Effects of Electronic Cigarette Flavors on Abuse Liability in Smokers (P3-Taste)
Phase: NA
Conditions: Electronic Cigarette Use
Sponsor: Virginia Commonwealth University

Effects of Electronic Cigarette Flavors on Abuse Liability in Smokers (P3 TASTE) 
 
Dr. Caroline Cobb, Associate Professor of Psychology & Dr. Andrew Barnes, Associate Professor of Health 
Behavior and Policy  
Initial Approval:   
2/15/2023 
 
Most recent approval: 12/17/2024 
 
THIS STUDY WAS NOT REQUIRED TO SUBMIT THE STATISTICAL ANALYSIS SECTION TO THE IRB. THE 
SECTION WAS ADDED TO THIS REPORT AND TAKEN FROM THE GRANT.  OUR PROCESSES HAVE BEEN 
UPDATED AND STUDIES APPROVED IN 2024 WOULD BE REQUIRED. 

Print
 
Close
HM20025464
View: SF - Study Identification
Date: Tuesday, September 2, 2025 2:57:03 PM
ID: HM20025464
HM20025464 - Caroline Cobb Amey
Effects of Electronic Cigarette Flavors on Abuse Liability in Smokers (P3-Taste)
  
Study Identification
1. * Select the Principal Investigator:
Caroline Cobb Amey
2. * Study Title:
Effects of Electronic Cigarette Flavors on Abuse Liability in Smokers (P3-Taste)
3. * Is this a student or trainee project in which activities will be carried out by that individual
under your supervision (for example, dissertation or degree-required projects):
  Yes
No
4. * Please select the primary department or center that this study is being conducted under:
Psychology
5. Select the VCU IRB numbers assigned to studies that are:
      1. Associated with this study
      2. Research registries this study will utilize
      3. Previously submitted versions of this study (closed, withdrawn, auto-withdrawn studies)
ID
Title
PI
HM20002567 CSTP Overall Screening and Registry Caroline Cobb Amey
6. Select all individuals who are permitted to edit the IRB protocol and should be copied on
communications (study staff will be entered later).  These individuals will be referred to as
protocol editors:
Last Name
First Name
E-Mail
Phone
Mobile
Amey
Caroline Cobb
cobbco@vcu.edu
 
 
Barnes
Andrew
abarnes3@vcu.edu
 
 
Carrico
 
carricoma@vcu.edu
 
 
Imran
Rabia
imranr@vcu.edu
 
 
Ogunleye
Elizabeth
ogunleyee@vcu.edu
 
 
7. * Select one of the following that applies to the project (selection will branch to new pages):
Note: VCU IRB offers guidance for many types of studies, including secondary data analysis
studies, internet research, registries, EFIC, HUD, and Emergency Use protocols.
See https://research.vcu.edu/human_research/guidance.htm 
Research Project or Clinical Investigation [*most exempt, expedited, and full board research studies]
Exception from Informed Consent (EFIC) for Planned Emergency Research
Humanitarian Use of Device for Treatment or Diagnosis
Humanitarian Use of Device for Clinical Investigation
Emergency Use of Investigational Drug, Biologic or Device
Treatment Use (Expanded Access to Investigational Product for Treatment Use)

Center or Institute Administrative Grant Review
Request for Not Human Subject Research Determination (i.e. request a letter confirming that IRB review is not
required)

HM20025464
View: SF2 - Federal Regulations
ID: HM20025464
HM20025464 - Caroline Cobb Amey
Effects of Electronic Cigarette Flavors on Abuse Liability in Smokers (P3-Taste)
  
Federal Regulations
1. * Is this a FDA regulated study?
FDA regulated research includes all clinical investigations involving a test article and a human
subject(s) that has been submitted for approval to the FDA or may be submitted in the future. 
Check Yes if
•    the study involves an IND/IDE, abbreviated IDE, IND/IDE exemption, HUD, expanded access,
or is otherwise subject to 21 CFR 56, 
•    the study involves a test article being administered or dispensed to subjects NOT according
to a clinicians9 medical judgment but rather, per the study protocol, OR
•    the study does not involve a test article but intends to provide safety or efficacy data to the
FDA.
 
  Yes
No
2. * Indicate the FDA regulated product(s) this study involves:

Drug

Medical Device

Biologic

Dietary Supplement

Food/Food Additive

Color Additive

Electronic Products for Human Use (radiation producing)

Tobacco Product

Other
3. * If "Other" selected above, provide description:
The study products used in this study include those that fall under FDA's regulatory authority. Some products have
been authorized by the FDA and others are awaiting decision-making and may be authorized and/or not authorized for
marketing by the FDA. Findings from this study are intended to help inform FDA tobacco product regulations.
4. * Is this study supported by the Department of Defense (DoD):
  Yes
No
5. * Check if any of the following funding sources apply to this research (including Direct and/or
Indirect funding):

Department of Education

Department of Justice

Environmental Protection Agency

None of the above

HM20025464
View: SF2 - IRB Panel Setup
ID: HM20025464
HM20025464 - Caroline Cobb Amey
Effects of Electronic Cigarette Flavors on Abuse Liability in Smokers (P3-Taste)
  
IRB Panel Setup
1. * To which IRB is this study being submitted for review?
VCU IRB
WCG IRB
NCI Central IRB
Advarra IRB
Other IRB
2. * Is this study transitioning to review by another IRB?
Yes - transitioning from VCU IRB to an external IRB (WCG, CIRB, Other)
Yes - transitioning from an external IRB (WCG, CIRB, Other) to VCU IRB
No or not applicable

HM20025464
View: SF2 - Review Setup
ID: HM20025464
HM20025464 - Caroline Cobb Amey
Effects of Electronic Cigarette Flavors on Abuse Liability in Smokers (P3-Taste)
  
Review Setup
1. * Select which study type best describes the majority of the study. Your response will help
determine which IRB panel should review this.
Bio-Medical Research
Social/Behavioral/Education (SBE) Research
2. * Which option(s) best describe the way(s) this study9s procedures will be conducted? (Select
all that apply.) This information may be used by the IRB in triaging studies during an
emergency.

In-person interactions / interventions with participants

Remote interactions / interventions with participants

Secondary data/specimen analyses with or without contact with study participants
3. * Would it be possible to convert in-person activities in your study to remote if there is an
approved contingency protocol? 
No, not possible to convert to remote activities
 
4. * Does this study involve greater than minimal risk:
  Yes No
5. * Review type requested: (subject to IRB approval):
Full Board
Expedited
Exempt
 
6. * Is this study initiated by a VCU investigator or a sponsor:
VCU Investigator initiated
Sponsor or industry initiated
 
 
The IRB has determined that the selected types of anticipated individual and social benefit apply to this study
 
The below information is read-only to investigators, and the categories are set by the IRB
during review. All categories will appear blank until the IRB has made a determination. If a
category is not checked, it does not apply to this study. This information may be used by the
IRB in triaging studies during an emergency situation.
Possible or minimal direct benefit to the community
Scientific benefit
 
  
  

HM20025464
View: SF2 - Initial Setup Complete
ID: HM20025464
HM20025464 - Caroline Cobb Amey
Effects of Electronic Cigarette Flavors on Abuse Liability in Smokers (P3-Taste)
  
Initial Setup Complete
Protocol Progress:
w INITIAL SETUP
e BACKGROUND, RATIONALE & GOALS
f RESEARCH PLAN
g CONSENT PLAN
h RISKS, PRIVACY & CONFIDENTIALITY
i POPULATIONS WITH SPECIAL CONSIDERATIONS
j INSTITUTIONAL REQUIREMENTS
k DOCUMENTS
Click Continue below to go to the next section
 

HM20025464
View: SF2 - Background, Rationale and Goals
ID: HM20025464
HM20025464 - Caroline Cobb Amey
Effects of Electronic Cigarette Flavors on Abuse Liability in Smokers (P3-Taste)
  
Background, Rationale and Goals
1. * Describe the study's background and what is currently known from the scientific literature,
including citations, or upload a citation list in document upload.  Use lay language whenever
possible.
FDA’s <public health standard= requires consideration of how tobacco product regulation will influence risks and
benefits to tobacco users and non-users. Among other things, FDA must be cognizant of regulatory impact on
transitions across tobacco products for current users, including initiation of one product and cessation of another and
dual use of both. These issues are particularly salient for e-cigarettes (ECIGs) due to their increasing popularity.
Addressing them through regulation will be challenging because ECIGs are an evolving product class with great
variability in liquid nicotine concentration, device power, rate of nicotine emission (i.e., nicotine flux), and flavors
(USDHHS, 2016; Talih et al., 2017). These factors can influence ECIG abuse liability, the likelihood that an ECIG will
maintain persistent use and dependence (e.g., Carter et al., 2009). Regulatory action intended to influence population-
level ECIG use must account for these factors.
If FDA is to understand how tobacco regulation will influence the risks and benefits to cigarette smokers, exclusive
ECIG users and dual users of ECIGs and tobacco cigarettes, it may learn much from robust scientific methods that
predict the likely population-level impact of potential regulatory action in these populations. Indeed, if FDA had scientific
methods that could predict these population-level outcomes, these methods could be used to generate data to guide
the development of potential regulation. Our goal is to provide these methods to FDA.
To do so, we use behavioral economic indices of abuse liability to examine to hypotheses related to three potential
regulatory actions: limiting nicotine concentration (ongoing study; completed study), constraining nicotine flux (nicotine
yield/unit time; ongoing study), and reducing flavor availability (the current study). We then use results from clinical lab
studies described here, along with results from other studies, to generate predictions about how these potential
regulatory actions might impact the population, and then test our predictions at the population level (in a separate study
not described in this protocol).
Carter LP, Stitzer ML, Henningfield JE, O'Connor RJ, Cummings KM, Hatsukami DK. (2009). Abuse liability
assessment of tobacco products including potential reduced exposure products. Cancer Epidemiol Biomarkers Prev.
18(12):3241-62.
Talih S, Balhas Z, Eissenberg T, Salman R, Karaoghlanian N, El Hellani A, Baalbaki R, Saliba N, Shihadeh A. (2015).
Effects of user puff topography, device voltage, and liquid nicotine concentration on electronic cigarette nicotine yield:
measurements and model predictions. Nicotine Tob Res. 17(2):150-7. PMC4837998
USDHHS (2016). E-cigarette Use Among Youth and Young Adults: A Report of the Surgeon General. Atlanta, GA:
USDHHS, CDC, National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health.
2. * Describe the study hypothesis and/or research questions.  Use lay language whenever
possible.
The purpose of this study is to determine if abuse liability indices will be impacted by varying flavors and ECIG nicotine
delivery capability (i.e., nicotine flux) among current combustible cigarette users.
We will compare abuse liability indices between three FDA authorized ECIG products that vary in nicotine flux (but are
all tobacco flavor) and own brand cigarettes. We will also test the influence of ECIG flavor availability (tobacco vs.
menthol) within three ECIG product classes.
We hypothesize that as nicotine flux is lowered, abuse liability indices will be lowered.
We also hypothesize that across ECIG product classes, abuse liability indices will be higher for menthol-flavored
products.
3. * Describe the study's specific aims or goals.  Use lay language whenever possible.
Aim 1: Compare the abuse liability of own brand (OB) cigarettes and three FDA-authorized tobacco flavor ECIGs that
vary by nicotine flux.
Aim 2: Test the influence of ENDS flavor availability (tobacco vs. menthol) within each ENDS product class.
4. * Describe the scientific benefit or importance of the knowledge to be gained:
The benefits of this research are of a scientific nature. Specifically, we aim to use study results to inform our
understanding of the abuse liability of ECIG liquid characteristics as well as provide information to guide the
appropriate regulation of ECIGs.
In particular, the use of ECIGs has become increasingly popular, especially among individuals aged 18-24. New
regulations are being targeted at this age group and need to be tested in this age group before implementation. The
overarching theme of the Center for the Study of Tobacco Products is to provide regulators (FDA and others) with a
suite of tools that allow them to test regulations before they are implemented to determine if those regulations will have

their intended consequences without causing harm (i.e., unintended consequences). If we cannot study the age group
the regulations are targeting, we cannot test potential regulations effectively.
We anticipate long term benefits to the public at large by adding to the limited body of knowledge involving these
products among tobacco users.
5. * Describe any potential for direct benefits to participants in this study:
None.
6. * Describe any potential for direct social impact in this study . For example, any engagement
with specific communities to respond to community-identified needs, or ways the study will
strengthen the well-being of the specific communities if applicable:
Results from this study will provide a broader public health impact to guide the appropriate regulation of ECIGs. We do
not anticipate any direct social impacts in this study.
7. Upload a supporting citation list if applicable:
 
Document
Name
Document
VersionDate
Modified
Uploaded
By
Type
Approved
View Informed
Consent
P3 TASTE_Informed
Consent_CLEAN_1.29.2024.pdf
0.15
2/20/2024
10:22 AM
Rabia Imran Consent/Assent/Information
Sheet
Yes
View Consent -
Tool
P3TASTE_Consent_Presentation_1.29.2024.pptx 0.06
1/30/2024
1:34 PM
Rabia Imran Consent/Assent/Information
Sheet
Yes
View Social Media
Plan
P3-TASTE Social Media Plan_10.2.2023.docx
0.01
10/2/2023
3:29 PM
Caroline
Cobb Amey
Recruitment/Advertising
Yes
View Social Media
and Craigslist
Ads
P3-TASTE_facebook and craiglist
ads_10.2.2023.docx
0.01
10/2/2023
3:29 PM
Caroline
Cobb Amey
Recruitment/Advertising
Yes
View Substance
Use
Resources
Handout
CSTP Substance Use
Resources_8.11.2023.docx
0.01
8/11/2023
5:11 PM
Caroline
Cobb Amey
Other
Yes
View Subjective
Measures
P3-TASTE-Session Subjective
Measures_CLEAN_08.09.2023.doc
0.03
8/11/2023
5:10 PM
Rabia Imran Research Measure
Yes
View P3 TASTE
Advertisement
for CSTP
Website
P3 TASTE - CSTP Website Study
Description_CLEAN_08.08.2023.docx
0.05
8/11/2023
5:09 PM
Rabia Imran Recruitment/Advertising
Yes
View Presession
Symptom
Questions
P3-Presession symptom Checklist-
CLEAN_08.09.2023.docx
0.05
8/11/2023
5:08 PM
Rabia Imran Research Measure
Yes
View Baseline Self
Report Physio
Measures
P3-TASTE_Baseline forms
All_CLEAN_8.11.2023.docx
0.06
8/11/2023
5:07 PM
Rabia Imran Research Measure
Yes
View Text, Email,
Call Scripts
P3-TASTE_Phone_e-mail_text
scripts_08.09.2023_CLEAN.docx
0.10
8/11/2023
5:06 PM
Rabia Imran Study
reminders/communications
Yes
View Referral
Program Card
Template
P3_Referral program
card_06.02.2023_CLEAN.docx
0.03
6/13/2023
1:48 PM
Rabia Imran Recruitment/Advertising
Yes
View COVID-19
Questions
COVID_Questions_P3_no longer using.docx
0.02
6/13/2023
1:35 PM
Rabia Imran Other
Yes
View P3
Taste_ETM
P3-TASTE_Measures_ETM__no longer
using.docx
0.04
6/13/2023
1:35 PM
Rabia Imran Research Measure
Yes
View Tobacco
Cessation
Resources
Handout
Cessation_handout_RI_04.29.2021.pdf
0.01
2/1/2023
3:32 PM
Caroline
Cobb Amey
Other
Yes
View U54 Grant
Application
Without
Budget
U54 Grant Application BUDGET PAGES
DELETED FOR IRB.pdf
0.01
10/28/2022
2:17 PM
Rabia Imran Funding Proposal
Not
Applicable

 
Document
Name
Document
VersionDate
Modified
Uploaded
By
Type
Approved
View CP-DPT &
DPT
P3-TASTE Drug Purchase Tasks_9.2.2022.docx
0.01
10/28/2022
2:03 PM
Rabia Imran Research Measure
Yes
View CP-DPT &
DPT - Tool
DPT_CDPT presentation_10.28.2022.pptx
0.01
10/28/2022
2:03 PM
Rabia Imran Research Measure
Yes
View Subjective
Measures -
Tool
Subjective Measures
presentation_10.28.2022.pptx
0.01
10/28/2022
2:00 PM
Rabia Imran Research Measure
Yes
View Barnes
Biosketch
P3 Barnes biosketch 06.22.17.FINAL.docx
0.01
10/28/2022
1:55 PM
Rabia Imran CV/Biosketch
Not
Applicable
View Lipato
Biosketch
Lipato Biosketch.pdf
0.01
10/28/2022
1:54 PM
Rabia Imran CV/Biosketch
Yes
View Caroline Cobb
(Amey) CV
CV_Cobb_August 2022.docx
0.01
10/28/2022
1:54 PM
Rabia Imran CV/Biosketch
Yes
View Baseline
Discounting
Task - MDT
P3_TASTE_Discounting Task_11.7.2018.pdf
0.01
10/28/2022
1:54 PM
Rabia Imran Research Measure
Yes
View U54 Project 3
Grant Docs
U54_Project 3 only docs.pdf
0.01
10/28/2022
1:53 PM
Rabia Imran Funding Proposal
Not
Applicable
View CSTP Parking
Map
CSTP Parking Map.docx
0.01
10/28/2022
1:52 PM
Rabia Imran Other
Not
Applicable
View Criticare
HR/BP
Manual
Criticare_Vitalcare_506N3_-_Service_manual.pdf 0.01
10/28/2022
1:52 PM
Rabia Imran Other
Not
Applicable
View Expired Air
CO Manual
CO Monitor Manual.pdf
0.01
10/28/2022
1:51 PM
Rabia Imran Other
Not
Applicable
View Information
about Blood
Pressure
BP results P3 flux 8.22.2022.docx
0.01
10/28/2022
1:51 PM
Rabia Imran Study
reminders/communications
Yes
View CSTP
Registry
Consent and
Survey
CSTP Registry Consent Form and Questions.pdf 0.01
10/19/2022
3:27 PM
Caroline
Cobb Amey
Other
Not
Applicable
  

HM20025464
View: SF2 - Study Population
ID: HM20025464
HM20025464 - Caroline Cobb Amey
Effects of Electronic Cigarette Flavors on Abuse Liability in Smokers (P3-Taste)
  
