Impact of Meditation on Bothersome Tinnitus
Phase: NA
Conditions: Tinnitus, Noise Induced Tinnitus, Tinnitus, Subjective, Tinnitus, Objective, Tinnitus Aggravated, Tinnitus, Pulsatile, Tinnitus, Spontaneous Oto-Acoustic Emission, Tinnitus, Clicking, Tinnitus, Tensor Tympani Induced
Sponsor: State University of New York at Buffalo

 
University at Buffalo Institutional Review Board (UBIRB) 
Office of Research Compliance | Clinical and Translational Research Center Room 5018 
875 Ellicott St. | Buffalo, NY 14203 
UB Federalwide Assurance ID#: FWA00008824 
Page 1 of 39 
 
 
Complete Research Protocol (HRP-503) 
 
Table of Contents 
Template Instructions.......................................................................................................... 2 
1.0 
Objectives ................................................................................................................ 4 
2.0 
Scientific Endpoints ................................................................................................. 4 
3.0 
Background .............................................................................................................. 5 
4.0 
Study Design .......................................................................................................... 10 
5.0 
Local Number of Subjects ..................................................................................... 11 
6.0 
Inclusion and Exclusion Criteria ............................................................................ 11 
7.0 
Vulnerable Populations .......................................................................................... 13 
8.0 
Eligibility Screening .............................................................................................. 14 
9.0 
Recruitment Methods ............................................................................................. 14 
10.0 Procedures Involved............................................................................................... 17 
11.0 Study Timelines ..................................................................................................... 20 
12.0 Setting .................................................................................................................... 21 
13.0 Community-Based Participatory Research ............................................................ 21 
14.0 Resources and Qualifications ................................................................................. 22 
15.0 Other Approvals ..................................................................................................... 23 
16.0 Provisions to Protect the Privacy Interests of Subjects .......................................... 23 
17.0 Data Management and Analysis ............................................................................ 24 
18.0 Confidentiality ....................................................................................................... 25 
A. 
Confidentiality of Study Data ............................................................................ 25 
B. 
Confidentiality of Study Specimens ................................................................... 26 
19.0 Provisions to Monitor the Data to Ensure the Safety of Subjects .......................... 26 
20.0 Withdrawal of Subjects .......................................................................................... 27 
21.0 Risks to Subjects .................................................................................................... 28 
22.0 Potential Benefits to Subjects ................................................................................ 29 
23.0 Compensation for Research-Related Injury ........................................................... 29 
24.0 Economic Burden to Subjects ................................................................................ 30 
25.0 Compensation for Participation ............................................................................. 30 
26.0 Consent Process ..................................................................................................... 30 
27.0 Waiver or Alteration of Consent Process ............................................................... 35 
28.0 Process to Document Consent ............................................................................... 35 
29.0 Multi-Site Research (Multisite/Multicenter Only)................................................. 36 
30.0 Banking Data or Specimens for Future Use .......................................................... 37 
31.0 Drugs or Devices.................................................................................................... 37 
32.0 Humanitarian Use Devices .................................................................................... 38 
 
 
 

 
Page 2 of 39 
 
Template Instructions 
Sections that do not apply: 
 In several sections, the addition of checkboxes for Not Applicable have been 
added to the template as responses.   
o If an N/A checkbox is present, select the appropriate justification 
from the list.   
o If an N/A checkbox is not present, or if none of the existing 
checkboxes apply to your study, you must write in your own 
justification. 
 In addition: 
o For research where the only study procedures are records/chart 
review:  Sections 19, 20, 22, 23, 24, 25, 31, and 32 do not apply. 
o For exempt research:  Sections 31 and 32 do not apply. 
 
Studies with multiple participant groups: 
 
 If this study involves multiple participant groups (e.g. parents and children), 
provide information in applicable sections for each participant group. Clearly 
label responses when they differ.  For example: 
Response:  
Intervention Group:  
 
Control Group: 
 
Formatting: 
 Do not remove template instructions or section headings when they do not apply 
to your study. 
If you are pasting information from other documents using the “Merge Formatting” 
Paste option will maintain the formatting of the response boxes. 
Amendments: 
 When making modifications or revisions to this and other documents, use the 
Track Changes function in Microsoft Word. 
 Update the version date or number on Page 3. 
 
 

 
Page 3 of 39 
 
PROTOCOL TITLE: 
Include the full protocol title. 
Response: Impact of Meditation on Bothersome Tinnitus 
 
 
PRINCIPAL INVESTIGATOR: 
Name 
Department 
Telephone Number 
Email Address 
Response:  
Brendan Fitzgerald 
Communicative Disorders and Sciences 
716-361-3271 
bpf4@buffalo.edu 
 
 
VERSION: 
Include the version date or number. 
Response: 3 
 
 
GRANT APPLICABILITY: 
Indicate whether this protocol is funded by a grant (e.g. NIH, foundation grant).  
For a grant with multiple aims, indicate which aims are covered by this research 
proposal. 
NOTE: This question does not apply to studies funded by a sponsor contract. 
Include a copy of the grant proposal with your submission.     
Response: This study is receiving no funding. 
 
 

 
Page 4 of 39 
 
RESEARCH REPOSITORY: 
Indicate where the research files will be kept, including when the study has been 
closed.  The repository should include, at minimum, copies of IRB 
correspondence (approval, determination letters) as well as signed consent 
documents.  This documentation should be maintained for 3 years after the study 
has been closed.   
Response:  
Location: 
Address: University at Buffalo – South Campus, Cary Hall 112A 
Department: Communicative Disorders and Sciences 
1.0 Objectives 
1.1 Describe the purpose, specific aims, or objectives of this research. 
Response: The purpose of this mixed methods correlational study is to investigate 
the effects of meditation on the level of bother in tinnitus patients in the United 
States. The researchers seek to understand the changes in bother as compared to 
the amount of time spent meditating. Data is obtained through the Insight Timer 
mediation application.  Outcome measures will include several validated and 
reliable measures. 
 
1.2 
State the hypotheses to be tested, if applicable. 
NOTE:  A hypothesis is a specific, testable prediction about what you expect to 
happen in your study that corresponds with your above listed objectives. 
Response: The reduction level of bother of tinnitus will correlate to the amount of 
time spent meditating. 
 
2.0 Scientific Endpoints 
 
2.1    Describe the scientific endpoint(s), the main result or occurrence under 
study.   
 
NOTE:  Scientific endpoints are outcomes defined before the study begins to determine 
whether the objectives of the study have been met and to draw conclusions from the data.  
Include primary and secondary endpoints.  Some example endpoints are:  reduction of 
symptoms, improvement in quality of life, or survival.  Your response should not be a 
date.   
Response:  Outcomes will be measured utilizing the Tinnitus Handicap 
Questionnaire, Tinnitus Functional Index, Hospital Anxiety and Depression Scale, 
and the University at Buffalo Tinnitus Intake Questionnaire to investigate the 
rReduction in level of bother created by the subject’s tinnitus before, during, and 
after the study period of 8 weeks. 
 
Commented [RJ1]: A response is required.  
Commented [2]: Are these all the measures, more, less? 
Consider The Mindful Attention Awareness Scale (MAAS) and/or 
The Five Facet Mindfulness Questionnaire (FFMQ) 
Commented [RJ3]: 12 weeks or 8? 
Commented [BF4R3]: 8 

 
Page 5 of 39 
 
3.0 Background 
3.1 Provide the scientific or scholarly background, rationale, and significance 
of the research based on the existing literature and how it will contribute to 
existing knowledge.  Describe any gaps in current knowledge.  Include 
relevant preliminary findings or prior research by the investigator.  
Response: Mindfulness is a practice of “careful attention to mental and physical 
processes.” ("Glossary of Buddhist Terms," 2018)  Mindfulness is a component of 
various types of spiritual practices including meditation, specifically, from 
Buddhist tradition.  While there are many types of meditative activities, Western 
medicine has begun to focus on practices most closely related to Vipassana 
Meditation, also known as, Insight Meditation.  Mindfulness can be considered a 
component of meditation practices, but can also be practiced and incorporated in 
to an individual’s daily activity. 
While meditation has long been a practice in several Eastern religions and 
spiritual practices, it most notably came to Europe and North America in the early 
1960s.  By 1976, the Insight Meditation Society, one of the first retreat centers in 
the United States, was founded by Joseph Goldstein, Sharon Salzburg, and Jack 
Kornfield ("Celebrating 40 Years (1976-2016)," 2018).  From this, developed the 
medical research around mindfulness of Jon Kabat-Zinn, Founder of the UMass 
Medical School Mindfulness Based Stress Reduction (MBSR) Program ("History 
of MBSR," 2017). 
Mindfulness practice has gained popularity as a first line medical intervention for 
three main reasons.  Mindfulness practice is non-invasive, non-pharmacologic, 
and has no significant side effects (Cebolla, Demarzo, Martins, Soler, & Garcia-
Campayo, 2017).  Since it is non-invasive, mindfulness on its own is rarely 
harmful, however, if used in the place of proven interventions can be dangerous.  
Those utilizing mindfulness practices and meditation must still be under the care 
of appropriate medical professionals.  As a non-pharmacologic intervention, it can 
be cost effective and not financially prohibitive or burdensome for patients.  
While the quality of instruction and subsequent practice should be further 
investigated, the practice itself has the potential to be available at little cost.  
Much like exercise, meditation and mindfulness practice can be subject to failure 
if a patient is not compliant to the regimen.  Since there is still much to know 
about the impacts of the types and qualities of meditation on an individual level, 
its potential benefits can greatly outweigh any risks. 
For the purposes of this study meditation and meditative activities will not be 
limited only to mindfulness, which can be one aspect of meditation.  Meditation 
can be categorized into three areas.  Focused attention (FA) or concentration 
meditation is a practice in which the practitioner focuses their attention on a 
singular idea or object (Rinpoche, 1980) as in breath awareness, metta or loving-
kindness meditation, or a repeated word or phrase as in transcendental 
meditation(Rinpoche, 1980).  This has typically become a starting point for most 
novice practitioners.  Open-monitoring (OM) includes mindfulness practice, in 
which the practitioner seeks to become aware of physical and emotional states, 
Formatted: Font: 12 pt

 
Page 6 of 39 
 
responses, and activities.  The third category of meditation is one that combines 
both Focused Attention and Open-monitoring Meditation.  This includes 
Vipassana practice, or Insight meditation, from which Kabat-Zinn has developed 
the MBSR model.  The first two practices rarely are exclusive of each other, but 
rather, a practitioner’s session may include FA and OM. 
Previous study of meditation has demonstrated activations and changes in specific 
regions of the brain.  Findings from Manna et al., indicate  
that expert meditators control cognitive engagement in conscious 
processing of sensory-related, thought and emotion contents, by massive 
self-regulation of fronto-parietal and insular areas in the left hemisphere, 
in a meditation state-dependent fashion.  We also found that anterior 
cingulate and dorsolateral prefrontal cortices play antagonist roles in the 
executive control of the attention setting in meditation tasks. …  Finally, 
our study suggests that a functional reorganization of brain activity 
patterns for focused attention and cognitive monitoring takes place with 
mental practice, and that meditation-related neuroplasticity is crucially 
associated to a functional reorganization of activity patterns in prefrontal 
cortex and in the insula. (2010) 
Others have confirmed through the use of fMRI that meditative methods of 
MBSR, Mindfulness Cognitive Behavioral Therapy (MCBT), and dispositional 
mindfulness – the present moment awareness in daily life – change functional and 
structural components of the prefrontal cortex, cingulate cortex, insula, 
hippocampus, and amygdala after an eight-week program. These findings indicate 
emotional and behavioral changes being related to those functional and structural 
changes (Gotink, Meijboom, Vernooij, Smits, & Hunink, 2016).  These changes 
were found to be similar to those noted in experienced meditators. 
Others found changes in functional connectivity in the medial prefrontal cortex, 
right thalamus/parahippocampal gyrus, and bilateral anterior insula/putamen 
during meditation.  These findings were associated with top-down cognitive, 
emotion, and attention control in the practice of mental silence in Sahaja Yoga 
meditation (Hernandez, Barros-Loscertales, Xiao, Gonzalez-Mora, & Rubia, 
2018). 
A meta-analysis by Merkes of fifteen studies on the effects of MBSR has 
demonstrated improved functional outcomes for chronic conditions including 
“fibromyalgia, chronic pain, rheumatoid arthritis, type 2 diabetes, chronic fatigue 
syndrome, multiple chemical sensitivity, and cardiovascular diagnoses.”  This 
analysis also reported no negative outcomes between baseline and follow-up 
assessments (Merkes, 2010). 
While it can be difficult to differentiate and locate the source of a patient’s 
tinnitus, it is thought to originate in any combination of three areas – namely 
peripherally from the auditory system, centrally, or from somatosensory input.  
Tinnitus is commonly associated with specific regions of the brain, particularly, 
the Dorsal Cochlear Nucleus, Central Auditory Pathway, and Auditory Cortex 
(Han, Lee, Kim, Lim, & Shin, 2009).  Most recently, using residual inhibition, 

 
Page 7 of 39 
 
Sedley et al. found tinnitus activity in the thalamus, and contrary to expectations, 
almost all of the auditory cortex and large portions of the temporal, parietal, 
sensorimotor, and limbic cortex (2015). 
Given tinnitus is believed to cause neuroplastic changes in several areas of the 
brain (Han et al., 2009) and that meditation and mindfulness activities are shown 
to make restorative changes in those same areas while improving emotional 
responses, this study investigates the association between the amount of time 
spent and type of meditation and relief from tinnitus through reduction of bother. 
McKenna et al., have found significant reduction of bother in patients with 
chronic tinnitus through the use of Mindfulness-Based Cognitive Therapy 
(MBCT), a standardized approach to tinnitus management following an eight-
week MBCT program led by clinical psychologists.  They rightly point out that 
much of the current research in non-standardized approaches, like the one 
proposed in this study, has been limited by small sample sizes (2018).  This study 
looks to add to the body of research for non-standardized interventions and lead to 
the possibility of increased access to care for patients. 
3.2 Include complete citations or references.  
Response:  
National Health and Nutrition Examination Survey. (2013).  Retrieved 
from https://wwwn.cdc.gov/nchs/nhanes/2011-2012/AUQ_G.htm. 
History of MBSR. (2017). Retrieved from 
https://www.umassmed.edu/cfm/mindfulness-based-programs/mbsr-
courses/about-mbsr/history-of-mbsr/ 
Celebrating 40 Years (1976-2016). (2018). Retrieved from 
https://www.dharma.org/about-us/ims-turns-40/ 
Glossary of Buddhist Terms. (2018). Retrieved from 
https://www.dharma.org/resources/glossary/ 
Alsubaie, M., Abbott, R., Dunn, B., Dickens, C., Keil, T. F., Henley, W., 
& Kuyken, W. (2017). Mechanisms of action in mindfulness-based 
cognitive therapy (MBCT) and mindfulness-based stress reduction 
(MBSR) in people with physical and/or psychological conditions: A 
systematic review. Clin Psychol Rev, 55, 74-91. 
doi:10.1016/j.cpr.2017.04.008 
Anheyer, D., Haller, H., Barth, J., Lauche, R., Dobos, G., & Cramer, H. 
(2017). Mindfulness-Based Stress Reduction for Treating Low Back Pain: 
A Systematic Review and Meta-analysis. Ann Intern Med, 1-9. 
doi:10.7326/m16-1997 
Bhatt, J. M., Lin, H. W., & Bhattacharyya, N. (2016). Prevalence, severity, 
exposures, and treatment patterns of tinnitus in the united states. JAMA 
Otolaryngology–Head & Neck Surgery, 142(10), 959-965. 
doi:10.1001/jamaoto.2016.1700 

 
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Candia, V., Wienbruch, C., Elbert, T., Rockstroh, B., & Ray, W. (2003). 
Effective behavioral treatment of focal hand dystonia in musicians alters 
somatosensory cortical organization. Proceedings of the National 
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Cebolla, A., Demarzo, M., Martins, P., Soler, J., & Garcia-Campayo, J. 
(2017). Unwanted effects: Is there a negative side of meditation? A 
multicentre survey. PLoS One, 12(9), e0183137. 
doi:10.1371/journal.pone.0183137 
Chou, R., Deyo, R., Friedly, J., Skelly, A., Hashimoto, R., Weimer, M., . . 
. Brodt, E. D. (2017). Nonpharmacologic Therapies for Low Back Pain: A 
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2459 
Gans, J. J., O'Sullivan, P., & Bircheff, V. (2014). Mindfulness Based 
Tinnitus Stress Reduction Pilot Study A Symptom Perception-Shift 
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Goldin, P., Ramel, W., & Gross, J. (2009). Mindfulness Meditation 
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242-257. doi:10.1891/0889-8391.23.3.242 
Gotink, R. A., Meijboom, R., Vernooij, M. W., Smits, M., & Hunink, M. 
G. (2016). 8-week Mindfulness Based Stress Reduction induces brain 
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Gotink, R. A., Younge, J. O., Wery, M. F., Utens, E., Michels, M., 
Rizopoulos, D., . . . Hunink, M. M. G. (2017). Online mindfulness as a 
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Han, B. I., Lee, H. W., Kim, T. Y., Lim, J. S., & Shin, K. S. (2009). 
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Henry, J. A., Zaugg, T. L., Myers, P. J., & Schechter, M. A. (2008). The 
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Henry, J. A., Zaugg, T. L., & Schechter, M. A. (2005). Clinical guide for 
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Hernandez, S. E., Barros-Loscertales, A., Xiao, Y., Gonzalez-Mora, J. L., 
& Rubia, K. (2018). Gray Matter and Functional Connectivity in Anterior 

 
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Hoge, E. A., Guidos, B. M., Mete, M., Bui, E., Pollack, M. H., Simon, N. 
M., & Dutton, M. A. (2017). Effects of mindfulness meditation on 
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meditation for the treatment of chronic low back pain in older adults: A 
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Rinpoche, G. (1980). Developing Single-pointed Concentration (N. 
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Wineland, A. M., . . . Piccirillo, J. F. (2015). Effects of Mindfulness Based 
Stress Reduction Therapy on Subjective Bother and Neural Connectivity 
in Chronic Tinnitus. Otolaryngology-Head and Neck Surgery, 152(5), 
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Christopher K., Nourski, Kirill V., . . . Griffiths, Timothy D. (2015). 
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Tang, Y. Y., Holzel, B. K., & Posner, M. I. (2015). The neuroscience of 
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Fung, T. S., Johnson, J. A., Bacon, S. L., & Carlson, L. E. (2013). 
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Syndrome Symptoms: A Randomized Wait-list Controlled Trial. 
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doi:10.1007/s12529-012-9241-6Study 
 
4.0 Study Design 
4.1 Describe and explain the study design (e.g. case-control, cross-sectional, 
ethnographic, experimental, interventional, longitudinal, observational). 

 
Page 11 of 39 
 
Response: This study is a non-randomized interventional study in which subjects 
with bothersome tinnitus will meditate to investigate how meditation effects the 
level of bother of their tinnitus.  
 
5.0 Local Number of Subjects 
5.1 Indicate the total number of subjects that will be enrolled or records that 
will be reviewed locally. 
Response: Target enrollment will be 30 subjects, however, the design of the study 
will allow for more or less. 
 
5.2 If applicable, indicate how many subjects you expect to screen to reach your 
target sample (i.e. your screen failure rate).  
Response: It is not expected that there will be a significant number of failures 
during screening. 
 
5.3 Justify the feasibility of recruiting the proposed number of eligible subjects 
within the anticipated recruitment period. For example, how many potential 
subjects do you have access to? What percentage of those potential subjects 
do you need to recruit? 
Response:  Subjects will be recruited from the University at Buffalo’s Tinnitus 
Support Group, which has 400 members, and the Speech-Language and Hearing 
Clinic.  Additionally, information will be sent to area ENT doctors and audiology 
clinics, ideally adding another 100 potential participants.  Online participants will 
be targeted through public announcements shared with various universities and 
clinics.  With a target of 30 participants, 6% of the potential pool will fulfill that 
goal.  
 
6.0 Inclusion and Exclusion Criteria 
6.1 Describe the criteria that define who will be included in your final study 
sample.  
NOTE:  This may be done in bullet point fashion. 
Response:  
 Adults, age 18 and above, self-reporting bothersome tinnitus lasting longer 
than three months. 
 Have been evaluated by an audiologist or otologist. 
 Those willing and able to utilize their own smart device or computer 
meeting the following requirements.  
Commented [RJ5]: This information is more appropriate to 
integrate into section 10.1.  Section 4.1 should simply be a brief 
description of the study design.  
Commented [RJ7]: This section is meant to describe the 
feasibility of the study.  This appears to be a description of 
recruitment methods. 
Commented [BF6]: Too vague? 
Commented [BF8]: Revise to reflect the group size not the 
potential enrollment 
Commented [RJ9]: Over 18? 
Commented [RJ10]: You may want to only include individuals 
with a smart phone or internet access.  

 
Page 12 of 39 
 
o For Mac: Requires iOS 10.0 or later. Compatible with iPhone, 
iPad, and iPod touch. 
o For Android: varies by device.  
o Data and/or Wi-Fi access 
 
6.2 Describe the criteria that define who will be excluded from your final study 
sample.   
NOTE:  This may be done in bullet point fashion.  
Response:   
 Individuals with meditation training or consistent meditation practice 
(practice that totals more than 20 minutes daily) within the past six 
months. 
 Those indicated by the Hospital Anxiety and Depression Scale to have 
“abnormal” indications for anxiety or depression. 
 Those with any conditions that would restrict them from being able to 
either sit, walk, or lie down for at least 30 minutes at a time. 
 
6.3 Indicate specifically whether you will include any of the following special 
populations in your study using the checkboxes below.   
 
NOTE:  Members of special populations may not be targeted for enrollment in 
your study unless you indicate this in your inclusion criteria. 
Response:   
☐ 
Adults unable to consent 
☐ 
Individuals who are not yet adults (infants, children, teenagers) 
☐ 
Pregnant women 
☐ 
Prisoners 
 
6.4 Indicate whether you will include non-English speaking individuals in your 
study.  Provide justification if you will exclude non-English speaking 
individuals.  
In order to meet one of the primary ethical principles of equitable selection 
of subjects, non-English speaking individuals may not be routinely excluded 
from research as a matter of convenience. 
In cases where the research is of therapeutic intent or is designed to 
investigate areas that would necessarily require certain populations who 
may not speak English, the researcher is required to make efforts to recruit 
and include non-English speaking individuals.  However, there are studies 

 
Page 13 of 39 
 
in which it would be reasonable to limit subjects to those who speak 
English.  Some examples include pilot studies, small unfunded studies with 
validated instruments not available in other languages, studies with 
numerous questionnaires, and some non-therapeutic studies which offer no 
direct benefit. 
Response: Subjects will be limited to English speaking individuals given that the 
study is not funded and the numerous questionnaires would not be able to be 
translated to ensure their reliability. 
 
7.0 Vulnerable Populations 
If the research involves special populations that are considered vulnerable, 
describe the safeguards included to protect their rights and welfare.   
NOTE: You should refer to the appropriate checklists, referenced below, to ensure you 
have provided adequate detail regarding safeguards and protections. You do not, 
however, need to provide these checklists to the IRB. 
7.1 For research that involves pregnant women, safeguards include: 
NOTE CHECKLIST: Pregnant Women (HRP-412) 
Response: There is no increased risk to pregnant women by participating in this 
study. 
  
☒☐ N/A:  This research does not involve pregnant women. 
7.2 For research that involves neonates of uncertain viability or non-viable 
neonates, safeguards include: 
NOTE CHECKLISTS: Non-Viable Neonates (HRP-413), or Neonates of Uncertain 
Viability (HRP-414) 
Response:  
 
☒☐ N/A:  This research does not involve non-viable neonates or neonates of 
uncertain viability. 
7.3 
For research that involves prisoners, safeguards include: 
NOTE CHECKLIST: Prisoners (HRP-415) 
Response:  
 
☒☐ N/A:  This research does not involve prisoners. 
7.4 For research that involves persons who have not attained the legal age for 
consent to treatments or procedures involved in the research (“children”), 
safeguards include:   
NOTE CHECKLIST: Children (HRP-416) 
Response:  
Commented [RJ11]: Your eligibility criteria and screening 
description does not address the possible enrollment of pregnant 
women.  Are you screening for pregnant women?  If so, how?  If 
there is no increased risk to including pregnant women because of 
the nature of this study, please state so here. 

 
Page 14 of 39 
 
 
☒☐ N/A:  This research does not involve persons who have not attained the 
legal age for consent to treatments or procedures (“children”). 
7.5 For research that involves cognitively impaired adults, safeguards include: 
NOTE CHECKLIST: Cognitively Impaired Adults (HRP-417) 
Response:  
 
☒☐ N/A:  This research does not involve cognitively impaired adults. 
7.6 Consider if other specifically targeted populations such as students, 
employees of a specific firm, or educationally or economically 
disadvantaged persons are vulnerable.  Provide information regarding 
their safeguards and protections, including safeguards to eliminate 
coercion or undue influence. 
Response: N/A 
 
8.0 Eligibility Screening  
8.1 
Describe screening procedures for determining subjects’ eligibility.  
Screening refers to determining if prospective participants meet inclusion and 
exclusion criteria.  
Include all relevant screening documents with your submission (e.g. screening 
protocol, script, questionnaire).  
Response: 
Screening will be performed using the attached form (Tinnitus Meditation 
Screener.) 
Interested participants will be mailed this form, return it to our clinic in 
person or by mail, and be notified of their enrollment at least two weeks 
prior to the beginning of the study. 
Online participants will be screened using an online version of the same 
form through REDCap.  
☐ 
N/A:  There is no screening as part of this protocol. 
9.0 Recruitment Methods 
☐ 
N/A:  This is a records review only, and subjects will not be 
recruited.  NOTE:  If you select this option, please make sure that 
all records review procedures and inclusion/exclusion screening 
are adequately described in other sections. 
9.1 
Describe when, where, and how potential subjects will be recruited.  
NOTE:  Recruitment refers to how you are identifying potential participants and 
introducing them to the study.  Include specific methods you will use (e.g. 
Commented [RJ12]: Why are you screening for these groups? 
Commented [BF13R12]: They may respond differently to the 
intervention.  Maybe this is not part of the screening process but 
rather the analysis in their demographic information. 
Formatted: Right:  0.5"
Commented [14]: https://drive.google.com/file/d/10rAjXaLHM
uUt-7ZKWKb2SmAY9NkQKDkc/view?usp=sharing 
Commented [BF15]: Possible to put on REDCap? 
Formatted: Font: Italic

 
Page 15 of 39 
 
searching charts for specific ICD code numbers, Research Participant Groups, 
posted advertisements, etc.). 
Response: Recruitment will begin following IRB approval and will end one week 
prior to the commencement of the study. 
The following methods will be used for recruitment: 
Area audiologists and otolaryngologists agreeing to participate in referring 
participants and UB Speech-Language and Hearing Clinic Faculty will be given 
information on this study to share with patients.  The following clinics and groups 
will be contacted with recruitment materials: 
 Diversified Hearing Services 
 Buffalo Hearing & Speech 
 Hearing Evaluation Services 
 Lake Shore Audiology 
 Dr. Ernesto Diaz-Ordaz, MD 
Interested patients will be given the Eligibility Screening Form to complete and 
send to or drop off at the UB Speech-Language and Hearing Clinic or utilize the 
link in the recruitment materials to an online version through REDCap. 
The UB Speech-Language and Hearing Clinic and Center for Hearing and 
Deafness host the Western New York Tinnitus Support Group, informational 
meetings for tinnitus patients and their families.  These patients have volunteered 
their information to be contacted regarding meetings and research taking place at 
UB.  Using the volunteered information from the Western New York Tinnitus 
Support group an informational letter (attached) will be sent by mail and email.  
This information is not derived from electronic medical records. 
Flyers will be used in these offices as a means for recruitment as well.  (Attached 
as Tinnitus Recruitment Flyer and Tinnitus Recruitment Flyer TEAR-OFFS) 
A digital version of the information contained in the aforementioned recruitment 
letter will be posted on ClinicalTrials.gov, the Buffalo Research Registry, and 
ResearchMatch.org. 
In addition to the Recruitment Letter information, Research Match will include 
the following: 
If you are interested in this study and having the research team 
contact you directly, please select the "Yes, I'm interested" link 
below. By clicking the "Yes, I'm interested" link, your contact 
information will be released to the research team. If you select the 
"No, thanks." link or do not respond to this study message, your 
contact information will not be released to the research team. 
 
QUICK LINK OPTION: YES     
QUICK LINK OPTION: NO 
Commented [RJ16]: Are you targeting specific practices?  
Commented [BF17R16]: I could likely produce a list of who 
I’ll send this out to if that would help. 
Formatted: Bulleted + Level: 1 + Aligned at:  0.75" +
Indent at:  1"
Commented [BF18]: https://buffalo.box.com/s/e4cwo9fvi6f4d2
o2hnnlzd2p4rkbk6zc 
Commented [RJ19]: Is this a database kept for future research 
purposes?  If so, I recommend including an IRB reference number of 
the study that was previously approved.  Either way, more detail is 
needed here. 
Commented [BF20R19]: This was a group that was started 
years ago and I’ve recently started running.  It’s a long standing list 
of folks who come to informational sessions throughout the year and 
to whom we send mailers to.  They’re often former patients, but they 
are made aware that there may be opportunities to participate in 
research.  So it may be used for recruitment again in the future.  
Does that answer your question? 
Formatted: Indent: Left:  1"

 
Page 16 of 39 
 
 
Thank you for your interest in ResearchMatch. 
Digital Display Boards at UB:  We will be posting a digital flyer on digital 
display boards located at the UB Jacobs Medical School, Clinical and 
Translational Research Center and UBMD upon approval from building 
administration. (Attached as TINNITUS Digital Display Board Post) 
 
 
9.2 Describe how you will protect the privacy interests of prospective subjects 
during the recruitment process.   
NOTE:  Privacy refers to an individual’s right to control access to him or herself.   
Response: All screening forms will be sent to the UB Speech-Language and 
Hearing Clinic and secured in a locked area.  From here forms will be relocated to 
a secure office in University at Buffalo – South Campus, Cary Hall 112A. 
Potential subjects participating online will submit information via REDCap where 
it will be stored.  Data may be extracted by UB’s CTSI office for analysis 
following completion of collection and stored securely by that office. 
Following recruitment and enrollment, all prospective subjects will be notified if 
they are enrolled.  Anyone not enrolled will be notified of such and their 
screening forms disposed of in secure trash. 
 
9.3 Identify any materials that will be used to recruit subjects.  
NOTE:  Examples include scripts for telephone calls, in person announcements / 
presentations, email invitations.  
For advertisements, include the final copy of printed advertisements with your 
submission. When advertisements are taped for broadcast, attach the final 
audio/video tape.  NOTE:  You may submit the wording of the advertisement prior 
to taping to ensure there will be no IRB-required revisions, provided the IRB also 
reviews and approves the final version. 
 Response: Participants will not be called directly to participate in this study, 
however, phone contact information will be provided in recruitment materials.  If 
interested participants do call the research team the following script will be used 
to give information: 
Researcher (R): Hello, this is [researcher’s name] from the Department of 
Communicative Disorders and Sciences.  I understand you may be interested in 
participating in a study involving tinnitus and meditation practice. 
[if affirmed] 
Formatted: Space Before:  12 pt
Formatted: Indent: Left:  0", Space Before:  12 pt
Commented [BF21]: Again, See redcap 
Commented [22]: Write AuD recruitment and patient/tinn. 
Group letters 
Commented [RJ23]: You will need a phone script to detail what 
is said to the subject when the researchers call to invite the 
participant to enroll in this study.   
 
The letter mentioned above should also be indicated here.  
Commented [BF24R23]: I wasn’t planning on recruiting by 
calling, but exclusively by letters and email.  Though, if I need a 
script if they call me to express their interest, would I need a script 
for that or simply follow my screener document and fill it out 
with/for them? 

 
Page 17 of 39 
 
R: Great. I’d like to tell you a bit more about the study and if you are still 
interested I can email an online form that you can complete to see if you are 
eligible to participate. 
R: This study will ask that you attend a brief meeting on [INSERT DATE AND 
TIME] or view a video of the session, whichever you would like.  In that session, 
you will learn how to meditate and use the app that we will use to track your 
meditation.  After the information session, I’ll ask you to meditate a half hour per 
day, five days per week, for eight weeks or at the very least, one hour per week.  
You will be asked to fill out surveys online and submit your data from the app.  
While the app is free, you will need to use Wi-Fi or data on your smart device or 
tablet that can run the application.  You would be responsible for any charges for 
data or Wi-Fi. 
Do you have any questions about the study or how this might work? 
Are you interested in participating in the study? 
o [if yes] I would like to take down your email and send you our eligibility 
screening form.  Can I have that? 
 [email will be sent using secure, UB email; prospective participant 
will be sent the appropriate link to the REDCap Screener] 
o [if no] Thank you for your time and consideration. 
R: I will send a link to that email that will bring you to the screening form.  After 
you fill that out, someone will contact you if you have been selected the study 
within two weeks.  This will not automatically enroll you.  You will sign a 
consent form before the study begins with more details about the study.  If you 
have questions, please contact me at this number (716) 222-2735 or email 
bpf4@buffalo.edu.  
Recruitment materials and letters are attached. 
 
10.0 
Procedures Involved 
10.1 Provide a description of all research procedures or activities being 
performed and when they are performed once a subject is screened and 
determined to be eligible. Provide as much detail as possible.   
NOTE:  This should serve as a blueprint for your study and include enough detail 
so that another investigator could pick up your protocol and replicate the research.  
For studies that have multiple or complex visits or procedures, consider the 
addition of a schedule of events table in in your response. 
Response:  
Interested participants will contact the researcher by phone or email and 
be emailed the screening form and return it to our clinic in person, by 
mail, or through the REDCap system.  They will be notified of their 
enrollment at least two weeks prior to the beginning of the study. 
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Page 18 of 39 
 
Following screening, eligible participants will be contacted by mail or 
email with information regarding the one-time meeting at UB. For 
subjects participating exclusively online, this session will be video 
recorded and posted to be viewed prior to the start of the intervention. 
At this meeting they will learn about the study, acknowledge their ability 
to utilize either a smart device or computer to report their meditation 
times, participate in an educational session, and sign consent forms.  
Online consent will be obtained through REDCap by a form.  Following 
consent, subjects will be asked to complete the first round of surveys and 
questionnaires which will include: 
 Tinnitus Handicap Questionnaire  
 Tinnitus Handicap Inventory 
 Tinnitus Functional Index 
 Hospital Anxiety and Depression Scale 
 Mindful Attention Awareness Scale 
 University at Buffalo Tinnitus Intake Questionnaire  
Subjects will begin their meditation practice at home using suggested 
guided meditations.   Subjects will be asked to create an account on the 
meditation website InsightTimer.  This website has an accompanying 
smart device application that allows users to access guided meditations 
and timed sessions. With an account, users’ session data is logged. 
Subjects will be encouraged to use guided meditations of their choice or 
timed meditation using the InsightTimer.  They will be asked to practice a 
half hour, five days per week for eight weeks.  Subjects must complete at 
least one hour per week to remain in the study.  Every week during the 
study, subjects will be asked to submit their data from the application into 
REDCap.  Subjects will have the PI’s email and a phone number for 
technical assistance. 
Subjects’ meditation practice will last for eight weeks with measures being 
utilized after week three and week eight. The following measures will be 
sent to participants by email and submitted through REDCap. 
 Tinnitus Handicap Questionnaire  
 Tinnitus Handicap Inventory 
 Tinnitus Functional Index 
 Hospital Anxiety and Depression Scale 
 Mindful Attention Awareness Scale 
 
10.2 Describe what data will be collected.   
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Indent at:  1"
Commented [RJ25]: What technology is needed? 
Formatted: Bulleted + Level: 1 + Aligned at:  0.75" +
Indent at:  1"
Commented [RJ26]: What application?  Please describe the 
requirement here in further detail. 
Commented [BF27R26]: I hope this is clearer now. 
Commented [RJ28]: You describe above participation for 3 
weeks.  Are there additional research procedures or activities that are 
required up to 8 weeks?  
Commented [BF29R28]: My language was unclear.  The 
intervention lasts 8 weeks with measures after weeks 3 and 8. 

 
Page 19 of 39 
 
NOTE:  For studies with multiple data collection points or long-term follow up, 
consider the addition of a schedule or table in your response. 
Response:  
 Each week, participants will enter the amount of time spent meditating on 
a form through REDCap. 
 Before week 1:  
o Tinnitus Handicap Questionnaire  
o Tinnitus Handicap Inventory 
o Tinnitus Functional Index 
o Hospital Anxiety and Depression Scale 
o Mindful Attention Awareness Scale 
o University at Buffalo Tinnitus Intake Questionnaire 
 After week 3: 
o Tinnitus Handicap Questionnaire  
o Tinnitus Handicap Inventory 
o Tinnitus Functional Index 
o Hospital Anxiety and Depression Scale 
o Mindful Attention Awareness Scale 
 After week 8: 
o Tinnitus Handicap Questionnaire  
o Tinnitus Handicap Inventory 
o Tinnitus Functional Index 
o Hospital Anxiety and Depression Scale 
o Mindful Attention Awareness Scale 
o  
10.3 List any instruments or measurement tools used to collect data 
(e.g. questionnaire, interview guide, validated instrument, data collection 
form).   
 
Include copies of these documents with your submission. 
Response:  
 Tinnitus Handicap Questionnaire  
 Tinnitus Handicap Inventory 
 Tinnitus Functional Index 

 
Page 20 of 39 
 
 Hospital Anxiety and Depression Scale 
 Mindful Attention Awareness Scale 
 University at Buffalo Tinnitus Intake Questionnaire 
 
10.4 Describe any source records that will be used to collect data about subjects 
(e.g. school records, electronic medical records). 
Response: No additional records will be requested or gathered from subjects. 
 
10.5 Indicate whether or not individual subject results, such as results of 
investigational diagnostic tests, genetic tests, or incidental findings will be 
shared with subjects or others (e.g., the subject’s primary care physician) 
and if so, describe how these will be shared. 
Response: Individual subject results will not be shared with any other parties. 
 
10.6 Indicate whether or not study results will be shared with subjects or others, 
and if so, describe how these will be shared. 
Response: Study results will be used towards the completion of the principal 
investigator’s Doctorate of Audiology degree, presented to the community, and 
published. 
 
11.0 
Study Timelines 
11.1 Describe the anticipated duration needed to enroll all study subjects. 
Response: Recruitment, screening and enrollment will take no more than two 
months. 
 
11.2 Describe the duration of an individual subject’s participation in the study. 
Include length of study visits, and overall study follow-up time. 
Response: Subjects will participate in the study for a total of eight weeks.  After 
providing consent, subjects will participate in an informational session at the UB 
Speech Language and Hearing Clinic lasting an hour and a half.  Online 
participants will view a video recording of this informational session before the 
start of the intervention. 
This study investigates meditation practice over the course of eight weeks.  The 
goal is averaging 30 minutes, five days each week and a requirement of at least 
one hour per week.  Subjects can practice their meditation anywhere, on their 
own. 
Commented [BF30]: https://drive.google.com/open?id=104a3h
bqsAAkvfesLVLFQCv168M2_RYQa 
Commented [31]: ATTACH Gantt chart 
Commented [32R31]: https://docs.google.com/spreadsheets/d/1
4xirM_wiNqlSiIwldV6XbiPVPIpRp3fExYkp2nOtwEQ/edit?usp=sh
aring 
Commented [RJ33]: 8 or 10 weeks?  
Commented [BF34R33]:  
Commented [RJ35]: At the end of week 2 or at enrollment? 
This is not indicated in section 10.1. 
Commented [RJ36]: What is the requirement?  Is it 30 minutes 
a day for 8 weeks? 

 
Page 21 of 39 
 
In addition to the initial information session, subjects will be asked to complete 
surveys that are emailed to them after the third and eighth weeks of the study and 
submitted through REDCap.  These surveys should take less than 30 minutes to 
complete each time they are administered. Additionally, subjects will enter their 
weekly meditation times in REDCap. 
 
11.3 Describe the estimated duration for the investigators to complete this study 
(i.e. all data is collected and all analyses have been completed). 
Response: The duration to complete this study will be 10 months. 
 
12.0 
Setting 
12.1 Describe all facilities/sites where you will be conducting research 
procedures.  Include a description of the security and privacy of the 
facilities (e.g. locked facility, limited access, privacy barriers).  Facility, 
department, and type of room are relevant.  Do not abbreviate facility 
names.   
NOTE:  Examples of acceptable response may be:  “A classroom setting in the 
Department of Psychology equipped with a computer with relevant survey 
administration software,” “The angiogram suite at Buffalo General Medical 
Center, a fully accredited tertiary care institution within New York State with 
badge access,” or, “Community Center meeting hall.” 
Response: The one in-person meeting of this study will be held at the UB Speech-
Language and Hearing Clinic in a room equipped with a computer and projector. 
 
12.2 For research conducted outside of UB and its affiliates, describe: 
 Site-specific regulations or customs affecting the research 
 Local scientific and ethical review structure 
NOTE:  This question is referring to UB affiliated research taking place outside 
UB, i.e. research conducted in the community, school-based research, 
international research, etc.  It is not referring to multi-site research.  UB affiliated 
institutions include Kaleida Health, ECMC, and Roswell Park Cancer Institute.   
Response:  
 
☒☐ N/A:  This study is not conducted outside of UB or its affiliates. 
13.0 
Community-Based Participatory Research 
13.1 Describe involvement of the community in the design and conduct of the 
research.  

 
Page 22 of 39 
 
NOTE:  Community-Based Participatory Research (CBPR) is a collaborative 
approach to research that equitably involves all partners in the research process 
and recognizes the unique strengths that each brings.  CBPR begins with a 
research topic of importance to the community, has the aim of combining 
knowledge with action and achieving social change to improve health outcomes 
and eliminate health disparities. 
Response:  
 
☒☐ N/A:  This study does not utilize CBPR. 
13.2 
Describe the composition and involvement of a community advisory 
board. 
Response:  
 
☒☐ N/A:  This study does not have a community advisory board. 
14.0 
Resources and Qualifications 
14.1 Describe the qualifications (e.g., education, training, experience, expertise, 
or certifications) of the Principal Investigator and staff to perform the 
research.  When applicable describe their knowledge of the local study sites, 
culture, and society.  Provide enough information to convince the IRB that 
you have qualified staff for the proposed research.  
NOTE:  If you specify a person by name, a change to that person will require prior 
approval by the IRB.  If you specify a person by role (e.g., coordinator, research 
assistant, co-investigator, or pharmacist), a change to that person will not usually 
require prior approval by the IRB, provided that the person meets the 
qualifications described to fulfill their roles. 
Response: The following roles are in place for the duration of this study. All study 
personnel are educated, trained, and licensed as required for their delegated role in 
this study.  All study personnel have also received the required university training.  
Principle Investigator: 
 
Graduate Student in Audiology 
 
Training and clinical experience in tinnitus management 
 
Participates in the Western New York Tinnitus Support Group 
Study Advisor: 
 
Licensed Doctor of Audiology 
 
American Speech and Hearing Association Certified in Clinical 
Competence in Audiology (CCC-A) 
 
Training and clinical experience in tinnitus management.  
 
 
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Commented [RJ37]: This is a good start.  You can always 
generalize qualifications (see example below). 
 
 
“All study personnel are educated, trained, and licensed as required 
for their delegated role in this study.  All study personnel have also 
received the required university training. 
 
PI is an educated, trained, board certified, and licensed research 
professor and interventional cardiologist working at the CTRC. Sub-
PIs are educated, trained, and licensed cardiac surgeons.  Sub-Is are 
educated, trained and licensed interventional cardiologists, 
neurologists and echocardiographers.  
 
Study staff will be trained in study procedures by the PI as needed.” 
Formatted: Font: Italic

 
Page 23 of 39 
 
Describe other resources available to conduct the research.  
14.2 Describe the time and effort that the Principal Investigator and research 
staff will devote to conducting and completing the research. 
NOTE:  Examples include the percentage of Full Time Equivalents (FTE), hours 
per week.  The question will elicit whether there are appropriate resources to 
conduct the research. 
Response: The PI will dedicate 6-12 hours weekly to this study.  The PI and study 
advisor that are assigned to this study will be able to devote sufficient time to the 
procedures in adherence with the protocol. 
 
14.3 Describe the availability of medical or psychological resources that subjects 
might need as a result of anticipated consequences of the human research, if 
applicable. 
NOTE:  One example includes: on-call availability of a counselor or psychologist 
for a study that screens subjects for depression. 
Response: Potential subjects scoring “abnormal” on the Hospital Anxiety and 
Depression Scale will be referred to area mental health services. 
 
14.4 Describe your process to ensure that all persons assisting with the research 
are adequately informed about the protocol, the research procedures, and 
their duties and functions. 
Response: The PI will be conducting all aspects of the study.  The study advisor 
will correspond weekly to ensure continued adherence to the protocol and 
procedures. 
 
15.0 
Other Approvals 
15.1 Describe any approvals that will be obtained prior to commencing the 
research (e.g., school, external site, funding agency, laboratory, radiation 
safety, or biosafety). 
Response: Access for a location for the in-person meeting at the beginning of this 
study will be obtained through the study advisor. 
 
☐ 
N/A:  This study does not require any other approvals. 
16.0 
Provisions to Protect the Privacy Interests of Subjects 
 
16.1 Describe how you will protect subjects’ privacy interests during the course 
of this research. 
Commented [38]: Again, not sure on the exact language to 
describe the specifics of who does what. 
Commented [RJ39]: You can state 3 hours a week or .5 FTEs.  
Whatever you and your research team can devote to conducting this 
study (example below). 
 
“The PI, study coordinator, or other study staff that are assigned to 
this study and will be able to devote sufficient time to the procedures 
in adherence with the protocol.” 
Commented [BF40R39]:  
Commented [RJ41]: Example: “All study personnel are 
required to receive study specific on-site training by the study PI. 
The PI will discuss the protocol, the procedures, and specific duties 
with all study personnel before the study starts.  Any training that is 
necessary will be done prior to start of any study procedures.” 
Commented [BF42R41]: Since it really is just my advisor and 
me, it seems a little tricky to word.  Is this ok? 
Commented [RJ43]: Do you need approval from the area 
offices for recruitment?  
Commented [BF44R43]: I’m supposing they would simply opt 
in or not. 

 
Page 24 of 39 
 
NOTE:  Privacy refers to an individual’s right to control access to him or herself.  
Privacy applies to the person.  Confidentiality refers to how data collected about 
individuals for the research will be protected by the researcher from release.  
Confidentiality applies to the data.   
Examples of appropriate responses include:  “participant only meets with a study 
coordinator in a classroom setting where no one can overhear”, or “the 
participant is reminded that they are free to refuse to answer any questions that 
they do not feel comfortable answering.”   
Response: Patients will be placed in a private location for obtaining informed 
consent and the administration of patient care.  Participants will be informed of 
the group instructional meeting and requested to maintain the privacy of others 
during the consent process.  All steps will be taken to ensure that patient’s privacy 
will be protected. 
 
16.2 Indicate how the research team is permitted to access any sources of 
information about the subjects.   
NOTE:  Examples of appropriate responses include:  school permission for review 
of records, consent of the subject, HIPAA waiver.  This question does apply to 
records reviews. 
Response: Consent of the subject. Any physical documents pertaining to the study 
(i.e.: screening forms, consent forms, and surveys) will be held in a secure 
location at the University at Buffalo – South Campus, Cary Hall 112A.  
Electronic information gathered by within REDCap of this information will be 
maintained and shared securely within REDCap. 
No electronic medical records systems will be accessed or used throughout the 
study. 
Contact information that is drawn from the Western New York Tinnitus Support 
group is maintained in a secured UB Box account.  This information is available 
to the Speech-Language and Hearing Clinic, since they assist in maintaining this 
list. 
 
17.0 
Data Management and Analysis 
17.1 Describe the data analysis plan, including any statistical procedures.  This 
section applies to both quantitative and qualitative analysis.  
Response: Data will be collected and secured using the REDCap System. 
Analysis may include the use of paired t-tests and/or ANOVA with assistance 
from UB’s office of Clinical and Translational Science Institute. 
 
17.2 If applicable, provide a power analysis.   
NOTE:  This may not apply to certain types of studies, including chart/records 
reviews, survey studies, or observational studies.  This question is asked to elicit 
Commented [RJ45]: Please delete.  This describes 
confidentiality, not privacy. Privacy refers to an individual’s right to 
control access to him or herself (example below).  
 
 
“Patients will be placed in a private location for obtaining informed 
consent and the administration of patient care.  Participants will not 
be placed in a common area and exposed to others. This is to prevent 
anyone else from overhearing any conversations regarding their 
personal information or study information.  All steps will be taken to 
ensure that patient’s privacy will be protected.” 
Formatted: Indent: Left:  0"
Commented [RJ46]: Please respond to this section.  

 
Page 25 of 39 
 
whether the investigator has an adequate sample size to achieve the study 
objectives and justify a conclusion.  
Response: N/A 
 
17.3 Describe any procedures that will be used for quality control of collected 
data. 
Response: N/A 
 
18.0 
Confidentiality 
 
A. Confidentiality of Study Data 
 
Describe the local procedures for maintenance of confidentiality of study data 
and any records that will be reviewed for data collection.   
 
18.1 
A.  Where and how will all data and records be stored?  Include 
information about:  password protection, encryption, physical controls, 
authorization of access, and separation of identifiers and data, as applicable.  
Include physical (e.g. paper) and electronic files. 
Response: Electronic records will be managed in the REDCap system.  Physical 
documents will be secured in University at Buffalo – South Campus, Cary Hall 
112A.  Data may be extracted by UB’s CTSI office for analysis following 
completion of collection and stored securely by that office. 
 
18.2 
A.  How long will the data be stored? 
Response: Data will be stored until June 1, 2020. 
 
18.3 
A.  Who will have access to the data? 
Response: The Principal Investigator, Study Advisor, and analysists assigned by 
UB’s CTSI office will have access to this data. 
 
18.4 
A.  Who is responsible for receipt or transmission of the data? 
Response: The data will be received by utilizing the REDCap system. 
 
18.5 
A.  How will the data be transported? 
Response:  Electronic data will be collected through REDCap. 
 
Commented [RJ47]: Please respond to this section. 

 
Page 26 of 39 
 
B. Confidentiality of Study Specimens 
 
Describe the local procedures for maintenance of confidentiality of study 
specimens.   
 
☒☐ N/A:  No specimens will be collected or analyzed in this research.   
(Skip to Section 19.0) 
 
18.6 
B.  Where and how will all specimens be stored?  Include information 
about:  physical controls, authorization of access, and labeling of specimens, as 
applicable.   
Response:  
 
18.7 
B.  How long will the specimens be stored? 
Response:  
 
18.8 
B.  Who will have access to the specimens? 
Response:  
 
18.9 
B.  Who is responsible for receipt or transmission of the specimens? 
Response:  
 
18.10 B.  How will the specimens be transported? 
Response: 
 
 
19.0 
Provisions to Monitor the Data to Ensure the Safety of 
Subjects 
☐ 
N/A:  This study is not enrolling subjects, or is limited to records review 
procedures only.  This section does not apply. 
 
NOTE:  Minimal risk studies may be required to monitor subject safety if the research 
procedures include procedures that present unique risks to subjects that require 
monitoring.  Some examples include:  exercising to exertion, or instruments that elicit 
suicidality or substance abuse behavior.  In such cases, N/A is not an acceptable 
response. 
 
19.1 Describe the plan to periodically evaluate the data collected regarding both 
harms and benefits to determine whether subjects remain safe. 

 
Page 27 of 39 
 
Response: N/A: This is a minimal risk study that does not pose any anticipated 
harm to participants. 
 
19.2 Describe what data are reviewed, including safety data, untoward events, 
and efficacy data. 
Response: N/A 
 
19.3 Describe any safety endpoints. 
Response: N/A 
 
19.4 Describe how the safety information will be collected (e.g., with case report 
forms, at study visits, by telephone calls with participants). 
Response: N/A 
 
19.5 Describe the frequency of safety data collection. 
Response: N/A 
 
19.6 Describe who will review the safety data. 
Response: N/A 
 
19.7 Describe the frequency or periodicity of review of cumulative safety data. 
Response: N/A 
 
19.8 Describe the statistical tests for analyzing the safety data to determine 
whether harm is occurring. 
Response: N/A 
 
19.9 Describe any conditions that trigger an immediate suspension of the 
research. 
Response: N/A 
 
20.0 
Withdrawal of Subjects 
☐ 
N/A:  This study is not enrolling subjects.  This section does not apply. 
 
Commented [RJ48]: Please respond to this section.  

 
Page 28 of 39 
 
20.1 Describe anticipated circumstances under which subjects may be withdrawn 
from the research without their consent. 
Response:  Subjects may be withdrawn for the following reasons: 
 Failure to submit mediation data in a timely manner. 
 Failure to complete surveys and questionnaires in a timely manner. 
 Failure to comply to participating in the intervention.  Subjects practicing 
meditation less than one hour per week may be withdrawn from the study. 
 
20.2 Describe any procedures for orderly termination.   
NOTE:  Examples may include return of study drug, exit interview with clinician.  
Include whether additional follow up is recommended for safety reasons for 
physical or emotional health. 
Response: Participants will be informed of their removal from the study and asked 
to complete questionnaires (Tinnitus Handicap Questionnaire, Tinnitus Handicap 
Inventory, Tinnitus Functional Index, Hospital Anxiety and Depression Scale, 
Mindful Attention Awareness Scale) via the REDCap system.  This intervention 
poses low risk from discontinuing abruptly. 
 
20.3 Describe procedures that will be followed when subjects withdraw from the 
research, including retention of already collected data, and partial 
withdrawal from procedures with continued data collection, as applicable. 
Response: Data already collected from subjects who withdraw will be analyzed 
up to the point of their last completed questionnaires. 
 
21.0 
Risks to Subjects 
21.1 List the reasonably foreseeable risks, discomforts, hazards, or 
inconveniences to the subjects related to their participation in the research. 
Consider physical, psychological, social, legal, and economic risks.  Include 
a description of the probability, magnitude, duration, and reversibility of the 
risks.  
NOTE:  Breach of confidentiality is always a risk for identifiable subject data. 
Response: Subjects will be asked to be seated and still for long periods of time.  
Some subjects may experience minor physical discomfort.  There may also be an 
increased risk for circulation to be reduced due to subjects being in one position 
for an extended period of time. 
 
21.2 Describe procedures performed to lessen the probability or magnitude of 
risks, including procedures being performed to monitor subjects for safety. 
Commented [RJ49]: Please respond to this section. 

 
Page 29 of 39 
 
Response:   To reduce discomfort and poor circulation that can occur in seated 
meditation, subjects will also be instructed to participate in lying or walking 
meditation. 
 
21.3 If applicable, indicate which procedures may have risks to the subjects that 
are currently unforeseeable. 
Response: N/A 
 
21.4 If applicable, indicate which research procedures may have risks to an 
embryo or fetus should the subject be or become pregnant. 
Response: N/A 
 
21.5 If applicable, describe risks to others who are not subjects. 
Response: N/A 
 
22.0 
Potential Benefits to Subjects 
22.1 Describe the potential benefits that individual subjects may experience by 
taking part in the research.  Include the probability, magnitude, and 
duration of the potential benefits.  Indicate if there is no direct benefit.   
NOTE:  Compensation cannot be stated as a benefit. 
Response: Benefits may include reduction in the level of bother of the subject’s 
tinnitus.  Because this study is a first of its kind, probability, magnitude, and 
duration cannot be reliably predicted, however, there have been several studies of 
mindfulness interventions demonstrating long-term positive outcomes and 
reduction of symptoms for patients with anxiety, depression, and chronic pain.  
Additionally, mindfulness practice was associated with “improvement in quality 
of life and/or sense of well-being” in a meta-analysis (Merkes, 2010). 
 
23.0 
Compensation for Research-Related Injury 
☒☐ N/A:  The research procedures for this study do not present risk of 
research related injury (e.g. survey studies, records review studies).  This 
section does not apply.   
23.1 
If the research procedures carry a risk of research related injury, 
describe the available compensation to subjects in the event that such injury 
should occur.   
Response: 
 
Commented [RJ50]: Please respond to this section.  If no direct 
benefit, indicate that.  

 
Page 30 of 39 
 
23.2 
Provide a copy of contract language, if any, relevant to compensation for 
research related injury. 
NOTE:  If the contract is not yet approved at the time of this submission, submit the 
current version here.  If the contract is later approved with different language regarding 
research related injury, you must modify your response here and submit an amendment 
to the IRB for review and approval. 
Response:  
 
24.0 
Economic Burden to Subjects 
24.1 Describe any costs that subjects may be responsible for because of 
participation in the research.   
NOTE:  Some examples include transportation or parking. 
Response: Subjects are responsible for postage for screening forms and 
transportation to the campus on the day of the in-person instruction. 
Subjects are responsible for data and Wi-Fi charges to their personal devices 
through the duration of the study. 
 
☐ 
N/A:  This study is not enrolling subjects, or is limited to records review 
procedures only.  This section does not apply. 
25.0 
Compensation for Participation 
25.1 
Describe the amount and timing of any compensation to subjects, 
including monetary, course credit, or gift card compensation. 
Response:  
 
☐ 
N/A:  This study is not enrolling subjects, or is limited to records 
review procedures only.  This section does not apply. 
☒☐ N/A:  There is no compensation for participation.  This section 
does not apply. 
26.0 
Consent Process 
26.1 Indicate whether you will be obtaining consent.   
NOTE:  This does not refer to consent documentation, but rather whether you will 
be obtaining permission from subjects to participate in a research study.   
Consent documentation is addressed in Section 27.0. 
☒☐ Yes 
(If yes, Provide responses to each question in this Section) 
☐ 
No 
(If no, Skip to Section 27.0) 
 
Commented [RJ51]: Are subjects required to pay for the 
postage of mailing the questionnaires back to the research team?  

 
Page 31 of 39 
 
26.2 Describe where the consent process will take place.  Include steps to 
maximize subjects’ privacy. 
Response:  All subjects will be directed to consent materials online through 
REDCap. 
 
26.3 Describe how you will ensure that subjects are provided with a sufficient 
period of time to consider taking part in the research study.   
NOTE:  It is always a requirement that a prospective subject is given sufficient 
time to have their questions answered and consider their participation.  See “SOP: 
Informed Consent Process for Research (HRP-090)” Sections 5.5 and 5.6. 
Response: Subjects will be sent consent links through REDCap immediately after 
eligibility is confirmed.  Subjects will have at least one week before the 
informational meeting to review this consent and ask questions as needed by 
phone or email. 
 
26.4 Describe any process to ensure ongoing consent, defined as a subject’s 
willingness to continue participation for the duration of the research study.   
Response: N/A 
 
26.5 Indicate whether you will be following “SOP: Informed Consent Process for 
Research (HRP-090).” If not, or if there are any exceptions or additional 
details to what is covered in the SOP, describe: 
 
The role of the individuals listed in the application who are involved in 
the consent process 
 
The time that will be devoted to the consent discussion 
 
Steps that will be taken to minimize the possibility of coercion or 
undue influence 
 
Steps that will be taken to ensure the subjects’ understanding 
Response:  
 
☒☐ We have reviewed and will be following “SOP: Informed Consent Process 
for Research (HRP-090).” 
 
Non-English Speaking Subjects  
☒☐ N/A:  This study will not enroll Non-English speaking subjects.   
(Skip to Section 26.8) 
Commented [RJ52]: Please respond to this section. 
Commented [BF53]: Will be done via REDCap 

 
Page 32 of 39 
 
26.6 Indicate which language(s) other than English are likely to be 
spoken/understood by your prospective study population or their legally 
authorized representatives. 
 
NOTE: The response to this Section should correspond with your response to 
Section 6.4 of this protocol. 
Response:  
 
26.7 If subjects who do not speak English will be enrolled, describe the process 
to ensure that the oral and written information provided to those subjects 
will be in that language.  Indicate the language that will be used by those 
obtaining consent. 
NOTE:  Guidance is provided on “SOP:  Informed Consent Process for Research 
(HRP-090).” 
Response:  
 
 
Cognitively Impaired Adults 
☒☐ N/A:  This study will not enroll cognitively impaired adults.   
(Skip to Section 26.9) 
26.8   Describe the process to determine whether an individual is capable of 
consent.  
Response:  
 
 
Adults Unable to Consent 
☒☐ N/A:  This study will not enroll adults unable to consent.  
(Skip to Section 26.13) 
When a person is not capable of consent due to cognitive impairment, a legally 
authorized representative should be used to provide consent (Sections 26.9 and 
26.10) and, where possible, assent of the individual should also be solicited 
(Sections 26.11 and 26.12). 
26.9  Describe how you will identify a Legally Authorized Representative (LAR).  
Indicate that you have reviewed the “SOP: Legally Authorized 
Representatives, Children, and Guardians (HRP-013)” for research in New 
York State.  
NOTE:  Examples of acceptable response includes: verifying the electronic 
medical record to determine if an LAR is recorded. 
Response:  

 
Page 33 of 39 
 
 
☐ 
We have reviewed and will be following “SOP: Legally Authorized 
Representatives, Children, and Guardians (HRP-013).”  
26.10 For research conducted outside of New York State, provide information 
that describes which individuals are authorized under applicable law to 
consent on behalf of a prospective subject to their participation in the 
research.  One method of obtaining this information is to have a legal 
counsel or authority review your protocol along with the definition of 
“legally authorized representative” in “SOP: Legally Authorized 
Representatives, Children, and Guardians (HRP-013).” 
Response:  
 
26.11 Describe the process for assent of the adults: 
 
Indicate whether assent will be obtained from all, some, or none of the 
subjects.  If some, indicate which adults will be required to assent and 
which will not. 
Response:  
 
 
If assent will not be obtained from some or all subjects, provide an 
explanation of why not. 
Response:  
 
26.12 Describe whether assent of the adult subjects will be documented and the 
process to document assent.   
NOTE:  The IRB allows the person obtaining assent to document assent on the 
consent document using the “Template Consent Document (HRP-502)” Signature 
Block for Assent of Adults who are Legally Unable to Consent. 
Response:  
 
 
Subjects who are not yet Adults (Infants, Children, and Teenagers) 
☒☐ N/A:  This study will not enroll subjects who are not yet adults.   
(Skip to Section 27.0) 
26.13 Describe the criteria that will be used to determine whether a prospective 
subject has not attained the legal age for consent to treatments or 
procedures involved in the research under the applicable law of the 
jurisdiction in which the research will be conducted (e.g., individuals under 
the age of 18 years).  For research conducted in NYS, review “SOP: 

 
Page 34 of 39 
 
Legally Authorized Representatives, Children, and Guardians (HRP-013)” 
to be aware of which individuals in the state meet the definition of 
“children.”  
NOTE:  Examples of acceptable responses include: verification via electronic 
medical record, driver’s license or state-issued ID, screening questionnaire. 
Response:  
 
26.14For research conducted outside of New York State, provide information 
that describes which persons have not attained the legal age for consent to 
treatments or procedures involved the research, under the applicable law of 
the jurisdiction in which research will be conducted.  One method of 
obtaining this information is to have a legal counsel or authority review 
your protocol along the definition of “children” in “SOP: Legally 
Authorized Representatives, Children, and Guardians (HRP-013).” 
Response:  
 
26.15 Describe whether parental permission will be obtained from: 
Response:  
☐  One parent even if the other parent is alive, known, competent, reasonably 
available, and shares legal responsibility for the care and custody of the 
child. 
☐ 
Both parents unless one parent is deceased, unknown, incompetent, or not 
reasonably available, or when only one parent has legal responsibility for 
the care and custody of the child. 
☐ 
Parent permission will not be obtained.  A waiver of parent permission is 
being requested. 
NOTE:  The requirement for parent permission is a protocol-specific determination 
made by the IRB based on the risk level of the research.  For guidance, review the 
“CHECKLIST: Children (HRP-416).”  
26.16Describe whether permission will be obtained from individuals other than 
parents, and if so, who will be allowed to provide permission.  Describe 
your procedure for determining an individual’s authority to consent to the 
child’s general medical care. 
Response:  
 
26.17 Indicate whether assent will be obtained from all, some, or none of the 
children.  If assent will be obtained from some children, indicate which 
children will be required to assent. 

 
Page 35 of 39 
 
Response:  
 
26.18 When assent of children is obtained, describe how it will be documented. 
Response:  
 
27.0 
Waiver or Alteration of Consent Process 
Consent will not be obtained, required information will not be disclosed, or the 
research involves deception. 
☒☐ N/A:  A waiver or alteration of consent is not being requested. 
27.1 If the research involves a waiver or alteration of the consent process, please 
review the “CHECKLIST: Waiver or Alteration of Consent Process (HRP-
410)” to ensure that you have provided sufficient information for the IRB to 
make the determination that a waiver or alteration can be granted.   
NOTE:  For records review studies, the first set of criteria on the “CHECKLIST: 
Waiver or Alteration of Consent Process (HRP-410)” applies.  
Response:  
 
27.2 If the research involves a waiver of the consent process for planned 
emergency research, please review the “CHECKLIST: Waiver of Consent 
for Emergency Research (HRP-419)” to ensure you have provided sufficient 
information for the IRB to make these determinations.  Provide any 
additional information necessary here: 
Response:  
 
28.0 
Process to Document Consent 
☐ 
N/A:  A Waiver of Consent is being requested.   
(Skip to Section 29.0) 
28.1 Indicate whether you will be following “SOP: Written Documentation of 
Consent (HRP-091).” If not or if there are any exceptions, describe whether 
and how consent of the subject will be obtained including whether or not it 
will be documented in writing.   
NOTE:  If your research presents no more than minimal risk of harm to subjects 
and involves no procedures for which written documentation of consent is normally 
required outside of the research context, the IRB will generally waive the 
requirement to obtain written documentation of consent.  This is sometimes 
referred to as ‘verbal consent.’  Review “CHECKLIST: Waiver of Written 
Documentation of Consent (HRP-411)” to ensure that you have provided sufficient 
information.  

 
Page 36 of 39 
 
If you will document consent in writing, attach a consent document with your 
submission.  You may use “TEMPLATE CONSENT DOCUMENT (HRP-
502)”.  If you will obtain consent, but not document consent in writing, attach the 
script of the information to be provided orally or in writing (i.e. consent script or 
Information Sheet).   
Response: All subjects will be consented through a form on REDCap. Subjects 
will be sent consent links through REDCap immediately after eligibility is 
confirmed.  Subjects will have at least one week before the informational meeting 
to review this consent and ask questions by phone or email as needed. 
 
☐ 
We will be following “SOP:  Written Documentation of Consent” 
(HRP-091). 
29.0 
Multi-Site Research (Multisite/Multicenter Only) 
☒☐ N/A:  This study is not an investigator-initiated multi-site study.  This 
section does not apply. 
 
29.1 If this is a multi-site study where you are the lead investigator, describe the 
processes to ensure communication among sites, such as: 
 
All sites have the most current version of the IRB documents, including 
the protocol, consent document, and HIPAA authorization. 
 
All required approvals have been obtained at each site (including 
approval by the site’s IRB of record). 
 
All modifications have been communicated to sites, and approved 
(including approval by the site’s IRB of record) before the 
modification is implemented. 
 
All engaged participating sites will safeguard data as required by 
local information security policies. 
 
All local site investigators conduct the study appropriately. 
 
All non-compliance with the study protocol or applicable requirements 
will be reported in accordance with local policy. 
Response:  
 
29.2 Describe the method for communicating to engaged participating sites: 
 
Problems 
 
Interim results 
 
Study closure 
Response:  
 
Commented [54]: Do I not need consent considering the risk is 
so low? 
Commented [RJ55R54]: You need to consent.  
Commented [BF56R54]:  

 
Page 37 of 39 
 
29.3 
Indicate the total number of subjects that will be enrolled or records that 
will be reviewed across all sites. 
Response:  
 
29.4 
If this is a multicenter study for which UB will serve as the IRB of record, 
and subjects will be recruited by methods not under the control of the local site 
(e.g., call centers, national advertisements) describe those methods.  
Response:  
 
30.0 
Banking Data or Specimens for Future Use 
☒☐ N/A:  This study is not banking data or specimens for future use or 
research outside the scope of the present protocol.  This section does not 
apply. 
30.1 If data or specimens will be banked (stored) for future use, that is, use or 
research outside of the scope of the present protocol, describe where the 
data/specimens will be stored, how long they will be stored, how the 
data/specimens will be accessed, and who will have access to the 
data/specimens.  
NOTE:  Your response here must be consistent with your response at the “What 
happens if I say yes, I want to be in this research?” Section of the Template 
Consent Document (HRP-502). 
Response:  
 
30.2 List the data to be stored or associated with each specimen. 
Response:  
 
30.3 Describe the procedures to release banked data or specimens for future 
uses, including: the process to request a release, approvals required for 
release, who can obtain data or specimens, and the data to be provided with 
specimens. 
Response:  
 
31.0 
Drugs or Devices 
☒☐ N/A:  This study does not involve drugs or devices.  This section does not 
apply. 
31.1 If the research involves drugs or devices, list and describe all drugs and 
devices used in the research, the purpose of their use, and their regulatory 
approval status.  

 
Page 38 of 39 
 
Response:  
 
31.2 Describe your plans to store, handle, and administer those drugs or devices 
so that they will be used only on subjects and be used only by authorized 
investigators. 
Response: 
 
If the drug is investigational (has an IND) or the device has an IDE or a claim 
of abbreviated IDE (non-significant risk device), include the following 
information: 
31.3 Identify the holder of the IND/IDE/Abbreviated IDE. 
Response:  
 
31.4 Explain procedures followed to comply with FDA sponsor requirements for 
the following:   
 
 
Applicable to: 
FDA Regulation 
IND Studies 
IDE studies 
Abbreviated 
IDE studies 
21 CFR 11 
X 
X 
 
21 CFR 54 
X 
X 
 
21 CFR 210 
X 
 
 
21 CFR 211 
X 
 
 
21 CFR 312 
X 
 
 
21 CFR 812 
 
X 
X 
21 CFR 820 
 
X 
 
Response:  
 
32.0 
Humanitarian Use Devices 
☒☐ N/A:  This study does not involve humanitarian use devices.  This does 
not apply. 
32.1 
For Humanitarian Use Device (HUD) uses provide a description of the 
device, a summary of how you propose to use the device, including a description 
of any screening procedures, the HUD procedure, and any patient follow-up 
visits, tests or procedures. 
Response:  
 

 
Page 39 of 39 
 
32.2 
 For HUD uses provide a description of how the patient will be informed 
of the potential risks and benefits of the HUD and any procedures associated with 
its use. 
Response: