Clinical Evaluation of the Efficacy of an Intra Oral Rinse for Patients With Xerostomia
Phase: NA
Conditions: Xerostomia
Sponsor: Sunstar Americas

 
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 
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 ................................................................ 8 
7.0 
Local Number of Subjects ....................................................................................... 9 
8.0 
Inclusion and Exclusion Criteria* ............................................................................ 9 
9.0 
Vulnerable Populations* ........................................................................................ 12 
10.0 Eligibility Screening* ............................................................................................ 13 
11.0 Recruitment Methods ............................................................................................. 14 
12.0 Procedures Involved*............................................................................................. 15 
13.0 Study Timelines* ................................................................................................... 19 
14.0 Setting .................................................................................................................... 20 
15.0 Community-Based Participatory Research ............................................................ 20 
16.0 Resources and Qualifications ................................................................................. 21 
17.0 Other Approvals ..................................................................................................... 22 
18.0 Provisions to Protect the Privacy Interests of Subjects .......................................... 22 
19.0 Data Management and Analysis* .......................................................................... 23 
20.0 Confidentiality* ..................................................................................................... 24 
A. 
Confidentiality of Study Data ......................................................................... 24 
B. 
Confidentiality of Study Specimens ................................................................ 25 
21.0 Provisions to Monitor the Data to Ensure the Safety of Subjects* ........................ 26 
22.0 Withdrawal of Subjects* ........................................................................................ 28 
23.0 Risks to Subjects* .................................................................................................. 29 
24.0 Potential Benefits to Subjects* .............................................................................. 30 
25.0 Compensation for Research-Related Injury ........................................................... 30 
26.0 Economic Burden to Subjects ................................................................................ 31 
27.0 Compensation for Participation ............................................................................. 31 
28.0 Consent Process ..................................................................................................... 31 
29.0 Waiver or Alteration of Consent Process ............................................................... 36 
30.0 Process to Document Consent ............................................................................... 37 
31.0 Multi-Site Research (Multisite/Multicenter Only)*............................................... 37 
32.0 Banking Data or Specimens for Future Use* ........................................................ 39 
 
 
 

 
Page 2 of 39 
IRB Version: 1/23/19 
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 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 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 39 
IRB Version: 1/23/19 
PROTOCOL TITLE: 
Include the full protocol title. 
Response: Clinical evaluation of the efficacy of an intra oral rinse for patients 
with xerostomia 
PRINCIPAL INVESTIGATOR: 
Name 
Department 
Telephone Number 
Email Address 
Response: Sebastian G. Ciancio, D.D.S. 
Department of Periodontics and Endodontics 
7168293848 
ciancio@buffalo.edu 
VERSION NUMBER/DATE: 
Include the version number and date of this protocol. 
Response: version 02, Date: 04/21/2020 
 
REVISION HISTORY 
 
Revision 
# 
Version Date 
Summary of Changes 
Consent 
Change? 
#1 
4/21/2020 
Changes made per IRB deferral comments 
yes 
#2 
5/13/2020 
Changes made per IRB comment 
yes 
 
 
 
 
 
 
 
 
 
 
 
 
FUNDING: 
Indicate any funding for this proposal. This should match the Funding Sources 
page in Click IRB. 
Response: This project is funded by Sunstar America.  
 
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 39 
IRB Version: 1/23/19 
NOTE: This question does not apply to studies funded by a sponsor contract. 
Include a copy of the grant proposal with your submission.     
Response: This project is not funded by a Grant.  
 
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: 250 Squire Hall 
Address: School of Dental Medicine, University at Buffalo, Buffalo, NY 14214 
 
Department: Department of Periodontics and Endodontics 
1.0 Study Summary 
 
Study Title 
Clinical evaluation of the efficacy of an intra oral rinse for 
patients with xerostomia 
Study Design 
Randomized, double –blind, placebo controlled cross over 
study 
Primary Objective 
1. To evaluate patients’ perception of efficacy of a new 
currently marketed mouth rinse (HYDRAL) for 
xerostomia compared to a placebo mouth rinse (negative 
control) and another currently marketed mouthrinse 
(Biotene) in reducing the symptoms of xerostomia. 
2. To determine the efficacies on dry mouth relief and on 
the patient’s Quality of Life (QoL) at the beginning and 
end of the study. 
 
Secondary 
Objective(s) 
1. To objectively evaluate the improvement of dry mouth 
symptoms by HYDRAL compared to the placebo and 
Biotene.  
2. To evaluate the safety of the test mouthrinse on teeth and 
oral soft tissues. 
3. To evaluate the patient’s preferences relative to the test 
mouthrinses. 
 
Research 
Intervention(s)/ 
Investigational 
Agent(s)  
Mouth rinse (HYDRAL) 
IND/IDE #  
N.A 

 
Page 5 of 39 
IRB Version: 1/23/19 
Study Population 
Adults males and females 
Sample Size 
39 
Study Duration for 
individual 
participants 
8 weeks 
Study Specific 
Abbreviations/ 
Definitions  
 
2.0 Objectives* 
2.1 Describe the purpose, specific aims, or objectives of this research. 
Response:  The objectives of this randomized double -blind placebo 
controlled cross over study are:  
1) To evaluate patients’ perception of efficacy of a new mouth rinse 
(HYDRAL) for xerostomia compared to a placebo mouth rinse 
(negative control) and another mouthrinse (Biotene) in reducing the 
symptoms of xerostomia. 
2)  To determine the efficacies on dry mouth relief and on the patient’s 
Quality of Life (QoL) at the beginning and end of the study. 
3) To objectively evaluate the improvement of dry mouth symptoms by 
HYDRAL compared to the placebo and Biotene.  
4) To evaluate the safety of the test mouthrinse on teeth and oral soft 
tissues. 
5) To evaluate the patient’s preferences relative to the test mouthrinses. 
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:  
1) HYDRAL performs as well as or better than Biotene in reduction of the 
symptoms.  HYDRAL performs better than the placebo rinse in reduction of 
the symptoms. 
2)  HYDRAL improves patient’s quality of life as well as or better than Biotene. 
HYDRAL performs better than the placebo rinse in improvement of patient’s 
Quality of Life (QoL) 
 
3.0 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.  