Study Population
1. * Provide the maximum number of individuals that
  1. May participate in any study interaction or intervention (Including screening, consenting,
and study activities)
      AND/OR
  2. You obtain any data/specimens about (regardless of identifiability) 
 at VCU and at other sites under the VCU IRB's oversight. See the help text for additional
guidance.
100 
2. If this is a multi-Center Project, what is the maximum anticipated number of subjects across all
sites?
N/A
3. * Provide justification for the sample size by explaining how you arrived at the expected number
of participants and why this number is adequate for answering the research questions:
This study manipulates e-cigarette flavor and nicotine flux systematically, testing the hypothesis that abuse liability will
be related directly to flux or flavor among a sample of cigarette smokers. Previous studies using this type of design are
limited.
Thus, we calculated a sample size to achieve a power of >0.80 with α <0.05 and assuming a small effect size (Cohen’s
f=0.20) and moderate repeated measures correlation (r=0.5) in a repeated measures ANOVA with nicotine flux as
within-subjects factors (N=32; GPower).
In this study, 36 cigarette users will attend the lab for 4 sessions: 1) own brand cigarette (always the first session), 2)
NJOY Ace 2.4% nicotine ECIG (Menthol and Classic Tobacco flavor), 3) NJOY Ace 5.0% nicotine ECIG (Menthol and
Classic Tobacco flavor), and 4) NJOY Daily ECIG 6% nicotine (Menthol and Extra Rich Tobacco).
We hypothesize that flux will be positively associated with willingness to pay (drug purchase task) and willingness to
substitute e-cigarettes for own brand cigarettes (cross-product drug purchase task), and inversely to price sensitivity
(drug purchase task) for all smokers.
We hypothesize that within class, menthol flavored products will be positively associated with willingness to pay (drug
purchase task) and willingness to substitute e-cigarettes for own brand cigarettes (cross-product drug purchase task),
and inversely to price sensitivity (drug purchase task) for all smokers.
It is possible that we would consent up to 100 participants in order to obtain 36 participants who complete the entire
study.
4. * List the study inclusion criteria:
All participants must be healthy (determined by self-report), at least 18 years old (verified by photo ID), willing to
provide informed consent, and attend the lab. Participants must agree to use designated products according to the
study protocol.
Participants must smoke cigarettes at least 3 days per week and on those days at least 1 cigarette smoked per day.
Participants must have a 'positive' cotinine cassette result to verify nicotine use.
Please note that beginning July 1, 2020, per HB1570 Virginia law "Provides an exception to the law prohibiting
possession of tobacco products, nicotine vapor products, or alternative nicotine products by a person less than 21
years of age when such possession is part of a scientific study being conducted by an organization for the purpose of
medical research to further efforts in cigarette and tobacco use prevention and cessation and tobacco product
regulation, provided that such medical research has been approved by an institutional review board pursuant to
applicable federal regulations or by a research review committee."
5. * List the study exclusion criteria:
Individuals with the following self-reported current, diagnosed medical condition(s) will be excluded automatically:
uncontrolled high blood pressure (via self-report or observed at screening; BP must be less than 160/100), heart-
related conditions (e.g., recent heart attack/stroke, coronary heart disease), severe immune system disorders (e.g.,
HIV/AIDS, multiple sclerosis), respiratory disorders (e.g., COPD, asthma), kidney diseases, liver diseases (e.g.,
cirrhosis), or seizures.
Individuals with other self-reported current, diagnosed medical conditions (e.g., diabetes, thyroid disease, lyme
disease) will be considered for exclusion after consultation with the PI and medical monitor. We ask a variety of
questions about participants' medical conditions that are not necessarily exclusionary in order to be able to consult with

the medical monitor about these conditions. Participants with any medical condition/medication that may affect
participant safety, study outcomes, or biomarker data will be excluded based on these consultations.
Individuals with current, diagnosed, psychiatric conditions that are uncontrolled will be excluded. A controlled
psychiatric illness is defined as one where the individual is taking medication and/or receiving other treatment (e.g.,
psychotherapy). In addition, individuals who have been to the ER and/or been hospitalized for a psychiatric condition in
the past year will be excluded.
Individuals with past month use of cocaine, opioids, benzodiazepines, and methamphetamine or other illegal
substances (other than cannabis) will be excluded. Individuals who report using cannabis greater than 15 days in the
past 30 and/or alcohol greater than 25 days in the past 30 days will be excluded.
Participants who choose not to answer questions related to inclusion/exclusion criteria will be excluded.
Participants who indicate their sex assigned at birth is female will be excluded if they are breast-feeding or test positive
for pregnancy (by urinalysis) at screening.
Those who intend to quit tobacco/nicotine use in the next 30 days will be excluded and referred to cessation treatment.
6. * Will individuals with limited English proficiency be included in or excluded  from this research?
Included
Excluded - safety concerns if participants are unable to communicate with the study team
Excluded - instruments/measures only validated in English
Excluded - no prospect of direct benefit to individual participants
Excluded - minimal risk study
Excluded - lack of budget/resources for translation and interpretation [provide an explanation in next question]
Excluded - other reason [provide an explanation in next question]
7. Justify the inclusion and exclusion criteria if you are either targeting, or excluding, a particular
segment of the population / community. Provide a description of the
group/organization/community and provide a rationale.
We are excluding individuals (<18 years old) as this group includes children for whom research risks may differ
compared those 18 or older. This younger age group is also likely to differ in important ways compared to individuals
aged 18 and older including likelihood of residing with a guardian/parent which may impact their response to research
questions of interest. We also exclude pregnant/breastfeeding individuals as tobacco/nicotine use is dangerous to a
fetus/child. We exclude individuals with certain health conditions that may be exacerbated by tobacco product
administration. We also exclude individuals with drug use histories that may raise the risk of participation or affect the
quality of data collected in the study.
  

HM20025464
View: SF2 - Background, Rationale & Goals Section Complete
ID: HM20025464
HM20025464 - Caroline Cobb Amey
Effects of Electronic Cigarette Flavors on Abuse Liability in Smokers (P3-Taste)
  
Background, Rationale & Goals Section Complete
Protocol Progress:
w INITIAL SETUP
x BACKGROUND, RATIONALE & GOALS
f RESEARCH PLAN
g CONSENT PLAN
h RISKS, PRIVACY & CONFIDENTIALITY
i POPULATIONS WITH SPECIAL CONSIDERATIONS
j INSTITUTIONAL REQUIREMENTS
k DOCUMENTS
Click Continue below to go to the next section

HM20025464
View: SF2 - Study Procedures
ID: HM20025464
HM20025464 - Caroline Cobb Amey
Effects of Electronic Cigarette Flavors on Abuse Liability in Smokers (P3-Taste)
  
Study Procedures
 
1. * Describe the study hypothesis and/or research questions.  Use lay language whenever
possible.
The purpose of this study is to determine if abuse liability indices will be impacted by varying flavors and ECIG nicotine
delivery capability (i.e., nicotine flux) among current combustible cigarette users.
We will compare abuse liability indices between three FDA authorized ECIG products that vary in nicotine flux (but are
all tobacco flavor) and own brand cigarettes. We will also test the influence of ECIG flavor availability (tobacco vs.
menthol) within three ECIG product classes.
We hypothesize that as nicotine flux is lowered, abuse liability indices will be lowered.
We also hypothesize that across ECIG product classes, abuse liability indices will be higher for menthol-flavored
products.
2. * Describe the study's specific aims or goals.  Use lay language whenever possible.
Aim 1: Compare the abuse liability of own brand (OB) cigarettes and three FDA-authorized tobacco flavor ECIGs that
vary by nicotine flux.
Aim 2: Test the influence of ENDS flavor availability (tobacco vs. menthol) within each ENDS product class.
3. * Choose all types of recruitment materials that may be used and upload them below:

E-mail invitations

Phone Solicitation scripts (i.e. cold calls or random-digit-dialing)

Flyers, Mailed Letters or Newspaper/TV/Radio Ads

TelegRAM announcements

Website text

Study-specific web sites (provide the design and text)

Social Media

EPIC MyChart Patient Portal research study descriptions

Psychology Research Participant Pool (SONA) study descriptions

Scripts for announcements made to groups

Other recruitment document

No recruitment materials
4. * If Other was selected above, describe the recruitment document that will be used:
Participants will be recruited for this study via the CSTP registry (HM20002567) and all recruitment materials are
located in that protocol with the exception of the study description that is posted on the CSTP website
(cstp.vcu.edu/studies) and Facebook/Instagram/Craigslist.org advertisements that are included as attachments in this
protocol. We also provide a social media plan document.
Scripts for communicating with participants (included with this usage protocol) are unique to this study.
5. * Describe the study procedures/methods for identifying and recruiting participants. Address all
of the following three aspects of recruitment in your response. 
1. Identification of potentially eligible participants or secondary data/specimens of interest.
     - What database(s) will be queried to identify secondary data/specimens
     - How VCU Informatics or VCU IRDS will be used for cohort identification (when applicable, see help text)
    - How potential participants' contact information will be obtained
2. Recruitment procedures to invite participation in the study (when applicable):
     - How each of the written or verbal recruitment materials and reminders (selected above) will be used
     - Who will contact, approach, or respond to potential participants
     - Locations where recruitment procedures will take place
     - The timing and frequency of recruitment attempts

3. Eligibility screening prior to consent and how those activities will be carried out (when
applicable)
See the help text for additional guidance.
Participants will be recruited via the CSTP registry (HM20002567) and other ads that direct potential participants to the
CSTP registry.
Potential participants will make the initial contact via telephone by calling the phone number provided on the
advertisements, or by going to the website provided on the advertisements. For the initial screening, we will use a
multi-study screening process/registry described in HM20002567. Because we use this process for multiple studies,
participants are actually screened for all ongoing studies at one time. For this reason, the script is vague. Participants
who appear eligible for this usage protocol based on the initial screening questionnaire from the registry are then
contacted, told more about this study using a short study description (see attachments), and if interested, participants
are invited for an in-person screening, where consent for this study will be obtained.
Participants must complete the screening process described in HM20002567 in order to participate in this usage
protocol, and must agree to be part of the CSTP registry in order to participate in this usage protocol (because we do
not have study-specific recruitment materials for this study).
Participants who have already consented to participate in the CSTP registry may be contacted via phone or e-mail and
told about this study. Individuals who are participants in other, ongoing CSTP studies (participants with whom we have
a pre-existing relationship) may be verbally referred to this study and directed to either call the laboratory or visit the
website indicated on the advertisements, if they are interested.
Participants who are eligible and who choose to enroll may be contacted via text for appointment reminders if they
agree (see scripts).
6. * Does this study have a separate protocol document (i.e. a multisite or sponsor's protocol) that
contains a detailed description of the study's methodology?
  Yes
No
7. * Since a separate protocol document is not uploaded, describe the proposed research using
language understandable to those IRB committee members whose expertise is not scientific.
The description must include:
 1. A statement explaining the study design
 2. A detailed description of all the procedures that will be followed to carry out the study,
preferably in sequential order, and in sufficient detail that the study's methods could be
replicated
 3. The schedule and frequency of when and how procedures will be conducted (e.g. in person,
online, phone, paper, etc.)
 4. A description of all research measures/tests/interventions that will be used, including
analyses/tests conducted on specimens/biological samples (if applicable)
See the help text for additional guidance
Overview. This study involves 36 cigarette users who will complete 4, within-subject, laboratory sessions that differ by
the product used: 1) own brand cigarette, 2) NJOY Ace 2.4% nicotine ECIG (Menthol and Classic Tobacco flavor), 3)
NJOY Ace 5.0% nicotine ECIG (Menthol and Classic Tobacco flavor), and 4) NJOY Daily ECIG 6% nicotine (Menthol
and Extra Rich Tobacco). The first condition for all subjects will be their own brand cigarette which is completed at the
conclusion of the in-person screening session or scheduled immediately following (if the participant is unable to
complete this condition at the in-person screening session). The subsequent three sessions will be assigned using a
Latin-square following enrollment and within each session participants will sample and evaluate two flavors of each
session’s product (session flavor order is incorporated into the Latin-square condition order assignment).
Participants. A total of 36 adults (age 18+) who currently use cigarettes will be enrolled. We will attempt to recruit an
equal number of menthol and non-menthol preferring smokers as well as men and women of diverse racial/ethnic
backgrounds, although this study is not intended to address gender or race/ethnic differences.
Recruitment and Enrollment. Participants will first be screened via phone or online, via a multi-study screening
process/registry described in HM20002567 (see attachment "Registry consent form and questions"). Participants are
automatically screened for all ongoing CSTP studies, but participants can tell study staff if they are interested in
screening for a particular study only, and study staff will make a note of this preference.
Once initial screening is completed (either over the phone or via the internet), potentially eligible participants will be
invited to the lab to complete in-person informed consent, additional screening, and familiarization with study
procedures (approximately 1 hr, $15/hour compensation). Once participants have been seated in a private study room,
research staff will communicate with the participants primarily using Zoom as an intercom, to speak/interact with
participants. Prior to in-person data collection, staff will review the informed consent in person and/or using a
Powerpoint/video tool to ensure they understand the study, its risks and benefits, and their rights as research
participants. Participants will have the opportunity to ask questions to the research staff, prior to signing the consent
document. Following documentation of informed consent, participants will complete baseline measures to confirm
eligibility, have their blood pressure and heart rate checked, provide a urine sample that will be tested for cotinine level

(to confirm current smoking status) and pregnancy (women only), and provide a exhaled breath carbon monoxide
(eCO) sample. Age will be verified by asking participants to provide some form of identification that includes a date of
birth. All study procedures (including subjectives, Drug Purchase Task, Cross-Product Drug Purchase Task) will be
reviewed/practiced using approved measures and/or Powerpoint/video-based tools. Participants also will complete the
Minute Discounting Task.
Individuals whose blood pressure levels are elevated (>=140 mmHg systolic or >=90 mmHg diastolic) during screening
or at a session will be provided with a blood pressure information sheet by the research staff (see study document).
This sheet will be provided at the first instance of elevated blood pressure observed during the study.
Participants who report illegal drug use at baseline or self-disclose at a later point in the study (other than
marijuana/cannabis) will be provided a copy of the Substance Use Resource Handout. Participants are not required to
take the handout.
Participants will be asked during the baseline questionnaire whether they would like to receive a brief summary of
study findings when the study is completed and if yes preferred contact information (for disbursement of this summary).
This information will be completed once the brief study summary is disbursed.
New recruits will replace participants who do not complete the study. Accrual ends when the required number of
completers is reached.
Products. Own brand tobacco cigarettes and alternative tobacco products will be purchased locally and/or online by
VCU approved staff. If own brand cigarettes are not available at the in-person screening session (due to supply-chain
or other access issues), participants will be asked to provide one of their own products and receive compensation for
use during that session ($5 for one cigarette). Alternative tobacco products tested will be 1) NJOY Ace 2.4% nicotine
ECIG (Menthol and Classic Tobacco flavor), 2) NJOY Ace 5.0% nicotine ECIG (Menthol and Classic Tobacco flavor),
and 3) NJOY Daily ECIG 6% nicotine (Menthol and Extra Rich Tobacco).
Of note in terms of regulatory status for the ECIG products tested. Products in Classic Tobacco flavor and Extra Rich
Tobacco are currently FDA authorized for marketing/sale in the US (as of 1.24.2023). Products in Menthol flavor are
still under FDA review for authorization and have not been denied for marketing/sale and thus are still legal for use for
those appropriate age (as of 1.24.2023).
Procedure. Following the in-person screening procedure and confirmation of eligibility, participants will be asked to
complete 4 sessions the first of which will begin immediately following the in-person screening (or a day/time that is
more convenient for the participant). Subsequent sessions must be scheduled at least 48 hours apart. Participants are
not required to abstain from nicotine/tobacco (as we are not testing the ability of these products to suppress abstinence
related symptoms or measure acute self-administration behavior), food, or caffeine prior to any session.
Of note, research staff will use Zoom, as an intercom to communicate with participants whenever possible during
sessions.
At the start of the session, participants will be asked about symptoms experienced since their last visit (with the
exception of session 1, if completed at the in-person screening session; see Presession symptom Checklist). Answers
given about respiratory and gastrointestinal symptoms will be compared to the participants’ previous answers, and if
any symptoms have become more frequent or more severe, the medical monitor and/or study nurse will be asked to
review the symptoms. In some cases, we may contact Dr. Lipato to determine if a session can proceed.
Next, participants will have their breath tested (expired carbon monoxide [CO]) and physiologic data collection will
begin. We will check blood pressure once at the beginning of the session and again at the end. Heart rate will be
measured continuously throughout the session. Immediately after session onset, participants will have a 30-minute rest
period.
During rest periods, participants will not be allowed eat or drink outside beverages, but we will provide water to drink
and they are invited to use their phone, read books/magazines, or watch movies that we provide to them.
After the 1st rest period, participants will complete subjective measures 1. Immediately after completing subjective
measures 1, participants will sample the session-specific product (5 self-directed ECIG/own brand cigarette puffs over
10 minutes). After sampling is complete they will complete subjective measures 2. Ten minutes after their sampling has
been completed, they will complete the DPT/CP-DPT. The DPT/CP-DPT takes approximately 10 to 15 minutes to
complete. Please note at session 1, only the DPT will be completed, blood pressure will be checked, physio data
collection will end, and then the session will end.
In sessions 2 and 3 and 4, after completing the 1st DPT/CP-DPT, participants will start the 2nd 30-minute rest period.
After the rest period, participants will complete subjective measures 3. Immediately after subjective measures 3,
participants will sample the other session-specific product (5 self-directed ECIG puffs over 10 minutes). After sampling
is complete they will complete subjective measures 4. Ten minutes after their sampling has been completed, they will
complete the DPT/CP-DPT.
After completing the 2nd DPT/CP-DPT, blood pressure will be checked, physio data collection will end, and participants
will be paid for their time.
The study procedures for session 1 should take no more than 70 minutes or 1.2 hours, and for sessions 2 and 3 and 4
should take no more than 140 minutes or 2.3 hours.
Please note there can be some variability in the session times due to participant behavior (i.e., taking shorter/longer
than expected to complete measures/tasks).
Session Timeline:

0m – eCO Check; Physiologic data collection begins, additional questions asked.
5m – Begin 30m Rest Period 1
35m – Subjectives 1
40m – Sample Product 1 (puffs)
50m – Subjective 2
60m - 1st DPT/CP-DPT
75m – Begin 30m Rest Period 2 / Physiologic data collection ends; Session 1 end
105m – Subjectives 3
110m – Sample Product 2 (puffs)
120m – Subjective 4
130m – 2nd DPT/CP-DPT
140m – Physiologic data collection ends; Session 2/3/4 end
Note: Product sampling will consist of 5 self-directed sample puffs for own brand cigarettes or ECIG conditions taken
over 10 minutes.
Measures.
Baseline measures. During the in-person eligibility screening, we will assess sociodemographic and income-related
information, discounting, health and psychiatric conditions, drug and alcohol use, history and patterns of tobacco use,
nicotine dependence/craving, and perceived harm and risk of tobacco products using standardized items from national
surveys (e.g., Behavioral Risk Factor Surveillance Survey; Tobacco Use Supplement to the Current Population
Survey). Urine samples will be tested immediately for cotinine (a major nicotine metabolite) using the NicAlert semi-
quantitative test (Jant Pharmaceutical Corporation, Encino, CA), and among women for pregnancy. For
eligible/enrolled participants, we will retain a urine sample (≤10 ml) for later analysis of tobacco-related biomarkers. We
will also be obtaining baseline physiological measures including: eCO and HR/BP. eCO will be assessed via a
BreathCO monitor (Vitalograph, Lenaxa, KS). HR/BP will be measured and saved electronically using software and
equipment that sounds an alarm if safety parameters are exceeded (Model 506, Criticare Systems).
The Minute Discounting Task is a series of hypothetical decision scenarios. Each scenario presents a choice between
receiving an amount of money now or an amount of money later. These choices are differentiated by the amount of
money at each time point and the length of time between the time points. Participants make a choice for five decision
scenarios which are automatically adjusted based upon individual responses; while there are approximately 30
potential scenarios, only five are presented to the participant. The task takes less than one minute to complete. Data is
collected via Qualtrics survey. Data is stored within Qualtrics under usernames and passwords assigned to some lab
staff.
Physiological measures. Physiological measures are being collected primarily for participant safety during sessions.
For eligible/enrolled participants, up to 10 ml of urine collected at the in-person screening session will be saved and
frozen for later analysis of tobacco-related biomarkers including nicotine and its metabolites (i.e., cotinine), propylene
glycol, and (4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol) (NNAL). HR/BP will be measured and saved electronically
using software and equipment that sounds an alarm if safety parameters are exceeded (Model 506, Criticare Systems).
Behavioral measures. Our primary behavioral measures are two behavioral choice tasks (Drug Purchase Task; Cross
Product-Drug Purchase Task).
The Drug Purchase Task (DPT) assesses hypothetical tobacco product purchasing behaviors for a tobacco product.
Please note this measure is tailored to own brand cigarette puffs and ECIG puffs. The outcomes from the DPT include
the breakpoint (highest price participants were willing to pay), elasticity (change in amount purchased as price
increases), Omax (highest amount individuals paid in any choice, i.e., maximum value of price*quantity), Pmax (the
price associated with Omax), and intensity (amount <purchased= when the price is zero/free). Data is collected via
REDCap survey and stored under username/password with specific access per user.
The Cross Product (CP)-DPT assesses cross-product purchasing behaviors between various tobacco products offered
at a fixed amount and own brand cigarettes offered at varying prices ($0-20.48). Please note this measure is tailored to
ECIG puffs. The main outcome for the CP-DPT is cross-price elasticity, or the extent to which purchasing of the
session-specific product increases when the price of own brand cigarettes increase. Both the DPT and CP-DPT tasks
are programmed to end early if participants report zero consumption for assessed products. Estimated time per
measure is <3 min. Data is collected via REDCap survey and stored under username/password with specific access
per user.
Subjective measures. Repeatedly within each condition we will use the Adapted Hughes/Hatsukami Questionnaire, the
Direct Effects of Nicotine Scale, the Direct Effects of Tobacco Scale, Pennington VAS Scale and several items that
utilize the Generalized Labeled Magnitude Scale and the General Labeled Hedonic Scale to measure tobacco
abstinence symptoms and other effects before and after each product sampling.
Subjectives 1 and 3 will not include product-specific questions (Direct Effects of Tobacco Scale, Generalized Labeled
Magnitude Scale and the General Labeled Hedonic Scale).
Subjectives 2 and 4, will include product-specific questions.
We will also ask a validation question during Subjectives 2 and 4 related to flavor of the product that was tried.
All data is collected via REDCap or Qualtrics survey and stored under username/password with specific access per
user.
Tobacco Cessation Resources. A brief handout containing information about tobacco cessation and available
resources will be provided to all participants who consent to this study. Participants are not required to take the
handout. This handout will be given at the end of their study participation (at screening if ineligible, at the end of their
last study session, or via email if they self-withdraw or are withdrawn by the PI/medical monitor). We provide this
information as it may assist individuals who are considering quitting tobacco now and/or quitting tobacco in the future.

Data analysis. Subjective, physiological, and behavioral data will be prepared as reported elsewhere (e.g., Barnes et
al., 2017; Rusted et al., 1998; Cobb et al., 2010). Elasticity is estimated using an exponential demand function with
nonsystematic DTP data excluded based on two criteria: trend, or whether the participant had a general decrease in
consumption from the lowest to highest price; and bounce, or whether a participant reported higher consumption at
sequential higher prices (Stein et al., 2015). In general, analysis will involve a mixed (between- and within-subject)
ANOVA. Demographic data will be examined to determine if there are significant between-group differences on
measures that may be related to study outcomes. Unexpected between group differences will be considered as
potential covariates in the primary analysis (see Evans et al., 2006). Statistical analyses may utilize regression,
ANOVA, or mixed linear models. Adjustments for sphericity violations and post-hoc testing using Tukey's HSD or
planned contrasts with Bonferroni corrections will be used (Keppel, 1991). Based upon the type and amount of missing
data, we may use accepted techniques such as multiple imputation (Allison, 2001).
8. * The IRB only reviews research activities, so indicate for each of the study activities described
in the question above or in the protocol which activities are:
  - Being performed exclusively for research purposes (i.e. they would not otherwise be done apart from this
study) VERSUS.
  - Alterations of routine activities/procedures (e.g. the study is altering the timing, frequency, method,
location, amount, etc.) VERSUS.
  - Being done for other purposes and whose data/results will be used secondarily in the study (e.g. standard
medical or psychological tests, routine education practices, quality improvement initiatives, etc.).
    See the help text for additional guidance
All of the procedures described above are performed exclusively for research purposes. There are no alterations of
routine procedure and no procedures would be performed if these individuals were not taking part in this research
study.
9. If applicable, describe alternatives (research or non-research) that are available to potential
participants if they choose not to participate in this study:
N/A
10. Upload any supporting tables or documents (e.g. protocol documents, figures/tables, data
collection forms, study communications/reminders):
Upload ALL instruments/guides that will be used or that participants will experience (i.e. see,
hear, complete), including measures, scripts/questions to guide interviews, surveys,
questionnaires, observational guides, etc,:
Upload ALL recruitment and screening materials, including such as ads, flyers, telephone or in-
person scripts, letters, email invitations, TelegRAM announcements, and postcard reminders,
screening scripts, screening forms, and screening measures:
 
Document
Name
Document
VersionDate
Modified
Uploaded
By
Type
Approved
View Informed
Consent
P3 TASTE_Informed
Consent_CLEAN_1.29.2024.pdf
0.15
2/20/2024
10:22 AM
Rabia Imran Consent/Assent/Information
Sheet
Yes
View Consent -
Tool
P3TASTE_Consent_Presentation_1.29.2024.pptx 0.06
1/30/2024
1:34 PM
Rabia Imran Consent/Assent/Information
Sheet
Yes
View Social Media
Plan
P3-TASTE Social Media Plan_10.2.2023.docx
0.01
10/2/2023
3:29 PM
Caroline
Cobb Amey
Recruitment/Advertising
Yes
View Social Media
and Craigslist
Ads
P3-TASTE_facebook and craiglist
ads_10.2.2023.docx
0.01
10/2/2023
3:29 PM
Caroline
Cobb Amey
Recruitment/Advertising
Yes
View Substance
Use
Resources
Handout
CSTP Substance Use
Resources_8.11.2023.docx
0.01
8/11/2023
5:11 PM
Caroline
Cobb Amey
Other
Yes
View Subjective
Measures
P3-TASTE-Session Subjective
Measures_CLEAN_08.09.2023.doc
0.03
8/11/2023
5:10 PM
Rabia Imran Research Measure
Yes
View P3 TASTE
Advertisement
for CSTP
Website
P3 TASTE - CSTP Website Study
Description_CLEAN_08.08.2023.docx
0.05
8/11/2023
5:09 PM
Rabia Imran Recruitment/Advertising
Yes
View Presession
Symptom
Questions
P3-Presession symptom Checklist-
CLEAN_08.09.2023.docx
0.05
8/11/2023
5:08 PM
Rabia Imran Research Measure
Yes

 
Document
Name
Document
VersionDate
Modified
Uploaded
By
Type
Approved
View Baseline Self
Report Physio
Measures
P3-TASTE_Baseline forms
All_CLEAN_8.11.2023.docx
0.06
8/11/2023
5:07 PM
Rabia Imran Research Measure
Yes
View Text, Email,
Call Scripts
P3-TASTE_Phone_e-mail_text
scripts_08.09.2023_CLEAN.docx
0.10
8/11/2023
5:06 PM
Rabia Imran Study
reminders/communications
Yes
View Referral
Program Card
Template
P3_Referral program
card_06.02.2023_CLEAN.docx
0.03
6/13/2023
1:48 PM
Rabia Imran Recruitment/Advertising
Yes
View COVID-19
Questions
COVID_Questions_P3_no longer using.docx
0.02
6/13/2023
1:35 PM
Rabia Imran Other
Yes
View P3
Taste_ETM
P3-TASTE_Measures_ETM__no longer
using.docx
0.04
6/13/2023
1:35 PM
Rabia Imran Research Measure
Yes
View Tobacco
Cessation
Resources
Handout
Cessation_handout_RI_04.29.2021.pdf
0.01
2/1/2023
3:32 PM
Caroline
Cobb Amey
Other
Yes
View U54 Grant
Application
Without
Budget
U54 Grant Application BUDGET PAGES
DELETED FOR IRB.pdf
0.01
10/28/2022
2:17 PM
Rabia Imran Funding Proposal
Not
Applicable
View CP-DPT &
DPT
P3-TASTE Drug Purchase Tasks_9.2.2022.docx
0.01
10/28/2022
2:03 PM
Rabia Imran Research Measure
Yes
View CP-DPT &
DPT - Tool
DPT_CDPT presentation_10.28.2022.pptx
0.01
10/28/2022
2:03 PM
Rabia Imran Research Measure
Yes
View Subjective
Measures -
Tool
Subjective Measures
presentation_10.28.2022.pptx
0.01
10/28/2022
2:00 PM
Rabia Imran Research Measure
Yes
View Barnes
Biosketch
P3 Barnes biosketch 06.22.17.FINAL.docx
0.01
10/28/2022
1:55 PM
Rabia Imran CV/Biosketch
Not
Applicable
View Lipato
Biosketch
Lipato Biosketch.pdf
0.01
10/28/2022
1:54 PM
Rabia Imran CV/Biosketch
Yes
View Caroline Cobb
(Amey) CV
CV_Cobb_August 2022.docx
0.01
10/28/2022
1:54 PM
Rabia Imran CV/Biosketch
Yes
View Baseline
Discounting
Task - MDT
P3_TASTE_Discounting Task_11.7.2018.pdf
0.01
10/28/2022
1:54 PM
Rabia Imran Research Measure
Yes
View U54 Project 3
Grant Docs
U54_Project 3 only docs.pdf
0.01
10/28/2022
1:53 PM
Rabia Imran Funding Proposal
Not
Applicable
View CSTP Parking
Map
CSTP Parking Map.docx
0.01
10/28/2022
1:52 PM
Rabia Imran Other
Not
Applicable
View Criticare
HR/BP
Manual
Criticare_Vitalcare_506N3_-_Service_manual.pdf 0.01
10/28/2022
1:52 PM
Rabia Imran Other
Not
Applicable
View Expired Air
CO Manual
CO Monitor Manual.pdf
0.01
10/28/2022
1:51 PM
Rabia Imran Other
Not
Applicable
View Information
about Blood
Pressure
BP results P3 flux 8.22.2022.docx
0.01
10/28/2022
1:51 PM
Rabia Imran Study
reminders/communications
Yes
View CSTP
Registry
Consent and
Survey
CSTP Registry Consent Form and Questions.pdf 0.01
10/19/2022
3:27 PM
Caroline
Cobb Amey
Other
Not
Applicable

HM20025464
View: SF2 - Project Details
ID: HM20025464
HM20025464 - Caroline Cobb Amey
Effects of Electronic Cigarette Flavors on Abuse Liability in Smokers (P3-Taste)
  
Project Details
An intervention includes both physical procedures by which information or biospecimens are gathered (e.g., venipuncture) and
manipulations of the subject or the subject's environment that are performed for research purposes.
An interaction includes communication or interpersonal contact between investigator and subject. It may include in-person,
online, written, or verbal communications.
Secondary information/biospecimens are information or biospecimens that have been or will be collected for some other
<primary= or <initial= activity and that will be used secondarily in the research study.
1. * Select all of the following types of interventions that apply to this study (selections will
branch):

Social/Behavioral interventions or experimentation / Tasks / Environmental manipulations

Deception (misleading participants through false or incomplete information)

Drug(s) / Biologics / Supplement(s) / Other Compounds (investigational products or products whose
administration is dictated by the study protocol and not per the physician's clinical judgment)

IV contrast administration for research-related imaging (will branch to the Drugs page)

Placebos

Safety and/or effectiveness evaluation of Bio-Medical Device(s), including in-vitro diagnostic devices/assays,
mobile medical apps, software functions, and HUDs used in clinical investigations

Washout Periods

Expanded Access – Treatment Use of an Investigational Product

Medical or Surgical Procedures (eg: physical exam, clinical procedures, scans, etc)

Specimen/biological sample collection

None of the Above
2. * Select all of the following types of interactions and methods of data collection that apply to
this study (selections will branch):

Surveys / Questionnaires /Written responses to questions (including data entry)

Active Internet data collection (i.e. using the internet to collect data, including online surveys, data
collection via Zoom, apps, etc.)

Passive Internet data collection (i.e. passively observing online behavior, bots)

Interviews / Focus Groups / Verbal responses to questions

Audio / Video recording or photographing participants

Observations

Educational Settings/Assessments/Procedures

None of the Above
3. * Select all types of recordings that will be made:

Audio

Video

Photographs
4. * Describe the purpose of the recordings, who will be recorded and when such recordings will
occur:
We will be using Zoom as an intercom for communications with participants during in-person screening and study
sessions. Sometimes, such as when explaining procedures or answering questions, research staff may notify
participants and then switch the camera on the participant computer 'on' so that we can facilitate a face to face
conversation. Other times, all cameras may be off and/or research staff may have only their computer camera 'on' so
that participants can see the researcher.

Zoom will not be recorded or stored or linked to participant IDs or used for any analysis purpose other than facilitating
face to face communications in combination with social distancing.
5. * Select all types of secondary information and/or specimens that apply to this study (selections
will branch):
See the help text for definitions.

Individually Identifiable Health Information (PHI)

Secondary data/specimens NOT from a research registry or repository

Information/specimens from a research registry or repository (Usage Protocol)

Information/specimens originally collected for a previous research study

Publicly available information/specimens

Government-generated or collected information that was or will be obtained for nonresearch activities [only
applicable to research conducted by or on behalf of a Federal department or agency]

No secondary data/specimens will be used
 

HM20025464
View: SF2 - Behavioral Intervention/Task Details
ID: HM20025464
HM20025464 - Caroline Cobb Amey
Effects of Electronic Cigarette Flavors on Abuse Liability in Smokers (P3-Taste)
  
Behavioral Intervention/Task Details
This page asks for details about the social/behavioral intervention, task, or environmental manipulation in the research.
Interventions include both physical procedures by which information is gathered and manipulations of the subject or the
subject's environment that are performed for research purposes. This might include activities such as playing computer
games, performing a task, thought/cognition activities, environmental manipulations, and educational activities.
If the study only involves surveys, interviews, or secondary data collection, go back to the Project Details page and uncheck
<Social/Behavioral interventions or experimentation / Tasks / Environmental manipulations= in Question 1.
1. * Describe the duration of the social/behavioral intervention, task, or
environmental manipulation:
4 sessions each from 1.2 to 2.3 hours
2. * Describe any potential harms or discomforts that participants could experience during the
intervention activity:
Physical Risks:
1. You may experience mild frustration while completing some of the study-related tasks.
2. On very rare occasions, you may experience small droplets of liquid during inhalation of the e-cigarette we provide.
You may find these droplets to be unexpected and/or unpleasant. This experience has been reported by e-cigarette
users, and they report that it is an annoyance that does not appear to present any known medical danger. If this
occurs, we will immediately replace the e-cigarette device you are using.
3. The e-cigarette liquid that we give you may contain less or more nicotine than you are used to, although some e-
cigarette users report using these products. Inform the study staff immediately if you experience any discomfort. You
may also experience side effects from products that contain nicotine such as acute increases in heart rate and blood
pressure, sweating, lightheadedness, dizziness, nausea, and nervousness. These side effects are unlikely in
individuals who use cigarettes regularly.
4. The Centers for Disease Control and Prevention advises that e-cigarette, or vaping products are unsafe for youths,
young adults, or women who are pregnant. Adults who do not currently use tobacco products should not start using e-
cigarette, or vaping, products. If you use e-cigarette products, monitor yourself for the below symptoms and promptly
seek medical attention if you have concerns about your health.
a. Some people who use e-cigarettes have reported experiencing seizures. Some of these individuals reported a prior
history of seizures or using other substances at the same time as their e-cigarette.
b. In some cases, e-cigarette use has led to respiratory illnesses such as difficulties breathing, shortness of breath,
cough, and/or chest pain before hospitalization. In some cases, e-cigarette use has led to death, although most of
these cases have been related to vaping THC.
c. In some cases, e-cigarette use has been associated with symptoms of mild to moderate gastrointestinal illness such
as nausea, abdominal pain, vomiting, diarrhea, fevers, or fatigue.
5. The use of e-cigarettes may include other side effects/risks such as a sore or scratchy throat and headache.
6. The researchers will let you know about any significant new findings (such as additional risks or discomforts) that
may make you change your mind about participating in the study.
Non-physical Risks
1. Participation in research might involve some loss of privacy. There is a small risk that someone outside the study
could see and misuse information about you.
2. The study questionnaires ask personal questions that are sensitive in nature. You may refuse to answer any
question that makes you feel uncomfortable.
3. * Will the intervention activity be physically invasive or painful?
  Yes
No
4. * Describe the impact the intervention activity will have on participants, including the nature
and duration of any impact(s):
Participants will be using an ECIG/cigarette that contains nicotine. They may experience the effects of nicotine use
which could include acute increases in heart rate and blood pressure, sweating, lightheadedness, dizziness, nausea,
and nervousness, although these are less likely in individuals who use nicotine-containing products regularly. All of the
participants are experienced, cigarette smokers. The duration of these impacts is expected to be no longer than the
length of the session.
5. * In the investigator's opinion, is there any reason to think that the participants will find the
intervention activity offensive or embarrassing? Explain why or why not.
No.

HM20025464
View: SF2 - Bio-Medical Drug / Biologic / Supplement / Other Compound Details
ID: HM20025464
HM20025464 - Caroline Cobb Amey
Effects of Electronic Cigarette Flavors on Abuse Liability in Smokers (P3-Taste)
  
Bio-Medical Drug / Biologic / Supplement / Other Compound
Details
1. * List all drugs and/or biologics:
 
Drug
Manufacturer
Types
FDA
Labeling
IND
Holder
IND
Number
View NJOY Ace 2.4% nicotine -
Menthol (flavor)
NJOY LLC
Other (Drug or
Compound Not Listed
Above)
Not
Applicable
Not
Required
 
View Own brand cigarettes
Various
Manufacturers
Other (Drug or
Compound Not Listed
Above)
Not
Applicable
Not
Required
 
View NJOY Ace 2.4% nicotine -
Classic Tobacco (flavor)
NJOY LLC
FDA Approved and
being used as approved
Not
Applicable
Not
Required
 
View NJOY Ace 5.0% nicotine -
Menthol (flavor)
NJOY LLC
Other (Drug or
Compound Not Listed
Above)
Not
Applicable
Not
Required
 
View NJOY Ace 5.0% nicotine -
Classic Tobacco (flavor)
NJOY LLC
FDA Approved and
being used as approved
Not
Applicable
Not
Required
 
View NJOY Daily 6% nicotine -
Menthol (flavor)
NJOY LLC
Other (Drug or
Compound Not Listed
Above)
Not
Applicable
Not
Required
 
View NJOY Daily 6% nicotine -
Extra Rich Tobacco (flavor)
NJOY LLC
FDA Approved and
being used as approved
Not
Applicable
Not
Required
 
2. * Will the Investigational Drug Service (IDS) pharmacy be utilized:
Not Applicable
3. * A. For each drug/biologic listed above, upload an investigator's drug brochure or package insert/FDA
labeling.
B1. For drug products that require an IND, upload at least one of the following for verification of
the IND number:
  - External sponsor's protocol including IND number and signed Form FDA 1572 for the VCU Principal
Investigator
  - Communication from the external sponsor verifying the IND number and signed Form FDA 1572 for the VCU
Principal Investigator
  - VCU sponsor-investigator's FDA IND protocol including IND number
  - Communication from the FDA with verification of the IND number
B2. For drug products that qualify for IND exemption under under 21 CFR 312.2(b), upload one of
the following for each applicable drug:
  - A document explaining, with protocol-specific information, how the drug's use in this study meets the
relevant criteria for IND exemption under 21 CFR 312.2(b).
  - The completed "Determination of IND Exemption for Marketed Drugs" form available on the VCU Faculty‐
Held IND or IDE website at go.vcu.edu/indide.
  - External sponsor's protocol including IND exemption information
  - Communication from the external sponsor verifying the IND exemption
  - Communication from the FDA with verification of IND exemption
C. If the Investigational Drug Service Pharmacy (IDSP) is not utilized, upload the IDSP
management plan approval.

 
Document
Name
Document
VersionDate
Modified
Uploaded
By
Type
Approved
View Informed
Consent
P3 TASTE_Informed
Consent_CLEAN_1.29.2024.pdf
0.15
2/20/2024
10:22 AM
Rabia Imran Consent/Assent/Information
Sheet
Yes
View Consent -
Tool
P3TASTE_Consent_Presentation_1.29.2024.pptx 0.06
1/30/2024
1:34 PM
Rabia Imran Consent/Assent/Information
Sheet
Yes
View Social Media
Plan
P3-TASTE Social Media Plan_10.2.2023.docx
0.01
10/2/2023
3:29 PM
Caroline
Cobb Amey
Recruitment/Advertising
Yes
View Social Media
and Craigslist
Ads
P3-TASTE_facebook and craiglist
ads_10.2.2023.docx
0.01
10/2/2023
3:29 PM
Caroline
Cobb Amey
Recruitment/Advertising
Yes
View Substance
Use
Resources
Handout
CSTP Substance Use
Resources_8.11.2023.docx
0.01
8/11/2023
5:11 PM
Caroline
Cobb Amey
Other
Yes
View Subjective
Measures
P3-TASTE-Session Subjective
Measures_CLEAN_08.09.2023.doc
0.03
8/11/2023
5:10 PM
Rabia Imran Research Measure
Yes
View P3 TASTE
Advertisement
for CSTP
Website
P3 TASTE - CSTP Website Study
Description_CLEAN_08.08.2023.docx
0.05
8/11/2023
5:09 PM
Rabia Imran Recruitment/Advertising
Yes
View Presession
Symptom
Questions
P3-Presession symptom Checklist-
CLEAN_08.09.2023.docx
0.05
8/11/2023
5:08 PM
Rabia Imran Research Measure
Yes
View Baseline Self
Report Physio
Measures
P3-TASTE_Baseline forms
All_CLEAN_8.11.2023.docx
0.06
8/11/2023
5:07 PM
Rabia Imran Research Measure
Yes
View Text, Email,
Call Scripts
P3-TASTE_Phone_e-mail_text
scripts_08.09.2023_CLEAN.docx
0.10
8/11/2023
5:06 PM
Rabia Imran Study
reminders/communications
Yes
View Referral
Program Card
Template
P3_Referral program
card_06.02.2023_CLEAN.docx
0.03
6/13/2023
1:48 PM
Rabia Imran Recruitment/Advertising
Yes
View COVID-19
Questions
COVID_Questions_P3_no longer using.docx
0.02
6/13/2023
1:35 PM
Rabia Imran Other
Yes
View P3
Taste_ETM
P3-TASTE_Measures_ETM__no longer
using.docx
0.04
6/13/2023
1:35 PM
Rabia Imran Research Measure
Yes
View Tobacco
Cessation
Resources
Handout
Cessation_handout_RI_04.29.2021.pdf
0.01
2/1/2023
3:32 PM
Caroline
Cobb Amey
Other
Yes
View U54 Grant
Application
Without
Budget
U54 Grant Application BUDGET PAGES
DELETED FOR IRB.pdf
0.01
10/28/2022
2:17 PM
Rabia Imran Funding Proposal
Not
Applicable
View CP-DPT &
DPT
P3-TASTE Drug Purchase Tasks_9.2.2022.docx
0.01
10/28/2022
2:03 PM
Rabia Imran Research Measure
Yes
View CP-DPT &
DPT - Tool
DPT_CDPT presentation_10.28.2022.pptx
0.01
10/28/2022
2:03 PM
Rabia Imran Research Measure
Yes
View Subjective
Measures -
Tool
Subjective Measures
presentation_10.28.2022.pptx
0.01
10/28/2022
2:00 PM
Rabia Imran Research Measure
Yes
View Barnes
Biosketch
P3 Barnes biosketch 06.22.17.FINAL.docx
0.01
10/28/2022
1:55 PM
Rabia Imran CV/Biosketch
Not
Applicable
View Lipato
Biosketch
Lipato Biosketch.pdf
0.01
10/28/2022
1:54 PM
Rabia Imran CV/Biosketch
Yes
View Caroline Cobb
(Amey) CV
CV_Cobb_August 2022.docx
0.01
10/28/2022
1:54 PM
Rabia Imran CV/Biosketch
Yes

 
Document
Name
Document
VersionDate
Modified
Uploaded
By
Type
Approved
View Baseline
Discounting
Task - MDT
P3_TASTE_Discounting Task_11.7.2018.pdf
0.01
10/28/2022
1:54 PM
Rabia Imran Research Measure
Yes
View U54 Project 3
Grant Docs
U54_Project 3 only docs.pdf
0.01
10/28/2022
1:53 PM
Rabia Imran Funding Proposal
Not
Applicable
View CSTP Parking
Map
CSTP Parking Map.docx
0.01
10/28/2022
1:52 PM
Rabia Imran Other
Not
Applicable
View Criticare
HR/BP
Manual
Criticare_Vitalcare_506N3_-_Service_manual.pdf 0.01
10/28/2022
1:52 PM
Rabia Imran Other
Not
Applicable
View Expired Air
CO Manual
CO Monitor Manual.pdf
0.01
10/28/2022
1:51 PM
Rabia Imran Other
Not
Applicable
View Information
about Blood
Pressure
BP results P3 flux 8.22.2022.docx
0.01
10/28/2022
1:51 PM
Rabia Imran Study
reminders/communications
Yes
View CSTP
Registry
Consent and
Survey
CSTP Registry Consent Form and Questions.pdf 0.01
10/19/2022
3:27 PM
Caroline
Cobb Amey
Other
Not
Applicable
 

HM20025464
View: SF2 - Sample Collection Details
ID: HM20025464
HM20025464 - Caroline Cobb Amey
Effects of Electronic Cigarette Flavors on Abuse Liability in Smokers (P3-Taste)
  
Sample Collection Details
1. * Select all of the types of samples that will be collected as part of this study.

