A Standardized Patient Education Video Program for Improvement of Post-Operative Recovery After Outpatient Upper Extremity Surgery
Phase: NA
Conditions: Analgesics, Opioid, Orthopedic Surgery, Ambulatory Surgery, Education, Patient, Injuries and Wounds
Sponsor: Carilion Clinic

CARILION CLINIC INSTITUTIONAL REVIEW BOARD 
 
IRB RESEARCH APPLICATION INSTRUCTIONS 
 
NOTE: This is a protected document!  
All responses will now appear as originally formatted and can be adjusted. 
 
This application is for use by researchers proposing to conduct human subjects research at Carilion 
Clinic, including the Jefferson College of Health Sciences, or who will use Carilion services as part of the 
research process. The application is for use by the Carilion Institutional Review Board, a committee 
charged with protecting the rights and welfare of human subjects in research. The entire application 
must be completed if the proposed research involves Carilion faculty, employees, students, facilities or 
patients.   
 
Research protocols may be reviewed at convened meetings of the IRB or through a single reviewer 
process involving the IRB chair and staff. The type of review is determined by the nature of the 
project, the level of potential risk to research subjects and the characteristics of the subject population. 
The final determination of the type of review applicable to a study is made by the IRB.  
 
 
Full Board Reviews: Research that would require review at a convened meeting of the IRB 
would include but is not limited to research that involves: 1)more than minimal risk, 
2)vulnerable populations, 3)experimental drugs or devices 4)invasive procedures, or 
5)deception (e.g., in behavioral research). A schedule of IRB meetings can be found on the 
Carilion IRB website. 
 
 
Expedited or Exempt Reviews: Some studies may not require review by the convened IRB, 
but may be eligible for “Expedited review” or “Exempt status” after review by one or more IRB 
members. Expedited studies involve no more than minimal risk to subjects.  Federal regulations 
define minimal risk as the probability that the magnitude of harm or discomfort anticipated in 
the research are not greater in of themselves than those ordinarily encountered in daily life or 
during the performance of routine physical or psychological examinations or tests.  Some 
research may be Exempt from further review once this initial determination is made.  The 
Carilion IRB must determine whether proposed studies meet the criteria for Expedited or 
Exempt review.  
 
Submission Instructions 
All Full Board, Expedited, and Exempt study submissions to the IRB should be submitted 
using this application.  Investigators should send the completed application to the IRB 
electronically.  If the researcher believes his or her project meets the criteria for Expedited 
or Exempt submissions, please send the application to Janet McDowell at 
jdmcdowell@carilionclinic.org 
For Full Board submissions, please send the application to Meredith Talmadge at 
mttalmadge@carilionclinic.org.  Signature pages may be sent electronically or faxed to 
(540) 985-5323. For further information call 853-0728.  
 
Note:  Consent Form and Information Sheets should be submitted in Word, not in pdf, 
because IRB staff may need to make revisions and edits to these documents.  Each CV 
should be sent in a separate electronic document so that IRB staff can file them 
individually in our electronic filing system. 
 
Please do not copy this page when submitting paper copies to the IRB office. 
 
 

 
 
Carilion Clinic Institutional Review Board 
INSTITUTIONAL REVIEW BOARD APPLICATION 
 
REGISTRATION WITH DEPARTMENT OF RESEARCH & DEVELOPMENT  
 
PER INSTITUTIONAL POLICY ALL PROJECTS MUST BE SUBMITTED WITH AN R&D PRE-APPROVAL OR APPROVAL 
LETTER STATING YOU ARE READY TO SUBMIT TO THE IRB.  DO YOU HAVE YOUR R&D LETTER? 
 
  Yes  (If yes, you MUST attach your R&D letter to this submission.)   
  No   (If no, do not submit your IRB project until you have your R&D letter.)   
 
 
You may contact the R&D Department at 540-985-8510. 
SECTION I: APPLICATION DATA 
 
Date Completing Form: 11/24/2017      
(Please change with each revision) 
 
Complete Title of Study: A Standardized Patient Education Video Program for Improvement of 
Post-Operative Recovery after Outpatient Upper Extremity Surgery 
 
 
Research Team (All individuals, whether Carilion associates or not, participating in the conduct of research 
under the direction of the principal investigator, including investigators, coordinators, those obtaining consent, 
etc.): 
 
Carilion Principal Investigator: Cassandra Mierisch  Credentials: MD 
Inter-office address: Orthopedics, ION, 2331 Franklin Rd SW, Roanoke, VA 24014 
Mailing Address (if external):       
 
 
 
 
 
  
Phone: 540-588-8076   
E-mail: crmierisch@carilionclinic.org 
 
Fax: 540-857-5306  
 
Other Investigator: Peter Apel     
 
 
Credentials: MD 
Inter-office address: Orthopedics, ION, 2331 Franklin Rd SW, Roanoke, VA 24014 
Role & Responsibilities: Recruit patients and assist in completing study requirements 
Mailing Address (if external):       
 
 
 
 
 
  
Phone: 540-725-1226   
E-mail: pjapel@carilionclinic.org  
Fax: 540-857-5306  
 
Other Investigator: Cay Mierisch     
 
 
Credentials: MD 
Inter-office address: Orthopedics, ION, 2331 Franklin Rd SW, Roanoke, VA 24014 
Role & Responsibilities: Recruit patients and assist in completing study requirements 
Mailing Address (if external):       
 
 
 
 
 
  
Phone: 540-725-1226   
E-mail: CMMierisch@carilionclinic.org 
 
Fax: 540-857-5306  
 
Study Coordinator: Allison Bell  
 
 
Credentials: MPH 
Inter-office address:       
Role & Responsibilities:       
Mailing Address (if external):       
 
 
 
 
 
  
Phone: 540-224-4661   
E-mail: aephillips2@carilionclinic.org 
 
Fax:        
 
Other Research Team Member: Soleille Everest  
Credentials: VTCSOM Medical Student 
Role & Responsibilities: Creation of study materials, data collection, analysis  
Inter-office address:       
Mailing Address (if external): 610 S Jefferson Street Apartment 712, Roanoke VA 24011  
 
 
 
 
  
Phone: 919-516-3713   
E-mail: severest@carilionclinic.org 
 
Fax:        
 
Other Research Team Member: Min Wang       
Credentials: PhD 
Role & Responsibilities: RedCAP, Technology and Analytics 
Inter-office address: Manager, Health Analytics Research Team, Carilion Administrative Services Bldg 
Mailing Address (if external):       
 
 
 
 
 
  
Phone: 540-510-4514       
 
E-mail: mmwang@carilionclinic.org 
 
Fax:        
 
NOTE: See last page of application to add additional investigators and research team members. 
 

 
 
All research team members must complete Carilion IRB education requirements before research can 
be approved. Further information regarding education requirements can be found on the Carilion IRB web site: 
http://www.carilionclinic.org/Carilion/IRB.  
 
 
 
Carilion IRB Application 
 
       
- 2 - 
 
(July 2016) 

 
 
1. Has the Principal Investigator ever had any research suspended or terminated by an IRB? 
 
  Yes          
  No    
 
 If yes, please explain:            
 
2. Has any version of this research protocol ever been submitted to any other IRB? 
 
  Yes          
  No         
 
 If yes, please attach a copy of all IRB correspondence  
     
3. Has the Principal Investigator ever been convicted of a crime, disciplined by a public or private medical 
organization, disciplined by a licensing authority or is the Principal Investigator currently the subject of such a 
proceeding? 
 
  Yes          
  No     
 
 If yes, please explain:            
 
 
4. Have any of the other investigators or study team members ever been convicted of a crime, disciplined by a 
public or private medical organization, disciplined by a licensing authority, or are any currently the subject of 
such a proceeding? 
 
  Yes          
  No     
 
 If yes, please explain:       
   
5. Location of Research: 
 
 
Check the facility where research activities will take place (please check all that apply): 
 
  CRMH 
 
  CNRVMC 
 
  JCHS 
 
  CC Physician’s Office 
  CRCH 
 
  CFMH 
 
  CRMH Rehab          
  Other: Carilion Institute of 
Orthopedics and Neurosciences (ION) 
 
 
List all departments within the facility where research activities will take place: Carilion Orthopedics 
 
6. Collaboration: 
 
 
Will this research involve collaboration with another institution?  
 Yes    
  No 
 
If yes, name the institution:        
 
7. Sponsor:  
 
 
Will this research be sponsored by an institution outside of Carilion?   
 Yes    
  No 
 
If yes, name the institution:        
 
8. Funding Source (check only one): 
 
  Carilion RAP grant  
  Federal/state agency (specify):       
  Other grant (specify):       
  Industry/commercial (specify):       
  Private, non-profit (specify):       
  No funding; equipment, supplies, and/or services will be provided (specify company):       
  No funding; no equipment, supplies, and/or services will be provided 
  Other (specify):       
 
9. Anticipated Start Date: October 1st, 2017 
 
10. Estimated Time Needed to Complete Study: September 30, 2018 
 
SECTION II: DRUG, DEVICE AND BIOLOGIC STUDIES ONLY   
 
 
        
  N/A 
 
11. What is the name(s) of the drug, device or biologic that will be used in this study:       
 
12. Please attach documentation to confirm FDA approval of this drug, device or biologic. Check one below: 
  Package Insert   
  Printed Information from the FDA website confirming FDA approval 
  Letter from FDA granting approval  
  Not available; FDA has not approved 
 
 
 
Carilion IRB Application 
 
       
- 2 - 

 
 
(July 2016) 
13. Does the research study involve an Investigational New Drug (IND) or Biologic? An IND number is required if 
a drug or biologic is used in a manner outside the labeling approved by the FDA. 
 
  Yes          
  No         
 
If yes, please provide the IND number assigned by the FDA. If an IND number is not available please 
explain why an IND was not obtained. If you believe the drug is exempt from IND approval, please 
submit an IND Determination form that can be found on the IRB web site. Note: Investigators may be 
asked to have an IND determination application submitted to the FDA. 
 
      
 
14. Does the research involve a device that is being used outside the labeling approved by the FDA? 
 
  Yes          
  No           
 
If yes: 
 
 
Please provide the Investigation Device Exemption (IDE) number provided by the FDA:  
 
      
 
Attach one of the following: 
 
     FDA letter granting an IDE 
     A letter from the sponsor or investigator/sponsor stating the study device is non-significant risk  
     A letter explaining why the investigation is exempt from IDE requirements 
 
SECTION III: STUDY PROTOCOL 
 
 
 
 
 
15. Study Abstract: Provide a brief, non-technical summary of the study, including study purpose and methods. 
 
The purpose of this study is to quantify the impact of a formalized pain management education 
program on the outcome and experience of patients undergoing outpatient, upper extremity, 
orthopedic surgery. Outcome measures include the validated Quality of Recovery-15 patient survey 
and PROMIS survey (selected short forms evaluating pain and medication side effects), as well as 
measures of patient behavior (amount of pain medication used, number of calls/visits to a medical 
provider for pain-related concerns), pain levels (1-10 scale), reported side effects, and patient 
knowledge as measured on a follow-up questionnaire. It is the premise of this study that patient 
education regarding perioperative pain management could benefit patients in several ways:  
1) empowering patients to make informed decisions regarding the pain medications and modalities 
they choose,  
2) reducing the incidence and severity of pain medication related side effects or complications,  
3) improving post-operative pain control,  
4) improving patient satisfaction, and  
5) reducing the use of narcotic. 
 
Four hundred (400) adult patients undergoing elective outpatient, upper extremity, orthopedic 
surgeries will be recruited by the surgeon-investigators. Patients will be randomized to view one of 
two educational programs: 1) a 2-video series regarding post-operative pain management or 2) a 
video regarding wound care and activity. Randomization will be stratified based on initial narcotic 
prescription size, which has been shown to influence narcotic use, and baseline pain medication use.1 
 
These patients will be encouraged to review the video online in the week before surgery.  An intake 
enrollment form will be completed by an investigator using demographic information available in the 
chart.  
 
Participants in both arms will complete their Patient Education Study Diary daily, for 7 days 
following their surgery.  There are two versions of this diary: the Wound Education Version asks 
patients to report daily pain mediation use. The Pain Education Version does not include this section 
as patients in the pain management arm of the study record this information in their Recovery Diary. 
                                            
1 The guidelines have been developed in conjunction with the upper extremity surgeons to reflect their current 
practice. The purpose of the guidelines is to reduce inadvertent variability, particularly when residents and other 
providers provide the post-operative prescription. Despite the guideline, the surgeon is still encouraged to provide 
the pain medication prescription he/she feels is most appropriate for the patient.  

 
 
The Patient Education Study Diary includes a daily pain scale, the QoR-151 on day 2, the selected 
PROMIS short forms on day 3 and knowledge quiz on day 7. It also contains opportunity to report 
dressing changes, co-analgesic modalities (ice, elevation, etc), and possible medication side effects. 
There are daily questions regarding confidence, feeling in control, and satisfaction. The final day also 
has questions regarding how many times the videos were viewed, the number of contacts with a 
healthcare provider for pain and wound related issues, and concurrent use of other sedating 
substances (sleeping pills, alchohol, street drugs, other sedating medications). . Patients in the control 
group (wound care) will also record all pain medications used each day along with any side effects of 
said medications. Participants in the intervention (pain management) group will record their pain 
medication use in the additional Recovery Medication Diary provided. The patient will return the 
diary at the first post-operative visit or by mail. 
 
Patients may be contacted   by phone within 7-10 days after the appointment if study materials are not 
complete. Information regarding the initial narcotic prescription, CPT procedure codes, concurrent 
NSAID prescription, and type of anaesthetic will be obtained from EPIC by chart review.  
 
 The patient will be contacted again by phone and/or mail 1 year after surgery (12-14 months) using 
the contact information available in EPIC to determine the self-reported prevalence of chronic pain 
and pain medication use (yes or no answers): 
1. Do you have pain on a daily or weekly basis? 
2. In the past year, have you taken prescription opioid (or narcotic) pain medication most days or 
most weeks?     
3. In the past year, have any other pain medications (prescription or over the counter) most days or 
most weeks? 
 
 
Measured outcomes will include: QoR-15 and PROMIS scores, number of narcotic pills used in the 
first week after surgery, daily pain level (by 0-10 rating scale), patient-reported satisfaction and 
feeling of control, related calls/visits to a health care providers,  use of non-narcotic adjunct pain 
relief modalities, incidence of side effects and adverse events, demonstrated patient knowledge as 
measured by score on the follow-up quiz, and prevalence of chronic pain, long term narcotic and non-
narcotic pain medication use.  Positive improvements in some or all of these measurements are 
expected with this patient education intervention.  
 
 
16. Background: Summarize background information about the research question(s.)  Tell why the research is 
needed and include the relevance of this research to the contribution of this field of study.  Also, provide 
references to relevant articles in the literature.  (If you have more than 10 references, please submit the list 
of references as a separate attachment.  Otherwise, please insert them here.) 
 
 
Pain after surgery is a common experience and is not always well controlled. Results from a recent five-year 
survey of adult surgical patients (N = 300)  showed ∼86% experienced pain after surgery; of these, 75% had 
moderate/extreme pain during the immediate post-surgical period, with 74% still experiencing these levels of 
pain after discharge. Post-surgical pain was the most prominent pre-surgical patient concern, and nearly half 
reported they had high/very high anxiety levels about pain before surgery. 2 
 
In the case of outpatient orthopedic surgery at Carilion, there are no guidelines or standardized practice for 
pre-operative education of the patient regarding post-operative pain control. The majority of teaching 
regarding pain management is usually undertaken by the discharge nurse shortly after the patient has 
emerged from anesthetic at a time when the patient’s ability to retain new knowledge may be compromised. 
Patients often leave hospital with local anesthetic or a block controlling their pain, only to experience a higher 
level of pain some hours later.  Patients then generally have the option of several medication choices 
(acetaminophen, narcotic or narcotic-combination medications, and non-steroidal anti-inflammatories) with 
which to essentially self-medicate at home, in combination with non-pharmaceutical modalities. Some 
patients are also regular users of central nervous system depressors, such as muscle relaxants, sleeping pills, 
anti-depressants, and alcohol, which may contribute to risk of serious complications.      
 
The importance of patient education regarding peri-operative pain control is agreed upon, although support 
in the literature, especially in the outpatient setting, is not strong.    In 2016, a clinical guideline for the 

 
 
management of post-operative pain was published jointly by American Pain Society, the American Society of 
Regional Anesthesia and Pain Medicine, and the American Society of Anesthesiologists' Committee on 
Regional Anesthesia, Executive Committee, and Administrative Council. Their recommendations included the 
following: 
“Patients should be counseled on how to take pain medications safely and to manage side effects to optimize 
pain control and recovery with return to usual activities. This might be particularly important for the growing 
number of outpatient surgical patients. Patients and families should be informed that the use of other central 
nervous depressants (including alcohol) or illicit drugs in combination with opioids can result in accidental 
overdose and death. Discharge teaching should include a discussion of the plan for reduction and 
discontinuation of opioids as the acute pain resolves, as well as appropriate disposal of unused supplies of 
opioids and other medications.”3 
 
Pre-operative education for post-discharge pain control has been promoted by AORN: “Effective 
communication between the patient, designated support person(s), and perioperative team members 
enhances the patient’s capacity for medication self-management after discharge.” 4 
   
Specific communication about pain has been shown to correlate strongly with patient satisfaction.  Five 
dimensions have been identified as impacting on patient satisfaction: information provision; physical 
comfort/discomfort; emotional support; involvement in care; and privacy.   In an inpatient setting, higher 
self-report of pain was associated with lower levels of satisfaction.  Patients reporting adequate teaching 
rated a higher satisfaction score (4.46) than patients reporting inadequate teaching. 2,5–8 
 
Patient education in the outpatient setting is essential in allowing the active participation of the patient in 
their own health care, and could reasonably increase patient safety in a way similar to in-hospital programs 
that have been shown to reduce medication errors. The effect of pre-operative patient education on 
decreasing narcotic use and improving pain control has been demonstrated on one study of 135 patients who 
were randomized to receive educational intervention vs no education.9 
 
Recent interest in the over-prescription of narcotic pain medication after outpatient surgery has led to several 
studies which suggest standardized protocols for prescription sizes. The Hand Section of the Department of 
Orthopedics at Carilion clinic has recently submitted for publication a manuscript showing the effect of initial 
prescription size on narcotic use in this setting. We are also participating in a multi-center international trial of 
narcotic vs. non-narcotic analgesics for pain control after carpal tunnel surgery.  Investigating the role of 
patient education in post-operative pain management is an extension of this line of research. 
 
This study will be a prospective, randomized, placebo-controlled experimental study investigating the effect of 
a formalized patient education program (videos and recovery diary handout) on patient experience and 
outcome after outpatient orthopedic upper extremity surgery, using both validated and non-validated 
outcome measures. 
 
 
17. Objectives: State the research hypothesis or the question that the research will answer. List the research 
objectives and expected outcomes. A primary outcome or objective must be identified. After the 
statement of the primary objective, secondary objectives may be listed. Objectives should be simple and 
specific. 
 
Hypothesis: Patient experience and outcome after outpatient upper extremity orthopedic surgery can 
be improved by a formalized education program (video and handout) regarding post-operative pain 
management. 
 
Primary outcome: 
 
1. QoR-15 scores (post-operative day “POD” 2), 
a. 15-question validated outcome measurement tool used in the setting of outpatient surgery 
which takes about 2.5 minutes to complete and includes pain as one of its outcome domains 
 
Secondary Outcomes: 

 
 
 
2. PROMIS short forms administered on POD 3 –  (GI belly pain 5a, GI nausea and vomiting 4a, Pain 
Intensity 3a, Pain Interference 4a, Sleep Disturbance 4a, Cognitive Function 4a) 
3. number of narcotic pills used – 7 days,  
4. daily pain level (by 0-10 rating scale) – 7 days,  
5. patient-reported satisfaction and feeling of control (4 point rating scale) 
6. number of pain-related calls/visits to a healthcare provider 
7. use of non-narcotic adjunct pain relief medication and modalities  
8. incidence of high risk activities (combining narcotics with muscle relaxants/sedatives/alcohol, etc.; 
combining prn NSAIDs with regularly dosed prescription NSAIDs, exceeding daily recommended doses) 
9. incidence of side effects and adverse events, 
10. demonstrated patient knowledge as measured by score on the follow-up quiz, and 
11. prevalence of chronic opioid use.   
 
Positive improvements in some or all of these measurements are expected with this patient education 
intervention.  The Quality of Recovery-15 survey is a 15-question validated outcome measurement tool used 
in the setting of outpatient surgery which takes about 2.5 minutes to complete and includes pain as one of its 
outcome domains 
 
18. Study Design: Give a description of the research design including use of placebo, randomization and an 
explanation of what is experimental. Include type of study: descriptive, retrospective, cross-sectional, 
longitudinal, prospective observational, pilot, experimental (controlled or non-controlled) or pilot. 
 
A prospective, randomized, controlled study. The experimental intervention is exposure of the subject to a 
standardized educational program on post-operative pain management, while the control is exposure to a 
standardized educational program on wound care.  
 
 
19. Study Population: Describe the subject population, including age, gender, ethnic characteristics and health 
status. State the inclusion/exclusion criteria along with how this was determined, and by whom. Please state 
whether pregnant women, children, or other vulnerable groups will be included or excluded.  Provide 
rationale for using or excluding special populations.  State the number of subjects or subject records 
necessary to complete the research. 
 
400 patients undergoing outpatient, upper extremity, orthopedic surgery meeting the following inclusion and 
exclusion criteria will be recruited. 
 
Inclusion Criteria 
1. Adult (age 18 or older) patients planning elective outpatient orthopedic surgery procedures by a 
Carilion Clinic hand surgeon will be eligible for the study. 
 
Exclusion criteria will include: 
1. Patients unable or unwilling to provide informed consent 
2. Patients unable to unwilling to participate in the trial (poor English language skills, blindness, 
cognitively disadvantaged, poor literacy skills, other barriers to participation) 
3. Patients who are or suspect they may be pregnant. 
4. Patients for whom the medical provider, in his professional judgment, does not feel that the study 
protocol would be appropriate. (to be tracked) 
 
Inclusion and exclusion criteria were selected by the PI with the intention to make the study 
population as inclusive as possible to represent since the goal of the videos is the have them available 

 
 
for general patient viewing. Pediatric patients and pregnant patients are excluded as these represent 
populations with special ethical and medical considerations (such as drug dosing, medication effect 
on the fetus) which are not addressed in this study.  Also, the educational program is designed for 
adult learners. 
 
 
20. Methodology: List all activities or procedures that will be performed (pre-treatment tests and medications, 
tests and medications used during therapy, diagnostic tests, x-rays, lab tests, questionnaires and other forms, 
interviews, chart reviews etc.) Describe how, when and where research activities will be administered and 
analyzed.  Distinguish any standard processes from those that are research.  Please describe 
activities/procedures in a step-by-step chronological order. State the length of time subjects will be in the 
study and the expected amount of time required for each study visit or activity. 
 
1. Recruitment – 10 minutes 
 
A desk-top sign advertising the study will be displayed in patient rooms used by the Hand Section 
providers for patient visits. 
 
All patients who are consented or scheduled for surgery during a clinic visit with a Hand Section 
provider at the ION building (when a designated enrollment investigator is present/available) will be 
considered for the study. These patients will be referred to the designated enrollment investigator, 
who will present the participation opportunity to the patient after the conclusion of the visit with the 
provider. The designated enrollment investigator may be a study coordinator, medical student, or 
other investigator, but will not be the treating physician. Study coordinators will be utilized in this 
role whenever possible, although scheduling and budget restraints will make mixed coverage 
necessary.    
 
The surgeon will inform the designated enrollment investigator (verbally) of the anticipated 
prescription class for use in randomization. The designated enrollment investigator will send the 
surgeon a staff message in EPIC to document that number for reference on the day of surgery. 
 
Patients who agree to participate in the study will sign the consent form. The designated enrollment 
investigator will keep track of all patients who are consented for surgery but do not enroll in the 
study, collecting only the number of such patients and their reason for not entering the study (patient 
declines or which eligibility criterion is not met). No identifying data or other demographic data will 
be collected from patients who do not consent to enter the study. This information will be recorded in 
REDCap. 
 
2. Randomization - < 1 minute 
 
They will then be randomized to a study group using a REdCap stratified randomization protocol.   
 

 
 
Randomization will by stratified by anticipated post-operative prescription (none, tramadol, 10 
narcotic pills, 20 narcotic pills, 30 narcotic pills, >30 narcotic pills). Other factors that will be 
controlled for through randomization include: 
1)  
 
The surgeon and other treating providers will be blinded as to the randomization of the patient.  In 
some cases, the patient may initiate a discussion with the surgeon which necessarily reveals the 
randomization – this is necessary to avoid interference with physician-patient communication 
(avoiding negatively impacting patient care) and will be considered acceptable for this study.  
 
3. Data collection – enrollment phase – 10 minutes 
 
An enrollment form is completed by the designated enrollment investigator based on patient interview 
and/or chart review at the time of enrollment.  
 
At the pre-operative visit prior to video viewing, patients will complete, using REDCap online with 
the assistance of an investigator, the following: 
 
I. 
Quality of Recovery 15 (2.5 minutes) 
II. 
PROMIS short forms in the following domains: (approximately 6 minutes) 
a. Physical Health – Gastrointestinal - Belly Pain 5a 
b. Physical Health – Gastrointestinal – Nausea and Vomiting 4a  
c. Mental Health – Cognitive Function 4a 
d. Sleep Disturbance 4a 
e. Pain Intensity 3a 
f. Pain Interference 4a 
 
4. Educational Intervention (experimental): (6-12 minute video, depending on randomization) 
1) Pain Management Education (Intervention) 
a. A series of two 6-minute videos. The first video, Managing Pain after Outpatient Surgery, 
Part 1, discusses a tiered approach to pain management, including rest, ice, elevation, 
distraction, and medication. Three classes of pain medication commonly used after 
surgery, including nonsteroidal anti-inflammatories, acetaminophen, and opioids, are 
discussed, including the role of each medication and the risks and side effects. Naloxone, 
an antidote to opioid medication for emergency use, is introduced. The second video, 
Managing Pain after Outpatient Orthopedic Surgery, Part 2, instructs the patient on how 
to make a Pain Plan with regard to post-operative pain medication, including the use of 
over the counter pain medications and a medication diary. (12 minutes) 
b. Recovery Medication Diary (1-7 minutes, daily, for 7 days) 
 
2) Wound Care Education (Control) 
a. A single video, Caring for Your Closed Wound, discusses the types of sutures that are 
used to close surgical wounds, the specifics of wound care and dressing changes, 
swelling management, restriction of physical activity, scarring of the surgical site and 

 
 
methods to reduce scarring, and guidance on when to call their physician if they suspect 
something to be wrong following their procedure. (6 minutes) 
 
 
 
Patients are encouraged to view the video(s) in the examining room of the clinic before departure on a 
tablet device. Patients who elect to watch the video will be offered a small bottle of water, due to the 
extended visit and as a “fidget” to aid in attention. The videos will also be “assigned” to the patient in 
MyChart through the GetWellNetwork, and also available for viewing online on the Carilion channel on 
YouTube.  
 
5. Patient packet dissemination (< 1 minute) 
 
All patients in the study will receive an enrollment package with includes a copy of the consent form, 
video web address, and Patient Education Diary (experimental or placebo version).  Patients in the Pain 
Control Video group will also receive a Recovery Diary corresponding to the video. 
 
6. Data Collection (1-7 minutes daily for 7 days) 
 
Patients are invited to view the video on the GetWellNetwork through MyChart and on YouTube. 
Viewing will be tracked by patient report, and by tracking views on the GetWellNetwork.  (Viewing by 
patient report will be used in statistical analysis, comparison to GetWellNetwork data will be 
exploratory.) 
 
Participants in both arms will complete a Patient Education Study Diary daily for 7 days following their 
surgery. Patients in the control group (wound care) will also record all pain medications used each day 
along with any side effects of the medications. Participants in the intervention (pain management) group 
will record their pain medication use in the additional Recovery Medication Diary provided.  
 
Patients will receive a phone call from either an investigator or the study coordinator on Day 1-3 and Day 
5-7 to remind them to complete their diaries and to answer any questions the patient may have (see 
attached script).  
 
Patients will return their diaries at their first post-operative visit. If they do not bring the diaries to the 
post-operative visit, they will be given a self-addressed, stamped envelope to facilitate return. Patients 
will be contacted by phone (with permission) <10  days and 14-21 days following surgery and again 21-
28 days after surgery if they have not returned their study materials as a reminder.  
 
The Follow-up Questionnaire will be completed at the 1st post-operative visit, or by phone within 7-10 
days of that appointment. The patient will be contacted again by phone and/or mail 1 year after surgery 

 
 
(12-14 months) using the contact information available in EPIC to determine the self-reported prevalence 
of chronic pain and pain medication use: 
1. Do you have pain on a daily or weekly basis? 
2. In the past year, have you taken prescription opioid (or narcotic) pain medication most days or 
most weeks?     
3. In the past year, have you used pain medications (prescription or over the counter) most days or 
most weeks? (list medications used on a daily or weekly basis for pain) 
 
 
 
 
 
 
7. Data Storage, Data Entry and Statistical Analysis 
 
Paper copies of study materials containing confidential patient information will be stored in locked boxes 
in the nursing station and in locked drawers in locked areas of the clinic/physician offices. Electronic 
copies of study materials/collection tools containing patient identifiers/confidential information will be 
stored on the Carilion S drive or on REDCAP as appropriate. All paper and electronic copies will be 
retained for 7 years and destroyed according to Carilion accepted research procedure. 
 
A working binder will be maintained for logistical purposes to track and coordinate enrollment, follow-up 
phone calls and visits, and collection of study materials. The binder will list subject number, name, phone 
number, dates of surgery and visits, and have columns to track progress through the study protocol. It will 
be maintained in a locked drawer in a locked office. 
 
Data Entry will be carried out by the investigators. 
 
Statistical analysis will be carried out with assistance of a Carilion Clinic biostatistician. Statistical 
analysis will include description of the study population and comparison of study groups based on 
demographic variables. This will include age, surgical site (hand, wrist, forearm/elbow, 
humerus/shoulder), and type of anesthesia (general vs. local) as these have been shown to affect post-
operative narcotic use. Analysis regarding the effect of age, gender, and surgery and medication related 
variables on the outcome measures will also be carried out. Primary and secondary outcome measures 
will be  
 
a. QoR-15 scores (primary outcome), 
b. PROMIS scores, 
c. number of narcotic pills used,  
d. daily pain level (by 0-10 rating scale),  

 
 
e. patient-reported satisfaction and feeling of control (4 point rating scale),  
f. number of pain-related calls/visits to a healthcare provider 
g. use of non-narcotic adjunct pain relief medications and modalities,  
h. incidence of high risk activities (combining narcotics with muscle 
relaxants/sedatives/alcohol, etc.; combining prn NSAIDs with regularly dosed prescription 
NSAIDs, exceeding daily recommended doses) 
i. 
incidence of side effects and adverse events,  
j. 
demonstrated patient knowledge as measured by score on the follow-up quiz, and 
k. prevalence of chronic pain, long term narcotic and non-narcotic pain medication use.  .   
 
Analysis regarding the effect of age, gender, and surgery and medication related variables on the outcome 
measures will also be carried out. 
 
How this study differs from the usual care a patient will receive: 
 
Patient education regarding post-operative pain management is usually conducted in an ad-hoc case-by-
case basis by the physician or representative that enrolls a patient for surgery. Review of medication for 
discharge by the nurse at the surgery facility and written post-operative instructions which includes some 
discussion of post-operative pain control are formalized and a routine part of patient care. This study 
differs from standard care through the addition of a standardized pre-operative education program in the 
form of the Pain Management Video series and Recovery Diary to care of the intervention group, and the 
addition of the Wound Healing Video to the control group. No part of the normal patient care will be 
removed as part of this study.  
 
 
 
 
Carilion IRB Application 
 
       
- 3 - 
(July 2016) 
21. Data Collection: Attach a copy of your data collection tool or spreadsheet listing exactly what data is to be 
gathered during this research study.  Describe below the data collection methods and how data be compiled 
for assessment. 
 
Data to be collected: 
 
Patient Demographic Data: 
Name 
EMPI 
CSN 
MRN 
Contact phone number 
Age 
Gender 
Pre-existing pain medication use (opioids, acetaminophen, NSAIDS, lyrica, Neurontin) 
Patient race, ethnicity, education level 
 
Data Related to Surgery: 

 
 
Date of Surgery 
Surgical Procedure(s) and anatomic location 
Patient weight  
Anesthetic Type 
Pain Medication Prescribed 
 
Outcome Measure Data: 
1. QoR-15 scores (primary outcome), 
2. Selected short form PROMIS questionnaires, 
3. number of narcotic pills used,  
4. daily pain level (by 0-10 rating scale) for days 0-7,  
5. patient-reported satisfaction and feeling of control (10 point rating scale),  
6. calls/visits to a health care provider for pain or related concerns 
7. use of non-narcotic adjunct pain relief medications and modalities,  
8. incidence of side effects and adverse events 
9. reported frequency of noting pain medication dose times, 
10. demonstrated patient knowledge as measured by score on the follow-up quiz, and 
prevalence of chronic pain, long term narcotic and non-narcotic pain medication use.     
Data will be collected by chart review (for demographic data and data pertaining to the surgery, anaesthetic, and 
initial narcotic prescription), physician and patient reporting, and by patient diary/surveys (which will be 
completed by the patient at home and returned at the follow-up visit or by mail). Follow-up phone calls will act as 
a reminder to help encourage completion of the study. Information regarding how many times a video was viewed 
will be collected by patient questionnaire (measured outcome to be used in analysis), reviewing Mychart data, and 
counting Youtube hits.  
 
 
22. Statistical Analysis: State how qualitative and/or quantitative data will be analyzed. This must include a 
statement from a statistician that there is sufficient power to determine the primary study outcome or 
objective. Other outcomes may be listed as secondary and descriptive. If this is a proof of concept or 
feasibility study that includes limited efficacy testing, there must be a statistician statement that the 
appropriate design is in place to determine whether an intervention should be recommended for broader 
efficacy testing. If a study is meant to be solely descriptive, then results apply only to the sample being 
studied and conclusions cannot be drawn about the larger population; therefore, the primary outcome or 
objective must be limited in scope. 
 
Standard descriptive statistics will be undertaken. All data will be integrated into a mixed model 
ANOVA with appropriate post-hoc comparisons by group as appropriate. Analysis will be carried out 
with the assistance of a qualified biostatistician.  
 
 
Power Calculation and Sample Size: 
The QoR-15 score is a validated outcome metric for quality of recovery (Stark 2013)1 and is the 
primary outcome measure for this study. Thus, the QoR was chosen for the power analysis and 
sample size calculation.  Using data from Stark et al 2013, the expected values for the QoR score are 
average (μ) of 120 and standard deviation (σ) of 251. We would consider a difference of 8 points to be 

 
 
clinically significant. Thus, using these values and with an α of 0.05 and β of 0.8, the calculated 
sample size is n = 154. Our study design will allow for a maximum attrition of up to 20% (39 
patients), thus we will enroll 200 patients per group (rounding up from 193). 
Our group performs approximately 2000 procedures annually (1,973 in FY2016), of which we 
anticipate 80% will be eligible for this study. Assuming a 50% enrollment rate, it is reasonable to 
project completion of enrollment in 6 months. Notably, the enrollment rate amongst eligible patients 
for our completed study on narcotic use after minor hand surgery was greater than 95%. However, 
this study does require more patient engagement, and so a more conservative estimate has been used. 
The video length as well as the length and complexity of the diary and surveys are being minimized. 
Patients will be contacted by phone (with permission) as well as have contact at their follow-up 
appointment(s) to assist with completion and return of materials. Self-addressed stamped return 
envelopes will be provided when the patient fails to bring study materials to the first post-operative 
visit. 
 
 
 
Statistical review was conducted by: Ellen S. Lockhart      (name of statistician)   
 
 
   
 
 
Carilion      (Department/Institution of statistician) 
 
If no statistical review was done, explain why:       
 
SECTION IV: RISKS AND BENEFITS 
 
23. Summarize the possible risks to subjects and how they have been minimized in the study design. Include risk 
of psychosocial harm (e.g., emotional distress, embarrassment, breach of confidentiality), economic harm 
(e.g., loss of employment or insurability, loss of professional standing or reputation, loss of standing within 
the community) and legal jeopardy (e.g., disclosure of illegal activity or negligence), as well as known side 
effects of study medication, if applicable, and risk of pain and physical injury. Define the level of risk (minimal 
risk, risk but with potential benefit to patient, risk but no benefit to patient). Describe any procedures that will 
be used to prevent or minimize risks or discomforts. Note: Most studies create at least a small risk of breach 
of confidentiality or privacy. 
 
This is a minimal risk study. Risks include breach of confidentiality due to the collection of patient protected 
health information. All collected data will be disclosed in the consent form.  
 
24. Describe all costs, if any, subjects may incur as a result of being in this study. 
 
Subjects will not incur any costs additional to those they would incur as part of their routine care. 
 
25. Describe how subjects will be compensated for injury incurred as a result of being in the study. 
 
This is a minimal risk study. Subjects will not be compensated for injury incurred as a result of being in this 
study.  
 
 
26. Is any deception used in the study or any aspect of the study kept secret from the subjects, such as the full 
purpose of the study? 
 
  Yes          
  No           
 
 
If yes, describe the deception involved and the debriefing procedures:  
 
27. Describe any direct benefit to individual subjects, to the group of individuals with the disease process you are 
researching, and/or to society based on scientific knowledge gained. Explain how the potential benefits 
offered by this research outweigh the risks. (Please note: payments, gifts, or other free services given as a 
token for participation are not benefits, but instead are classified as compensation.) 
 
The investigators believe that both the Pain Management and Wound Care educational programs help 
patients be more prepared for their surgical recovery, although this has not been demonstrated 
experimentally.  Data gathered during this study may help researchers understand what educational materials 
are helpful to patients making pain management decisions, and how these materials influence their pain 
management choices after surgery. 
 

 
 
SECTION V: RECRUITMENT 
 
28. Number of Subjects/Enrollment Goal. The enrollment goal must match the number of subjects needed to 
meet the primary outcome.  If this is a retrospective record review, this figure is the number of records that 
will be used for analysis. Note: Once research begins and it is anticipated the enrollment goal will be 
exceeded, the IRB must be notified. In some cases, prior IRB approval must be given to exceed the 
enrollment goal. 
 
Locally:  400     At all Sites:          
 
***If this study is a retrospective record review only, you may skip to Section VII*** 
 
 
Carilion IRB Application 
 
       
- 4 - 
(July 2016) 
 
29. Will subjects receive any compensation or gifts to participate? 
 
  Yes         
  No          
  N/A 
 
 
If yes, specify payment amount, how it will be prorated and how payment will be made: The patient will 
be provided a “thank you” gift in the form of a Carilion branded “I made a DIFFERENCE!” cup (see 
recruitment flyer for image). The cups have been approved by Carilion Marketing. They are valued at 
$3.87. The cup will be given to the patient at their first post-operative visit, regardless of whether the 
patient has completed the study, withdrawn from the study, or is yet to return study materials.   
 
30. Will you, the sponsor, or Contract Research Organization offer any fee to physicians for the referral of 
potential subjects? 
 
  Yes          
  No 
 
31. Will recruitment materials be used? 
 
  Yes          
  No           
 
If yes, check all that apply and include with this submission: 
 
  Brochure 
 
 
 
  Radio/Television script 
 
 
  E-mail   
 
 
 
  Newspaper Ad 
 
  Recruitment letter 
 
 
  Website advertisement (including Facebook, Craigslist, etc.) 
  Flyer/Poster 
 
 
 
  Telephone or in-person script 
  Clinical trial website posting 
 
  Other (please specify):       
 
STEP 1: IDENTIFICATION OF POTENTIAL SUBJECTS  
To “identify” a potential subject refers to steps you plan to take to determine which individuals may qualify to 
participate in your study so that you can decide which individuals to contact about taking part. 
 
32. How do you plan to identify potential subjects? (check all that apply) 
 
  Medical Chart Review, Clinic Schedule Review, or QA-QI Database Review (own patient population) 
 
*Study team requests Waiver of Informed Consent and, if any HIPAA identifiers are collected, a Waiver of  
 
HIPPA Authorization for recruitment purposes 
 Medical Chart Review, Clinic Schedule Review, or QA-QI Database Review (other physicians/practices 
 
patient population) 
 
*Study team requests Waiver of Informed Consent/HIPAA Authorization for recruitment purposes 
 Potential subjects will not be directly identified by the researchers.  The potential subject will obtain IRB-
 
approved written information about the study from his or her health care provider/faculty or from an 
 
advertisement, flyer, brochure, website, etc.   The potential subject would then contact the researcher if 
 
he or she is interested. 
 Researchers who ARE NOT treating clinicians of potential subjects will ask treating clinicians for referrals 
 
of eligible patients interested in the study.  Treating clinicians identify potentially eligible patients and 
 
provide researchers with patient contact information with patient permission documented (e.g. 
 
email/letter to researcher from treating clinician states patient permission given. Researcher documents 
 
permission in research record.) 
 
*Study team requests Waiver of Informed Consent/HIPAA Authorization for recruitment purposes 
  Contact information will be provided by a patient’s Carilion health care provider without the patient’s 
 
knowledge to the researchers AND this is a minimal risk study that does not involve investigative drugs, 
 
devices, biologics or medical or surgical procedures.  
 
*Study team requests Waiver of Informed Consent /HIPAA Authorization for recruitment purposes 

 
 
 Review of Registry/Database in which individuals have previously signed a consent giving their permission 
 
to be contacted for future studies 
 Student Records 
 
*Study team requests Waiver of Informed Consent for recruitment purposes 
 Other – please explain: see 33 
 
33. Please describe the identification process. List all information you plan to collect during the identification 
process prior to contacting potential subjects. This includes the inclusion/exclusion criteria and demographics 
to determine if a person qualifies for a study before contacting that person to be a potential subject. 
 
Treating providers, who are also investigators, will identify potential subjects that are 18 years of age or older 
and are planning/scheduling outpatient orthopedic surgery and will ask the patient (personally or through a 
treatment team delegate) if they would mind meeting with the designated enrollment investigator present in 
the clinic that day.  
 
Script: 
 
“Mr/Ms  ___________________. I think you would qualify to participate in a study about educating patients 
before surgery.  The study involves watching a video designed to help you prepare for surgery. Would you be 
interested in meeting with a study representative to see if you qualify and learn more? Don’t feel any 
pressure - it won’t affect your care either way.” 
 
If a patient does not wish to meet with the designated enrollment investigator, the designated enrollment 
investigator will be informed that one patient declined to meet with them, and that information will be 
retained for tracking purposes. If the treating provider knows that a patient who is meets inclusion criteria 
would not qualify for the study due to exclusion criteria, he or she will also pass on the information that one 
patient who is planning surgery was not referred for consideration for failing to meet exclusion criteria, and 
this information will be recorded.  
 
34. Who will conduct the identification process? 
 
 Principal investigator 
  Other investigator (specify): Dr. Peter Apel, Dr. Cesar Bravo, Dr. Cay Mierisch, Dr. Horatiu Dancea, Dr. 
Hugh Hagan, Dr. Anthony Capito  
  Research coordinator (specify):       
  Other research team member (specify):       
 
Carilion IRB Application 
 
       
- 5 - 
 
(July 2016) 
STEP 2: CONTACTING OF POTENTIAL SUBJECTS 
To “contact” a potential subject refers to the initial contact method you plan to use to reach a potential subject to 
determine if he or she would be interested in taking part in your study. 
 
35. How will potential subjects be contacted? (please check all that apply) 
 
  Direct in-person contact    
  Telephone call  
  Letter  
 E-mail 
 Potential subject will not be contacted.  Potential subject will contact the researchers by responding to a 
 
flyer, brochure, e-mail, etc.) (Please skip to #39.) 
 
36. Who will contact the potential subject?  (please check all that apply) 
 
 Principal investigator 
  Other investigator (specify names): Dr. Peter Apel, Dr. Cesar Bravo, Dr. Cay Mierisch, Dr. Horatiu 
Dancea, Dr. Hugh Hagan, Soleille Everest, Dr. Anthony Capitlr 
  Research coordinator (specify names): Allison Bell 
  Other research team member (specify names):       
 
37. If potential subjects are patients of Carilion Clinic, please check the appropriate scenario: 
 
  Patients will be contacted by the researcher who is also the treating clinician or by a member 
of his/her treatment personnel or by his/her Carilion research personnel. Potential subjects will be  
      assured that their decision will not affect their treatment or care or relationship with the treating clinician.  
    *Submit letter, email, or phone script (if applicable) using appropriate IRB template. 
  Patients will be contacted by their treating clinician who is not the researcher by letter with 
 
information about the research study.   * Submit letter using appropriate IRB template.  

 
 
 
Check all that apply: 
   The letter will be co-signed by the principal investigator and sent by the research team. 
 
*Study team requests Waiver of Informed Consent/HIPAA Authorization for recruitment 
purposes 
   The letter will indicate that the patient will be called by researchers to discuss study.  The 
letter will include a telephone number to call or post card to return to indicate patient does 
not want to be contacted. *Submit phone recruitment script.   
   The research involves the collection of sensitive information (e.g. illegal behavior, drug, or 
alcohol use; mental illness; sexual behavior.)  The letter will include a telephone number to 
call or post card to return if patient is interested in learning more.  Patient will not be 
contacted until he/she calls or returns post card. 
  Researchers who ARE NOT treating clinicians of patients will contact patients: 
 
 after patients have given permission to a treating clinician to share contact information with 
the research team and permission is documented   
 without the patients’ prior permission AND this is a minimal risk study that does not involve 
investigative drugs, biologics or surgical procedures. Check one: 
 Contact will be via letter, phone, direct-email. *Submit letter, email, phone script using the 
appropriate IRB template.  
 Potential subjects will be approached in person while at a Carilion Clinic hospital or clinic. 
 
*Submit recruitment script using the appropriate IRB template. 
 
38. If potential subjects are not Carilion Clinic patients, describe what will be said to potential subjects to 
introduce them to the research. If an investigator has direct authority over potential subjects who are 
students, medical residents or employees, then explain how recruitment will avoid undue influence. For 
example, someone from the research team who does not have direct authority will make the initial contact 
OR potential subjects will be assured a decision not to participate in the research will not affect grades or job 
evaluations. Submit any letter, email, phone or other recruitment script that will be used. 
 
N/A 
 
STEP 3: SCREENING OF POTENTIAL SUBJECTS   
To “screen” a potential subject refers to additional information that will be collected or activities that will take 
place after he or she has been identified and contacted and prior to obtaining informed consent for the study.  
This could include asking questions to a potential subject to determine whether he or she meets eligibility criteria. 
Note: To comply with HIPAA regulations, only the minimum necessary protected health information may be 
collected at this time. This means only questions relating to the inclusion and exclusion criteria may be asked. 
 
Carilion IRB Application 
 
       
- 6 - 
 
(July 2016) 
39. Please describe the screening process for your study. Please include whether you plan to ask potential 
subjects to do anything or answer questions prior to signing an informed consent document. For example: 
patients will come to the first visit fasting, stop taking medications, change diet, etc.    
 
Patients will meet with the designated enrollment investigator and be evaluated for eligibility for participation 
in the study using the inclusion and exclusion criteria stipulated in the protocol.  
 
 
 N/A (If N/A, please skip to Section VI) 
 
40. Who will conduct the screening? 
 
 Principal investigator 
  Other investigator (specify):  Dr. Peter Apel, Dr. Cesar Bravo, Dr. Cay Mierisch, Dr. Horatiu Dancea, Dr. 
Hugh Hagan, Emily Fischer,Dr. Anthony Capito Soleille Everest 
  Research coordinator (specify): Allison Bell 
  Other research team member (specify):       
 
41. List all information you plan to record during the screening process. (Attach screening data collection tool or 
an inclusion/exclusion checklist.)  *Study team requests Waiver of Informed Consent and, if any HIPAA 
identifiers are collected, a Waiver of HIPPA Authorization for recruitment purposes. 
 
Inclusion Criteria 
1. Adult (age 18 or older) patients planning elective outpatient orthopedic surgery procedures by a 
Carilion Clinic hand surgeon will be eligible for the study. 
 
Exclusion Criteria 
1. Patients unable or unwilling to provide informed consent 

 
 
2. Patients unable to unwilling to participate in the trial (poor English language skills, blindness, 
cognitively disadvantaged, poor literacy skills, other barriers to participation) 
3. Patients who are or suspect they may be pregnant. 
4. Patients for whom the medical provider, in his professional judgment, does not feel that the study 
protocol would be appropriate.  
 
 
SECTION VI: STUDY POPULATIONS 
 
42. Does the research involve intervention or interaction with individuals? (Examples include physical procedures, 
written or verbal communication with individuals, or surveys.) 
 
  Yes          
  No    
 
***If no, you may skip the remainder of this section and go directly to Section VII***         
 
43. Which vulnerable populations may be included in this study? Check all that apply: 
  Children/Minors (less than 18 years old) 
  Wards of State 
  Pregnant women 
 
 
  
  Fetuses 
  Neonates of uncertain viability OR non-viable neonates 
  Prisoners (Please contact IRB prior to submission of application.) 
  Mentally disabled persons* 
  Cognitively impaired persons* 
  Limited or non-readers 
  Non-English speakers (You must use either a translated consent form or short form. Contact IRB office.) 
  Economically disadvantaged persons 
 Educationally disadvantaged persons 
  Employees under the investigator’s supervision or authority 
  Students under the investigator’s supervision or authority 
  Patients in emergency situations 
 
 
 
 
  Terminally ill patients 
  Others that may be vulnerable to coercion:       
 
*If persons are without decision making capacity, please submit a Legally Authorized Representative 
Investigator Assurance Form.  This form is located on the IRB website. 
 
44. If persons in any of the vulnerable groups checked above will be enrolled into this study, please explain the 
additional safeguards that will be used to protect the rights and welfare of those subjects.  Check all that 
apply: 
  For economically disadvantaged subjects, there will be no financial screening of potential subjects and 
 
any eligible patient will be allowed to enroll regardless of financial standing or insurance status.   
  For educationally disadvantaged subjects, additional time will be spent with them to ensure their 
 
understanding of the research participation by answering questions and clarifying any issues.  The 
 
consent will be read to them if necessary. 
  For limited or non-readers, the consent will be read to them and additional time will be spent with them 
 
to ensure their understanding of the research participation by answering questions and clarifying any 
 
issues.  This process and the subject’s signature will be witnessed by someone who is not part of the 
 
research team. 
 
 
Carilion IRB Application 
 
       
- 7 - 
 
(July 2016) 
  For students, medical residents, or employees under investigator’s authority, an investigator, research 
 
coordinator, or other member of the research team that does not have direct authority over the students 
 
or employees will obtain information consent.  
  Other (specify):       
  
 
45. If this research does not exclude children please assess the level of risk involved (check only one): 
 
  N/A 
  Minimal risk (no greater than those ordinarily encountered in daily life or during the performance of 
 
routine physical or psychological examinations) 
  Greater than minimal risk but has potential benefit 
  Greater than minimal risk but no foreseen benefit 
 

 
 
46. For research involving children, will an assent form be used? Assent is not required if the intervention or 
procedure involved in the research holds out a prospect of direct benefit that is important to the health or 
well-being of the child and is available only in the context of research.  Please note: if the child is <7 years of 
age, a discussion is not required. 
 
  Yes          
  No          
  N/A 
 
47. Do you request a waiver of assent? 
 
  Yes          
  No          
  N/A 
 
If yes, please explain justification:       
 
48. Does the research exclude pregnant women?     
  Yes          
  No 
 
If you marked No above, then please affirm the following by marking each box: 
 
  Preclinical studies and clinical studies have been conducted and provide data for assessing potential risks 
 
to pregnant women and fetuses, or it is not scientifically appropriate to do this. 
  The risk to the fetus is caused solely by interventions or procedures that hold out the prospect of direct 
 
benefit for the woman and/or fetus; or, if there is no such prospect of benefit, the risk to the fetus is 
 
minimal and the purpose of the research is the development of important biomedical knowledge which 
 
cannot be obtained by any other means. 
  Any risk is the least possible for achieving the objectives of the research. 
  The research holds out the prospect of direct benefit to the pregnant woman and/or fetus, or no benefit 
 
for the woman nor fetus and risk to the fetus is minimal and the purpose of the research is the 
 
development of important biomedical knowledge that cannot be obtained by any other means. 
  Each individual providing consent will be fully informed regarding the reasonably foreseeable impact of 
 
the research on the fetus or neonate. 
  No inducements, monetary or otherwise, will be offered to terminate a pregnancy. 
  Individuals engaged in the research will have no part in any decisions as to the timing, method or 
 
procedures used to terminate a pregnancy. 
  Individuals engaged in the research will have no part in determining the viability of a neonate. 
 
Please affirm the following by marking each box if they apply to your research: 
 
  If the research holds out the prospect of direct benefit solely to the fetus, then the consent of the 
 
pregnant woman and the father will be obtained (father’s consent need not be obtained if he is 
 
unavailable, incompetent, or temporarily incapacitated; or the pregnancy resulted from rape or incest). 
  For children who are pregnant, assent and permission will be obtained. 
 
49. If you plan to enroll subjects that may be cognitively impaired, describe how you plan to assess decision 
making capacity prior to consent:       
 
Will consent be obtained from a surrogate decision-maker for incompetent subjects? 
 
  Yes          
  No 
 
 
 
 
 
 
 
Carilion IRB Application 
 
       
- 8 - 
 
(July 2016) 
 

 
 
 
SECTION VII: INFORMED CONSENT 
 
For guidance on required elements for a Carilion informed consent document, go to the Carilion IRB website; see 
New Submissions, Section 2, Informed Consent Guidelines. 
 
50. Are you planning to obtain written (signed) informed consent from subjects for this research? 
 
  Yes, I am planning to obtain consent and signature using a consent form (If yes, please skip to #52)    
  No, I am planning to obtain consent without a signature using an information sheet (Please go to #52) 
  No, I am planning to obtain only verbal consent (Please go to #52) 
  No, I am requesting a Waiver of Informed Consent (Please skip to #59) 
 
51. Please answer the following questions to request a Waiver of the Requirement to Obtain Signed Consent: 
 
 Is the informed consent document the only record linking the subject and the research, and is the 
principal risk the potential harm resulting from a breach of confidentiality? 
 
  Yes          
  No           
 
 Does the research involve any procedure for which written consent is normally required outside of the 
research context? 
 
  Yes          
  No 
 
52. Describe the process of how informed consent will be obtained from study subject. 
 
Patients who are interested in the study will meet with the designated enrollment investigator present in the 
clinic after their visit with their provider. The designated enrollment investigator with explain the study and 
review the consent form with the patient. If the patient wishes to participate, consent will be obtained. The 
patient will be offered some time to consider their decision or discuss participation with a family member or 
friend. As this is a minimal-risk study, same-day consent will be used. Requiring the study participant to 
attend an additional visit in order to give more time to consider participation would impose an undue burden 
on the study participant.  
 
 
53. Who will conduct the consent discussion with the subject? (Check all that apply): 
 
 Principal investigator 
  Other investigator (specify): Dr. Peter Apel, Dr. Cesar Bravo, Dr. Cay Mierisch, Dr. Horatiu Dancea, Dr. 
Hugh Hagan, Emily Fischer Soleille Everest 
  Research coordinator (specify): Allison Bell 
  Other research team member (specify):       
  For Survey Studies only:  Information sheet will be mailed and no discussion will take place 
 
54. Will a student (VTCSOM, Jefferson College, other college or university) be obtaining consent from subjects? 
(This does not include questionnaire or survey studies.) 
 
  Yes          
  No 
 
If yes, then the Principal Investigator must sign an attestation of training at the end of this form. 
 
55. Where will informed consent process take place: 
 
 In a private room 
 In a waiting room 
  In an open ward 
  In a group setting (Group consent is allowed only in special situations.  Explain process):       
  At potential subject’s residence 
  In emergency situations (Explain process):       
  Online (Explain process):       
  Over the phone (Phone consent is allowed only in special situations.  Explain process):       
  Other (specify):       
 
56. How will you assure there is sufficient opportunity for the subject to consider whether to take part? Check all 
that apply: 
 
  Subjects will be allowed to take home unsigned consent form for consideration prior to signing it 
  Subjects will be allowed a waiting period of       hours to consider their decision 
  Other (specify):  The patient will be offered some time during the interview, including a break, to 
consider their decision or discuss participation with a family member or friend. The patient will be allowed 
time to ask questions and for all questions to be answered to their satisfaction. As this is a minimal-risk 
study, same-day consent will be used. Requiring the study participant to attend an additional visit in order to 
give more time to consider participation would impose an undue burden on the study participant. 

 
 
    
57. What questions will be asked to assess the subjects’ understanding of informed consent? Check all that 
apply: 
 
 What is the purpose of this research? 
 What are the risks and benefits of being in this study?  
 How is being in this study different from ordinary treatment? 
 How long will you be in this study? 
 Other (specify):       
 
 
Carilion IRB Application 
 
       
- 9 - 
 
(July 2016) 
58. Please use Carilion IRB Informed Consent Templates located on our website.  How will you assure the 
consent form or information sheet is written at a level that can be understood by the research subjects?  
 
  Determine grade level and reading ease by using spelling and grammar function in Microsoft Word 
 
Provide Scores Here: 9.4 
  Use another readability formula or index (specify type used and results here):       
 
Note:  Consent Forms with difficult reading scores may be returned for editing and may delay IRB review 
       
 
***You may skip the remainder of this section and go directly to Section VIII*** 
 
Waiver of Informed Consent 
 
59. Does the research involve more than minimal risk (no greater than those ordinarily encountered in daily life 
or during the performance of routine physical or psychological examinations) to subjects or to their privacy? 
 
  Yes         
  No           
 
60. Will the waiver adversely affect the rights and welfare of the subjects? 
 
  Yes         
  No           
 
61. Is the waiver needed because obtaining consent is impracticable? Please check the appropriate option below. 
Note, by choosing any option in this category you confirm that data will not include psychotherapy notes and 
that the study is not subject to FDA research regulations.  
 
o 
This study is a retrospective medical record review and/or retrospective review of specimens. 
Obtaining informed consent is impracticable because of the large number of records and/or 
specimens involved. Note: If data/specimens are sought from a small group of patients, obtaining 
consent may be considered practicable even it is inconvenient. 
 
  Yes         
  No 
 
o 
Obtaining informed consent is impracticable because the sample size is so large (e.g. population-base 
studies or epidemiology trials) that including only those samples/records/data for which consent can 
be obtained would prohibit conclusions to be drawn or bias the sample such that conclusions would 
be skewed. 
 
  Yes         
  No 
 
o 
Obtaining informed consent is impracticable because the research is looking at issues such as 
outcomes/morbidity data where not having access to data from all subjects would affect the 
statistical outcome of the study. 
 
  Yes         
  No 
 
o 
Other reason obtaining informed consent is impracticable:       
 
62. Will the research yield information of direct clinical relevance for the subjects? 
 
  Yes         
  No 
 
63. Will subjects be provided with additional pertinent information after participation? 
 
  Yes         
  No 
 
 
SECTION VIII: HIPAA 
 
 
 
 
 
 
 
                     
 
64. Do you plan to access a Carilion healthcare record during your research study?    
 
 
  Yes 
  No (If no, please skip to #69) 
 
65. Please check whether these items will be collected or recorded from a Carilion healthcare record: 
 

 
 
 
name 
 
 
 
 
 
 
 
 
  Yes   
  No 
 
 
a geographic subdivision smaller than state except for the first 
three digits of the zip code 
 
 
 
 
 
  Yes   
  No 
 
 
an element of a date, except year, for dates related to an individual, 
including birth date, admission date, discharge date and date of death; 
and all ages over 89 and all elements of such ages may be aggregated 
into a category of age 90 or older 
 
 
 
 
  Yes   
  No 
 
 
telephone numbers 
 
 
 
 
 
 
  Yes   
  No 
 
 
Carilion IRB Application 
 
       
- 10 - 
 
(July 2016) 
 

 
 
 
fax numbers 
 
 
 
 
 
 
 
  Yes   
  No 
 
 
electronic mail address  
 
 
 
 
 
  Yes   
  No 
 
 
social security number  
 
 
 
 
 
  Yes   
  No 
 
 
medical record number  
 
 
 
 
 
  Yes   
  No 
 
 
health plan beneficiary numbers  
 
 
 
 
  Yes   
  No 
 
 
account numbers 
 
 
 
 
 
 
  Yes   
  No 
 
 
certificate/license numbers 
 
 
 
 
 
  Yes   
  No 
 
 
vehicle identifiers, including license plate number 
 
 
  Yes   
  No 
 
 
device identifiers and serial numbers 
 
 
 
 
  Yes   
  No 
 
 
Web Universal Resource Locators (URLs) 
 
 
 
  Yes   
  No 
 
 
Internet Protocol (IP) address numbers  
 
 
 
  Yes   
  No 
 
 
biometric identifiers, including finger and voice prints 
 
 
  Yes   
  No 
 
 
 
full face photographic images and any comparable image 
 
  Yes   
  No 
 
 
 
any other unique identifying number, characteristic, code 
 
  Yes   
  No 
 
66. Do you plan to collect or record individually identifiable health information about subjects from a healthcare 
record at any other (non-Carilion) healthcare provider, health plan (e.g. insurer), employer, or healthcare 
clearinghouse (e.g. billing service) at any point in the project? (See list of identifiers above.) 
 
  Yes         
  No 
 
 
 
If yes, please list all identifiers you plan to collect:       
 
67. Will the individually identifiable data be related to or linked to the past, present, or future physical or mental 
health condition of an individual; the provision of health care to an individual; or the past, present, or future 
payment for the provision of health care to an individual? 
 
  Yes         
  No           
  N/A, we are not collecting or recording any identifiers listed above 
 
68. Will the individually identifiable data be created or received by any person or entity that is a health care 
provider or an employee of any part of Carilion? 
 
  Yes         
  No 
  N/A, we are not collecting or recording any identifiers listed above 
 
If you answered “yes” to #65 OR if you answered “yes” to #66, #67, AND #68 then you must 
either 1) obtain written HIPAA authorization from each research subject (in the informed 
consent form) or 2) request a HIPAA waiver.   
 
69. Do you request a HIPAA waiver to conduct your research?          
  Yes 
   
  No 
 
****If no, please skip to Section IX*** 
 
A HIPAA waiver can only be granted if the research cannot practicably be conducted without the 
waiver and the use of the PHI poses no more than minimal risk to the privacy of the individuals. 
 
 
Waiver of Authorization (HIPAA Waiver) 
 
70. Describe how the use of PHI in this study poses no greater than minimal risk to participants’ privacy. 
 
      
 
71. When will identifiers be destroyed?  (Identifiers must be destroyed at earliest opportunity) 
 
 End of study 
       Years after the end of the study (enter # of years) 
  Other (please specify):       
 
72. Could the research be carried out practicably without the use of PHI? 
 
  Yes         
  No 
 
73. Is the waiver needed because obtaining HIPAA authorization is impracticable? Please check the appropriate             
option below. 
 
o 
All information needed has been collected retrospectively (e.g. medical record review research). Not 
having access to data from all patients requested would create selection bias and therefore affect the 
statistical outcome of the research. 
 
  Yes         
  No 
 
 
Carilion IRB Application 
 
       
- 11 - 
 
(July 2016) 

 
 
o 
The sample size required is so large (e.g. population-based studies, epidemiology research) that including 
only those samples/records/data for which authorization can be obtained would prohibit conclusions to be 
drawn or bias the sample such that conclusions would be skewed. 
 
  Yes         
  No 
 
o 
Other reason obtaining authorization is impracticable:       
 
74. Do you assure that any data identifying subjects used in this study will not be disclosed to anyone other than 
the research team, sponsor, and oversight groups? 
 
  Yes         
  No 
 
75. Do you assure that you will not use this data for any other research unless you receive IRB approval? 
 
  Yes         
  No 
 
SECTION IX: DATA PROTECTION PLAN 
 
76. Is the private information being requested the minimum necessary to meet the research goals? 
 
  Yes         
  No          
  N/A 
 
77. What records or data will you be using or collecting? Check all that apply: 
 
  New data for this study 
  Data already collected for another research study 
  Data already collected for administrative purposes 
  Medical records; approximately how many records:  400 
  Electronic information from clinical database 
  Other:       
 
78. Will any sensitive information be collected, such as information regarding sexual behavior, HIV status, 
recreational drug use, illegal behaviors, physical abuse, mental health disorders, etc.? 
 
  Yes       
  No  
 
 
If yes, what sensitive information will be collected? sensitive information on possible drug misuse. The PI 
will seek a certificate of confidentiality from the NIH. 
 
79. The standard at Carilion to protect identifiable data used in research is to use a code and link system. Two 
files should be kept in two separate secure locations.  One file should use a unique code for each subject in 
connection with any sensitive or health information.  The other file (the link) associates the unique code with 
subject identifiers (e.g. name, medical record number). Please describe how you will store data using the 
options below. 
 
  Retrospective Record Review Only: The master list will contain direct subject identifiers such as 
 
name and MRN along with a unique subject code. It will be stored separately from the coded research 
 
data set at all times. The research data set will not include any HIPAA identifiers with the exception of a 
 
date. 
  Prospective Collection of Data, including surveys or collection of new data: While initial collection of 
 
research data may contain identifying information, it must be stored using a code linked to the subject’s 
 
identity using a master list. All HIPPA identifiers will be stripped from the initial research data collection 
 
data tools and replaced with a unique subject code. 
  Prospective Collection of Sensitive Data, including surveys or collection of new data: Research data 
 
will be linked to identifiers by a unique subject code at all times. The code will be linked to a master list 
 
that contains identifying information. The master list and coded research data will be stored in separate 
 
locations.   
 
80. Where will data be stored? Please check all that apply: 
 
 Hardcopy data in a locked office in a locked cabinet 
 Electronic data on a password protected, encrypted Carilion laptop  
 Electronic data on a password protected, Carilion-encrypted flash drive   
 Electronic data on a password protected, secure drive on a Carilion server 
 
 
 
Select the software to be used: 
 
  Excel  
  SoftMed 
 
 
  Other: Describe REDCAP 
 
 
 
 
Carilion IRB Application 
 
       
- 12 - 
 

 
 
(July 2016) 
No other storage options are permitted, including the use of personal laptops, flash drives or other portable 
devices. Data must not be placed in a cloud or other hosted environment. Any exceptions must be approved 
by the Carilion Privacy and Information Security Officer and documentation provided to the IRB. 
 
81. Please describe how you plan to protect identifying information from improper use and disclosure by 
answering the questions below. 
 
a) Who will have access to identifiers?  Investigators and study coordinator 
b) How will you limit access to the identifiers?  Securing data collected on paper in locked cabinets with 
limited access and storing electronic data using encrypted, password protected files on the Carilion S Drive 
and/or in REDcap 
c) When and how will the identifiers be destroyed? Destruction of data 7 years after completion of study, per 
Carilion guidelines. 
 
SECTION X: MEDIA USE 
 
 
 
 
 
82. Will any media be used to record subjects’ voice or image? 
 
     
  Yes       
  No 
 
 
If yes, describe what media will be used, how the media will be used, and justify why it is necessary to 
use the media to collect data:       
 
83. Will the subjects’ voice or image be recorded without their knowledge? 
 
     
  Yes       
  No 
 
 
If yes, describe the deception and the debrief procedures:       
 
SECTION XI: SAFETY & MONITORING 
 
84. Describe the process for dealing with adverse events and unanticipated problems. 
 
All adverse events or unanticipated problems will be immediately reported to the PI, who will be primarily 
responsible for assessing risk to study participants and suspending the study if significant risk is suspected 
until remediation can be planned and measures implemented. Adverse events will be reported to the IRB 
using the appropriate form in a timely fashion. 
 
85. Is there a Data Safety Monitoring Board or other safety oversight committee? 
 
  Yes          
  No           
 
 
If yes: 
 
What is the name of the board or committee?       
If the DSMB is local, please name the members.       
How frequently will the data be reviewed for safety? 
 
  Every 3 months          
  Every 6 months          
  Annually          
  Unknown 
  Other:        
 
 
If no: 
 
How will the data be monitored to ensure the safety of subjects? This is a minimal risk study. No formal 
interim data analysis is planned. 
 
86. Are there plans for visits by sponsor monitors or auditors to review study documents for regulatory 
requirements? 
 
  Yes          
  No          
  N/A 
 
 
If yes, Identify the group that will be conducting the monitoring/auditing visit(s) and the number of times 
you anticipate this occurring over the next year:       
 
87. Does this project involve research using any of the following? 
 
  Yes          
  No   
Mammalian cell/tissue culture (includes established cell lines or primary isolation  
 
 
 
 
of cell lines from tissue, blood, etc.)   
  Yes          
  No  
Cultivated microorganisms (isolated, grown in vitro and used for non-diagnostic  
 
 
 
 
research, i.e. isolation of biohazardous organisms from patient samples) 
  Yes          
  No  
Research animals 
  Yes          
  No  
Molecular cloning, recombinant DNA or gene therapy techniques 
 

 
 
If you checked yes on any of the above boxes, you are required to contact the Carilion Clinic 
Research Safety Committee at 985-8510 for important guidance. 
 
 
 
 
 
 
Carilion IRB Application 
 
       
- 13 - 
 
(July 2016) 
 
 
SECTION XII: STORED DATA AND HUMAN BIOLOGICAL MATERIALS REPOSITORIES 
 
 
Databases and specimen repositories, also known as registries or banks, are used to store data and/or specimens 
for future use. When the use is for clinical purposes or quality improvement, IRB approval is not required. 
However, when the use is for research purposes, the databases/repositories must be approved by the IRB (45 
CFR 46 and 45 CFR 160 & 164).  
 
88. Will this research collect and store data/specimens (blood, urine, biopsy tissue, saliva, etc.) for future 
research beyond the parameters of this study? 
 
  Yes          
  No   
 
***If no, you may skip the remainder of this section and go directly to Section XIII*** 
 
89. Will the data/specimens collected for this research be stored in an existing repository at Carilion that is used 
for future research? 
 
  Yes          
  No 
 
 
If yes, provide repository name:       
 
90. Will the data/specimens collected for this research be stored in a non-Carilion repository that is used for 
future research? 
 
  Yes          
  No 
 
 
If yes, attach a protocol or other information describing the repository operations. 
 
91. Will the data/specimens collected be stored in a repository for future research that will be developed and 
operated by the researcher(s)? 
 
  Yes          
  No 
 
 
If yes, you must also submit a Specimen/Data Repository Application to the IRB     
 
SECTION XIII: SUBMISSION INCLUSIONS 
 
Please check which of the following required materials you are including with this submission. If information is 
submitted electronically, signature pages must be faxed or hand delivered (mailed). 
 
 
Protocol (Not required for investigator-initiated research; this application serves as protocol.) 
 
Main consent form(s) 
 
Tissue banking consent form 
 
Assent form, if required for research involving children 
 
Information sheet 
 
Grant application 
 
Investigator brochure for drug studies 
 
Completed Form 1572 for drug studies 
 
Manufacturer reference material for device studies 
 
Legally Authorized Representative Investigator Assurance Form 
 
Recruitment script or other recruitment materials 
 
Any subject questionnaire or survey 
 
Any data collection tool that will be used to record subject information 
 
Inclusion/Exclusion Checklist 
 
Curriculum Vitae if first-time applicant 
 
IRB fee, if applicable: 
   
$1,500 application fee for full-board industry-sponsored research  
  
$750 application fee for expedited industry-sponsored research 
 
 
 
 
 
 

 
 
 
 
 
 
 
 
 
 
 
 
Carilion IRB Application 
 
       
- 14 - 
 
(July 2016) 
 

 
 
SECTION XIV: CERTIFICATION OF PRINCIPAL INVESTIGATOR 
 
By signing this document the investigator confirms: 
 
1. I am not currently debarred by the US FDA from involvement in clinical research studies. 
2. I am not involved in any regulatory or misconduct litigation or investigation by the FDA. 
3. If this study involves any funding or resources from an outside source, or if I will be sharing data outside of 
Carilion Clinic prior to publication, I will contact the Research & Development Department regarding the need 
for a contract and letter of indemnification. If it is determined that either a contract or letter of 
indemnification is needed, subjects cannot be enrolled until these documents are complete. 
4. The proposed research project will be conducted by me or under my close supervision. It will be conducted in 
accordance with the protocol approved by the IRB. 
5. No subjects will be recruited or enrolled on this study until the investigator has received written notification of 
IRB approval. 
6. No personnel will be allowed to work on this protocol until they have completed the required IRB training and 
the IRB has given its approval. 
7. All personnel working on this study will follow all IRB Policies and Procedures and Guidelines as stated on the 
Carilion-IRB web site and all applicable HHS/FDA regulations. 
8. I will ensure that all those delegated tasks relating to this study, whether explicitly or implicitly, are capable 
through expertise, training or experience to undertake those tasks. 
9. Implications of the study have been discussed with all Departments that might be affected by it and I have 
obtained their agreement for the study to take place. 
10. Any materials used to recruit subjects will be approved by the IRB prior to use. 
11. Any modifications of the protocol or consent form will not be initiated without prior written approval from the 
IRB except when necessary to eliminate immediate hazards to the subjects. 
12. Any serious deviation from or violation of the protocol will be reported to the IRB in writing within ten days of 
discovering the deviation/violation. Serious is defined as any deviation/violation that significantly affects the 
safety of the subjects or the scientific quality of the study. 
13. Local adverse events that are serious, unexpected and related or possibly related will be reported to the IRB 
within seven calendar days of the site learning of the event. 
14. Unanticipated problems that are unexpected, related or possibly related to the research, and place subjects 
or others at a greater risk of harm will be reported to the IRB within seven calendar days of the site learning 
of the problem. 
15. Any significant findings that become known in the course of the research that might affect the willingness of 
subjects to enroll or to continue to take part will be promptly reported to the IRB. 
16. The continuation status report for this study will be completed and returned to the IRB at least 30 days prior 
to the expiration date. 
17. All subjects will sign a copy of the most current (non–expired) consent form prior to any study procedures 
being performed. Assent will be obtained from children prior to participating in study if required. Legal 
representatives may be substituted for subject if applicable. 
18. The Carilion IRB office will be notified within 30 days of a change in the Principal Investigator or of the 
closure of this study. 
19. Research records will be maintained and the IRB is authorized to inspect these records. 
20. Information gained during any research at Carilion is confidential. Specifically, information about Carilion, its 
patients, employees, physicians, and customers shall be kept confidential and not discussed in or out of 
Carilion except where it directly relates to legitimate clinical or research purposes. Any unauthorized access to 
Carilion patient, employee, physician or customer information through medical records, documents, 
computerized databases or otherwise is strictly prohibited and will be considered a serious breach of 
confidentiality which may result in immediate termination of research and/or other action.  
21. If for any reason the principal investigator can no longer perform the duties as outlined above for an 
extended period of time, the investigator will close the study or transfer the duties of PI to the sub-
investigator or to another qualified individual. Failure to do this will result in suspension of the study. 
 
            
 
 
 
 
 
                
Carilion Principal Investigator (signature) 
 
         Date 
  
 
Dr. Cassandra Mierisch 
Principal Investigator Name (printed) 
 
 
 
 
 
Carilion IRB Application 
 
       
- 15 - 
 
(July 2016) 

 
 
 
 
Department Chair Signature:  You must obtain the signature of the appropriate department chair or designee.  
This signature indicates that the research has scientific merit and that the research has appropriate support and 
resources to be conducted. 
 
 
       
 
 
 
 
 
 
      
Department Chair or designee (signature) 
 
 
Date 
 
 
      
Department Chair or designee name (printed) 
 
Principal Investigator Attestation of Informed Consent Training for Students:  I certify that the 
following student(s) who will be obtaining informed consent for this study will have observed a mock informed 
consent discussion or actual informed consent discussion conducted by an experienced research team member 
and have been observed conducting a mock informed consent discussion or actual informed consent discussion 
by an experienced research team member before being allowed to interact with study subjects. In addition, I 
certify these students have 1) Completed the Cornerstone research modules on “The informed Consent Process 
for Clinical Research” and “Recruitment of Study Subjects.” 2) Viewed the video General Informed Consent 
Requirements” posted on the Education tab of the Office for Human Protections website 
https://www.hhs.gov/ohrp/education/training/ded_video.html  3) Viewed the 3 informed consent videos posted 
on the IRB website. 
 
 
Soleille Everest  
 
 
 
 
 
 
VTCSOM 
Student name (printed)  
 
 
 
 
Name of School 
 
 
         
 
 
 
 
 
 
      
Student name (printed)  
 
 
 
 
Name of School 
 
 
       
 
 
 
 
 
 
      
Student name (printed)  
 
 
 
 
Name of School 
 
 
       
 
 
 
 
 
 
      
Principal Investigator (signature) 
 
 
 
Date 
 
 
      
Principal Investigator name (printed) 
 
 
 
 
 
 
 
 
 
 
 
 
 
Carilion IRB Application 
 
       
- 16 - 
 
(July 2016)

 
 
Other Investigator: Cesar Bravo     
 
 
Credentials: MD 
Inter-office address: Orthopedics, ION, 2331 Franklin Rd SW, Roanoke, VA 24014 
Role & Responsibilities: Recruit patients and assist in completing study requirements 
Mailing Address (if external):       
 
 
 
 
 
  
Phone: 540-725-1226   
E-mail: CJBravo@carilionclinic.org 
 
Fax:        
 
Other Investigator: Horatiu Dancea     
 
 
Credentials: MD 
Inter-office address: Orthopedics, ION, 2331 Franklin Rd SW, Roanoke, VA 24014 
Role & Responsibilities: Recruit patients and assist in completing study requirements 
Mailing Address (if external):       
 
 
 
 
 
  
Phone: 540-725-1226    
E-mail: hcdancea@carilionclinic.org 
 
Fax:        
 
Other Investigator: Hugh Hagan     
 
 
Credentials: MD 
Inter-office address: Orthopedics, ION, 2331 Franklin Rd SW, Roanoke, VA 24014 
Role & Responsibilities: Recruit patients and assist in completing study requirements 
Mailing Address (if external):       
 
 
 
 
 
  
Phone: 540-725-1226    
E-mail: hjhagan@carilionclinic.org 
 
Fax:        
 
Other Investigator: Dr. Anthony Capitl      
 
Credentials: MD 
Inter-office address: Orthopedics, ION, 2331 Franklin Rd SW, Roanoke, VA 24014 
Role & Responsibilities: Recruit patients and assist in completing study requirements 
Mailing Address (if external):       
 
 
 
 
 
  
Phone: 540-725-1226   
E-mail: aecapito@carilionclinic.org 
 
Fax:        
 
Other Investigator:            
 
Credentials:  
Inter-office address:       
Role & Responsibilities:       
Mailing Address (if external):       
 
 
 
 
 
  
Phone:         
E-mail:        
Fax:        
 
Other Research Team Member:        
Credentials:       
Role & Responsibilities:       
Inter-office address:       
Mailing Address (if external):       
 
 
 
 
 
  
Phone:         
E-mail:        
Fax:        
 
Other Research Team Member:        
Credentials:       
Role & Responsibilities:       
Inter-office address:       
Mailing Address (if external):       
 
 
 
 
 
  
Phone:         
E-mail:        
Fax:        
 
Other Research Team Member:        
Credentials:       
Role & Responsibilities:       
Inter-office address:       
Mailing Address (if external):       
 
 
 
 
 
  
Phone:         
E-mail:        
Fax:        
 
Other Research Team Member:        
Credentials:       
Role & Responsibilities:       
Inter-office address:       
Mailing Address (if external):       
 
 
 
 
 
  
Phone:         
E-mail:        
Fax:        
 
Other Research Team Member:        
Credentials:       
Role & Responsibilities:       
Inter-office address:       
Mailing Address (if external):       
 
 
 
 
 
  
Phone:         
E-mail:        
Fax: