Mechanisms Underlying Local and Systemic Effects of Massage
Phase: NA
Conditions: Muscle Atrophy
Sponsor: Esther Dupont-Versteegden

Mechanisms Underlying Local and Systemic Eﬀects of Massage 
NCT04131712 
R21AT010847 
April 2024

PROTOCOL TYPE (VERSION 4)
0 unresolved
comment(s)
Which IRB
Medical
NonMedical
Protocol Process Type
Exemption
Expedited
Full
(Must be risk level 1)
 
IMPORTANT NOTE: You will not be able to change your selections for "Which IRB" and "Protocol Process Type" after
saving this section. If you select the wrong IRB or Protocol Process Type, you may need to create a new application. 
See below for guidance on these options, or refer to ORI's "Getting Started" page. Please contact the Office of Research Integrity
(ORI) at 859-257-9428 with any questions prior to saving your selections.
 
*Which IRB*
The Medical IRB reviews research from the Colleges of:
Dentistry
Health Sciences
Medicine
Nursing
Pharmacy and Health Sciences
and Public Health.
 
The Nonmedical IRB reviews research from the Colleges of:
Agriculture
Arts and Sciences
Business and Economics
Communication and Information
Design; Education
Fine Arts
Law
and Social Work
Note: Studies that involve administration of drugs, testing safety or effectiveness of medical devices, or invasive medical procedures
must be reviewed by the Medical IRB regardless of the college from which the application originates. 
*Which Protocol Process Type* 
Under federal regulations, the IRB can process an application to conduct research involving human subjects in one of three ways: 
by exemption certification
by expedited review.
by full review;
The investigator makes the preliminary determination of the type of review for which a study is eligible. Please refer to ORI's "Getting
Started" page for more information about which activities are eligible for each type of review.
 
The revised Common Rule expanded exemption certification category 4 for certain secondary research with
identifiable information or biospecimens. The regulations no longer require the information or biospecimens to be
existing.  For more information see the Exemption Categories Tool.
Section 1 Page 1 of 2
IRB Approval
4/13/2023
IRB # 43499
IRB3

 
Section 1 Page 2 of 2
43499

CONTINUATION REVIEW/FINAL REVIEW
0 unresolved
comment(s)
In accordance with federal regulations and/or local policies, the IRB conducts periodic review of all currently approved projects. If
you need your IRB approval to continue and you do not complete and submit the required materials in a timely manner, IRB
approval will expire at the end of your current approval period.
If you have any questions, please contact the Office of Research Integrity at 859-257-9428 or email IRBsubmission@uky.edu.
To initiate your continuation review (CR)/annual administrative review (AAR), or properly close your study, complete this section
and update/correct all other sections of your IRB application as applicable. 
***IMPORTANT*** Before leaving this page to update other sections of your application, be sure to SAVE this section first.
1. Status of the Research
Check the statement(s) that best describe(s) the current status of your research: 
No subjects have enrolled to date.
Recruitment and/or enrollment of new subjects or review of records/specimens continue.
Study is closed to enrollment, but subjects still receive research-related interventions (e.g., treatment, blood draws).
Study enrollment is permanently closed; subjects have completed all research-related interventions; and the study remains active
only for long-term follow-up of subjects (see Tool Tip above for info on long-term follow-up of subjects).*
Research has progressed to the point that it involves 1) Data analysis, including analysis of identifiable private information or
identifiable biospecimens; and/or 2) Accessing follow-up clinical data from procedures that subjects would undergo as part of clinical
care.*
The remaining research activities are limited only to data analysis. There is access to records or specimens either directly or
through codes or links to the data.*
The remaining research activities are limited only to data analysis. There is no subject/record/specimen identifying codes or links to
the data; the researcher or research team cannot readily ascertain the subject's identity.*
All study activities are complete. IRB approval can be inactivated.
*Possibility that review will move from Full to Expedited.
2. If subjects have been enrolled within the last year, and the IRB approved a consent/assent form for your study:
Please attach a complete, signed copy for the last two subjects enrolled with each consent/assent form/HIPAA form since the last
annual review. 
(Example: If 3 different approved consent forms were used since the last annual review, please provide the two most recent signed
copies of each version for a total of six.)
Attachments
Attach Type
File Name
Entire Signed Consent Form HuMA38 Consent.pdf
Entire Signed Consent Form HuMA39 Consent.pdf
3. Informed Consent
If the study is open to subject enrollment, please go to the Informed Consent section of the E-IRB Application and verify
attachment(s) include:
One clean copy in PDF (without the IRB Approval stamp) of the currently approved consent/assent document(s), or,
If requesting changes to the consent/assent document(s), submit one copy with the changes highlighted (and designate Document
Type as "Highlighted"), and one clean copy in PDF (without the changes highlighted).
If the study is open to subject enrollment and the IRB has waived the requirement to document informed consent, please go
to the Informed Consent section of the E-IRB Application and verify attachment(s) include:
One clean copy in PDF of the currently approved document used for the informed consent process (e.g., cover letter, phone
script), or,
If requesting changes to the consent/assent document(s), submit one copy with the changes highlighted (and designate Document
Type as "Highlighted"), and one clean copy in PDF (without the changes highlighted).
Section 2 Page 1 of 9
43499

If the study is closed to subject enrollment, please go to the Informed Consent section of the E-IRB Application and remove
Informed Consent Documents designated to get an IRB approval stamp to avoid having them appear valid for enrollment.
4. Unanticipated Problems Involving Risk to Subjects or Others/Adverse Events Summary & Assessment
Did any problems/adverse events occur during the last 12 months?
Yes
No
In the space below, provide a written summary of both unanticipated problems* and available information regarding adverse events
since the last review (e.g., initial review or annual/continuing review). The amount of detail provided in such a summary will vary
depending on the type of research being conducted; in many cases, such a summary could be a brief statement that there have been
no unanticipated problems and that adverse events have occurred at the expected frequency and level of severity as documented in the
research protocol, the informed consent document, and investigator’s brochure (if applicable). The summary must include the PI’s
assessment whether the problems/adverse events warrant changes to the protocol, consent process, or risk/benefit ratio.
Note: It is the IRB's expectation that all unanticipated problems involving risk to subjects or others or related deaths requiring prompt
reporting are submitted in the appropriate time frame (See Policy [PDF]). Your response to this Annual/Continuing Review is
considered assurance that all prompt reportable problems/adverse events have been submitted for IRB review.
We have recorded one adverse event in the past 12 months that has not been reported to the IRB. This
information has been included in the attached progress report as well as submitted as a separate AE and
deviation submission to go along with this CR.
*For multisite studies, the written summary should describe external events determined to be unanticipated problems involving risk to
subjects or others.
5. Subject Info To-Date
Our records for the previously approved IRB application indicate the IRB approved estimate of subjects to be enrolled (or
records/specimens reviewed) is:
140
Enter the number of enrolled subjects (or records/specimens reviewed) that have not been previously reported to the IRB
9
Our records for the previously approved IRB application indicate the previous total # of subjects enrolled (or records/specimens
reviewed) since activation of the study is:
40
The new total number of subjects enrolled (or records/specimens reviewed) since activation of the study: 
49
Please review the Project Info section for the IRB approved estimate of subjects to be enrolled (or records/specimens reviewed).
If this new total exceeds your approved estimate of subjects to be enrolled (or records/specimens reviewed), please update the
number in the field for Number of Human Subjects in the Project Info section.
6. Data and Safety Monitoring Board (DSMB)/Plan (DSMP)
If your study is monitored by a DSMB or under a DSMP, attach all documentation (i.e. summary report; meeting minutes) representing
Data and Safety Monitoring activities that have not been previously reported to the IRB.
Attachments
Attach Type
File Name
CR Data Safety Monitoring Doc
022823 DSMB LOCl - Massage II.pdf
CR Data Safety Monitoring Doc
DSMB Review 021523 Dupont Massage.pdf
Section 2 Page 2 of 9
43499

7. Since the most recent IRB Initial/Continuation Review Approval:
Have there been any participant complaints regarding the research?
Yes
No
If yes, in the field below, provide a summary describing the complaints.
Have any subjects withdrawn from the research voluntarily or by you as the PI for reasons related to safety, welfare, or problems
related to the conduct of the research? If a participant does not meet the screening criteria for a study even if they signed a screening
consent it is NOT considered a withdrawal.
Yes
No
If yes, in the field below, provide a detailed explanation to the withdrawal(s) including if participants were lost to contact.
One subject was withdrawn by the PI due to the schedule of events not being able to be followed.
Has any new and relevant literature been published since the last IRB review, especially literature relating to risks associated with
the research?
Yes
No
If yes, attach a copy of the literature as well as a brief summary of the literature including, if pertinent, the impact of the findings on the
protection of human subjects.
Attachments
Have there been any interim findings?
Yes
No
If yes, attach a copy of Interim Findings.
Attachments
Have subjects experienced any benefits?
Yes
No
If yes, in the field below, provide a description of benefits subjects have experienced.
Have there been any inspections/audits/quality improvement reviews of your research protocol resulting in the need for
corrective action in order to protect the safety and welfare of subjects?
Yes
No
If yes, please attach documentation evidencing the outcome(s) and any corrective action(s) taken as a result.
Attachments
Was an FDA 483 issued as a result of any inspections/audits?
Yes
No
If yes, submit documentation using attachment button above.
8. Risk Level:
Our records for the previously approved IRB application show your research is:
Risk
Level: 3
Has something during the course of your research changed the level of risk?
Yes
No
If yes, go to the Risk Level section, mark the appropriate risk level, and in the field below, describe why the risk level has changed:
Section 2 Page 3 of 9
43499

9. Funding/Support:
Our records for the previously approved IRB application indicate your research is being submitted to, supported by, or conducted in
cooperation with the following external or internal agency(ies) or funding program(s):
Grant application pending
(HHS) Dept. of Health & Human Services
(NIH) National Institutes of Health
(CDC) Centers for Disease Control & Prevention
(HRSA) Health Resources and Services Administration
(SAMHSA) Substance Abuse and Mental Health Services Administration
(DoJ) Department of Justice or Bureau of Prisons
(DoE) Department of Energy
(EPA) Environmental Protection Agency
Federal Agencies Other Than Those Listed Here
Industry (Other than Pharmaceutical Companies)
Internal Grant Program w/ proposal
Internal Grant Program w/o proposal
National Science Foundation
Other Institutions of Higher Education
Pharmaceutical Company
Private Foundation/Association
U.S. Department of Education
State
Other:
National Center for Complementary and Integrative Health (NCCIH)
Please update the Funding/Support section of your IRB application if needed, including the following attachments if they contain
changes not previously reported to the IRB:
A current copy of your protocol if you are conducting industry/pharmaceutical research;
A current Investigator Brochure (submit a copy with all changes underlined).
A new or revised grant application for this project.
Did your project receive extramural funding?
Yes
No
If yes, please review and correct if necessary, the OSPA Account # information under the Funding/Support section of your IRB
application.
If the project is externally funded, has the sponsor offered any of the research team enrollment incentives or other personal benefit
bonuses? (e.g., cash/check, travel reimbursements, gift checks, etc.)
Yes
No
N/A
Note: It is University of Kentucky policy that personal benefit bonuses are not allowed. If these conditions change during the course of
the study, please notify the IRB.
10. Project Information
Our records for the previously approved IRB application indicate your estimated project end date is:
06/30/2023
If you have a new estimated project end date, please go to the Project Info section and change the date in the field for Anticipated
Ending Date of Research Project.
11. Study Personnel
Our records for the previously approved IRB application indicate the following individuals are study personnel on this project (if
applicable):
Section 2 Page 4 of 9
43499

Last Name
First Name
Confides
Amy
Holbrook
Kathryn
Hommel
Leta
Rice
Linda
Watts
Linda
Chamblin
Lisa
Tillery
Melanie
Camper
Zenith
Kaenzig
Janet
Moylan
Jennifer
Biddle
Martha
True
Laura
Long
Douglas
Vincent
Sylvia
Elgumati
Sumya
Bowlds
Hannah
Cole
Jill
Butterfield
Timothy
Brown
Paul
Kern
Philip
DeCoster
Ryan
Bruns
Reva
Minix
Kathleen
Maynard
Marshall
Stiehler
Julie
Smith
Kayla
Buckler
Regan
Devine
Amber
Hunt
Emily
Gamble
Bethanie
Eisenhut
Sarah
Allman
Ariel
Finch
Megan
Mandal
Prabin
Memmini
Allyssa
Farrar
Nicholas
Swain
Audrie
Section 2 Page 5 of 9
43499

Last Name
First Name
Van Pelt Jr
Douglas
Ross
James
Skaggs
Kylee
Forenback
Denece
Nieto
Alayne
Please review the individuals listed above and update your records as needed in the Study Personnel section of the E-IRB application,
being sure that each individual listed has completed or is up-to-date on the mandatory human research protection training [see the
policy on Mandatory Human Subject Protection Training FAQs (required every three years)].
12. Progress of the Research
To meet federal requirements the IRB is relying on your RESEARCH DESCRIPTION as a protocol summary and
their expectation is that it is up-to-date. If the currently approved protocol (or research description) in your E-IRB
application is outdated, please make applicable changes, and describe in the field below any substantive changes and
explain why they are essential. If none, insert "N/A" in the text field below. If you are closing your study, you may use the
space below to summarize the final status of the research.
A progress report has been attached in additional materials.
Note: No changes in the research procedures should have occurred without previous IRB review. Approval from the IRB must
be obtained before implementing any changes.
Provide a brief summary of any modifications that affect subject safety and/or welfare approved by the IRB since the
last initial or continuation review (If none, insert "N/A" in the text field below.):
N/A
Attach one copy of the most recent progress report sent to the FDA, if available. All PI-sponsored IND/IDE studies are
required to submit a copy of the FDA progress report.
Attachments
13. Confidentiality/Security
Review your Research Description section and update the Confidentiality portion, if necessary, to describe measures for security of
electronic and physical research records (e.g., informed consent document(s), HIPAA Authorization forms, sensitive or private data).
14. Subject Demographics
Our records for the previously approved IRB application indicate the following categories of subjects and controls are
included in your research:
Children (individuals under age 18)
Wards of the State (Children)
Emancipated Minors
Students
College of Medicine Students
UK Medical Center Residents or
House Officers
Impaired Consent Capacity Adults
Pregnant Women/Neonates/Fetal
Material
Section 2 Page 6 of 9
43499

Prisoners
Non-English Speaking
International Citizens
Normal Volunteers
Military Personnel and/or DoD
Civilian Employees
Patients
Appalachian Population
Please review the Subject Demographics section of your IRB application for accuracy, and note the following:
If during the course of your research 1) any prisoners have been enrolled, OR 2) subjects have been enrolled that became involuntarily
confined/detained in a penal institution that have not been previously reported to the IRB, go to Subject Demographic section in your E-
IRB application and mark “prisoners” in the categories of subjects to be included in the study, if it is not already marked.
Note: If either 1 or 2 above apply, and you have received funding from the Department of Health and Human Services (HHS), a
Certification Letter should have been submitted to the Office for Human Research Protections (OHRP); prisoners and individuals who
have become involuntarily confined/detained in a penal institution cannot continue participation in the research until OHRP issues
approval. If the Certification has not been submitted, contact the Office of Research Integrity.
Based on the total # of subjects who have enrolled, complete the subject demographic section below:
     Participant Demographics
Cisgender Man 
Cisgender Woman 
TGNB/TGE 
Unknown/Not Reported
American
Indian/Alaskan
Native
Asian
Black or
African
American
Latinx
Native
Hawaiian or
Other Pacific
Islander
White
American
Arab/Middle
Eastern/North
African
Indigenous
People
Around the
World
More than
One Race
Unknown or
Not Reported
                                                                                                   
If unknown, please explain why:
15. Research Sites
1
3
2
3
12
26
1
1
Section 2 Page 7 of 9
43499

Our records for the previously approved IRB application indicate that you are conducting research at the following sites:
UK Sites
UK Classroom(s)/Lab(s)
UK Clinics in Lexington
UK Clinics outside of Lexington
UK Healthcare Good Samaritan Hospital
UK Hospital
Schools/Education Institutions Schools/Education
Institutions
Fayette Co. School Systems *
Other State/Regional School Systems
Institutions of Higher Education (other than UK)
Other Medical Facilities
Bluegrass Regional Mental Health Retardation Board
Cardinal Hill Hospital
Eastern State Hospital
Nursing Homes
Shriner’s Children’s Hospital
Other Hospitals and Med. Centers
Correctional Facilities
Home Health Agencies
International Sites
Other:
If the above listed sites are not accurate, go to the Research Sites section of the E-IRB application to update the facilities at which
research procedures have been or will be conducted.
If you are adding a new off-site facility, you may also need to update your E-IRB application Research Description,
Research Sites, Informed Consent, and other affected sections as well as any documents which will list the off-site facility.
Documents needing updating may include, but not limited to:
Consent forms (attachment under Informed Consent section)
Brochures (attachment under Additional Info section)
Advertisements (attachment under Research Description section) ;
Letter of support (attachment under Research Sites section)).
Please revise applicable sections and attachments as necessary.
16. Disclosure of Significant Financial Interest
Disclosure of Significant Financial Interest:
Our records for the previously approved IRB application indicate that you, your investigators, and/or key personnel (KP) have a
significant financial interest (SFI) related to your/their responsibilities at the University of Kentucky (that requires disclosure per the
UK administrative regulation 7:2): 
Yes
No
If you need to update your records, please go to the PI Contact Information section and/or Details for individuals listed in the Study
Personnel section to change your response to the applicable question(s).
Section 2 Page 8 of 9
43499

17. Supplementals
To ensure the IRB has the most accurate information for your protocol you are expected to re-visit the E-IRB application sections and
make corrections or updates as needed. At a minimum you are being asked to review the following sections for accuracy:
STUDY DRUG INFORMATION—Please review for accuracy.
STUDY DEVICE INFORMATION—Please review for accuracy.
RESEARCH ATTRIBUTES—Please review for accuracy.
OTHER REVIEW COMMITTEES -- Please review for accuracy.
If applicable, submit one copy of the entire signed HIPAA Authorization form for the same last TWO subjects enrolled.
Attachments
Section 2 Page 9 of 9
43499

PROJECT INFORMATION
0 unresolved
comment(s)
Title of Project: (Use the exact title listed in the grant/contract application, if applicable). 
If your research investigates any aspect of COVID-19, please include "COVID19" at the beginning of your Project Title and Short Title 
The Cellular Effects of Massage of Human Skeletal
Muscle Tissue
Short Title Description 
Please use a few key words to easily identify your study - this text will be displayed in the Dashboard listing for your study.
Human Massage
Anticipated Ending Date of Research Project: 
Maximum number of human subjects (or records/specimens to be reviewed) 
140
After approval, will the study be open to enrollment of new subjects or new data/specimen collection? 
Yes
No
6/30/2024
Section 3 Page 1 of 1
43499

PI CONTACT INFORMATION
0 unresolved
comment(s)
Principal Investigator (PI) role for E-IRB access
The PI is the individual holding primary responsibility on the research project with the following permissions on the E-IRB application:
1. Read; 
2. write/edit;
3. receive communications; and 
4. submit to the IRB (IR, CR, MR, Other Review*).
If research is being submitted to or supported by an extramural funding agency such as NIH, a private foundation or a
pharmaceutical/manufacturing company, the PI listed on the grant application or the drug protocol must be listed as PI here. 
Please fill in any blank fields with the appropriate contact information (gray shaded fields are not editable). Required fields left blank will
be highlighted in pink after you click "Save".
To change home and work addresses, go to myUK and update using the Employee Self Service (ESS) portal. If name has changed,
the individual with the name change will need to submit a 'Name Change Form' to the Human Resources Benefits Office for entering
into SAP. The new name will need to be associated with the individual's Link Blue ID in SAP before the change is reflected in E-IRB.
Contact the HR Benefits Office for additional information.
The Principal Investigator's (PI) contact information is filled in automatically based on who logged in to create the application.
If you are not the Principal Investigator, do NOT add yourself as study personnel.
To change the PI contact information on an application in Researcher edit status:
click "Change Principal Investigator";
search for the PI's name using the search feature;
click "Select" by the name of the Principal Investigator, then "Save Contact Information".
You will automatically be added as study personnel with editing permissions to continue editing the application.
Change  Principal Investigator:
First Name: Esther
Room# &
Bldg: 204L CHARLES T
WETHINGTON BLDG
Last Name: Dupont-Versteegden
Speed
Sort#: 
405360200
Middle Name
Department:
Dept Code: 7N600
 
PI’s
Employee/Student
ID#:
10164584
Rank: 
Professor
 
PI's Telephone #: 859323110080592
Degree: Ph.D.
PI's e-mail
address: eedupo2@email.uky.edu
PI's FAX
Number: 8593236003
PI is R.N.
Yes
No
HSP Trained: Yes
HSP Trained
Date: 12/30/2021
RCR Trained: Yes
Do you, the PI, have a significant financial interest related to your responsibilities at the University of Kentucky (that requires
disclosure per the UK administrative regulation 7:2)?
Yes
No
Health Sciences - Rehabilitati …

Section 4 Page 1 of 2
43499

Section 4 Page 2 of 2
43499

RISK LEVEL
0 unresolved
comment(s)
Indicate which of the categories listed below accurately describes this protocol
(Risk Level 1) Not greater than minimal risk
(Risk Level 2) Greater than minimal risk, but presenting the prospect of direct benefit to individual subjects
(Risk Level 3) Greater than minimal risk, no prospect of direct benefit to individual subjects, but likely to yield generalizable
knowledge about the subject's disorder or condition.
(Risk Level 4) Research not otherwise approvable which presents an opportunity to understand, prevent, or alleviate a serious
problem affecting the health or welfare of subjects.
*“Minimal risk” means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of
themselves from those ordinarily encountered in daily life or during the performance of routine physical or psychological
examination or tests.
Refer to UK's guidance document on assessing the research risk for additional information.
Section 5 Page 1 of 1
43499

SUBJECT DEMOGRAPHICS
0 unresolved comment(s)
Age level of human subjects: (i.e., 6 mths.; 2yrs., etc..) 18 yrs to 30 yrs
Study Population:
Describe the characteristics of the subject population, including age range, gender, ethnic background and health status. Identify the criteria for inclusion and
exclusion. 
Provide the following information:
A description of the subject selection criteria and rationale for selection in terms of the scientific objectives and proposed study design;
A compelling rationale for proposed exclusion of any sex/gender or racial/ethnic group;
Justification for the inclusion of vulnerable groups such as children, prisoners, adults with impaired consent capacity, or others who may be vulnerable to
coercion or undue influence.
Please consider these resources: 
NIH Diversity Policy 
FDA Diversity Guidance 
This study will include 70 subjects of either gender. Subjects will be randomly assigned to the following groups: (1) normal weight-bearing, massage (WB-M),
(2) normal weight bearing, no massage (WB-C) (3) ULLS, no massage (U-C), and (4) ULLS, massage (U-M). Inclusion criteria are as follows: healthy subjects
aged 18-30 years. Exclusion criteria include: 
• BMI over 27
• Have current lower extremity musculoskeletal injuries
• Have had previous lower extremity surgeries or injury
• Activities of daily living require long periods of standing or driving a manual transmission car.
• Evidence or signs and symptoms of metabolic syndrome or disorder (diagnosis of diabetes or insulin resistance, elevated BP, high fasting blood sugar, 
abnormal cholesterol or triglyceride levels).
• Thyroid disorder
• Acute or chronic infections 
• Use of systemic steroids, anabolic steroids, or growth hormone
• Are currently pregnant
• Have a family history of bleeding problems (“free bleeder"), as evidence by:
o unexplained nosebleeds (epistaxis)
o excessive or prolonged menstrual blood flow (menorrhagia)
o prolonged bleeding after minor cuts, dental procedures, tooth brushing or flossing, or trauma
• Are using medications that increase the risk of bleeding (unless it can be safely stopped):
o Aspirin
o Clopidogrel
o non-steroidal anti-inflammatory drugs
o any anticoagulation therapy (warfarin or heparin)
• Are allergic to Betadine or Xylocaine HCI.
• Any other condition or events considered exclusionary by the PI and /or physician, such as non-compliance
Attachments
Indicate the targeted/planned enrollment of the following members of minority groups and their subpopulations. Possible demographic
sources: Census Regional Analyst Edition, Kentucky Race/Ethnic Table, Kentucky Population Data. 
(Please note: The IRB will expect this information to be reported at Continuation Review time for Pre-2019 FDA-regulated
Expedited review and Full review applications):
Participant Demographics
Cisgender Man 
Cisgender Woman 
TGNB/TGE 
Unknown/Not Reported
American
Indian/Alaskan
Native:
Asian:
Black/African
American:
Latinx:
Native
Hawaiian/Pacific
Islander:
White:
American
Arab/Middle
Eastern/North
African:
Indigenous
People Around
3
3
9
9
2
2
56
56
Section 6 Page 1 of 3
43499

the World:
More than One
Race:
Unknown or Not
Reported:
 
If unknown, please explain why:
Indicate the categories of subjects and controls to be included in the study. You may be required to complete additional forms depending on
the subject categories which apply to your research. If the study does not involve direct intervention or direct interaction with subjects, (e.g.,
record-review research, outcomes registries), do not check populations which the research does not specifically target. For example: a large
record review of a diverse population may incidentally include a prisoner or an international citizen, but you should not check those categories
if the focus of the study has nothing to do with that status.
Check All That Apply (at least one item must be selected)
Children (individuals under age
18)
Wards of the State (Children)
Emancipated Minors
Students
College of Medicine Students
UK Medical Center Residents or
House Officers
Impaired Consent Capacity
Adults
Pregnant Women/Neonates/Fetal
Material
Prisoners
Non-English Speaking (translated
long or short form)
International Citizens
Normal Volunteers
Military Personnel and/or DoD
Civilian Employees
Patients
Appalachian Population
ADDITIONAL INFORMATION:
Please visit the IRB Survival Handbook for
more information on:
Children/Emancipated Minors
Students as Subjects
Prisoners
Impaired Consent Capacity Adults
Economically or Educationally
Disadvantaged Persons
Other Resources:
UKMC Residents or House Officers
[see requirement of GME]
Non-English Speaking [see also the
E-IRB Research Description section
on this same topic]
International Citizens [DoD SOP may
apply]
Military Personnel and/or DoD Civilian
Employees
Section 6 Page 2 of 3
43499

Traumatic brain injury or acquired brain
injury
Severe depressive disorders or Bipolar
disorders
Schizophrenia or other mental disorders
that
involve serious cognitive disturbances
Stroke
Developmental disabilities
Degenerative dementias
CNS cancers and other cancers with
possible CNS involvement
Late stage Parkinson’s Disease
Late stage persistent substance
dependence
Ischemic heart disease
HIV/AIDS
COPD
Renal insufficiency
Diabetes
Autoimmune or inflammatory disorders
Chronic non-malignant pain disorders
Drug effects
Other acute medical crises
Assessment of the potential recruitment of subjects with impaired consent capacity (or likelihood):
Check this box if your study does NOT involve direct intervention or direct interaction with subjects (e.g., record-review research, secondary
data analysis). If there is no direct intervention/interaction you will not need to answer the impaired consent capacity questions.
Does this study focus on adult subjects with any conditions that present a high likelihood of impaired consent capacity or fluctuations in
consent capacity? (see examples below)
Yes
No
If Yes and you are not filing for exemption certification, go to "Form T", complete the form, and attach it using the button below.
Examples of such conditions include:
Attachments
Section 6 Page 3 of 3
43499

INFORMED CONSENT/ASSENT PROCESS/WAIVER
0 unresolved
comment(s)
For creating your informed consent attachment(s), please download the most up-to-date version listed in "All Templates" under the
APPLICATION LINKS menu on the left, and edit to match your research project.
Additional Resources:
Informed Consent/Assent Website
Waiver of Consent vs. Waiver of Signatures
Sample Repository/Registry/Bank Consent Template
Consent/Assent Tips:
If you have multiple consent documents, be sure to upload each individually (not all in a combined file).
If another site is serving as the IRB for the project, attach the form as a “Reliance Consent Form” so the document will not receive
a UK IRB approval stamp; the reviewing IRB will need to stamp the consent forms.
Changes to consent documents (e.g., informed consent form, assent form, cover letter, etc...) should be reflected in a 'tracked
changes' version and uploaded separately with the Document Type "Highlighted Changes".
It is very important that only the documents you wish to have approved by the IRB are attached; DELETE OUTDATED FILES --
previously approved versions will still be available in Protocol History.
Attachments that are assigned a Document Type to which an IRB approval stamp applies will be considered the version(s) to be
used for enrolling subjects once IRB approval has been issued. 
Document Types that do NOT get an IRB approval stamp are:
"Highlighted Changes",
"Phone Script", and
"Reliance Consent Form",
"Sponsor's Sample Consent Form".
How to Get the Section Check Mark
1. You must:
a) provide a response in the text box below describing how investigators will obtain consent/assent, and 
b) check the box for at least one of the consent items and/or check mark one of the waivers
2. If applicable attach each corresponding document(s) as a read-only PDF.
3. If you no longer need a consent document approved (e.g., closed to enrollment), or, the consent document submitted does not
need a stamp for enrolling subjects (e.g., umbrella study, or sub-study), only select "Stamped Consent Doc(s) Not Needed".
4. After making your selection(s) be sure to scroll to the bottom of this section and SAVE your work!
Check All That Apply
Informed Consent Form (and/or Parental Permission Form and/or translated short form)
Assent Form
Cover Letter (for survey/questionnaire research)
Phone Script
Informed Consent/HIPAA Combined Form
Debriefing and/or Permission to Use Data Form
Reliance Consent Form
Sponsor's sample consent form for Dept. of Health and Human Services (DHHS)-approved protocol
Stamped Consent Doc(s) Not Needed
Attachments
Attach Type
File Name
Informed Consent/HIPAA Combined Form 43499 Massage IRB Consent Clean 101222.pdf
Informed Consent Process:
Using active voice, describe how investigators will obtain consent/assent. Include:
Section 7 Page 1 of 3
43499

the circumstances under which consent will be sought and obtained
the timing of the consent process (including any waiting period between providing information and obtaining consent)
who will seek consent
how you will minimize the possibility of coercion or undue influence
the method used for documenting consent
if applicable, who is authorized to provide permission or consent on behalf of the subject
if applicable, specific instruments or techniques to assess and confirm potential subjects’ understanding of the information
Note: all individuals authorized to obtain informed consent should be designated as such in the E-IRB "Study Personnel" section of
this application.
Special considerations may include:
Obtaining consent/assent for special populations such as children, prisoners, or people with impaired decisional capacity
Research Involving Emancipated Individuals 
If you plan to enroll some or all prospective subjects as emancipated, consult with UK legal counsel prior to submitting this
application to the IRB. Include research legal counsel’s recommendations in the "Additional Information" section as a separate
document.
Research Involving Non-English Speaking Subjects 
For information on inclusion of non-English speaking subjects, or subjects from a foreign culture, see IRB Application Instructions
for Recruiting Non-English Speaking Participants or Participants from a Foreign Culture.
Research Repositories 
If the purpose of this submission is to establish a research repository describe the informed consent process. For guidance
regarding consent issues, process approaches, and sample language see the Sample Repository/Registry/Bank Consent
Template.
Informed consent will be obtained written and orally. The PI or additional researchers listed on Form A will obtain consent from the
subjects and payment will not be made available at this time to ensure consent will be obtained solely on voluntary basis. The method
of documentation includes a written form including the eight federally required elements. Informed consent will be read orally to the
subject and will be made available for the subject to read. Written consent will be obtained prior to any procedures being performed
on each subject including massage and the biopsy.
All subjects will be given contact numbers in case any questions or complaints arise. Questions can be directed to the principal
investigator, Dr. Dupont-Versteegden, who will be in contact with the study physicians performing the biopsies. Should a complaint
arise, subjects will be asked to provide a written account of the complaint while the researchers will also provide their own account of
the situation. All complaints will be collected, reported, and hand delivered to the IRB and ORI.
Request for Waiver of Informed Consent Process
If you are requesting IRB approval to waive the requirement for the informed consent process, or to alter some or all of the
elements of informed consent, complete, Section 1 and Section 2 below.
Note: The IRB does not approve waiver or alteration of the consent process for greater than minimal risk research, except
for planned emergency/acute care research as provided under FDA regulations. Contact ORI for regulations that apply to
single emergency use waiver or acute care research waiver (859-257-9428).
SECTION 1.
Check the appropriate item:
I am requesting a waiver of the requirement for the informed consent process.
I am requesting an alteration of the informed consent process.
If you checked the box for this item, describe which elements of consent will be altered and/or omitted, and justify the
alteration.
SECTION 2.
Explain how each condition applies to your research.
a) The research involves no more than minimal risk to the subject.
b) The rights and welfare of subjects will not be adversely affected.
c) The research could not practicably be carried out without the requested waiver or alteration.
d) Whenever possible, the subjects or legally authorized representatives will be provided with additional pertinent information
after they have participated in the study.
Section 7 Page 2 of 3
43499

Request for Waiver of Signatures
If you are requesting IRB approval to waive the requirement for signatures on informed consent forms, your research
activities must fit into one of three regulatory options:
1. The only record linking the participant and the research would be the consent document, and the principal risk would be
potential harm resulting from a breach of confidentiality (e.g., a study that involves participants who use illegal drugs).
2. The research presents no more than minimal risk to the participant and involves no procedures for which written consent
is normally required outside of the research context (e.g., a cover letter on a survey, or a phone script).
3. The participant (or legally authorized representative) is a member of a distinct cultural group or community in which
signing forms is not the norm, the research presents no more than minimal risk to the subject, and there is an appropriate
alternative mechanism for documenting that informed consent was obtained.
Select the option below that best fits your study. 
If the IRB approves a waiver of signatures, participants must still be provided oral or written information about the study.
To ensure you include required elements in your consent document, use the Cover Letter Template as a guide. There is
an English and a Spanish version.
 
Option 1
Describe how your study meets these criteria:
a) The only record linking the participant and the research would be the consent document:
b) The principal risk would be potential harm resulting from a breach of confidentiality (i.e., a study that involves subjects
who use illegal drugs).
Under this option, each participant (or legally authorized representative) must be asked whether (s)he wants to sign a
consent document; if the participant agrees to sign a consent document, only an IRB approved version should be
used.
Option 2
Describe how your study meets these criteria:
a) The research presents no more than minimal risk to the participant:
b) Involves no procedures for which written consent is normally required outside of the research context (i.e. a cover
letter on a survey, or a phone script):
Option 3
Describe how your study meets these criteria:
a) The subject (or legally authorized representative) is a member of a distinct cultural group or community in which
signing forms is not the norm.
b) The research presents no more than minimal risk to the subject.
c) There is an appropriate alternative mechanism for documenting that informed consent was obtained.
Section 7 Page 3 of 3
43499

STUDY PERSONNEL
0 unresolved comment(s)
Do you have study personnel who will be assisting with the research?
After selecting 'Yes' or 'No' you must click the 'Save Study Personnel Information' button. 
Yes
No
Manage Study Personnel
Identify other study personnel assisting in research project:
The individual listed as PI in the 'PI Contact Information' section should NOT be added to this section.
If the research is required for a University of Kentucky academic program, the faculty advisor is also considered study personnel and should be listed below.
***Residents and students who are PI’s are encouraged to designate the faculty advisor or at least one other individual as a contact with an editor role (DP).***
Role: DP = Editor (individual can view, navigate, and edit the application for any review phase (IR, CR/FR, MR) or 'Other Review", and submit Other Reviews on
behalf of the PI.)
Role: SP = Reader (individual can view and navigate through the currently approved application only.)
To add an individual via the below feature:
Search for personnel;
Click "select" by the listing for the person you want to add;
For each person, specify responsibility in the project, whether authorized to obtain informed consent, AND denote who should receive E-IRB notifications (contact
status).
NOTE: Study personnel must complete human subject protection (HSP) and Responsible Conduct of Research (RCR) training before implementing any
research procedures. For information about training requirements for study personnel, visit UK’s HSP FAQ page, the RCR Getting Started page, or
contact ORI at 859-257-9428. If you have documentation of current HSP training other than that acquired through UK CITI, you may submit it to ORI
(HSPTrainingSupport@uky.edu) for credit.
Study personnel assisting in research project: 
Last
Name
First
Name
Responsibility In
Project
Role
A
C
Contact
Degree
StatusFlag
(HSP)
(HSP)Date
(RCR)
Removed?
Last
Updated
SFI
Biddle
Martha
Project
Assistance/Support
SP
N
N
 
P
Y
10/28/2020
Y
N
12/16/2019
N
Brown
Paul
Project
Assistance/Support
SP
N
N
 
P
Y
09/22/2020
Y
N
08/31/2022
N
Bruns
Reva
Project
Assistance/Support
SP
N
N
 
P
Y
02/21/2023
Y
N
12/16/2019
N
Buckler
Regan
Project
Assistance/Support
SP
N
N
 
P
Y
04/14/2021
Y
N
05/20/2021
N
Butterfield
Timothy
Co-Investigator
SP
Y
N
 
P
Y
04/22/2020
Y
N
01/23/2018
N
Camper
Zenith
Data Collection
SP
N
N
 
P
Y
02/08/2023
Y
N
02/22/2023
N
Cole
Jill
Project
Assistance/Support
SP
N
N
 
P
Y
02/21/2023
Y
N
12/16/2019
N
Confides
Amy
Project
Assistance/Support
SP
N
N
 
P
N
02/18/2020
Y
N
04/08/2020
N
Devine
Amber
Project
Assistance/Support
SP
N
N
 
P
Y
11/23/2021
Y
N
08/31/2022
N
Finch
Megan
Project
Assistance/Support
SP
N
N
 
P
Y
08/08/2022
Y
N
08/31/2022
N
Forenback
Denece
Project
Assistance/Support
SP
N
N
 
P
Y
01/08/2021
Y
N
02/25/2021
N
Gamble
Bethanie
Project
Assistance/Support
SP
N
N
 
P
Y
10/03/2022
Y
N
10/11/2022
N
Hommel
Leta
Project
Assistance/Support
SP
N
N
 
P
Y
01/18/2022
Y
N
01/23/2018
N
Kern
Philip
Co-Investigator
SP
N
N
 
P
Y
07/03/2020
Y
N
01/23/2018
N
Long
Douglas
Study Coordinator
DP
Y
Y
 
P
Y
02/17/2022
Y
N
01/23/2018
N
Mandal
Prabin
Project
Assistance/Support
SP
N
N
 
P
Y
06/27/2022
Y
N
08/31/2022
N
Maynard
Marshall
Project
Assistance/Support
SP
N
N
 
P
Y
06/16/2022
Y
N
08/31/2022
N
Moylan
Jennifer
Project
Assistance/Support
SP
N
N
 
P
Y
09/10/2020
Y
N
01/23/2018
N
Nieto
Alayne
Data Collection
SP
N
N
 
P
Y
05/16/2022
Y
N
02/22/2023
N
Ross
James
Project
Assistance/Support
SP
N
N
 
P
Y
04/27/2022
Y
N
08/31/2022
N
Section 8 Page 1 of 2
43499

Last
Name
First
Name
Responsibility In
Project
Role
A
C
Contact
Degree
StatusFlag
(HSP)
(HSP)Date
(RCR)
Removed?
Last
Updated
SFI
Swain
Audrie
Project
Assistance/Support
SP
N
N
 
P
Y
02/11/2022
Y
N
08/31/2022
N
Vincent
Sylvia
Project
Assistance/Support
SP
N
N
 
P
Y
02/16/2021
Y
N
08/31/2022
N
Watts
Linda
Project
Assistance/Support
SP
N
N
 
P
Y
11/10/2021
Y
N
10/24/2022
N
Allman
Ariel
Project
Assistance/Support
SP
N
N
 
P
N
07/28/2015
 
Y
01/23/2018
N
Bowlds
Hannah
Project
Assistance/Support
SP
N
N
 
P
Y
08/03/2020
Y
Y
03/28/2023
N
Chamblin
Lisa
Project
Assistance/Support
SP
N
N
 
P
Y
08/02/2022
Y
Y
02/25/2021
N
DeCoster
Ryan
Project
Assistance/Support
SP
Y
N
 
S
N
09/04/2019
 
Y
01/23/2018
N
Eisenhut
Sarah
Project
Assistance/Support
SP
N
N
 
P
N
07/29/2015
 
Y
01/23/2018
N
Elgumati
Sumya
Project
Assistance/Support
SP
N
N
 
P
N
03/25/2017
 
Y
09/13/2020
N
Farrar
Nicholas
Project
Assistance/Support
SP
N
N
 
P
N
10/31/2016
 
Y
01/23/2018
N
Holbrook
Kathryn
Project
Assistance/Support
SP
N
N
 
P
N
12/12/2018
N
Y
02/25/2021
N
Hunt
Emily
Project
Assistance/Support
SP
Y
N
 
P
N
01/24/2018
 
Y
07/28/2021
N
Kaenzig
Janet
Project
Assistance/Support
SP
N
N
 
P
Y
05/09/2021
Y
Y
12/14/2018
N
Memmini
Allyssa
Project
Assistance/Support
SP
N
N
 
P
N
09/16/2016
 
Y
01/23/2018
N
Minix
Kathleen
Project
Assistance/Support
SP
N
N
 
P
Y
04/12/2021
Y
Y
02/22/2023
N
Rice
Linda
Project
Assistance/Support
SP
N
N
 
P
Y
09/10/2021
Y
Y
05/16/2022
N
Skaggs
Kylee
Project
Assistance/Support
SP
N
N
 
P
Y
11/01/2022
Y
Y
02/22/2023
N
Smith
Kayla
Project
Assistance/Support
SP
N
N
 
P
N
06/04/2019
N
Y
07/28/2021
N
Stiehler
Julie
Project
Assistance/Support
SP
N
N
 
P
Y
04/15/2021
Y
Y
05/16/2022
N
Tillery
Melanie
Project
Assistance/Support
SP
N
N
 
P
Y
10/05/2021
Y
Y
02/22/2023
N
True
Laura
Project
Assistance/Support
SP
N
N
 
P
N
04/13/2020
N
Y
07/28/2021
N
Van Pelt Jr
Douglas
Project
Assistance/Support
SP
Y
N
 
S
Y
08/26/2020
N
Y
07/28/2021
N
Section 8 Page 2 of 2
43499

RESEARCH DESCRIPTION
0 unresolved
comment(s)
You may attach a sponsor’s protocol pages in the “Additional Information” section and refer to them where necessary in
the Research Description. However, each prompt that applies to your study should contain at least a summary paragraph.
Pro Tips:
Save your work often to avoid losing data.
Use one of the attachment buttons in this section or under the Additional Information section to include supplemental
information with your application. During the document upload process, you will be able to provide a brief description
of the attachment.
Background
Include a brief review of existing literature in the area of your research. You should identify gaps in knowledge that should be addressed
and explain how your research will address those gaps or contribute to existing knowledge in this area. For interventional research,
search PubMed and ClinicalTrials.gov for duplicative ongoing and completed trials with same condition and intervention(s).
Massage is considered a manipulative and body-based therapy in complementary and integrative medicine (CIM). With about 18
million individuals undergoing massage therapy annually, it is the 5th most widely used form of CIM in the U.S.1 It is defined as “a
mechanical manipulation of body tissues with rhythmical pressure and stroking for the purpose of promoting health and well-being.”2
There are many different techniques of massage with Swedish massage, a combination of effleurage, petrissage, friction, vibration,
and percussion, being one of the most common.3 The proposed benefits of massage, as stated by the American Massage Therapy
Association (AMTA), are relief of muscle tension and stiffness, faster healing of strained muscles and sprained ligaments, reduced
muscle pain, swelling and spasm, greater joint flexibility and range of motion, and even enhanced athletic performance.4 Evidence has
also shown massage to have an influence on immune function, depression, relaxation/sleep, and overall quality of life.4-6
With several cited and reported benefits of massage, and the increased usage of it as a treatment option, more research is needed to
provide evidence of it as an effective and valid treatment. If research continues to prove it to be safe and effective, more health care
professionals can use and suggest it as a treatment option and more insurance companies will likely begin to cover the costs of these
treatments. Previous literature, however, has concluded that more standardized controlled techniques are needed in massage
research to truly validate its effectiveness.3
Animal research has clarified many uncertainties associated with massage but whether or not these findings are applicable to humans
has yet to be determined. It is unknown if the same physiological effects seen in animals are seen in humans, and whether a similar
dosage produces those effects. Crane et al.7 were the first to perform a mechanistic study on the effects of massage on human
tissue. Their results revealed that massage may be beneficial in reducing inflammation and promoting mitochondrial biogenesis in
skeletal muscle that has been acutely damaged after exercise.7 
Skeletal muscle plays a significant role in maintaining function and contributing to our overall health.8 Conditions that involve
immobilization, bed rest, or any other types of disuse cause atrophy and several other effects in muscle tissue. Due to the impaired
muscle function associated with atrophy9, it is vital, clinically, to find interventions that attenuate or even possibly reverse muscle
atrophy that is commonly caused by disuse. It would be ideal to find interventions that patients who are not able to exercise, such as
those in the intensive care unit (ICU), can receive to help maintain their skeletal muscle integrity and function.
Our preliminary data on rats have shown that massage has an anabolic effect in growth-perturbed muscles. Massage enhanced protein
synthesis and muscle size in animals undergoing regrowth after atrophy. Also, massage applied during a period of disuse-induced
atrophy attenuated muscle loss and reversed the level of protein synthesis to normal. However, unperturbed muscle did not show this
growth-promoting effect. These results indicate that massage could serve as an intervention for the loss of muscle during atrophy and
aid in regrowth. However, studies in humans have not been performed yet.
The unilateral lower limb suspension (ULLS) method has been recently developed to mimic the 0-g conditions in space and assist in
assessing the efficacy of interventions to combat muscle atrophy and facilitating in-vivo muscle performance studies.10 ULLS has
been shown to mimic bed rest and is a valid technique.11 Just as muscle tissue responds to loading, muscle responds to unloading as
well. Unloading a muscle can result in muscle atrophy at a weekly rate of about 2.5% particularly for knee extensors.10 Short term
ULLS (10-16 days) doesn’t seem to result in large macroscopic changes in muscle size or CSA but individual muscle fiber size has
been shown to decrease at a weekly rate that varies between 3-8% across different studies.10 In specific studies, increased markers
for muscle proteolysis were found after 3 days of ULLS10 and protein synthesis rate appeared to decrease after 10 days of ULLS.9
ULLS is a well-accepted model for disuse-induced muscle atrophy.10 There are few systemic or general deconditioning effects that
have been discovered from incorporating ULLS into research procedures.10 Overall, ULLS has been shown to be a valid, practical,
and cost-effective method to induce atrophy and study the effects on skeletal muscle.10
Objectives
List your research objectives. Please include a summary of intended research objectives in the box below.
The objective of this study is to determine if an optimal load of massage induces protein synthesis and increases cross sectional area
Section 9 Page 1 of 10
43499

in unperturbed or atrophied human skeletal muscle tissue. In addition, we will determine whether an optimal load induces muscle
damage and causes a satellite cell response in control and atrophied human skeletal muscle tissue while also examining extracellular
vesicles and their possible role in a physiological phenomenon called the crossover effect. We hypothesize that 15 min of massage
with a 35 N load for 4 days will not induce muscle damage but will still cause an increase of satellite cells, extracellular vesicles, as well
as in cross sectional area and protein synthesis.
Study Design
Describe and explain the study design (e.g., observational, secondary analysis, single/double blind, parallel, crossover, deception, etc.).
Clinical Research: Indicate whether subjects will be randomized and whether subjects will receive any placebo.
Community-Based Participatory Research: If you are conducting community-based participatory research (CBPR), describe
strategies for involvement of community members in the design and implementation of the study, and dissemination of results from
the study.
Qualitative research: Indicate ranges where flexibility is needed, if a fixed interview transcript is not available, describe interview
topics including the most sensitive potential questions.
Research Repositories: If the purpose of this submission is to establish a Research Repository (bank, registry) and the material
you plan to collect is already available from a commercial supplier, clinical lab, or established IRB approved research repository,
provide scientific justification for establishing an additional repository collecting duplicate material. Describe the repository design
and operating procedures. For relevant information to include, see the UK Research Biospecimen Bank Guidance or the UK
Research Registry Guidance.
This study is designed as a randomized control trial. Figure 1 shows the time line for the study. There will be four groups of subjects,
(1) normal weight-bearing with massage (WB-M), (2) normal weight bearing without massage (WB-C) (3) ULLS, no massage (control,
U-C), and (4) ULLS with massage (U-M). We expect to recruit 140 subjects to in order in fully enroll 128 (32 per group, n = 3 per group
for attrition). For measurement of protein synthesis, participants will ingest three 50 mL doses of heavy water (2H2O) for the first two
days and the dose will decrease to two 50 mL doses per day (a total of 1000 mL of heavy water for each subject over the course of
the trial). 3-4 blood draws will be taken on days 2, 5, 7, and 9 and each will be drawn at the same time each day. Subjects in U-C and U-
M groups will have their left leg immobilized and suspended using a hinged knee brace. Those immobilized will be required to wear the
brace and use crutches at all times, except while showering and sleeping. Immobilization will begin on day 2 and will continue until the
end of the study (day 9). Members of the research team will use a custom-made device to massage the quadriceps region of subjects’
left leg and leave the right leg unaffected in the WB-M and U-M groups. Massage treatments will begin on day 3 and will take place
every other day (day 5, 7, 9) until the end of the study. A baseline muscle biopsy of the vastus lateralis will be taken from the right leg
on day 2, prior to the first massage. Muscle biopsies will then be taken from both legs 4-6 hours after the last massage on day 9, and
the muscle tissue will be frozen for further examination. (See Figure 1). Sham treatment for the WB-C and U-C groups will include us
touching the skin using a light brushing technique.
For the weight bearing groups as comparison groups,they will also have to drink deuterium oxide heavy water over 9 days which is
associated with 3-4 blood draws but will not have to wear a brace or use crutches. Weight bearing control groups will only have one
biopsy taken on day 9 while weight bearing massage groups will have two biopsies taken (day 2- right leg, and day 9- left massaged
leg). This will still allow for effective comparison between groups and will reduce burden on these participants. We will enroll the weight
bearing groups after immobilization groups to ensure that those interested in the study will not drop out after possible randomization
into the immobilization group.
Attachments
Subject Recruitment Methods & Advertising
Describe how the study team will identify and recruit subjects. Please consider the following items and provide additional information as
needed so that the IRB can follow each step of the recruitment process.
How will the study team identify potential participants?
Who will first contact the potential subjects, and how?
Will you use advertisements? If so, how will you distribute those?
How and where will the research team meet with potential participants?
If applicable, describe proposed outreach programs for recruiting women, minorities, or disparate populations.
How you will minimize undue influence in recruitment?
Attach copies of all recruiting and advertising materials (emails, verbal scripts, flyers, posts, messages, etc.).
For additional information on recruiting and advertising:
IRB Application Instructions - Advertisements
PI Guide to Identification and Recruitment of Human Subjects for Research
Information regarding the study will be made available to students and personnel at the University of Kentucky, Lexington campus,
using flyers. Individuals who work or study under the faculty member(s) of the study staff will be excluded from the study. Subjects may
be recruited from other ongoing or concluded studies. If eligible subjects express interest in participation, we will contact the subject
via e-mail or phone. There will be an opportunity for subjects to ask any individual questions before informed consent is obtained.
Informed consent will be obtained prior to the beginning of testing for inclusion/exclusion criteria. Participants will be chosen based on
their availability and embodying healthy status as indicated in our inclusion and exclusion criteria.
Information regarding the study will be made available to students and personnel at the University of Kentucky, Lexington campus,
using flyers. The CCTS has an extensive marketing and recruitment program who will advise us on optimal recruiting strategies. These
Section 9 Page 2 of 10
43499

strategies may include:
Print advertisements: The study will recruit subjects through flyers, brochures, posters, Research Spotlights, ads placed on campus
and in the surrounding community and region (Study Team will place/remove ads), including but not limited to the UK Medical Center,
UK Clinics, Good Samaritan Hospital, Student Center, UHS, the 5 UK Center for Clinical and Translational Research wall mounts,
Cardinal Hill, monitor screens, and area facilities and businesses. 
Internet and Social Media: This study will be advertised on recruitment internet webpages in digital or video form (e.g.,
UKclinicalresearch.com, ResearchMatch.org, CenterWatch.com, CISCRP, UK, CCTS and may utilize Google Adwords). The study will
be promoted via social media, including Facebook boost ads, UK_CCTS Facebook, UK_CCTS Twitter, UK_CCTS Instagram, UK and
UKHC social media, and departmental/lab pages. If advertised on UKClinicalresearch.com, the online study flyer will include an option
for interested individuals to enter and submit their contact information, they will be asked whether study team can contact them (Yes or
No) via study-related text messages, and CCTS will also ask, ‘How did you learn about the study? Internet and social media
recruitment will follow the terms of use for each site utilized. The study will also be promoted through UK HC monitor screens. 
Research Participant Registries: Potential participants may be identified from registry databases, including but not limited to
ResearchMatch.org*, Wellness Health and You, Sanders Brown Center on Aging, Infectious Disease, Dentistry, and the Markey
Cancer Center.
*ResearchMatch.org will be utilized as a recruitment tool for this protocol. ResearchMatch.org is a national electronic, web-based
recruitment tool that was created through the Clinical & Translational Science Awards Consortium in 2009 and is maintained at
Vanderbilt University as an IRB-approved data repository (see IRB #090207)." Once UK IRB approval is obtained the researcher or
proxy will upload a flyer with no contact information will by email via ResearchMatch to selected de-identified participants in the
ResearchMatch registry. If the de-identified participant selects “Yes, I’m interested!” the researcher or proxy will receive information
about participant and they may contact them with more information about their research study. If the participant selects “No, thanks”,
researcher or proxy will not receive any information from de-identified participant.
Outreach activities: The CCTS attends outreach activities to promote research participation in general (e.g., Roots & Heritage Festival,
Latino Festival, Eastern Kentucky University, Transylvania Health fairs, etc.) and will brings all relevant study flyers that are enrolling
participants.
Attachments
Attach Type
File Name
Advertising
REHAB-191 MON[1] MP edit APPROVED.pdf
Advertising
REHAB-191_flyerAPPROVED.pdf
Advertising
REHAB-191_ResearchMatch email APPROVED.pdf
Advertising
REHAB-191_SocialMedia APPROVED.pdf
Section 9 Page 3 of 10
43499

Back to Top
Research Procedures
Describe how the research will be conducted.
What experience will study participants have?
What will study participants be expected to do?
How long will the study last?
Outline the schedule and timing of study procedures.
Provide visit-by-visit listing of all procedures that will take place.
Identify all procedures that will be carried out with each group of participants.
Describe deception and debrief procedures if deception is involved.
Differentiate between procedures that involve standard/routine clinical care and those that will be performed specifically for this
research project. List medications that are explicitly forbidden or permitted during study participation.
Cyclic Compressive Loading (CCL) Device Reliability and Validity Testing:
Forty participants will be requested to participate in pilot testing of the CCL device. This testing will be used to validate the equipment.
Two different clinicians will massage all participants for 15 minutes on two separate days. The load applied to the tissue will be
measured and compared between clinicians and days. This will allow analysis of inter-rater reliability and test-retest reliability. The
same inclusion and exclusion criteria for the participants will be used as in the original study.
Medical Health Questionnaire:
Potential subjects will be verbally screened to see if they are eligible for this study.
Heavy Water:
Deuterium oxide heavy water (2H2O) is a stable, non-radioactive isotope that is indistinguishable from normal water. It is simply water
that has a higher amount of a natural, but less abundant, form of hydrogen. Subjects will be required to ingest the heavy water for 9
days. (99% D2O, Cambridge Isotope Laboratories). A target of 1-2% enrichment is achieved during a one week priming stage and
maintained for the remainder of the study. Subjects will be sent home with 50 mL doses of heavy water in sealed sterile vials. The first
two days, they will consume one 50 mL vial of the heavy water three times a day (150mL/day). The next 7 days, they will consume one
50 mL vial twice a day (100mL/day). This will total 1000mL of water per subject. Over the course of the 9 day trial, the subjects’ blood
will be drawn on day 2, 5, 7, and 9. 
Blood Draws:
Blood samples will be obtained for protein synthesis measures and for the assessment of exosomes and circulating miRNAs. Left
over blood will be stored in the lab indefinitely. Approximately 5-25 ml will be drawn.
Immobilization: 
Participants of the immobilization/massage and immobilization/no massage groups will be placed in a knee immobilizer on their left leg
and crutches, and will be non-weight-bearing starting on day 2 (after the first two days of heavy water intake) of the 9 day trial for a total
of 7 days. The participants will be required to log and explain on the attached Immobilization Time Log any time they did not use/wear
the crutches or knee immobilizer in order to track compliance. 
Massage: 
Subjects will report to the Human Performance Lab, in room B04A of the Multidisciplinary Science building. A custom-made cyclic
compressive loading (CCL) device will be used to apply a mechanical load to the left thigh starting on day 3. The knee immobilizer will
be removed, and the subjects will be positioned right lateral recumbent with their left hip and leg slightly flexed and the left leg
supported by a wedge to maintain anatomical position in the frontal plane. The CCL device will be a commercially available massage
roller instrumented with a strain gage to measure applied load. Massage application using a 35 newton load will be applied for 15
minutes every other day over the course of 7 days (days 3, 5, 7, and 9). The CCL device will be placed 10cm proximal to the superior
pole of the patella over the vastus lateralis muscle of the left leg, and a normal force of 35N will be applied while rolling the device
proximally along the length of the vastus lateralis at a rate equal to one muscle length over 2 seconds. Without interruption, the
direction of the massage will then be reversed and the same load and loading rate will be applied proximal to distal. Thus, one
complete cycle of massage to the vastus lateralis will take 4 seconds, corresponding to a duty cycle of 0.25Hz. Massage will continue
for 15 minutes, resulting in approximately 225 complete cycles. Sham treatment (WB-C and U-C) groups will receive a light touching
on the skin using a light brushing technique. 
We have previously shown that the beneficial effects of massage can be optimized by application of the appropriate dose12, including
considerations for timing of massage application13, duration of massage14 and the magnitude of applied load.5,12 Therefore, we
have used allometric scaling laws to calculate optimal loads based on our early investigations demonstrating effectiveness of
massage for limiting inflammation and accelerating recovery after injury in rabbit skeletal muscle.15 We have used this method to
successfully scale the optimized loads to rats5 and have applied the same methods to calculate the appropriate loads for human
massage. We have determined that the optimal load for human vastus lateralis is a normal force of 35N.
Muscle Biopsies:
On day 2 of the study (after the first two days of heavy water intake), a baseline muscle biopsy will be taken from the vastus lateralis
muscle of the right leg. Subjects will be instructed not to eat or drink anything for breakfast the last day of the study when they come in
for the last massage and the biopsies. Subjects will be provided a light breakfast consisting of a choice of bagel with cream cheese or
Section 9 Page 4 of 10
43499

granola bar or muffin with banana and orange juice. Four hours after the last bout of massage one muscle biopsy will be taken from the
left and the right vastus lateralis each. Biopsies (100-300 mg tissue) will be taken by one of the two physicians on the study or the
physician assistants listed in the protocol. The tissue will be frozen for analysis by the experimenters. In exercise literature a waiting
period of about 2-6 hours is what is shown to demonstrate changes in the expression of genes associated with muscle size
regulation.16,17 In an effort to respect the subjects’ time, a waiting period of 4-6 hours was decided. The subjects are allowed to walk
around after the massaging, but are asked to refrain from exercising for the 4 hours in between the massage treatment and the muscle
biopsy.
Muscle Biopsy Procedure: 
A muscle biopsy sample will be obtained from the vastus lateralis. The biopsy procedure will proceed as follows for each subject
taking approximately 45 minutes. Subjects will report to the procedural room located in the Center for Clinical and Translational
Science (CCTS). Subjects will lie down and have a 1 inch by 1 inch portion of hair removed with a disposable razor on the outer
surface of the thigh as necessary. The site will then be cleaned with alcohol followed by the application of Betadine. A local anesthetic
(1% Xylocaine HCl, 3cc) will be used to numb an area the size of a quarter on the site of the outer thigh over the vastus lateralis muscle
approximately a hand width above the knee using a 23-gauge, 1 inch needle, subcutaneously. Anesthetic will further be injected into
the subcutaneous space of the numbed area from the muscle to the dermis. After 5-10 minutes, a sterile scalpel will be used to test
for numbness before the procedure proceeds. In our experience, 5 minutes is adequate to sufficiently numb the area for the biopsy
procedure. A ¼ inch wide incision will be made through the skin in the center of the anesthetized area with a sterile, single-use, #11
disposable scalpel. The incision needs to perforate the fascia of the vastus lateralis muscle sufficiently to allow for subsequent entry
of the biopsy needle. The depth of the incision will be adjusted to accommodate estimated subcutaneous fat depth. A sterile 5 mm
Berkstrom biopsy needle (Pelomi Industries, Denmark) will be passed through the ¼ inch incision into the muscle and a small piece
(the size of a pencil eraser, equal to ~ 100-300 mg) of muscle will be removed. The angle of entry for the biopsy will be medial to
lateral. The biopsy team will use the suction biopsy technique, whereby a small amount of suction with a Monoject 60cc syringe
attached via sterile tubing to the end of the trocar will be applied to the needle prior to closing of the trocar, which enhances the
investigators’ ability to maximize the amount of muscle obtained. A conchotome may also be used to remove the muscle. Manual
pressure will be applied to the wound until bleeding stops. The muscle biopsy site will be cleaned with an alcohol preparation to clear
all betadine and standard procedures will be used to close the wound. The biopsied area will be covered with gauze and a pressure
wrap applied. The muscle tissue obtained will be divided into pieces and processed for analysis of muscle phenotype.
COVID-19 testing: 
During the pandemic, participants will be required to have a negative COVID-19 test before undergoing any muscle biopsy until further
notice.
Attachments
Data Collection & Research Materials
In this section, please provide the following:
Describe all sources or methods for obtaining research materials about or from living individuals (such as specimens, records,
surveys, interviews, participant observation, etc.), and explain why this information is needed to conduct the study.
For each source or method described, please list or attach all data to be collected (such as genetic information, interview scripts,
survey tools, data collection forms for existing data, etc.).
If you will conduct a record or chart review, list the beginning and end dates of the records you will view.
Demographic information
Results of blood tests after ingestion of heavy water
Analysis of muscle biopsies
Social Security Number
Attachments
Resources
Describe the availability of the resources and adequacy of the facilities that you will use to perform the research. Such resources may
include:
Staffing and personnel, in terms of availability, number, expertise, and experience;
Computer or other technological resources, mobile or otherwise, required or created during the conduct of the research;
Psychological, social, or medical services, including equipment needed to protect subjects, medical monitoring, ancillary care, or
counseling or social support services that may be required because of research participation;
Resources for communication with subjects, such as language translation/interpretation services.
This protocol will be performed at the CCTS. The CCTS comprises a research staff that is specially trained to make complex research
observations and accurate patient assessments and documentation, to utilize precision in the collection and processing of specimens
for research purposes, and to implement exemplary safe patient care practices. This unit is available to conduct research procedures
for investigators throughout the institution or, under certain conditions, outside the institution.
All muscle tissue will be used in the laboratory of Dr. Dupont-Versteegden and Dr. Butterfield.
Section 9 Page 5 of 10
43499

Potential Risks & Benefits
Risks
Describe any potential risks – including physical, psychological, social, legal, ability to re-identify subjects, or other risks. Assess
the seriousness and likelihood of each risk.
Which risks may affect a subject’s willingness to participate in the study?
Describe likely adverse effects of drugs, biologics, devices or procedures participants may encounter while in the study.
Qualitative research - describe ethical issues that could arise while conducting research in the field and strategies you may use to
handle those situations.
Describe any steps to mitigate these risks.
Benefits
Describe potential direct benefits to study participants – including diagnostic or therapeutic, physical, psychological or emotional,
learning benefits. This cannot include incentives or payments.
State if there are no direct benefits.
Describe potential benefits to society and/or general knowledge to be gained.
Describe why potential benefits are reasonable in relation to potential risks. If applicable, justify why risks to vulnerable subjects are
reasonable to potential benefits.
There are some potential risks associated with the procedures presented in this protocol.
Muscle Biopsies: With the biopsy procedures, there is a risk of bleeding, bruising, pain, infection, and scarring of the skin. Bleeding
could rarely result in development of a hematoma. Pain and soreness usually resolves within 24-48 hrs post-procedure. Numbness of
the skin near the biopsy site may occur and is usually temporary, but this numbness may persist indefinitely. An allergic reaction to the
anesthetic also may occur but is rarely seen.
Heavy Water (2H2O): The only side effect reported by others is (in rare subjects) a sensation of dizziness or vertigo soon after the first
dose. This is presumed to be due to a disequilibrium between H2O and 2H2O in the inner ear, and some subjects are sensitive to this.
This side effect, when it occurs, goes away and the initial dosing will occur in the CCTS where subjects are monitored. 
Blood Draws: With drawing blood, there is a risk of soreness, bruising, pain, infection, bleeding, and fainting. Any pain, bruising, or
soreness will usually resolve without any treatment. Any infection, bleeding, or fainting can be treated. 
Massage: The only side effect reported from massage is possible soreness during and/or after the session. It will go away with or
without treatment within 24-48 hours so treatment is not required.
Immobilization: With use of the knee brace there is a risk of chaffing, muscle atrophy of the immobilized leg, and muscle soreness of
the non-immobilized leg. It is important to note that all effects with use of the knee brace are reversible.
Participants will receive no personal benefit by becoming involved with this study. However, subjects are helping the investigators gain
knowledge to better understand the effect of massage on healthy human muscle and to possibly help identify therapies associated
with massage.
Available Alternative Opportunities/Treatments
Describe alternative treatments or opportunities that might be available to those who choose not to participate in the study, and which
offer the subject equal or greater advantages. If applicable, this should include a discussion of the current standard of care treatment(s).
Participation in this study is strictly voluntary. There are no other alternative treatments, procedures, or choices for the subjects except
for not to participate in the study.
Back to Top
Records, Privacy, and Confidentiality
Specify where the data and/or specimens will be stored and how the researcher will ensure the privacy and confidentiality of both.
Specify who will have access to the data/specimens and why they need access.
Describe how data will be managed after the study is complete:
If data/specimens will be maintained, specify whether identifiers will be removed from the maintained information/material.
If identifiers will not be removed, provide justification for retaining them and describe how you will protect confidentiality.
If the data/specimens will be destroyed, verify that this will not violate retention policies and will adhere to applicable facility
requirements.
If this study will use de-identified data from another source, describe what measures will be taken to ensure that subject identifiers are
not given to the investigator.
If applicable, describe procedures for sharing data/specimens with collaborators not affiliated with UK.
For additional considerations: 
Return of Research Results or Incidental Research Findings 
HIPAA policies 
FERPA policies 
Section 9 Page 6 of 10
43499

Procedures for Transfer agreements 
Information regarding multi-site studies 
NIH Genomic Data Sharing (GDS) Policy 
Digital Data
Materials obtained in this study are for the primary purpose of research. Materials will include the muscle biopsy analysis. Muscle
biopsies will be stored in the laboratories of Drs. Dupont-Versteegden and Butterfield. For confidentiality and privacy, each subject will
be given a study identification number. All electronic data will be stored on an encrypted jump drive and any information will be
transferred on a password-protected computer. All hardcopy data will be locked in a filing cabinet found within a locked office located
within the College of Health Sciences offices. Only approved study personnel will have access to this locked office.
All data will be either stored in locked file cabinets, on secured password protected computer spreadsheets, within the investigator’s
laboratories (after the tissue has been de-identified). Each subject will be identified using only a study identification number and the
investigators of this study will keep private all research records that identify the subjects. The information obtained from this research
will be combined and presented in written materials, but these materials will not contain any subject identification. Only personnel
associated with this study will have access to the data and to keep information confined, all subject information will be kept under lock
and key.
All procedures proposed as part of this research protocol will be conducted or supervised by trained and experienced professionals in
their fields. For the muscle biopsy samples, appropriate technique and all usual precautions including sterilization to help avoid any risk
associated with these procedures will be taken. Patients will be asked to discontinue medications that may be associated with
excessive bleeding, including aspirin and non-steroidal anti-inflammatory drugs, for at least five days prior to the biopsy procedure. We
will recommend that patients remain active following the procedure which may mitigate against the pain and soreness/tightness post
procedure. Post-procedure analgesics will be provided if requested and if medically appropriate, but the individual will be responsible
for cost as outlined in “What happens if you get hurt or sick”. All participants will be given an instruction sheet for post-muscle biopsy
care with phone contact numbers (Appendix G). The responsible study physician and an established method of contact for the study
personnel to this study physician will be in place at the time of the biopsy. The research coordinator will follow up with the participant
day 1 and day 2 after the muscle biopsy. The study physician will arrange a visit to evaluate the biopsy site if there are any concerns
expressed by the participant or if there is any concern by study personnel. In case of an adverse event during the procedure,
personnel will have access to an AED located close by and will be trained in both CPR and AED. Confidentiality will be maintained at
all times. All data and specimens will be stored in a locked office or laboratory where it can be only accessed by study personnel.
Subject information will not be discussed outside of the research team.
UK IRB policies state that IRB-related research records must be retained for a minimum of 6 years after study closure. Do
you confirm that you will retain all IRB-related records for a minimum of 6 years after study closure?
Yes
No
Payment
Describe the incentives (monetary or other) being offered to subjects for their participation. If monetary compensation is offered,
indicate the amount and describe the terms and schedule of payment. Please review this guidance for more information on payments to
subjects, including restrictions and expectations.
Participants will receive compensation based on which group they are randomly assigned to. All participants will receive $15 for blood
draws and $50 per biopsy. Those assigned to the immobilization group will receive $100 for unloading. The participants will receive a
$65 bonus for completion of the study for a total of $375 if they are in the immobilization groups and $130-$180 for weight bearing
control groups.
Costs to Subjects
Include a list of services and/or tests that will not be paid for by the sponsor and/or the study (e.g., MRI, HIV). Keep in mind that a
subject will not know what is “standard” – and thus not covered by the sponsor/study – unless you tell them.
There will be no costs to the participants.
Data and Safety Monitoring
The IRB requires review and approval of data and safety monitoring plans for greater than minimal risk research or NIH-funded/FDA-
regulated clinical investigations.
If you are conducting greater than minimal risk research, or your clinical investigation is NIH-funded, describe your Data and Safety
Monitoring Plan (DSMP). Click here for additional guidance on developing a Data and Safety Monitoring Plan.
If this is a non-sponsored investigator-initiated protocol considered greater than minimal risk research, and if you are planning on
using a Data and Safety Monitoring Board (DSMB) as part of your DSMP, click here for additional guidance for information to
include with your IRB application.
Because this protocol involves muscle biopsy procedures, the study will be monitored by a Data and Safety Monitoring Board (DSMB).
The UK CCTS has a standing DSMB and this established board will monitor this study for recruitment, adverse events, and
compliance, and report to the IRB every 6 months. The DSMB is chartered to comply with the regulatory needs of a broad spectrum of
Section 9 Page 7 of 10
43499

institutional protocols and are familiar with the compliance requirements of federal agencies. The DSMB will review protocol
performance, regulatory requirements, particularly the reporting of adverse events, as well as documents necessary for IRB approval.
The DSMB can audit protocols when necessary and communicates directly with the IRB. 
Risk Assessment: A serious adverse event (AE) is defined as either fatal or life-threatening, requires inpatient hospitalization or
prolongation of an existing hospitalization, results in persistent or significant disability/incapacity, is medically significant or requires
intervention to prevent one or other of the outcomes listed above. This study is greater than minimal risk.
Grading scale for AE intensity: 
Mild: Discomfort noticed but no disruption of normal daily activity. 
Moderate: Discomfort sufficient to reduce or affect normal daily activity. 
Severe: Incapacitating with inability to work or perform normal daily activity. 
Attribution scale for AE reporting: 
Probable: AE is related to the procedure (biopsies), including pain, bleeding, infection, and death, if death resulted from one of the
aforementioned complications. 
Possible: AE follows the biopsy within a reasonable period (within 7 days), but may have been produced by other factors.
Remote: AE does not follow the biopsy within a reasonable period (more than 7 days) and could readily have been produced by other
factors. 
Unrelated: AE is judged to be clearly due to extraneous causes and does not meet the above criteria.
Monitoring Plan Monitoring for adverse events will be conducted in real-time by the principal investigators and study coordinator. Risks
involved with this study are considered greater than minimal risk.
AE Reporting Serious AEs will be reported verbally to the IRB and CCTS within 24 hours and in writing within 48 hours of the event.
Unanticipated events will be reported to the CCTS in real time and to the IRB no later than 48 hours after the event. Annual reporting of
adverse events will be conducted with the IRB annual review/renewal according to their protocol. These reports will also be forwarded
to the CCTS. The CCTS Administration will be informed within 15 days if for any reason the IRB or any other body temporarily or
permanently suspends the study.
Data Accuracy and Protocol Compliance All protocols involving human subjects will be directly supervised by the PI or her colleagues
to assure compliance. All samples will be coded to eliminate bias. Detailed plans for maintaining subject confidentiality are described
in the consent form. 
Conflict of Interest There is no conflict of interest. Investigators on this project have extensive experience with similar protocols and
are well qualified to monitor progress and to determine what rate of unexpected AEs is acceptable. For these reasons, Dr. Dupont-
Versteegden and her colleagues are capable of monitoring for safety objectively and without bias.
Back to Top
Future Use and Sharing of Material (e.g., Data/Specimens/Information)
If the material collected for this study will be used by members of the research team or shared with other researchers for future studies,
please address the following:
list the biological specimens and/or information that will be kept
briefly describe the types, categories and/or purposes of the future research
describe any risks of the additional use
describe privacy/confidentiality protections that will be put into place
describe the period of time specimens/information may be used
describe procedures for sharing specimens/information with secondary researchers
describe the process for, and limitations to, withdrawal of specimens/data
N/A.
Are you recruiting or expect to enroll Non-English Speaking Subjects or Subjects from a Foreign Culture? (does not include short
form use for incidentally encountered non-English subjects)
Yes
No
Non-English Speaking Subjects or Subjects from a Foreign Culture
Recruitment and Consent:
Section 9 Page 8 of 10
43499

Describe how information about the study will be communicated to potential subjects appropriate for their culture, and if necessary,
how new information about the research may be relayed to subjects during the study. 
When recruiting Non-English-speaking subjects, provide a consent document in the subject’s primary language. After saving this
section, attach both the English and translated consent documents in the “Informed Consent" section. 
Cultural and Language Consultants:
The PI is required to identify someone who is willing to serve as the cultural consultant to the IRB.
This person should be familiar with the culture of the subject population and/or be able to verify that translated documents are
the equivalent of the English version of documents submitted.
The consultant should not be involved with the study or have any interest in its IRB approval.
Please include the name, address, telephone number, and email of the person who agrees to be the cultural consultant for
your study.
ORI staff will facilitate the review process with your consultant. Please do not ask them to review your protocol separately.
For more details, see the IRB Application Instructions on Research Involving Non-English Speaking Subjects or Subjects from a
Foreign Culture. 
Local Requirements:
If you will conduct research at an international location, identify and describe:
relevant local regulations
data privacy regulations
applicable laws
ethics review requirements for human subject protection
Please provide links or sources where possible. If the project has been or will be reviewed by a local ethics review board, attach a
copy in the “Additional Information/Materials” section. You may also consult the current edition of the International Compilation of
Human Research Standards
Section 9 Page 9 of 10
43499

Does your study involve HIV/AIDS research and/or screening for other reportable diseases (e.g., Hepatitis C, etc…)?
Yes
No
HIV/AIDS Research
If you have questions about what constitutes a reportable disease and/or condition in the state of Kentucky, see ORI’s summary
sheet: “Reporting Requirements for Diseases and Conditions in Kentucky" [PDF].
HIV/AIDS Research: There are additional IRB requirements for designing and implementing the research and for obtaining
informed consent. Describe additional safeguards to minimize risk to subjects in the space provided below.
For additional information, visit the online IRB Survival Handbook to download a copy of the "Medical IRB's requirements for
Protection of Human Subjects in Research Involving HIV Testing" [D65.0000] [PDF], and visit the Office for Human Research
Protections web site for statements on AIDS research, or contact the Office of Research Integrity at 859-257-9428.
PI-Sponsored FDA-Regulated Research
Is this an investigator-initiated study that:
1) involves testing a Nonsignificant Risk (NSR) Device, or
2) is being conducted under an investigator-held Investigational New Drug (IND) or Investigational Device Exemption (IDE)?
Yes
No
PI-Sponsored FDA-Regulated Research
If the answer above is yes, then the investigator assumes the regulatory responsibilities of both the investigator and sponsor. The
Office of Research Integrity provides a summary list of sponsor IND regulatory requirements for drug trials [PDF], IDE regulatory
requirements for SR device trials [PDF], and abbreviated regulatory requirements for NSR device trials [PDF]. For detailed
descriptions see FDA Responsibilities for Device Study Sponsors or FDA Responsibilities for IND Drug Study Sponsor-
Investigators.
Describe the experience/knowledge/training (if any) of the investigator serving as a sponsor (e.g., previously held an
IND/IDE); and
Indicate if any sponsor obligations have been transferred to a commercial sponsor, contract research organization (CRO),
contract monitor, or other entity (provide details or attach FDA 1571).
IRB policy requires mandatory training for all investigators who are also FDA-regulated sponsors (see Sponsor-Investigator
FAQs). A sponsor-investigator must complete the applicable Office of Research Integrity web based training, (drug or device)
before final IRB approval is granted.
Has the sponsor-investigator completed the mandatory PI-sponsor training prior to this submission?
Yes
No
If the sponsor-investigator has completed equivalent sponsor-investigator training, submit documentation of the content for the
IRB’s consideration. 
Attachments
Section 9 Page 10 of 10
43499

HIPAA
0 unresolved
comment(s)
Is HIPAA applicable?
Yes
No
(Visit ORI's Health Insurance Portability and Accountability Act (HIPAA) web page to determine if your research falls under the HIPAA
Privacy Regulation.)
If yes, check below all that apply and attach the applicable document(s): 
HIPAA De-identification Certification Form
HIPAA Waiver of Authorization
Attachments
Section 10 Page 1 of 1
43499

STUDY DRUG INFORMATION
0 unresolved
comment(s)
The term drug may include:
FDA approved drugs,
unapproved use of approved drugs,
investigational drugs or biologics,
other compounds or products intended to affect structure or function of the body, and/or
complementary and alternative medicine products such as dietary supplements, substances generally recognized as safe (GRAS)
when used to diagnose, cure mitigate, treat or prevent disease, or clinical studies of e-cigarettes examining a potential therapeutic
purpose.
Does this protocol involve a drug including an FDA approved drug; unapproved use of an FDA approved drug; and/or an
investigational drug?
Yes
No
If yes, complete the questions below. Additional study drug guidance.
LIST EACH DRUG INVOLVED IN STUDY IN THE SPACE BELOW
Drug Name:
Note: Inpatient studies are required by Hospital Policy to utilize Investigational Drug Service (IDS) pharmacies (Oncology or
Non-Oncology). Use of IDS is highly recommended, but optional for outpatient studies. Outpatient studies not using IDS
services are subject to periodic inspection by the IDS for compliance with drug accountability good clinical practices. 
Indicate where study drug(s) will be housed and managed:
Investigational Drug Service (IDS) UK Hospital
Other Location:
Is the study being conducted under a valid Investigational New Drug (IND) application?
Yes
No
If Yes, list IND #(s) and complete the following:
IND Submitted/Held by:
Sponsor:
Held By:
Investigator:
Held By:
Other:
Held By:
Checkmark if the study is being conducted under FDA’s Expanded Access Program (e.g., Treatment IND)
or if this is an Individual Patient Expanded Access IND (FDA Form 3926).
FDA's Expanded Access Program Information for Individual Patient Expanded Access INDs, and attach the
following:
FDA Form 3926;
FDA expanded access approval or correspondence;
Confirmation of agreement from manufacturer or entity authorized to provide access to the product.
For guidance and reporting requirements at the conclusion of treatment see the Expanded Access SOP.
Complete and attach the required Study Drug Form picking "Study Drug Form" for the document type. Any
Section 11 Page 1 of 2
43499

applicable drug documentation (e.g., Investigator Brochure; approved labeling; publication; FDA correspondence,
etc.) should be attached using "Other Drug Documentation" for the document type.
Attachments
Section 11 Page 2 of 2
43499

STUDY DEVICE INFORMATION
0 unresolved
comment(s)
A DEVICE may be a:
component, part, accessory;
assay, reagent, or in-vitro diagnostic device;
software, digital health, or mobile medical app;
other instrument if intended to affect the structure or function of the body, diagnose, cure, mitigate, treat or prevent disease; or
a homemade device developed by an investigator or other non-commercial entity and not approved for marketing by FDA.
For additional information, helpful resources, and definitions, see ORI's Use of Any Device Being Tested in Research web page.
Does this protocol involve testing (collecting safety or efficacy data) of a medical device including an FDA approved device,
unapproved use of an approved device, humanitarian use device, and/or an investigational device?
Yes
No
[Note: If a marketed device(s) is only being used to elicit or measure a physiologic response or clinical outcome, AND, NO data will
be collected on or about the device itself, you may answer “no” above, save and exit this section, (Examples: a chemo drug study
uses an MRI to measure tumor growth but does NOT assess how effective the MRI is at making the measurement; an exercise study
uses a heart monitor to measure athletic performance but no safety or efficacy information will be collected about the device itself, nor
will the data collected be used for comparative purposes against any other similar device).]
If you answered yes above, please complete the following questions.
LIST EACH DEVICE BEING TESTED IN STUDY IN THE SPACE BELOW
Device Name:
Is the study being conducted under a valid Investigational Device Exemption (IDE),
Humanitarian Device Exemption (HDE) or Compassionate Use?
Yes
No
If Yes, complete the following: 
IDE or HDE #(s)
IDE/HDE Submitted/Held by:
Sponsor:
Held By:
Investigator:
Held By:
Other:
Held By:
 Check if this is a Treatment IDE or Compassionate Use under the Food and Drug Administration (FDA)
Expanded Access program.
For Individual or Small Group Expanded Access, see FDA's Early Expanded Access Program Information,
and attach the following:
FDA expanded access approval or sponsor’s authorization;
An independent assessment from an uninvolved physician, if available;
Confirmation of agreement from manufacturer or entity authorized to provide access to the product.
For guidance and reporting requirements at the conclusion of treatment see the Medical Device SOP.
Section 12 Page 1 of 2
43499

Does the intended use of any research device being tested (not clinically observed) in this study meet the regulatory definition of
Significant Risk (SR) device?
Yes. Device(s) as used in this study presents a potential for serious risk to the health, safety, or welfare of a subject and (1) is
intended as an implant; or (2) is used in supporting or sustaining human life; or (3) is of substantial importance in diagnosing,
curing, mitigating or treating disease, or otherwise prevents impairment of human health; or (4) otherwise presents a potential
for serious risk to the health, safety, or welfare of a subject.
No. All devices, as used in this study do not present a potential for serious risk to the health, safety, or welfare of
subjects/participants.
Complete and attach the required Study Device Form, picking the "Study Device Form" for the document type. Any
applicable device documentation (e.g., Manufacturer information; patient information packet; approved labeling; FDA
correspondence, etc.) should be attached using "Other Device Documentation" for the document type.
Attachments
Section 12 Page 2 of 2
43499

RESEARCH SITES
0 unresolved
comment(s)
To complete this section, ensure the responses are accurate then click "SAVE".
A) Check all the applicable sites listed below at which the research will be conducted. If none apply, you do not need to check any
boxes.
UK Sites
UK Classroom(s)/Lab(s)
UK Clinics in Lexington
UK Clinics outside of Lexington
UK Healthcare Good Samaritan Hospital
UK Hospital
Schools/Education Institutions
Fayette Co. School Systems *
Other State/Regional School Systems
Institutions of Higher Education (other than UK)
*Fayette Co. School systems, as well as other non-UK
sites, have additional requirements that must be
addressed. See ORI's IRB Application Instructions -
Off-site Research web page for details.
Other Medical Facilities
Bluegrass Regional Mental Health Retardation Board
Cardinal Hill Hospital
Eastern State Hospital
Norton Healthcare
Nursing Homes
Shriner’s Children’s Hospital
Veterans Affairs Medical Center
Other Hospitals and Med. Centers
Correctional Facilities
Home Health Agencies
International Sites
Research activities conducted at performance sites that are not owned or operated by the University of Kentucky, at sites
that are geographically separate from UK, or at sites that do not fall under the UK IRB’s authority, are subject to special
procedures for coordination of research review. Additional information is required (see IRB Application Instructions - Off-
Site Research web page), including:
A letter of support and local context is required from non-UK sites. See Letters of Support and Local Context on the
IRB Application Instructions - Off-Site Research web page for more information.
Supportive documentation, including letters of support, can be attached below.
NOTE: If the non-UK sites or non-UK personnel are engaged in the research, there are additional federal and
university requirements which need to be completed for their participation. For instance, the other site(s) may need
to complete their own IRB review, or a cooperative review arrangement may need to be established with non-UK
Section 13 Page 1 of 2
43499

sites.
Questions about the participation of non-UK sites/personnel should be discussed with the ORI staff at (859) 257-
9428.
List all other non-UK owned/operated locations where the research will be conducted:
Describe the role of any non-UK site(s) or non-UK personnel who will be participating in your research.
Attachments
B) Is this a multi-site study for which you are the lead investigator or UK is the lead site?
Yes
No
If YES, describe the plan for the management of reporting unanticipated problems, noncompliance, and submission of protocol
modifications and interim results from the non-UK sites:
C) If your research involves collaboration with any sites and/or personnel outside the University of Kentucky, then it is considered
multisite research and IRB reliance issues will need to be addressed. This may include national multi-center trials as well local studies
involving sites/personnel external to UK. If you would like to request that the University of Kentucky IRB (UK IRB) serve as the lead
IRB for your study, or if you would like the UK IRB to defer review to another IRB, please contact the IRBReliance@uky.edu.
Section 13 Page 2 of 2
43499

RESEARCH ATTRIBUTES
0 unresolved
comment(s)
Indicate the items below that apply to your research. Depending on the items applicable to your research, you may be required to
complete additional forms or meet additional requirements. Contact the ORI (859-257-9428) if you have questions about additional
requirements.
Not applicable
Check All That Apply
Academic Degree/Required Research
Alcohol/Drug/Substance Abuse Research
Biological Specimen Bank Creation (for sharing)
Cancer Research
CCTS-Center for Clinical & Translational Science
Certificate of Confidentiality
Clinical Research
Clinical Trial - Phase 1
Clinical Trial
Collection of Biological Specimens for internal banking and use
(not sharing)
Community-Based Participatory Research
Deception
Educational/Student Records (e.g., GPA, test scores)
Emergency Use (Single Patient)
Gene Transfer
Genetic Research
GWAS (Genome-Wide Association Study) or NIH Genomic Data
Sharing (GDS)
Human Cells, Tissues, and Cellular and Tissue Based Products
Individual Expanded Access or Compassionate Use
International Research
Planned Emergency Research Involving Exception from
Informed Consent
Recombinant DNA
Registry or data repository creation
Stem Cell Research
Suicide Ideation or Behavior Research
Survey Research
Transplants
Use, storage and disposal of radioactive material and radiation
producing devices
Vaccine Trials
For additional requirements and information:
Cancer Research (MCC PRMC)
Certificate of Confidentiality (look up
"Confidentiality/Privacy...")
CCTS (Center for Clinical and Translational
Science)
Clinical Research (look up "What is the definition
of....)
Clinical Trial
Collection of Biological Specimens for Banking
(look up "Specimen/Tissue Collection...")
Collection of Biological Specimens (look up
"Specimen/Tissue Collection...")
Community-Based Participatory Research (look
up "Community-Engaged...")
Data & Safety Monitoring Board (DSMB)
*For Medical IRB: Service Request Form for
CCTS DSMB
Data & Safety Monitoring Plan
Deception*
*For deception research, also go to the E-IRB
Application Informed Consent section,
checkmark and complete "Request for Waiver
of Informed Consent Process"
Emergency Use (Single Patient) [attach
Emergency Use Checklist] (PDF)
Genetic Research (look up "Specimen/Tissue
Collection...")
Gene Transfer
HIV/AIDS Research (look up "Reportable
Diseases/Conditions")
Screening for Reportable Diseases [E2.0000]
(PDF)
International Research (look up "International &
Non-English Speaking")
NIH Genomic Data Sharing (GDS) Policy (PDF)
Planned Emergency Research Involving Waiver
of Informed Consent*
*For Planned Emergency Research Involving
Waiver of Informed Consent, also go to the E-
IRB Application Informed Consent section,
checkmark and complete "Request for Waiver
of Informed Consent Process"
Use, storage and disposal of radioactive material
and radiation producing devices
Section 14 Page 1 of 2
43499

Section 14 Page 2 of 2
43499

FUNDING/SUPPORT
0 unresolved
comment(s)
If the research is being submitted to, supported by, or conducted in cooperation with an external or internal agency or funding program,
indicate below all the categories that apply. 
Not applicable
Check All That Apply
Grant application pending
(HHS) Dept. of Health & Human Services
(NIH) National Institutes of Health
(CDC) Centers for Disease Control &
Prevention
(HRSA) Health Resources and Services
Administration
(SAMHSA) Substance Abuse and Mental
Health Services Administration
(DoJ) Department of Justice or Bureau of
Prisons
(DoE) Department of Energy
(EPA) Environmental Protection Agency
Federal Agencies Other Than Those Listed
Here
Industry (Other than Pharmaceutical
Companies)
Internal Grant Program w/ proposal
Internal Grant Program w/o proposal
National Science Foundation
Other Institutions of Higher Education
Pharmaceutical Company
Private Foundation/Association
U.S. Department of Education
State
Click applicable listing(s) for additional requirements and information:
(HHS) Dept. of Health & Human Services
(NIH) National Institutes of Health
(CDC) Centers for Disease Control & Prevention
(HRSA) Health Resources & Services Administration
(SAMHSA) Substance Abuse & Mental Health Services
Administration
Industry (Other than Pharmaceutical Companies) [IRB Fee Info]
National Science Foundation
(DoEd) U.S. Department of Education
(DoJ) Department of Justice or Bureau of Prisons 
(DoE) Department of Energy Summary and Department of Energy
Identifiable Information Compliance Checklist
(EPA) Environmental Protection Agency
Other:
National Center for
Complementary and Integrative
Health (NCCIH)
Specify the funding source and/or cooperating organization(s) (e.g., National Cancer Institute, Ford Foundation, Eli Lilly
& Company, South Western Oncology Group, Bureau of Prisons, etc.):
 
National Center for Complementary
and Integrative Health (NCCIH)
Add Related Grants
If applicable, please search for and select the OSPA Account number or Electronic Internal Approval Form (eIAF) #
(notif #) associated with this IRB application using the "Add Related Grants" button. 
If required by your funding agency, upload your grant using the "Grant/Contract Attachments" button.
Add Related Grants
Grant/Contract Attachments
Section 15 Page 1 of 2
43499

The research involves use of Department of Defense (DoD) funding, military personnel, DoD facilities, or other DoD resources.
(See DoD SOP and DoD Summary for details)
Yes
No
Using the “attachments” button (below), attach applicable materials addressing the specific processes described in
the DoD SOP.
DOD SOP Attachments
Additional Certification: (If your project is federally funded, your funding agency may request an Assurance/ Certification/Declaration
of Exemption form.) Check the following if needed:
Protection of Human Subjects Assurance/Certification/Declaration of Exemption (Formerly Optional Form – 310)
Assurance/Certification Attachments
Section 15 Page 2 of 2
43499

OTHER REVIEW COMMITTEES
0 unresolved
comment(s)
If you check any of the below committees, additional materials may be required with your application submission.
Does your research fall under the purview of any of the other review committees listed below? [If yes, check all that apply and attach
applicable materials using the attachment button at the bottom of your screen.]
Yes
No
Institutional Biosafety Committee
Radiation Safety Committee
Radioactive Drug Research Committee
Markey Cancer Center (MCC) Protocol Review
and Monitoring Committee (PRMC)
Graduate Medical Education Committee (GME)
Office of Medical Education (OME)
Additional Information
Institutional Biosafety Committee (IBC) - Attach required IBC
materials
Radiation Safety Committee (RSC) - For applicability, see
instructions and attach form
Radioactive Drug Research Committee (RDRC)
Markey Cancer Center (MCC) Protocol Review and Monitoring
Committee (PRMC)** - Attach MCC PRMC materials, if any, per
instructions.
Office of Medical Education (OME)
Graduate Medical Education Committee (GME)
Attachments 
** If your study involves cancer research, be sure to select "Cancer Research" in the "Research Attributes"
section. ORI will send your research protocol to the Markey Cancer Center (MCC) Protocol Review and Monitoring
Committee (PRMC). The MCC PRMC is responsible for determining whether the study meets the National Cancer Institute
(NCI) definition of a clinical trial and for issuing documentation to you (the investigator) which confirms either that PRMC
approval has been obtained or that PRMC review is not required. Your IRB application will be processed and reviewed
independently from the PRMC review.
Section 16 Page 1 of 1
43499

ADDITIONAL INFORMATION/MATERIALS
0 unresolved
comment(s)
Do you want specific information inserted into your approval letter?
Yes
No
Approval Letter Details:
If you wish to have specific language included in your approval letter (e.g., serial #, internal tracking identifier, etc…), type that
language in the box below exactly as it should appear in the letter. The text you enter will automatically appear at the top of all
approval letters, identical to how you typed it, until you update it. Don't include instructions or questions to ORI staff as those will
appear in your approval letter. If these details need to be changed for any reason, you are responsible for updating the
content of this field.
Additional Materials:
If you have other materials you would like to include for the IRB's consideration, check all that apply and attach the corresponding
documents using the Attachments button below.
Detailed protocol
Dept. of Health & Human Services (DHHS) approved protocol (such as NIH sponsored Cooperative Group Clinical Trial)
Other Documents
Protocol/Other Attachments
Attach Type File Name
Other
43499 Massage Progress Report CR 032823.pdf
NOTE: Instructions for Dept. of Health & Human Services (DHHS)-approved protocol]
If you have password protected documents, that feature should be disabled prior to uploading to ensure access for IRB review.
To view the materials currently attached to your application, click “All Attachments” on the left menu bar.
Section 17 Page 1 of 1
43499

SIGNATURES (ASSURANCES)
0 unresolved
comment(s)
Introduction
All IRB applications require additional assurances by a Department Chairperson or equivalent (DA), and when applicable, a Faculty
Advisor or equivalent (FA). This signifies the acceptance of certain responsibilities and that the science is meritorious and deserving of
conduct in humans. The person assigned as DA should not also be listed in the Study Personnel section, and the individual assigned
as FA should be listed in the Study Personnel section.
For a list of responsibilities reflected by signing the Assurance Statement, refer to "What does the Department Chairperson’s
Assurance Statement on the IRB application mean?"
For a detailed illustration of how to complete this section, please review the short video tutorial "Signatures (Assurance) Section - How
to Complete" in the E-IRB Video Tutorial Library. 
Required Signatures:
First
Name
Last Name
Role
Department
Date
Signed
 
Janice
Kuperstein
Department
Authorization
Health
Sciences -
Rehabilitati
01/24/2018
01:23 PM
View/Sign
Esther
Dupont-
Versteegden
Principal
Investigator
Health
Sciences -
Rehabilitati
01/24/2018
01:19 PM
View/Sign
Department Authorization
 This is to certify that I have reviewed this research protocol and that I attest to the scientific validity and importance of
this study; to the qualifications of the investigator(s) to conduct the project and their time available for the project; that
facilities, equipment, and personnel are adequate to conduct the research; and that continued guidance will be provided
as appropriate. When the principal investigator assumes a sponsor function, the investigator has been notified of the
additional regulatory requirements of the sponsor and by signing the principal investigator Assurance Statement, confirms
he/she can comply with them.
*If the Principal Investigator is also the Chairperson of the department, the Vice Chairperson or equivalent should complete
the "Department Authorization".
**IF APPLICABLE FOR RELIANCE: I attest that the principal investigator has been notified of the regulatory requirements of
both the Reviewing and Relying IRBs, according to the information provided in the E-IRB application. The attached Reliance
Assurance Statement, signed by the principal investigator, confirms that he/she can comply with both sets of IRB
requirements.
Principal Investigator’s Assurance Statement
I understand the University of Kentucky's policies concerning research involving human subjects and I agree:
1. To comply with all IRB policies, decisions, conditions, and requirements;
2. To accept responsibility for the scientific and ethical conduct of this research study;
3. To obtain prior approval from the Institutional Review Board before amending or altering the research protocol or
implementing changes in the approved consent/assent form;
4. To report to the IRB in accord with IRB/IBC policy, any adverse event(s) and/or unanticipated problem(s) involving risks to
subjects;
5. To complete, on request by the IRB for Full and Expedited studies, the Continuation/Final Review Forms;
6. To notify the Office of Sponsored Projects Administration (OSPA) and/or the IRB (when applicable) of the development of
any financial interest not already disclosed;
7. Each individual listed as study personnel in this application has received the mandatory human research protections
Section 18 Page 1 of 2
43499

education (e.g., CITI);
8. Each individual listed as study personnel in this application possesses the necessary experience for conducting research
activities in the role described for this research study.
9. To recognize and accept additional regulatory responsibilities if serving as both a sponsor and investigator for FDA
regulated research.
Furthermore, by checking this box, I also attest that:
I have appropriate facilities and resources for conducting the study;
I am aware of and take full responsibility for the accuracy of all materials submitted to the IRB for review;
If applying for an exemption, I also certify that the only involvement of human subjects in this research study will be in the
categories specified in the Protocol Type: Exemption Categories section.
If applying for an Abbreviated Application (AA) to rely on an external IRB, I understand that certain items above (1, 3, 4, 7-8)
may not apply, or may be altered due to external institutional/IRB policies. I document my agreement with the Principal
Investigator Reliance Assurance Statement by digitally signing this application.
*You will be able to "sign" your assurance after you have sent your application for signatures (use Submission section). Please notify the
personnel required for signing your IRB application after sending for signatures. Once all signatures have been recorded, you will need
to return to this section to submit your application to ORI. 
Section 18 Page 2 of 2
43499

SUBMISSION INFORMATION
0 unresolved
comment(s)
*** If this Continuation Review entails a change in the scope of your activities to include COVID-19 related research, please
insert “COVID19” at the start of your Project and Short Titles.***
Each Section/Subsection in the menu on the left must have a checkmark beside it (except this Submission section) indicating the
Section/Subsection has been completed. Otherwise your submission for IRB review and approval cannot be sent to the Office of
Research Integrity/IRB.
If applicable, remember to update the Approval Letter Details text box under the Additional Information section
If your materials require review at a convened IRB meeting which you will be asked to attend, it will be scheduled on the next available
agenda and you will receive a message to notify you of the date.
If you are making a change to an attachment, you need to delete the attachment, upload a highlighted version that contains the changes
(use Document Type of "Highlighted Changes"), and a version that contains the changes without any highlights (use the appropriate
Document Type for the item(s)). Do not delete approved attachments that are still in use.
Principal Investigator’s Assurance Statement
I understand the University of Kentucky’s policies concerning research involving human subjects, and I attest to:
1. Having reviewed all the investigational data from this study, including a compilation of all internal and external unanticipated
problems.
2. Having reviewed, if applicable, information from the sponsor including updated investigator brochures and data and safety
monitoring board reports.
I also attest that I have reviewed pertinent materials concerning the research and concluded either:
A. The human subject risk/benefit relationship is NOT altered, and that it is not necessary to modify the protocol or the informed
consent process,
OR,
B. The human subject risk/benefit relationship has been altered, and have previously submitted or am including with this
continuation review submission, a modification of the research protocol and informed consent process.
By checking this box, I am providing assurances for the applicable items listed above. 
Your protocol has been submitted.
Section 19 Page 1 of 1
43499

 
Document Type
File Loaded
Document Description
File
Size
Modified
By
Mod Date
ApprovalLetter
ApprovalLetter.pdf
 
0.079
ovmo223 4/14/2023
8:54:52 AM
Stamped Consent Form
43499 Massage IRB Consent Clean
101222.pdf
 
0.288
ovmo223 4/14/2023
8:54:52 AM
AddInfoProduct
43499 Massage Progress Report CR
032823.pdf
Progress Report
0.107
delong2
3/28/2023
4:17:38 PM
CR_DataSafetyMonitoring
DSMB Review 021523 Dupont
Massage.pdf
DSMB Submitted
Materials
0.526
delong2
3/28/2023
3:54:37 PM
CR_DataSafetyMonitoring
022823 DSMB LOCl - Massage II.pdf
Letter of Continuation
from DSMB
0.230
delong2
3/28/2023
3:53:45 PM
CR_EntireConsent
HuMA39 Consent.pdf
HuMA39 Consent
0.396
delong2
3/28/2023
3:46:28 PM
CR_EntireConsent
HuMA38 Consent.pdf
HuMA38 Consent
0.394
delong2
3/28/2023
3:45:47 PM
Informed ConsentHIPAA
Combined Form
43499 Massage IRB Consent Clean
101222.pdf
Consent Clean
0.217
delong2
10/13/2022
9:55:47 AM
AdditionInfoConsiderations
43499 Massage Progress Report CR
051622.pdf
Protocol Progress
Report
0.156
delong2
5/16/2022
10:03:51 AM
Advertising
REHAB-191_SocialMedia
APPROVED.pdf
Social Media Approved
0.157
delong2
2/24/2020
2:17:06 PM
Advertising
REHAB-191_ResearchMatch email
APPROVED.pdf
Research Match PR
Approved
0.034
delong2
2/24/2020
2:16:54 PM
Advertising
REHAB-191_flyerAPPROVED.pdf
Flyer Approved
0.137
delong2
2/24/2020
2:16:14 PM
Advertising
REHAB-191 MON[1] MP edit
APPROVED.pdf
Monitor PR Approval
1.322
delong2
2/24/2020
2:15:48 PM
Download all
Section 20 Page 1 of 1
43499

Protocol Changes
Protocol Number: 43499
Click link to sort Changed Date
Study Personnel Changes:
Project Information ProjectEndDate changed by delong2 on 3/29/2023 11:25:19 AM
6/30/20234 12:00:00 AM
10171824
Name
Bowlds, Hannah
Email
 Hannah.Bowlds@uky.edu
Role 1
 SP
Role 2
 Project Assistance/Support
Is Contact
 N
Room
 
Dept Code
 
Dept Desc
 
SFI
 N
Is PIRN
 
Section 21 Page 1 of 1
43499

 
Protocol Type Comment by Samuel Bell - ORI to PI on 3/29/2023 11:07:39 AM
A couple of screening comments. Please see the following sections of the protocol for specifics: 
- Project Information
- Study Personnel
Project Information Comment by Samuel Bell - ORI to PI on 3/29/2023 8:43:57 AM
It's recommended to extend the projected project end date by at least one calendar year. 
Study Personnel Comment by Douglas Long - PI to PI on 3/29/2023 11:29:37 AM
Study personnel have been notified of HSP refreshers needed. These will be completed asap. Project info end date was also extended by 1 
year. 
Study Personnel Comment by Samuel Bell - ORI to PI on 3/29/2023 8:46:13 AM
Also, FYI - Timothy Butterfield's HSP training is set to expire in mid-April. They should plan to complete refresher HSP training as soon as 
possible. 
Study Personnel Comment by Samuel Bell - ORI to PI on 3/29/2023 8:45:23 AM
Amy Confides' human subject protection training has expired. They will need to complete refresher HSP training or be temporarily removed 
from the protocol in order to process the approval. More information on refresher HSP training can be found at the following link: 
https://www.research.uky.edu/office-research-integrity/three-year-refresher-hsp-training-faqs
Section 22 Page 1 of 1
43499