Electronic Cigarette Use in Young Adult Men and Women
Phase: NA
Conditions: Cigarette Smoking, Tobacco Use
Sponsor: Yale University

 
HIC Protocol#: 1612018726 PI Camenga   Page 1 of 30   Version 8 Date 10.18.2017 
 
STUDY PROTOCOL: 
 
YALE UNIVERSITY 
 
                                  HUMAN INVESTIGATION COMMITTEE 
 
                                     Application to Involve Human Subjects in Biomedical Research 
100 FR1 (2016-1)  
 
SECTION I: ADMINISTRATIVE INFORMATION 
 
Title of Research Project:  
Electronic Cigarette Use in Young Adult Men and Women 
Principal Investigator: 
Deepa Camenga 
Yale Academic Appointment: 
Assistant Professor 
Department: Emergency Medicine 
Campus Address:  
464 Congress Avenue Suite 260, New Haven CT 06519 
Campus Phone : 
2037378310 
Fax : 2037854580 
Pager: 
2034944078 
E-mail: deepa.camenga@yale.edu 
Protocol Correspondent Name & Address (if different than PI): 
  
Campus Phone :  
Fax :  
E-mail:  
Yale Cancer Center CTO Protocol Correspondent Name & Address (if applicable): 
 
Campus Phone :  
Fax :  
E-mail:  
Business Manager: Breonna Harrington 
Campus Phone : (203) 737-
4210 
Fax : 
2037854580 
E-mail:   
breonna.harrington@yale.edu 
 
Investigator Interests: 
Does the principal investigator, or do any research personnel who are responsible for the design, 
conduct or reporting of this project or any of their family members (spouse or dependent child) 
have an incentive or interest, financial or otherwise, that may affect the protection of the human 
subjects involved in this project, the scientific objectivity of the research or its integrity? Note: 
The Principal Investigator (Project Director), upon consideration of the individual’s role and 
degree of independence in carrying out the work, will determine who is responsible for the 
design, conduct, or reporting of the research.  
See Disclosures and Management of Personal Interests in Human Research 
http://www.yale.edu/hrpp/policies/index.html#COI  
  xxxxxxNo  
 
Do you or does anyone on the research team who is determined by you to be responsible for the 
design, conduct or reporting of this research have any patent (sole right to make, use or sell an 

 
HIC Protocol#: 1612018726 PI Camenga   Page 2 of 30   Version 8 Date 10.18.2017 
 
invention) or copyright (exclusive rights to an original work) interests related to this research 
protocol? 
  xxxxNo 
 
 
 
 
SECTION II: GENERAL INFORMATION 
 
1. Performing Organizations:  Identify the hospital, in-patient or outpatient facility, school or 
other agency that will serve as the location of the research.  Choose all that apply: 
  
a. Internal Location[s] of the Study: 
 Magnetic Resonance Research Center  
 Yale University PET Center 
     (MR-TAC)    
 
 
 
 YCCI/Church Street Research Unit (CSRU) 
 Yale Cancer Center/Clinical Trials Office (CTO)    
 YCCI/Hospital Research Unit (HRU) 
 Yale Cancer Center/Smilow 
 
 YCCI/Keck Laboratories 
 Yale-New Haven Hospital 
 
 Yale-New Haven Hospital—Saint Raphael 
Campus 
 Cancer Data Repository/Tumor Registry 
 Specify Other Yale Location: 
 
 
 
 
 
b. External Location[s]: 
 APT Foundation, Inc. 
 
 
 
 Haskins Laboratories 
 Connecticut Mental Health Center 
 
 John B. Pierce Laboratory, Inc. 
 Clinical Neuroscience Research Unit (CNRU) 
Veterans Affairs Hospital, West Haven 
 
 Other Locations, Specify:  
 
 
 International Research Site  
(Specify location(s)):  SATU 1 Long Wharf New Haven, CT 
 
c. Additional Required Documents (check all that apply): 
 N/A 
*YCCI-Scientific and Safety Committee (YCCI-SSC) 
 
Approval Date:  
*Pediatric Protocol Review Committee (PPRC)  
 
Approval Date:  
*YCC Protocol Review Committee (YRC-PRC)  
 
Approval Date: 
 
*Dept. of Veterans Affairs, West Haven VA HSS 
 
Approval Date:  
*Radioactive Drug Research Committee (RDRC) 
 
Approval Date:  
 YNHH-Radiation Safety Committee (YNHH-RSC) 
 
Approval Date:  
 Yale University RSC (YU-RSC)  
 
 
 
Approval Date: 
 Magnetic Resonance Research Center PRC (MRRC-PRC) 
Approval Date: 
 *Nursing Research Committee 
 
 
 
 
Approval Date: 
 YSM/YNHH Cancer Data Repository (CaDR)  
 
Approval Date:  
 Dept. of Lab Medicine request for services or specimens form 
 Imaging on YNHH Diagnostic Radiology equipment request form (YDRCTO request) found 
at  http://radiology.yale.edu/research/ClinTrials.aspx) 
*Approval from these committees is required before final HIC approval is granted. See 
instructions for documents required for initial submission and approval of the protocol. Allow 
sufficient time for these requests. Check with the oversight body for their time requirements. 
 
STUDY 2 

 
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2. Probable Duration of Project: State the expected duration of the project, including all 
follow-up and data analysis activities.  
 
January 2017 through June 2018 (data collection and follow-up with participants) and continued 
data analysis from Sept 2017- Sept 2018. 
 
3. Research Type/Phase: (Check all that apply) 
a. Study Type 
   
 Single Center Study 
 
b. Study Phase 
 N/A 
    
 Pilot  
 Phase I 
 Phase II 
 Phase III 
 Phase IV 
    
 Other (Specify)  
4. Area of Research: (Check all that apply) Note that these are overlapping definitions and 
more than one category may apply to your research protocol. Definitions for the following 
can be found in the instructions section 4c: 
 Clinical Research: Patient-Oriented 
   
 Clinical Research: Outcomes and  
 Clinical Research: Epidemiologic and Behavioral  
        
      Health Services 
 Translational Research #1 (“Bench-to-Bedside”) 
 Interdisciplinary Research 
 Translational Research #2 (“Bedside-Comm”) 
 Community-Based Research 
 
5.   Is this study a clinical trial?  
 
 
Yes 
 
No 
 
 
6. Does the Clinical Trials Agreement (CTA) require compliance with ICH GCP (E6)?  N/A 
 
7. Will this study have a billable service? 
Yes 
 
 No
 
 
8.. Are there any procedures involved in this protocol that will be performed at YNHH or one of 
its affiliated entities?  Yes ___ No _xx__  If Yes, please answer questions a through c and note 
instructions below.  If No, proceed to Section III. 
 
SECTION III: FUNDING, RESEARCH TEAM AND TRAINING 
 
1. Funding Source:  
 
PI  
Title of Grant 
Name of Funding Source  
Funding 
Funding Mechanism 
 
Suchitra 
Krishnan-Sarin 
and Stephanie 
O’Malley 
Yale Tobacco 
Center for 
Regulatory Science 
Pilot Grant program 
NIH/NIDA 
 
 
4P50DA036151-04   
 
  Federal 
  State 
  Non 
Profit 
  Industry 
  Other 
For Profit  
  Other 
 
Grant-M#     IRES 13-
002663        
Contract#  
Contract Pending 
  
Investigator/Department 
Initiated 
  Sponsor Initiated 
  Other, Specify: 
 

 
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2. Research Team:  List all members of the research team. Indicate under the affiliation column whether 
the investigators or study personnel are part of the Yale faculty or staff, or part of the faculty or staff 
from a collaborating institution, or are not formally affiliated with any institution. ALL members of 
the research team MUST complete Human Subject Protection Training (HSPT) and Health 
Insurance Portability and Accountability Act (HIPAA) Training before they may be listed on the 
protocol.  See NOTE below. 
 
NOTE: The HIC will remove from the protocol any personnel who have not completed required training. 
A personnel protocol amendment will need to be submitted when training is completed. 
 
SECTION IV: 
 PRINCIPAL INVESTIGATOR/FACULTY ADVISOR/ DEPARTMENT CHAIR AGREEMENT 
 
 
Name 
Affiliation: Yale/Other 
Institution (Identify) 
 
NetID 
Principal Investigator  
Deepa Camenga 
Yale 
Drp9 
Role: Co I 
Ralitza Gueorguieva 
Yale 
rg268 
Role: Co I 
Suchitra Krishnan-Sarin 
Yale 
Sk236 
Role: RA 
Stephanie Dwy 
APT 
sd596 
Role: RA 
Skye Orazietti (MAIDEN 
NAME Skye Peters) 
APT 
sp537 
Role: Statistician 
Fanyong Li 
Yale 
fl86 
Role: Study Investigator 
       Krysten Bold 
Yale 
kb667 
Role:  Consultant 
Thomas Liss 
Yale 
tbl3 
Role: Data Manager 
Elaine LaVelle 
Yale 
et17 
As the principal investigator of this research project, I certify that: 
▪ 
The information provided in this application is complete and accurate. 
▪ 
I assume full responsibility for the protection of human subjects and the proper conduct of the research. 
▪ 
Subject safety will be of paramount concern, and every effort will be made to protect subjects’ rights and 
welfare. 
▪ 
The research will be performed according to ethical principles and in compliance with all federal, state 
and local laws, as well as institutional regulations and policies regarding the protection of human subjects. 
▪ 
All members of the research team will be kept apprised of research goals. 
▪ 
I will obtain approval for this research study and any subsequent revisions prior to my initiating the study 
or any change and I will obtain continuing approval of this study prior to the expiration date      
      of any approval period. 
▪ 
I will report to the HIC any serious injuries and/or other unanticipated problems involving risk to 
      participants. 
▪ 
I am in compliance with the requirements set by the University and qualify to serve as the principal 
investigator of this project or have acquired the appropriate approval from the Dean’s Office or Office of 
the Provost, or the Human Subject Protection Administrator at Yale-New Haven Hospital, or have a 
faculty advisor. 
▪ 
I will identify a qualified successor should I cease my role as principal investigator and facilitate a 
smooth transfer of investigator responsibilities. 
Deepa Camenga, MD  
 
 
 
 
 
 
 
 
 
 
 
12/5/16  
 

 
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Department Chair’s Assurance Statement 
Do you know of any real or apparent institutional conflict of interest (e.g., Yale ownership of a 
sponsoring company, patents, licensure) associated with this research project? 
 Yes (provide a description of that interest in a separate letter addressed to the HIC.) 
X No 
 
As Chair, do you have any real or apparent protocol-specific conflict of interest between yourself and 
the sponsor of the research project, or its competitor or any interest in any intervention and/or method 
tested in the project that might compromise this research project? 
Yes (provide a description of that interest in a separate letter addressed to the HIC) 
X No 
 
I assure the HIC that the principal investigator and all members of the research team are qualified by 
education, training, licensure and/or experience to assume participation in the conduct of this research 
trial. I also assure that the principal investigator has departmental support and sufficient resources to 
conduct this trial appropriately. 
 
   Lori Post 
  
 
 
 
12/6/16 
   Chair Name (PRINT) and Signature   
     
 
 
 Date 
 
   Emergency Medicine_____________________________ 
   Department 
 
 
YNHH Human Subjects Protection Administrator Assurance Statement 
Required when the study is conducted solely at YNHH by YNHH health care providers. 
 
As Human Subject Protection Administrator (HSPA) for YNHH, I certify that: 
▪ I have read a copy of the protocol and approve it being conducted at YNHH. 
▪ I agree to notify the IRB if I am aware of any real or apparent institutional conflict of interest. 
▪ The principal investigator of this study is qualified to serve as P.I. and has the support of the hospital 
for this research project. 
 
  ______________________________________ 
 
 
 
 
 
 
 
 
    YNHH HSPA Name (PRINT) and Signature         
 
 
Date 
 
 
 
 
 
 
 

 
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RESEARCH PLAN 
 
STUDY 2 
1. Statement of Purpose: State the scientific aim(s) of the study, or the hypotheses to be tested.  
 
Due to poor recruitment levels with our original study design, we are requesting a revision of the 
protocol to reflect updated study procedures.  As of 9/28/17- we have enrolled one patient in the 
study who has completed all study procedures. The data for this 1 participant will be analyzed, 
but not included in the total n for STUDY 2. This participant has completed all study procedures 
and will not be informed directly that the study 1 has been modified to STUDY 2, as the 
modification was not due to concern of risk to subjects, rather that a sufficient number of 
subjects in our local community did not meet eligibility criteria..  
 
 
Our revised protocol (named STUDY 2), instead of focusing on both naturalistic dual use 
behaviors and behaviors while switching to e-cigarettes, now is focusing only on the naturalistic 
behaviors of  32non-treatment seeking young adult e-cigarette/combustible tobacco product dual 
users.  Combustible tobacco products include cigarettes, cigars, cigarillos, hookah, roll your 
own cigarettes). 
 
In this one-year pilot study of  32 non-treatment seeking young adult e-cigarette/combustible 
tobacco product dual users (16 males/16 females), we will use smartphone-based ecological 
momentary assessment (EMA) to gather real-time data of e-cigarette and combustible tobacco 
product behaviors during a naturalistic 1-week combustible tobacco product/e-cigarette dual use 
period. (1) Participants will respond to daily random prompts assessing in-the-moment use of e-
cigarettes/cigarettes and the subjective factors (ratings of satisfaction and withdrawal) and 
contextual factors (location, activity, social cues) associated with each episode of use. They will 
also complete daily electronic diaries to document e-cigarette use episodes/day, amount of e-
liquid used, cigarettes smoked/day, nicotine concentrations and flavors used during the day, and 
how satisfied they were with the e-cigarette experience during the study. They will be queried 
about whether they changed product constituents (flavors, numbers of flavors, nicotine 
concentrations). We will also collect markers of carbon monoxide and nicotine exposure (CO, 
cotinine) throughout the study. 
 
STUDY 2 
Aim 1: To determine how within-subject’s ratings of subjective factors (withdrawal, satisfaction 
with tobacco products) change between episodes of e-cigarette use vs. episodes of other 
combustible tobacco product use (cigarettes, cigars, cigarillos and/or hookah). 
 
Hypothesis A: Young adult dual users, particularly males, will report lower satisfaction 
and higher withdrawal scores with episodes of e-cigarette use, in comparison to episodes 
of combustible tobacco product. 
 
Aim 2: To examine gender differences in e-cigarette use patterns among young adult dual users. 
 

 
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Aim 3: To examine gender differences in e-cigarette use patterns among young adult dual users. 
Hypothesis B: Young men will be more likely smoke/vape for the rewarding effects of 
nicotine. 
 
Hypothesis C: Young women will be more likely to smoke/vape in response to contextual 
reasons. 
 
Exploratory Aim: To examine sex differences in within-subjects’ changes in cotinine levels 
during the dual use periods.  
 
 
STUDY 2 
2. Research Plan:  
a. Overview: In this one-year pilot study of 32 non-treatment seeking young adult e-
cig/combustible tobacco product dual users (15 males/15 females), we will use smartphone-
based ecological momentary assessment (EMA) to gather real-time data of e-cigarette and  
combustible tobacco product behaviors during a 1-week cig/e-cigarette dual use period. 
Participants will be eligible if they self-report use of e-cigarettes at least one day during the 
past 7 days and use of at least one other combustible tobacco product at least one day during 
the past 7 days. Participants will respond to daily random prompts assessing in-the-moment 
use of e-cigs/combustible tobacco products and the subjective factors (ratings of satisfaction 
and withdrawal) and contextual factors (location, activity, social cues) associated with each 
episode of use. They will also complete daily electronic diaries to document e-cigarette use 
episodes/day, amount of e-liquid used, combustible tobacco products smoked/day, nicotine 
concentrations and flavors used during the day, and how satisfied they were with the e-
cigarette experience during the study. They will also be queried about whether they changed 
product constituents (flavors, numbers of flavors, nicotine concentrations). We will also 
collect markers of carbon monoxide and nicotine exposure (CO, cotinine) throughout the 
study. 
 
b. Settings: We will recruit participants from Southeastern CT (New Haven County, CT; 75% 
White, 13% Black, 3% Asian; ethnicity: 15% Latino). We expect some participants will be 
college students from other areas, thus generalizing our findings. Baseline study visits will 
occur at the APT Foundation, Inc. and follow-up visits may occur at APT, CSRU or public 
locations (i.e. coffee shops, libraries etc.) 
 
c. Participants:  See Inclusion and Exclusion Criteria 
 
d. Procedures:   
 
Recruitment and Screening: Our team has developed an age-appropriate, targeted strategy for 
recruitment (see III). Potential participants will be recruited through flyers, targeted 
advertisements on Facebook, Craigslist, and on public boards in local colleges, and through the 
Yale Center for Clinical Investigation volunteer database. Screening options will be provided 
(phone/text, or the Yale Qualtrics online survey system).  We are confident we can recruit 3-4 
participants/month over 9 months to reach sample size of n=30 32 in 1 year.   

 
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Study Entry: We will contact participants who meet inclusion criteria to schedule an in-person 
assessment at APT Foundation, Inc. Potential participants will meet with the Study Research 
Associate to be re-screened for eligibility. Women will provide a urine sample to verify 
pregnancy status. We will collect breath CO and salivary cotinine samples. After obtaining 
written consent, participants will complete a battery of baseline questionnaires. The RA will 
ask participants to provide cell, home, and work phone numbers, addresses, and contact 
information for at least 2 locaters. The RA will notify each participant of the time of their 
next assessment by text/phone and mail. If after 3 attempts by telephone/text the participant 
cannot be contacted, the RA will contact the other 2 locators. We will also use this method to 
contact participants if they have ≥ 24 hours of missing data. 
 
STUDY 2 
Participant Training upon Study Enrollment: The RA will teach participants to use the 
smartphone-based EMA data collection tool and to follow CM procedures. Participants will 
be instructed to: (1) continue smoking combustible tobacco products ad libitum without 
changing their smoking frequency/pattern during the  study; (2) provide and use their own 
combustible tobacco products and e-cigarette and liquid during the study. The subjects will 
be paid for the week of EMA participation and CM-reinforced CO monitor video 
submissions at the follow-up appointment. 
 
EMA data collection tool: We will use the MetricWire Android and iOS mobile applications 
(“apps”) for EMA data collection.(64) Participants will submit responses to survey questions 
and upload multimedia via the app. With guidance from the Canadian and U.S. 
Governments, the app is designed in careful reference to Good Clinical Practice (GCP), 
including the FDA’s part 11 HIPAA regulatory compliance. The app generates random 
prompts with the ability to set minimal interval time between prompts. Participants will also 
be prompted to complete daily night-time diaries. 5.1. Quality Checks and Procedures: Data 
will be stored on a HIPAA and 21 CFR Part 11 compliant servers and encrypted during 
transit. Study investigators will have access through an encrypted web-based application. 
Participant data is uploaded from the mobile app when it is connected to wireless. The RA 
will check the database daily to complete and correct data entry.  
 
STUDY 2 
Contingency management (CM) procedure: On days 1-7, the MetricWire app will randomly 
prompt participants twice daily (in am and pm) to record a video of them blowing into the 
CO monitor. They will text/email (via their phone) the video to the study phone/e-mail. To 
promote video documentation, participants will receive $1 for each on-time, valid video 
submission; this will continue to increase by $1 per valid video submission for each 
consecutive daily video submission up to a maximum of $14/day on Day 7 per Table 1. 
There will be a reset contingency for lack of video submission; participant’s payments will 
be reset to the initial ($2.00/day) amount. The total possible CM payment is $56, and total 
possible compensation for study participation is $150 (Table 1). 
 
 

 
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UPDATED Table 1: Study 2 Study Flow and Contingency Management Reinforcement Schedule 
 
WEEK 1 
Day 0 
1 
2 
3 
4 
5 
6 
7 
DAY 8-10 
TOTALS 
Study visit * 
Baseline 
study 
visit ($15) 
  
a 
  
  
  
  
  
F/U visit 
($15) and 
payment 
for EMA  
$30  
Remuneration for 
EMA 
  
Participant completed smart-phone based Ecological Momentary Assessments 
  
$50  
85% EMA 
completion 
incentive 
  
  
  
  
  
  
  
  
  
$14  
CO breath test: On-
time/valid sample,     
regardless of the 
CO value 
  
$2  
$4  
$6  
$8  
$10  
$12  
$14  
  
$56  
(split for am/pm 
payment) 
  
($1/$1) 
($2/$2) 
($3/$3) 
($4/$4) 
($5/$5) 
($6/$6) 
($7/$7) 
  
  
*Study visit activities: a) Review EMA procedures via phone 
TOTAL: 
  
$150  
 
Length of Study Visits 
Baseline: 1.5 hours 
STUDY 2 Follow-Up (Day 8-10): Up to 30 minutes 
 
 

 
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e. Primary Outcome: The primary outcomes are daily mean withdrawal scores (measured 
3x/day with the Mood and Physical Symptoms Scale) and satisfaction with e-cigarette 
(measured daily with a 1-10 Likert scale).(65) 
 
STUDY 2 
f. Baseline assessments Demographics:  age, gender, race, ethnicity, and level of schooling 
completed. Combustible Tobacco Product Smoking: Structured Timeline Follow-Back 
(TLFB) interviews will document the # of combustible tobacco products smoked per day 
during the past 28 days.(66) E-Cigarette Use: Structured TLFB interviews will 
document the # of episodes of e-cigarette use per day during the past 28 days. We will 
also query participants about nicotine concentrations used, flavors used, and the mls of 
liquid used/day.  We already have extensive experience with the collection of these 
measures from work with adolescent e-cigarette users in the Yale TCORS project. 
Nicotine Dependence: Fagerstrom Test of Nicotine Dependence-R,  a 6-item scale to 
estimate the severity of dependence.(67) Abstinence Self-Efficacy:  The Smoking Self 
Efficacy Questionnaire to measure self-efficacy.(68) Preferred Product Features: 
Participants will be asked to bring their preferred cigarette and e-cigarette to the baseline 
visit. We will record the brand/type of cigarette and e-cigarette (brand, nicotine 
concentration, flavor, battery voltage, tank/cartridge size, propylene glycol/vegetable 
glycerin ratio). 
 
STUDY 2 
g. Time based and Event based sampling procedure (EMA):   
 
Daily Momentary Assessments: Participants will be randomly prompted with the 
MetricWire app up to 3x daily to provide data on e-cigarette/combustible tobacco product 
use in the last 15 minutes, the type of e-cigarette/combustible tobacco product used 
(brand/type), subjective factors (withdrawal) and the contextual factors surrounding the 
episode. Subjective factors will include Mood and Withdrawal. To maintain brevity 
during the random prompts, We will use the Mood and Physical Symptoms Scale 
(MPSS) to measure severity of five withdrawal symptoms (depressed, irritable, restless, 
hungry and poor concentration) and urge to smoke (craving).(65) Total score ranges from 
5 to 25 with a higher score indicating a higher severity of withdrawal symptoms, we will 
use the International Positive and Negative Affect Schedule Short Form’s measures of 
negative affect.(69) Participants will rate on a 5 point scale their agreement with 
experiencing the following emotion: (upset, hostile, ashamed, nervous, afraid). 
Contextual factors will include questions about Companionship (“During this 
smoking/vaping episode, who were you around?” (smoker, person who is vaping, non-
smoker, alone)), Location (“Where were you?” (home, work/school, vehicle, 
bar/restaurant/store, other)), and Activity (“What were you doing?” (eating/drinking a 
non-alcoholic beverage, drinking alcohol, working/reading/studying, traveling, 
socializing, other)). Participants will have 30 minutes to respond to random prompts; 
otherwise data will be considered lost. Each random prompt will be date- and time-
stamped and record whether the assessment was completed, missed, delayed, or 
disbanded. This method aims to accrue a representative sample of occasions focused on 
the participants’ immediate state.  

 
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STUDY 2 
Daily Electronic (e-) Diaries: Participants will fill in daily night-time e- diaries via the 
app to provide data on e-cigarette use (episodes of e-cigarette use/ day) and combustible 
tobacco product smoking (# combustible tobacco products smoked/day). They will 
provide a rating of satisfaction with the e-cigarette they used during the day, and overall 
satisfaction rating of using their e-cigarette (1-10 Likert scales). Participants will record 
pictures of the e-cigarette(s) used during that day via the MetricWire app and provide a 
description of features. We have chosen daily night-time e-diaries to minimize participant 
burden. 
 
STUDY 2 
h. In-person study visits: In-person visits will occur in public places or study offices at 
baseline and follow-up. In addition to the CM procedures for CO monitor video 
submission, saliva cotinine samples will be collected at baseline, and follow-up to 
explore changes in cotinine levels.  
 
3. Genetic Testing    N/A 
 
 
4. Subject Population: Provide a detailed description of the types of human subjects who will 
be recruited into this study. 
STUDY 2 
We plan to recruit 32 non-treatment seeking young adult e-cig/cigarette dual users (15 
males/15 females), who use both e-cigarettes and combustible tobacco products. See V.7 for 
Inclusion/Exclusion Criteria. 
 
5. 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 
 Non-English Speaking 
 Prisoners  
 Economically disadvantaged persons 
 Decision ally 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 (If yes, see Instructions section VII #4 for further 
requirements) 
 
6. Inclusion/Exclusion Criteria: What are the criteria used to determine subject inclusion or    
exclusion? 
 
STUDY 2 
Inclusion Criteria. Each participant must:  

 
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(1) be 18 through 29 years of age;  
(2) use at least one type of combustible tobacco product (cigarettes, cigars, cigarillos, 
hookah, roll your own cigarettes) on at least 1 day during the past 7 days (DURING the 
PAST 7 days, on how many days did you use a combustible tobacco product ? (1 or more) 
(3) use e-cigarettes on at least one day during the past 7 days 
4) have access to an e-cigarette 
 
(5) fluent in English;  
(6) have a functioning cell phone for personal use with wireless, camera,  and application (via 
Apple or Android platform) capability; 
(7) have access to wireless networks at least once daily;  
(8) have self-reported good health. 
 
 
Exclusion Criteria. Participants who: (1) report serious medical illness; (2) are enrolled in a 
substance abuse or smoking cessation program/research study;(3) are interested in using smoking 
cessation pharmacotherapy during the study (to isolate effects of e-cigarette from 
pharmacotherapy); (4) take any psychoactive medications; (5) are women who are 
currently/planning to be pregnant or breastfeeding. 
 
7. How will eligibility be determined, and by whom?  
 
Participants who are potentially interested in participating will have three methods to contact the 
study 
 
1. Eligibility can be determined via use of a screening from by the PI/RA with the subject 
during in person recruitment. 
2. Potential participants can elect to be screened via phone.  In this case, eligibility can be 
determined via phone by use of a screening form by the PI/RA. 
3. Potential participants can elect to screened via an online Qualtrics form.  In this case 
the RA/PI will review the responses in Qualtrics to determine eligibility 
4. Potential participants can elect to be screened via text. In this case potential participants 
will be informed that text communication is vulnerable to breach of confidentiality.   
 
8. Risks: Describe the reasonably foreseeable risks, including risks to subject privacy, 
discomforts, or inconveniences associated with subjects participating in the research.  
 
 The potential risks in this study are related to:  
 
1. 
Risks Associated with Rating Scales and Assessments Risks from the rating scales and 
assessments, self-reports, and interviews are not beyond usual research procedures. 
Research assessments are all non-invasive, and should add no risk. The major 
disadvantages are the time taken to complete them and possible breach of 
confidentiality. The rating scales and structured assessments are all non-invasive and 
have been utilized in clinical studies with no known negative outcomes and should also 

 
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add no risks to subjects, as our past experience indicates. Our past experience with 
these measures indicates that they are acceptable to subjects. Any potential risks (e.g., 
discussion of upsetting events), however, will be minimized through the use of a 
trained, experienced Research Associates, supervised by Drs. Camenga and Krishnan-
Sarin. All adverse events will be immediately reported to the PI by research staff.   
STUDY 2 
2. 
Breath and saliva Collection - Participants will have breath samples taken to measure 
CO at baseline and follow-up. Testing will be performed by a trained research associate 
with the Bedfont PICO-Smokerylzer® breath CO monitor (Bedfont Scientific Ltd., 
Rochester, UK). There are no known risks associated with this test. Subjects exhale into 
a disposable plastic mouthpiece attached to the monitor; there should be no risk of 
infection. Saliva collection for cotinine is non-invasive. 
 
3. 
Risks Associated with Loss of Confidentiality The main risk associated with the study 
is the possibility that confidential information obtained during the study will be 
disclosed. All efforts will be made to protect subjects’ confidentiality. The alternative 
to participation is for a potential subject to decide NOT to participate. Confidentiality 
of the results are specifically protected by Federal laws, and all records will be 
identified by code number only, with the master file kept under lock by the Project 
Director.  
STUDY 2 
4. 
Use of electronic cigarette: Participants will be current combustible tobacco product 
smokers who have experience with e-cigarettes.  The electronic cigarette delivers 
nicotine in much the same way that a regular cigarette does, through inhalation. 
Participants will provide and use their own e-cigarettes (including all components, 
parts and accessories, and e-liquids (including flavorings) during this study. 
i. Nicotine exposure: The participants are required to be current combustible 
tobacco product smokers, and are, therefore, already self-administering 
nicotine. Nicotine intake during pregnancy may be associated with increased 
risk for spontaneous abortion, increased perinatal mortality and with low 
infant birth weights.  We will exclude females who are pregnant/planning to 
become pregnant or nursing from this study.   
ii. The most frequently reported adverse events reported in a clinical trials 
and cohort studies of e-cigarettes included cough, dry mouth, shortness of 
breath, throat irritation, and headache.(70) Other adverse events may 
include nausea and stomach cramps. Several studies have noted that the 
reported adverse events were classified as mild. 
iii. A 2016 Cochrane Review of 3 RCTs and 21 cohort studies found that 
none of the studies reported serious adverse events considered related to 
electronic cigarette use. The most frequently reported AEs were mouth 
and throat irritation, most commonly dissipating over time. 
 
9. Minimizing Risks: Describe the manner in which the above-mentioned risks will be 
minimized. 
Protections Against Risks include:  
 

 
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1. Inclusion and exclusion criteria and the use of a trained research associate will help to avoid 
the enrollment of subjects into this study who are either ineligible or who would be at greater 
risk for complications because of psychiatric, or medical illnesses.   
2. All patient interactions will be conducted in areas that are as private as possible in the clinic 
(APT) or public setting.  
3. Once enrolled, subjects will be given a unique study number, to which only members of our 
research team will have access. Computerized subject data will be password protected. All 
identifiable information will be stored in a locked research cabinet in a locked until. All 
subjects will be assigned a study subject number. Subsequently, subjects will be identified in 
the Case Report Forms (CRFs) only by that number and an encoded version of their initials 
(i.e., John Doe = JDO). A list of numbers and the corresponding names will be maintained by 
the Project Director.  
4. Any identifiable information that is obtained in connection with this study will be disclosed 
only with subject permission or as required by U.S. or State law. Individually identifiable 
health information will be protected in accordance with the Health Insurance Portability and 
Accountability Act of 1996. We will clearly explain our mandated obligation to report 
incidents, including suspicion of child or elder abuse or neglect, threats of harm to self and 
others. Data will only be reported in aggregate. During an audit or program evaluation, 
representatives from the Yale Human Investigation Committee and from the National 
Institutes of Health may have access to subject data, but will strictly adhere to the rules of 
confidentiality. Upon completion of the study, all computerized subject datasets will be de-
identified and stored in a password-protected study computer, to which only the PI and study 
personnel will have access.  All paper files with subject information will remain in locked 
files in the study office of the Project Director, until they are destroyed, after all analyses are 
complete and after the federal requisite waiting period (7 years) to maintain records. Any 
information published as a result of the study will be such that it will not permit identification 
of any subject. 
5. Protection of the health-related information collected via MetricWire 
MetricWire is a cloud-based data collection and analytics platform. The MetricWire platform 
provides users with the ability to log, analyze, and visualize data collected from smartphones, 
tablets and the web. The MetricWire system includes the following components which will 
transmit PHI: 
 
Mobile Applications: MetricWire provides Android and iOS mobile applications that allow 
participants to view study details, submit responses to survey questions and upload 
multimedia. This application will be used to collect daily momentary assessments during the 
study.  The Android Mobile application is a native application written in Java using the 
Android Software Development Kit (SDK) provided by Google, the creators of Android. The 
iOS Mobile application is a native application written in Objective--C using the Apple 
Software Development Kit (SDK) provided by Apple, the creators of iOS. Data is encrypted 
and transferred from the app to the server when the smartphone is connected to wireless 
networks. 
 
Participant Portal: The Participant Portal is a web application that allows participants to 
submit responses to survey questions and upload multimedia. Participant will have the option 

 
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to complete the daily nighttime assessments via this portal. The Participant Portal is accessed 
at my.metricwire.com. 
 
Research Portal: The Research Portal is a web application that is used by the study 
investigators to design and deploy studies to mobile devices and the web. The Research 
Portal is accessed via research.metricwire.com. 
 
Data Security:  Through the Metric Wire’s Notice of Privacy Practices ("Privacy Notice") 
individuals are informed of the Company’s legal duties and these Policies and Procedures, as 
well as their individual rights with respect to their Protected Health Information.(71) The 
data obtained from the MetricWire app is stored on Health Insurance Portability and 
Accountability Act (HIPAA) and 21 CFR Part 11 compliant servers and it is encrypted 
during transit. All employees of MetricWire must adhere to HIPAA. Researchers can access 
the data at any time in real time via the web-based Research Portal. MetricWire supports 
symmetric AES--‐128, AES--‐192 and AES--‐256 based on the organization's preference for 
data storage. If mandated, asymmetric encryption can be implemented for the data storage. 
All symmetric keys are encrypted using the Scrypt Key Derivation function and stored in 
HMAC--‐SHA256. The passwords and data is encrypted using TLS v1, 1.1 or 1.2(based on 
the latest protocol the user’s browser supports) in transit.(72) 
 
The resulting database will be property of the Yale University investigators.  This data and 
any kind of logs, will be kept in a secure HIPAA compliant database stored at Yale School of 
Medicine. This server is firewall and password protected, with limited access only to 
investigators.  
 
 
10. 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.) For more information, see the Instructions, 
page 24. 
 
a.  
What is the investigator’s assessment of the overall risk level for subjects 
participating in this study?    
 
 
MINIMAL RISK 
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.  
d. For multi-site studies for which the Yale PI serves as the lead investigator: N/A 
i. How will adverse events and unanticipated problems involving risks to subjects or 
others be reported, reviewed and managed? 
ii. What provisions are in place for management of interim results? 
iii. What will the multi-site process be for protocol modifications? 
 
 
Monitoring for data integrity and safety will be the responsibility of the investigators and the 
Yale Human Investigation Committee (HIC). The principal investigator will be responsible for 
monitoring the data, assuring protocol compliance, conducting the safety reviews, and the 
specified frequency of the reviews at a minimum of every 6 months (including when reapproval 

 
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of the protocol is sought). During the review process, the principal investigator will evaluate 
whether the study should continue unchanged, require modification/amendment, continue or 
close to enrollment. Either the principal investigator or the HIC have the authority to stop or 
suspend the study or require modifications.  
 
The risks associated with the current study are deemed minimal. Although we have assessed the 
proposed study as one of minimal risk, the potential exists for anticipated and/or unanticipated 
adverse events, serious or otherwise, to occur since it is not possible to predict with certainty the 
absolute risk in any given individual or in advance of first-hand experience with the proposed 
study methods. Therefore, we provide a plan for monitoring the data and safety of the proposed 
study from  http://www.yale.edu/hrpp/forms-templates/biomedical.html  for Minimal risk. 
 
The principal investigator is responsible for monitoring the data, assuring protocol compliance, 
and conducting the safety reviews at the specified frequency monthly.  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 and 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 adverse events or other problems are not 
anticipated. In the unlikely event that such events occur, Reportable Adverse 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 will be reported in writing within 48 hours 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 adverse 
events that occur during the conduct of this research project through regular study meetings, and 
via email as they are reviewed by the principal investigator.   The protocol’s research monitor(s), 
funding agencies, and regulatory and decision-making bodies will be informed of severe adverse 
events within 5 days of the event becoming known to the principal investigator. 
 
STUDY 2 
11. Statistical Consideration: Describe the statistical analyses that support the study design.  
 
Data analysis will be conducted with SAS (Cary, NC) by Drs. Gueorguieva and Bold (Co-I) and 
the Yale Center for Analytic Sciences. Effect size estimates with 95% CIs will be constructed for 
each Aim to inform future studies.   
 
Overview: This is an observational study of e-cigarette and combustible tobacco product use in 
young adults. Data analysis will be conducted in collaboration with Ralitza Gueorguieva, PhD 
(Co-I) and the Yale Center for Analytic Sciences. We will conduct all analyses with the latest 
version of SAS (Cary, NC) software. We will calculate descriptive statistics prior to statistical 
analyses and evaluate data distributions of continuous predictors. If data are approximately 
normally distributed or can be transformed to normality, we will use linear mixed models for 
statistical analysis. Generalized linear mixed models will be used for non-normal data (e.g. 

 
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logistic mixed models for binary data; negative binomial or Poisson mixed effects models for 
count data). Effect size estimates with 95% CIs will be constructed for each specific aim to 
inform future studies. 
a. Justification of Sample Size: Estimation of sample size (n=32) is based on achieving a 
clinically meaningful precision in effect size estimates for the primary outcome of interest. 
With 30 subjects we will be able to construct a 95% CI for the mean change in e-cigarette 
episodes/day from week 1 to 2 of width up to 0.37 standard deviations away from the mean 
(Aim 1) and 95% CI for the slopes of the regression relationships in Aim 2 of half-widths up 
to approximately 0.67 of the corresponding slope values. The obtained interval estimates will 
be used to inform future larger definitive studies.  
Analysis Plan: Aim 1 will determine how within-subject’s ratings of subjective factors 
(withdrawal, satisfaction with tobacco products) change between episodes of e-cigarette use 
vs. episodes of other combustible tobacco product use (cigarettes, cigars, cigarillos and/or 
hookah) 
 
During e-cigarette and combustible tobacco product use periods. We will evaluate the 
variability in levels of satisfaction and withdrawal scores during these periods. Correlations 
between repeated measures on an individual will be modeled with random subject effects.  
Aim 2 will evaluate gender differences in e-cigarette use patterns among young adult dual 
users mean changes in e-cigarette use between the dual use and exclusive e-cigarette use 
period that differ by sex. We will evaluate changes in contextual factors and will assess effect 
sizes and construct 95% CIs for change in e-cigarette use  
 
 
 
12.  Data Management:   
Quantitative outcomes will be collected using paper forms which will be double entered into a 
secure database.  Error checking and data validation will occur weekly and any problems will be 
queried and resolved immediately.  Dr. Camenga will create monthly data quality reports to 
check for completeness and accuracy of key variables, as well as rates of recruitment, retention, 
and follow-up.  Baseline demographics and smoking behaviors will be summarized.  Continuous 
data will be expressed as mean values with standard deviations and categorical data will be 
presented as counts with percentages.   

 
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SECTION VII: RECRUITMENT/CONSENT AND ASSENT PROCEDURES  
1. Targeted Enrollment: Give the number of subjects: 
a.   targeted for enrollment at Yale for this protocol_32 
b.    If this is a multi-site study, give the total number of subjects targeted across all sites___  
 
2. Indicate recruitment methods below.  Attach copies of any recruitment materials that will 
be used. 
 
 Flyers 
 
 
 
 Internet/Web Postings 
 
 
 Radio 
 Posters 
 
 
 
 Mass E-mail Solicitation  
 
 Telephone 
 Letter 
 
 
 
 Departmental/Center Website 
 
 Television 
 Medical Record Review*  
 Departmental/Center Research Boards 
 Newspaper 
 Departmental/Center Newsletters 
 Web-Based Clinical Trial Registries 
 
  YCCI Recruitment database 
 Clinicaltrials.gov Registry (do not send materials to 
HIC) 
 Other (describe): 
 
 
3.  Recruitment Procedures:  
a. Describe how potential subjects will be identified. 
 
Through our previous studies, our team has developed an age-appropriate, targeted strategy for 
recruitment. Potential participants will be recruited through flyers, advertisements on Facebook 
(targeted to 18-through 29-year-olds in CT), craigslist, and on public boards in New Haven, and 
through the Yale Center for Clinical Investigation volunteer database.  Screening options will be 
provided. 
 
b. 
Describe how potential subjects are contacted. 
 
Potential participants can contact the study to determine eligibility through the following 
methods: 
 
1. Phone call: Potential subjects can call the study PI via the phone number listed on the 
recruitment materials at be screened via phone and schedule an intake appointment if 
eligible. 
2. Text: Potential subjects can text the word STUDY to the study text number 203-376-
4459 listed on the recruitment materials. When they do this they will receive a link to 
the Qualtrics screening eligibility questionnaire (Appendix DD) 
3. Potential participants can scan a QR code or enter a website bitlink that will direct them 
to a Yale Qualtrics website wherein subjects learn information about the study and can 
elect to contact the study via fill out  the Qualtrics Screening Form or to call the study 
number. 
4.  
 
 
Procedure to schedule study visit for eligible participants: 

 
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If they are found to be eligible they will be asked whether they would like to be contacted via 
text/phone to schedule an intake appointment. The RA/PI will then text/call the potential subject 
to schedule an intake. Given the breadth of screening procedures used, at the onset of the 
intake appointments, subjects will be rescreened to ensure study eligibility prior to consent. 
c. Who is recruiting potential subjects?  
The PI or a research assistant will recruit potential subjects. 
 
4. Screening Procedures 
a. Will email or telephone correspondence be used to screen potential subjects for 
eligibility prior to the potential subject coming to the research office? 
 Yes  
 No 
b.  If yes, identify below all health information to be collected as part of screening and 
check off any of the following HIPAA identifiers to be collected and retained by the 
research team during this screening process.  
 
HEALTH INFORMATION TO BE COLLECTED: 
 
HIPAA identifiers:  
 Names  
 All geographic subdivisions smaller than a State, including: street address, city, county, 
precinct, zip codes and their equivalent geocodes, except for the initial three digits of a zip code 
if, according to the current publicly-available data from the Bureau of the Census: (1) the 
geographic unit formed by combining all zip codes with the same three initial digits contains more 
than 20,000 people, and (2) the initial three digits of a zip code for all such geographic units 
containing 20,000 or fewer people is changed to 000.  
  Telephone numbers 
 Fax numbers  
 E-mail addresses 
 Social Security numbers – for participant reimbursement card 
 Medical record numbers 
 Health plan beneficiary numbers  
 Account numbers  
  All elements of dates (except year) for dates related to an individual, including: birth date, 
admission date, discharge date, date of death, all ages over 89 and all elements of dates (including 
year) indicative of such age, except that such ages and elements may be aggregated into a single 
category of age 90 or older  
 Certificate/license numbers  
 Vehicle identifiers and serial numbers, including license plate numbers  
 Device identifiers and serial numbers  
 Web Universal Resource Locators (URLs)  
 Internet Protocol (IP) address numbers  
 Biometric identifiers, including finger and voice prints  
 Full face photographic images and any comparable images  
 Any other unique identifying numbers, characteristics, or codes  
 
Additional health measures for screening will include: 

 
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Combustible tobacco product smoking history 
E-cigarette use history 
Health Status (self-reported) 
Enrollment in substance use/smoking cessation program/research study. 
Interest in using smoking cessation medications 
Medication history (use of any psychoactive medication) 
For Women: Pregnancy status, current/plan for pregnant or breastfeeding 
 
5.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 (POTENTIAL RELATIONSHIP) 
 No 
If yes, describe the nature of this relationship.   Deepa Camenga, MD is pediatrician who 
provides clinical care at the Adolescent Clinic at the Yale New Haven Hospital primary Care 
Center. There is a potential risk that an eligible participant may have received care from Dr. 
Camenga in the Primary Care Center, however this study does not recruit directly from the 
Primary Care Center and participation in the study will not affect the nature of the treatment 
the participants receive in the PCC. 
 
6. 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 purposes only  
☐ For inclusion of non-English speaking subject if short form is being used and a translated 
HIPAA research authorization form is not available on the University’s HIPAA website 
 
i. Describe why it would be impracticable to obtain the subject’s authorization for 
use/disclosure of this data; 
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; 
 
Consent waiver will be requested for initial patient screening via telephone and Yale 
Qualtrics survey (Via text or web), done only to determine subject eligibility.  We request a 
waiver for HIPAA authorization to obtain their phone number for voice and text and/or 
email as this method is equivalent to having a person leave their phone number on a voice 
mail and is being used to attract young adults to contact the research team. 
 

 
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Participants will provide verbal consent for the screening process and this consent is also 
included in the Qualtrics screening eligibility survey.    
 
7. After eligibility has been decided, written consent will be requested from all participating 
subjects upon enrollment.  It would be impractical to obtain written consent and consent for 
HIPAA authorization for phone screening procedures as screening will be done on the 
phone, text, or web 
By signing this protocol application, 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. 
 
7. Required HIPAA Authorization: If the research involves the creation, use or disclosure of 
protected health information (PHI), separate subject authorization is required under the 
HIPAA Privacy Rule. Indicate which of the following forms are being provided: 
 
  
 Compound Consent and Authorization form 
 
  
 HIPAA Research Authorization Form 
 
 
8. Consent Personnel: List the names of all members of the research team who will be obtaining 
consent/assent.  
Deepa Camenga, Thomas Liss, RA-  Stephanie Dwy and Skye Orazietti (Maiden Name Skye 
Peters). 
 
9. 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.  
 
After the screening process is complete and subject is found to be eligible, the RA/PI will schedule 
them for an in person intake.  At this intake, all eligible participants will be asked for written 
consent using the Yale HIC approved combined consent/HIPAA form.  All eligible participants 
will also be asked to provide contact information in the following manner.  In addition to providing 
their own personal contact information, participants will be asked to give the names of two friends 
or relatives whom we can contact to obtain this information. We will contact these individuals only 
if we are unable to contact the participant directly and then only for the purpose of obtaining 
forwarding address and phone number. We will inform the person that the participant has 
authorized us to contact them and they will be asked if they are willing to give out this 
information. If they decline, they will not be contacted again. The participant will be advised that 
these people that you have given us their name and information so if we need to call them they are 
already aware. Participants will be given the option to list a contact person from an office/clinic 
that they attend for medical are.  If they choose to list this contact, we will ask the participant to 

 
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sign a release so we can call the office/clinic if we have difficulty finding the participant for 
follow-up interviews. If the participant is unable to complete an in-person or phone interview, we 
may send them a follow-up questionnaire with a self-addressed, stamped envelope. If they are 
unable to come to the clinic but are willing to complete an interview we will meet the participant at 
a public place to collect a breath carbon monoxide sample and salivary cotinine sample, and 
questionnaire data.  
 
10. 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.  
 
Through the verbal interaction with the potential subject, the PI or research assistant will make 
an assessment of the subject’s ability and capacity to consent to the research.  Participants must 
be young adults, therefore we do not expect that they will be a higher than usual risk of having 
fluctuating, limited, or diminishing decision-making capacity during the course of the research 
study, 
 
11. Documentation of Consent/Assent: Specify the documents that will be used during the 
consent/assent process. Copies of all documents should be appended to the protocol, in the same 
format that they will be given to subjects.  
 
Yale HIC-approved compound consent and authorization form and a separate written permission 
to allow videotaping. 
 
12. 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.  
 
N/A- Non-English speaking subjects do not meet inclusion criteria 
 
13. 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 a consent waiver  
 
 Requesting a waiver of signed consent 
       
 Requesting a full waiver of consent 
    
A. Waiver of signed consent: (Verbal consent from subjects will be obtained. If PHI is 
collected, information in this section must match Section VII, Question 6) 
 Requesting a waiver of signed consent for Recruitment/Screening only  
If requesting a waiver of signed consent, please address the following: 
a. Would the signed consent form be the only record linking the subject and the research? 
 Yes  
 No 
b. Does a breach of confidentiality constitute the principal risk to subjects?  
 Yes  
 No 
 

 
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OR 
 
c. Does the research activity pose greater than minimal risk?  
 Yes If you answered yes, stop. A waiver cannot be granted.  Please note: 
Recruitment/screening is generally a minimal risk research activity   
 No  
AND 
d. Does the research include any activities that would require signed consent in a non-
research context? 
 Yes  
 No  
 
SECTION VIII: PROTECTION OF RESEARCH SUBJECTS 
 
    Confidentiality & Security of Data: 
 
a. How will the research data be collected, recorded and stored?  
 
Research data will be collected from study subjects by the PI or trained Research Associates 
(RA) who has successfully completed all required HIC and HIPAA training, using the paper 
study forms approved by Yale HI. Subjects will also be able to complete these same forms via 
a laptop as a survey administered through the Yale Qualtrics program These forms will only 
include the subject’s unique identifier, which is assigned to the subject at the time of 
enrollment, to which only study researchers will have access.   
 
See V.10.5. for description of data security plan for MetricWire app. 
 
All information that is obtained in connection with this study will remain confidential and will 
be disclosed only with subject permission or as required by U.S. or State law.  All collected 
data will be stored in locked files, in the locked study-dedicated office of the Principal 
Investigator, with access granted only to the study research team.  Paper data will be 
computerized (entered into a study database) and password protected, with access granted only 
to the study research team.    Data will only be reported in aggregate.  Data will be deidentified 
prior to formal data analysis, making individual subject identification impossible.   
 
 
b. How will the digital data be stored? 
 CD  
 DVD  
 Flash Drive  
 Portable Hard    
    Drive  
 Secured Server  
 Laptop Computer   
 Desktop Computer  
 Other 
 
c. 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 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  
          

 
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 Once enrolled, subjects will be given a unique study number, to which only members of our 
research team will have access.  Study data will be kept protected and treated as confidential at all 
times.  Computerized subject data will be password protected.  Moveable devices will be encrypted 
to protect identifiable information, following University policy. Only study researchers will have 
access to the link between subject name and identifier.   
 
d. 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. 
 
Any identifiable information that is obtained in connection with this study will remain confidential 
and will be disclosed only with subject permission or as required by U.S. or State law.  Once 
enrolled, subjects will be given a unique study number, to which only members of our research 
team will have access.  Study data will be kept protected and treated as confidential at all times.  
Computerized subject data will be password protected.  Data will only be reported in aggregate.  
Data will be de-identified prior to formal data analysis, making individual subject identification 
impossible.   
 
Upon completion of the study, all computerized subject datasets will be de-identified and stored 
in a password-protected study computer, to which only the PI, investigators and study personnel 
will have access.  All paper files with subject information will remain in locked files in the study 
office of the PI, until they are destroyed, after all analyses are complete.  At that time, all data will 
be destroyed using an approved method as performed by, or with the assistance of ITS Med.  
 
 
e. Who will have access to the protected health information (such as the research sponsor, the 
investigator, the research staff, all research monitors, FDA, Yale Cancer Center Data and 
Safety Monitoring Committee (DSMC), SSC, etc.)? (please distinguish between PHI and 
de-identified data)  
 
Only the PI, investigators and study personnel will have access to the data which will be kept 
securely on a password-protected server. 
 
During an audit or program evaluation, representatives from the Yale Human Investigation 
Committee and from the National Institutes of Health may have access to subject data, but will 
strictly follow rules of confidentiality.   
 
f. If appropriate, has a Certificate of Confidentiality been obtained? 
We will not obtain a certificate of confidentiality 
 
g. Are any of the study procedures likely to yield information subject to mandatory reporting   
requirements? (e.g., HIV testing – reporting of communicable diseases; parent interview -
incidents of child abuse, elderly abuse, etc.). Please verify to whom such instances will need 
to be reported.  
 
NO 

 
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SECTION IX: 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.)  
 
This study does not provide direct benefits to the participant. Although the proposed research 
poses minimal risks to participants, the benefits to scientific knowledge are numerous. The 
results from this study may help scientists understand how young men and women switch from 
cigarettes to e-cigarettes.  
 
 
         SECTION X: RESEARCH ALTERNATIVES AND ECONOMIC CONSIDERATIONS 
 
1.     Alternatives: What other alternatives are available to the study subjects outside of the 
research? 
 
The alternative to participating in the proposed study is to not participate.  
 
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.  
 
Participants will receive payments per the schedule below (and Table 1) 
STUDY 2 
• $15 for each in person study visit ($30 total) 
• $50 for completion of the EMA procedures 
• Up to $14 for completion of 85% of more of the EMA prompts 
• Up to $56 for on-time and valid video recordings of breath CO measurement 
• TOTAL Possible payment=$150 (of which $56 is earned through CM) 
 
 
 
 
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.   
 
Subjects will be responsible for the costs associated with: 
1. 
Purchasing their e-cigarette, e-liquid, or any other e-cigarette product components. 
2. 
Transportation to and from study visits 
3. 
Operating their cell phone 
   

 
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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). 
.  
 
a.     Will medical treatment be available if research-related injury occurs?  
 
b.     Where and from whom may treatment be obtained?  
 
c.     Are there any limits to the treatment being provided?  
 
d.     Who will pay for this treatment?  
 
e.     How will the medical treatment be accessed by subjects?  
 
 
Subjects who develop a mental or physical problem as a result of involvement in this study, will 
have appropriate treatment arranged.  The subject’s insurance carrier will be expected to pay the 
costs of such treatment. No financial compensation is available for this treatment. 
 
 
 

 
HIC Protocol#: 1612018726 PI Camenga   Page 27 of 30   Version 8 Date 10.18.2017 
 
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