Preliminary Effectiveness of Remotely Monitored Blood Alcohol Concentration Device as Treatment Modality
Phase: NA
Conditions: Alcohol Use Disorder
Sponsor: Yale University

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IRB# 2000027787
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HRP-503B – BIOMEDICAL RESEARCH PROTOCOL 
(2017-1)
Protocol Title: Preliminary Effectiveness of Remotely Monitored Blood Alcohol Concentration Device as 
Treatment Modality
Principal Investigator: Frank D. Buono, Ph.D.
Version Date: June 1, 2020
(If applicable) Clinicaltrials.gov Registration #:  NCT04380116
INSTRUCTIONS
This template is intended to help investigators prepare a protocol that includes all of the necessary information 
needed by the IRB to determine whether a study meets approval criteria. Read the following instructions 
before proceeding:
1.
Use this protocol template for a PI initiated study that includes direct interactions with research 
subjects. Additional templates for other types of research protocols are available in the system Library.
2.
If a section or question does not apply to your research study, type “Not Applicable” underneath.
3.
Once completed, upload your protocol in the “Basic Information” screen in IRES IRB system. 
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SECTION I: RESEARCH PLAN
1.
Statement of Purpose: State the scientific aim(s) of the study, or the hypotheses to be tested. 
The purpose of the current study is to evaluate the usage and acceptability of the Soberlink’s blood alcohol 
concentration (BAC) unit in collaboration with Aware treatment to assess increased sobriety within patients 
suffering from alcohol use disorder (AUD).  
The specific AIMS will be: 
1)
To determine the effectiveness of Soberlink’s ability to increase abstinence 
2)
To evaluate the impact of Soberlink’s device on the participant based on their quality of health and 
sobriety.
3)
To evaluate the extent to which need for higher levels of follow-up care and treatment is reduced for 
individuals who have had access to the Soberlink device.
2.
Probable Duration of Project: State the expected duration of the project, including all follow-up and data 
analysis activities.  
The duration of the time of the study will be two years to complete.  This will include (as seen on Figure 1) 
time for IRB approval and recruitment, randomization and completion the study, follow-up and lastly analysis 
with dissemination.  
Figure 1: Overview and Timeline 
0
3
6
9
12
15
18
21
24
4
Phase 1 IRB and Recruitment 
…
9
Phase 2 Randomization and Trial 
15
Phase 3 Follow-up
3
Phase 4 - Analysis and Dissemination
3.
Background: Describe the background information that led to the plan for this project. Provide references to 
support the expectation of obtaining useful scientific data.
Alcohol dependence (AD) has been characterized as a chronic disorder that presents an enduring vulnerability 
to relapse. Unfortunately, AD treatment is commonly delivered as a series of acute care sessions (Etheridge, 
Craddock, Dunteman, & Hubbard, 1995; McLellan, Lewis, O'Brien, & Kleber, 2000), which means that 
individuals seeking treatment often face the challenge of maintaining sobriety upon returning to the same 
environment where they had struggled with alcohol dependence previous to seeking treatment. Studies have 
shown that 40%–60% of patients treated for alcohol problems relapse within 3 months, and this rate 
increases to 70%–80% within 12 months (Bradizza, Stasiewicz, & Paas, 2006; McLellan et al., 2000; Witkiewitz 
& Marlatt, 2004). medical costs associated with alcohol use disorders (AD) are over $120 billion per year, until 
very recently, there has been relatively little involvement of physicians or other general healthcare providers 
in the treatment of AUDs (Sacks et al., 2015). By convention, most contemporary AUD treatment has been 
delivered outside mainstream healthcare by specialty “treatment programs” that are time-limited by 
insurance restrictions and highly structured to deliver a standardized “program” of care (McLellan et al., 
2005; Foll et al., 2009). 
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Outcome research has typically concentrated upon program “graduation” rates and “posttreatment” 
abstinence as standard measures of treatment “success” or “failure” (McLellan et al., 2005).There are 
conceptual (McKay and Hiller-Sturmhöfel, 2011; McLellan et al., 2014) and some methodological indications 
(Kim et al., 2011; Oslin et al., 2014) that ADs may be better managed using a chronic illness approach. 
However, for the reasons described above, there is not yet the evidence-base needed to guide a 
personalized, chronic care approach to the treatment of ADs, or even to guide the use of monitoring 
technology within that treatment approach. Previous research on the use of mobile phones for AD treatment 
include telephone-based monitoring of medication adherence (Stoner & Hendershot, 2012), behavioral self-
control training to withstand cravings (Yu et al., 2012), and video-recording breathalyser tests to measure 
breath alcohol content (BrAC) combined with contingency management procedures (Alessi & Petry, 2013). 
Two recent studies used, the Addiction-Comprehensive Health Enhancement Support System (ACHESS) 
(Gustafson et al., 2014) and Location-Based Monitoring and Intervention for Alcohol Use Disorders (LBMI-A) 
(Dulin, Gonzalez, & Campbell, 2014) to monitor patients with AD. These two smartphone applications with 
composite functions have proven effective in reducing the incidence of hazardous drinking and promoting 
abstinence. 
Soberlink is a comprehensive alcohol monitoring system designed to remotely monitor a person’s Blood 
Alcohol Concentration (BAC). Combining a professional grade handheld breathalyzer with wireless 
connectivity, the technology includes real-time facial recognition, robust tamper detection and real-time 
alerting. The Soberlink System also provides professionals with a password protected, HIPAA compliant 
healthcare portal where they can set up a variety of advanced reporting tools. Soberlink is designed and 
assembled in the United States and is one of the few FDA 510(k) cleared medical devices in remote alcohol 
monitoring. The breathalyzer device uses fuel cell technology to detect BAC, is handheld, and includes an 
embedded camera. It uses wireless technology to send the data in real-time. The cloud-based monitoring 
system includes a scheduler that automatically tracks scheduled tests and sends reminders to the client for 
testing. Retesting is automatically scheduled if a positive test is received or if a client’s identity cannot be 
verified. The device locks out for 15 minutes to ensure alcohol evaporates before the next test. Facial 
Recognition software ensures identity is approved or declined in real-time. Artificial intelligence is used to 
report on testing and Green, Yellow and Red visual icons are used in all reporting to identify events.
Aware Recovery Care (ARC) is an in-home addiction treatment program that provides highly intensive, 
rigorously monitored, 52 weeks of intensive outpatient care, based on a chronic disease model of care. This 
model was first used in 2012 and delivers a four-phased, year-long program treating substance use disorder. 
The approach implements principles of evidence-based practices including Motivational Interviewing, 
Cognitive Behavioral Therapy, and Dialectical Behavioral Therapy, in the home setting. Additionally, all 
families are offered education and the opportunity to participate in the treatment process. ARC works to 
transform the home environment into a healthy, healing environment for clients and families to recover. ARC 
supports clients in creating and maintaining both structure and recovery that is tailored to each individual's 
needs. 
4.
Research Plan: Summarize the study design and research procedures using non-technical language that can 
be readily understood by someone outside the discipline. Be sure to distinguish between standard of care vs. 
research procedures when applicable, and include any flowcharts of visits specifying their individual times and 
lengths. Describe the setting in which the research will take place.
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Study Sites/Feasibility. The study will be conducted in at clinical office for Aware Recovery Center (North Haven, 
CT). The census of the facility on average recruits 38 new individuals a month and they currently have 300. This 
will be the first study, completed at this site, which is a randomized control treatment design.  
Procedure: 
 (www.randomized.com). Individuals will be placed into one of two conditions (Soberlink+Aware; Named Group 1) 
or (Aware; Named Group 2).  Both groups will be consented by either the principal investigator or the research 
assistants who will be present at all screenings and ensured that they understand their rights. Participants will be 
told they are allowed to leave or withdraw for the study without penalty or hindering the relationship between 
themselves and Aware Recovery.  
Figure 2: Time Intervals for Assessments
Soberlink+Aware/ Group 1: 
Group 1
This group will include access to the Aware treatment (see ‘Aware treatment’ below), and access to the Soberlink 
device. A research assistant will train the participant and provide an orientation (see orientation to Soberlink 
below) for what will be taught.  All participants will be complete screening and outcome assessments, along with 
using the Soberlink device for the first time. The participant’s Soberlink device will be set up to test participants 
twice a day.  Reminder emails (see attached reminder emails) will be sent out the day before, and the day of the 1 
month, 2 month and 3-month surveys that will be completed online in the participant’s home through a secure 
link sent directly to them.  Subsequent phone calls will be made by the research assistant to the participant if they 
have missed their evaluation.  Upon completion of the surveys, the participants in group 1 will be paid, and 
reminded of the subsequent follow-ups. The estimated time of the process will take 45 to 60 minutes to 
complete.  
Orientation to Soberlink
Patients assigned to the Soberlink-Aware condition will receive a 30-minute orientation to the Soberlink, including 
an initial their first administration of the BAU. Participants will learn the following: 
1.
The Soberlink System consists of a wireless Breathalyzer that uses a professional grade fuel cell sensor to 
detect alcohol levels at an accuracy of +/-.005 BAC. 
2.
The device also has an embedded camera and uses Facial Recognition software to automatically identify 
the client at the end of the test. 
3.
The participant will have a set testing schedule that consists of a minimum of 2 tests per day. The 
participant will have a test window of 2 hours with a Late window of 1 hour. 
4.
When the participant blows into the Soberlink device, it will capture the BAC level while the embedded 
camera takes a photo of the participant during the test
The breathalyzer device uses fuel cell technology to detect BAC, is handheld, and includes an embedded camera. 
It uses wireless technology to send the data in real-time. The cloud-based monitoring system includes a scheduler 
that automatically tracks scheduled tests and sends reminders to the client for testing. Retesting is automatically 
scheduled if a positive test is received or if a client’s identity cannot be verified. The device locks out for 15 
minutes to ensure alcohol evaporates before the next test. Facial Recognition software ensures identity is 
Admission
1 Month Eval
2 Month Eval
3 Month Eval
6 week
Follow-Up
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approved or declined in real-time. Artificial intelligence is used to report on testing and Green, Yellow and Red 
visual icons are used in all reporting to identify events.
All individuals in group 1 will be required to complete two BAC’s per day.  A testing window will be scheduled with 
each individual between 7am to 9am (morning BAC) and 8pm to 10pm (evening BAC). During the testing window, 
all individual in this group can provide the BAC at any time within the window, all tests performed outside the 
window will be recorded but counted as unscheduled test on the BAC spreadsheet. All participants can opt in to 
receive a text-reminder sent by Soberlink’s automated server to remind the patient about their morning and 
evening BACs. 
Individuals who miss two consecutive BAC’s will be followed up by either Research Assistant or the PI. Individuals 
who miss four consecutive BAC’s without contact of the PI or the research assistant will be temporarily hold 
unless the individual has expressed thoughts of leaving the study prematurely. Missing more than six consecutive 
BACs without communication will result in termination from the study by the PI.  A pilot study contacted at Aware 
prior to the PI being involved demonstrated little reactivity or premature departure for those who had access to 
the Soberlink device.  
Aware/Group 2 :
This group will not receive access or training to Soberlink device, however they will be recruited to complete the 
same set of surveys at the same time intervals (See Figure 2). Upon completion of the surveys, the participants in 
group 2 will be paid, and told reminded the subsequent follow-ups. Reminder emails (see attached reminder 
emails) will be sent out the day before, and the day of the 1 month, 2 month and 3 month evaluations.  
Subsequent phone calls will be made by the research assistant to the participant if they have missed their 
evaluation.  The estimated time of the process will take under 30 minutes to complete.  
Aware Treatment: Aware Recovery Care (ARC) is an in-home addiction treatment program that provides highly 
intensive, rigorously monitored, 52 weeks of intensive outpatient care, based on a chronic disease model of care. 
The approach implements principles of evidence-based practices including Motivational Interviewing, Cognitive 
Behavioral Therapy, and Dialectical Behavioral Therapy. Additionally, all families are offered education and the 
opportunity to participate in the treatment process. The client's individualized treatment team consists of a 
licensed professional (nurse or master’s level clinician), two Certified Recovery Advisors (CRAs), and an LMFT. The 
clients care team is overseen by a master's level alcohol and drug counselor, an advanced practicing nurse, and an 
addiction psychiatrist. The licensed professional is responsible for leading the team, collaborating with external 
providers, communicating with family members and providing referrals to external providers as needed.  The 
CRAs are lived-experience advisors, at least one of whom is both age and gendered match in order to provide a 
more intimate therapeutic relationship. CRAs are responsible for delivering a staged biopsychosocial curriculum. 
Familial involvement is another key component of this model, with education and frequent communication 
provided. All care teams include a Licensed Marriage and Family Therapist for 6 family therapy sessions, as well as 
4 family education sessions delivered by a special trained family education facilitator. 
Randomization. At the randomization visit, the research assistant will conduct assessments to evaluate alcohol 
use. Eligible patients will be assigned to one of the two groups using randomization sequence. The 
randomization sequence will allow for equal representation between two groups without bias on gender, age 
or ethnicity given all individuals will be categorized as single variable
 Assessments: 
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We are planning to assess a broad range of subject characteristics, process measures and treatment 
outcomes over the 3-month trial and at the 6 week post treatment follow-up (See Table 1). Baseline 
assessments are designed to ensure that patients meet eligibility criteria and that important predictor 
variables such as cognitive impairment are assessed. Baseline measures include evaluation and understanding 
of the extent of the AUD issue from a several different vantages points. Primary outcome measures include 
reductions in days per week of use and negative BAU screens for alcohol. Monthly assessments will take 
approximately 30 minutes and monthly and follow-up’s 45 minutes. Patients will be paid $10 for the baseline 
and monthly assessments, $25 for follow-up assessments (up to $65 total).
Table 1. List of Assessments
Screening & Baseline Assessments 
a)
Generalized Anxiety Disorder (GAD-7) will be used to assess for generalized anxiety 
b)
The Structured Clinical Interview for DSM-V (SCID) will be used to assess lifetime and current 
DSM- V substance use and Axis I and II psychiatric disorders181 and screen patients for 
psychiatric eligibility.
c)
Patient Health Questionnaire (PHQ-9) will be used for depression symptoms for the past 2 weeks.
d)   Substance Use History will assess frequency, intensity and duration of use and route of 
administration of drugs.
e)
Alcohol Abstinence Self-Efficacy Scale will evaluate the participant’s beliefs of alcohol usage.
Outcome Measures.
a)
Soberlink (BAC): sensor to detect alcohol levels at an accuracy of +/-.005 BAC. BAC is 
established by the manufacturer based on predetermined cut off points
The Time Line Follow Back (TLFB), administered by research administer onto a secure web-
server. Will be used to collect self-reported frequency, quantity and route of administration of 
prescription opioids, cocaine, alcohol and other drugs use during the preceding 30 days, and 
b)
use 185-
187
c)
Quality of Life Scale is a self-directed survey that assess the quality of life of the individual.  
d)    Soberlink Use Survey is a self-directed survey that evaluates the effectiveness of the device. 
e)   The Drug Risk Response Test (DRRT) 189,190 is a role-playing assessment of coping responses to 
drug use risk situations, and takes 8-10 minutes to complete. The instrument is composed of six 
audio-taped scenarios. Patients are instructed to imagine that they are in the situation and 
provide a detailed account to how they would respond to that situation. Patient accounts are 
recorded and scored by trained evaluators. The instrument provides 4 measures: the number of 
coping responses, the number of activities per response, the quality of the best response and the 
quality of the overall response The measure has been show to mediate days of drug abstinence
f) AUDIT C- is brief alcohol screen that reliably identifies patients who are hazardous drinkers or have 
active alcohol use disorders. 
Data monitoring procedures involve an organizational structure of clearly defined tasks assigned to all 
research personnel involved in the conduct of this study. The organizational structure used to ensure quality of 
data in this project include: 1) extensive training and close supervision of research assistants in data collection; 
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2) direct entry of most data at time of collection; and 3) utilization of on-line error- checking procedures. The 
PI supervises data procedures. All error corrections are fully documented in the research records of the study. 
All research personnel are required to participate in and document training in protection of human subjects 
and the responsible conduct of scientific research. Data entry and review in this study will be conducted using a 
web-based data collection and monitoring system. Another set of automatic email reports, sent on a weekly or 
less frequent basis, provides a set of designated recipients (e.g., the PI or Project Director) with information 
about study logistics, such as number of subjects enrolled, number of subjects active in the protocol, gender 
composition of the sample, percentage of missing data by each assessment instrument, or any other 
information necessary to monitor the progress of the project and the compliance with the protocol. A fully 
computerized system allows this type of monitoring without furnishing investigators with data that could 
influence the outcome of the study. The system meets the highest security and reliability standards. All 
connections to the systems are secured and encrypted using 128-bit strong encryption protocols and only 
authorized users are able to access the system. 
5.
Genetic Testing   
N/A ☒
A. Describe
i.
the types of future research to be conducted using the materials, specifying if immortalization of 
cell lines, whole exome or genome sequencing, genome wide association studies, or animal 
studies are planned Write here
ii.
the plan for the collection of material or the conditions under which material will be received 
Write here
iii. the types of information about the donor/individual contributors that will be entered into a 
database Write here
iv. the methods to uphold confidentiality Write here
B. What are the conditions or procedures for sharing of materials and/or distributing for future research 
projects? Write here
C. Is widespread sharing of materials planned? Write here
D. When and under what conditions will materials be stripped of all identifiers? Write here
E. Can donor-subjects withdraw their materials at any time, and/or withdraw the identifiers that connect 
them to their materials?  Write here
i.
How will requests to withdraw materials be handled (e.g., material no longer identified: that is, 
anonymized) or material destroyed)? Write here
F.
Describe the provisions for protection of participant privacy Write here
G. Describe the methods for the security of storage and sharing of materials  Write here
6.
Subject Population: Provide a detailed description of the types of human subjects who will be recruited into 
this study.
We will recruit 110 individuals with alcohol use disorder as diagnosed by the DSM-5.  They will be recruited at 
Aware Recovery Center in North Haven, CT.  
7. Subject classification: Check off all classifications of subjects that will be specifically recruited for enrollment in 
the research project. Will subjects who may require additional safeguards or other considerations be enrolled 
in the study? If so, identify the population of subjects requiring special safeguards and provide a justification 
for their involvement.
☐Children
☐ Healthy 
☐Fetal material, placenta, or dead fetus
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☐Non-English Speaking
☐ Prisoners
☐Economically disadvantaged persons
☐Decisionally Impaired
☐ Employees
☐Pregnant women and/or fetuses
☐Yale Students 
☐ Females of childbearing potential
NOTE: Is this research proposal designed to enroll children who are wards of the state as potential subjects?
Yes ☐  No ☒ 
8. Inclusion/Exclusion Criteria: What are the criteria used to determine subject inclusion or exclusion?
Inclusion Criteria: 1) are at least 21 years old, 2) currently enrolled at Aware In home treatment, and 3) Primary 
or secondary DSM-5 diagnosis of alcoholism use disorder (AUD). 
Exclusion Criteria: 1) Current suicide or homicide risk, 2) meet criteria for DSM-IV current psychotic disorder, or 
bipolar disorder, 3) does not have phone access with text message capabilities , 4) Unable to read or understand 
English, 5) Unable to complete the study because of anticipated incarceration or move, 6) Life-threatening or 
unstable medical problems, 7) No course of current or pending legal action, 8) Soberlink results being used for 
child custody or legal circumstance.
9. How will eligibility be determined, and by whom? 
Subjects will be interviewed by a trained and supervised research assistant to determine interest in 
participating in the study and eligibility.  Participants will be interviewed at the Aware facility prior during the 
admission process, or via Zoom or telephone if the subject is unable to present to the clinic, using standardized 
psychological assessments or will complete similar standardized self-report forms. Eligibility will be evaluated 
by the research assistant and reviewed with the project director or PI prior to initiation
10. Risks: Describe the reasonably foreseeable risks, including risks to subject privacy, discomforts, or 
inconveniences associated with subjects participating in the research. 
The main risk associated with the study is the possibility that confidential information obtained during the 
study will be disclosed, given the social and legal sanctions associated with the use of psychoactive 
substances and psychiatric symptoms. Patient names and other identifying information do not appear on 
research records. Finally, we will clearly explain our mandated obligation to report incidents, as well as 
suspicion of child abuse or neglect, and risk of harm to self or others, and advise subjects that continued 
alcohol use alone does not require reporting to child protection services.
Soberlink: All Soberlink results are sent directly from devices to Soberlink web portal where they are stored 
under specific password protected account, that only the PI and the research assistant will have access to.  
Soberlink uses Rackspace servers to host our sites which all use a Secure Sockets Layer (SSL) certificate and 
our public facing sites go beyond that and use an Extended Validation SSL (EVSSL or EV SSL) certificate. These 
Certs prevent online transaction fraud, EVSSL certificates help organizations gain consumer trust by providing 
secure transaction processes.  All of the SSL Certificates use AES 256 encryption which is considered the 
industry standard.
Rating Scales and Assessments: These are all noninvasive and should add no risk. The major disadvantage is 
the time it takes to complete them. Confidentiality of these results is specifically protected by Federal laws, 
and all records will be identified by code number only, with the master file kept under lock by the Principal 
Investigator.
11. Minimizing Risks: Describe the manner in which the above-mentioned risks will be minimized.
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Confidentiality with regard to collected materials will be maintained via a numbered reference system 
maintained by the principal investigator. Subjects’ names will appear only on a consent form and “key” form 
kept in a secured cabinet by the PI, separate from the subject records.  All collected materials will be kept in 
locked file cabinets in a secured office. Inclusion and exclusion criteria, and the use of trained clinical 
interviewers in the assessment phase of the study will help to avoid the acceptance of subjects into this study 
who have either insignificant substance abuse or significant psychiatric contraindications to both treatments in 
this study.  In cases of psychological deterioration or worsening substance abuse, we will recommend to 
patients to contact their physician immediately and consider withdrawing from the study to receive more 
intensive treatments.  When necessary subjects will be withdrawn from this study and research staff will assist 
patients with appropriate sites for treatment such as the care coordinator, their sponsor or the emergency 
room.  In instances of suicidal or homicidal risk, appropriate authorities including their primary provider will be 
informed and necessary actions (seeking crisis/suicidality evaluations and possible hospitalization) taken. 
Soberlink have facial recognition to confirm its the correct participant testing, while also have internal sensors 
and algorithms that can detect if the participant is using an alternative air source (i.e. air pump) or sample is 
not consistent with human breath. 
 
12. Data and Safety Monitoring Plan: Include an appropriate Data and Safety Monitoring Plan (DSMP) based on 
the investigator’s risk assessment stated below. (Note: the HIC will make the final determination of the risk to 
subjects.)
a. 
What is the investigator’s assessment of the overall risk level for subjects participating in this 
study? The risks associated with participating in this study can be categorized as minimal (i.e., 
risks are commensurate with everyday risks associated with drug abuse treatment and data have 
adequate protection for maintaining confidentiality).
b.
If children are involved, what is the investigator’s assessment of the overall risk level for the 
children participating in this study? N/A
c.
Include an appropriate Data and Safety Monitoring Plan. Examples of DSMPs are  
available here http://your.yale.edu/policies-procedures/forms/420-fr-01-data-and-safety-
monitoring-plans-templates for
i.
Minimal risk
ii.
Greater than minimal
d. For multi-site studies for which the Yale PI serves as the lead investigator:
i.
How will adverse events and unanticipated problems involving risks to subjects or others be 
reported, reviewed and managed? NA
ii.
What provisions are in place for management of interim results? NA
iii.
What will the multi-site process be for protocol modifications? NA
The principal investigator is responsible for monitoring the data, assuring protocol compliance, and 
conducting the safety reviews at the specified frequency monthly, quarterly.  During the review 
process the principal investigator will evaluate whether the study should continue unchanged, require 
modification/amendment, or close to enrollment.
The principal investigator, the Institutional Review Board (IRB) have the authority to stop or suspend 
the study or require modifications.
This protocol presents minimal risks to the subjects and Unanticipated Problems Involving Risks to Subjects or 
Others (UPIRSOs), including adverse events, are not anticipated. In the unlikely event that such events occur, 
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Reportable Events (which are events that are serious or life-threatening and unanticipated (or anticipated but 
occurring with a greater frequency than expected) and possibly, probably, or definitely related) or 
Unanticipated Problems Involving Risks to Subjects or Others that may require a temporary or permanent 
interruption of study activities will be reported immediately (if possible), followed by a written report within 5 
calendar days of the Principal Investigator becoming aware of the event to the IRB (using the appropriate forms 
from the website) and any appropriate funding and regulatory agencies. The investigator will apprise fellow 
investigators and study personnel of all UPIRSOs and adverse events that occur during the conduct of this 
research project through regular study meetings and/or via email as they are reviewed by the principal 
investigator. The protocol’s research monitor, study sponsors, funding and regulatory agencies will be informed 
of serious adverse events within 5 days of the event becoming known to the principal investigator.
13. Statistical Considerations: Describe the statistical analyses that support the study design. 
A sample size of 110 would provide >80% power (α= .05) to detect a medium to large effect size (d= .65) and 
allow to fully evaluate gender differences. Greater power is provided by the repeated measures GEE and 
LMM analysis for the primary outcomes of BAC screen negative for alcohol drugs and days/month of self-
reported illicit drug use. Sample size calculations for LMM are dependent on the number of repeated events, 
the retention rate, and the interclass correlation, in addition to the alpha level, the expected effect size, and 
the statistical power 198. The current randomized trial would provide estimates to guide a power analysis for 
a large Stage II study. Statistical procedures and models for analyzing data have been selected according to 
the research hypotheses being investigated and the types of data available. We will use α< .05, but will use 
appropriate corrections for multiple tests. Statistical analyses will be conducted on an intention-to-treat 
sample using SPSS. Using chi square and t-tests, we will first conduct preliminary analyses of the adequacy of 
the randomization procedure, the comparability of baseline measures for the two groups, and the possible 
need for covariates in the analyses of treatment outcome data.
SECTION II: RESEARCH INVOLVING DRUGS, BIOLOGICS, RADIOTRACERS, PLACEBOS AND DEVICES
If this section (or one of its parts, A or B) is not applicable, check off N/A and delete the rest of the section.
A.  RADIOTRACERS
☒N/A
1.
Name of the radiotracer: Write here
2.
Is the radiotracer FDA approved?    ☐YES 
☐NO
If NO, an FDA issued IND is required for the investigational use unless RDRC assumes oversight. 
3.
Check one:   ☐IND#  Write here or  ☐RDRC oversight (RDRC approval will be required prior to use)
4.    Background Information: Provide a description of previous human use, known risks, and data addressing 
dosage(s), interval(s), route(s) of administration, and any other factors that might influence risks. If this is the first 
time this radiotracer is being administered to humans, include relevant data on animal models. 
Write here
4.    Source:  Identify the source of the radiotracer to be used. Write here
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5.    Storage, Preparation and Use: Describe the method of storage, preparation, stability information, method of 
sterilization and method of testing sterility and pyrogenicity.
 Write here
B.  DRUGS/BIOLOGICS    ☒N/A
1.
If an exemption from IND filing requirements is sought for a clinical investigation of a drug product that is 
lawfully marketed in the United States, review the following categories and complete the category that 
applies (and delete the inapplicable categories):
Exempt Category 1: The clinical investigation of a drug product that is lawfully marketed in the United States 
can be exempt from IND regulations if all of the following are yes: 
1.
The intention of the investigation is NOT to report to the FDA as a well-controlled study in support 
of a new indication for use or to be used to support any other significant change in the labeling for 
the drug.
☐
2.
The drug that is undergoing investigation is lawfully marketed as a prescription drug product, and 
the intention of the investigation is NOT to support a significant change in the advertising for the 
product.
☐
3.
The investigation does NOT involve a route of administration or dosage level or use in populations 
or other factor that significantly increases the risks (or decreases the acceptability of the risks) 
associated with the use of the drug product
☐
4.
The investigation will be conducted in compliance with the requirements for institutional (HIC) 
review and with the requirements for informed consent of the FDA regulations (21 CFR Part 50 and 
21 CFR Part 56).
☐
5.
The investigation will be conducted in compliance with the requirements regarding promotion and 
charging for investigational drugs.
☐
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 Exempt Category 2 (all items i, ii, and iii must be checked to grant a category 2 exemption)
☐i. The clinical investigation is for an in vitro diagnostic biological product that involves one or
more of the following (check all that apply):
☐ Blood grouping serum
☐ Reagent red blood cells 
☐ Anti-human globulin
☐ii. The diagnostic test is intended to be used in a diagnostic procedure that confirms the
diagnosis made by another, medically established, diagnostic product or procedure; and
☐iii. The diagnostic test is shipped in compliance with 21 CFR §312.160.
 Exempt Category 3
☐ The drug is intended solely for tests in vitro or in laboratory research animals if shipped in accordance with 
21 CFR 312.60
 Exempt Category 4 
☐ A clinical investigation involving use of a placebo if the investigation does not otherwise require submission 
of an IND. 
2. 
Background Information: Provide a description of previous human use, known risks, and data addressing 
dosage(s), interval(s), route(s) of administration, and any other factors that might influence risks. If this is the first 
time this drug is being administered to humans, include relevant data on animal models. 
Write here
3. 
Source:  Identify the source of the drug or biologic to be used. Write here
a)
Is the drug provided free of charge to subjects? ☐YES 
☐NO 
If yes, by whom? Write here
4.
Storage, Preparation and Use: Describe the method of storage, preparation, stability information, and for 
parenteral products, method of sterilization and method of testing sterility and pyrogenicity.
 Write here
Check applicable Investigational Drug Service utilized:
    ☐  YNHH IDS                                                        ☐  CMHC Pharmacy                                           ☐ West Haven VA
    ☐  PET Center                                                      ☐    None      
    ☐  Other: 
Note: If the YNHH IDS (or comparable service at CMHC or WHVA) will not be utilized, explain in detail how the PI 
will oversee these aspects of drug accountability, storage, and preparation.  
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5.
Use of Placebo: 
☐Not applicable to this research project
If use of a placebo is planned, provide a justification which addresses the following:
a)
Describe the safety and efficacy of other available therapies. If there are no other available therapies, state 
this. Write here
b)
State the maximum total length of time a participant may receive placebo while on the study. 
Write here
c)
Address the greatest potential harm that may come to a participant as a result of receiving placebo. 
Write here
d)
Describe the procedures that are in place to safeguard participants receiving placebo. 
Write here
6.
Continuation of Drug Therapy After Study Closure   ☐Not applicable to this project
Are subjects provided the opportunity to continue to receive the study drug(s) after the study has ended?
☐ Yes   If yes, describe the conditions under which continued access to study drug(s) may apply as well as 
conditions for termination of such access.  Write here
☐ NO   If no, explain why this is acceptable. Write here
 B.  DEVICES
 ☐N/A
1.
Are there any investigational devices used or investigational procedures performed at Yale-New Haven 
Hospital (YNHH) (e.g., in the YNHH Operating Room or YNHH Heart and Vascular Center)?  ☐Yes   ☒No   
 If Yes, please be aware of the following requirements:
A YNHH New Product/Trial Request Form must be completed via EPIC: Pull down the Tools tab in the EPIC Banner, 
Click on Lawson, Click on “Add new” under the New Technology Request Summary and fill out the forms 
requested including the “Initial Request Form,” “Clinical Evidence Summary”, and attach any other pertinent 
documents. Then select “save and submit” to submit your request;   AND
Your request must be reviewed and approved in writing by the appropriate YNHH committee before 
patients/subjects may be scheduled to receive the investigational device or investigational procedure.
2.
Background Information: Provide a description of previous human use, known risks, and any other factors 
that might influence risks. If this is the first time this device is being used in humans, include relevant data on 
animal models. 
The Soberlink device has been FCC and FDA approved, and has been utilized in several all clinical trials 
evaluating the efficacy and durability of the device. It has demonstrated by Skipper et al (2014) as a pilot 
study, and by Koffarnus, et al 2017 as a randomized control study to evaluate the preliminary efficacy within 
adults with alcohol use disorder.  The device utilizes face-id to recognize and document the individual who is 
providing a BAC, however all information is stored directly onto the Soberlink’s secure server (see below for 
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security measures). Given that it has been approved by the FCC, all other risks have been minimalized based 
on research. 
3.
Source: 
a) Identify the source of the device to be used. Soberlink Cellular 
b) Is the device provided free of charge to subjects? ☒Yes   ☐No    
4.
Investigational device accountability:  State how the PI, or named designee, ensures that an investigational 
device is used only in accordance with the research protocol approved by the HIC, and maintains control of 
the investigational device as follows:
a)
Maintains appropriate records, including receipt of shipment, inventory at the site, dispensation or use 
by each participant, and final disposition and/or the return of the investigational device (or other 
disposal if applicable): Write here
b)
Documents pertinent information assigned to the investigational device (e.g., date, quantity, batch or 
serial number, expiration date if applicable, and unique code number): Write here
c)
Stores the investigational device according to the manufacturer's recommendations with respect to 
temperature, humidity, lighting, and other environmental considerations: Write here
d)
Ensures that the device is stored in a secure area with limited access in accordance with applicable 
regulatory requirements: Write here
e)
Distributes the investigational device to subjects enrolled in the IRB-approved protocol: Write here
SECTION III: RECRUITMENT/CONSENT AND ASSENT PROCEDURES 
1. Targeted Enrollment: Give the number of subjects: 110
a.
Targeted for enrollment at Yale for this protocol: 110 
b.
If this is a multi-site study, give the total number of subjects targeted across all sites: N/A
2.
Indicate recruitment methods below.  Attach copies of any recruitment materials that will be used.
☒Flyers
☐ Internet/web postings
☐ Radio
☐ Posters
☐ Mass email solicitation
☐ Telephone
☐ Letter
☐ Departmental/Center website
☐ Television
☐ Medical record review* 
☐ Departmental/Center research boards
☐ Newspaper
☐ Departmental/Center newsletters
☐ Web-based clinical trial registries
☐ Clinicaltrails.gov 
☐ YCCI Recruitment database
☐ Social Media (Twitter/Facebook): 
☒ Other: Word of mouth 
* Requests for medical records should be made through JDAT as described at 
http://medicine.yale.edu/ycci/oncore/availableservices/datarequests/datarequests.aspx
3.  Recruitment Procedures: 
a. Describe how potential subjects will be identified. 
Clinicians at Aware Recovery Care (ARC) will inform potential participants through word of mouth about the 
research opportunity at ARC. Clinicians can direct them to the flyers or provide the contact information of the 
PI to set up a meeting.  Flyers will be hung around the main facility and breakout rooms where potential 
participate congregate. The flyer provides name and telephone number of where the PI can be reached.
b. Describe how potential subjects are contacted. Patients will be enrolled at Aware Recovery Center a 
Connecticut community practice will be invited to participate as patient respondents. Patients will be recruited 
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through a flyer posted and word of mouth (through their clinician) at the Aware facility.  Patients who call 
about information about the study will be screened based on inclusion criteria and ability to understand and 
read English.  Individuals who meet the criteria will meet with the research assistant either in person, via Zoom, 
or via telephone to be evaluated for eligibility.
c. Who is recruiting potential subjects? Research Assistants and/or the PI of the study 
4. Assessment of Current Health Provider Relationship for HIPAA Consideration:
Does the Investigator or any member of the research team have a direct existing clinical relationship with any 
potential subject? 
☐Yes, all subjects
☐Yes, some of the subjects
☒No
If yes, describe the nature of this relationship. Write here
5. Request for waiver of HIPAA authorization: (When requesting a waiver of HIPAA Authorization for either the 
entire study, or for recruitment purposes only.  Note: if you are collecting PHI as part of a phone or email 
screen, you must request a HIPAA waiver for recruitment purposes.)
Choose one: 
☐ For entire study - –
☒ For recruitment/screening purposes only– 
☐ For inclusion of non-English speaking subject if short form is being used and there is no translated HIPAA 
research authorization form available on the University’s HIPAA website at hipaa.yale.edu.
i.
Describe why it would be impracticable to obtain the subject’s authorization for use/disclosure of this 
data: It would be impracticable to obtain signed authorization prior to screening since the subjects 
will either call into the lab for screening or will be referred by the patient’s clinician. 
ii.
If requesting a waiver of signed authorization, describe why it would be impracticable to obtain the 
subject’s signed authorization for use/disclosure of this data: After seeing a flyer or being referred to 
the PI by the clinician, potential subject who call the PI/research team will be screened for eligibility 
over the phone or via Zoom.  The waiver of written authorization allows for the collection of PHI. If 
the subject is found to be ineligible, the PHI will not be kept. It would be impractical for all 
participants to have a signed authorization prior to enrollment in the research study as some will be 
calling from an off-site location and asking them to physically sign something may not be possible. 
Not enrolling these subjects into this minimal risk study because they are unable to sign a form could 
negatively influence the analysis. 
The investigator assures that the protected health information for which a Waiver of Authorization has been 
requested will not be reused or disclosed to any person or entity other than those listed in this application, except 
as required by law, for authorized oversight of this research study, or as specifically approved for use in another 
study by an IRB.
Researchers are reminded that unauthorized disclosures of PHI to individuals outside of the Yale HIPAA-Covered 
entity must be accounted for in the “accounting for disclosures log”, by subject name, purpose, date, recipients, 
and a description of information provided.  Logs are to be forwarded to the Deputy HIPAA Privacy Officer.
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6.
Process of Consent/Assent: Describe the setting and conditions under which consent/assent will be obtained, 
including parental permission or surrogate permission and the steps taken to ensure subjects’ independent 
decision-making. 
The process of consent will take place in person during the first study visit when possible. However, if the 
participant cannot meet with the research team due to one of the following: 1) not able to transport 
him/herself to the location,  2) autoimmune disease or 3) due to social distancing requirements, the consent 
process will take place remotely (see below),.  All potential subjects interested in the study will be fully 
informed about all aspects of the study using the appropriate consent attachment (adult consent or parental 
consent with child assent) and invited to participate. The PI or a research assistant will meet with them to read 
through the informed consent document to ensure that they each understand the content and to answer any 
potential questions that may arise.  Potential participants will be given a copy of the consent forms if they 
would like more time to decide if they wish to participate. Participants can request and keep a copy of the 
informed consent document. Participants will be informed that they are free to decline participation and 
withdraw from the study at any time and that neither action will adversely affect their relationship with study 
personnel or their clinic staff.
If the consent is not completed in-person, a secure email will be sent to the individual with an attached specific 
Zoom (www.zoom.com) ID, and time to meet online. The participant will meet with the either the PI or RA to 
complete the consent. Signature of the consent will be conducted electronically through Zoom. Zoom has the 
capabilities to allow participants to electronically sign (e-sign) their names, through manually signing their 
name with their finger on the screen through an IPAD or through a mouse on a computer. Patients can retain 
copies of the signed consent through a secondary secure email sent directly to them by the PI or RA.  Given 
that all clients at Aware have access to an online capability and have a secure registered email, there is no 
additional risks to the client. 
7.
Evaluation of Subject(s) Capacity to Provide Informed Consent/Assent: Indicate how the personnel obtaining 
consent will assess the potential subject’s ability and capacity to consent to the research being proposed. 
For all participants, the PI or a research assistant will meet with them to read through the informed consent 
document.  Each participant will be asked repeatedly throughout the consent whether they understand what is 
presented.  In addition, subjects will be asked to provide a summary of their understanding of the consent. 
Participants will also be asked what questions they have about the study procedures, their rights and 
obligations and the expectations and obligations of the study staff. When it is clear that they understand the 
material, both the research staff and the participant will sign two consents and the participant will retain a 
copy for their records
8.
Non-English Speaking Subjects: Explain provisions in place to ensure comprehension for research involving 
non-English speaking subjects. If enrollment of these subjects is anticipated, translated copies of all consent 
materials must be submitted for approval prior to use. 
Non-english speaking subjects will not be included in this protocol.
As a limited alternative to the above requirement, will you use the short form* for consenting process if you 
unexpectedly encounter a non-English speaking individual interested in study participation and the translation of 
the long form is not possible prior to intended enrollment?  YES ☐  NO ☒
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Note* If more than 2 study participants are enrolled using a short form translated into the same language, then 
the full consent form should be translated into that language for use the next time a subject speaking that 
language is to be enrolled.
Several translated short form templates are available on the HRPP website (yale.edu/hrpp) and translated HIPAA 
Research Authorization Forms are available on the HIPAA website (hipaa.yale.edu). If the translation of the short 
form is not available on our website, then the translated short form needs to be submitted to the IRB office for 
approval via modification prior to enrolling the subject.   Please review the guidance and presentation on use of 
the short form available on the HRPP website.
If using a short form without a translated HIPAA Research Authorization Form, please request a HIPAA waiver in 
the section above. 
9.
Consent Waiver: In certain circumstances, the HIC may grant a waiver of signed consent, or a full waiver 
of consent, depending on the study. If you will request either a waiver of consent, or a waiver of signed consent 
for this study, complete the appropriate section below.  
☐Not Requesting any consent waivers 
☒Requesting a waiver of signed consent:
☒ Recruitment/Screening only (if for recruitment, the questions in the box below will apply to 
recruitment activities only)
☐ Entire Study (Note that an information sheet may be required.)
 For a waiver of signed consent, address the following:
Would the signed consent form be the only record linking the subject and the research?  YES ☐  NO ☐ 
Does a breach of confidentiality constitute the principal risk to subjects? YES ☐  NO ☐
 
OR
Does the research pose greater than minimal risk? YES ☐    NO☐ 
Does the research include any activities that would require signed consent in a non-research context? YES ☐   
NO ☐
 ☐ Requesting a waiver of consent :
☐ Recruitment/Screening only (if for recruitment, the questions in the box below will apply to 
recruitment activities only)
☐ Entire Study 
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For a full waiver of consent, please address all of the following:

Does the research pose greater than minimal risk to subjects?  
☐ Yes If you answered yes, stop. A waiver cannot be granted.  
☐ No

Will the waiver adversely affect subjects’ rights and welfare? YES ☐    NO☐

Why would the research be impracticable to conduct without the waiver?  

Where appropriate, how will pertinent information be returned to, or shared with subjects at a later date?  
n/a
SECTION IV: PROTECTION OF RESEARCH SUBJECTS
    Confidentiality & Security of Data:
1.
What protected health information (medical information along with the HIPAA identifiers) about subjects will 
be collected and used for the research?   We will collect names, addresses, email addresses, phone numbers, 
birth date and admission, discharge dates, and psychiatric diagnosis. 
2.
How will the research data be collected, recorded and stored? 
Data will be stored two in two servers: 1) Soberlink uses Rackspace servers to host our sites which all use a 
Secure Sockets Layer (SSL) certificate and all of the SSL Certificates use AES 256 encryption which is considered 
the industry standard. This server will collect, record and store all data regarding any data that is inputted from 
the Soberlink device.   2) All surveys will be stored through Qualtrics. Qualtrics is an approved vendor of Yale 
University, and will securely store, record and store all participants surveys.   
3.
How will the digital data be stored? ☐CD  ☐DVD  ☐Flash Drive  ☐Portable Hard  Drive   ☒Secured Server  
☒Laptop Computer  ☐Desktop Computer  ☐Other
4.
What methods and procedures will be used to safeguard the confidentiality and security of the identifiable 
study data and the storage media indicated above during and after the subject’s participation in the study? 
All survey information will be stored on a privately maintained, Yale approved vendor (Qualtrics) for all data 
collection.  Specific native IPADs will be utilized for intake/admission only.  All other survey’s will be completed 
online in the participant’s home through a secure link sent directly to them.  Soberlink uses Rackspace servers to 
host our sites which all use a Secure Sockets Layer (SSL) certificate and our public facing sites go beyond that and 
use an Extended Validation SSL (EVSSL or EV SSL) certificate. These Certs prevent online transaction fraud, EVSSL 
certificates help organizations gain consumer trust by providing secure transaction processes.  All of the SSL 
Certificates use AES 256 encryption which is considered the industry standard.
The PI and his research team will have access to coded information and will be responsible for all data 
collection and analysis. All information will be stored on Yale’s secure server and will be encrypted. 
Information will not be uploaded to the sponsored server as identifiable data. Only aggregate 
information that does not consist of identifiers will be distributed to Soberlink, and Aware Recovery 
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Care. A copy of the de-identified information will be stored on a secure server at Yale. All data will be 
coded through in a password protected Microsoft Access file.  
All portable devices must contain encryption software, per University Policy 5100.  If there is a technical reason a 
device cannot be encrypted please submit an exception request to the Information Security, Policy and Compliance 
Office by clicking on url http://its.yale.edu/egrc or email it.compliance@yale.edu
5.
What will be done with the data when the research is completed? Are there plans to destroy the identifiable 
data? If yes, describe how, by whom and when identifiers will be destroyed. If no, describe how the data and/or 
identifiers will be secured. Files with identifiable data will be destroyed upon completion of the study in 
regulation with University Policy, non-PHI will be kept indefinitely for data analysis.   
6.
If appropriate, has a Certificate of Confidentiality been obtained? N/A
SECTION V: POTENTIAL BENEFITS
Potential Benefits: Identify any benefits that may be reasonably expected to result from the research, either to 
the subject(s) or to society at large. (Payment of subjects is not considered a benefit in this context of the risk 
benefit assessment.) 
There is no direct benefit to  individuals. We hope individuals who are randomized into the Aware+Soberlink 
group will receive access to the Soberlink device to monitor their alcohol usage and give them a permanent 
product measurement. Those who are not randomized into the control group will still have access to the Aware 
Model.  All individuals will have access to the Aware In-home treatment model. A five-phase step down model 
that provides access to continual care through an integrated team of medical, nursing, counselors and home 
health advisors coming to the patient’s home.  
The study will assist in evaluating the efficacy of the combined effect of Soberlink and Aware Model and given 
the limited risks of the current study the study would be categorized as minimal (risks are commensurate with 
everyday risks associated with alcohol abuse treatment as an adequate protection of confidentiality).  This 
information is important in order to develop cost-effective treatments for alcohol dependence, which ultimately 
would be of great benefit to society. Given the anticipated benefits to subjects and to society, the low risks to 
subjects are reasonable.
Patients who are randomized to the Soberlink group will have receive the Soberlink device and four months of 
service for no charge (390 USD).  Soberlink will purchase gift cards for the PI and PI/RA will distribute them to the 
participant. 
         SECTION VI: RESEARCH ALTERNATIVES AND ECONOMIC CONSIDERATIONS
1.
Alternatives: What other alternatives are available to the study subjects outside of the research? 
Patients are not restricted from seeking any ancillary treatment (i.e. Alcoholic Anonymous). 
2.
Payments for Participation (Economic Considerations): Describe any payments that will be made to subjects, 
the amount and schedule of payments, and the conditions for receiving this compensation.
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All patients in both groups (Soberlink+Aware and Aware) will be receive gift cards incentives of the following 
increments for completing assessments: Evaluations, Month 1, Month 2, Month 3will be 10USD. The six week 
follow-up appointment will be 25USD. The total compensation per person is 65USD.  
3.
Costs for Participation (Economic Considerations): Clearly describe the subject’s costs associated with 
participation in the research, and the interventions or procedures of the study that will be provided at no cost 
to subjects. 
For this study there will be no direct costs associated with participation in the research.  The study will not 
cover any costs that participants incur for their access to the internet or web browser.  Patients will be 
responsible for their own coverage through this.  
4.
In Case of Injury: This section is required for any research involving more than minimal risk, and for minimal 
risk research that presents the potential for physical harm (e.g., research involving blood draws).
N/A. The research is expected to involve only minimal risk.
a.
Will medical treatment be available if research-related injury occurs? NA
b.
Where and from whom may treatment be obtained? NA
c.
Are there any limits to the treatment being provided? NA
d.
Who will pay for this treatment? NA
e.
How will the medical treatment be accessed by subjects? NA
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IMPORTANT REMINDERS
Will this study have a billable service?  Yes ☐ 
 No☒
A billable service is defined as any service rendered to a study subject that, if he/she was not on a study, would 
normally generate a bill from either Yale-New Haven Hospital or Yale Medical Group to the patient or the patient’s 
insurer. The service may or may not be performed by the research staff on your study, but may be provided by 
professionals within either Yale-New Haven Hospital or Yale Medical Group (examples include x-rays, MRIs, CT 
scans, specimens sent to central labs, or specimens sent to pathology). Notes: 1. There is no distinction made 
whether the service is paid for by the subject or their insurance (Standard of Care) or by the study’s funding 
mechanism (Research Sponsored). 2. This generally includes new services or orders placed in EPIC for research 
subjects. 
If answered, “yes”, this study will need to be set up in OnCore, Yale’s clinical research management system, for 
Epic to appropriately route research related charges. Please contact oncore.support@yale.edu
Are there any procedures involved in this protocol that will be performed at YNHH or one of its affiliated entities?  
Yes ☐  No ☒ 
If Yes, please answer questions a through c and note instructions below.  
a. Does your YNHH privilege delineation currently include the specific procedure that you will perform? Yes ☐  No 
☐
b. Will you be using any new equipment or equipment that you have not used in the past for this procedure? Yes 
☐  No ☐
c. Will a novel approach using existing equipment be applied? Yes ☐  No ☐
 
If you answered “no” to question 4a, or "yes" to question 4b or c, please contact the YNHH Department of 
Physician Services (688-2615) for prior approval before commencing with your research protocol.
IMPORTANT REMINDER ABOUT RESEARCH AT YNHH 
Please note that if this protocol includes Yale-New Haven Hospital patients, including patients at the HRU, the 
Principal Investigator and any co-investigators who are physicians or mid-level practitioners (includes PAs, APRNs, 
psychologists and speech pathologists) who may have direct patient contact with patients on YNHH premises 
must have medical staff appointment and appropriate clinical privileges at YNHH. If you are uncertain whether 
the study personnel meet the criteria, please telephone the Physician Services Department at 203-688-2615. By 
submitting this protocol as a PI, you attest that you and any co-investigator who may have patient contact has a 
medical staff appointment and appropriate clinical privileges at YNHH.
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