Objective Assessment of Pain Thresholds in Women With Vulvodynia
Conditions: Vulvodynia
Sponsor: State University of New York at Buffalo

Cover Page for Protocol and Statistical Plan 
 
Official Title: 
Objective Assessment of Pain Thresholds in Women with 
Vulvodynia 
NCT number: 
NCT04461210 
Document Type: 
Study Protocol and Statistical Analysis Plan 
Date of the 
Document: 
08/29/2024 
 
 

 
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 32 
 
Complete Research Protocol (HRP-503) 
 
Table of Contents 
Template Instructions ....................................................................................................... 2 
1.0 
Study Summary ........................................................................................................ 4 
2.0 
Objectives* .............................................................................................................. 5 
3.0 
Scientific Endpoints* ............................................................................................... 5 
4.0 
Background* ............................................................................................................ 6 
5.0 
Study Design* .......................................................................................................... 7 
6.0 
Study Intervention/Investigational Agent ................................................................ 7 
7.0 
Local Number of Subjects ....................................................................................... 8 
8.0 
Inclusion and Exclusion Criteria* ............................................................................ 8 
9.0 
Vulnerable Populations* ........................................................................................ 10 
10.0 Eligibility Screening* ............................................................................................ 11 
11.0 Recruitment Methods ............................................................................................. 11 
12.0 Procedures Involved*............................................................................................. 12 
13.0 Study Timelines* ................................................................................................... 14 
14.0 Setting .................................................................................................................... 14 
15.0 Community-Based Participatory Research ............................................................ 15 
16.0 Resources and Qualifications ................................................................................. 16 
17.0 Other Approvals ..................................................................................................... 17 
18.0 Provisions to Protect the Privacy Interests of Subjects .......................................... 17 
19.0 Data Management and Analysis* .......................................................................... 18 
20.0 Confidentiality* ..................................................................................................... 19 
A. 
Confidentiality of Study Data ......................................................................... 19 
B. 
Confidentiality of Study Specimens ................................................................ 20 
21.0 Provisions to Monitor the Data to Ensure the Safety of Subjects* ........................ 20 
22.0 Withdrawal of Subjects* ........................................................................................ 21 
23.0 Risks to Subjects* .................................................................................................. 22 
24.0 Potential Benefits to Subjects* .............................................................................. 23 
25.0 Compensation for Research-Related Injury ........................................................... 23 
26.0 Economic Burden to Subjects ................................................................................ 24 
27.0 Compensation for Participation ............................................................................. 24 
28.0 Consent Process ..................................................................................................... 24 
29.0 Waiver or Alteration of Consent Process ............................................................... 29 
30.0 Process to Document Consent ............................................................................... 29 
31.0 Multi-Site Research (Multisite/Multicenter Only)*............................................... 30 
32.0 Banking Data or Specimens for Future Use* ........................................................ 31 
 
 
 

 
Page 2 of 32 
IRB Version: 5/6/19 
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 6, 21, 22, 24, 25, 26 and 27 do not apply. 
o For exempt research:  Section 6 may not apply. Section 6.1 will 
still apply if there is a study intervention. 
 
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 Example 
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 32 
IRB Version: 5/6/19 
PROTOCOL TITLE: 
Include the full protocol title. 
Response:  
Objective Assessment of Pain Thresholds in Women with Vulvodynia 
 
PRINCIPAL INVESTIGATOR: 
Name  Vanessa M. Barnabei, MD, PhD 
 
Department 
Obstetrics and Gynecology 
 
Telephone Number 
716-323-0615 
Email Address  
vmbarnab@buffalo.edu 
Response:  
 
VERSION NUMBER/DATE: 
Include the version number and date of this protocol. 
Response:  
V2 1/13/2022REVISION HISTORY 
 
Revision 
# 
Version Date 
Summary of Changes 
Consent 
Change? 
V2 
1/13/2022 
Added “One-Time Plastic Reward Card” to 
section 27.0  
No 
V3 
10/06/2023 
Updated Version # 
No 
 
 
 
 
V4 
02/28/2024 
Addition of investigator 
No 
V5 
08/29/2024 
Minor change to recruitment methods 
No 
 
FUNDING: 
Indicate any funding for this proposal. This should match the Funding Sources 
page in Click IRB. 
Response:  
Jacobs School of Medicine and Biomedical Sciences, Clinical 
Translational Research Award 
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. 

 
Page 4 of 32 
IRB Version: 5/6/19 
NOTE: This question does not apply to studies funded by a sponsor contract. 
Include a copy of the grant proposal with your submission.     
Response: Jacobs School of Medicine and Biomedical Sciences, Clinical 
Translational Research Award 
 
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: Password-protected computer files 
Address: 955 Main Street, Buffalo, NY 
Department: Obstetrics and Gynecology 
1.0 Study Summary 
 
Study Title 
Objective Assessment of Pain Thresholds in Women with 
Vulvodynia 
Study Design 
Clinical Trial 
Primary Objective 
Develop annotated pain maps showing region and size of 
area sensitive to mechanical stimulus. The pain maps will be 
created by combining IR images, photographs, and clinical 
input, and will be correlated with patient co-morbidities. 
Secondary 
Objective(s) 
a-Determine changes in the location and size of sensitive 
regions following various conventional clinical interventions 
for vulvodynia. 
b-Develop a large, information-rich database of annotated 
pain maps from patients, and use Artificial Intelligence to 
identify patterns and trends. 
Research 
Intervention(s)/ 
Investigational 
Agent(s)  
Infrared imaging of the vulva and assessment of pain 
intensity using cotton-tipped swab. 
IND/IDE #  
N/A 
Study Population 
Women with vulvodynia and healthy controls 
Sample Size 
60 women (30 in each group) 
Study Duration for 
individual 
participants 
One day 1 hour 

 
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IRB Version: 5/6/19 
Study Specific 
Abbreviations/ 
Definitions  
 
2.0 Objectives* 
2.1 Describe the purpose, specific aims, or objectives of this research. 
Response:  
We have been developing a novel medical technique for the diagnosis and 
classification of vulvodynia.  The technique will quantitatively quantify the 
magnitude and location of areas of sensitivity to touch/pressure and 
simultaneously use thermal and photo imaging to identify regions of 
inflammation.  The technique builds on current methodology used in assessment 
and knowledge about the known pathophysiology of the disorder.  For this aspect 
of study, we will assess thermal indicators of inflammation with an infrared 
camera and subjective pain sensitivity with traditional methods.  Through this 
combination of measurements, we plan to expand the diagnostic tools used in 
patient care as well as on the classification of this heterogeneous disorder.  
Specific aims include developing annotated pain maps that show regions of 
sensitivity and changes in temperature; determining changes in the above 
parameters during and after traditional medical treatment for the condition; and 
developing a large database of annotated pain maps for use with artificial 
intelligence to identify patterns and trends which will be correlated with clinical 
outcome data. 
2.2 
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:  
Women with vulvodynia will show specific patterns of pain sensitivity and 
inflammatory changes (identified by thermography) compared to women without 
vulvar pain. 
3.0 Scientific Endpoints* 
 
3.1    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: 
Thermographic evidence of inflammation in the areas of pain sensitivity in 
women with provoked vulvodynia compared to normal controls. 

 
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4.0 Background* 
4.1 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:  
Vulvodynia is a heterogeneous group of clinical conditions defined by the 
International Society for the Study of Vulvovaginal Disease  as chronic vulvar discomfort 
or pain, characterized by burning, stinging, irritation or rawness of the female genitalia 
[1].  The true prevalence is unknown but is estimated at 9-12% of the adult female 
population, with up to 2 million women affected. These chronic conditions cause 
significant burden in terms of quality of life and relationship dysfunction, especially for 
women with provoked vestibulodynia (pain at the opening of the vagina (“vestibule”) 
with vaginal penetration or attempted vaginal penetration) which interferes with normal 
sexual function [2]. This is a “hidden” women’s issue that is under-reported and under-
treated because it causes embarrassment and feelings of inadequacy.  The clinical 
management of localized, provoked vulvodynia has been disorganized and somewhat 
arbitrary [3]. Studies suggest that most women see a variety of providers over the course 
of months to years before the condition is diagnosed correctly.  Diagnosis of these 
conditions is based on clinical picture, absence of other causes, and physical exam.  
During the exam, a cotton-tipped swab is used to assess for areas of tenderness and the 
patient is asked to rate her level of pain on a Likert scale.  This has been the standard of 
care for many years, but reproducibility has not been assessed.  In addition, monitoring 
response to therapy is also very subjective.  Even return to sexual activity is not a reliable 
indicator of patient’s pain, since many women will continue to engage in sexual activity 
to avoid relationship discord. We have been developing a novel medical technique for the 
diagnosis and classification of vulvodynia.  The technique will quantitatively measure 
mechanical sensitivity to touch/pressure simultaneously with thermal indicators of 
inflammation.  The technique builds on current methodology used in assessment and 
knowledge about the known pathophysiology of the disorder.  Through this combination 
of measurements, we plan to expand the diagnostic tools used in patient care as well as 
on the classification of this heterogeneous disorder.   
   
4.2 Include complete citations or references.  
Response:  
1. Bornstein J, Goldstein AT, Stockdale CK et al.  2015 ISSVD, ISSWSH, and IPPS 
Consensus Terminology and Classification of Persistent Vulvar Pain and Vulvodynia.  L 
Lower Genit Tract Dis 2016;20:126-130. 
2. Edwards L.. Vulvodynia.  Clin Obstet Gynecol 2015;58;143-152 
3. Falsetta ML et al.  A review of the available clinical therapies for vulvodynia 
management and new data implicating proinflammatory mediators in pain elicitation.  
BJOG 2016;124:210-218. 
 

 
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5.0 Study Design* 
5.1 Describe and explain the study design (e.g. case-control, cross-sectional, 
ethnographic, experimental, interventional, longitudinal, observational). 
Response:  
Prospective study of women with vulvodynia and normal controls. We plan to 
evaluate a novel technique that quantifies both pain intensity and records 
thermographic changes of the vulva in women with a clinical diagnosis of 
provoked vulvodynia and normal controls.  The study subjects will have a new or 
prior diagnosis of provoked vulvodynia and will be invited to participate in this 
evaluation.  Women with prior diagnosis of vulvodynia will be symptomatic and 
untreated at the time of assessment.  Control subjects will be unaffected women 
presenting for routine care who do not have vulvar pain or other active vulvar or 
vaginal disorder as these may interfere with thermographic mapping.    
6.0 
Study Intervention/Investigational Agent 
6.1  
Describe the study intervention and/or investigational agent (e.g., 
drug, device) that is being evaluated. 
Response: Thermographic imaging of the vulva combined with subjective 
pressure sensitivity assessments, overlaid onto a pain map of the vulva. 
6.2 
Drug/Device Handling: If the research involves drugs or 
device, 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. 
• 
If the control of the drugs or devices used in this protocol will 
be accomplished by following an established, approved 
organizational SOP (e.g., Research Pharmacy SOP for the 
Control of Investigational Drugs, etc.), please reference that 
SOP in this section. 
Response:  
NA 
 
6.3 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: 
• 
Identify the holder of the IND/IDE/Abbreviated IDE. 
• 
Explain procedures followed to comply with sponsor 
requirements for FDA regulated research for the following: 

 
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IRB Version: 5/6/19 
 
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:  
The device has no contact with the patient, it takes IR and photo images remote 
from the patient, and so is not subject to IDE.  
7.0 Local Number of Subjects 
7.1 Indicate the total number of subjects that will be enrolled or records that 
will be reviewed locally. 
Response: 60 (sixty) 
 
7.2 If applicable, indicate how many subjects you expect to screen to reach your 
target sample (i.e. your screen failure rate).  
Response: 100 
 
7.3 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: The PI sees an average of 5 new patients per month diagnosed with 
vulvodynia and has many established patients who can be assessed when they 
come in for follow-up. For affected women, the goal would be to recruit close to 
100% of them. The Ob/Gyn practice is an eight-person general Ob/Gyn practice 
that sees 50-70 women per week for routine gynecologic care.  Only a small 
fraction of these women will need to be recruited. 
 
8.0 Inclusion and Exclusion Criteria* 
8.1 Describe the criteria that define who will be included in your final study 
sample.  
NOTE:  This may be done in bullet point fashion. 
Response:  

 
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IRB Version: 5/6/19 
Women > 18 years of age 
Women seeking care for vulvar pain 
Controls: Women seeking routine gynecologic care 
8.2 Describe the criteria that define who will be excluded from your final study 
sample.   
NOTE:  This may be done in bullet point fashion.  
Response:   
Women < 18 years of age 
Pregnancy 
Women with vulvar or vaginal disorder other than pain 
8.3 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 
 
8.4 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 
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:  

 
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IRB Version: 5/6/19 
Non-English speakers are not eligible for inclusion in the study. This is a non-
therapeutic study which will offer no direct benefit. 
9.0 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. 
9.1 For research that involves pregnant women, safeguards include: 
NOTE CHECKLIST: Pregnant Women (HRP-412) 
Response: 
  
☒ 
N/A:  This research does not involve pregnant women. 
9.2 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. 
9.3 
For research that involves prisoners, safeguards include: 
NOTE CHECKLIST: Prisoners (HRP-415) 
Response:  
 
☒ 
N/A:  This research does not involve prisoners. 
9.4 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:  
 
☒ 
N/A:  This research does not involve persons who have not attained the 
legal age for consent to treatments or procedures (“children”). 
9.5 For research that involves cognitively impaired adults, safeguards include: 
NOTE CHECKLIST: Cognitively Impaired Adults (HRP-417) 
Response:  
 

 
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☒ 
N/A:  This research does not involve cognitively impaired adults. 
9.6 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  
10.0 
Eligibility Screening* 
10.1 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:  Exclusion criteria include pregnancy, age < 18 years, and active vulvar 
and vaginal disorder other than pain, to be assessed in two ways: during the 
recruitment interview and at the time of the exam. 
 
☐ 
N/A:  There is no screening as part of this protocol. 
11.0 
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. 
11.1 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. 
searching charts for specific ICD code numbers, Research Participant Groups, 
posted advertisements, etc.). 
Response: Women will be approached by the PI when they come to the clinical 
suite for evaluation of vulvar pain (subjects).  Women will be approached by their 
own provider prior to routine annual exam to ask permission for the PI or study 
coordinator to discuss the study with them (controls).  Some women will be called 
by the study coordinator in advance of their scheduled clinic visit and invited to 
participate in the study to save time on the day of the visit.  The consent form will 
be discussed with them and then signed when they arrive for their clinic visit. 
 
11.2 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.   

 
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Response: Women will be approached by telephone prior to their study visit or in 
private once they have been ushered into an exam room by clinical staff.  If a 
patient agrees to consider recruitment, study staff will then explain the study and 
patient’s participation in a private room.   
11.3 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: N/A – we are using a direct recruitment method.  
 
12.0 
Procedures Involved* 
12.1 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:  
All procedures will be performed on the same day as screening and consent and 
are expected to take 30-60 minutes.  An annotated pain map of the vulva will be 
created based on subjective assessment of pain, and thermographic imaging.  
A.  Images and Thermographic readings will be taken with an infrared camera prior to 
any physical contact with the vulva of the patient other than by placing a calibrated paper 
drape circumferentially on the vulva outside of the area of interest.  The drape will be 
calibrated to maintain pain map/image size comparison between patients.  
B.  Subjective pain at several predetermined loci will be assessed with a cotton swab 
(standard of care) and rated on a Likert scale of 0-10.  This data will be added to the 
thermographic map.  
C.  Comparative analysis of the two measures will be performed (separate from visit).  
Patient demographic and health data (see table below) will be collected by direct 
participant interview and review of the patient’s chart in Allscripts. 
 
12.2 Describe what data will be collected.   
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:  

 
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IRB Version: 5/6/19 
Patient Name 
DOB 
MR# 
Date of Visit 
 
Vulvar images, both plain and infrared. 
Pain sensitivity data on a Likert scale of 0-10 using cotton-tipped swabs. 
Status (PVD or Control) 
Race 
Gravida 
Para 
Vaginal Births 
Cesarean Births 
Sexually Active 
Dyspareunia 
Smoking 
Marital Status 
Education Level 
Medical History 
Depression 
Anxiety 
Fibromyalgia 
Chronic Pelvic Pain 
Interstitial Cystitis 
Endometriosis 
Irritable Bowel Syndrome 
TMJ 
Other 
h/o yeast infections 
h/o BV 
h/o abuse 
PVD Patients Only 
Symptom Duration 
Pain Map Score 
Pain Diary Score 
FSDS 
Previous Rx (Y/N) 
Previous Rx (type) 
 

 
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12.3 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: Please see the attached data collection form.  
 
12.4 Describe any source records that will be used to collect data about subjects 
(e.g. school records, electronic medical records). 
Response: Electronic medical records (Allscripts) will be accessed to obtain 
information for the data collection form only if the patient-provided information 
is incomplete or unclear. 
 
12.5 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: No 
 
12.6 Indicate whether or not study results will be shared with subjects or others, 
and if so, describe how these will be shared. 
Response: No, although study results of de-identified data may be presented or 
published in a scientific context. 
 
13.0 
Study Timelines* 
13.1 Describe the anticipated duration needed to enroll all study subjects. 
Response: Two years 
 
13.2 Describe the duration of an individual subject’s participation in the study. 
Include length of study visits, and overall study follow-up time. 
Response: Participant will only have one study visit lasting from 30-60 minutes. 
 
13.3 Describe the estimated duration for the investigators to complete this study 
(i.e. all data is collected and all analyses have been completed). 
Response: Three years 
 
14.0 
Setting 

 
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14.1 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 Obstetrics and Gynecology clinical suite at Conventus Office Building, 4th 
floor for data acquisition; and Dr. Glenna Bett’s laboratory at Sherman Hall, 
South Campus of the University at Buffalo for data analysis.  The de-identified 
data will be shared through UB-Box. 
 
14.2 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. 
15.0 
Community-Based Participatory Research 
15.1 Describe involvement of the community in the design and conduct of the 
research.  
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. 

 
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15.2 
Describe the composition and involvement of a community advisory 
board. 
Response:  
 
☒ 
N/A:  This study does not have a community advisory board. 
16.0 
Resources and Qualifications 
16.1 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:  
Dr. Vanessa M. Barnabei, the Principal Investigator of the study and Emeritus 
Professor at UB, is a board-certified Ob/Gyn with over 40 years of clinical and 
research experience.  Dr. Barnabei is the only provider in Western New York with 
significant clinical experience and expertise in the care of women with 
vulvodynia.  Dr. Tova Ablove is Associate Professor of Ob/Gyn is an expert in 
female pelvic health and has many years of research experience in gynecologic 
health.  Dr. Glenna Bett is Associate Professor of Ob/Gyn and Physiology and 
Biophysics and Dr. Randall Rasmusson is Professor of Physiology and 
Biophysics.  Drs. Bett and Rasmusson are fulltime UB faculty members and have 
many years of experience in development and medical applications of 
electrophysiologic devices.  Study coordinator TBD. 
Describe other resources available to conduct the research.  
16.2 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:  
0.1 FTE for each of the investigators. 
16.3 Describe the availability of medical or psychological resources that subjects 
might need as a result of anticipated consequences of the human research, if 
applicable. 

 
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NOTE:  One example includes: on-call availability of a counselor or psychologist 
for a study that screens subjects for depression. 
Response:  
NA – We do not anticipate a need for additional medical or psychological 
resources.  
16.4 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 study team has regular meetings to discuss and design the research project.  
All investigators are CITI trained.  Only the PI, Dr. Barnabei, and the study 
coordinator, will have direct contact with the study patients. 
17.0 
Other Approvals 
17.1 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:  
 
☒ 
N/A:  This study does not require any other approvals. 
18.0 
Provisions to Protect the Privacy Interests of Subjects 
18.1 Describe how you will protect subjects’ privacy interests during the course 
of this research. 
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:  
Participants will meet with the PI or the study coordinator in a private exam room 
in the clinical suite where no one can overhear.  They will be given ample time to 
consider study participation, ask questions, and sign the consent.  All patients will 
be reminded that participation is voluntary and will not affect the care they 
receive. 
18.2 Indicate how the research team is permitted to access any sources of 
information about the subjects.   

 
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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 and HIPAA authorization will be obtained for access to the patient’s 
medical record to confirm medical history and medications which may impact 
patient’s participation. 
19.0 
Data Management and Analysis* 
19.1 Describe the data analysis plan, including any statistical procedures.  This 
section applies to both quantitative and qualitative analysis.  
Response: Both visible and infrared images will be acquired using our state-of-
the-art FLIR E-95 camera. The E-95 is one of the best IR cameras available. It has 
very high spatial resolution and temperature sensitivity. In summation: if there is 
any correlation between temperature and vulvodynia, this camera will be able to 
see it.  The camera’s software stores both of these images along with metadata in 
a single jpeg. We have already designed our own custom software to extract the 
raw temperature data from these files. Our software will control the camera 
remotely through a USB link. This, along with mounting the camera on a tripod, 
will ensure that there is minimal “smearing” of the image due to small 
uncontrollable movements of the person operating the camera. This will give us 
the highest accuracy possible. In addition, our graphical software interface will 
allow the user to mark the image to indicate where sensitivity to pressure or an 
increase in thermal activity was observed. As we expect spatial variation in 
temperature from the affected area to the unaffected, we will provide the user with 
a variety of options for subtracting the average body temperature to make the 
difference more visible. All data will be stored securely to maintain patient 
confidentiality. Once we have collected enough data, we can begin the process of 
establishing the metrics by which we can diagnose the patients. Considering all of 
our data (pressure, temperature, color (from visible light image)) we can 
determine the connection of each to a positive diagnosis and assign a finally 
probability to our result.  
 
19.2 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 
whether the investigator has an adequate sample size to achieve the study 
objectives and justify a conclusion.  
Response: This is a pilot study.  No power analysis will be performed. 
 
19.3 Describe any procedures that will be used for quality control of collected 
data. 

 
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Response: We are focusing on detecting vulvodynia alone, so we will choose 
patients that are otherwise healthy. Any patient with a pre-existing condition that 
may affect the outcome of our experiments will be excluded from the study.  
 
20.0 
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.   
 
20.1 
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:  
All study data, including images, will be maintained on a password-protected, 
HIPAA-compliant computer in the Department of  Obstetrics and Gynecology, 
Jacobs School of Medicine.  Data on this computer will identify patients only by a 
code.  The key code with patient identifiers, stored as an Excel spreadsheet, will 
be kept in a separate, secure location on a password-protected, HIPAA-compliant 
computer in the Department of Obstetrics and Gynecology. 
20.2 
A.  How long will the data be stored? 
Response:  
Indefinitely. 
20.3 
A.  Who will have access to the data? 
Response:  
The PI and co-investigators. 
20.4 
A.  Who is responsible for receipt or transmission of the data? 
Response:  
The PI and co-investigators. 
 
20.5 
A.  How will the data be transported? 
Response: 
On a password-protected, HIPAA-compliant flash drive. 
 

 
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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 21.0) 
 
20.6 
B.  Where and how will all specimens be stored?  Include information 
about:  physical controls, authorization of access, and labeling of specimens, as 
applicable.   
Response:  
 
20.7 
B.  How long will the specimens be stored? 
Response:  
 
20.8 
B.  Who will have access to the specimens? 
Response:  
 
20.9 
B.  Who is responsible for receipt or transmission of the specimens? 
Response:  
 
20.10 B.  How will the specimens be transported? 
Response: 
 
 
21.0 
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. 
 
21.1 Describe the plan to periodically evaluate the data collected regarding both 
harms and benefits to determine whether subjects remain safe. 

 
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Response:  
UB Box will be monitored to ensure that only study investigators have accessed 
the data files. 
21.2 Describe what data are reviewed, including safety data, untoward events, 
and efficacy data. 
Response:  
NA 
 
21.3 Describe any safety endpoints. 
Response:  
None. 
21.4 Describe how the safety information will be collected (e.g., with case report 
forms, at study visits, by telephone calls with participants). 
Response:  
NA 
21.5 Describe the frequency of safety data collection. 
Response:  
NA 
21.6 Describe who will review the safety data. 
Response:  
NA 
21.7 Describe the frequency or periodicity of review of cumulative safety data. 
Response:  
NA 
21.8 Describe the statistical tests for analyzing the safety data to determine 
whether harm is occurring. 
Response:  
NA 
21.9 Describe any conditions that trigger an immediate suspension of the 
research. 
Response:  
Data breach. 
22.0 
Withdrawal of Subjects* 
☐ 
N/A:  This study is not enrolling subjects.  This section does not apply. 

 
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22.1 Describe anticipated circumstances under which subjects may be withdrawn 
from the research without their consent. 
Response:  
Participants who consent but cannot complete the study procedures, if for 
example they have abnormal findings at the time of the exam, will be withdrawn 
from the study at the time of the study visit. 
22.2 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:  
If patient cannot complete the study at the time of the study visit, no additional 
procedures will be performed at that time 
22.3 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:  
If a patient chooses to return to complete the study procedures, her biographical and 
demographic data will be saved.  If she cannot return, previously collected data will be 
destroyed for control participants and saved for affected women, since this data would be 
collected for the routine assessment anyway.  If a participant decides to leave the 
research, she can contact the investigator so that the investigator can remove any personal 
medical information from the study records. 
 
23.0 
Risks to Subjects* 
23.1 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:  
There is minimal risk to subjects from participation in this study except minor 
discomfort from the cotton-tipped swab.  There is no immediate risk to the 
imaging.  Breach of confidentiality is a small risk of participation although every 
effort will be done to maintain security of PHI. 
23.2 Describe procedures performed to lessen the probability or magnitude of 
risks, including procedures being performed to monitor subjects for safety. 

 
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Response: See section 20.1 for ways to mitigate the risk of breach of 
confidentiality.  
23.3 If applicable, indicate which procedures may have risks to the subjects that 
are currently unforeseeable. 
Response: N/A  
 
23.4 If applicable, indicate which research procedures may have risks to an 
embryo or fetus should the subject be or become pregnant. 
Response:  
None. 
NA 
23.5 If applicable, describe risks to others who are not subjects. 
Response:  
NA 
24.0 
Potential Benefits to Subjects* 
24.1 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:  
There is no benefit directly to subjects for participation.  Data from this study may 
improve the diagnosis and care of women with vulvodynia in the future. 
25.0 
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.   
25.1 
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: There is no possibility of research-related injury.  
 
25.2 
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. 

 
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Response: N/A  
 
26.0 
Economic Burden to Subjects 
26.1 
Describe any costs that subjects may be responsible for because of 
participation in the research.   
NOTE:  Some examples include transportation or parking. 
Response:  
The study procedures may extend the length of time the patients are in the clinic 
which means more time away from work and may increase the cost of parking 
slightly. 
☐ 
N/A:  This study is not enrolling subjects, or is limited to records review 
procedures only.  This section does not apply. 
27.0 
Compensation for Participation 
27.1 
Describe the amount and timing of any compensation to subjects, 
including monetary, course credit, or gift card compensation. 
Response:  
Upon completion of study procedures, subjects will be given a $25 One-Time 
Plastic Reward Card to compensate them for time spent and transportation costs. 
☐ 
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. 
28.0 
Consent Process 
28.1 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 29.0. 
☒ 
Yes 
(If yes, Provide responses to each question in this Section) 
☐ 
No 
(If no, Skip to Section 29.0) 
 
28.2 Describe where the consent process will take place.  Include steps to 
maximize subjects’ privacy. 
Response:  
Consent will be obtained in a private exam room within the Obstetrics and 
Gynecology suite at the Conventus Office Building, 1001 Main Street, Buffalo. 
28.3 Describe how you will ensure that subjects are provided with a sufficient 
period of time to consider taking part in the research study.   

 
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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 allowed as much time as they need to review the requirements of 
study participation and ask to questions. 
28.4 Describe any process to ensure ongoing consent, defined as a subject’s 
willingness to continue participation for the duration of the research study.   
Response:  
Prior to and during the exam, the investigator will verbally confirm that subject 
wishes to continue. 
28.5 Indicate whether you will be following “SOP: Informed Consent Process for 
Research (HRP-090).” Pay particular attention to Sections 5.4-5.9. 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:  
HRP-090 will be followed. 
☒ 
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 28.8) 
28.6 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 8.4 of this protocol. 
Response:  
 

 
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28.7 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, how you will ensure that subjects are provided with 
a sufficient period of time to consider taking part in the research study, and 
any process to ensure ongoing consent. 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 28.9) 
28.8   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 28.13) 
When a person is not capable of consent due to cognitive impairment, a legally 
authorized representative should be used to provide consent (Sections 28.9 and 
28.10) and, where possible, assent of the individual should also be solicited 
(Sections 28.11 and 28.12). 
28.9  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:  
 
☐ 
We have reviewed and will be following “SOP: Legally Authorized 
Representatives, Children, and Guardians (HRP-013).”  
28.10 For research conducted outside of New York State, provide information 
that describes which individuals are authorized under applicable law to 

 
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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:  
 
28.11 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:  
 
28.12 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 29.0) 
28.13 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: 
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. 

 
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Response:  
 
28.14For 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:  
 
28.15 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).”  
28.16Describe 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:  
 
28.17 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. 
Response:  
 
28.18 When assent of children is obtained, describe how it will be documented. 
Response:  

 
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29.0 
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. 
29.1 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:  
 
29.2 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:  
 
30.0 
Process to Document Consent 
☐ 
N/A:  A Waiver of Consent is being requested.   
(Skip to Section 31.0) 
30.1 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.  
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:  

 
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☒ 
We will be following “SOP:  Written Documentation of Consent” 
(HRP-091). 
31.0 
Multi-Site Research (Multisite/Multicenter Only)* 
☒ 
N/A:  This study is not an investigator-initiated multi-site study.  This 
section does not apply. 
 
31.1 
Indicate the total number of subjects that will be enrolled or records that 
will be reviewed across all sites. 
Response:  
 
31.2 If this is a multi-site study where you are the lead investigator, describe the 
processes to ensure communication among sites, such as the following.  
• 
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 in 
accordance with applicable federal regulations and local laws. 
• 
All non-compliance with the study protocol or applicable requirements 
will be reported in accordance with local policy. 
Response:  
 
31.3 Describe the method for communicating to engaged participating sites.  
• 
Problems (inclusive of reportable events) 
• 
Interim results 
• 
Study closure 
Response:  
 
31.4 
If this is a multicenter study where you are a participating 
site/investigator, describe the local procedures for maintenance of 
confidentiality.  
• 
Where and how data or specimens will be stored locally? 

 
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• 
How long the data or specimens will be stored locally? 
• 
Who will have access to the data or specimens locally? 
• 
Who is responsible for receipt or transmission of the data or 
specimens locally? 
• 
How data and specimens will be transported locally? 
Response:  
 
31.5 
If this is a multicenter study and subjects will be recruited by methods not 
under the control of the local site (e.g., call centers, national 
advertisements) describe those methods.  Local recruitment methods are 
described elsewhere in the protocol. 
• 
Describe when, where, and how potential subjects will be 
recruited. 
• 
Describe the methods that will be used to identify potential 
subjects. 
• 
Describe materials that will be used to recruit subjects. (Attach 
copies of these documents with the application. For 
advertisements, attach the final copy of printed advertisements. 
When advertisements are taped for broadcast, attach the final 
audio/video tape. You may submit the wording of the 
advertisement prior to taping to preclude re-taping because of 
inappropriate wording, provided the IRB reviews the final 
audio/video tape.) 
Response:  
 
32.0 
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. 
32.1 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:  
Data will be stored on an encrypted password-protected UB server in the 
Department of Obstetrics and Gynecology for 10 years. 

 
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32.2 List the data to be stored or associated with each specimen. 
Response:  
Clinical data collected during the exam (infrared photos and pain map) and 
demographic data from the data collection sheet. 
32.3 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:  
Only the investigators will have access to stored data. 
All future use of data from this study outside the scope of this protocol will 
be submitted to the IRB for review.