Evaluating Changes in Middle Ear Pressure Caused by CPAP
Phase: NA
Conditions: Eustachian Tube Disorder
Sponsor: University of Virginia

IRB-HSR#19158: Evaluating changes in middle ear pressure caused by CPAP 
 
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IRB-HSR PROTOCOL 
Investigator Agreement 
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. That if this study involves any funding or resources from an outside source, or if you will be sharing data 
outside of UVA prior to publication that you will contact the Dean’s office 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 submitted to and approved by the IRB including any 
modifications, amendments or addendums submitted and approved by the IRB throughout the life of the 
protocol.  
5. That no personnel will be allowed to work on this protocol until they have completed the IRB-HSR On-line 
training and the IRB-HSR has been notified. 
6. That all personnel working on this protocol will follow all IRB-HSR Policies and Procedures as stated on the 
IRB-HSR Website http://www.virginia.edu/vprgs/irb/ and on the School of Medicine Clinical Trials Office 
Website:  http://knowledgelink.healthsystem.virginia.edu/intranet/hes/cto/sops/sop_index.cfm 
7. I will ensure that all those delegated tasks relating to this study, whether explicitly or implicitly, are 
capable through expertise, training , experience or credentialing to undertake those tasks.   
8. I confirm that the implications of the study have been discussed with all Departments that might be 
affected by it and have obtained their agreement for the study to take place.  
9. That no subjects will be recruited or entered under the protocol until the Investigator has received the 
signed IRB-HSR Approval form stating the protocol is open to enrollment 
10. That any materials used to recruit subjects will be approved by the IRB-HSR prior to use.  
11. That all subjects will sign a copy of the most current consent form that has a non-expired IRB-HSR approval 
stamp. 
12. That any modifications of the protocol or consent form will not be initiated without prior written approval 
from the IRB-HSR, except when necessary to eliminate immediate hazards to the subjects. 
13. 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.   
14. I will report immediately to the IRB any unanticipated problems involving risk to subjects or to others 
including adverse reactions to biologics, drugs or medical devices.   
15. That any serious deviation from the protocol will be reported promptly to the Board in writing. 
16. That any data breach will be reported to the  IRB, the UVa Corporate Compliance and Privacy Office , UVa 
Police as applicable.  
17. That the continuation status report for this protocol will be completed and returned within the time limit 
stated on the form. 
18. That the IRB-HSR office will be notified within 30 days of a change in the Principal Investigator or of the 
closure of this study. 
19. That a new PI will be assigned if the current PI will not be at UVA for an extended period of time.  If the 
current PI is leaving UVa permanently, a new PI will be assigned PRIOR to the departure of the current PI.  

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20. All study team members will have access to the current protocol and other applicable documents such as 
the IRB-HSR Application, consent forms and Investigator Brochures. 
21. Signed consent forms and other research records will be retained in a confidential manner.  Records will 
be kept at least 6 years after completion of the study.  
22. No data/specimens may be taken from UVa without a signed Material Transfer Agreement between 
OSP/SOM Grants and Contracts Office and the new institution.  Original study files are considered 
institutional records and may not be transferred to another institution. I will notify my department 
administration regarding where the originals will be kept at UVa.  The material transfer agreement will 
delineate what copies of data, health information and/or specimens may be taken outside of UVa.  It will 
also approve which HIPAA identifiers may be taken outside of UVa with the health information or 
specimens. 
23. If any member of study team leaves UVa, they are STRONGLY ENCOURAGED to use Exit Checklist found on 
IRB-HSR website at http://www.virginia.edu/provost/facultyexit.pdf. 
 
The IRB reserves the right to terminate this study at any time if, in its opinion, (1) the risks of further 
experimentation are prohibitive, or (2) the above agreement is breached. 
 
Investigators Experience 
Dr. Kesser is an associate professor in the division of otology/neurotology within the department of 
Otolaryngology – Head and Neck Surgery.  He has over fifteen years of experience functioning clinically and as 
an investigator.  He has numerous publications in the field of otology including chronic ear disease, the subject 
of this study.  He has ample clinical experience with the long term medical and surgical management of these 
patients. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Signatures 
 
Principal Investigator 
 
____________________________ 
____________________________ 
_______ 
Principal Investigator 
Principal Investigator 
Date 
Signature 
Name Printed 
 
 
The Principal Investigator signature is ONLY required if this is a new protocol, a 5 year update or a modification 
changing the Principal Investigator. 
 
 
Department Chair 
BY SIGNING THIS DOCUMENT THE DEPARTMENT CHAIR AGREES: 
1. To work with the investigator and with the board as needed, to maintain compliance with this 
agreement. 
2. That the Principal Investigator is qualified to perform this study. 
3. That the protocol is scientifically relevant and sound. 
 
___________________________ 
_______________________  
_________ 
Department Chair or Designee  
Department Chair or Designee 
Date 
Signature 
Name Printed 
 
 
The person signing as the Department Chair cannot be the Principal Investigator or a sub-investigator on this 
protocol. 
The Department Chair or Designee signature is ONLY required if this is a new protocol or a modification 
changing the Principal Investigator. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Brief Summary/Abstract 
In theory, patients with Eustachian tube dysfunction as defined by negative pressure on tympanometry will have 
more resistance in the Eustachian tube.  Thus, the pressure required to open should higher than the pressure in 
patients with normal function.  This relationship has never been evaluated.  It would have an impact not only 
when considering CPAP as a treatment modality, but also when considering CPAP in post-operative patients 
undergoing otologic surgery.  We hypothesize an inverse relationship between middle ear pressure and air 
pressure as delivered by CPAP required to create both subjective (“popping” the ears) and objective 
(tympanometric and otoscopic) increase in middle ear pressure.  We will begin recruiting participants from clinic 
and the general population.  Each individual participant will be assigned a participant ID.   The participant will be 
brought to the exam room and fitted with a new CPAP mask.  Photodocumentation of otoscopic examination will 
be obtained for baseline as well as tympanometric measurement.  Starting at a set pressure, the patient will be 
given a set number of breaths.  Then, the setting will be increased until a maximum tolerable pressure is reached 
(no higher than 20 cm H2O).  The participant will be asked to notify the examiner when he or she has a sensation 
of his ears “popping”, and that level will be documented.  Photodocumentation and tympanometric 
measurement will be obtained.  These will be used to plot correlation between opening pressure and both initial 
middle ear pressure as observed on tympanometry and otoscopic evlauations.  The Sade classification scheme will 
be used to grade otoscopic findings.  These findings will be analyzed using SPSS and tests include Spearman 
correlations, t-tests, and Wilcoxon Rank-Sum Test.  
Background 
1. Provide the scientific background, rationale and relevance of this project.   
Eustachian tube dysfunction and chronic otitis media 
 
Eustachian tube dysfunction is a poorly defined and understood clinical entity.  While it is agreed upon that it is 
the primary etiology of chronic otitis media, particularly in adults, the exact physiology has been elusive.  While 
many different theories have been proposed with evidence presented in addition, Cummings (Flint, et al.) 
describes two key physiological changes, whether it be mechanical obstruction (e.g., adenoid hypertrophy) or 
functional (normal anatomy with poor function).  The former is likely more common in children with the latter 
best described in patients with cleft palate.  Purely anatomical comparisons have not provided a definite etiology 
for why some individuals have significantly greater dysfunction.   
 
In describing the clinical entity of Eustachian tube dysfunction, the literature varies between symptom 
descriptions, objective findings, and clinical outcomes (ie, need for surgery, etc.).  Even when using objective 
findings, there is disagreement as to what degree of negative pressure on tympanometry constitutes Eustachian 
tube dysfunction.  Attempts to measure function have been unsuccessful.  A recent review by Norman, et al. 
found such significant variation in how ETD was defined in the literature that it was felt that no reasonable 
conclusions could be drawn regarding specific, consistent diagnostic criteria.  While multiple symptom score 
indices have been proposed, including the Eustachian tube dysfunction questionnaire (ETDQ-7, Figure 1), they 
have not reached widespread use.   
 
 
 

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Figure 1.  The Seven Item Eustachian Tube Dysfunction Questionnaire (ETDQ-7). 
 
Over the past 1 month, how much has each of the 
following been a problem for you?  
 
No Problem 
 
Moderate Problem 
Severe Problem 
1. Pressure in the ears? 
1 
2 
3 
4 
5 
6 
7 
2. Pain in the ears? 
1 
2 
3 
4 
5 
6 
7 
3. A feeling that your ears are clogged or “under water”? 
1 
2 
3 
4 
5 
6 
7 
4. Ear symptoms when you have a cold or sinusitis? 
1 
2 
3 
4 
5 
6 
7 
5. Crackling or popping sounds in the ears? 
1 
2 
3 
4 
5 
6 
7 
6. Ringing in the ears? 
1 
2 
3 
4 
5 
6 
7 
7. A feeling that your hearing is muffled? 
1 
2 
3 
4 
5 
6 
7 
 
Treatment of ETD has also been elusive.  While many methods have been proposed, including but not limited to 
devices such as the Otovent (Kestrel Medical, United Kingdom), surgical interventions such as balloon dilation, 
myringotomy with ventilation tube placement, laser coagulation, and others, none has provided sufficient data to 
prove a long-term benefit of the stated intervention.  The value of preventing progression of chronic otitis media 
and its sequelae – including cholesteatoma, hearing loss, severe infections, and need for repeated surgical 
interventions – is unquestioned.   
 
Continuous positive air pressure therapy 
 
Continuous positive air pressure therapy (CPAP) is a highly successful treatment of an increasingly common 
problem – obstructive sleep apnea (OSA).  Patients using CPAP for OSA have been evaluated in regard to middle 
ear function.  Common otologic complaints related to CPAP include aural fullness and the development of serous 
otitis media.  On the whole, CPAP use is quite safe for the middle ear, although rare case reports have suggested 
association with negative side effects including a single report of perilymph fistula formation.  The most likely 
mechanism by which the ears are affected by CPAP is that air is forced into the Eustachian tube.  Multiple studies 
have found higher middle ear pressures with CPAP use, although in patients without ETD, the middle ear pressure 
is likely to revert to a normal pressure.  The impact of CPAP on the middle ear still has significant room for 
investigation. 
Hypothesis to be Tested 
There is a specific CPAP pressure at which individuals’ Eustachian tubes will allow air to be transmitted to 
middle ear.  We will be able to correlate this to initial middle ear pressure.   
Primary outcome measure: CPAP pressure required for middle ear insufflation. 
Secondary outcome measures: 
- 
Change in middle ear pressure with CPAP use 
- 
Otoscopic findings 
- 
Patient symptom survey (ETDQ-7) 
 
Study Design: Biomedical 
1.  Will controls be used?No 
2. What is the study design? Cohort study    
3. Does the study involve a placebo?No 

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Human Participants 
Ages: 18-99 
Sex: 
M or F 
Race: Any 
 
Subjects- see below 
1.  Provide target # of subjects (at all sites) needed to complete protocol.29 
2.  Describe expected rate of screen failure/ dropouts/withdrawals from all sites.  5% 
3.  How many subjects will be enrolled at all sites?   31 
4.  How many subjects will sign a consent form under this UVa protocol?    31 
5. Provide an estimated time line for the study. 
After IRB approval, we anticipate completion of enrollment and study completion within 2 months.  Data 
analysis will be concluded within 6 months of study initiation.  No follow up is required. 
Inclusion/Exclusion Criteria 
1.  List the criteria for inclusion  
 Age >18 
 No use of CPAP within past 30 days 
 Individuals presenting to the UVA otolaryngology clinic who are otherwise healthy 
 
2.  List the criteria for exclusion 
 Pre-existing cardiopulmonary disease that presents a risk with CPAP use 
 Inability to tolerate CPAP 
 Recent otologic surgery 
 
3.  List any restrictions on use of other drugs or treatments. None 
Statistical Considerations 
1. 
Is stratification/randomization involved? 
As there will be no comparison group, there will not be stratification or randomization.  Any grouping will be 
performed in the data analysis portion based on data acquired within the study. 
 
2.  What are the statistical considerations for the protocol?  
Primary endpoint:  
 CPAP pressure at which a significant change in middle ear pressure occurs 
Secondary endpoints:  
 Tympanometry  
 Otoscopy 
 ETDQ-7 
 
 
 

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3.  Provide a justification for the sample size used in this protocol.   
We anticipate accruing 5-10 participants per week.  The accrual goal will be 32, with an interim analysis at 16.  
We anticipate a very low dropout rate, but will account for a 5% rate.  Based on calculations assuming a -0.500 
correlation between “opening pressure” (CPAP pressure) and starting middle ear pressure, 29 participants are 
needed to show statistically significant differences.  There is no required follow up, so this provides minimal 
drop-out risk. 
 
4.  What is your plan for primary variable analysis? 
We will perform Spearman correlation calculations to estimate the relationship of CPAP pressure at which the 
ears “pop” to the initial and final tympanometric pressure as well as the change in tympanometric pressure. 
5.  What is your plan for secondary variable analysis?  
We will use t-tests and/or ANOVA to assess the relationship of the above pressures to ETDQ-7 responses as 
well as using ROC curve analyses to determine if there is a true tympanometric pressure cut point to define 
ETD. 
6. Have you been working with a statistician in designing this protocol?No 
 
7.  Will data from multiple sites be combined during analysis?  No 
Biomedical Research 
 
1.  What will be done in this protocol?    
 Each individual participant will be assigned a participant ID.  
 
  The participant will be brought to the exam room and fitted with a new CPAP mask.   
 
 Photo-documentation of otoscopic examination will be obtained for baseline as well as tympanometric 
measurement.   
 
 Starting at a set pressure, the patient will be given a set number of breaths.  Then, the setting will be 
increased until the maximum tolerable pressure or a maximum pressure of 20 cm H2O has been 
reached.   
 
 The patient will be asked to notify the examiner when he or she has a sensation of his ears “popping”, 
and that level will be documented.   
 
 Photo-documentation and tympanometric measurement will be obtained. 
 
2. List the procedures, in bullet form, that will be done for RESEARCH PURPOSES as stipulated in this 
protocol. 
 Tympanometry 
 Otoscopy 
 Short term use of CPAP (10 minutes) 
 ETDQ-7 for our research purposes. 

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3. Will you be using data/specimens in this study that were collected previously, with the use of a research 
consent form, from another research study?No 
 
4.  Will any of the procedures listed in item # 2 have the potential to identify an incidental finding? This 
includes ALL procedures, assessments and evaluations that are being done for RESEARCH PURPOSES that 
may or may not be considered investigational. yes  
__x__This examination(s) utilizes non-standard/investigational, technique, equipment, etc.  It is 
impossible to determine the significance of such results, therefore abnormalities will not be 
shared with the subject because the meaning of the exam is not yet proven and is of unknown 
clinical benefit.   
 
5.  Do any of the procedures listed above, under question # 2, utilize any imaging procedures for RESEARCH 
PURPOSES? No 
6. Will you be using viable embryos?No 
7. Will you be using embryonic stem cells?No 
8.  Are any aspects of the study kept secret from the participants?  No 
9.  Is any deception used in the study?    No  
10. If this protocol involves study treatment, explain how a subject will be transitioned from study 
treatment when they have completed their participation in the study. NA 
11. Will your study involve measures (C-SSRS/BID/SCID etc.) used to assess for depression and/or suicidality 
for research purposes?  No 
Taping/Photography 
1.  Will participants be recorded on audiotape?  No 
 
2.  Will participants be photographed or recorded on videotape?  Yes 
 
►IF YES, answer the following questions.   
2a.  Will their faces be shown?No  
 
2b.  What steps will be taken to protect the privacy of the subjects? 
The device used to take the photographs (iPhone) will be secured per UVA protocol and 
only used for research purposes.   The images will only be tied to a participant ID.  The 
images will only be of the ear drum and as such will not allow for identification if seen. 
 
2c.  What data will be captured from the photo or videotape that could not be obtained in 
other ways? Image of the tympanic membrane (ear drum).  This cannot otherwise be 
reviewed in a blinded fashion. 
 
2d.  How is this data critical to this research? 
This provides an additional clinical measurement that allows for analysis of patients. 
 
2e.  When will data from the tapes be transcribed? 

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Within one month of obtaining them they will be transferred to a secure file and deleted 
from the portable device.   
 
2f.  When will the tapes be destroyed?At the conclusion of the study. 
 
2g.  Will participants be photographed, recorded or videotaped without their knowledge?   
No 
 
3.  If a subject withdraws from the study how will you withdraw them from the audiotape, videotape or 
photograph? Delete the files. 
Data and Safety Monitoring Plan 
1.  Definition: 
1.1 How will you define adverse events (AE)) for this study?  
__x___An adverse event will be considered any undesirable sign, symptom or medical or 
psychological condition even if the event is not considered to be related to the investigational 
drug/device/intervention. Medical condition/diseases present before starting the investigational 
drug/intervention will be considered adverse events only if they worsen after starting study 
treatment/intervention.  An adverse event is also any undesirable and unintended effect of 
research occurring in human subjects as a result of the collection of identifiable private information 
under the research.  Adverse events also include any problems associated with the use of an 
investigational device that adversely affects the rights, safety or welfare of subject s. 
1.2 How will you define serious adverse events? 
__x___A serious adverse event will be considered any undesirable sign, symptom, or medical 
condition which is fatal, is life-threatening, requires or prolongs inpatient hospitalization, results 
in persistent or significant disability/incapacity, constitutes a congenital anomaly or birth 
defect, is medically significant and which the investigator regards as serious based on 
appropriate medical judgment. An important medical event is any AE that may not result in 
death, be life-threatening, or require hospitalization but may be considered an SAE when, 
based upon appropriate medical judgment, it may jeopardize the patient and may require 
medical or surgical intervention to prevent one of the outcomes listed in the definitions of SAEs.  
1.3 What is the definition of an unanticipated problem?  
Do not change this answer 
An unanticipated problem is any event, experience that meets ALL 3 criteria below: 
 Is unexpected in terms of nature, severity or frequency given the research procedures that 
are described in the protocol-related documents AND in the characteristics of the subject 
population being studies 
 Related or possibly related to participation in research.  This means that there is a 
reasonable possibility that the incident may have been caused by the procedures involved 
in the research study. 

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 The incident suggests that the research placed the subject or others at greater risk of harm 
than was previously known or recognized OR results in actual harm to the subject or others 
 
1.4 What are the definitions of a protocol violation and/or noncompliance?  
Do not change this answer 
A protocol violation is defined as any change, deviation, or departure from the study design or 
procedures of research project that is NOT approved by the IRB-HSR prior to its initiation or 
implementation.  Protocol violations may be major or minor violations.   
 
Noncompliance can be a protocol violation OR deviation from standard operating procedures, 
Good Clinical Practices (GCPs), federal, state or local regulations.   Noncompliance may be serious 
or continuing.  
Additional Information: see the IRB-HSR website at  
http://www.virginia.edu/vpr/irb/HSR_docs/Forms/Protocol_Violations_%20Enrollment_Exceptions
_Instructions.doc 
 
1.5 If pregnancy occurs how will this information be managed? 
 
___x__ Other Study enrollment and completion will occur in the same encounter, so it is not 
possible for the pregnancy status to change during the study. 
 
1.6 What is the definition of a Protocol Enrollment Exception?   
___x__NA- No outside sponsor 
 
1.7 What is the definition of a data breach? 
Do not change this answer 
A data breach is defined in the HITECH Act (43 USC 17932) as an unauthorized acquisition, access, 
or use of protected health information (PHI) that compromises the security or privacy of such 
information. 
Additional Information may be found on the IRB-HSR Website: Data Breach 
2.  Identified risks and plans to minimize risk 
 
2.1 What risks are expected due to the intervention in this protocol? 
Expected Risks related to study 
participation. 
Frequency 
 
 Runny Nose 
 Skin irritation 
 Dry mouth 
 Swallowing air 
 Nasal congestion, epistaxis 
 Abdominal discomfort 
____Occurs frequently 
__x__Occurs infrequently 
____Occurs rarely 
____Frequency unknown 
 Dizziness 
____Occurs frequently 

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 Trouble breathing 
 
____Occurs infrequently 
__x__Occurs rarely 
____Frequency unknown 
Violation of subject’s privacy and 
confidentiality 
Minimized due to the requirements of 
the privacy plan in this protocol 
The common risks of CPAP are mouth dryness, rhinorrhea, nasal congestion, and aerophagia, which are all 
mild.  Rare risks of moderate to severe complications include epistaxis, otologic complaints, dizziness, and 
trouble breathing. 
 
2.2   List by bullet format a summary of safety tests/procedures/observations to be performed that will 
minimize risks to participants:  N/A 
2.3 Under what criteria would an INDIVIDUAL SUBJECT’S study treatment or study participation be stopped 
or modified 
___x__At subject, PI or sponsor’s request 
 
___x__Treatment would be stopped if the subject had a serious adverse event deemed related to 
study, or study drug will be increased if the subject tolerates dosing 
 
 
2.4 Under what criteria would THE ENTIRE STUDY need to be stopped.   
___x__Per IRB, PI 
 
2.5 What are the criteria for breaking the blind/mask? 
___x__Other:: If an otoscopic finding were identified that was not noted on clinical exam.    
 
2.6 How will subject withdrawals/dropouts be reported to the IRB prior to study completion? 
__x___IRB-HSR continuation status form  
3.  Adverse Event / Unanticipated Problem Recording and Reporting 
 
3.1 Will all adverse events, as defined in section 1.1, be collected/recorded? No 
►IF NO, what criteria will be used?  
 
_x____Only adverse events that are deemed related AND serious  
 
3.2 How will adverse event data be collected/recorded?  
___x__Spreadsheet: paper or electronic 
 
3.3. How will AEs be classified/graded?  
___x__World Health Organization Criteria (WHO) 
_X_ Serious/Not serious  
 
 

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3.4 What scale will the PI use when evaluating the relatedness of adverse events to the study 
participation?   
__x___The PI will determine the relationship of adverse events to the study 
 using the following scale: 
 
Related:      
 
AE is clearly related to the intervention 
Possibly related: 
AE may be related to the intervention 
Unrelated:  
 
AE is clearly not related to intervention 
 
3.5 When will recording/reporting of adverse events/unanticipated problems begin? 
 
___x__After subject begins study drug/ device placement/intervention /study-related 
procedure/specimen collection 
 
3.6 When will the recording/reporting of adverse events/unanticipated problems end? 
__x___ Subject completes intervention and follow up period of protocol 
 
3.7 How will Adverse Events, Unanticipated Problems, Protocol Violations and Data Breaches be 
reported?  Complete the table below to answer this question 
 
Type of Event 
To whom will it 
be reported: 
Time Frame for 
Reporting 
How reported? 
Any internal event resulting 
in death that is deemed 
DEFINITELY related to (caused 
by) study participation 
An internal event is one that 
occurs in a subject enrolled in 
a UVa protocol 
IRB-HSR 
Within 24 hours 
IRB Online and phone call 
 
www.irb.virginia.edu/ 
 
Internal, Serious, Related, 
Unexpected adverse event  
 
  
IRB-HSR 
Within 7 calendar 
days from the 
time the study 
team received 
knowledge of the 
event. 
 
Timeline includes 
submission of 
signed hardcopy 
of AE form. 
IRB Online 
 
www.irb.virginia.edu/ 
 
For Device Studies:  
Unanticipated adverse device 
effects (internal) 
IRB-HSR 
Within 10 
calendar days of 
the study team 
receiving 
knowledge of the 
event 
IRB Online 
 
www.irb.virginia.edu/ 
 
Unanticipated Problems that 
are not adverse events or 
IRB-HSR 
 
Within 7 calendar 
days from the 
Unanticipated Problem report 
form.  

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protocol violations  
This would include a Data 
Breach.   
 
time the study 
team received 
knowledge of the 
event.  
 
http://www.virginia.edu/vprgs
/irb/HSR_docs/Forms/Reportin
g_Requirements-
Unanticipated_Problems.doc ) 
Protocol 
Violations/Noncompliance 
The IRB-HSR only requires that 
MAJOR violation be reported, 
unless otherwise required by 
your sponsor, if applicable. 
 
OR 
 
Enrollment Exceptions 
See definition- only allowed if 
there is a commercial sponsor 
or a DSMB that has granted 
the enrollment exception.  
IRB-HSR 
 
 
Within 7 calendar 
days from the 
time the study 
team received 
knowledge of the 
event.  
 
Protocol Violation, 
Noncompliance and 
Enrollment Exception 
Reporting Form 
 
 
http://www.virginia.edu/vprgs
/irb/hsr_forms.html 
 
Go to 3rd bullet from the 
bottom. 
  
Data Breach  
The UVa 
Corporate 
Compliance and 
Privacy Office 
 
 
 
ITC:  if breach 
involves  
electronic data  
 
 
 
 
Police if breach 
includes items 
that are stolen: 
 
Stolen on UVA 
Grounds 
 
OR  
 
Stolen off UVa 
Grounds- contact 
police 
department of 
jurisdiction of last 
known location of 
PHI 
As soon as 
possible and no 
later than 24 
hours from the 
time the incident 
is identified. 
 
As soon as 
possible and no 
later than 24 
hours from the 
time the incident 
is identified. 
 
IMMEDIATELY.  
 
 
UVa Corporate Compliance and 
Privacy Office- Phone 924-9741 
 
 
 
 
ITC:  Information Security 
Incident Reporting procedure,  
http://www.itc.virginia.edu/se
curity/reporting.html 
 
 
 
 
 
 
 
 
UVa Police-Phone- (434) 924-
7166 
  
4.    How will the endpoint data be collected/recorded.  
___x__Protocol specific case report forms  

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5. Data and Safety Oversight Responsibility 
 
5.1. Who is responsible for overseeing safety data for this study?  
 
___x__No additional oversight body other than PI at UVa  
 
5.2. What is the composition of the reviewing body and how is it affiliated with the sponsor? n/a  
 
5.3. What items will be included in the aggregate review conducted by the PI?  
___x__All adverse events 
_____Unanticipated Problems 
_____Protocol violations/Issues of noncompliance 
_____Audit results 
_____Application of dose finding escalation/de-escalation rules  
_____Application of study designed stopping/decision rules 
_____Early withdrawals 
_____Whether the study accrual pattern warrants continuation/action 
_____Endpoint data 
5.4 How often will aggregate review occur? 
For additional information on aggregate review see: 
www.virginia.edu/vpr/irb/hsr/continuations.html#aggreview 
_____NA- PI is not the overall person overseeing the safety data for this study.     
_____Per Enrollment/Events 
__x___Annually 
 
5.5. How often will a report, regarding the outcome of the review by the DSMB/DSMC, be sent to the 
UVa PI? n/a 
 
5.6. How will a report of the information discussed in question 5.4 OR 5.5 be submitted to the IRB?   
 
__x___Part of IRB-HSR continuation status form 
Risk/ Benefit Analysis 
1.  What are the potential benefits for the participant as well as benefits which may accrue to society in 
general, as a result of this study? 
We do not anticipate any direct benefits to the patient in this study.  We anticipate a benefit to society in that 
we will have a better understanding of the amount of CPAP pressure required to affect the middle ear.  This 
may allow for use as treatment (for patients with ETD) and/or for advisory data in post-operative patients 
after ear surgery. 
 

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2.  Do the anticipated benefits justify asking subjects to undertake the risks?   
The risks of this procedure are seen as very low.  The subjects will be screened for any comorbid 
cardiopulmonary disease that may increase the risk of adverse events with CPAP use.   
Bibliography 
1. Akbulut S, Demir MG, Salepci BM, et al. Efficacy of continuous positive airway pressure on middle ear atelectasis: A 
double-blind placebo-controlled clinical trial. Laryngoscope. 2015.  
2. Aksoy F, Yildirim YS, Ozturan O, Veyseller B, Cuhadaroglu C. Eustachian tube function in patients receiving 
continuous positive airway pressure treatment for sleep apnea syndrome. J Otolaryngol Head Neck Surg. 
2010;39(6):752-756.   
3. Casey WF, Drake-Lee AB. Nitrous oxide and middle ear pressure. A study of induction methods in children. 
Anaesthesia. 1982;37(9):896-900.  
4. Degerli S, Acar B, Sahap M, Horasanli E. Effect of laryngoscopy on middle ear pressure during anaesthesia induction. 
Int J Clin Exp Med. 2013;6(9):809-813. 
5. Drake-Lee AB, Casey WF, Ogg TW. Anaesthesia for myringotomy. the effect of nitrous oxide and intermittent 
positive pressure ventilation in children with secretory otitis media. Anaesthesia. 1983;38(4):314-318.  
6. Endara-Bravo A, Ahoubim D, Mezerhane E, Abreu RA. Alternobaric vertigo in a patient on positive airway pressure 
therapy. J Clin Sleep Med. 2013;9(12):1347-1348.  
7. Lin FY, Gurgel RK, Popelka GR, Capasso R. The effect of continuous positive airway pressure on middle ear pressure. 
Laryngoscope. 2012;122(3):688-690. 
8. Mccormick J, Hildrew D, Lawlor C, Guittard J, Worley NK. Otic barotrauma resulting from continuous positive airway 
pressure: Case report and literature review. The Ochsner Journal. 2015.  
9. Norman G, Llewellyn A, Harden M, et al. Systematic review of the limited evidence base for treatments of 
eustachian tube dysfunction: A health technology assessment. Clin Otolaryngol. 2014;39(1):6-21.  
10. Sivri B, Sezen OS, Akbulut S, Coskuner T. The effect of continuous positive airway pressure on middle ear pressure. 
Laryngoscope. 2013;123(5):1300-1304.  
11. Stangerup SE, Sederberg-Olsen J, Balle V. Autoinflation as a treatment of secretory otitis media. A randomized 
controlled study. Arch Otolaryngol Head Neck Surg. 1992;118(2):149-152. 
12. Thom JJ, Carlson ML, Driscoll CLW, et al. Middle ear pressure during sleep and the effects of continuous positive 
airway pressure. Am J Otolaryngol. 2015;36(2):173-177.  
13. Yung MW. The effect of nasal continuous positive airway pressure on normal ears and on ears with atelectasis. Am J 
Otol. 1999;20(5):568-572.  
14. Yung MW. Permanent mastoid vent: A new treatment for persistent eustachian tube obstruction. Clin Otolaryngol 
Allied Sci. 1998;23(1):93-96. 
15. McCoul ED, Anand VK, Christos PJ. Validating the clinical assessment of eustachian tube dysfunction: The eustachian 
tube dysfunction questionnaire (ETDQ-7). Laryngoscope. 2012;122(5):1137-1141. 
16. Flint P, et al.  Cummings Otolaryngology. 5th edition.  Mosby Elsevier, Philadelphia, PA.  2010. 
APPENDIX:  Support Source 
1. Describe what will be provided and by whom.   
ResMed:  
 1 CPAP machine 
 50 masks 
2. Do you confirm that you will obtain a contract/ material transfer agreement with the provider via 
the Medical Center Procurement office or Office of Sponsored Programs (OSP) ospnoa@virginia.edu? 

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Yes 
 
APPENDIX:  Legal/Regulatory 
Recruitment 
The following procedures will be followed: 
 Finders fees will not be paid to an individual as they are not allowed by UVa Policy. 
 All recruitment materials will be approved by the IRB-HSR prior to use.  They will be submitted to 
the IRB after the IRB-HSR has assigned an IRB-HSR # to the protocol. 
 Only those individuals listed as personnel on this protocol will recruit and or conduct the 
consenting process with potential subjects.  
 
Retention Incentives 
Any item used by the sponsor/ study team to provide incentive to a subject to remain in the study, other than 
compensation identified in the Payment section, will be submitted to the IRB for review prior to use.  The IRB-
HSR will provide the study team with a Receipt Acknowledgement for their records.  Retention incentive items 
are such things as water bottles, small tote bags, birthday cards etc.  Cash and gift cards are not allowed as 
retention incentives.  
 
Clinical Privileges 
The following procedures will be followed:  
 Investigators who are members of the clinical staff at the University of Virginia Medical Center must 
have the appropriate credentials and been granted clinical privileges to perform specific clinical 
procedures whether those procedures are experimental or standard.  
 The IRB cannot grant clinical privileges.   
 Performing procedures which are outside the scope of the clinical privileges that have been granted 
may result in denial of insurance coverage should claims of negligence or malpractice arise. 
 Personnel on this protocol will have the appropriate credentials and clinical privileges in place before 
performing any procedures required by this protocol.  
 Contact the Clinical Staff Office- 924-9055 or 924-8778 for further information. 
 
Sharing of Data/Specimens 
Data and specimens collected under an IRB approved protocol are the property of the University of Virginia.  
You must have “permission” to share data/ specimens outside of UVa other than for a grant application and or 
publication.  This “permission” may come in the form of a contract with the sponsor or a material transfer 
agreement (MTA) with others.  A contract/ MTA is needed to share the data outside of UVa even if the data 
includes no HIPAA identifiers and no code that could link the data back to a HIPAA identifier.   
 No data will be shared outside of UVa, beyond using data for a grant application and or publication, 
without a signed contract/MTA approved by the SOM Grants and Contracts office/ OSP or written 
confirmation that one is not needed. 
 No specimens will be shared outside of UVa without a signed contract/MTA approved by the SOM 
Grants and Contracts office/ OSP or written confirmation that one is not needed. 
 
Prisoners 

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If the original protocol/ IRB application stated that no prisoners would be enrolled in this study and 
subsequently a subject becomes a prisoner, the study team must notify the IRB immediately.  The study team 
and IRB will need to determine if the subject will remain in the study.  If the subject will remain in the study, 
the protocol will have to be re-reviewed with the input of a prisoner advocate.  The prisoner advocate will also 
have to be involved in the review of future continuations, modifications or any other reporting such as 
protocol violations or adverse events.   
 
Prisoner- Individuals are prisoners if they are in any kind of penal institution, such as a prison, jail, or juvenile 
offender facility, and their ability to leave the institution is restricted. Prisoners may be convicted felons, or 
may be untried persons who are detained pending judicial action, for example, arraignment or trial. 
For additional information see the OHRP website at  http://www.hhs.gov/ohrp/policy/populations/index.html 
Compensation in Case of Injury  
If a subject requests compensation for an injury, the study team should notify the IRB-HSR (924-
9634/2439847) the UVa Health System Patient Relations Department (924-8315).  As a proactive courtesy, the 
study team may also notify UVa Health System Patient Safety and Risk Management (924-5595). 
 
On request, the study team should provide  the Risk Management Office with the following 
information/documents: 
 Subject Name and Medical Record Number 
 Research medical records 
 Research consent form 
 Adverse event report to IRB 
 Any letter from IRB to OHRP 
 
Subject Complaints  
During a research study, the study team may receive complaints from a subject.  If the study team is uncertain 
how to respond to a complaint, or is unable to resolve it with the subject, the study team may contact the IRB-
HSR (924-9634/243-9847), the UVa Health System Patient Relations Department (924-8315). 
 
Request for Research Records from Search Warrant or Subpoena 
If the study team receives a request for research records from a search warrant or subpoena, they should 
notify UVa Health Information Services at 924-5136. It is important to notify them if information from the 
study is protected by a Certificate of Confidentiality.   
 
APPENDIX:  Unapproved Device Use  (Unapproved Device being used but not evaluated)  
INSTRUCTIONS: This section is to provide the IRB with information about the safety of a device that is being 
USED, but not evaluated in this study for safety and efficacy.  The device may have FDA approval and is being 
used for a non-approved indication OR the device may not have FDA approval [these are typically known as 
Research Use Only (RUO) Devices].  Again the RUO Device is only being USED and NOT being evaluated for 
safety and efficacy in this study. The information below will be used by the IRB to make a minimal risk 
determination regarding this protocol.   
 
 

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1. List name of device(s) being used in an unapproved manner in this protocol.    
ResMed AirSense 10 CPAP machine 
 
2. Do you confirm the device is only being USED and NOT being evaluated in this study? Yes 
 
3. Is the device a Research Use Only (RUO) device?No 
 
►If the device is NOT a RUO device, is the device currently approved for any indication?Yes 
 
►If the device is currently approved list the indication: 
Obstructive sleep apnea 
 
►If the device is currently approved, do you confirm that results will not be used in clinical 
care of the subject (e.g. will not be used for diagnosis or treatment?)Yes 
 
4. In how many humans has this device been used previously as it is being used in this study?    0 
 
5. Describe pertinent human data that is available regarding the safety of this device as you are using it in 
this protocol.  
Other CPAP devices have been used in multiple other studies of patients with Eustachian tube dysfunction, 
with a total of 84 patients among three studies (Akbulut, et al, Yung, Lin, et al).  The only side effects 
experienced were minor and included mild claustrophobia and otalgia.  The duration of use for this study is 
shorter than has previously been studied (in sleep apnea). 
 
6. If this protocol will be used in children, describe any previous use of this device with children of a similar 
age range as it is being used in this study. NA 
 
7. What steps will be taken to minimize risk? 
The short term, monitored nature of this study will allow a patient to immediately cease use if they have 
any discomfort or other intolerance. 
 
8. Would you consider the use of this device to be minimal risk?  Why or why not?  
Yes – CPAP as a whole and this machine in particular have been rigorously studied for application in 
obstructive sleep apnea at the same pressures we will be using the machine.  The short term, 
monitored nature of this study will allow a patient to immediately cease use if they have any 
discomfort or other intolerance. 
 
 
 
 
 

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APPENDIX:  Recruitment 
Recruitment includes identifying, review of records to determine eligibility or any contact to determine a 
potential subjects interest in the study. 
 
*The UVa HIPAA covered entity is composed of the  UVa VP Office of Research, the Health System, School of 
Medicine, School of Nursing, Nutrition Services (Morrisons), the Sheila C. Johnson Center, the Exercise and 
Sports Injury Laboratory and the Exercise Physiology Laboratory.   
 
1. How do you plan to identify potential subjects? 
 To "identify" a potential subject refers to steps you plan to take to determine which individuals 
would qualify to participate in your study. This does NOT include steps to actually contact those 
individuals. 
 If your study involves more than one group of subjects (e.g. controls and cases or subjects and 
caregivers) note below which groups are being identified by the given method.  
 Check the methods you plan to utilize: 
 
a.____ Chart Review/ Clinic Schedule Review/ Database Review from a database established for 
health care operations (departmental clinical database) or an Improvement Project (e.g.  
Performance Improvement, Practice Improvement, Quality Improvement).   
 
If you plan to obtain data from the UVa Enterprise Data Warehouse (EDW) please see option b 
below.   
 
DHHS: Study team requests Waiver of Consent to identify potential subjects.  
 
HIPAA: Allowed under Preparatory to Research if PHI to be accessed.  
 
IMPORTANT 
Keep in mind that PHI in the medical record may only be accessed by individuals who 
work under the UVa HIPAA covered entity; which means they meet one of the following 
criteria: 
--a UVa student working in the UVa HIPAA Covered Entity*   
--a faculty or staff member in a PAID appointment in  the UVA HIPAA Covered Entity* 
 
b____ Review of a database that was established to keep data to be used for future 
research such as the CDR, departmental research database or use of data from a separate 
current active research protocol.     
If you plan to obtain data from the UVa Enterprise Data Warehouse (EDW) you are required 
to submit your request to the CDR.  The CDR staff will work with the EDW to obtain the data 
you need.   
DHHS: Study team requests Waiver of Consent to identify potential subjects. 
 
HIPAA: Allowed under Preparatory to Research if PHI to be accessed.  

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IMPORTANT 
Keep in mind that PHI in the medical record may only be accessed by individuals who 
work under the UVa HIPAA covered entity; which means they who meet one of the 
following criteria: 
--a UVa student working in the UVa HIPAA Covered Entity*   
--a faculty  or staff member in a PAID appointment in  the UVA HIPAA Covered Entity* 
 
The information from which you are obtaining potential subjects must also have an IRB 
protocol approval.  If this item is checked, enter the IRB # below.  
 
IRB# ________________ 
If obtaining information from the Clinical Data Repository (CDR) insert IRB # 10797 
 
c. ____ Patients UVa health care provider supplies the UVa study team with the patients 
contact information without patients’ knowledge. 
 
DHHS: Study team requests Waiver of Consent to identify potential subjects.  
 
HIPAA: Allowed under Preparatory to Research if PHI will be shared by the health care 
provider.  
 
IMPORTANT 
Keep in mind that PHI may only be given to individuals who work under the UVa HIPAA 
covered entity; which means they meet one of the following criteria: 
--a UVa student working in the UVa HIPAA Covered Entity*   
--a faculty or staff member in a PAID appointment in the UVA HIPAA Covered Entity* 
 
d. __x__ Patient obtains information about the study from their health care provider.  The 
patient contacts the study team if interested in participating. (Health care provider may 
or may not also be the a member of the study team) 
DHHS:  NA 
HIPAA:  Allowed under Health Care Operations 
 
If this choice is checked, check 3d-INDIRECT CONTACT below.  
 
e. ____ Potential subjects will not be directly identified. They will respond to an 
advertisement such as a flyer, brochure etc.   
If this choice is checked, check 3d- INDIRECT CONTACT below.  
DHHS & HIPAA:  NA 
 

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f. _____ Potential subjects have previously signed a consent to have their name in a 
registry/database to be contacted for future studies of this type.   
IRB#  of registry/ database:  ________________ 
DHHS & HIPAA:  NA 
 
If item # a, b or c is checked above and if this protocol involves the use of protected health 
information do you confirm the following to be true? n/a 
 The use or disclosure is sought solely to review protected health information as 
necessary to prepare the research protocol or other similar preparatory purposes. 
 No PHI will be removed from the UVa covered entity. 
 The PHI that the researcher seeks to use or access is necessary for the research 
purposes. 
 
2. How will potential subjects be contacted? 
To "contact" a potential subjects refers to the initial contact you plan to take to reach a potential 
subject to determine if they would be interested in participating in your study.  This may include 
direct contact by such methods as by letter, phone, email or in-person or indirect contact such as 
the use of flyers, radio ads etc.  
 
If your study involves more than one group of subjects (e.g. controls and cases or subjects and 
caregivers) note below which groups are being contacted by the given method.    
 
Check the methods below you plan to utilize: 
a.____Direct contact of potential subjects by the study team via letter, phone, direct e-
mail. Members of study team ARE NOT health care providers of patients.  Information 
will not be collected from psychotherapy notes.  
Note:  Letter, phone, direct email scripts must be approved by IRB prior to use.  
See IRB-HSR Website for templates. 
 
DHHS/HIPAA: Study team requests a Waiver of Consent and Waiver of HIPAA 
Authorization to contact potential subjects.  
 
IMPORTANT:   
Keep in mind that if PHI was collected during the identification phase that 
contact with potential subjects may only be performed by individuals who work 
under the UVa HIPAA covered entity; which means they meet one of the 
following criteria: 
 a UVa student working in the UVa HIPAA Covered Entity*   
 a faculty  or staff member in a PAID appointment in  the UVA HIPAA Covered 
Entity* 
 

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b.____Potential subjects will be approached while at UVa Hospital or Health Clinic by a 
person who is NOT a member of their health care team.  Information will not be 
collected from psychotherapy notes.  
DHHS & HIPAA: Study team requests a Waiver of Consent and a Waiver of HIPAA 
Authorization to contact potential subjects.  
 
IMPORTANT:   
Keep in mind that contacting individuals in a clinical setting may only be performed by 
individuals who work under the UVa HIPAA covered entity; which means they  meet one 
of the following criteria: 
a UVa student working in the UVa HIPAA Covered Entity*   
a faculty  or staff member in a PAID appointment in  the UVA HIPAA Covered Entity* 
 
You should share the following information with the potential subject:  
 Your name 
 Who you are:  physician, nurse etc. at the University of Virginia.    
 Why you want to speak with them 
 Ask if you have their permission to explain the study to them 
 If asked about how you obtained their information use one of the following as an 
option for response.     
o DO NOT USE THIS RESPONSE UNLESS YOU HAVE OBTAINED PERMISSION 
FROM THEIR UVa PHYSICIAN:  Your doctor, Dr. insert name wanted you 
to be aware of this research study and gave us permission to contact you.    
o We obtained your information from your medical records at UVa.   
o Federal regulations allow the UVa Health System to release your 
information to researchers at UVa, so that we may contact you regarding 
studies you may be interested in participating.  We want to assure you 
that we will keep your information confidential.  
 IF THE PERSON SEEMS ANGRY, HESITANT OR UPSET, THANK THEM FOR THEIR 
TIME AND DO NOT ENROLL THEM IN THE STUDY.  YOU MAY ALSO REFER THEM 
TO THE IRB-HSR AT 924-9634. 
 
c.__x__Direct contact of potential subjects by the study team by approaching in person 
at UVa or via letter, phone, direct e-mail. Members of study team contacting potential 
subjects ARE health care providers of patients.  
If you are not approaching them in person but using a letter, phone call or direct email 
please note that the letter, phone, direct email scripts must be approved by IRB prior to 
use.   
See IRB-HSR Website for templates. 
 
DHHS:  Study team requests a Waiver of Consent to contact potential subjects 
HIPAA:  Allowed under Health Care Operations.  

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d.____ Indirect contact (flyer, brochure, TV, broadcast emails, patient provided info 
about the study from their health care provider and either the patient contacts study 
team or gives their healthcare provider permission for the study team to contact them.) 
The indirect method used (flyer, brochure, TV, broadcast emails) must be approved by 
the IRB prior to use.    The IRB does not need to review any type of script to use when 
the potential subject responds to the indirect method.   
 
DHHS & HIPAA:  NA 
 
e. ____  Potential subjects are not patients.  The study does not include obtaining 
subjects health information.   Subjects will be contacted directly via email, phone, 
letter or presentation in group setting with consent then obtained individually in a 
private setting.  
If you are not approaching them in person but using a letter, phone call or direct 
email please note that the letter, phone, direct email scripts must be approved by 
IRB prior to use.   
See IRB-HSR Website for templates. 
 
DHHS: Study team requests a Waiver of Consent to contact potential subjects.  
HIPPA:  NA 
 
3. Will any additional information be obtained from a potential subject during "prescreening"?   
Pre-screening for IRB purposes is the term used to describe activities PRIOR to obtaining Informed 
Consent and may not include any research procedures.  
  
The activities may involve pre-screening of potential subjects over the telephone or in person is 
generally performed to determine their initial eligibility for, and, interest in a study and is a 
common strategy in the recruitment process.  
Questions appropriate for pre-screening address the specific inclusion/exclusion criteria for the 
study and other issues of suitability, for example, an individual's ability to come to the research site 
multiple times.  
It is not appropriate at this point in the process (i.e. prior to obtaining informed 
consent/enrollment) to gather information that is not directly related to assessing eligibility and 
suitability (e.g. obtaining complete medical histories, obtaining blood specimens for lab tests).  
An additional telephone script is not required, for this pre-screening process, in addition to any 
scripts required under Recruitment question # 2.   
Yes  
Pre-screening questions: 
- 
Have you used CPAP in the last month? 
- 
Do you have any significant cardiopulmonary disease? 
- 
If yes, what diagnoses do you carry? 
 

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IF YES, submit any documents that will be used to collect pre-screening information so that the IRB 
may confirm what questions will be asked. 
NOTE: To comply with HIPAA regulations only the minimum necessary information may be 
collected at this time.  This means that only questions pertaining to the Inclusion and Exclusion 
Criteria may be asked.   
 
IF YES, 
DHHS:   study team requests a Waiver of Documentation of Consent for Pre-screening questions.  
 
HIPPA: 
HIPAA does not apply if: 
--no PHI is collected or 
--if PHI is collected from a potential subject  by an individual from a department that is not part of 
the HIPAA covered entity. 
 
HIPAA does apply if the collection occurs by individuals* who work in a department that is part of 
the HIPAA covered entity.   
 
In this case the collection will be covered under Health Care Operations/ 
 
These individuals are those that meet one of the following criteria:  
--a UVa student working in the UVa HIPAA Covered Entity*   
--a faculty  or staff member in a PAID appointment in  the UVA HIPAA Covered Entity* 
 
IF YES, Will any of the questions involve health information?Yes 
 
IF YES, will you collect HIPAA identifiers with the health information?No 
 
4. Do you plan to ask the subjects to do anything, other than answering questions, for the study 
prior to signing a consent? No 
 
5. How will the consenting process take place with either the prospective subject, the subject’s 
legally authorized representative or parent/legal guardian of a minor ( if applicable)?    
HIPPA:  
If the individual, obtaining consent, works under the HIPAA Covered Entity consenting is 
covered under Health Care Operations. 
 
If the individual obtaining consent does not work under the HIPAA covered entity, HIPAA does 
not apply.  
 
The consent process will take place in a separate room from the clinic room.  The patient will 
voluntarily agree to move to this space to proceed with the consenting process.  The consent 
will be reviewed by either a sub-investigator or by a clinical research coordinator. 

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6. Will subjects sign a consent form for any part of the study? yes 
7.  Will the study procedures be started the same day the subject is recruited for the study? Yes 
 
►IF YES, explain in detail why the subject cannot be given more time to make a decision to 
consent.  
Functionally, it would require another trip for a set of procedures that will take less than 15 
minutes.  It would be unreasonable to ask the subject to return another day and financially 
irresponsible to pay for such an inconvenience. 
 
►IF YES, explain in detail what will be done to assure the potential subject has enough time 
to make an informed decision. 
If they have any reservations, they will be allowed to consider the study and return if desired. 
 
8.  Is there the potential to recruit economically or educationally disadvantaged subjects, or other 
vulnerable subjects such as students or employees?Yes 
 
IF YES, what protections are in place to protect the rights and welfare of these subjects so 
that any possible coercion or undue influence is eliminated?   
It will be explicitly conveyed that we are in no way providing treatment to them and this is fully 
to further our understanding of Eustachian tube function. 
 
9. Do you need to perform a “dry run” of any procedure outlined in this protocol?   No 
 
Privacy Plan 
 
The following procedures must be followed.  
 The data will be secured per the Data Security Plan of this protocol. 
 Only investigators for this study and clinicians caring for the patient will have access to data.  They will each 
use a unique login ID and password that will keep confidential.   The password should meet or exceed the 
standards described on the Information Technology Services (ITS) webpage about The Importance of 
Choosing Strong Passwords. 
 Each investigator will sign the University’s Electronic Access Agreement forward the signed agreement to the 
appropriate department as instructed on the form. 
If you currently have access to clinical data it is likely that you have already signed this form.  You are not 
required to sign it again.  
 UVa University  Data Protection Standards will be followed 
http://www.virginia.edu/informationsecurity/dataprotection.   
 If identifiable data is transferred to any other location such as a desktop, laptop, memory stick, CD etc. the 
researcher must follow the University’s  “Electronic Storage of Highly Sensitive Data Policy”. Additional 
requirements may be found in the University's Requirements for Securing Electronic Devices.  
 If identifiable data is taken away from the UVa Health System, Medical Center Policy # 0218 will be 
followed.  

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 Data will be securely removed from the server/drive, additional computer(s), and electronic media 
according to the University's Electronic Data Removal Policy.  
 Data will be encrypted or removed if the electronic device is sent outside of UVa for repair according to 
the University's Electronic Data Removal Policy. 
 If PHI will be faxed, researchers will follow the Health System Policy # 0194.     
 If PHI will be emailed, researchers will follow the Health System Policy # 0193 and University Data 
Protection Standards . 
 Data may not be analyzed for any other study without additional IRB approval.  
 If you are using patient information you must follow Health System Policy  # 0021. 
 Both data on paper and stored electronically will follow the University's Record Management policy and 
the Commonwealth statute regarding the Destruction of Public Records. 
Summary of Requirements to Comply with UVa Health System, Medical Center and University Policies and 
Guidance as noted above: 
Highly Sensitive Data is: 
-personal information that can lead to identity theft if exposed or 
-data that reveals an individual’s health condition and/or history of health services use.  
Protected Data (PHI) a type of Highly Sensitive Data, is data combined with a HIPAA identifier  
Identifiable Data under HIPAA regulations is considered to be Highly Sensitive Data at UVa. 
A Limited Data Set (LDS) under HIPAA regulations is considered to be Moderately Sensitive Data at UVa. The only HIPAA identifiers 
associated with data: dates and or postal address information limited to town or city, state, and zip code.   
Will not include subjects age if older than 89 or subjects DOB if older than 89.   

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Highly Sensitive Data 
(Identifiable Health Info per HIPAA )  
Moderately Sensitive Data  
(Limited Data Set and De-identified data per 
HIPAA) 
General Issues  
General Issues 
Discussions in private 
Do not share with those not on the study team or 
those who do not have a need to know. 
 
Do not share with those not on the study team or 
those who do not have a need to know 
Password protect  
Password protect 
Physically secure (lock) hard copies at all times if not 
directly supervised.  
If not supervised hard copies must have double 
protection (e.g. lock on room OR cabinet AND in 
building requiring swipe card for entrance).    
 
Physically secure (lock) hard copies at all times if 
not directly supervised.   
For electronic documents turn off File Sharing; turn 
on firewalls; use up to date antivirus and 
antispyware; delete data securely. 
 
For electronic documents turn off File Sharing; turn 
on firewalls; use up to date antivirus and 
antispyware; delete data securely. 
 
Encrypt 
See Encryption Solutions Guidance  
Files on Health System Network drives are 
automatically encrypted.  If not stored there it is study 
teams responsibility to make sure data are encrypted. 
 
If device sent out for service or repair, encrypt or 
remove data AND contract for repair using a UVa 
Purchase order. 
If device sent out for service or repair, encrypt or 
remove data AND contract for repair using a UVa 
Purchase order. 
Store files on a network drive specifically designated 
for storing this type of data, e.g. high-level security 
server/drives managed by Information Technology 
Services or the “F” and “O” managed by Heath 
Systems Computing Services.  You may access it via a 
shortcut icon on your desktop, but you are not 
allowed to take it off line to a local drive such as the 
desktop of your computer (e.g. C drive) or to an 
individual  Use Device*.  May access via VPN 
 
Do not share with sponsor or other outside group 
before consent is obtained or the IRB has granted 
appropriate approvals and contract/ MTA is in place  
Do not share with sponsor or other outside group 
before consent is obtained or the IRB has granted 
appropriate approvals and contract/ MTA is in 
place 
If collected without consent/ HIPAA authorization 
will NOT be allowed to leave UVa HIPAA covered 
entity unless disclosure is approved by the IRB and 
the disclosure is tracked in EPIC  
If collected without consent/ HIPAA authorization 
will NOT be allowed to leave UVa HIPAA covered 
entity unless disclosure is approved by the IRB and 
an MTA is in place prior to sharing of data 

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Highly Sensitive Data 
(Identifiable Health Info per HIPAA )  
Moderately Sensitive Data  
(Limited Data Set and De-identified data per HIPAA) 
Electronic Data Collection & Sharing  
Electronic Data Collection & Sharing 
(e.g. smart phone app, electronic consent using 
tablet etc.) 
MUST consult with ISPRO or Health System Web 
Development Office: 434-243-6702 
 University Side:    IT-
Security@virginia.edu  
 Health System: Web Development Center:   
 
Individual-Use Device  
Individual-Use Device 
Do not save to individual-use device* without 
written approval of your Department AND VP  
or Dean.   
If approval obtained, data must be password  
protected and encrypted. 
 
Do not save an email attachment containing 
HSD to an individual use device  
( e.g. smart phone)  
 
E Mail 
E Mail 
Do not share via email with Outlook Web/ or 
forward email using other email vendors like 
Gmail/ Yahoo  
 
Do not send via email on smart phone unless 
phone is set up by Health System  
 
Email may include name, medical record 
number or Social Security number only if 
sending email to or from a person with * HS in 
their email address. 
NOTE: VPR & IRB staff do not meet this criteria!  
In addition to sharing LDS, may include initials if 
persons sending and receiving email work within the 
UVa HIPAA covered entity.** 
FAX 
FAX 
Verify FAX number before faxing 
Verify FAX number before faxing 
Use Fax Cover Sheet with Confidentiality 
Statement 
Use Fax Cover Sheet with Confidentiality Statement 
Verify receiving fax machine is in a restricted 
access area 
Verify receiving fax machine is in a restricted access 
area 
Verify intended recipient is clearly indicated 
Verify intended recipient is clearly indicated 
Recipient is alerted to the pending transmission 
and is available to pick it up immediately 
Recipient is alerted to the pending transmission and 
is available to pick it up immediately 

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Highly Sensitive Data 
(Identifiable Health Info per HIPAA )  
Moderately Sensitive Data  
(Limited Data Set and De-identified data per HIPAA) 
Electronic Data Collection & Sharing  
Electronic Data Collection & Sharing 
(e.g. smart phone app, electronic consent 
using tablet etc.) 
MUST consult with ISPRO or Health System 
Web Development Office: 434-243-6702 
 University Side:    IT-
Security@virginia.edu  
 Health System: Web Development Center:   
 
Individual-Use Device  
Individual-Use Device 
Do not save to individual-use device* without 
written approval of your Department AND VP  
or Dean.   
If approval obtained, data must be password  
protected and encrypted. 
 
Do not save an email attachment containing 
HSD to an individual use device  
( e.g. smart phone)  
 
E Mail 
E Mail 
Do not share via email with Outlook Web/ or 
forward email using other email vendors like 
Gmail/ Yahoo  
 
Do not send via email on smart phone unless 
phone is set up by Health System  
 
Email may include name, medical record 
number or Social Security number only if 
sending email to or from a person with * HS in 
their email address. 
NOTE: VPR & IRB staff do not meet this 
criteria!  
In addition to sharing LDS, may include initials if 
persons sending and receiving email work within the 
UVa HIPAA covered entity.** 
FAX 
FAX 
Verify FAX number before faxing 
Verify FAX number before faxing 
Use Fax Cover Sheet with Confidentiality 
Statement 
Use Fax Cover Sheet with Confidentiality Statement 
Verify receiving fax machine is in a restricted 
access area 
Verify receiving fax machine is in a restricted access 
area 
Verify intended recipient is clearly indicated 
Verify intended recipient is clearly indicated 
Recipient is alerted to the pending 
Recipient is alerted to the pending transmission and 

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*  Individual Use Device – examples include smart phone, CD, flash (thumb) drive, laptop, C drive of your 
computer,  
**The UVa HIPAA covered entity is composed of the UVa VP Office of Research, the Health System, School of 
Medicine, School of Nursing, Nutrition Services (Morrison’s), the Sheila C. Johnson Center, the Exercise and 
Sports Injury Laboratory and the Exercise Physiology Laboratory.   
 
transmission and is available to pick it up 
immediately 
is available to pick it up immediately 
Highly Sensitive Data 
(Identifiable Health Info per HIPAA )  
Moderately Sensitive Data  
(Limited Data Set and De-identified data per HIPAA) 
Electronic Data Collection & Sharing 
Electronic Data Collection & Sharing 
(e.g. smart phone app, electronic consent 
using tablet etc.) 
MUST consult with ISPRO or Health System 
Web Development Office: 434-243-6702 
University Side:    IT-Security@virginia.edu  
Health System: Web Development Center:   
Contract must include required security 
measures.  
 
May NOT be stored in places like UVaBox, 
UVaCollab, QuestionPro.  
May also NOT be stored in non-UVa licensed 
cloud providers, such as Dropbox, Google 
Drive, SkyDrive, Survey Monkey, etc.  
May be stored in places like UVaBox, UVaCollab, 
QuestionPro.   
May NOT be stored in non-UVa licensed cloud 
providers, such as Dropbox, Google Drive, SkyDrive, 
Survey Monkey, etc.  
LOST OR STOLEN:  
LOST OR STOLEN: 
Must report in accordance with protocol/ in 
accordance with the Information Security 
Incident Reporting Policy. 
 
Any data breach will also be reported to the 
IRB of Record if the report meets the criteria 
of an Unanticipated Problem.   
Must report in accordance with protocol/ in 
accordance with the Information Security Incident 
Reporting Policy. 
 
Any data breach will also be reported to the IRB of 
Record if the report meets the criteria of an 
Unanticipated Problem.