 
Page 6 of 39 
IRB Version: 1/23/19 
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: The primary endpoint is a reduction of dry mouth symptoms  
 
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: Currently, the prevalence of dry mouth varies widely among the 
general population. When asked, 14–46% of the adult population complains about 
dry mouth problems, women more than men [1]. Xerostomia is generally defined 
as a subjective feeling of dry mouth, often the result of hyposalivation caused by 
different medical issues. All grades of xerostomia may impact on oral health and 
quality of life [2]. Long-term causes of hyposalivation include chronic diseases 
(diabetes, Sjögren’s syndrome, Parkinson’s disease, rheumatoid arthritis, etc.), 
illness of the parotid glands, malignancies in the head and neck region and their 
treatment, as well as head and neck surgery or anamnestic radiation. Another 
underrated main cause of xerostomia in the general population is medication-
induced xerostomia [3]. Older age in combination with a large number of 
prescribed drugs ranks as an important activator for xerostomia [4–6]. The clinical 
oral effects of xerostomia are many and include difficulties in speaking, 
swallowing or eating, a reduced or altered taste sensation, atrophy of mucosal 
tissue with pain, demineralization of the teeth, and often occurrence of secondary 
infections of oral tissues [7]. 
Yet there is almost no evidence in the literature regarding treatment of this special 
patient population with medication-induced xerostomia with symptom-relieving 
products, or evidence-based guidelines as to which products can be recommended 
to patients and how effective they are [8]. The efficacy of therapies is mainly 
described in populations with post-radiotherapy xerostomia [9–13]. In this study, 
we intend to investigate and compare the efficacy of GUM Hydral and Biotène 
Oral balance. 
4.2 Include complete citations or references.  
Response: 
[1]. 
Sreebny LM (2000) Saliva in health and disease: an appraisal and 
update. Int Dent J 50:140–161 
[2]. 
Davies AN (2000) A comparison of artificial saliva and chewing 
gum in the management of xerostomia in patients with advanced 
cancer. Palliat Med 14:197–203 
[3]. 
 Nederfors T, Isaksson R, Mornstad H, Dahlof C (1997) 
Prevalence of perceived symptoms of dry mouth in an adult Swedish 

 
Page 7 of 39 
IRB Version: 1/23/19 
population relation to age, sex and pharmacotherapy. Community 
Dent Oral Epidemiol 25:211–216 
[4]. 
Bardow A, Nyvad B, Nauntofte B (2001) Relationships between 
medication intake, complaints of dry mouth, salivary flow rate and 
composition, and the rate of tooth demineralization in situ. Arch Oral 
Biol 46:413–423 
[5]. 
Locker D (1995) Xerostomia in older adults: a longitudinal study. 
Gerodontology 12:18–25 
[6]. 
Villa A, Abati S (2011) Risk factors and symptoms associated with 
xerostomia: a cross-sectional study. Aust Dent J 56:290–295. doi: 
10.1111/j.1834-7819.2011.01347.x 
[7]. 
Epstein JB, Stevenson-Moore P (1992) A clinical comparative trial 
of saliva substitutes in radiation-induced salivary gland hypofunction. 
Spec Care Dentist 12:21–23 
[8]. 
Barbe AG, Bock N, Derman SH, Felsch M, Timmermann L, Noack 
MJ (2016) Self-assessment of oral health, dental health care and oral 
health-related quality of life among Parkinson's disease patients. 
Gerodontology. doi:10.1111/ger.12237 
[9]. 
Kirstila V, Lenander-Lumikari M, Soderling E, Tenovuo J (1996) 
Effects of oral hygiene products containing lactoperoxidase, lysozyme, 
and lactoferrin on the composition of whole saliva and on subjective 
oral symptoms in patients with xerostomia. ActaOdontol Scand 
54:391–397 
[10]. Kirstila V, Lenander-Lumikari M, Tenovuo J (1994) Effects of  
lactoperoxidase-system-containing toothpaste on dental plaque and 
whole saliva in vivo. Acta Odontol Scand 52:346–353 
[11]. Kielbassa AM, Shohadai SP, Schulte-Monting J (2001) Effect of 
saliva substitutes on mineral content of demineralized and sound 
dental enamel. Support Care Cancer 9:40–47 
[12]. Warde P, Kroll B, O'Sullivan B, Aslanidis J, Tew-George E, 
Waldron J, Maxymiw W, Liu FF, Payne D, Cummings B (2000) A 
phase II study of Biotene in the treatment of postradiation xerostomia 
in patients with head and neck cancer. Support Care Cancer 8:203–
208 
[13]. Epstein JB, Emerton S, Le ND, Stevenson-Moore P (1999) A 
double-blind crossover trial of Oral Balance gel and Biotene 
toothpaste versus placebo in patients with xerostomia following 
radiation therapy. Oral Oncol 35:132–13. 
5.0 Study Design* 
5.1 Describe and explain the study design (e.g. case-control, cross-sectional, 
ethnographic, experimental, interventional, longitudinal, observational). 

 
Page 8 of 39 
IRB Version: 1/23/19 
Response: Randomized double -blind placebo controlled cross over study. 
Randomization-Patients will be assigned to the study product using a random numbers 
table. Both the placebo rinse and the “active “test rinses” will be provided by the sponsor 
in similar bottles labeled with a code label for each bottle. The code and patient numbers 
will be kept in a sealed cabinet in 250 squire Hall. The code will only be broken if there 
is need to identify a patient with adverse effects which may be attributed to the rinse they 
were given.  
 
 
6.0 
Study Intervention/Investigational Agent 
1.1 Description: Describe the study intervention and/or investigational 
agent (e.g., drug, device) that is being evaluated. 
Response: HYDRAL Oral rinse and Biotene rinse contain one or more of 
the following: Sorbitol, Sodium citrate, Propanediol, 
Polyvinylpyrrolidone, Betaine, PEG-40 Hydrogenated Castor Oil, Xylitol, 
Taurine, Citric acid, Sodium hydroxide, Methyl paraben, Flavor, Mild 
Mint flavor, Sodium hyaluronate, Cetylpyridinium chloride, Sucralose, 
Stevia Redaudiana Extract, Glycerin, Propylene Glycol, Poloxamer 407, 
Sodium Benzoate, Hydroxyethyl Cellulose, Propylparaben, Sodium 
Phosphate, Disodium Phosphate 
 
6.1 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: An inventory of the study products and dispensing logs will be 
maintained by the Clinical Coordinator.  Unused materials will be disposed. 
6.2 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: 

 
Page 9 of 39 
IRB Version: 1/23/19 
 
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 is not investigational and is in commercial use. The device 
holds a 510(K) by the FDA (attached in devices section of the IRB submission 
portal). 
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: 39 
7.2 If applicable, indicate how many subjects you expect to screen to reach your 
target sample (i.e. your screen failure rate).  
Response: We anticipate screening 125 subjects to reach our target sample of 39.  
 
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? 
8.0 Inclusion and Exclusion Criteria 
Response: The number of subjects needed for this study  is based on the 
feasibility of the study.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: Individuals may be included in the study provided they meet all 
of the following inclusion criteria:  
• Must have read, understood and signed an informed consent prior to 
being entered into the study,  
• Must be 18 to 80 years of age, male or female,  
• Have at least 20 natural or restored teeth,  
• Have a complaint of xerostomia,  

 
Page 10 of 39 
IRB Version: 1/23/19 
• Have an unstimulated salivary flow rate <0.20 ml/minute which 
represents a significant reduction of normal salivary function, 6)Must 
have subjective xerostomia symptom: minimum level of 4 on a 10 
centimeters Visual Analog Scale (VAS).  The question, using a VAS 
scale, would be” How would you score your dryness on the basis of a 
scale of 1 to 10?” and on the left would be zero, and on the right would 
be severe (10). They would have to score a 4 or higher to be in the 
study. We would ask this same question both before and after the two 
week usage period,  
• Agree not to have a dental prophylaxis or any other elective, non-
emergency dental procedures (other than those provided during the 
study) any time during the study,  
• Agree to abstain from the use of any products for xerostomia other 
than those provided in the study  
• Agree to comply with the conditions and schedule of the study. 
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:   Individuals are not eligible for participation in this study if 
any of the following are noted:  
• Physical limitations or restrictions that might preclude normal tooth 
brushing. 
• Evidence of gross oral pathology, including widespread caries or 
chronic neglect, extensive restoration, pre-existing gross plaque or soft 
or hard tissue tumor of the oral cavity. 
• Presence of severe gingivitis with 30 or more sites showing bleeding 
on probing. 
• Evidence of major oral hard or soft tissue lesions or trauma at the 
baseline visit as determined by the Investigator/Examiner. 
• Chronic disease with concomitant oral manifestations other than 
xerostomia 
• Conditions requiring antibiotic treatment prior to dental prophylaxis 
and invasive procedures, such as heart murmur, history of rheumatic 
fever, valvular disease or certain prosthetic implants.  
• History of hepatic or renal disease, uncontrolled diabetes, or other 
serious conditions or transmittable diseases. 
• Taking concomitant medications which may interfere with oral tissues 
such as anticoagulants, NSAID’s, and those shown to enlarge gingival 
tissues. 

 
Page 11 of 39 
IRB Version: 1/23/19 
• A positive pregnancy test at visit one would also cause your removal 
from the study. 
• Subjects who are currently undergoing, or require, extensive dental 
work, orthodontic treatment or periodontal surgery or orthodontic 
treatment in the preceding 3 months 
• Currently using bleaching trays 
• History of radiotherapy, head and neck cancer or Sjogren’s syndrome. 
• History of significant adverse effects following use of oral hygiene 
products such as toothpastes and mouthrinses. 
• Subjects who are nursing, pregnant or plan to become pregnant for the 
duration of the study.  
• Eating disorders 
• Recent history of substance abuse  
• Participation in other clinical studies within 14 days of screening 
• Smoking >10 cigarettes/day 
• Chewing tobacco 
• Daily use of symptom alleviating products against xerostomia within 7 
days of screening. 
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 

 
Page 12 of 39 
IRB Version: 1/23/19 
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: Non-English speaking individuals will be included only if adequate 
translation support can be obtained. We will include a copy of written informed 
consent to the IRB in a translated format prior to enrolling of a subject who 
requires translation. 
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:  

 
Page 13 of 39 
IRB Version: 1/23/19 
 
☒ 
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:  
 
☒ 
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: Seven days before screening visit potential subjects shall be advised to 
stop using their usual dry mouth remedy.  Since some mouthrinses and other oral 
hygiene products have a residual effect on oral tissues, we are asking the potential 
subjects to cease using these products for one week prior to their visit so that we 
can evaluate the status of their oral tissues. Male and female subjects will read 
and sign the informed consent prior to enrollment.  Subjects will be asked about 
demographics, medical history, general health status and current medication 
usage, and the information will be recorded.  
The subjects will be asked if they currently experience any problems such as 
burning, stinging, irritation, etc., and if so, the nature of the effect, severity and 
onset time (if known) will be recorded.  
VAS scoring of lubrication or moisture of your mouth will be scored and 
unstimulated saliva flow will be measured (Inclusion Criteria). A qualified dental 
examiner will perform an oral soft and hard tissue examination (OST) to verify 
that the subjects meet the inclusion and exclusion criteria.   
Following the OST exam, qualifying subject’s unstimulated saliva will be 
collected over a 5 minutes time period and the volume measured to determine if 
they meet the study criteria for xerostomia. VAS question related to symptoms of 
xerostomia will be completed (>=4 cm is required for inclusion).  Subjects will 

 
Page 14 of 39 
IRB Version: 1/23/19 
also be asked to refrain from eating or drinking for 1 hour prior to being 
examined. 
Upon completion of the screening visit, the Principal Investigator or his designee 
will review subject screening reports and determine whether or not the subject 
qualifies for study enrollment.  If the subject qualifies, an appointment date will 
be set for Visit 1 which could be immediately follow the screening 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:  
The study will be advertised in UB dental school clinics and on UB campuses. 
The subjects will be recruited over a period of approximately 3 months following 
IRB approval using flyers (uploaded on click IRB) which will be posted in the 
aforementioned places. The advertisement will also be posted on the UB Dental 
School website, and UB’s Participate in Research Portal. Also, the study team 
will utilize UB’s Clinical and Translational Science Institute for recruitment 
assistance and consultation. 
Patients who are interested in participating will be questioned according to a 
standard telephone script designed to include inclusion/exclusion criteria 
(uploaded on click IRB). If eligible to be included, subjects will be invited for a 
screening exam at the Center for Dental Studies, UB School of Dental Medicine 
 
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.   
Response: Potential participants are contacting the research team if interested in 
participating and are therefore controlling their own privacy interests during 
recruitment.  The center for clinical dental research is a private space that allows 
data collection while maintaining privacy of the patient. In addition, the data 
collection, storage, communication and analysis will be carried out in compliance 
with privacy regulations of University at Buffalo and the School of Dental 
Medicine. 

 
Page 15 of 39 
IRB Version: 1/23/19 
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: Flyers will be used for recruitment. These documents have been 
attached in the IRB submission online. Patients who are interested in participating 
will be questioned according to a standard telephone script designed to include 
inclusion/exclusion criteria (uploaded on click IRB). If eligible to be included, 
subjects will be invited for a screening exam at the Center for Dental Studies, UB 
School of Dental Medicine. 
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: If a potential patient is a mouthrinse user, we will be sending them a 
Consent Form for the study which they will be asked to read, sign and date and 
return to us. Also,  If they have any concerns or questions, we will discuss with 
them. Once we receive the signed consent form, we will give patients a screening 
visit appointment, and remind them to cease use of any mouthrinses for 7 days 
prior to the appointment.   At the screening visit, every potential subject will be 
consented again and interviewed.  Subjects who sign the Informed Consent Form 
and meet eligibility criteria will then have an Oral Screening Examination by the 
Primary Examiner.  After review of the results of the Informed Consent, 
Screening Interview and Screening Oral Examination, the Principal Investigator 
or designee will determine whether or not a subject should be enrolled in the 
study. 
Screening 
Seven days before screening visit potential subjects shall stop using their usual 
dry mouth mouthrinse as outlined above..  Male and female subjects will again 
read and sign the informed consent with a staff member of the study as a witness..  
Since some mouthrinses have a residual effect on oral tissues, we are asking the 
potential subjects to cease using these products for one week prior to their visit so 
that we can evaluate the status of their oral tissues  .  Interested patients will be 
contacted at least 7 days prior to the screening visit to read, sign and date the 
Consent Form and then start the one  week withdrawal of current mouthrinse 

 
Page 16 of 39 
IRB Version: 1/23/19 
before coming to the screening visit. The study team will then call the patient 
after the Consent Form is mailed to answer any questions or concerns that they 
may have. The patient can mail the Consent Form back in a stamped self- 
addressed envelope. The withdrawal of mouthrinse can begin once the study team 
receives the Consent Form and notifies the patient of its receipt. Subjects will be 
asked about demographics, medical history, general health status and current 
medication usage, and the information will be recorded. 
 The subjects will be asked if they currently experience any problems such as 
burning, stinging, irritation, etc., and if so, the nature of the effect, severity and 
onset time (if known) will be recorded.  
VAS scoring of lubrication or moisture of your mouth will be scored and 
unstimulated saliva flow will be measured (Inclusion Criteria). A qualified dental 
examiner will perform an oral soft and hard tissue examination (OST) to verify 
that the subjects meet the inclusion and exclusion criteria.   
Following the OST exam, qualifying subject’s unstimulated saliva will be 
collected over a 5 minutes time period and the volume measured to determine if 
they meet the study criteria for xerostomia. VAS question related to symptoms of 
xerostomia will be completed (>=4 cm is required for inclusion).  Subjects will 
also be asked to refrain from eating or drinking for 1 hour prior to being 
examined. 
If the patient meets the study criteria and has time to participate in visit 1, they 
may enter the study following the screening visit.  If acceptable for the study, this 
screening visit will serve as their Visit I baseline.  
Visit I  
This visit will last approximately 1 hour. The following will happen at this visit: 
Subjects will be asked to refrain from eating or drinking for 1 hour prior to being 
examined. If Screening visit and Visit 1 don’t happen at the same day, the study 
staff will update Inclusion/Exclusion Criteria, medical history and concurrent 
medications.  
Subjects will complete VAS question (Appendix A), Xerostomia questionnaire 
(Appendix B) and Oral Health Impact Profile -14 (OHIP-14) (Appendix C) for the 
baseline information. 
A qualified dental examiner will perform an oral soft and hard tissue examination 
(OST), unstimulated saliva flow measurement and the objective assessment of 
oral health condition using the standardized instrument, Revised Oral Assessment 
Guide (ROAG) (Appendix D).  Some intraoral photographs will be taken. 
They will then be given their assigned product to use four times daily for two 
weeks. Subjects will maintain a daily diary (Appendix E) of their product usage 
and any oral effects they experience and will answer all diary questions.  
Compliance will be assessed by subject diary and measurement of when unused 
portion is returned to the clinic.  

 
Page 17 of 39 
IRB Version: 1/23/19 
The subjects will be instructed not to use any other xerostomia products for the 
duration of the study and to follow their normal oral hygiene procedures. All 
subjects will be provided with a soft toothbrush and regular fluoride toothpaste to 
use during the study. Subjects will be scheduled to return in approximately 2 
weeks, and will be instructed to refrain from eating and drinking for 
approximately 1 hour prior to their next visit. They will be advised to follow the 
instructions carefully and return to the study center with their assigned 
mouthrinse, and diary after 2 weeks for their next examination.  Subjects will 
receive a reminder call prior to Visit 2. 
Visit 2 
After 2 weeks, subjects will return to the office to return their dairy.  This visit 
will last approximately 1.5 hour. The following will happen at this visit: The 
study staff will update of medical history and concurrent medications. Adverse 
experiences will be noted and recorded during the study. 
The study examiner will perform ROAG(Appendix D) to assess the subject’s oral 
health condition.  
Subjects will complete VAS question (Appendix A), Xerostomia questionnaire 
(Appendix B) and OHIP-14 (Appendix C) for after 2 weeks use of the first 
product.  At Visit 2, they will also complete Product Performance and Attributes 
Questionnaire for the first product (Appendix F). 
A qualified dental examiner will perform OST, unstimulated saliva flow 
measurement and the objective measurement of xerostomia symptoms (Appendix 
D).  Some intraoral photographs will be taken.   
Subjects will then remain in the study center for 60 minutes to evaluate whether 
their mouth feels moist or lubricated, xerostomia relief by questionnaire at 5, 15, 
30, 45 and 60 minutes after the in-office use of their assigned product rinse 
(Appendix G).   
Visit 3 
After a 1-week washout, subjects will return to the office to begin the second 
period of the study, using the same study procedures and be assigned the alternate 
treatment rinse as in Visit 1. 
At the end of Visit 4 (examination for the second product) they will go through a 
1 week wash out period and then return for Visit 5 (baseline for the third product) 
and study will be completed in visit 6. 
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: The various data collection points are shown in Table 1 (Study 
Schedule).  

 
Page 18 of 39 
IRB Version: 1/23/19 
Events 
Scree
ning 
Visit 
1 
Visit 
2 
Visit 
3 
Visit 
4 
Visit 
5 
Visit 
6 
First 
product 
Second 
product 
Third 
product 
Informed Consent, 
Demographics, 
Inclusion/Exclusion Criteria, 
Medical History, Concurrent 
meds 
X 
 
 
 
 
 
 
Demographics Questionnaire 
X 
 
 
 
 
 
 
Oral Soft/Hard Tissue Exam & 
Photos 
 
X 
X 
X 
X 
X 
X 
Update of Inclusion/Exclusion 
Criteria, Medical History and 
Conmeds 
 
X 
X 
X 
X 
X 
X 
Unstimulated saliva flow 
X 
(<0.2) 
X 
X 
X 
X 
X 
X 
VAS  
X 
(>=4) 
X 
X 
X 
X 
X 
X 
Questionnaires (Xerostomia, 
QoL) 
 
X 
X 
X 
X 
X 
X 
Objective xerostomia endpoint 
(ROAG) 
 
X 
X 
X 
X 
X 
X 
Product Distribution 
 
X 
X 
X 
X 
X 
X 
Diary Disbursement  
 
X 
 
X 
 
X 
 
Compliance Check 
 
 
X 
 
X 
 
X 
Product Attribute Questionnaire 
 
 
X 
 
X 
 
X 
Immediate Post-Rinse 
Evaluation 
 
 
X 
 
X 
 
X 
Adverse Events 
 
 
X 
X 
X 
X 
X 
 
 
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:  

 
Page 19 of 39 
IRB Version: 1/23/19 
a. Demographics Questionnaire 
b. Intraoral camera  
c. Medical History  
d. VAS question (Appendix A),  
e. Xerostomia questionnaire (Appendix B)  
f. Oral Health Impact Profile -14 (OHIP-14) (Appendix C)  
g. Revised Oral Assessment Guide (ROAG) (Appendix D) 
h. Daily Diary (Appendix E) 
i. Product Performance and Attributes Questionnaire for the first product (Appendix 
F) 
j. Immediate Post-Rinse Evaluation (Appendix G) 
k. Oral soft and hard tissue examination form 
l. Unstimulated saliva flow measurement form 
m. Adverse Events form 
12.4 Describe any source records that will be used to collect data about subjects 
(e.g. school records, electronic medical records). 
Response: No source records will be used to collect data about subjects. 
 
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: The data collected in the study will not be shared with the subjects or a 
third party. The data will be used solely for purposes of this investigation 
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: The data collected in the study will not be shared with the subjects or a 
third party. The data will be used solely for purposes of this investigation. Results 
post-completion of the study may be published in a de-identified format. 
13.0 
Study Timelines* 
13.1 Describe the anticipated duration needed to enroll all study subjects. 
Response: Approximately 3 months will be needed for enrollment. 
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. 

 
Page 20 of 39 
IRB Version: 1/23/19 
Response: Study duration is approximately 8 weeks and includes 6 visits if the 
screening is on the same day as visit 1. Each visit is approximately 45 mins to 1.5 
hour.  
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: 6 months including data analysis. 
 
 
 
14.0 
Setting 
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: Center for Dental Studies, University at Buffalo School of Dental 
Medicine. The Center for Dental Studies is a dedicated space for clinical dental 
investigations. 
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 

 
Page 21 of 39 
IRB Version: 1/23/19 
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. 
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: The principal investigator (PI) has extensive experience in clinical 
dental research. The PI has conducted over 60 clinical trials spanning 45 years. In 
addition, the support staffs in the study have undergone professional training 
(including dentistry and dental hygiene) to render dental examinations and care 
and have collaborated with the PI on multiple projects. The clinical coordinator 
has been associated with the Center for over 20 years. 
 
 
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: PI-2%, Study Coordinator 10%, Study Examiner 16% 
 

 
Page 22 of 39 
IRB Version: 1/23/19 
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. 
NOTE:  One example includes: on-call availability of a counselor or psychologist 
for a study that screens subjects for depression. 
Response: If an adverse event occurs, the subject may be scheduled for a follow-
up or under the direction of the Principal Investigator referred to a physician or 
dentist for treatment.  Serious Adverse Events will be followed to the extent of 
resolution possible. Also, Subjects enrolled in the study may elect to withdraw at 
any time for any reason. 
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: A pre-study briefing will be conducted by the PI with the staff of the 
Center for Dental Studies to ensure that the study staff understands the design and 
methodology of the study. Support staff will be encouraged to seek help from the 
PI if they are concerns/questions related to the study procedures. 
 
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: The clinical dental research center is a dedicated space equipped for 
private discussions with the patient. This space will be used to collect personal 
data as it pertains to the study as well as for obtaining informed consent  

 
Page 23 of 39 
IRB Version: 1/23/19 
18.2 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: The research team will collect data, by consent of the subject, as it 
relates to this study in order to determine if inclusion and exclusion criteria are 
met. All subject identification will be coded so that the subject’s identity is 
protected Further, clinical data will be used to assess the efficacy and safety of the 
mouthrinse. Additional sources of data from other healthcare providers will not be 
accessed.  
All subjects will sign and be given a copy of the informed consent agreement The 
Principal Investigator will maintain the original informed-consent document in 
the case report folder. 
Prior to commencing the study, the Principal Investigator will obtain approval 
from the Institutional Review Board (IRB) in Compliance with Federal 
Regulations (21 CFR 56).  The IRB will be consulted on the required information 
for review. Variations or changes in the protocol will not be implemented until 
approved by the Institutional Review Board. 
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: This is a randomized double-blind placebo controlled crossover 
study comparing the HYDRAL Oral rinse to Biotene rinse, and HYDRAL 
Oral rinse to placebo.  A one-week wash-out period will be adopted 
between phases to eliminate any possible carry-over effect of a treatment 
from previous phase.  The primary endpoint is a reduction of dry mouth 
symptom in VAS (0-10 scale).  To control for the Type I error rate of 
incorrectly rejecting the null hypothesis, a two-sided significance level of 
0.025 will be used.  A power analysis for a crossover study estimated that 
with 80% power, 33 subjects will be required to detect a minimal 
difference in mean VAS of 0.8.  To account for withdrawal and other 
factors (e.g. failed measurement), a total of 39 subjects will be recruited 
and randomized into the study. 
Descriptive statistics for all subjects will be performed for background and 
demographic variables. Continuous variables are expressed as frequencies 
(n), mean +/- SD and categorical variables are expressed as frequencies (n) 
and percentages (%).  To evaluate the primary end point, an Analysis of 
variance will be applied to examine the possible residual or carryover 
effects of treatments.  If no residual effect is found,  paired t test or 
Wilcoxon sign-rank test where appropriate, will be used to compare 
treatments; however, if residual effect is significant, a mixed model (with 
unstructured covariance matrix) will be performed with treatment, period, 

 
Page 24 of 39 
IRB Version: 1/23/19 
and interaction of treatment and period as fixed effects to account for 
treatment, period, and carryover effect.  For categorical variables, percent 
or proportion of subjects will be calculated and a Chi-square test or 
McNemar test will be used.  All statistical tests will be conducted using 
SAS version 9 (SAS Institute Inc. Cary, NC). 
 
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: The number of subjects needed for this study with adequate power is 
based on a power analysis of 0.8. 
19.3 Describe any procedures that will be used for quality control of collected 
data. 
Response: The PI and the clinical study member are calibrated in the collection of 
data required for this 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: Data (paper records) will be stored at 250 Squire Hall, School of 
Dental Medicine, University at Buffalo under the control of the PI and will be 
restricted by a lock-key that can only be accessed by members of the research 
team on this protocol. 
All collected data will be on forms in which the subjects’ identity is coded and the 
code can only be broken if an emergency situation occurs which requires 
knowledge of the product the subject is using. All data will only be available to 
study staff and to a biostatistician who will also not know identity. All data will 
be kept in a locked file cabinet in 250 Squire Hall (PI’s office).  
All patient identification will be by a coded-key (subject numbers). The code will 
be stored in a sealed envelope and stored in the PI’s locked cabinet (250 Squire 
Hall). The envelope will not be opened unless required by an emergency situation 

 
Page 25 of 39 
IRB Version: 1/23/19 
related to product use by the patient.   This form and all collected data will also be 
stored in a locked file cabinet in 250 Squire Hall (PI’s office). All data collected 
electronically such as  patients evaluations, patient excel log, and patient 
demographics will be stored in a password protected file on our clinical computer 
in our Center for Dental Studies. 
20.2 
A.  How long will the data be stored? 
Response: The data will be stored for duration of study, data analysis and possible 
publication (anticipated total of 6 months). 
20.3 
A.  Who will have access to the data? 
Response: PI and members of the research team. 
 
20.4 
A.  Who is responsible for receipt or transmission of the data? 
Response: PI 
 
20.5 
A.  How will the data be transported? 
Response: Data may be transported either through secure paper mail (USPS) or 
de-identified electronic for statistical analysis (off-site biostatistician).  
 
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) 
 
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: N/A 
 
20.7 
B.  How long will the specimens be stored? 
Response: N/A 
 
20.8 
B.  Who will have access to the specimens? 
Response: N/A 
 

 
Page 26 of 39 
IRB Version: 1/23/19 
20.9 
B.  Who is responsible for receipt or transmission of the specimens? 
Response: N/A 
 
20.10 B.  How will the specimens be transported? 
Response: N/A 
 
 
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. 
Response: In addition to the efficacy parameters, safety parameters will be 
collected by members of the research team. This will ensure a study with minimal 
risk to the participants and early detection of adverse reactions. If an adverse 
event occurs, the subject may be scheduled for a follow-up or under the direction 
of the Principal Investigator referred to a physician or dentist for treatment.  
Serious Adverse Events will be followed to the extent of resolution possible.  The 
Principal Investigator will note the follow-up and resolution of Adverse Events on 
the Adverse Events From (uploaded to click IRB). All serious or unsuspected 
adverse events will be reported to the IRB.  Any Serious Adverse Events that 
occur during the clinical study period will be reported promptly by the Principal 
Investigator to the IRB within 24 hours of receiving the information. 
 
21.2 Describe what data are reviewed, including safety data, untoward events, 
and efficacy data. 
Response: Study personnel will make note of any health issues they observe or 
that the subject mentions spontaneously.  Recording will include expected or 
unexpected Adverse Events such as illnesses, injuries, accidents, reactions to a 
concomitant medication, or worsening of a progressive disease state. An 
evaluation of the subject’s extra- and intra- oral tissues will also be conducted to 
determine whether any visible adverse response to the test article occurred.  In 
addition subjects will be queried about any other signs or symptoms they have 
noticed during the course of the study. Adverse events will be evaluated by the 

 
Page 27 of 39 
IRB Version: 1/23/19 
Principal Investigator as to whether they were likely caused by the study 
mouthrinse and classified on the Adverse Events Form as related or unrelated to 
the study product. Adverse Events will also be classified as mild, moderate, or 
severe and reported by organ system. 
 
21.3 Describe any safety endpoints. 
Response: Adverse oral mucosal reactions. 
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: Adverse events will be evaluated by the Principal Investigator as to 
whether they were likely caused by the study mouthrinse and classified on the 
Adverse Events Form as related or unrelated to the study product. Adverse Events 
will also be classified as mild, moderate, or severe and reported by organ system 
 
21.5 Describe the frequency of safety data collection. 
Response: At each study visit, the subject will be asked an open-ended question 
about whether he/she experienced any changes in general health or medication 
intake since the prior visit; the response will be recorded.  
 
21.6 Describe who will review the safety data. 
Response: PI 
 
21.7 Describe the frequency or periodicity of review of cumulative safety data. 
Response: At each study visit, the subject will be asked an open-ended question 
about whether he/she experienced any changes in general health or medication 
intake since the prior visit; the response will be recorded.   
 
21.8 Describe the statistical tests for analyzing the safety data to determine 
whether harm is occurring. 
Response: Safety will be assessed by subjective comments and oral hard and soft 
tissue exams. A comparison between test and placebo groups using a t test will 
allow us to compare any adverse effects occurring in the study. 
21.9 Describe any conditions that trigger an immediate suspension of the 
research. 
Response: No adverse reactions resulting in suspension of the research is 
anticipated. The products being tested are commercially available and have a 
510(K) approval by FDA. However, if an adverse event occurs that the PI 
determines to (1) have a serious effect on the health and well-being of the subject 

 
Page 28 of 39 
IRB Version: 1/23/19 
and/or (2) be treatment-related, the study will be suspended immediately and 
reported to the IRB as soon as possible. If the adverse event is determined to be 
treatment related, the study will not be resumed. without the approval of the IRB. 
 
22.0 
Withdrawal of Subjects* 
☐ 
N/A:  This study is not enrolling subjects.  This section does not apply. 
 
22.1 Describe anticipated circumstances under which subjects may be withdrawn 
from the research without their consent. 
Response: Subjects enrolled in the study may elect to withdraw at any time for 
any reason. Additionally, subjects may be withdrawn from the study at the request 
of the Principal Investigator for the following reasons: 
1. Subject does not return for follow-up and cannot be contacted to reschedule 
within +/- 5 days of each visit. 
2. An adverse event that requires discontinuation of the study mouthrinse in the 
judgment of the Principal Investigator 
3. Subject refusal or failure to comply with the study protocol 
4. Protocol violation(s) or deviation(s) that compromise the use of the subject’s 
data 
5. Subject has started taking any concomitant medications that interfere with 
results including anticoagulants, NSAIDS, or drugs that have been shown to 
enlarge gingival tissues. 
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: All subjects withdrawn from the study by request or by the Principal 
Investigator must be seen, if they consent, for a close-out evaluation. The reason 
for withdrawal will be recorded by the Principal Investigator or designee.  
Subjects who experience complications and discontinue the study on their own 
will be scheduled, if they consent, for an immediate follow-up/close-out 
examination to determine whether an adverse event is present, and if so, the 
causation of the adverse event will be recorded. If treatment is needed for any 
adverse event causing withdrawal, the subject will be monitored until return to 
normal conditions. Every effort will be made to follow up with subjects who 
withdraw from the study. The unused product will be disposed 
 
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. 

 
Page 29 of 39 
IRB Version: 1/23/19 
Response: If patients withdraw or are withdrawn from the study, the reason for 
withdrawal will be retained and de-identified in the final report of the study. 
Subjects who withdraw prior to last visit will be replaced with another subject and 
given the same treatment. To maintain the double-blind, the treatment will be 
determined by a third party who provided the randomization codes. 
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: Possible adverse effects include dislike for taste and allergy to 
ingredient(s). Subject should not be or become pregnant while on this research 
study. Since the ingredients are considered to be safe(GRAS) by the U.S. Food 
and Drug Administration and some are found in food, the risk of a bad reaction or 
effect is low. Increase in plaque is not anticipated since the subjects will be 
allowed to brush in the study using their usual brushing method. Patient’s proper 
oral hygiene regimen should control any significant plaque accumulation. 
23.2 Describe procedures performed to lessen the probability or magnitude of 
risks, including procedures being performed to monitor subjects for safety. 
Response: Subjects who experience complications and discontinue the study on 
their own will be scheduled, if they consent, for an immediate follow-up/close-out 
examination to determine whether an adverse event is present, and if so, the 
causation of the adverse event will be recorded. If treatment is needed for any 
adverse event causing withdrawal, the subject will be monitored until return to 
normal conditions. (Every effort will be made to follow up with subjects who 
withdraw from the study.)  
 
23.3 If applicable, indicate which procedures may have risks to the subjects that 
are currently unforeseeable. 
Response: Adverse effects to the mouthrinse. 
 
23.4 If applicable, indicate which research procedures may have risks to an 
embryo or fetus should the subject be or become pregnant. 
Response: This study will not include pregnant women. 
 
23.5 If applicable, describe risks to others who are not subjects. 
Response: We do not anticipate any risks to non-subject individuals. 

 
Page 30 of 39 
IRB Version: 1/23/19 
 
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 may be benefit to subjects. Possible benefits include additional 
moisturizing, lubrication and comfort to oral tissues. 
 
 
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: We do not anticipate research related injury. However, in the unlikely 
event of an adverse reaction, compensation will be carried out as follows: The 
subject will get medical treatment if injured as a result of taking part in this study. 
The study doctor will explain the treatment options to the subject and tell the 
subject where to get treatment. UB has no program to pay for medical care for 
research related injury. Generally, this care will be billed to the subject’s 
insurance company or other third party.  
 
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. 
Response: The contract states similar information to that listed in 25.1 as 
follows: If a Study participant is injured from the investigational medical 
device or a study procedure that is required solely for Study purposes, 
Sponsor will be responsible to cover the cost of treating that injury 
(including hospitalization). Full financial responsibility for payment of 
such expenses resulting from an injury or illness suffered in the course of 
the Study will rest with the Sponsor, except to the extent that such 
expenses are attributable to the negligence or willful misconduct of the 

 
Page 31 of 39 
IRB Version: 1/23/19 
Institution.  In no event will Sponsor admit fault or liability on behalf of 
Institution without first obtaining Institution’s prior written consent.  
  
 
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: We do not anticipate any significant economic burden to the subjects 
due to enrollment in this clinical research. If the subjects do not have funds for 
travel to the study site, appropriate funds will be provided and deducted from their 
final compensation of $175. 
☐ 
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: Study subjects will be compensated $175 upon completion of the 
study.  The study requires subjects to come to a clinic for a screening visit and 6 
repeat visits and a payment of $175 check will partly compensate subjects for 
their mileage, time, and the inconvenience and slight discomfort of undergoing 
the dental examinations. Subjects will receive a check in the mail, 3-4 weeks after 
the completion of the study. There will be no compensation for the screening 
visit. If a subject voluntarily withdraws from the study, or if withdrawn by the 
Investigator for any reason, he/she will be compensated on a pro rata basis  of $25 
per completed visit with the exception of the screening visit. 
 
☐ 
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 27.0. 
☒ 
Yes 
(If yes, Provide responses to each question in this Section) 
☐ 
No 
(If no, Skip to Section 27.0) 

 
Page 32 of 39 
IRB Version: 1/23/19 
 
28.2 Describe where the consent process will take place.  Include steps to 
maximize subjects’ privacy. 
Response: At the screening visit prior to initiation of any study-related 
procedures, subjects will be informed about the nature and purpose of the study, 
the study procedures, participation and termination conditions, and the risks and 
benefits of participating.   The subject will have the opportunity to ask questions 
about the study in private and then must freely agree to give written consent in 
order to participate in the study 
 
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.   
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 given adequate time at the screening visit to read the 
consent form and ask any questions related to the study 
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: This study includes only 6 visits over an  8-weeks period if the 
screening visit is at the same time as visit 1. Otherwise there will be 7 visits. 
Subjects enrolled in the study may elect to withdraw at any time for any reason. 
 
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:  
 
☒ 
We have reviewed and will be following “SOP: Informed Consent Process 
for Research (HRP-090).” 
 
Non-English Speaking Subjects  

 
Page 33 of 39 
IRB Version: 1/23/19 
☐ 
N/A:  This study will not enroll Non-English speaking subjects.   
(Skip to Section 26.8) 
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 6.4 of this protocol. 
Response: Non-English speaking individuals will be included only if adequate 
translation support can be obtained. We will include a copy of written informed 
consent to IRB in a translated format prior to enrolling a subject that requires 
translation. 
 
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: Study personnel are primarily English speakers. If a non-English 
speaker would like to be enrolled in the study, they will be enrolled if translation 
support can be obtained for both oral and written communication in that language. 
The informed consent will be translated into the required language for the subject 
and explained by the translator, who will be present during all visits. The subject 
will be provided opportunity to ask questions to the study staff (through the 
translator) and make an informed decision.  
 
 
Cognitively Impaired Adults 
☒ 
N/A:  This study will not enroll cognitively impaired adults.   
(Skip to Section 26.9) 
28.8   Describe the process to determine whether an individual is capable of 
consent.  
Response:  
 
 
Adults Unable to Consent 

 
Page 34 of 39 
IRB Version: 1/23/19 
☒ 
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). 
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 
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: N/A. 
 
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: N/A 
 
• 
If assent will not be obtained from some or all subjects, provide an 
explanation of why not. 
Response: N/A 
 
28.12 Describe whether assent of the adult subjects will be documented and the 
process to document assent.   

 
Page 35 of 39 
IRB Version: 1/23/19 
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: N/A 
 
 
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) 
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. 
Response: Subjects will be asked to provide a state-issued photo ID for 
confirmation of age. 
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: N/A 
 
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. 

 
Page 36 of 39 
IRB Version: 1/23/19 
☐ 
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: N/A 
 
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: N/A 
 
28.18 When assent of children is obtained, describe how it will be documented. 
Response: N/A 
 
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: N/A 
 
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: N/A 

 
Page 37 of 39 
IRB Version: 1/23/19 
 
30.0 
Process to Document Consent 
☐ 
N/A:  A Waiver of Consent is being requested.   
(Skip to Section 29.0) 
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: At the first visit prior to initiation of any study-related procedures, 
subjects will be informed about the nature and purpose of the study, the study 
procedures, participation and termination conditions, and the risks and benefits of 
participating. The subject will have the opportunity to ask questions about the 
study in private and then must freely agree to give written consent in order to 
participate in the study.  HRP-502 is attached in the online IRB submission. 
 
☒ 
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: N/A. 
 
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. See 
“WORKSHEET: Communication and Responsibilities (HRP-830).”: 

 
Page 38 of 39 
IRB Version: 1/23/19 
• 
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: N/A. 
 
31.3 Describe the method for communicating to engaged participating sites (see 
“WORKSHEET: Communication and Responsibilities (HRP-830)”): 
• 
Problems (inclusive of reportable events) 
• 
Interim results 
• 
Study closure 
Response: N/A 
 
31.4 
If this is a multicenter study where you are a participating 
site/investigator, describe the local procedures for maintenance of 
confidentiality. (See “WORKSHEET: Communication and 
Responsibilities (HRP-830).”) 
• 
Where and how data or specimens will be stored locally? 
• 
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: N/A 
 
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 elsewheres in the protocol. 
• 
Describe when, where, and how potential subjects will be 
recruited. 

 
Page 39 of 39 
IRB Version: 1/23/19 
• 
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: N/A 
 
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: N/A. 
 
32.2 List the data to be stored or associated with each specimen. 
Response: N/A. 
 
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: N/A.