sensitive nature. Do you still wish to receive the 
link to the eConsent via email/text?”
The patient will receive the link via their preferred modality and review it.
An IRB Research team member will review the each section of the consent in detail with 
the participant. The patient will be asked if they have any further questions about the 
research study.
A number of teach-back and openended questions will be used to assess patient 
understanding regarding the research study and what is/is not expected of them.
The subject will type their name and date and use their finger, cursor, or stylus (if it is 
available to them) to sign in the signature field.
The participant will receive a copy of their signed consent form via email or in person at 
their next regularly scheduled visit.
If the patient elects to receive a copy of their consent form via email, the designated IRB 
approved research team member will verbally state, “Carilion Clinic cannot control the 
security of email messages once we send them, therefore we need your permission to 
email you the copy of your signed consent. Please be aware that while the email title will 
not include your lymphedema the attachment to the email will contain study consent. 
Someone else accessing your email messages could click on the attachment and read the 
consent, and therefore learn about your lymphedema, which you may consider to be of a 
private or sensitive nature. By providing your email address, you are authorizing Carilion 
Clinic to email you a copy of your signed form." If a signed copy of the consent will be 
emailed to the subject using REDCap, the subjects must provide their e-mail address on 
the completion page, and the following statement will be included in the field where the 
email address is "Enter your email to receive confirmation message? A confirmation email 
is supposed to be sent to all respondents that have completed the survey, but because 
your email address is not on file, the confirmation email cannot be sent automatically. If 
you wish to receive it, enter your email address below." 
A summary of the conversation, any pertinent questions that were addressed during the 
call, and the signed consent form will be recorded in a research note in Epic. Specifically, 
the following points will be recorded in the research note:
The method that was used to discuss the study with the potential subject 
(discussion happened over the phone)
The questions that the potential subject asked

10.  
The time the potential subject was given to make their decision
How long the conversation lasted
The process of verifying the individual’s identity over the phone and then with the 
eConsent signature, as described above
Research tasks will only be completed after the informed consent document is signed.
12.6  How will you ensure that subjects or LARs have sufficient opportunity to consider whether or not to participate?
Check all that apply:
Subjects will be provided the consent form to take home for consideration prior to signing.
Subjects will be allowed a waiting period to consider their decision.
Other
Please specify waiting period:
2 to 3 days
12.7  How will the subjects’ or LARs understanding of the consent information presented be assessed? 
Check all that apply:
Subjects will be asked to “Teach-Back” the study to the researchers
Subjects will be asked open-ended questions about the research (purpose, procedures, risks, 
alternatives, voluntary nature)
A tool or post-consent assessment will be used
Other
Specify the "teach back" questions or open-ended questions that the subject will be asked to describe in their 
own words in order to assess their understanding.
Open-ended Questions:
Can you please describe the study in your own words?
What would you have to do if you decide to participate in the study?
Is there anything that you can or can not do while participating in this study?
How long will your participation in the study be?
Multiple Choice Questions:
What will you do as part of the study?
Wear an investigational device as part of my therapy
Receive no therapy at all
Only complete surveys
None of the above
I am able to withdraw from the study at any point in time.
True
False
I will be asked to attend my appointments more frequently as a result of my participation in this study.
True
False

1.  
2.  
3.  
4.  
5.  
6.  
7.  
1.  
2.  
3.  
4.  
5.  
6.  
7.  
12.8  Utilizing 
 has additional requirements. Please describe the following:
eConsent
The method to verify the identity of the individual providing consent;
How participants will sign the eConsent (ex: type their name, use stylus or finger to sign);
If potential participants will sign the consent while having a virtual conversation or if they will have additional time 
to consider their participation;
If use of LAR is being requested, how you will ensure this individual is an appropropriate LAR per Virginia 
requirements and verify their identity.
The occupational therapist (OT) listed at the beginning of this application will identify 
potential participants (based on established inclusion and exclusion criteria) from their 
patient pool. All consenting procedures will be completed by the Carilion Affiliated or 
VTCSOM IRB approved team members.
The occupational therapist will verbally bring up this research study during a patient's 
regularly scheduled treatment visit, which is typically about an hour long. Lymphedema is 
treated with a combination of massage and compression, giving the OT leeway to talk to a 
patient while they are delivering hands-on treatment. They will give a brief explanation of 
what will happen to the patient and how it will/will not impact their care. Only the 
occupational therapist will initially approach potential subjects.
If a patient expresses interest in participating in the study, the OT will give them an 
unsigned copy of the consent document to take home and read over. The OT will confirm 
their contact information and the best time to reach out to them. Then, the OT will reach 
out to a designated IRB approved research team member.
This encounter will be documented as a research note in Epic by a designated IRB 
approved research team member.
Two to three days after the initial contact has been made, a designated IRB approved 
research team member will attempt to contact the patient via phone call, limiting the 
number of attempts to three. There will be no voicemail left. If the designated IRB 
approved research team member cannot reach the patient during this time, they will not 
be included in the research study.
If the designated IRB approved research team member is able to successfully make 
contact with the patient, they will first confirm the patient’s identity by asking them to 
state their name and date of birth. This will create a passcode based on known information 
(first two letters of legal first name followed by first two letters of legal last name followed 
by last 2 digits of birth year). Each section of the consent form will be reviewed in detail 
before consent is obtained. The designated IRB approved research team member will ask 
the patient if they have any questions about the study.
After the patient has expressed interest in the study and agreed to participate, they will be 
allowed to choose whether they would like to undergo consent in person, at their next 
regularly scheduled office visit or remotely, via eConsent.
eCONSENT
The eConsent process will take place over the phone. The patient will be asked whether 
they would prefer to get the link to the eConsent form emailed or texted to them.
Once communication modalities have been confirmed, the designated IRB approved 
research team member will have to state the following: “Carilion Clinic cannot control the 
security of email or text messages once we send them, therefore we need your permission 
to text or email you the link to the eConsent form for the study we discussed. Please be 
aware that while the email title will not include your lymphedema, the body of the email 
will contain the link to the study. Someone else accessing your email/text messages could 
click on the link and read the consent, and therefore learn about your lymphedema, which 
you may consider to be of a private or sensitive nature. Do you still wish to receive the 
link to the eConsent via email/text?”
The patient will receive the link via their preferred modality and review it.
An IRB Research team member will review the each section of the consent in detail with 
the participant. The patient will be asked if they have any further questions about the 
research study.
 
A number of teach-back and open-ended questions will be used to assess patient 
understanding regarding the research study and what is/is not expected of them
The subject will type their name and date and use their finger, cursor, or stylus (if it is 
available to them) to sign in the signature field.
The participant will receive a copy of their signed consent form via email or in person at 
their next regularly scheduled visit.

8.  
9.  
10.  
If the patient elects to receive a copy of their consent form via email, the designated IRB 
approved research team member will verbally state, “Carilion Clinic cannot control the 
security of email messages once we send them, therefore we need your permission to 
email you the copy of your signed consent. Please be aware that while the email title will 
not include your lymphedema the attachment to the email will contain study consent. 
Someone else accessing your email messages could click on the attachment and read the 
consent, and therefore learn about your lymphedema, which you may consider to be of a 
private or sensitive nature. By providing your email address, you are authorizing Carilion 
Clinic to email you a copy of your signed form." If a signed copy of the consent will be 
emailed to the subject using REDCap, the subjects must provide their e-mail address on 
the completion page, and the following statement will be included in the field where the 
email address is "Enter your email to receive confirmation message? A confirmation email 
is supposed to be sent to all respondents that have completed the survey, but because 
your email address is not on file, the confirmation email cannot be sent automatically. If 
you wish to receive it, enter your email address below." 
A summary of the conversation, any pertinent questions that were addressed during the 
call, and the signed consent form will be recorded in a research note in Epic. Specifically, 
the following points will be recorded in the research note:
The method that was used to discuss the study with the potential subject 
(discussion happened over the phone)
The questions that the potential subject asked
The time the potential subject was given to make their decision
How long the conversation lasted
The process of verifying the individual’s identity over the phone and then with the 
eConsent signature, as described above
Research tasks will only be completed after the informed consent document is signed.
12.9  If the enrollment of subjects who cannot read the consent form, due to visual impairment, literacy, or other issues, is 
anticipated, how will consent be obtained and documented? 
Refer to 45 CFR 46.117(b)(2) or 21 CFR 50.27(b)(2) for information regarding when the use of a short form 
is appropriate. A witness to the consent process is needed.
N/A
Short form
Other mechanism
Consent form read to participant with witness present
12.10  How will you ensure research participants remain informed about the study and continue to agree to participate in the 
research study after their initial informed consent has been obtained?
N/A
If new information arises that may affect the participants willingness to participate, this 
information will be presented to the participant so that they may decide if they would like to 
continue. This information would be passed down from the Data Safety Monitoring Committee. 
13.0  
 Privacy and Confidentiality
13.1  Does the research include interaction with or observation of subjects?
 Yes  
 No
13.3  Select the data points that will be reviewed, collected, recorded, or created for research purposes, including screening or 
recruitment.
Check all that apply:
name

all geographic subdivisions smaller than a State, including street address, city, county, 
precinct, zip code, and their equivalent geocodes, except for the initial three digits of a zip 
code if, according to the current publicly available data from the Bureau of the Census:
an element of a date, except year, for dates related to an individual, including birth date, 
admission date, discharge date and date of death; and all ages over 89 and all elements of 
such ages may be aggregated into a category of age 90 or older
telephone numbers
fax numbers
electronic mail address
social security number
medical record number/ master patient index (MPI)
health plan beneficiary numbers
account numbers
hospital account receivable (HAR)/contact serial number (CSN)
certificate/license numbers
vehicle identifiers, including license plate number
device identifiers and serial numbers
Web Universal Resource Locators (URLs)
Internet Protocol (IP) address numbers
biometric identifiers, including finger and voice prints
full face photographic images and any comparable image
any other unique identifying number, characteristic, code
None of the above
13.4  Will any of the above data points be reviewed, collected, recorded, or created from the medical record (or other healthcare 
records)?
 Yes  
 No
Since you plan to access or use PHI from the Medical Record, you must contact the 
 at 
HART Team
Carilion Clinic immediately to ensure the data you will need is accessible and to discuss data management 
and storage.  Do not proceed with the submission of this application until you have done so.
13.5  Is the private information being requested the minimum necessary to meet the research goals?
 Yes  
 No
13.6  Under the 
, when accessing or using PHI, a HIPAA Authorization of the subject must be obtained, or the 
HIPAA Privacy Rule
IRB must grant a waiver.
Indicate which of the following apply (more than one may be selected):
The HIPAA Authorization is embedded in the research consent document.
A partial waiver of the requirement for HIPAA Authorization is requested (e.g., for screening 
or for some subjects, such as a retrospective cohort)
A full waiver of the requirement for HIPAA Authorization is requested
The HIPAA Authorization will be sought but one or more required elements will be eliminated 
or altered
The PHI accessed or used for this research is a Limited Data Set (LDS) and a Data Use 
Agreement (DUA) is or will be in place prior to accessing or obtaining the LDS.
HIPAA Authorization will be obtained as a separate document (only permitted if required by 
sponsor)
Other
13.7  Will educational records protected under the 
(FERPA) be accessed or used for the 
Family Educational Rights and Privacy Act 
research?

  Yes  
  No
13.8  Does the research involve the administration or use of surveys, interviews, or other evaluations or examinations protected 
under the 
(PPRA)?
Protection of Pupil Rights Amendment 
  Yes  
  No
13.9  Will the research records (other than the consent form) and/or specimens contain data that is identifiable, coded, or de-
identified?
Identifiable (includes direct identifiers or information such that subject identities could be 
ascertained)
Coded or linked (identifying information that would enable the investigator or collaborator to 
readily ascertain the identity of the individual to whom the private information or specimens 
pertain has been replaced with a number, letter, symbol, etc., and a key to decipher the code 
exists, enabling linkage of the identifying information to the private information or specimens)
De-identified or unlinked (specimens/data cannot be linked to specific individuals by anyone, 
including the Carilion investigator, either directly or indirectly through coding systems)
13.10  Where will research data be stored during the period the research is active? Describe the security controls in place, 
including physical safeguards for paper records and technical safeguards for electronic records 
Storage options other than those listed below are NOT currently permitted, including the use of Carilion 
provided or personal laptops, flash drives or other portable devices, non-Carilion cloud or other hosted 
environment. Any exceptions to the list above must be approved by the Carilion Privacy and Information 
Security Officer and documentation provided to the IRB.
 
 
Hardcopy data in a locked office in a locked cabinet
Electronic data on a password protected, secure drive on a Carilion server (contact 
mmtenzer@carilionclinic.org to set up a shared drive)
REDCap (contact mmtenzer@carilionclinic.org to discuss use of REDCap)
Sponsor’s electronic data capture system
SPARC Carilion Secure Research Environment (contact mmtenzer@carilionclinic.org to discuss)
13.11  Provide any additional information pertaining to the storage and management of the 
research data. 
Best research pratice is to have data management plan which will help you manage 
and protect your data, meet funder requirements, and help others use and protect 
your data, if shared. A well structured project can help protect the confidentiality of 
patient and participant data. Carefully planned data management also allows for a 
better use of your time and resources. For guidance on data management pratices, 
please review the 
 and upload your data management plan 
Harvard Catalyst document
into the Supplemental documents.
Carilion Clinic's REDCap software will be used as the central location for data collection. REDCap (research 
electronic data capture) provides a secure, web-based application designed to support data management and 
collection for research/QA/QI studies. Carilion's REDCap servers are securely housed on site in a limited access 
data center, and all data are stored on Carilion's firewall protected network. The Health Analytics Research Team 
supports the proper development of projects and surveys in REDCap, observing appropriate change control and 
enforcing appropriate security controls. Data collection projects are built with a study-specific data dictionary, 
enforcing intuitive, accurate, consistent and complete data entry. REDCap also provides a survey tool for 
building and managing online surveys. Health Analytics Research team restricts user access to the IRB-approved 
project research team utilizing the approved processes and standards of TSG. REDCap is HIPAA compliant and 
provides audit trails. Data can be easily exported in several formats to a secure network directory for combination 
with extracted data, if appropriate, and analysis with common statistical packages.
Carilion Clinic's SPARC secure research environment will be used to store and analyze the datasets for analysis. 
SPARC (Storage and Programs Accelerating Research Collaborations)is Carilion’s web-based, secure research 

environment, that provides accessible storage of research project files in addition to advanced analytics programs 
to apply to those files for analysis. Current product offerings are SAS Viya and Statistics, R and R-studio, 
Python, and NVIVO, in addition to Microsoft Excel, Powerpoint and Word.AWS offerings may be possible to 
implement, depending on the needs of the project.Once access is authorized through an IRB approved protocol 
and a signed end user agreement, the clients utilize their institution’s credentials to sign in.Data are prevented 
from download from the environment, without appropriate permissions and managed by the Health Analytics 
Research Team (HART). Folders are set up specifically for each approved project, with access limited to the 
research team, as specified on the protocol. This mitigates most of the risk of privacy breach.
13.12  How long will research records, data, and specimens be retained following completion of the 
study?  Where will study records will be retained when the study has been closed (long-term 
storage)?
Describe when and how the identifiers, if applicable, will be destroyed. If specimens will be retained, describe 
where.  
Please note that any data involving PHI must be maintained for a minimum of 6 years, and data that does 
not contain PHI must be maintained for a minimum of 3 years. In many cases, identifiers will need to be 
retained after the research is completed (e.g., for publication or data verification purposes or because of 
contractual requirements or grant terms). 
Please click the Help bubble to the right for more information on minimum storage requirements.
Research data will be maintained on REDCap for at least 6 years after the conclusion of the study 
per Carilion Clinic SOP.
13.14  Please state the specific identifiers that will be recorded/documented within the research records, including on specimens, 
and why they are needed.
Patient name, DOB, telephone number, and electronic mail address will be recorded/documented within the 
research records. Patient name and DOB is necessary to link longitudinal data points with the correct individual. 
Telephone number and electronic email address is necessary for the consent process.
13.15  Who will have access to identifiers?
Research team members who have been approved by the IRB will have access to identifiers.
13.16  How will access to the identifiers be protected?
All data will either be stored on Carilion Clinc’s REDCap, SPARC research environment, or within a secured and 
encrypted shared drive provided by Carilion Clinic. Shared drive may only be accessed through apps.
carilionclinic.org. Outside collaborators cannot access the shared drive.
13.17  Describe whether data will be aggregated/summarized in publications or presentation, or whether individual participant 
results will be published/presented.
Data will be aggregated and summarized in publications and presentations. No identifiers will be listed.
13.18  Will research records include information that subjects or others might consider to be sensitive in nature?
E.g.,communicable disease status, substance abuse, mental health information, illegal behaviors, etc.
  Yes  
  No
14.0  
Request for Partial Waiver, Full Waiver, or Alteration of HIPAA Authorization
14.6  Describe how you will utilize PHI for purposes of recruitment and describe how the use of PHI in this study poses no greater 
than minimal risk to participants’ privacy.

A partial waiver of authorization will be requested to access PHI for the purpose of pre-screening patients and 
assessing eligibility criteria. Pre-screening by chart review poses no greater than minimal risk to participants' 
privacy because all chart review activities are conducted through EPIC, a secure, password-protected 
environment. Access to PHI will be limited to research team members involved in patient pre-screening, as 
indicated in sections 3 and 4, in order to further protect patient privacy. Additionally, data collected will be 
protected using REDCap. 
14.7  Describe why the research could not practicably be carried out without the use of PHI for recruitment.
In this study, access to PHI is necessary for determining study eligibility. Designated study team members will 
need access to clinic schedules and patient charts in order to verify if participant meets eligibility criteria and is a 
candidate for a study introduction conversation. 
14.8  Describe why the research could not be practicably carried out without the partial waiver for recruitment.
Pre-screening by chart review would not be possible without a partial waiver of HIPAA authorization. This study 
has several important inclusion/exclusion criteria that must be met prior to enrollment. The study team members 
 Additionally, it is not feasible to 
do not want to potentially introduce this project to patients who are ineligible.
obtain consent/HIPAA Authorization from every patient in order to verify eligibility.
14.9  Do you assure that any data identifying subjects used in this study will not be disclosed to anyone other than the research 
team, sponsor, and oversight groups?
 Yes  
 No
14.10  Do you assure that you will not re use or disclose this data for any other research unless you receive IRB approval?
 Yes  
 No
15.0  
Sharing of Research Data/Specimens
15.1  Describe the data or specimens to be transferred, transmitted, or shared and the purpose of sharing.
All data obtained as a result of this study (see attached data collection tool) will be stored in the 
secure, Carilion Clinic research environment, which includes REDCap, Shared Drives, and SPARC. 
Data will only be shared with research team members without a conflict of interest, and they will 
have password-protected access to the aforementioned secure tools. Only research team 
members who been approved by the IRB will have access. This access will be established and 
maintained by the Carilion Clinic HART team. Furthermore, these collaborators will have access to 
patient identifiers only as necessary to interact with patients, conduct study tasks, and 
communicate with the rest of the research team. 
15.2  Describe procedures for verifying that proposed use is consistent with the informed consent under which materials were 
collected.
Any data collected as part of this research study will only be shared, transferred, or transmitted to the 
collaborators of this IRB application who have completed necessary CITI trainings as verified by the VT and 
Carilion IRB. Only research team members who have been approved by the IRB to have access will have 
access to this data. No identifiable data will be transferred or transmitted outside of Carilion REDCap or Sparc.
15.3  Categorize the identifiability of the data/specimens that will be shared.
Identifiable (data/specimens includes direct identifiers such as name, identifying elements of 
PHI, or that the type or nature of the information is such that the identify of individual 
subjects may readily be ascertained) 
Linked/coded (a link exists from the specimen to the identifiable information) 

De-Identified (The specimens/data CANNOT be linked back to the identifiable information or 
medical record by anyone) 
15.4  Describe the information to be shared in detail, including which of the 18 HIPAA identifiers or other sensitive information 
will be shared, and justify the need to share identifiable data. 
Describe who will maintain the link, if applicable.
As part of this research project, we will collect patient name, date of birth, email address, and telephone number. 
All consenting procedures will be completed by the Carilion Affiliated or VTCSOM IRB approved team members. 
This information is necessary to share with outside collaborators from VTCSOM and VT in order to properly pre-
screen patients and obtain informed consent. This sharing will be limited to members of the research team who 
have been approved by the IRB to have access. This information will be stored on the secure, password-
protected Carilion Clinic research environment as set up and maintained by the Carilion Clinic HART team. 
Additionally, measurements and survey data as detailed in section 18.3 will be collected during the study. This is 
detailed on the data collection tool provided in the supplemental documents, which will be used as the REDCap 
template. 
15.5  Who will data or specimens be sent to or shared with, including their name, title, and role on research?
This sharing will be limited to certain members of the study team who have been approved by the IRB to have 
access. These team members have completed the necessary CITI training as dictated by Carilion Clinic, which 
has been verified by the VT IRB.
15.6  Describe how the data or specimens will be transferred, transmitted, or shared and how it will be protected in the new 
location.
Once data is obtained, it will not be transferred to locations outside of Carilion Clinic. All data obtained as a 
result of this study (see attached data collection tool) will be stored in the secure, Carilion Clinic research 
environment, which includes REDCap, Shared Drives, and SPARC. Data will only be shared with the VTCSOM 
and VT collaborators listed on this IRB protocol, and they will have password-protected access to the 
aforementioned secure tools. This access will be established and maintained by the Carilion Clinic HART team. 
Furthermore, these collaborators will have access to patient identifiers only as necessary to interact with patients, 
conduct study tasks, and communicate with the rest of the research team. 
15.7  Who will be responsible for supervision of non- Carilion Clinic personnel to ensure the appropriate storage and security of 
the data/specimens, and that future proposed research has undergone IRB review?
The Carilion Clinic PI listed on this IRB application will be responsible for the supervision of non-Carilion 
Clinic personnel to ensure appropriate PHI storage and security. All data that is generated as part of this study 
will remain protected within Carilion Clinic. Currently, there is no plan to use this data for outside research 
purposes. If this data were to be transferred outside of Carilion Clinic for the purpose of further research, it will 
be the PI's responsibility to collaborate with external investigators to ensure that the proposed research has 
undergone IRB review. 
15.8  Who will own the specimens/data once they are shared? 
Please submit any signed agreements in the Initial Submission Packet.
Carilion Clinic will own all data created over the course of this research project. 
15.9  If the specimens being shared will be retained in a repository for possible future research, provide the protocol for the 
repository and the external investigator’s IRB approval letter for the repository in the Initial Submission Packet.
N/A
16.0  
Research Settings/Performance Sites
16.1  Indicate the sites where research activities will occur, or from which subject data or specimens will be obtained, and a brief 

summary of the activities that will occur at each.
N/A (Select this option if this research is a Medical/Chart Review ONLY)
Site
Summary
CRMH
CRCH
CNRVMC
CFMH
JCHS
CRMH Rehab
Riverside
Crystal Spring Medical Office 
Building
Other Carilion Clinic 
Physician’s Office
Blue Ridge Cancer Care 
(BRCC) / US Oncology
Fralin Biomedical Research 
Institute at VTC
VT Blacksburg Campus
Assisted Living Facility 
or Nursing home
Other Locations (specify):
Carilion Clinic Outpatient 
Therapy
213 Gilbert Street, 
Blacksburg VA 24060
2900 Lamb Circle, 
Entrance 8, 
Christiansburg VA 24073
17.0  
Applicable Regulations for ClinicalTrials.gov Registration

17.1  Is this study FDA-regulated?
 Yes  
 No
17.2  Is this research funded wholly or in part by NIH?
  Yes  
  No
17.3  Is this study a Clinical Trial, as defined by FDA or NIH, and therefore needing registration on ClinicalTrials.gov? Click the 
help button to the right to learn more about the definition of a clinical trial.
 Yes  
 No
17.5  Is the clinical trial already registered in ClinicalTrials.gov?
Not yet, but clinical trial will be registered prior to enrolling any subjects 
Yes 
No, this clinical trial will not be registered 
ClinicalTrials.gov #:
TBD
The following statement must be included verbatim in the consent form for  trials that are/will be 
Note: 
registered on ClinicalTrials.gov:
 
"A description of this clinical trial will be available on 
, as required by U.S. 
http://www.ClinicalTrials.gov
Law. This website will not include information that can identify you. At most, the website will include a 
summary of the results. You can search this website at any time."
 
17.6  Who is responsible for registering this trial in ClinicalTrials.gov and ensuring information is updated, as necessary? Please 
provide a name if the person is at Carilion or listed on the research team, or state the sponsor or lead site if the sponsor or 
lead site will register the trial.
 The responsible party for an applicable clinical trial (ACT) must register the trial and 
submit results information. The responsible party is defined as:
The sponsor of the clinical trial, as defined in 21 CFR 50.3; or
The principal investigator (PI) of such clinical trial if so designated by a sponsor, 
grantee, contractor, or awardee, so long as the PI is responsible for conducting the 
trial, has access to and control over the data from the clinical trial, has the right to 
publish the results of the trial, and has the ability to meet all of the requirements for 
the submission of clinical trial information
The responsible party for an ACT must submit the required clinical trial information no later 
 after enrollment of the 
 participant, but registration is highly recommended 
than 21 days
first
before enrollment begins due to some journal requirements.
Dr. Andy Muelenaer
18.0  
Study Procedures
18.1  Provide a step-by-step description of the research procedures and/or and interactions with human subjects. 
Provide a study schedule and list all activities or procedures that will be performed and 
describe the frequency and duration of research procedures, diagnostic and research 

1.  
2.  
3.  
4.  
5.  
6.  
tests, questionnaires or surveys, specimen collection, and experiments, including 
screening, intervention, follow-up etc in step-by-step chronological order. State the 
length of time subjects will be in the study and the expected amount of time required for 
each study visit or activity.  Describe how, when and where research activities will be 
administered and analyzed.   If the research includes blinding, indicate 
whether researchers or subjects will be “unblinded” to study assignment and describe 
when and how this will be done.
For each study visit, participants will be asked to arrive 45 minutes before the beginning 
of their regularly scheduled follow-up visit. Research activities will take 45 minutes. 
Upon early arrival to their regularly scheduled appointment, participants will be fitted for 
their very own, “athletic sleeve” by a member of the research team. This athletic sleeve 
will be used throughout the duration of the study. Patients will be asked to come wearing 
a tank top or short-sleeved t-shirt. If they do not come dressed as such, they will have the 
opportunity to change in a private space.
Before donning the athletic sleeve, a member of the research team will measure the 
patient’s upper limb circumference and induration and administer a baseline survey using 
the first section of the Lymphedema Life Impact Scale (LLIS - document attached). Upper 
extremity circumference will be measured in centimeters at several points, which are: 
palmar crease, the wrist below the styloid process, wrist + 10 cm, wrist + 20 cm, wrist + 
30 cm, and wrist + 40 cm. Upper extremity induration will be measured at the same 
points as circumference. These measurements are being taken solely for research 
purposes and should take approximately 3 minutes.
The athletic sleeve will be donned by the patient and the novel therapeutic device will be 
placed over it. A standardized sequence of vibratory therapy will be applied. The 
standardized sequence of vibratory therapy is as follows 
This code goes through a series of 5 total phases for a 36 minute total treatment. 
The details of
each phase, and the total time spent in that phase are detailed below.
Proximal Prep Phase (Total Time: 7 minutes) All proximal motors, 5-8, are 
on for the entire phase.
Distal Prep Phase (Total Time: 7 minutes) All distal motors, 1-4, are on for 
the entire phase.
Decongestion Phase (Total Time: 4 minutes) Moving proximal to distal, 
motor 8 to 1, the motors are turned on for 30 seconds then turned off 
before moving to the next motor pair.
Clearing Phase (Total Time: 4 minutes) Moving distal to proximal, motor 1 
to 8, the motors are turned on for 30 seconds then
turned off before moving to the next motor pair.
Reabsorption Phase (Total Time: 14 minutes) Moving distal to proximal, 
motors are turned on at different intensities mimicking a wave pattern.
The pattern moves up the arm for 16 cycles. Use of this device will not impact 
standard of care in any way. The participant may ask to stop the research session 
at any time
The participant may ask to stop the research session at any timeThe athletic sleeve will 
then be removed, and a member of the research team will measure the patient’s upper 
limb circumference and induration and administer a survey using the first section of the 
Lymphedema Life Impact Scale. These measurements are being taken solely for research 
purposes and should take approximately 3 minutes. Patients will be asked if they 
experienced any side effects or adverse effects.
Standardized decongestive therapy will be performed by qualified personnel. This step 
takes approximately 1 hour and would happen regardless or whether or not patients are 
enrolled in this study. The exact sequence and modality of therapy varies significantly 
from patient to patient, but a "typical" treatment session is as follows.

7.  
Treatment today included:
Manual Therapy provided for 30 minutes:
Large Vibration tool (https://www.rehab-store.com/p-magic-wand-
) was applied at moderate pressure/compression on low 
massager.html
setting x 3 minutes on each quadrant of the upper extremity covering 
anterior and posterior side of proximal arm and forearm to decrease pain, 
inflammation, and protein rich edema.
Large Vibration tool was then used to assist in lymphatic flow by using 
sweeping motion from distal to proximal on the upper extremity.
Small vibration tool (https://www.rehab-store.com/p-rolyan-mini-
) was applied to posterior side of the upper extremity in 
massager.html
horizontal position and secured with a Coban wrap (https://fsastore.com
/nexcare-no-hurt-self-adherent-wrap-3-in-x-80-in-tan/23594.html?
gad_source=1&gclid=Cj0KCQiAnrOtBhDIARIsAFsSe51So6bK8D3doG
ZZBzIxJLCcWTedkUUnBubn2Jr6nw7FyfTDwd9nGKcaAnMpEALw_wcB
) at minimum pressure x 6 min to decrease protein rich edema and 
lymphatic stagnation in distal forearm.
After removal of Coban and small vibration tool, patient’s forearm induration 
changed from moderate to mild.
Patient tolerated massage techniques of effleurage, petrissage, and cross 
friction to help alleviate pain, discomfort, muscle adhesions, and immobility 
to upper extremity and shoulder girdle area.
Myofascial release completed to pec, bicep, and deltoid to decrease fascial 
adhesions, decrease chronic inflammation, decrease pain, and increase 
range of motion.
Manual lymphatic drainage performed to abdomen, trunk, and upper 
extremity to increase lymphatic flow and decrease stagnation in tissues.
Manual Lymph Drainage performed to stimulate lymph nodes and lymphatic 
vessels to increase their activity and promote lymph flow using techniques 
of 3 seconds on/3 seconds off skin stretch and feathering toward inguinal 
lymph node group.
Patient tolerated active moving cupping techniques this date to lateral trunk 
to decrease fibrosis and edema.
NDT treatment techniques provided during manual treatment of placement 
and hold, loading and joint compression provided for postural alignment to 
increase upright posture to decrease pain while engaging in ADLs and IADLs.
Therapeutic Activity provided for 30 minutes:
Therapist applied US to insertion of pec major to decrease adhesions and 
edema. US was applied at non thermal setting at 3 megahertz, 20% duty 
cycle and 1.5 output while patient was placed in active stretch x 7 minutes.
Patient instructed on stretching exercises of shoulder flexion and abduction.
Patient completed stretches with minimal assistance to maximize range of 
motion.
Patient instructed on each type of massage and pressure and sequence for 
each. 
Patient educated on at home whole body exercises including light intensity 
cardio to increase strength and endurance.
Patient instructed on pain relief techniques of using massage and vibration 
tools to decrease pain. Patient's caregiver instructed on all types of massage 
and sequence and pressure for each to decrease pain.
At the conclusion of the standardized decongestive therapy, the measurements and 
surveys conducted in step 3 will be repeated. Patients will also be asked if they 
experienced any side effects with the standard of care treatment.

8.  
9.  
10.  
This series of steps will be repeated at the patients’ weekly follow-up visits for four weeks. 
Standardized decongestive therapy for lymphedema is most often performed on a weekly 
basis (and is one of the inclusion criteria for this study). Therefore, choosing this visit 
frequency would not greatly alter a patient's schedule or ability to perform other daily 
tasks. At the end of the four weeks, the patients will receive a $20 Kroger gift card as 
compensation for their participation.
If a patient chooses to withdraw from the study early or needs to be removed from the 
study for their own safety, notes will be added to research documentation and the patient’
s Epic chart indicating their departure from the study. Going forward, they would receive 
standard decongestive therapy as before their participation in the study. They will receive 
a prorated compensation fee for their participation. 
Study subject limb circumference, induration data, and survey data will be analyzed using 
a paired t-test.
You must attach surveys, instruments, interview questions, focus group questions, etc. in the Initial 
Submission Packet and label them clearly. 
18.2  Specify which procedures, tests, visits, etc. described above are part of 
 at Carilion Clinic and which 
usual standard of care
are being performed solely for research purposes. If procedures, tests, visits are routinely performed for clinical care, but 
are providing data for this research study, state this as well.
Measurements of upper extremity circumference and induration along with assessment of pain level and presence
/absence of side effects/adverse effects will be collected solely for research purposes. Use of the novel 
therapeutic device will also be done solely for research purposes. Standardized decongestive therapy is performed 
as part of the usual standard of care for lymphedema at Carilion Clinic. Patients would receive this if they were 
not part of this study. While decongestive therapy is routinely performed as part of clinical care, it is also 
producing data for this study, as we will be measuring upper extremity circumference and induration along with 
assessing the participant's pain level and experience of side effects after administration of this therapy. 
18.3  Describe the data collection methods and how data be compiled and collected for assessment. State 
whether the data/specimens to be utilized in the repository are already in existence (retrospective) or 
if the data will be generated in the future (prospective).
 is 
"Retrospective data"
data that is already in existence at the time of application receipt by the 
 Retrospective is in reference to the date the data was 
, 
IRB.
GENERATED not the date the data is 
If all data is retrospective, please provide the start date from which data will be 
COLLECTED. 
collected and the end date, and note that ALL data must be in existence at time of submission of 
this application.
Example: This IRB application is being submitted on 12/1/21 and is collecting data on a 
standard of care surgery and looking at patient outcomes. All surgeries for this 
retrospective studies will be completed between 11/31/2018 and 11/31/2021 (the day 
before the study is submitted to the IRB). This study will likely qualify for a waiver of 
consent.
 includes any data (including data from the medical record) that are 
"Prospective data"
not 
 
, even if the data is 
currently in existence at the time of receipt of the application by the IRB
being collected solely for Standard of Care. Prospective data collection typically requires 
 from the participant to be able to use their clinical data or specimens for 
informed consent
research purposes. If all data is prospective, please state date range from which data will be 
generated.
Example: This IRB application is being submitted on 12/1/21 and the study is collecting 
data on a standard of care surgery and looking at patient outcomes. All surgeries for this 
prospective studies will be completed between 1/1/2022 and 1/1/2025. This study will 
require informed consent UNLESS a waiver of consent is requested and justified.
Attach a copy of your data collection tool or spreadsheet listing exactly what data is to 
be gathered during this research study.
This research project will collect prospective data. The research team will collect the following specific 
measurements:
Upper extremity circumference (measured in centimeters)
Upper extremity induration

Lymphedema Life Impact Scale (LLIS - first section only)
Any side effects or adverse effects experienced
All measurements will be taken by designated study team members. 
Upper extremity circumference will be measured in centimeters at several points, which are: palmar crease, the 
wrist below the styloid process, wrist + 10 cm, wrist + 20 cm, wrist + 30 cm, and wrist + 40 cm. Upper extremity 
induration will be measured at the same points as circumference.
Induration will be measured using a durometer (
placed on 
Rex Gauge Co. Model 1600 Dial Durometer Type OO) 
the aforementioned points on the ventral surface of the proximal forearm.
Lymphedema-related physical complaints will be measured using the first section of the Lymphedema Life 
Impact Scale, a validated survey already widely used in the clinical care of lymphedema. 
Side effects and adverse effects are thoroughly detailed in section 23.1. Side effects include, but are not limited 
to, a skin tingling sensation, pain/soreness/swelling, dizziness, headache, nausea, and shortness of breath. 
These side effects will be recorded in the Data Collection Tool template inside the secure Carilion Clinic research 
environment.
18.4  Describe how long individual participants will be actively in the study. If there will be a period of time after the active 
component of the study where participants will still be in the study (ex: participants outcomes are being extracted from the 
medical record at 1 year, but the last research study visit was at 3 months), state this as well.
Patients will be actively participating in the study once a week, for four weeks. 
18.5  Describe how long the entire study is expected to last, including data analysis.
Patient recruitment for this study would take anywhere from 6 to 8 months. Each study participant will have 4 
weeks of treatment, but each participant may not start at the exact same time, so study activities will take 
anywhere from 2 to 3 months. We will spend one month compiling and analyzing data. Altogether, this research 
project will take anywhere from 9 to 12 months.
18.6  Describe the qualifications of study personnel conducting the research procedures. This could include medical training 
specific to conducting the interventional procedures in this research, phlebotomy training for those drawing blood, study 
protocol specific training to be provided by the sponsor, or any other training to demonstrate that the research personnel 
 
are appropriately quailified to conduct the study.  
The specific interventional procedures involved in this research study include donning and doffing of the 
proprietary device, implementation of the proprietary device, measurement of limb circumference, and 
induration, and administration of the LLIS. The PI will ensure that all study team members have completed CITI 
training and are well-versed in the above procedures. 
Research team members will be trained on the use of the device by one of the inventors. Training will include 
the following benchmarks
Putting the device on a study subject's arm and adjusting it so that it fits snugly
Connecting the device to the external power bank and turning it on. Turning the device on is simple, and 
involves flicking a switch 
Carefully removing the device from a study subject's arm
Safely storing the device in its designated space
Research team members without a demonstrated conflict of interest are able to obtain 
measurements that result in the creation of data. Dr. Muelenaer, Tara Newberry (listed on this 
application), and Leah Thomas (VT collaborator) will train the entire research team on how to interact with 
patients and conduct study procedures that result in research data as well as document and report adverse 
events. This training will be logged and signed by one of the aforementioned trainers. 
18.7  Please describe appropriate alternatives to the study procedures or course of treatment.
(For example: not to participate, standard of care treatment, other research study, same treatment offered off 
study)

At any point in time, patients may choose to opt out or not participate in the study. This will be made abundantly 
clear before any data is collected. If patients choose not to participate, they will only receive the standard of care 
for lymphedema, which is decongestive lymphatic drainage massage, and they will not receive treatment with the 
experimental device
19.0  
Research Involving Device(s)
19.1  Device Name:
View Details
Device Name
Is the Device FDA Approved
LymphaVibe 
No 
Manufacturer/Supplier of 
Device
VT BEAM 
Will Devices be supplied at no 
Cost
Yes 
Is the Device FDA Approved
No 
Is an IDE necessary
No  
19.2  Describe any credentialing procedures and training in the use of the device that will occur prior to use.
Since the device (LymphaVibe) to be used in this research study is novel and proprietary, there is no official 
credentialing procedure. 
Dr. Muelenaer, Dr. Arena, Leah and Seth all played an important part in the development of this device from the 
ground up and know its operation inside and out. These individuals will formally train everyone else listed on this 
IRB in proper donning and doffing, operation, storage, maintenance, and troubleshooting of this device. Those 
that are trained on the use of this device will be maintained on a log in the Research Binder.
The below research team members may be trained on the device. This largely depends on individual research 
member schedules and how well individuals are able to cover research visits (i.e. less research team members 
may be trained if the need is not as great)
Dr. Ralph Brown (PI)
Annette Fielder (OT)
Evgeniya Molotkova (medical student)
Cara Spivey (research coordinator)
Selah Wangler (undergraduate student)
Jennifer Rechani (undergraduate student)
19.3  Who will assume primary responsibility for the storage of the device used in this study?
Name:
Seth Jarvis and Leah Thomas
19.4  Describe storage and control of the device, including precautions being taken to minimize the chances of device use by health 
care providers not listed on this application.
(Ex: special ordering requirements, labeling, separate stocking, etc.).
The device will be stored securely, outside of the Carilion Clinic facility where research activities will be taking 
place as to avoid confusion between it and any other routinely utilized equipment. It will be brought in as needed 
for each patient and returned to its storage area afterwards. While in the clinic for study procedures, the device 
will be stored in a clear plastic tub that is labeled with the PI name, IRB number, and research study title. In 
addition to this information, the verbiage "Do NOT use as part of routine care. This device is for research 
activities ONLY" will be clearly written on the container. Providers at the aforementioned facility are aware of 
this research taking place and know that this device is investigational and currently for research use only. 

Attach the PMA or cleared (510k) by FDA if used in accordance with labeling, or for investigational devices, 
attach sponsor/FDA risk assessment documentation if available in the Initial Submission Packet. Attach 
sponsor device manual of operations if available.
20.0  
Research Review of Data/Records
20.1  What types of records will be reviewed for this research study?
Medical record/medical chart
Films/x-rays
Data in a database
Hospital administrative/billing records
Quality improvement records
Publically available database
Other
Provide a detailed description about your selection above, including if the records are already in existence 
at the time of this submission or if you will be accessing future records, and special permissions that may 
be needed to access the data/records:  
Carilion Affiliated or VTCSOM Research Team members who have been approved by the IRB to 
access identifiable information will be reviewing medical records to confirm patient eligibility for this research 
study. The records that will be used in this study are already in existence at the time of this submission. 
20.2  What is the original purpose of the data being reviewed?
Clinical Care
Collected as part of routine business activities
Research Study
Collected under Repository Protocol
Other
20.3  If collected as part of a previous research study or repository protocol, enter the IRB number for the study.
N/A
20.4  Is the data identifiable private information or Protected Health Information (PHI)?
 Yes  
 No
21.0  
Incidental Findings
21.1  Does this study involve any imaging procedures (x-rays, CT, MRI, PET, ultrasound, etc.) specifically for research purposes?
  Yes  
  No
21.2  Does the research include any of the following?
Exams, blood tests, genetic tests or markers, or other tests or procedures that may generate 
incidental or secondary findings, including disease or conditions other than the one under 
study, or familial relationships including paternity and ancestry.
Testing for communicable diseases
None

22.0  
Identification/Recruitment of Subjects
22.1  How do you plan to identify potential subjects?
To “identify” a potential subject refers to procedures to determine which individuals may qualify to 
participate in the study in order to decide which individuals to contact about taking part.
 
Check all that apply:
Existing Record Review, 
including Medical Chart 
Review, Clinic Schedule 
Review, or QA-QI Database 
Review.
Select all that apply:
Patients’ records 
reviewed will be those 
from research team’s 
own patient population
Patients’ records will 
be those from other 
physicians or medical 
practices’ patient 
population
* You must request Waiver of 
Informed Consent and, if any 
HIPAA identifiers are 
collected, a Waiver of HIPAA 
Authorization for recruitment 
purposes.
Researchers who ARE NOT 
treating clinicians of potential 
subjects will ask treating 
clinicians for referrals of 
eligible patients interested in 
the study.
Select all that apply:
Treating clinicians will 
identify potentially 
eligible patients and 
obtain patient 
permission before 
providing researchers 
with patient contact 
information.
Treating clinician will 
provide 
documentation of 
patient permission in a 
email/letter to 
researcher, and 
researcher must 
document permission 
in research record.
*You must request a Waiver of 
Informed Consent/HIPAA 
Authorization for recruitment 
purposes.
Potential subjects will not be 
directly identified by the 
researchers from existing 
records.  The potential subject 
will obtain IRB-approved 
information about the study 
from an advertisement, flyer, 
brochure, website, grand 
rounds presentation, 
department meeting, etc.  In 
most cases, the potential 
Comments:

1.  
2.  
3.  
4.  
subject will contact the 
researcher if interested.
Review of Registry/Database 
in which individuals have 
previously signed a consent 
giving their permission to be 
contacted for future studies.
Comments:
Student Records
Comments:
Other
Please specify other:
22.2  Please describe the identification process.
List all information you plan to collect and record during the identification process PRIOR to contacting 
potential subjects. This includes the inclusion/exclusion criteria and demographics to determine if a person 
qualifies for a study before contacting that person to be a potential subject.
Prior to starting the day, the occupational therapist listed in this application will scan their clinic schedule 
and identify patients that meet study inclusion/exclusion criteria. This occupational therapist works at 
both of the locations listed above.
They will verbally bring up this research study to eligible patients during their regularly scheduled 
treatment visit, which is typically about an hour long. Lymphedema is treated with a combination of 
massage and compression, giving the occupational therapist (OT) leeway to talk to a patient while they 
deliver hands-on treatment. The OT will give a brief explanation of what will happen to the patient and 
how it will/will not impact their care.
If a patient expresses interest in participating in the study, the occupational therapist will give them an 
unsigned copy of the consent document to take home and read over. The OT will verbally confirm that 
the patient is interested in participating in this study. Additionally, the OT will confirm the patient's 
contact information (phone number and email address if applicable) and the best time to reach out to 
them. Then, the OT will reach out to a member of the research team and relay the patient’s contact 
information.
After receiving the patient's demographics (name and DOB) from the OT, a designated 
member of the research team (who is Carilion Affiliated or a VTCSOM student and has 
been approved by the IRB) will access the patient's chart via Epic and confirm their eligibility 
according to the inclusion/exclusion criteria. 
22.3  Through what methods will potential subjects be contacted or recruited?
Check all that apply. To “recruit” a potential subject refers to the initial contact method you plan to use to 
convey information to a potential subject to determine if he or she would be interested in taking part in your 
study.
Direct in-person contact
Telephone call
Letter
E-mail
Brochure
Radio/Television script
Newspaper Ad
Online advertisement (including Facebook, Twitter, Craigslist, other websites, etc.)

1.  
2.  
3.  
4.  
5.  
6.  
7.  
Flyer/Poster
Snowball sampling
Clinical trial website posting
Other
None (there will be no interaction or intervention with potential participants in this study)
22.4  Please provide any additional details about how potential subjects will initially be contacted, who will contact them, or how 
they will be introduced to the research.
If recruitment material is being mailed, emailed, or otherwise distributed, 
describe where/how the distribution list will be obtained.
If potential subjects will be recruited by telephone, describe how many times 
the research team will attempt to call / leave a voice message. 
When subjects respond to recruitment material, describe the information that 
will be provided to them about the study and the information that will be 
collected from subjects (e.g. name, telephone number, etc.). Describe also, how 
many times you will attempt to respond to call the subject back / leave a voice 
message.
The occupational therapist (provider) listed at the beginning of this application will identify potential 
participants (based on established inclusion and exclusion criteria) from their patient pool.
The provider will verbally bring up this research study during a patient's regularly scheduled treatment 
visit, which is typically about an hour long. Lymphedema is treated with a combination of massage and 
compression, giving the provider leeway to talk to a patient while they are delivering hands-on 
treatment. They will give a brief explanation of what will happen to the patient and how it will/will not 
impact their care.
If a patient expresses interest in participating in the study, their provider will give them an unsigned copy 
of the consent document to take home and read over. The provider will confirm that the patient is 
agreeable to being contacted by the research team and confirm their contact information and the best 
time to reach out to them. Then, the provider will reach out to a member of the research team and relay 
the patient’s contact information. 
Contact by telephone will only occur once the potential participant has been approached in person and 
verified interest in the study. Initial contact by phone will only occur by Carilion Affiliated or 
VTCSOM IRB approved team members unless the participant gives verbal permission to be 
contacted by a VT Team member, which will then be documented in the research record
This encounter will be documented as a research note in Epic by a member of the research team.
Two to three days after the initial contact has been made, a designated member of the research team 
will attempt to contact the patient via phone call, limiting the number of attempts to three. If the research 
team member cannot reach the patient during this time, they will not be included in the research study.
If the study team is able to make contact with the patient, they will have the option to either undergo e-
consent or choose to sign the consent form at their next regularly scheduled office visit. All consenting 
procedures will be completed by the Carilion Affiliated or VTCSOM IRB approved team members.
22.5  After potential subjects are identified, describe the pre-screening process that will take place prior to obtaining informed 
consent.
This could include asking questions to a potential subject to determine whether he or 
she meets eligibility criteria, for example: patients will answer questions about their 
medical history, be expected to come to the first screening visit after fasting, stop 
taking medications, change diet, etc.  To comply with HIPAA regulations, only the 
minimum necessary protected health information may be collected at this time. This 
means only questions relating to the inclusion and exclusion criteria may be asked.
No prescreening will take place
During the pre-screening process, patients will be asked to confirm their legal name and date of birth (to verify 
identity). They will also be asked to verify their past medical history, as our inclusion criteria stipulates a current 
diagnosis of lymphedema. Additionally, patients will be asked about their current health, as our exclusion criteria 
excludes patients with certain chronic conditions from participating in the research study. 
22.6  Indicate whether pre-screening information will be retained on persons who do not ultimately participate in the study and 
what specific information, including identifiers, will be retained.

Identifiers from patients that decide to not participate in the research study will be maintained on file. This is for 
the sole purpose of creating a running list so that patients who are not interested in participating are not contacted 
more than once. 
Attach all recruitment materials, letters, phone scripts, flyers, etc. in the Supplemental 
Documents section after you complete the IRB application.
23.0  
Risks and Risk Minimization and Benefits
23.1  List the possible risks, discomforts, or harms to subjects associated with the research.
If the risks differ based on group assignment, describe for each group. Estimate the (1) probability of 
occurrence, (2) the seriousness, and (3) the duration of each risk. If this information is captured in the 
protocol or investigators brochure (IB) or other materials, indicate the document and page numbers where 
the information can be located.
Possible risks, discomforts, or harms include:
Physical: The pressure of the device is less than that of an inflated blood pressure cuff. It is most comparable to a 
blood pressure cuff that has been well-fitted, but has not been inflated. The device utilizes a level of vibration that 
has been demonstrated to be similar to devices currently in use by lymphedema therapists. Please see this link for 
a commercially available vibrator that is similar to what is typically used. 
Skin tingling sensation
Skin tingling sensation is a common occurrence, but it is mild and will subside after treatment 
has ended.
Pain, soreness, or swelling
Pain, soreness, or swelling is an uncommon occurrence, but it is mild and will subside after the 
device is removed and treatment has ended. 
Dizziness
Dizziness is an uncommon occurrence, but it is mild and will subside after treatment has ended. 
Headache
Headache is an uncommon occurrence, but it is mild and will subside after treatment has ended. 
Nausea
Nausea is an uncommon occurrence, but it is mild and will subside after treatment has ended.
Shortness of Breath
Shortness of breath is an uncommon occurrence, but it is mild and will subside after treatment 
has ended.
Confidentiality:
Potential loss of confidentiality and release of medical information
Potential of this risk is low since data is shared only with personnel listed in this IRB application and is stored 
securely in the Carilion Clinic research environment (REDCap, SPARC, and secure Shared Drive). This risk is of 
moderate seriousness and the duration of the risk is as long as this study is active plus 6 years, as Carilion Clinic 
SOP stipulates that study data be maintained for 6 years after the conclusion of research activities.  
There may also be risks of stress, emotional distress, embarrassment, or inconvenience.

1.  
2.  
Citations:
Lerner, R. “Complete decongestive physiotherapy and the Lerner Lymphedema Services Academy of 
Lymphatic Studies (the Lerner School).” Cancer vol. 83,12 Suppl American (1998): 2861-3. doi:10.1002/
(sici)1097-0142(19981215)83:12b+<2861::aid-cncr39>3.0.co;2-v
Szuba, A., Achalu, R. and Rockson, S.G. (2002), Decongestive lymphatic therapy for patients with breast 
carcinoma-associated lymphedema. Cancer, 95: 2260-2267. https://doi.org/10.1002/cncr.10976
23.2  Define adverse events (AEs), serious adverse events (SAEs), and unanticipated problems (UAPs) for the study. Describe the 
protocol-specific reporting procedures, including who will be responsible for each step (e.g., PI), timeframes for reporting, 
how reports will be distributed, and follow-up that will occur.
Ensure that the reporting procedures meet the reporting requirements of Carilion 
Clinic IRB, the FDA, NIH, OHRP, sponsor, study leadership and any other 
regulatory body that applies to the study, as applicable. Please note that all 
Carilion Privacy breaches must also be reported to the Privacy office by the 
PI.  Noncompliance must be reported to the IRB as well as Office of Integrity and 
Compliance.
Adverse events (AEs):
Pain, soreness, or swelling in the area being treated or adjacent areas that is NOT alleviated with 
removing the device
Headache
Dizziness
Nausea
Shortness of breath
Skin irritation or rash
Serious adverse events (SAE):
Infection at the site of treatment
Unanticipated problem (UAP):
N/A
PI will be responsible for reporting any AEs, SAEs, or UAPs. 
23.3  Describe the actions that will be taken to minimize the risks associated with participation in this research. 
If this research includes risks that might require immediate or prompt medical management, describe access 
to/availability of emergency medical equipment and trained personnel at each setting where procedures that 
impart physical/health risks will take place. If this information is available in the study protocol indicate the 
page numbers where the information can be located.
Participants will be asked verbally whether the external non-clinical team members can be present to perform the 
research activities. A clinically trained Carilion team member (not an inventor) will be present to perform and 
oversee all research activities. Clinical research team members may also be present who could provide assistance 
in a medical emergency. Medical equipment will be present as needed. The participant will be monitored closely 
during data collection in the clinic. To protect confidentiality research records will be stored on secure and 
encrypted Carilion Clinic servers.
 
23.4  For studies involving drugs, devices, biologics, or imaging, describe the type of pregnancy testing that will occur and how 
frequently it will be conducted on women of reproductive potential.

Include:
If pregnancy testing will not be conducted, provide the reason. 
State the types of  birth control methods women of reproductive potential will 
be instructed to use.
If women will not be instructed about acceptable methods of birth control, 
provide the reasoning. 
Describe the birth control methods men of reproductive potential will be 
instructed to use. If men will not be instructed about acceptable methods of 
birth control, provide the reasoning.
While this research study does involve a medical device, there is little evidence to suggest devices and treatment 
techniques that are similar pose any threat to a woman of reproductive potential. Therefore, this study does not 
require routine pregnancy testing. 
23.5  Does the research include screening tools, questionnaires, or procedures that may indicate the presence of serious depression 
and/or suicidal ideation?
  Yes  
  No
23.6  Describe the Data Safety Monitoring Plan or Data Safety Monitoring Board, or indicate the page(s) of the protocol or name 
of the document where this information can be located.  While a robust Data Safety Monitoring Plan is REQUIRED for 
greater than minimal risk studies, a plan should also be in place for studies that are minimal risk.  Please click on the Help 
circle to the right for information on writing a DSM plan based in risk levels of the research.
Include:
The data that will be reviewed, including safety data, untoward events, and 
efficacy data;   
Who is responsible for reviewing the data;
How the safety information will be obtained and documented (e.g., case report 
forms, by telephone calls with participants, printouts of laboratory results, 
etc.);   
The frequency or periodicity of review of cumulative data;
The statistical tests for analyzing the safety data to determine whether harm is 
occurring;
Any conditions that trigger an immediate suspension of the research or other 
action for the research.
For this study, a Data Safety and Monitoring Committee (DSMC) will be established. The 
committee consists of a physician, lymphedema therapist, and biomedical engineer. They will be 
familiar with the project, but will have no direct involvement in it. The DSMC will review any 
reports of anticipated side effects, unanticipated side effects, serious adverse events and 
unanticipated problems. The study population consists of 15 subjects. Routinely, after each of the 
first 2 cohorts of 5 study subjects each, the DSMC will conduct a review. The DSMC will only have 
access to de-identified data. Until this review is completed, and the DMSC makes a 
recommendation to continue, no subjects will be enrolled and studied. The DMSC will make its 
determinations based upon review of data that includes the incidence of side effects (physical 
risks and harms outlined in section 23.1) and incidence of adverse events and serious adverse 
events (outlined in section 23.2) For occurrence of any unanticipated side effects or adverse 
events, the study will be immediately suspended, and these conditions will be reviewed by the 
DSMC, followed by reporting to the IRB. The study will only continue if recommended by the 
DMSC and permitted by the IRB. Data that will be provided to the IRB if the Stop/Pause is 
activated will be submitted in writing, and include full disclosure of all data collected, and any 
written annotations associated with the study in the patient chart. A recommendation of whether 
the study should continue without modification, continue with modification, or no longer continue 
from the DSMC will be provided to the IRB in writing after each meeting is held.
23.7  Describe the plans and rationale for conducting an interim analysis.
  Yes  
  No

23.8  Have stopping rules been established for the study, including for reasons of futility?
 Yes  
 No
Describe the stopping rules:
If any of the following were to occur during the course of the research study, the study will be discontinued. 
Bleeding or bruising
Interference with electronic devices such as, but not limited to, hearing aids and mobile phones
Any evidence of increasing edema with use of the device
23.9  Are there defined criteria (ex: rates of adverse events) for when study interventions should be discontinued?
 Yes  
 No
Describe the criteria:
If any of the following were to occur during the course of the research study, the study will be discontinued. 
Bleeding or bruising
Interference with electronic devices such as, but not limited to, hearing aids and mobile phones
Any evidence of increasing edema with use of the device
23.10  Are there exams or procedures that the subject will be asked to have done or follow to safely withdraw from the study?
  Yes  
  No
23.11  Will subjects who withdraw from the interventional component of the study be asked for their permission to continue to 
gather information about them through follow up visits, phone calls, records review, or other methods?
Yes 
No 
N/A 
23.12  Describe the potential benefits to science and/or society expected from this research.
In general, we do not expect patients to directly benefit from this research study. They will still be receiving the 
standard of care decongestive lymphatic massage from their occupational therapist, and use of the device will do 
little to change overall outcomes. If this study is able to demonstrate both safety and efficacy of the device, this 
opens up further opportunities for comparison against existing pneumatic pumps and other devices labeled for at-
home use. Devices that are currently available on the market are bulky, expensive, and not very user friendly, and 
this device can provide a much needed solution for providing lymphedema maintenance care between 
appointments with a lymphedema-specialized occupational therapist. 
23.13  Are individual subjects expected to directly benefit from participating in this research? 
Note: Compensation is not considered a benefit.
  Yes  
  No
24.0  
Costs and Compensation
24.1  Will the subject, or the subject’s insurance, be responsible for any medical costs incurred as a result of participation in the 
research? 

Take into account medical costs associated with study procedures, drugs, or devices.
  Yes  
  No
24.3  Will subjects be reimbursed for any expenses related to their research participation, including medical costs, travel, parking, 
or transportation?
  Yes  
  No
24.4  Will subjects receive any monetary compensation (cash, check, or giftcard) or non-monetary gifts, incentives, or tokens of 
appreciation for participating in this research? 
Note: Reimbursement for costs is not considered compensation.  Use of raffles or lotteries are discouraged at 
Carilion Clinic since the compensation is not being equitably dispersed to participants. Raffles and lotteries 
may be permitted on a case-by-case basis with appropriate justification.
 Yes  
 No
Please ensure the following language is in the consent document:
Include if payment for the study will be less than $100 in the next calendar year: 
Payments made to you as compensation for your participation will be tracked by the research 
team. This information will be submitted to Carilion’s financial department for central tracking. If 
you receive greater than $600 from Carilion in a calendar year, this is considered taxable 
compensation and will be reported to the Internal Revenue Service (IRS). You will be issued a 
1099 tax form by Carilion if you meet this reporting threshold.
Include if payment for the study will be $100 or more in the next calendar year: In 
order to receive compensation for your participation, you will be asked to complete an Internal 
Revenue Service (IRS) W-9 form. Your social security number will be required to complete the 
IRS form.  Compensation to study subjects greater than $600 in a calendar year is considered 
taxable compensation and is reportable to the Internal Revenue Service (IRS). Carilion will be 
required to provide your name, social security number, address, and amount of payment to the 
IRS. You will be issued a 1099 tax form by Carilion if you meet this reporting threshold. This 
information and your payment amount will be kept secure and confidential in our research 
financial records and Carilion’s financial office.  This information will not be associated with the 
study name or the research data you provide as a participant
24.5  Please describe the compensation.
Include the amount and method of payment, and the distribution plan for the payment (payment received at each 
visit, payment at end of study, completion bonus, etc.). If a non-monetary item will be provided, state the 
approximate retail value of the item, when subjects will receive the item, any conditions or requirements that 
must be fulfilled for subjects to receive the item(s), and a picture of or link to the item online, if possible.
All participants will receive a $20 Kroger gift card for their participation at the conclusion of their study visits. If 
the participant does not complete all study visits, their compensation will be prorated at $5 per study visit and 
will be provided to them after their last study visit.
24.6  If the research involves children or adults unable to consent to participation, explain who will receive the monetary 
compensation or non-monetary item(s).
N/A
25.0  
Application Questions Complete
25.1  You have now completed the IRB Application. Please click Save & Continue to proceed to the Initial Submission Packet.

Date Completing Form:
02/29/2024
The Initial Submission Packet is a short form filled out after the IRB application has been completed and 
is where you will attach protocol-related documents, such as consent forms and recruitment materials. 
You will also be able to conduct a final review of the IRB application.
 
The PI will be required to sign off on the final Initial Submission Packet. The study may then proceed to 
the Department Signoff, if necessary based on the application type selected, and may require COI review 
before proceeding to the IRB.
 
You can view the Submission History of the study at any time to determine the status.