Amniotic Fluid

Blood

Buccal Smears

Saliva

Tissue

Urine

Stool

Other
2. * If Other, please describe the type of sample being collected:
At screening and upon arrival at the laboratory for the research sessions, participants’ expired air carbon monoxide will
be measured. Samples will not be stored.
3. * In order to collect urine, will an indwelling catheter be placed solely for the research study:
  Yes
No
4. * Describe how the sample will be collected and the collection schedule. For each type of
sample, include information about
- The procedures that will be followed to collect the sample
- The role(s) of the individuals who will collect the sample
- The volume/size range of the sample
- The timing and frequency of sample collection
Expired air carbon monoxide samples will be taken using the device manufacturer guidance for length of breath hold
and timing at screening and at the beginning of each session. Disposable mouthpiece tubes will be used at each
participant/session. Carbon monoxide device readings will be recorded by research staff following each test.
Urine will be collected during the baseline screening to test for recent nicotine exposure and for current pregnancy for
women. About 10 to 30 mL is required for testing purposes, participants may provide more but it is not required.
For eligible/enrolled participants, up to 10 ml of urine collected at the in-person screening session will be saved and
frozen for later analysis of tobacco-related biomarkers including nicotine and its metabolites (i.e., cotinine), propylene
glycol, and (4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol) (NNAL).
Participants will be given a urine collection cup to collect their own urine in a nearby bathroom and return to the
laboratory space (<20 ft away) where the specimen will be processed. After screening tests have been completed and
samples stored, the urine sample is disposed using approved procedures for biohazardous waste.
Research staff will be responsible for performing all sample collection procedures.
5. * Will genetic testing or genetic analyses be conducted on any of the samples:
  Yes
No
 

HM20025464
View: SF2 - Active Internet Data Collection
ID: HM20025464
HM20025464 - Caroline Cobb Amey
Effects of Electronic Cigarette Flavors on Abuse Liability in Smokers (P3-Taste)
  
Active Internet Data Collection
1. * Describe the platform/technology chosen for collecting the data and transmitting data
securely over the internet. If proposing a non-VCU approved platform, give the rationale for
selecting the technology instead of a VCU-approved platform.
The in-person screening questionnaires, questionnaires administered during session, and the follow-up survey will be
administered via REDCap. All of the data will be stored in REDCap and viewing will be restricted to those personnel
associated with this protocol (listed under personnel).
There are several reasons for choosing REDCap. First, electronic administration of forms is more efficient than paper
forms and leads to less data entry (and possible errors). Second, REDCap is a secure way to collect data from
participants.
One measure (Minute Discounting Task) is collected via a VCU-supported Qualtrics account.
2. * Describe how data will be linked or unlinked to identifiers including email addresses, names,
and/or IP address.
If a participant enrolls in this study, they are given a numeric code (the study ID) that is connected 1) to their consent
(i.e., name) via a paper key, and 2) added to their CSTP registry information (the registry ID) via a separate variable in
our administrative form.
The study ID appears on all subsequent documents/data forms.
The paper key is maintained in the study binder so that we can demonstrate that a particular data set is associated
with a particular consent document. This paper key and consent documents are stored separately from each other and
separately from all data (under double lock).
The electronic key is maintained in the registry project and the study project.This key will be deleted when data
collection for the study has been completed.
3. * How will you protect your data collection from fraudulent responses:
As data will be collected in-person, with a small number of participants, we do not anticipate issues with fraudulent
responses (i.e., that might occur if we were using a completely online survey).
4. * Is there an alternative method for completion of the data collection other than the internet?
  Yes
No
5. * If yes, describe the alternative(s).
Study forms/measures can be completed on paper if necessary during in-person assessments.
6. * Describe how individuals will be able to skip or not answer particular questions.  If any
questions are mandatory, provide justification.
Participants do not have to answer any particular question that they do not want to answer. If a participant does not
want to answer a question, they can inform study staff who can note this and remove answers (some of our
questionnaires do not have an option to skip the question because it is difficult to add this option in REDCap without
making the forms confusing, and also, if we make all the questions in REDCap optional, we find that this leads to
participants missing questions by mistake).
7. If not including children, describe any procedures used to verify that research participants are
adults.
We ask participants for their age and date of birth several times (telephone or online screening, in-person screening)
and verify that the answers are the same. We will also check ID during the in-person screening to verify that the
participant is eligible.
  

HM20025464
View: SF2 - Secondary Data/Specimen Details
ID: HM20025464
HM20025464 - Caroline Cobb Amey
Effects of Electronic Cigarette Flavors on Abuse Liability in Smokers (P3-Taste)
  
Secondary Data/Specimen Details
1. * Describe the source(s) and nature of the information/specimens being obtained. This response
should:
  a. Identify where the data/specimens will come from (e.g., another researcher's registry,
pathology lab, commercial source, medical records, etc.); and
  b. List what types of specimens will be obtained (when applicable); and/or
  c. List all data elements that will be obtained (when applicable). A data collection form or
other documentation may be uploaded and referenced here.
Contact information and eligibility requirements are obtained from this registry. Eligibility questions include information
about cigarette and electronic cigarette use, alcohol, and drug use, health issues, and medication use. This data is
used for screening and eligibility purposes.
We may also ask participants who are currently participating in other, ongoing studies at the CSTP if they are
interested in participating in this study. There is a script for this communication in the documents section. Interested
participants will be asked to complete the in-person screening visit for this study.  
2. * Describe whether any agreement exists between you and data/specimen provider that states
you will never have access to the ability to identify the participants (i.e. access to identifiers or
the code key) and that you will not attempt to re-identify individuals.
The registry contains identifying information such as names. If a participant enrolls in this study, they are given an
alpha-numeric code. We do plan to link this alpha-numeric code with participants' registry data (as a separate variable
that we use administratively to keep track of which registry participants are in which usage protocol). This separate
variable can be deleted when this usage protocol is closed. We can re-identify participants.
3. * When the information/specimens were originally collected, did individuals provide consent for
secondary research use of their data/specimens (i.e. consent to another research study or to a
research registry)?
  Yes
No
4. * Provide name(s) of the registry/repository being accessed.
CSTP Overall Screening and Registry
5. * Site having responsibility for the management of this registry/repository:
VCU
Non-VCU
6. If the registry / repository is located at VCU, provide the IRB number for the registry /
repository.
HM20002567
7. * Is the original consent form that participants signed upon entry into the registry /repository
available?
  Yes
No
8. If YES, the original consent is available, upload it for the IRB to reference
 
Document
Name
Document
VersionDate
Modified
Uploaded
By
Type
Approved
View Informed
Consent
P3 TASTE_Informed
Consent_CLEAN_1.29.2024.pdf
0.15
2/20/2024
10:22 AM
Rabia Imran Consent/Assent/Information
Sheet
Yes
View Consent -
Tool
P3TASTE_Consent_Presentation_1.29.2024.pptx 0.06
1/30/2024
1:34 PM
Rabia Imran Consent/Assent/Information
Sheet
Yes
View Social Media
Plan
P3-TASTE Social Media Plan_10.2.2023.docx
0.01
10/2/2023
3:29 PM
Caroline
Cobb Amey
Recruitment/Advertising
Yes

 
Document
Name
Document
VersionDate
Modified
Uploaded
By
Type
Approved
View Social Media
and Craigslist
Ads
P3-TASTE_facebook and craiglist
ads_10.2.2023.docx
0.01
10/2/2023
3:29 PM
Caroline
Cobb Amey
Recruitment/Advertising
Yes
View Substance
Use
Resources
Handout
CSTP Substance Use
Resources_8.11.2023.docx
0.01
8/11/2023
5:11 PM
Caroline
Cobb Amey
Other
Yes
View Subjective
Measures
P3-TASTE-Session Subjective
Measures_CLEAN_08.09.2023.doc
0.03
8/11/2023
5:10 PM
Rabia Imran Research Measure
Yes
View P3 TASTE
Advertisement
for CSTP
Website
P3 TASTE - CSTP Website Study
Description_CLEAN_08.08.2023.docx
0.05
8/11/2023
5:09 PM
Rabia Imran Recruitment/Advertising
Yes
View Presession
Symptom
Questions
P3-Presession symptom Checklist-
CLEAN_08.09.2023.docx
0.05
8/11/2023
5:08 PM
Rabia Imran Research Measure
Yes
View Baseline Self
Report Physio
Measures
P3-TASTE_Baseline forms
All_CLEAN_8.11.2023.docx
0.06
8/11/2023
5:07 PM
Rabia Imran Research Measure
Yes
View Text, Email,
Call Scripts
P3-TASTE_Phone_e-mail_text
scripts_08.09.2023_CLEAN.docx
0.10
8/11/2023
5:06 PM
Rabia Imran Study
reminders/communications
Yes
View Referral
Program Card
Template
P3_Referral program
card_06.02.2023_CLEAN.docx
0.03
6/13/2023
1:48 PM
Rabia Imran Recruitment/Advertising
Yes
View COVID-19
Questions
COVID_Questions_P3_no longer using.docx
0.02
6/13/2023
1:35 PM
Rabia Imran Other
Yes
View P3
Taste_ETM
P3-TASTE_Measures_ETM__no longer
using.docx
0.04
6/13/2023
1:35 PM
Rabia Imran Research Measure
Yes
View Tobacco
Cessation
Resources
Handout
Cessation_handout_RI_04.29.2021.pdf
0.01
2/1/2023
3:32 PM
Caroline
Cobb Amey
Other
Yes
View U54 Grant
Application
Without
Budget
U54 Grant Application BUDGET PAGES
DELETED FOR IRB.pdf
0.01
10/28/2022
2:17 PM
Rabia Imran Funding Proposal
Not
Applicable
View CP-DPT &
DPT
P3-TASTE Drug Purchase Tasks_9.2.2022.docx
0.01
10/28/2022
2:03 PM
Rabia Imran Research Measure
Yes
View CP-DPT &
DPT - Tool
DPT_CDPT presentation_10.28.2022.pptx
0.01
10/28/2022
2:03 PM
Rabia Imran Research Measure
Yes
View Subjective
Measures -
Tool
Subjective Measures
presentation_10.28.2022.pptx
0.01
10/28/2022
2:00 PM
Rabia Imran Research Measure
Yes
View Barnes
Biosketch
P3 Barnes biosketch 06.22.17.FINAL.docx
0.01
10/28/2022
1:55 PM
Rabia Imran CV/Biosketch
Not
Applicable
View Lipato
Biosketch
Lipato Biosketch.pdf
0.01
10/28/2022
1:54 PM
Rabia Imran CV/Biosketch
Yes
View Caroline Cobb
(Amey) CV
CV_Cobb_August 2022.docx
0.01
10/28/2022
1:54 PM
Rabia Imran CV/Biosketch
Yes
View Baseline
Discounting
Task - MDT
P3_TASTE_Discounting Task_11.7.2018.pdf
0.01
10/28/2022
1:54 PM
Rabia Imran Research Measure
Yes
View U54 Project 3
Grant Docs
U54_Project 3 only docs.pdf
0.01
10/28/2022
1:53 PM
Rabia Imran Funding Proposal
Not
Applicable
View CSTP Parking
Map
CSTP Parking Map.docx
0.01
10/28/2022
1:52 PM
Rabia Imran Other
Not
Applicable

 
Document
Name
Document
VersionDate
Modified
Uploaded
By
Type
Approved
View Criticare
HR/BP
Manual
Criticare_Vitalcare_506N3_-_Service_manual.pdf 0.01
10/28/2022
1:52 PM
Rabia Imran Other
Not
Applicable
View Expired Air
CO Manual
CO Monitor Manual.pdf
0.01
10/28/2022
1:51 PM
Rabia Imran Other
Not
Applicable
View Information
about Blood
Pressure
BP results P3 flux 8.22.2022.docx
0.01
10/28/2022
1:51 PM
Rabia Imran Study
reminders/communications
Yes
View CSTP
Registry
Consent and
Survey
CSTP Registry Consent Form and Questions.pdf 0.01
10/19/2022
3:27 PM
Caroline
Cobb Amey
Other
Not
Applicable
 
 
  

HM20025464
View: SF2 - Costs to Participants
ID: HM20025464
HM20025464 - Caroline Cobb Amey
Effects of Electronic Cigarette Flavors on Abuse Liability in Smokers (P3-Taste)
  
Costs to Participants
1. * Select all categories of costs that participants or their insurance companies will be
responsible for:

Participants will have no costs associated with this study

Study related procedures that would be done under standard of care

Study related procedures not associated with standard of care

Administration of drugs / devices

Study drugs or devices

Other
 

HM20025464
View: SF2 - Compensation
ID: HM20025464
HM20025464 - Caroline Cobb Amey
Effects of Electronic Cigarette Flavors on Abuse Liability in Smokers (P3-Taste)
  
Compensation
It is recommended that investigators consult with VCU Procurement Services before proposing a compensation plan
(monetary or non-monetary) to the IRB to ensure the plan will comply with VCU policies. Refer to WPP XVII-2 for the IRB’s
guidelines about compensating research participants.
1. * Describe any compensation that will be provided including:
   1. total monetary amount
   2. type (e.g., gift card, research pre-paid card, cash, check, merchandise, drawing, extra class
credit)
   3. how it will be disbursed
   4. how you arrived at this amount
   5. What identifiers and tax forms will be required for compensation purposes (i.e. W-9 form,
SSN, V#, addresses, etc.)
1. Participants will be paid $15/hr for completing the in-person screening to determine eligibility to participate (~1.5 hrs;
~$23). For the study sessions, participants will be paid $50 for completion of the first session (+$5 if they provide one
own brand cigarette for use; $55 in total), $75 for session 2, $100 for session 3, and $125 for session 4.
For the in-person screening/sessions, participants will be provided $12 for travel/parking compensation.
Total potential compensation for this study is up to $438.
This amount does not include potential referral card fee payments (up to an additional $100).
Participants who complete the in-person screening visit will be given 5 cards with information about our laboratory and
a numerical/alphabetical code that is linked to that participant (name, e-mail address). These cards could be given to
friends/family members who might want to participate in any of the lab's studies which include an in-person screening
visit. If a friend/family member with a card appears eligible to participate (via the CSTP registry), comes to an in-person
screening visit, and brings the card (for any of our studies that include an in-person screening visit), we will send the
original participant $20 per card via Amazon gift code to their e-mail address. The original participant will not be told
who brought in the card(s). In total, the maximum amount a participant could receive from this referral program is $100.
Because of the relatively low amount of money participants can earn from this referral program, as well as the low
likelihood that all five cards linked to one participant will be brought back to the laboratory, we do not feel this strategy
is coercive.
2. All payments will be in the form of cash with the exception of the referral card fee payments (Amazon gift card via
email).
3. Payments are dispersed by the research staff in-person or via email.
4. Payment amounts were derived from previously performed studies at this lab and other groups with similar
activities/participant populations.
5. Participants will be asked to complete a W-9 tax form with all fields completed including SSN for any in-person cash
payments (although they can refuse to complete this form).
2. If compensation will be pro-rated, explain the payment schedule.
If a session must be discontinued for reasons beyond the control of the participant, the participant will be paid for the
time spent the time spent in the laboratory ($15/hour).
Regarding the referral fee program - Participants receive $20 per card returned via Amazon gift code to their e-mail
address. In total, the maximum a participant could receive from this referral program is $100.
  

HM20025464
View: SF2 - Contingency Plan
ID: HM20025464
HM20025464 - Caroline Cobb Amey
Effects of Electronic Cigarette Flavors on Abuse Liability in Smokers (P3-Taste)
  
Contingency Plan
This page will be used by the IRB in the event that an institution-wide emergency situation arises that requires
contingency plans. 
A contingency plan describes the alternative procedures that a study would want to use in case of an emergency that
prevented normal study activities from occurring. It is a form of adaptive protocol. It enables the VCU IRB to quickly
approve alternative study activities along with criteria for when those activities would or would not be put into effect.
For example, in 2020, some studies had a COVID-19 Contingency Protocol approved that described alternative
remote procedures that they would switch to whenever the University restricted in-person research activities.
In all studies, investigators are strongly encouraged to plan prospectively and build flexibilities into their regular
protocols (regardless of whether an emergency situation exists) as well as think about what they would do in an
emergency situation. For example, windows for timed study visits, ranges instead of exact values, flexibilities in
inclusion criteria, etc. Flexibility and adaptations that are built into the protocol will reduce the number of changes
that have to be submitted to the IRB and should reduce the number of incidents of deviations and noncompliance by
investigators.
Further instructions and smartform questions on this page will be released from the IRB in the event of such an
institution-wide emergency situation.
 

HM20025464
View: SF2 - Research Plan Complete
ID: HM20025464
HM20025464 - Caroline Cobb Amey
Effects of Electronic Cigarette Flavors on Abuse Liability in Smokers (P3-Taste)
  
Research Complete
Protocol Progress:
w INITIAL SETUP
x BACKGROUND, RATIONALE & GOALS
y RESEARCH PLAN
g CONSENT PLAN
h RISKS, PRIVACY & CONFIDENTIALITY
i POPULATIONS WITH SPECIAL CONSIDERATIONS
j INSTITUTIONAL REQUIREMENTS
k DOCUMENTS
Click Continue below to go to the next section
 

HM20025464
View: SF2 - Consent Process
ID: HM20025464
HM20025464 - Caroline Cobb Amey
Effects of Electronic Cigarette Flavors on Abuse Liability in Smokers (P3-Taste)
  
Consent Process
1. * List all consent groups:
 
Group
Types
Waivers
Roles
Roles
-
Other
Electronic
SignaturesConsent
Coercion Decision Re-
Consent
View All
participants
Signed
Consent
by
Participant
No
Waivers
Requested
Research Nurse
Principal Investigator
Co/Sub-Investigator
Research Coordinator
Research Assistant
Trainee/Student(working
on project)
 
Not using
electronic
signature
platforms
Consent will be
obtained in a
private room
located at the
Center for the
Study of Tobacco
Products (CSTP).
Consent will be
obtained at in-
person screening.
Consent will be on-
going and
assumed when a
participant makes
and completes
follow up
appointments.
Participants are
read the consent
form aloud via a
pre-recorded voice-
over Powerpoint
presentation/video
or in real-time by a
staff member and
encouraged to ask
questions before
signing. At any
point participants
can chose not to
continue with the
various levels of
screening for this
study (the
online/telephone
consent/screening
and in-person
consent/screening).
Removing
physical
symbols of
authority
like white
coats or
police
badges
Sitting down
beside the
participant
instead of
standing
over them
Other
protection(s)
not listed
here –
describe
below
Participants
will be
given as
much time
as
necessary
to consider
the
research
study and
consent
form before
deciding
whether or
not to
participate.
 
2. Upload any consent / assent documents:
 
Document
Name
Document
VersionDate
Modified
Uploaded
By
Type
Approved
View Informed
Consent
P3 TASTE_Informed
Consent_CLEAN_1.29.2024.pdf
0.15
2/20/2024
10:22 AM
Rabia Imran Consent/Assent/Information
Sheet
Yes
View Consent -
Tool
P3TASTE_Consent_Presentation_1.29.2024.pptx 0.06
1/30/2024
1:34 PM
Rabia Imran Consent/Assent/Information
Sheet
Yes
View Social Media
Plan
P3-TASTE Social Media Plan_10.2.2023.docx
0.01
10/2/2023
3:29 PM
Caroline
Cobb Amey
Recruitment/Advertising
Yes
View Social Media
and Craigslist
Ads
P3-TASTE_facebook and craiglist
ads_10.2.2023.docx
0.01
10/2/2023
3:29 PM
Caroline
Cobb Amey
Recruitment/Advertising
Yes
View Substance
Use
Resources
Handout
CSTP Substance Use
Resources_8.11.2023.docx
0.01
8/11/2023
5:11 PM
Caroline
Cobb Amey
Other
Yes

 
Document
Name
Document
VersionDate
Modified
Uploaded
By
Type
Approved
View Subjective
Measures
P3-TASTE-Session Subjective
Measures_CLEAN_08.09.2023.doc
0.03
8/11/2023
5:10 PM
Rabia Imran Research Measure
Yes
View P3 TASTE
Advertisement
for CSTP
Website
P3 TASTE - CSTP Website Study
Description_CLEAN_08.08.2023.docx
0.05
8/11/2023
5:09 PM
Rabia Imran Recruitment/Advertising
Yes
View Presession
Symptom
Questions
P3-Presession symptom Checklist-
CLEAN_08.09.2023.docx
0.05
8/11/2023
5:08 PM
Rabia Imran Research Measure
Yes
View Baseline Self
Report Physio
Measures
P3-TASTE_Baseline forms
All_CLEAN_8.11.2023.docx
0.06
8/11/2023
5:07 PM
Rabia Imran Research Measure
Yes
View Text, Email,
Call Scripts
P3-TASTE_Phone_e-mail_text
scripts_08.09.2023_CLEAN.docx
0.10
8/11/2023
5:06 PM
Rabia Imran Study
reminders/communications
Yes
View Referral
Program Card
Template
P3_Referral program
card_06.02.2023_CLEAN.docx
0.03
6/13/2023
1:48 PM
Rabia Imran Recruitment/Advertising
Yes
View COVID-19
Questions
COVID_Questions_P3_no longer using.docx
0.02
6/13/2023
1:35 PM
Rabia Imran Other
Yes
View P3
Taste_ETM
P3-TASTE_Measures_ETM__no longer
using.docx
0.04
6/13/2023
1:35 PM
Rabia Imran Research Measure
Yes
View Tobacco
Cessation
Resources
Handout
Cessation_handout_RI_04.29.2021.pdf
0.01
2/1/2023
3:32 PM
Caroline
Cobb Amey
Other
Yes
View U54 Grant
Application
Without
Budget
U54 Grant Application BUDGET PAGES
DELETED FOR IRB.pdf
0.01
10/28/2022
2:17 PM
Rabia Imran Funding Proposal
Not
Applicable
View CP-DPT &
DPT
P3-TASTE Drug Purchase Tasks_9.2.2022.docx
0.01
10/28/2022
2:03 PM
Rabia Imran Research Measure
Yes
View CP-DPT &
DPT - Tool
DPT_CDPT presentation_10.28.2022.pptx
0.01
10/28/2022
2:03 PM
Rabia Imran Research Measure
Yes
View Subjective
Measures -
Tool
Subjective Measures
presentation_10.28.2022.pptx
0.01
10/28/2022
2:00 PM
Rabia Imran Research Measure
Yes
View Barnes
Biosketch
P3 Barnes biosketch 06.22.17.FINAL.docx
0.01
10/28/2022
1:55 PM
Rabia Imran CV/Biosketch
Not
Applicable
View Lipato
Biosketch
Lipato Biosketch.pdf
0.01
10/28/2022
1:54 PM
Rabia Imran CV/Biosketch
Yes
View Caroline Cobb
(Amey) CV
CV_Cobb_August 2022.docx
0.01
10/28/2022
1:54 PM
Rabia Imran CV/Biosketch
Yes
View Baseline
Discounting
Task - MDT
P3_TASTE_Discounting Task_11.7.2018.pdf
0.01
10/28/2022
1:54 PM
Rabia Imran Research Measure
Yes
View U54 Project 3
Grant Docs
U54_Project 3 only docs.pdf
0.01
10/28/2022
1:53 PM
Rabia Imran Funding Proposal
Not
Applicable
View CSTP Parking
Map
CSTP Parking Map.docx
0.01
10/28/2022
1:52 PM
Rabia Imran Other
Not
Applicable
View Criticare
HR/BP
Manual
Criticare_Vitalcare_506N3_-_Service_manual.pdf 0.01
10/28/2022
1:52 PM
Rabia Imran Other
Not
Applicable
View Expired Air
CO Manual
CO Monitor Manual.pdf
0.01
10/28/2022
1:51 PM
Rabia Imran Other
Not
Applicable

 
Document
Name
Document
VersionDate
Modified
Uploaded
By
Type
Approved
View Information
about Blood
Pressure
BP results P3 flux 8.22.2022.docx
0.01
10/28/2022
1:51 PM
Rabia Imran Study
reminders/communications
Yes
View CSTP
Registry
Consent and
Survey
CSTP Registry Consent Form and Questions.pdf 0.01
10/19/2022
3:27 PM
Caroline
Cobb Amey
Other
Not
Applicable
  

HM20025464
View: SF2 - Consent Plan Complete
ID: HM20025464
HM20025464 - Caroline Cobb Amey
Effects of Electronic Cigarette Flavors on Abuse Liability in Smokers (P3-Taste)
  
Consent Plan Complete
Protocol Progress:
w INITIAL SETUP
x BACKGROUND, RATIONALE & GOALS
y RESEARCH PLAN
z CONSENT PLAN
h RISKS, PRIVACY & CONFIDENTIALITY
i POPULATIONS WITH SPECIAL CONSIDERATIONS
j INSTITUTIONAL REQUIREMENTS
k DOCUMENTS
Click Continue below to go to the next section
 

HM20025464
View: SF2 - Risks, Discomforts, Potential Harms and Monitoring
ID: HM20025464
HM20025464 - Caroline Cobb Amey
Effects of Electronic Cigarette Flavors on Abuse Liability in Smokers (P3-Taste)
  
Risks, Discomforts, Potential Harms and Monitoring
1. * Describe the risks of each research procedure to participants or others. For each identified
risk, provide an assessment of the anticipated seriousness and likelihood of the risk. Some
examples of possible risks include but are not limited to:
Physical risks (e.g. bodily harms or discomforts, side effects, etc.)
Psychological risks (e.g. emotional, mental, or spiritual harms or discomforts, changes to thoughts,
beliefs, or behaviors, etc.)
Research data risks (e.g. loss of confidentiality and privacy)
Social or legal risks (e.g. impacts on relationships or reputation, legal or criminal justice actions for self
or others, etc.)
Financial risks (e.g. impacts on income, employability, or insurability, loss of services, etc.)
Other risks (e.g. unforeseeable risks of experimental procedures, risks related to particular study
designs (randomization, washout, placebo, withholding care/services, deception), etc.)
See the help text for additional guidance.
There are few risks associated with this study.
1. There is some risk of frustration while completing study procedures.
2. We have read that users of the ECIG device we are using in this study sometimes experience small drops of liquid
during inhalation, and we have occasionally noticed this during our testing of the product. If this occurs, participants
may find the droplets unexpected and/or unpleasant. We believe that is unlikely that these small droplets of liquid
present any medical danger.
3. The ECIG liquid used may contain less or more nicotine than participants normally ingest, but these effects are
unlikely in individuals who use cigarettes regularly. Participants also might experience side effects from products that
contain nicotine such as acute increases in heart rate and blood pressure, sweating, lightheadedness, dizziness,
nausea, and nervousness.
4. The Centers for Disease Control and Prevention advises that e-cigarette, or vaping products are unsafe for youths,
young adults, or women who are pregnant. Adults who do not currently use tobacco products should not start using e-
cigarette, or vaping, products. If you use e-cigarette products, monitor yourself for all of these symptoms and promptly
seek medical attention if you have concerns about your health.
a. Some people who use e-cigarettes have reported experiencing seizures. Some of these individuals reported a prior
history of seizures or using other substances at the same time as their e-cigarette.
b. In some cases, e-cigarette use has led to respiratory illnesses such as difficulties breathing, shortness of breath,
cough, and/or chest pain before hospitalization. In some cases, e-cigarette use has led to death, although most of
these cases have been related to vaping THC.
c. In some cases, symptoms of mild to moderate gastrointestinal illness such as nausea, abdominal pain, vomiting,
diarrhea, or fevers or fatigue have been reported.
5. The use of e-cigarettes may include other side effects/risks such as a sore or scratchy throat and headache.
6. There is some risk of loss of confidentiality.
7. The procedures in this research are known to hurt a pregnancy or fetus in the following ways: cigarette smoking
during pregnancy raises risk for pre-term birth, birth defects, and bleeding during pregnancy/delivery; cigarette smoking
also can negatively impact fertility. The research may also hurt a pregnancy or fetus in ways that are unknown. These
may be a minor inconvenience or may be so severe as to cause death. Participants should not be or become pregnant
or father a baby while on this research study.
8. In addition to these risks, this research may hurt participants in ways that are unknown. These may be a minor
inconvenience or may be so severe as to cause death.
2. * Describe how each of the risks/harms/discomforts identified above will be minimized:
During the sessions, if the participant reports experiencing small droplets of ECIG liquid during inhalation, we will
immediately replace the product they are using in the session.
We will inform participants of the other ECIG-related side effects during the informed consent process. These risks are
minimized by limited exposure to ECIGs in study sessions. We do not anticipate participants taking more than 5-10
total puffs per session. The risk of overexposure to nicotine from the ECIGs administered is also minimized by enrolling

current cigarette smokers (cigarettes are among the most efficient and effective nicotine delivery systems currently
marketed).
The risk of seizures is minimized by excluding participants with any history of seizures, and by having a full-time RN
available, as well as monitoring of vital signs. In addition, some of the reported seizures occurred in users who were
using other substances such as marijuana or amphetamines--the risk of seizures in this study is reduced as we are
administering nicotine and no other substances.
The risk of respiratory illnesses related to ECIG use is minimized by the limited ECIG use that occurs in each session.
Participants are expected to take no more than 5-10 puffs of either their own brand CIG or session-specific ECIGs at
each session. Participants are informed about recent reports of ECIG-related respiratory illnesses and are informed
that the CDC has advised people to stop vaping. Participants are also advised to monitor themselves for symptoms
and to seek medical attention if they have concerns. In addition, we will ask about respiratory and gastrointestinal
symptoms at screening and before each session begins. Answers given at the beginning of each session will be
compared to the participants' previous answers, and if any symptoms have increased, Dr. Lipato will be asked to
review the symptoms. In some cases, we may contact Dr. Lipato to determine if a session can proceed.
We recruit individuals aged 18 + who use nicotine-containing products at similar or higher daily/weekly frequencies that
they would be exposed in the laboratory setting. Our protocol ensures that study-related nicotine/tobacco exposure is
similar to or less than what participants may expose themselves to as part of their ordinary life.
Nicotine-related side effects: It is possible that participants may experience unpleasant symptoms associated with over
consumption of nicotine during study sessions when tobacco products are administered (e.g., increased heart
rate/blood pressure, dizziness, nausea). Importantly, this population will have experience with nicotine consumption.
We will exclude individuals at baseline screening that have high blood pressure (meet safety criteria defined below) or
withdraw those enrolled if we observe repeated high blood pressure during study sessions (dependent on consultation
with medical monitor). The likelihood of these effects is very low. As part of the informed consent process, we will
inform participants of potential side effects associated with nicotine consumption.
Our sessions and surveys are optimized in length to make them as short as possible while ensuring collection of
primary study outcomes. We believe sessions that last <2 hours and the number of subjective and behavioral
assessments per session are not worthy of noting as discomforting.
Loss of confidentiality is a possibility but we minimize this risk by using a double locked filing cabinet, a password
protected database (REDCap) and limiting access to authorized study personnel only. We also assign a unique ID
code to participants instead of using their name or other identifiable data to track their participation.
The support of the research staff will minimize potential frustration during study sessions. Research staff will be
available for questions and support throughout the study sessions. If ever study tasks become unmanageable,
participants will be offered the opportunity to end the session early and potentially repeat the session at a later date or
to discontinue participation. The study staff is well trained to identify signs of frustration and proper support responses.
.
In addition, non-invasive computerized monitoring equipment allows for minute-by-minute, real-time monitoring of
participants' heart rate. If needed, we can monitor blood pressure as well throughout the session. Research personnel
are trained to alert the research nurse if heart rate continually exceeds 120 beats per minutes, if systolic BP continually
exceeds 160 mm Hg, or if diastolic BP continually exceeds 100 mm Hg. Individuals whose heart rate and/or BP levels
remain elevated will be monitored by the nurse, and if necessary emergency responders will be notified. Emergency
medical coverage is available via the emergency room that is approximately 1.5 miles from the CSTP.
We screen for pregnancy among participants to reduce these risks and inform participants of risks to the baby, during
pregnancy/delivery, as well as negative fertility-related effects. We advise participants not to become pregnant or father
a baby during the study.
We also inform participants of unknown negative effects related to study participation. Being open about these risks is
an important step.
We also monitor the research literature and public health authorities for any changes in risks associated with cigarette
smoking and/or ECIG use.
3. * Describe any potential risks or harms to a community or a specific population based on study
findings (e.g. information that could be stigmatizing or derogatory):
None
4. Where appropriate, discuss provisions for ensuring necessary medical, professional, or
psychological intervention in the event of adverse events to the subjects:
Research personnel are trained to alert the research nurse if heart rate continually exceeds 120 beats per minute, if
systolic BP continually exceeds 160 mm Hg, or if diastolic BP continually exceeds 100 mm Hg. Individuals whose heart
rate and/or BP levels remain elevated will be monitored by the research nurse and if, necessary, emergency
responders will be notified. Emergency medical coverage will be available via the emergency room that is 1.5 miles
from the CSTP.
Individuals whose BP levels are elevated (>=140 mmHg systolic or >=90 mmHg diastolic) during baseline screening or
at a session will be provided with a blood pressure information sheet by the research staff (see study document). This
sheet will be provided at the first instance of elevated blood pressure observed during the study.
5. * Describe criteria for when the investigator would withdraw an individual participant from the
study; such as safety or toxicity concerns, emotional distress, inability to comply with the

protocol, etc.:
Participants may be withdrawn from the study if the PI or study nurse has any safety concerns (such as high blood
pressure or heart rate) during sessions.
If participant cannot complete a session due to unforeseen circumstances (i.e., family emergency), we allow multiple
attempts, but do not have a specified number of attempts that are allowed, as it depends on the circumstances of each
participant.
6. * Summarize any pre-specified criteria that would trigger the investigator/sponsor/monitoring
committee to stop or change the study protocol due to safety concerns:
We do not have any prespecified criteria for stopping or changing the study protocol due to safety concerns.  
Data and Safety Monitoring
Data and safety monitoring is a system for checking the study’s data at regular intervals over the study period
to identify and address issues that could affect the safety of research participants. This requirement is in
accordance with 45 CFR 46.111.
The purpose of data and safety monitoring plan is to set forth study team procedures for
monitoring/addressing:
- Participant safety (physical, psychological, etc.)
- Data validity
- Early stopping (termination) based upon changes in risks and benefits.
7. * Indicate if this study will have a Data Safety Monitoring Board (DSMB) or a Data Safety
Monitoring Plan (DSMP): [Required for all greater than minimal risk studies]

DSMB

DSMP

No DSMB/DSMP [Note: This response is not applicable for greater than minimal risk studies]
8. * Describe your Data Safety Monitoring Plan for monitoring the study9s data to ensure the safety
of participants. This plan should include (but is not limited to) the following elements:
1. Who will monitor data
2. What data and/or processes will be reviewed
3. When and how frequently monitoring will occur
4. What report/documentation will be submitted to the IRB at the time of continuing reviews
See the help text for additional guidance.
1. Who will monitor data: The Co-PIs (Drs. Cobb and Barnes) and the medical monitor (Dr. Lipato)
2. What data and/or processes will be reviewed:
-Baseline sociodemographic characteristics of enrolled study participants
-Reasons for ineligibility following in-person screening
-Retention and disposition of study participants including any complaints about the study and reasons for participant
withdrawal
-Responses to the pre-session symptom checklist
-Protocol deviations/violations
-Any other regulatory issues
-Adverse events
-Serious adverse events
-Unanticipated problems
3. When and how frequently monitoring will occur:
Any adverse events and protocol deviations/violations that occur during the study sessions will be monitored and
documented by the research staff and communicated as soon as possible to PI/medical monitor for review/response.
We will follow VCU IRB reporting requirements for all adverse events and protocol deviations/violations that may occur.
We also will review all of the items listed in #2 in a summary report annually.
4. What report/documentation will be submitted to the IRB at the time of continuing reviews:
A summary report that includes all of the items listed in #2 will be submitted to the IRB at the time of the continuing
reviews.
 
 
  

HM20025464
View: SF2 - Privacy
ID: HM20025464
HM20025464 - Caroline Cobb Amey
Effects of Electronic Cigarette Flavors on Abuse Liability in Smokers (P3-Taste)
  
Privacy
Privacy refers to an individual’s right to control how others view, record, or obtain information about them. When
privacy is violated it can involve such things as
Being asked personal questions in a public setting;
Being publicly identified as having a particular characteristic or diagnosis;
Being seen entering a place that might be stigmatizing;
Being photographed, videotaped or observed without consent;
Disclosure of personal information to unauthorized people
Privacy is not the same as confidentiality because privacy protections apply to people, and confidentiality
protections apply to data. Confidentiality protections should be described on the Data Confidentiality page of this
form, not here.
Instructions for this page:
Select all the applicable ways that the research team will protect participants' privacy throughout the course of the
study. The options listed include some of the most common best practices. Not all will be applicable to every study. 
**The IRB will expect studies to operationalize all selected checkboxes into the conduct of the research.
To elaborate on any response, also click the <Other Protections= checkbox to provide further explanation in the last
free-text question.
Read the entire page before filling out the form.
1. * Protections when conducting one-on-one in-person interventions or interactions (for groups
see Q2 below):

Conducting study activities in locations that maximize privacy (limited people around, closing doors,
drawing drapes around beds, monitoring voice volume, etc.)

Verifying identity before discussing personal information.

Asking the participant if they are comfortable answering questions in that location

Asking the participant if they are comfortable with having other people present (if any)

Moving away from other people when conducting activities in public spaces or offering a private space

Offering other options of ways to respond to sensitive questions (i.e. pointing, clicking, or writing) if
uncomfortable verbally responding

Using generic signs on research rooms and spaces, particularly for research on stigmatizing or sensitive topics

Other protections not listed in this question – describe below

N/A – study has no in-person interventions or interactions with participants
 
2. * Protections when conducting group interventions or interactions:

Conducting study activities in locations that maximize privacy (limited people passing by, closing doors,
monitoring voice volume, etc.)

Moving to a more private area to answer questions or to discuss concerns

Discussing privacy with the participants and the importance of not talking outside the group about what other
people say during the group session

Allowing participants to use a pseudonym or limiting use of individuals’ names during the group activity

Asking everyone in a public group setting (e.g. classrooms, workshops) to turn something in (blank or filled) so
participants do not have to self-identify when turning in materials

Collecting paper forms in a closed box or envelope rather than passing to others or leaving in an open area

Limiting participant identifiers that would be visible on paper documents (i.e. using study IDs instead of
direct identifiers)

Allowing people to distance themselves from other participants during group activities

Offering other options of ways to respond to sensitive questions (i.e. pointing, clicking, or writing instead of
speaking)


Using generic signs on research rooms and spaces, particularly for research on stigmatizing or sensitive topics

Ensuring non-participating individuals are not captured on recordings or in photos

Other protections not listed in this question – describe below

N/A – study has no group interventions or interactions
 
3. * Protections when conducting remote interventions or interactions (e.g. phone, text, email,
video-conference, tele-health, online, etc.):

Conducting study activities in locations where study staff can maximize their own privacy (limited
people around, closing doors, monitoring voice volume, etc.)

Leaving/sending generic messages that avoid using study and participant identifiers, such as names, study
titles, clinics, study topics, etc.

Obtaining permission prior to sending text messages

Advising the participant to move to a location where they are comfortable answering questions and will not be
overheard - incorporate this instruction into your study materials

Advising online participants to complete the activity at a time and location where they will be comfortable
answering questions - incorporate this instruction into your study materials

Ensuring non-participating individuals are not captured on recordings or in photos

Offering other options of ways to complete the activity (i.e. online, paper, phone) if more privacy is desired

Offering a way to save and return later to the online activity if privacy is compromised

Other protections not listed in this question – describe below

N/A – study has no remote interventions or interactions with participants
 
4. * Protections when mailing study materials to/from participants:

Obtaining permission to mail study materials

Confirming/verifying the accuracy of addresses before mailing items

Ensuring the participant is able to personally receive mailed materials and has a way to protect their own privacy
if they do not want others to know they are receiving research communications (i.e. notifying participants of
when to expect it)

Using return address labels and document headers that avoid study identifiers, such as study names, clinics,
study topics, etc.

Avoiding or limiting use of participant identifiers and health information on mailed documents (i.e. using study
IDs instead of direct identifiers)

Providing a return mailing address label or pre-addressed envelope to ensure returned items are sent to the
correct address

Communicating receipt of mail from participants and/or asking them to notify you when they mail it to ensure
study documents are not lost in transfer

Offering other options of ways to complete the activity (i.e. by phone or online) if desired

Other protections not listed in this question – describe below

N/A – not mailing any materials to/from participants
 
5. * Protections when analyzing or disseminating study data *Applicable to all studies*:

Working only in locations where the study team can ensure privacy (not working in close proximity to
non-study personnel, closing doors, closing/putting away documents/files before leaving, etc.)

Securing physical materials only in locations that ensure privacy (access limited to authorized study
personnel)

Only sharing data/specimens in accordance with the Sharing Plan outlined in this smartform

Obtaining explicit parental permission before disseminating or sharing recordings or photos of children

Blurring/redacting/hiding faces and other identifiable features/marks (tattoos, scars, birthmarks, distinctive voice,
etc.) in recordings or photos prior to disseminating or sharing

Only publishing or presenting aggregate results or findings (i.e. no individual-level information)

Taking additional steps to protect participant identities when publishing or presenting individual-level information,
quotations, results, images – describe below

Other protections not listed in this question – describe below

 
6. Describe any other way(s) that the research team will protect participants' privacy. See the
help text for additional guidance.
Participants' privacy and comfort will be addressed throughout the course of the study. During the intake process and
session, participants will be seated in a private room. All study procedures will take place behind closed doors. We will
use Zoom (like an intercom) to communicate with participants from outside of the session room, but will not use a
camera for the computers in the session rooms, nor will the participants' name be entered into Zoom. We will also use
a password-protected Zoom session. Participants will be informed that they may withdraw from the research study
should they find any research procedures unacceptable. All participants and data will be treated with professional
standard of confidentiality. Data are identified by numeric code only and stored under double lock or in REDCap.
Participants' names are not directly linked to data. Briefly, a numeric code is assigned to each participant when they
provide informed consent, and the part of the numeric code relates to the order in which the individual consented. This
numeric code appears on all data. Access to the key and the consent documents is restricted to study investigators
and staff: these individuals perform the informed consent and conduct the study with the participants so they already
know who the participants are and observe the participants as data are collected. Participants' research-related
information will be withheld, consistent with the law, unless permission is given to release such information.
Effectiveness is indexed by previous experience: we have used these procedures for over 20 years and have not had a
single incident in which a participants' confidential information has been compromised.
In addition, the way in which the referral program will be administered (with participants who complete this study being
given cards with alphanumeric codes linked to their names/e-mail addresses) reduces the risk of a loss of privacy, as
the original participant will not be told who brought in the card(s).
  

HM20025464
View: SF2 - Data Confidentiality and Storage
ID: HM20025464
HM20025464 - Caroline Cobb Amey
Effects of Electronic Cigarette Flavors on Abuse Liability in Smokers (P3-Taste)
  
Data Confidentiality and Storage
Confidentiality refers to the way private, identifiable information about a participant or defined community is
maintained and shared. It describes how the study’s research materials (data, specimens, records, etc.) are protected
from unauthorized access.
Instructions for this page:
Select all the ways that the research team will keep the study materials and data confidential throughout the course
of the study. Not all will be applicable to every study. 
To elaborate on any response, also click the <Other Protections= checkbox to provide further explanation in the last
free-text question.
Read the entire page before filling out the form.
1. * Protections for paper research materials:

Maintaining control of paper documents at all times, including when at an off-campus location

Limiting or avoiding use of participant identifiers on paper documents (i.e. using study IDs instead of
direct identifiers)

Storing paper documents in a secure location accessible only to authorized study personnel

Promptly transcribing, scanning, or abstracting data from paper into electronic platforms with destruction of the
paper copy

Proper destruction of paper records (and obtaining prior permission when required) in accordance with
VCU Records Management policies

Other protection not listed in this question – describe below

N/A – no paper research materials
2. * Protections for research specimens:

Maintaining control of specimens at all times, including when at an off-campus location

Storing specimens in a secure location accessible only to authorized study personnel

Labeling specimens with subject ID or other coded information instead of direct identifiers

Final destruction of specimens will be in accordance with VCU policies and specimen containers will be
devoid of any identifiable information

Other protection not listed in this question – describe below

N/A – no research specimens
3. * Protections for electronic files/data - See https://ts.vcu.edu/about-us/information-security/data-
management-system/

*Required for all studies* Use VCU-approved methods of data storage, transmission, and transfer (see
https://dms.vcu.edu)

Remotely accessing VCU network storage to store data when at off-campus locations

Ensuring unauthorized individuals who might share a device do not have access to study materials (e.g.
individual logins, separate accounts)

Using VCU-approved data collection tools and apps (e.g. REDCap) and storing exported analysis files in
VCU-approved storage locations (see https://dms.vcu.edu)

When using non-VCU-approved electronic data collection tools, storage locations, data transfer platforms, and
mobile apps (e.g. Dropbox, Box, Survey Monkey, Fitbits, novel apps, multi-site data collection platforms):
• consulting with VCU Information Security on proper data management (see https://ts.vcu.edu/askit/essential-
computing/information-security/);
• advising participants about the terms of use and privacy policies of those sites/apps;
• limiting or avoiding use of identifiers; and
• removing data promptly from the external location after transferring it to a VCU storage location

De-identifying the research data by replacing subjects’ names with assigned subject IDs

Storing the study’s linkage key in a password-protected and VCU-approved storage location (see
https://dms.vcu.edu)

When analyzing particularly sensitive information, using computers that are unconnected from the internet.

Proper destruction of electronic records (and obtaining prior permission when required) in accordance
with VCU Records Management policies


Other protection not listed in this question – describe below
4. * Protections for computers and research devices/apps that are provided to participants for use
in the study and taken out of the lab (i.e., giving participants a phone or iPad to take home,
wearable trackers, apps, etc.):

Transferring data promptly from the device/app given to the participant to a VCU storage location

Setting strong passwords on computers and research devices (when applicable) that leave VCU with
participants

Device/app set up by VCU Information Security

When providing devices or mobile apps to children, informing parents about the settings and how to manage
them (if applicable), internet access, and any other installed apps on the device

Other protection not listed in this question – describe the device/app and protection below

N/A – no computers or devices/apps being provided for participant use outside the lab
5. * Protections for email/online communications

Only using VCU/VCU Health email addresses for study-related communications

Only using VCU/VCU Health–approved methods of teleconferencing or video conferencing (e.g. Zoom)
(for studies involving HIPAA, contact VCU or VCU Health Information Security [as appropriate] about
HIPAA-compliant systems)

Other protection not listed in this question – describe below

N/A – no email/online communications
6. Specify any other places where this study9s paper and electronic research data and/or physical
specimens will be stored and any other ways they will be secured from improper use and
disclosure. 
See the help text for additional guidance.
Any paper based records will be kept in a locked cabinet in the CSTP lab in a locked room with entry to the lab secured
by a keypad and only accessed by authorized study personnel.
An electronic copy of each consent form will be stored in Veeva Site Vault per new requirements for clinical studies.
All computers and storage devices will be kept in locked cabinets and/or within locked laboratory rooms. Electronic
records will be made available only to those personnel in the study through the use of access controls (passwords).
Identifiers will be removed from study-related data and data will be coded with a key stored in a separate, secure
location. Electronic data (with study IDs only) is stored in REDCap and/or in excel spreadsheets that are saved either
on hard drives and/or a VCU server. Data from the online registry, as well as the in-person screen and from sessions
will be stored in and can only be accessed through the password-secured system REDCap. Only approved CSTP staff,
faculty, and students will have keys and/or electronic access to this information.
Identifiers will be removed from study-related data and data will be coded with a key stored in a separate, secure
location in a locked cabinet. All web-based surveys will have data secured via passwords. De-identified data will be
transferred to secure servers that are password protected for data cleaning and analysis. No data will be stored under
any other departments.
Some data are recorded using software separate from REDCap. These data are stored on password protected
computers and backed-up on secure datakeys that require a password (IronKey).
Software types are as follows:
REDCap for self-report data, including baseline and session measures which include subjective questionnaires, and
some abuse liability measures (see the document "Drug Purchase Tasks (DPT)")
Hyperterminal is used to collect physiological data. The data file is stored locally, under a username and password
protected profile. It is then copied to secure storage locations (such as Ironkey or R-Drive) after each session.
The Minute Discounting Task (see, 'Baseline Discounting Task - MDT' document) is collected at baseline or in-person
screening visits via Qualtrics. Data is stored within Qualtrics under usernames and passwords assigned to some lab
staff.
Urine samples are labeled with participant code numbers and stored in a -80 degree freezer in a locked laboratory
space. The samples are stored separately from identifying information (consent forms).
7. * If research data/specimens will be sent/released to person(s) or group(s) outside of the VCU
study team or the PI9s department for the conduct of this protocol (not for future sharing),
1) identify the data/specimen recipient(s) along with their VCU department or other institutional
or organizational affiliation(s).
2) give a description of what identifiers and/or codes will accompany the data/specimens.
If data/specimens are not being sent/released outside of the VCU study team or the PI9s

department, state that:
Data with identifiers will not be released to any person or group outside the study team.
8. * Select all identifiers that will be collected at any time as part of this study (including for
recruitment, data gathering, data analysis, etc.), even if the data will eventually be anonymized:

Names

Geographic Locators Below State Level

Social Security Numbers

Dates (year alone is not an identifier)

Ages over 89 (age under 89 is not an identifier)

Phone Numbers

Facsimile Numbers

E-mail Addresses

Medical Record Numbers

Device Identifiers

Biometric Identifiers

Web URLs

IP Addresses

Account Numbers

Health Plan Numbers

Full Face Photos or Comparable Images

License/Certification Numbers

Vehicle ID Numbers

Other Unique Identifier

No Identifiers

Employee V#
9. If "Other Unique Identifier" was selected above, describe the identifiers:
Participant ID.
10.   * If the study will code (i.e. de-identify) the research data by replacing subjects9 names and/or
other identifiers with assigned subject IDs, explain the following aspects of the coding process:
- The process for how subject IDs will be generated/assigned (e.g. random, sequential)
- Whether there will be a key that links the subject ID with direct identifiers. If there will be no
linkage key, state that.
If a key will be created, describe
- The place where the key will be stored
- The role(s) of all individuals who will have access to the key
- When the key will be destroyed
See the help text for guidance.  
Data are identified by numeric code only. Participants' names are not directly linked to data. Briefly, a numeric code is
assigned to each participant when they provide informed consent, and the numeric part of the code relates to the order
in which the individual consented. This participant numeric code appears on all subsequent documents/data forms. A
key is maintained in the study binder so that we can demonstrate that a particular data set is associated with a
particular consent document. The key and consent documents are stored separately from each other and separately
from all data (under double lock or in REDCap). Access to the key and the consent documents is restricted to study
investigators, staff, and students: these individuals perform the informed consent and conduct the study with the
participants, so they already know who the participants are and observe the participants as data are collected. Data
keys will be destroyed at the end of the study once the minimum time required for data retention has been met per
VCU Data Retention Policy and/or sponsor retention requirements. De-identified data may be stored indefinitely.

HM20025464
View: SF2 - Data Retention
ID: HM20025464
HM20025464 - Caroline Cobb Amey
Effects of Electronic Cigarette Flavors on Abuse Liability in Smokers (P3-Taste)
  
Data Retention
1. * Select all of the ways that individually identifiable information obtained during pre-screening
and/or screening will be handled for individuals who DO NOT qualify for the study:

N/A - study does not require screening procedures

Immediately destroy the information and identifiers (no data collected)

Immediately destroy the identifiers connected with the data (anonymization)

Store until the end of study & then destroy

Use as "screening failure" data by members of the study team

Provide to others outside of the research team (with the participant's permission)

Request permission from participant to maintain and use the identifiable information

Other
2. If Other, explain how the information will be handled.
All in-person screening procedures occur after participants have consented to the full study. All data collected may be
included in reports/presentations/publications including reasons for screening failure among enrolled participants.
3. * Will participants be able to withdraw their data (paper, electronic, or specimens) from the
study (e.g. ask that it be destroyed or returned) if they no longer wish to participate? (FDA-
regulated studies should select No – see help text)
  Yes
No
4. * What will happen to the research materials (e.g. data, specimens, documents, etc.) when the
research has been completed?
Stored indefinitely with identifiers removed
Stored indefinitely with identifiers attached
Destroyed at the end of study once the minimum time required for data retention has been met per VCU Data
Retention Policy and/or sponsor retention requirements
Destroyed when notified by sponsor but not less than the minimum time required for data retention per VCU
Data Retention Policy
Other
5. * Will audio/video recordings and full face photographs be destroyed?
  Yes
No
6. If yes, describe at what point and how recordings will be destroyed:
7. If no, explain why the recordings need to be maintained:
There will be no recordings.
 
  

HM20025464
View: SF2 - Sharing Plan
ID: HM20025464
HM20025464 - Caroline Cobb Amey
Effects of Electronic Cigarette Flavors on Abuse Liability in Smokers (P3-Taste)
  
Sharing Plan
This page addresses times when investigators may be required to share information about participants or may desire
to share their research information/specimens with the aim of advancing science. This page creates a plan for when
and how information/specimens could be shared.
Try to anticipate all reasonably foreseeable sharing so that the consent document can also reflect that information.
However, it is acceptable to amend this page later and explain either how re-consent of previously and currently
enrolled participants will occur or why re-consent should not be required.
The IRB reviews this page against the consent document (if one exists) to demonstrate the ethical principle of
Respect for Persons by confirming that plans for sharing do not go against what participants would understand
about the use of their data/specimens.
The IRB also ensures there are adequate protections for the privacy of participants and the confidentiality of
participants' data/specimens when data is shared with others.
1. * Is it likely investigators could discover information about child/elder abuse or neglect that
would require mandatory reporting by the investigators or staff?
The Code of Virginia requires that most medical personnel and all employees of institutions of higher
education report suspected child/elder abuse or neglect.
  Yes
No
2. *  Is it likely investigators could discover a previously unknown reportable disease or condition
that would require mandatory reporting by the investigators or staff (i.e., HIV , coronavirus,
hepatitis, etc.)?
  Yes No
3. * Will the sponsor or investigator obtain a Certificate of Confidentiality for this study?
Certificates of Confidentiality  (CoC) are issued by the National Institutes of Health (NIH), the FDA and CDC to
protect identifiable research information from forced disclosure. All human subject research studies
regardless of funding can qualify to receive a CoC. A CoC is automatically issued for research that was
ongoing on December 13, 2016. or initiated after that date. For more information, see
https://humansubjects.nih.gov/coc/
No – Will not obtain CoC for this study
Yes – CoC has been obtained or issued automatically
Yes – CoC request is pending
4. * Select the way(s) that information or biospecimens (including DNA) may be used by the VCU PI
or VCU study team for other future research projects (i.e. analyses beyond/apart from the aims
of this study)?
See help text for definitions.

Will use directly identifiable information or specimens.
(8Directly identifiable9 means that identifiers like name, medical record number, social security number, etc. are
included in/attached to the dataset/specimens. Maintaining identifiable data for future research is treated as a
registry by the VCU IRB. The IRB must approve the new research use in an amendment to this study or as part
of a new study before the project is initiated. VCU IRB studies will be asked more questions about this on a later
page)

Will use de-identified or indirectly identifiable information or specimens.
(8De-identified9 means that a linkage/key code exists that links identifiers to data/specimens. When the
researcher holds both the data and the key, the VCU IRB considers the subjects to be readily identifiable.
Maintaining identifiable data for future research uses is treated by the IRB as a registry. The IRB must approve

the new research use in an amendment to this study or as part of a new study before the project is initiated.
VCU IRB studies will be asked more questions about this on a later page)

Will use anonymized information or specimens.
(8Anonymized9 means that 1) no linkage/key codes exist that link identifiers to data/specimens; and 2) subjects
cannot be readily identified, i.e. no direct or indirect identifiers or identifiable combinations of variables. The VCU
IRB considers uses of anonymized data/specimens to not be human subject research.)

Will use aggregate results (summary-level results), not individual-level information or specimens.
(The VCU IRB considers uses of aggregate data to not be human subject research because there are no
individual subjects.)

Will contribute to an existing registry or repository
(VCU IRB studies will be asked more questions about this on a later page.)

Will not use information/specimens for purposes beyond this study.

Not sure and will submit an amendment when known

Other use(s) of individual-level information in a way not listed above
5. * Select the way(s) the VCU PI/study team may share information or biospecimens (including
DNA) with other researchers who are not on this study team (i.e. for analyses beyond/apart
from the aims of this study). 
See help text for definitions.

Will share directly identifiable information or specimens with other researchers.
(8Directly identifiable9 means that identifiers like name, medical record number, social security number, etc. are
included in/attached to the dataset/specimens. Maintaining identifiable data for future research uses is treated
by the VCU IRB as a registry. The data recipient9s use of identifiable data would require them to obtain IRB
review. VCU IRB studies will be asked more questions about this on a later page.)

Will share de-identified or indirectly identifiable information or specimens with other researchers.
(8De-identified9 means that a linkage/key code exists that links identifiers to data/specimens. The VCU
researcher maintains the key but does not share it with any other researchers. The recipient9s use of de-
identified data/specimens may not be human subject research if there is documentation that the key will never
be shared with the recipient, but they should check with their own IRB about review requirements. VCU IRB
studies will be asked more questions about this on a later page.)

Will share anonymized information or specimens with other researchers.
(8Anonymized9 means that 1) no linkage/key codes exist that link identifiers to data/specimens; and 2) subjects
cannot be readily identified (i.e. no direct or indirect identifiers or identifiable combinations of variables). The
VCU IRB considers uses of anonymized data/specimens by other researchers to not be human subject
research, but the recipient should check with their own IRB about review requirements.)

Will only share aggregate results (summary-level results), not individual-level information or specimens.
(The VCU IRB considers uses of aggregate data to not be human subject research because there are no
individual subjects. The data recipient should check with their own IRB about review requirements.)

Will contribute to an existing registry or repository (VCU IRB studies will be asked more questions about this on
a later page.)

Will submit data to an NIH genomic data repository (VCU IRB studies will be asked more questions about this on
a later page.)

Will not share information/specimens with other researchers.

Not sure and will submit an amendment when known


Other sharing of individual-level information with other researchers
6. * Since you responded in a question above that you may use or share anonymous, individual
level data, indicate why the proposed use or sharing of anonymous data/specimens is not
inconsistent with what participants would have reasonably understood from the consent
document about the uses of their information. (Select all that apply.)

The consent form states that after identifiers are removed, information or specimens could be used for
future research studies without additional informed consent from the subject (this is a new element of
consent included in consent templates as of May 2018)

The consent form or exempt information sheet is silent about whether/how information or specimens could be
used for future research studies.

The information or specimens were/will be obtained under a waiver of informed consent, waiver of HIPAA
authorization, or an exempt study that did not use an information sheet.

Other reason why anonymous use/sharing is not inconsistent with the consent document
7. * The Principal Investigator certifies that prior to releasing an anonymized dataset or
anonymized specimens the following conditions will all be met:
 - all 18 HIPAA identifiers (including all dates) will be removed;
  - all indirectly identifiable data elements (unusual, rare, uncommon data) will be removed, grouped,
suppressed, or otherwise transformed to no longer be readily identifiable;
  - a different subject ID will be assigned than the one used for the main study and a linkage key will not be
kept; and
  - the PI will review the dataset/specimens to confirm that the remaining information could not be used alone
or in combination with any other information to re-identify the participants represented in the data.
See help text for more information.
Yes
No
8. * The Principal Investigator certifies that after the study has been closed with the VCU IRB, the
following conditions will be met whenever individual level research information and/or
specimens are used or shared:
  - The identities of participants who are represented in the dataset/specimens will not be readily ascertainable
or otherwise re-identifiable by the recipient;
  - If a linkage/code key is created, it will be maintained at VCU and not shared with the recipient under any
circumstances;
  - The PI will have no knowledge that the remaining information could be used alone or in combination with
any other information to identify the individuals represented in the data; and
  - The PI agrees to abide by this sharing plan even after the study has been closed with the VCU IRB.
Yes
No
N/A - No sharing will occur
9. If the Certificate of Confidentiality has been obtained by the PI, upload it here:
 
Document
Name
Document
VersionDate
Modified
Uploaded
By
Type
Approved
View Informed
Consent
P3 TASTE_Informed
Consent_CLEAN_1.29.2024.pdf
0.15
2/20/2024
10:22 AM
Rabia Imran Consent/Assent/Information
Sheet
Yes
View Consent -
Tool
P3TASTE_Consent_Presentation_1.29.2024.pptx 0.06
1/30/2024
1:34 PM
Rabia Imran Consent/Assent/Information
Sheet
Yes
View Social Media
Plan
P3-TASTE Social Media Plan_10.2.2023.docx
0.01
10/2/2023
3:29 PM
Caroline
Cobb Amey
Recruitment/Advertising
Yes
View Social Media
and Craigslist
Ads
P3-TASTE_facebook and craiglist
ads_10.2.2023.docx
0.01
10/2/2023
3:29 PM
Caroline
Cobb Amey
Recruitment/Advertising
Yes

 
Document
Name
Document
VersionDate
Modified
Uploaded
By
Type
Approved
View Substance
Use
Resources
Handout
CSTP Substance Use
Resources_8.11.2023.docx
0.01
8/11/2023
5:11 PM
Caroline
Cobb Amey
Other
Yes
View Subjective
Measures
P3-TASTE-Session Subjective
Measures_CLEAN_08.09.2023.doc
0.03
8/11/2023
5:10 PM
Rabia Imran Research Measure
Yes
View P3 TASTE
Advertisement
for CSTP
Website
P3 TASTE - CSTP Website Study
Description_CLEAN_08.08.2023.docx
0.05
8/11/2023
5:09 PM
Rabia Imran Recruitment/Advertising
Yes
View Presession
Symptom
Questions
P3-Presession symptom Checklist-
CLEAN_08.09.2023.docx
0.05
8/11/2023
5:08 PM
Rabia Imran Research Measure
Yes
View Baseline Self
Report Physio
Measures
P3-TASTE_Baseline forms
All_CLEAN_8.11.2023.docx
0.06
8/11/2023
5:07 PM
Rabia Imran Research Measure
Yes
View Text, Email,
Call Scripts
P3-TASTE_Phone_e-mail_text
scripts_08.09.2023_CLEAN.docx
0.10
8/11/2023
5:06 PM
Rabia Imran Study
reminders/communications
Yes
View Referral
Program Card
Template
P3_Referral program
card_06.02.2023_CLEAN.docx
0.03
6/13/2023
1:48 PM
Rabia Imran Recruitment/Advertising
Yes
View COVID-19
Questions
COVID_Questions_P3_no longer using.docx
0.02
6/13/2023
1:35 PM
Rabia Imran Other
Yes
View P3
Taste_ETM
P3-TASTE_Measures_ETM__no longer
using.docx
0.04
6/13/2023
1:35 PM
Rabia Imran Research Measure
Yes
View Tobacco
Cessation
Resources
Handout
Cessation_handout_RI_04.29.2021.pdf
0.01
2/1/2023
3:32 PM
Caroline
Cobb Amey
Other
Yes
View U54 Grant
Application
Without
Budget
U54 Grant Application BUDGET PAGES
DELETED FOR IRB.pdf
0.01
10/28/2022
2:17 PM
Rabia Imran Funding Proposal
Not
Applicable
View CP-DPT &
DPT
P3-TASTE Drug Purchase Tasks_9.2.2022.docx
0.01
10/28/2022
2:03 PM
Rabia Imran Research Measure
Yes
View CP-DPT &
DPT - Tool
DPT_CDPT presentation_10.28.2022.pptx
0.01
10/28/2022
2:03 PM
Rabia Imran Research Measure
Yes
View Subjective
Measures -
Tool
Subjective Measures
presentation_10.28.2022.pptx
0.01
10/28/2022
2:00 PM
Rabia Imran Research Measure
Yes
View Barnes
Biosketch
P3 Barnes biosketch 06.22.17.FINAL.docx
0.01
10/28/2022
1:55 PM
Rabia Imran CV/Biosketch
Not
Applicable
View Lipato
Biosketch
Lipato Biosketch.pdf
0.01
10/28/2022
1:54 PM
Rabia Imran CV/Biosketch
Yes
View Caroline Cobb
(Amey) CV
CV_Cobb_August 2022.docx
0.01
10/28/2022
1:54 PM
Rabia Imran CV/Biosketch
Yes
View Baseline
Discounting
Task - MDT
P3_TASTE_Discounting Task_11.7.2018.pdf
0.01
10/28/2022
1:54 PM
Rabia Imran Research Measure
Yes
View U54 Project 3
Grant Docs
U54_Project 3 only docs.pdf
0.01
10/28/2022
1:53 PM
Rabia Imran Funding Proposal
Not
Applicable
View CSTP Parking
Map
CSTP Parking Map.docx
0.01
10/28/2022
1:52 PM
Rabia Imran Other
Not
Applicable
View Criticare
HR/BP
Manual
Criticare_Vitalcare_506N3_-_Service_manual.pdf 0.01
10/28/2022
1:52 PM
Rabia Imran Other
Not
Applicable

 
Document
Name
Document
VersionDate
Modified
Uploaded
By
Type
Approved
View Expired Air
CO Manual
CO Monitor Manual.pdf
0.01
10/28/2022
1:51 PM
Rabia Imran Other
Not
Applicable
View Information
about Blood
Pressure
BP results P3 flux 8.22.2022.docx
0.01
10/28/2022
1:51 PM
Rabia Imran Study
reminders/communications
Yes
View CSTP
Registry
Consent and
Survey
CSTP Registry Consent Form and Questions.pdf 0.01
10/19/2022
3:27 PM
Caroline
Cobb Amey
Other
Not
Applicable
  

HM20025464
View: SF2 - Pertinent Results and Incidental Findings
ID: HM20025464
HM20025464 - Caroline Cobb Amey
Effects of Electronic Cigarette Flavors on Abuse Liability in Smokers (P3-Taste)
  
Pertinent Results and Incidental Findings
1. * Is it likely investigators could discover a participant's previously unknown condition (e.g.
pregnancy, disease, suicidal thoughts, wrong paternity, genetic results, or other findings that
may be of importance to health or well-being) or if a participant is engaging in illegal or
reportable activities:
  Yes
No
2. * Describe what possible pertinent results or incidental findings stemming from research-only
procedures may be discovered.
During screening, we assess blood pressure.
During screening, we assess if those whose sex assigned at birth was female are pregnant.
During screening, we ask questions about cannabis use and other illicit drugs.
During screening and at the beginning of a session, we ask about respiratory and gastrointestinal symptoms.
3. * Explain what actions or procedures research personnel should take to inform the PI of such a
discovery :
Findings for blood pressure and pregnancy will be communicated to participants verbally (and via a paper document
for blood pressure only) during the in-person screening visit (and for blood pressure, possibly at other visits). These
findings will only be communicated to the participant and will be communicated by the study staff conducting the
screening and/or session. In the event of high blood pressure or a positive pregnancy test, the study staff will
communicate this information and advise the participant to seek treatment.
For blood pressure specifically, individuals whose blood pressure levels are elevated (>=140 mmHg systolic or >=90
mmHg diastolic) during screening or at a session will be provided with a blood pressure information sheet by the
research staff (see study document). This sheet will be provided at the first instance of elevated blood pressure
observed during the study.
If a participant reports cannabis use, although some aspects of cannabis use may be illegal (such as possession or
more than very small quantities), the research staff will not take any actions. This study has a certificate of
confidentiality, which provides additional protections for participants.
Individuals who engage in illicit drug use in the past month will not be eligible for an in-person screen or to participate
in the clinical laboratory portion of the study. We will provide a Substance Use Resources Handout to those who
disclose illicit drug use other than marijuana/cannabis.
Answers given about respiratory and gastrointestinal symptoms will be compared to the participants' previous answers
and if any symptoms have increased, Dr. Lipato will be asked to review the symptoms. In some cases, we may ask Dr.
Lipato to determine if a session can proceed.
4. * Will findings be disclosed to participants and/or any other person/group outside of the study
team?
  Yes
No
5. * Describe a communication plan addressing:
1. What criteria will be used to determine which pertinent and/or incidental findings will be
communicated, including the following for health related findings:
    --- The reliability of the tests/images, such as being done in a CLIA-certified lab,
    --- Whether the meaning and significance of the findings are known,
    --- Whether the findings reveal a significant risk of a serious health condition,
    --- Whether there is an accepted treatment for the health condition revealed by the findings,
and
    --- The risks both of knowing and not knowing the findings, including risks to family members
from genetic testing results.
2. What information will be provided during the consent process about the plans for
communicating pertinent and/or incidental findings;
3. Whether the participants will be given the option of refusing communication of some or all

types of pertinent and/or incidental findings to themselves, their family members, and/or any
other individuals or groups; and
4. To whom and by whom the findings will be communicated, when, and how. 
In the event of high blood pressure or a positive pregnancy test or other responses to the presession symptom
checklist of concern, the study staff will communicate this information to the appropriate party according to Virginia
state law, seek guidance from the medically responsible investigator (MRI) and/or PI, and at the recommendation of
the MRI and/or PI, at times, advise the participant to seek treatment.
Findings for blood pressure and pregnancy will be communicated to participants verbally (and via a paper document
for blood pressure only) during the in-person screening visit. These findings will only be communicated to the
participant and will be communicated by the study staff conducting the screening. In the event of high blood pressure
or a positive pregnancy test, the study staff will advise the participant to seek treatment.
For blood pressure specifically, individuals whose blood pressure levels are elevated (>=140 mmHg systolic or >=90
mmHg diastolic) during screening or at a session will be provided with a blood pressure information sheet by the
research staff (see study document). This sheet will be provided at the first instance of elevated blood pressure
observed during the study.
The reliability of the blood pressure monitor is not known, nor is the reliability of the pregnancy tests we use.
The blood pressure measurement could reveal a significant health risk, depending on how high it is.
There is accepted treatment for high blood pressure.
There are no risks to knowing about high blood pressure or pregnancy.
Participants do not have the option of refusing communication about their blood pressure or pregnancy test results.
Any adverse events may be reported to the study sponsor at FDA/NIH as needed/per their request.
Any information about adverse events reported to individuals outside of the study team will not include participants'
names, DOBs, or other identifying information. Currently, the consent form indicates that such data might be shared
with the study sponsor:
"Personal information about you might be shared with or copied by authorized representatives from the following
organizations for the purposes of managing, monitoring, and overseeing this study:
-The study Sponsor, representatives of the sponsor, and other collaborating organizations
-Representatives of VCU and the VCU Health System
-Officials of the Department of Health and Human Services"
 

HM20025464
View: SF2 - Risk Benefit Complete
ID: HM20025464
HM20025464 - Caroline Cobb Amey
Effects of Electronic Cigarette Flavors on Abuse Liability in Smokers (P3-Taste)
  
Risk Benefit Complete
Protocol Progress:
w INITIAL SETUP
x BACKGROUND, RATIONALE & GOALS
y RESEARCH PLAN
z CONSENT PLAN
{ RISKS, PRIVACY & CONFIDENTIALITY
i POPULATIONS WITH SPECIAL CONSIDERATIONS
j INSTITUTIONAL REQUIREMENTS
k DOCUMENTS
Click Continue below to go to the next section
 

HM20025464
View: SF2 - Populations with Special Considerations
ID: HM20025464
HM20025464 - Caroline Cobb Amey
Effects of Electronic Cigarette Flavors on Abuse Liability in Smokers (P3-Taste)
  
Populations with Special Considerations
1. * Check all participant groups that will be either
  a) Specifically included in this study or
  b) Discernable in the research data/specimens.
  (Selections will branch)

Children

Emancipated minors

Wards of the State

Pregnant women or fetuses

Neonates or Post-delivery Materials

Prisoners

Decisionally Impaired Adults

VCU / VCUHS students or trainees

VCU / VCU Health System employees

Individuals with limited English proficiency

Active military personnel

Student populations in K-12 educational settings or other learning environments

Members of a federally recognized American Indian and Alaska Native tribe

None of the Above
 
          
          

HM20025464
View: SF2 - Populations with Special Considerations Section Complete
ID: HM20025464
HM20025464 - Caroline Cobb Amey
Effects of Electronic Cigarette Flavors on Abuse Liability in Smokers (P3-Taste)
  
Populations with Special Considerations Section Complete
Protocol Progress:
w INITIAL SETUP
x BACKGROUND, RATIONALE & GOALS
y RESEARCH PLAN
z CONSENT PLAN
{ RISKS, PRIVACY & CONFIDENTIALITY
| POPULATIONS WITH SPECIAL CONSIDERATIONS
j INSTITUTIONAL REQUIREMENTS
k DOCUMENTS
Click Continue below to go to the next section

HM20025464
View: SF2 - Study Funding
ID: HM20025464
HM20025464 - Caroline Cobb Amey
Effects of Electronic Cigarette Flavors on Abuse Liability in Smokers (P3-Taste)
  
Study Funding
1. * Have you applied for funding:
  Yes
No
2. Is this study already funded:
  Yes
No
3. * Select all funding sources for this study (pending or awarded):

Industry

Direct Federal

Indirect Federal

State/Local Government

Non-Profit - Sponsored Project

Non-Profit - Gift

Internal Grant

Investigator/Departmental Funds

None

Other
4. * In addition to providing funding support, what is the funding source9s role in this study? Select
all that apply:

Solely providing funding support

Providing resources (e.g. study drug, device)

Providing guidance to the researcher but does NOT make decisions about study design

Study design/Creation of the study protocol

Collaborator in the research (helps design and/or conduct the study) [list the funder as a site on the Types of
Sites page]

Data or sample analysis regardless of identifiability
5. Select all related funding proposals and contracts that have been submitted through the
Division of Sponsored Programs (DSP):
RAMS-SPOT ID#
(FP/PT/PD#)
Direct Sponsor PI
Title
StatusStartEnd
FP00006477
National Institutes of
Health
Thomas
Eissenberg
Center for the Study of
Tobacco Products
Funded  
 
6. If the following conditions are ALL met, provide the index code where the HRPP will charge
Single IRB (sIRB) fees associated with this review:
1.  The study is externally funded (fees do not apply if the study is not funded), AND
2. Multiple sites are executing the same research protocol (i.e. multicenter research), AND
3. VCU IRB will provide IRB review on behalf of one or more non-VCU sites
N/A

7. * Does the funder require the IRB to review this proposal for grant congruence?
  Yes
No
 

HM20025464
View: SF2 - Types of Sites
ID: HM20025464
HM20025464 - Caroline Cobb Amey
Effects of Electronic Cigarette Flavors on Abuse Liability in Smokers (P3-Taste)
  
Types of Sites
VCU Site Information
1. * Select all VCU sites that will be utilized in this study:

Children's Hospital of Richmond at VCU

Clinical Research Services Unit (CRSU)

Massey Cancer Center

VCU Health Community Memorial Hospital

VCU Health Tappahannock Hospital

VCU Medical Center

Other VCU Health Location

VCU Monroe Park Campus

VCU Qatar

Other VCU Site
 
Non-VCU Site Information 
Non-VCU sites should be selected whenever any of the following situations apply:
   a) Non-VCU sites that will be collaborating  on a VCU-led study (i.e. involved in conducting the research,
including being involved in the study interpretation or analysis of data and/or authorship of presentations or
manuscripts related to the research.)  
   b) Non-VCU sites that will be deferring to the VCU IRB for IRB review
   c) Non-VCU sites where VCU investigators will be overseeing study interventions or interactions
   d) Non-VCU sites/locations where VCU investigators will conduct study activities
2. * Select any of the following non-VCU sites utilized in this study:

McGuire VAMC

Foreign Sites

Other Non-VCU Sites

No Non-VCU Sites
3. * Is this a multi-center study being led by VCU?
  Yes No
4. For Non-VCU Sites: For each site or institution listed as "Site Engaged -- Requests to Rely on
VCU IRB Review," upload:
- Completed Local Context Form for Relying on VCU's IRB
- Site specific informed consent form(s)  and HIPAA authorization(s), if applicable
For Foreign Sites: For each Cultural Consultant upload a CV/Biosketch that includes a clear
description of cultural expertise:
 
Document
Name
Document
VersionDate
Modified
Uploaded
By
Type
Approved
View Informed
Consent
P3 TASTE_Informed
Consent_CLEAN_1.29.2024.pdf
0.15
2/20/2024
10:22 AM
Rabia Imran Consent/Assent/Information
Sheet
Yes
View Consent -
Tool
P3TASTE_Consent_Presentation_1.29.2024.pptx 0.06
1/30/2024
1:34 PM
Rabia Imran Consent/Assent/Information
Sheet
Yes
View Social Media
Plan
P3-TASTE Social Media Plan_10.2.2023.docx
0.01
10/2/2023
3:29 PM
Caroline
Cobb Amey
Recruitment/Advertising
Yes

 
Document
Name
Document
VersionDate
Modified
Uploaded
By
Type
Approved
View Social Media
and Craigslist
Ads
P3-TASTE_facebook and craiglist
ads_10.2.2023.docx
0.01
10/2/2023
3:29 PM
Caroline
Cobb Amey
Recruitment/Advertising
Yes
View Substance
Use
Resources
Handout
CSTP Substance Use
Resources_8.11.2023.docx
0.01
8/11/2023
5:11 PM
Caroline
Cobb Amey
Other
Yes
View Subjective
Measures
P3-TASTE-Session Subjective
Measures_CLEAN_08.09.2023.doc
0.03
8/11/2023
5:10 PM
Rabia Imran Research Measure
Yes
View P3 TASTE
Advertisement
for CSTP
Website
P3 TASTE - CSTP Website Study
Description_CLEAN_08.08.2023.docx
0.05
8/11/2023
5:09 PM
Rabia Imran Recruitment/Advertising
Yes
View Presession
Symptom
Questions
P3-Presession symptom Checklist-
CLEAN_08.09.2023.docx
0.05
8/11/2023
5:08 PM
Rabia Imran Research Measure
Yes
View Baseline Self
Report Physio
Measures
P3-TASTE_Baseline forms
All_CLEAN_8.11.2023.docx
0.06
8/11/2023
5:07 PM
Rabia Imran Research Measure
Yes
View Text, Email,
Call Scripts
P3-TASTE_Phone_e-mail_text
scripts_08.09.2023_CLEAN.docx
0.10
8/11/2023
5:06 PM
Rabia Imran Study
reminders/communications
Yes
View Referral
Program Card
Template
P3_Referral program
card_06.02.2023_CLEAN.docx
0.03
6/13/2023
1:48 PM
Rabia Imran Recruitment/Advertising
Yes
View COVID-19
Questions
COVID_Questions_P3_no longer using.docx
0.02
6/13/2023
1:35 PM
Rabia Imran Other
Yes
View P3
Taste_ETM
P3-TASTE_Measures_ETM__no longer
using.docx
0.04
6/13/2023
1:35 PM
Rabia Imran Research Measure
Yes
View Tobacco
Cessation
Resources
Handout
Cessation_handout_RI_04.29.2021.pdf
0.01
2/1/2023
3:32 PM
Caroline
Cobb Amey
Other
Yes
View U54 Grant
Application
Without
Budget
U54 Grant Application BUDGET PAGES
DELETED FOR IRB.pdf
0.01
10/28/2022
2:17 PM
Rabia Imran Funding Proposal
Not
Applicable
View CP-DPT &
DPT
P3-TASTE Drug Purchase Tasks_9.2.2022.docx
0.01
10/28/2022
2:03 PM
Rabia Imran Research Measure
Yes
View CP-DPT &
DPT - Tool
DPT_CDPT presentation_10.28.2022.pptx
0.01
10/28/2022
2:03 PM
Rabia Imran Research Measure
Yes
View Subjective
Measures -
Tool
Subjective Measures
presentation_10.28.2022.pptx
0.01
10/28/2022
2:00 PM
Rabia Imran Research Measure
Yes
View Barnes
Biosketch
P3 Barnes biosketch 06.22.17.FINAL.docx
0.01
10/28/2022
1:55 PM
Rabia Imran CV/Biosketch
Not
Applicable
View Lipato
Biosketch
Lipato Biosketch.pdf
0.01
10/28/2022
1:54 PM
Rabia Imran CV/Biosketch
Yes
View Caroline Cobb
(Amey) CV
CV_Cobb_August 2022.docx
0.01
10/28/2022
1:54 PM
Rabia Imran CV/Biosketch
Yes
View Baseline
Discounting
Task - MDT
P3_TASTE_Discounting Task_11.7.2018.pdf
0.01
10/28/2022
1:54 PM
Rabia Imran Research Measure
Yes
View U54 Project 3
Grant Docs
U54_Project 3 only docs.pdf
0.01
10/28/2022
1:53 PM
Rabia Imran Funding Proposal
Not
Applicable
View CSTP Parking
Map
CSTP Parking Map.docx
0.01
10/28/2022
1:52 PM
Rabia Imran Other
Not
Applicable

 
Document
Name
Document
VersionDate
Modified
Uploaded
By
Type
Approved
View Criticare
HR/BP
Manual
Criticare_Vitalcare_506N3_-_Service_manual.pdf 0.01
10/28/2022
1:52 PM
Rabia Imran Other
Not
Applicable
View Expired Air
CO Manual
CO Monitor Manual.pdf
0.01
10/28/2022
1:51 PM
Rabia Imran Other
Not
Applicable
View Information
about Blood
Pressure
BP results P3 flux 8.22.2022.docx
0.01
10/28/2022
1:51 PM
Rabia Imran Study
reminders/communications
Yes
View CSTP
Registry
Consent and
Survey
CSTP Registry Consent Form and Questions.pdf 0.01
10/19/2022
3:27 PM
Caroline
Cobb Amey
Other
Not
Applicable
 
 

HM20025464
View: SF2 - Personnel
ID: HM20025464
HM20025464 - Caroline Cobb Amey
Effects of Electronic Cigarette Flavors on Abuse Liability in Smokers (P3-Taste)
  
Personnel
1. * List all VCU/VCUHS personnel who are key study personnel.
Key personnel are defined as including:
     - Conflict of interest investigators, including
     - the PI
     - the Lead Student/Trainee Investigator,
     - medically/Psychologically responsible investigator(s)
     - FDA Form 1572 investigators, and
     - Other personnel whose roles are essential to the conduct of the research.
Note: Individuals who are not key personnel are not required to be listed here, but PIs still bear the
responsibility to document the delegation of responsibilities in the study records.
PIs may elect to use the Study Roster activity button in RAMS-IRB (available after approval) as an alternative
way to document study staff involvement and delegation of responsibilities. Personnel changes made to the
non-key personnel listed in the separate Study Roster activity do not require an amendment.
 
Name
Roles
Roles
-
Other
ResponsibilitiesResponsibilities -
Other
QualificationsQualifications
- Other
COI
Investigator
View Caroline
Cobb
Amey
Principal Investigator
 
Data Analysis
Project
Coordination
Participant
Consent
Data Collection -
Lab
Data Management
Participant
Identification
Data Entry
Study Design
Data Coding
Participant
Recruitment
Data Collection -
Interviews/Surveys
 
Experience -
Research
Education
and/or
Professional
Preparation
 
yes
View Andrew
Barnes
Co/Sub-Investigator
 
Data Analysis
Project
Coordination
Participant
Consent
Data Collection -
Lab
Data Management
Participant
Identification
Data Entry
Study Design
Data Coding
Participant
Recruitment
Data Collection -
Interviews/Surveys
 
Experience -
Research
Education
and/or
Professional
Preparation
 
yes

 
Name
Roles
Roles
-
Other
ResponsibilitiesResponsibilities -
Other
QualificationsQualifications
- Other
COI
Investigator
View Alison
Breland
Co/Sub-Investigator
 
Data Analysis
Project
Coordination
Participant
Consent
Data Collection -
Lab
Participant
Identification
Data Entry
Study Design
Data Coding
Participant
Recruitment
Data Collection -
Interviews/Surveys
 
Experience -
Research
Education
and/or
Professional
Preparation
 
yes
View Thomas
Eissenberg
Co/Sub-Investigator
 
Data Analysis
Data Management
Participant
Identification
Study Design
 
Experience -
Research
Education
and/or
Professional
Preparation
 
yes
View Thokozeni
Lipato
Medical or
Psychological
Responsible
Investigator
 
Data Management
Participant
Identification
Data Entry
Clinical Services
 
Experience -
Research
Experience -
Clinical
Education
and/or
Professional
Preparation
 
yes
View Nicoleta
Gaitan
Research Nurse
 
Project
Coordination
Other
Participant
Recruitment
Clinical Services
Provide medical safety
supervision/consultation
Experience -
Research
Experience -
Clinical
Education
and/or
Professional
Preparation
 
no
View Rabia
Imran
Research Assistant
 
Data Analysis
Project
Coordination
Data Collection -
Direct Observation
Participant
Consent
Data Collection -
Lab
Data Management
Data Entry
Data Coding
Participant
Recruitment
Data Collection -
Interviews/Surveys
 
Experience -
Research
Experience -
Related Skills
Education
and/or
Professional
Preparation
 
no
View Augustus
White
Research Assistant
 
Data Analysis
 
Experience -
Research
 
no

 
Name
Roles
Roles
-
Other
ResponsibilitiesResponsibilities -
Other
QualificationsQualifications
- Other
COI
Investigator
Trainee/Student(working
on project)
Data Collection -
Direct Observation
Participant
Consent
Data Collection -
Lab
Data Management
Data Entry
Data Coding
Participant
Recruitment
Data Collection -
Interviews/Surveys
Education
and/or
Professional
Preparation
Student
View Rose Bono Research Assistant
 
Data Analysis
Data Management
Data Coding
 
Experience -
Research
Education
and/or
Professional
Preparation
 
no
View Mary
Bridgman
Research Assistant
 
Data Analysis
Project
Coordination
Data Collection -
Direct Observation
Participant
Consent
Data Collection -
Lab
Data Management
Data Entry
Data Coding
Participant
Recruitment
Data Collection -
Interviews/Surveys
 
Experience -
Research
Experience -
Related Skills
Education
and/or
Professional
Preparation
 
no
View Melody
Falter
Research Assistant
 
Data Analysis
Project
Coordination
Participant
Consent
Data Collection -
Lab
Data Management
Participant
Identification
Data Entry
Data Coding
Participant
Recruitment
Data Collection -
Interviews/Surveys
 
Experience -
Research
Experience -
Related Skills
Education
and/or
Professional
Preparation
 
no
View Carrico
Research Assistant
Trainee/Student(working
on project)
 
Data Analysis
Participant
Consent
Data Collection -
Lab
 
Experience -
Research
Experience -
Related Skills
 
no

 
Name
Roles
Roles
-
Other
ResponsibilitiesResponsibilities -
Other
QualificationsQualifications
- Other
COI
Investigator
Data Management
Participant
Identification
Data Entry
Data Coding
Participant
Recruitment
Data Collection -
Interviews/Surveys
Education
and/or
Professional
Preparation
Student
View Elizabeth
Ogunleye
Trainee/Student(working
on project)
 
Data Analysis
Project
Coordination
Data Collection -
Direct Observation
Participant
Consent
Data Collection -
Lab
Data Management
Participant
Identification
Data Entry
Data Coding
Participant
Recruitment
Data Collection -
Interviews/Surveys
 
Experience -
Research
Experience -
Related Skills
Education
and/or
Professional
Preparation
Student
 
no
2. Identify all independent investigators and key personnel at non-VCU sites who will be engaged
in this study AND who DO NOT have IRB approval for this study from their own institution.
 NameRoles
Roles
-
Other
ResponsibilitiesResponsibilities
- Other
QualificationsQualifications
- Other
COI
Investigator
There are no items to display
3. If independent investigators or community engaged investigators are listed above,describe the human subjects
training these individuals will complete and the process that will be used to ensure that all
persons assisting with the research are adequately informed about the protocol and their
research related duties and functions: 
This study will be conducted in Dr. Eissenberg's and Breland's Center for the Study of Tobacco Products. In over 15
years, the CSTP has conducted numerous IRB-approved studies involving cigarette smokers and e-cigarette users. All
laboratory personnel are experienced, well-trained and aware of their protocol-related responsibilities. Additionally,
most lab personnel, including the Co-PIs have offices on the same floor in the same building and communicate daily in-
person regarding all study-related issues. Lab meetings are held bi-monthly in order to communicate the status of
specific studies and any issues related to ongoing studies. Thurs, communication may occur as often as every day,
either in person or via email.
Communication with between laboratory staff and the Co-PIs/Medical Monitor occurs as soon as possible during
and/or after any adverse event occurs. The Co-PIs and Medical Monitor are available by mobile phone, office phone,
and email. These numbers are posted centrally in the laboratory.
4. * Upload a CV or Biosketch for the PI, Medically/Psychologically Responsible Investigators and
the lead Student/Trainee Investigators. Do not upload CVs or Biosketches for other individuals.
 
Document
Name
Document
VersionDate
Modified
Uploaded
By
Type
Approved
View Informed
Consent
P3 TASTE_Informed
Consent_CLEAN_1.29.2024.pdf
0.15
2/20/2024
10:22 AM
Rabia Imran Consent/Assent/Information
Sheet
Yes
View Consent -
Tool
P3TASTE_Consent_Presentation_1.29.2024.pptx 0.06
1/30/2024
1:34 PM
Rabia Imran Consent/Assent/Information
Sheet
Yes

 
Document
Name
Document
VersionDate
Modified
Uploaded
By
Type
Approved
View Social Media
Plan
P3-TASTE Social Media Plan_10.2.2023.docx
0.01
10/2/2023
3:29 PM
Caroline
Cobb Amey
Recruitment/Advertising
Yes
View Social Media
and Craigslist
Ads
P3-TASTE_facebook and craiglist
ads_10.2.2023.docx
0.01
10/2/2023
3:29 PM
Caroline
Cobb Amey
Recruitment/Advertising
Yes
View Substance
Use
Resources
Handout
CSTP Substance Use
Resources_8.11.2023.docx
0.01
8/11/2023
5:11 PM
Caroline
Cobb Amey
Other
Yes
View Subjective
Measures
P3-TASTE-Session Subjective
Measures_CLEAN_08.09.2023.doc
0.03
8/11/2023
5:10 PM
Rabia Imran Research Measure
Yes
View P3 TASTE
Advertisement
for CSTP
Website
P3 TASTE - CSTP Website Study
Description_CLEAN_08.08.2023.docx
0.05
8/11/2023
5:09 PM
Rabia Imran Recruitment/Advertising
Yes
View Presession
Symptom
Questions
P3-Presession symptom Checklist-
CLEAN_08.09.2023.docx
0.05
8/11/2023
5:08 PM
Rabia Imran Research Measure
Yes
View Baseline Self
Report Physio
Measures
P3-TASTE_Baseline forms
All_CLEAN_8.11.2023.docx
0.06
8/11/2023
5:07 PM
Rabia Imran Research Measure
Yes
View Text, Email,
Call Scripts
P3-TASTE_Phone_e-mail_text
scripts_08.09.2023_CLEAN.docx
0.10
8/11/2023
5:06 PM
Rabia Imran Study
reminders/communications
Yes
View Referral
Program Card
Template
P3_Referral program
card_06.02.2023_CLEAN.docx
0.03
6/13/2023
1:48 PM
Rabia Imran Recruitment/Advertising
Yes
View COVID-19
Questions
COVID_Questions_P3_no longer using.docx
0.02
6/13/2023
1:35 PM
Rabia Imran Other
Yes
View P3
Taste_ETM
P3-TASTE_Measures_ETM__no longer
using.docx
0.04
6/13/2023
1:35 PM
Rabia Imran Research Measure
Yes
View Tobacco
Cessation
Resources
Handout
Cessation_handout_RI_04.29.2021.pdf
0.01
2/1/2023
3:32 PM
Caroline
Cobb Amey
Other
Yes
View U54 Grant
Application
Without
Budget
U54 Grant Application BUDGET PAGES
DELETED FOR IRB.pdf
0.01
10/28/2022
2:17 PM
Rabia Imran Funding Proposal
Not
Applicable
View CP-DPT &
DPT
P3-TASTE Drug Purchase Tasks_9.2.2022.docx
0.01
10/28/2022
2:03 PM
Rabia Imran Research Measure
Yes
View CP-DPT &
DPT - Tool
DPT_CDPT presentation_10.28.2022.pptx
0.01
10/28/2022
2:03 PM
Rabia Imran Research Measure
Yes
View Subjective
Measures -
Tool
Subjective Measures
presentation_10.28.2022.pptx
0.01
10/28/2022
2:00 PM
Rabia Imran Research Measure
Yes
View Barnes
Biosketch
P3 Barnes biosketch 06.22.17.FINAL.docx
0.01
10/28/2022
1:55 PM
Rabia Imran CV/Biosketch
Not
Applicable
View Lipato
Biosketch
Lipato Biosketch.pdf
0.01
10/28/2022
1:54 PM
Rabia Imran CV/Biosketch
Yes
View Caroline Cobb
(Amey) CV
CV_Cobb_August 2022.docx
0.01
10/28/2022
1:54 PM
Rabia Imran CV/Biosketch
Yes
View Baseline
Discounting
Task - MDT
P3_TASTE_Discounting Task_11.7.2018.pdf
0.01
10/28/2022
1:54 PM
Rabia Imran Research Measure
Yes
View U54 Project 3
Grant Docs
U54_Project 3 only docs.pdf
0.01
10/28/2022
1:53 PM
Rabia Imran Funding Proposal
Not
Applicable

 
Document
Name
Document
VersionDate
Modified
Uploaded
By
Type
Approved
View CSTP Parking
Map
CSTP Parking Map.docx
0.01
10/28/2022
1:52 PM
Rabia Imran Other
Not
Applicable
View Criticare
HR/BP
Manual
Criticare_Vitalcare_506N3_-_Service_manual.pdf 0.01
10/28/2022
1:52 PM
Rabia Imran Other
Not
Applicable
View Expired Air
CO Manual
CO Monitor Manual.pdf
0.01
10/28/2022
1:51 PM
Rabia Imran Other
Not
Applicable
View Information
about Blood
Pressure
BP results P3 flux 8.22.2022.docx
0.01
10/28/2022
1:51 PM
Rabia Imran Study
reminders/communications
Yes
View CSTP
Registry
Consent and
Survey
CSTP Registry Consent Form and Questions.pdf 0.01
10/19/2022
3:27 PM
Caroline
Cobb Amey
Other
Not
Applicable
  

HM20025464
View: SF2 - Conflict of Interest
ID: HM20025464
HM20025464 - Caroline Cobb Amey
Effects of Electronic Cigarette Flavors on Abuse Liability in Smokers (P3-Taste)
  
Conflict of Interest
The PI should ask the questions on this page of all research personnel who are engaged in the research, including
subrecipient investigators and personnel. 
1. * To the best of your knowledge, do you (as PI) or any other engaged individual have a financial
interest related to this study?
Financial interest include utilizing your licensed intellectual property in the study; serving as a
paid consultant, or advisory board member, or officer/director with a related entity; and equity
or business ownership in a company that is related to this project
  Yes No
2. * If Yes, provide:
- Name(s) of engaged individual(s) with a related financial interest
- Brief description of financial interest
Any individual named here should be designated as a 8COI Investigator9 on the Personnel page,
even if they were not initially designated as a 8COI Investigator9, and complete a Financial
Interest Report (FIR) in the Activity and Interest Reporting System (AIRS). Ensure that all
designated 'COI investigators,' including the PI, and any others listed here with related
interests are up to date in the AIRS (https://airs.research.vcu.edu) 
Dr. Eissenberg is a paid consultant in litigation against the tobacco industry and the electronic cigarette industry. 
3. * To the best of your knowledge, do you (as PI) or any other engaged individual have a non-
financial interest related to this study?
Non-financial Interests could include such things as:
- utilizing your unlicensed intellectual property in the study,
- serving as an unpaid advisory board member or officer/director with a related entity, and
- equity or business ownership in a company that has yet to make a profit and is related to this
project
- conflict of time/effort,
- personal and professional relationships/affiliations,
- intellectual passions or personal beliefs
- other factors that could create bias in the study
  Yes No
4. * Describe any If Yes, provide:
- Name(s) of the engaged individual(s) with a related non-financial interest
- Brief description of the non-financial interest
Any individual named here should also complete a Financial Interest Report (FIR) in the Activity
and Interest Report System (AIRS), even if they were not initially designated as a 'COI
Investigator.' Ensure that all designated 'COI investigators,' including the PI, and any others
listed here with related interests are up to date in the AIRS (https://airs.research.vcu.edu)
Dr. Eissenberg is named on a patent application for a device that measures the puffing behavior or electronic cigarette
users.  
5. Describe any institutional conflict of interest that you or any member of the research team are aware of that
pertains to this research:
 An institutional conflict of interest is a situation in which financial interests of the University or University
leadership may affect research activities at VCU.
N/A
  

HM20025464
View: SF2 - Other VCU Requirementsv2
ID: HM20025464
HM20025464 - Caroline Cobb Amey
Effects of Electronic Cigarette Flavors on Abuse Liability in Smokers (P3-Taste)
  
Other VCU Requirements
This page asks questions on behalf of other ancillary offices, committees and departments at VCU regarding
institutional requirements that could apply to this research. In some cases, these requirements could also
impact the consent process or other aspects of the IRB's review.
Based upon answers provided earlier in this form, certain ancillary sections below may not have questions
displayed if those requirements are not applicable to this study.
1. Cost Coverage Analysis
         Information on coverage analysis requirements and processes can be found through VCU’s Clinical
Research Compliance Program at https://research.vcu.edu/human-research/clinical-research/vcu-clinical-research-
coverage-analysis/ 
 
1. * VCU requires that all clinical research studies be evaluated to determine if a Coverage
Analysis is required. Has your study been evaluated by an institutionally designated
Coverage Analysis Specialist?
Yes
No
Not Applicable
 
2. ClinicalTrials.gov Program & OnCore
For guidance, see https://cctr.vcu.edu/support/consultation/clinical-trials-gov/ or email CCTRCTGOV@vcu.edu
1. * Is this a Clinical Trial?
  Yes No 
2. * ThePI acknowledges awareness of the following requirements for posting clinical trial
consent forms:
 
  - Each clinical trial under the 2018 Common Rule that is conducted or supported by a Federal
department or agency must post one IRB-approved consent form that was used to enroll subjects on a
publicly available Federal website [45 CFR 46.116(h)].
  - When engaged in multi-site research, the VCU PI is responsible for confirming with the lead site who
is responsible for posting the informed consent form.
  - When VCU is the lead site, the VCU PI is responsible for posting the informed consent form (unless
the federal department or agency will post it).
  Yes No 
3. Community Engagement
For more information, see https://community.vcu.edu/
1. * Is this a community engaged research study? (See help text for definitions)
  Yes
No
 
4. Family Educational Rights and Privacy Act (FERPA) Requirements
For guidance, see  https://rar.vcu.edu/records/family-educational-rights-and-privacy-act/
1. * Does this study involve obtaining information from VCU students' educational records
(see help text)?
  Yes
No
5. Research Data Privacy Requirements
Contact the VCU Research Data Privacy Office with questions: https://research.vcu.edu/integrity-and-
compliance/compliance/research-data-privacy/

1. * Does this study involve the VCU site (regardless of the IRB of record), or any sites under
the VCU IRB'9s oversight, obtaining data in, or from, a foreign country? 
  Yes No   
 
6. Information Security
For guidance, see https://ts.vcu.edu/askit/essential-computing/information-security/
1. * Using the VCU Data Classification Tool, please determine the appropriate data
classification category for the data that will be collected or used in this research.
Note: if the data falls into Category 1, a data security management plan is required by University
Information Security Office.
See help text for information on accessing the VCU Data Classification Tool, and for information on
creating a data security management plan at https://dms.vcu.edu.
Category 1: all data that require breach notifications in the event of improper release, including
personally identifiable information covered by HIPAA and Commonwealth of Virginia regulations.
Category 2: all proprietary data that if improperly released has the potential to cause harm to the
institution, its mission or its reputation that do not require breach notifications.
2. * I confirm use of the VCU Data Classification Tool at https://go.vcu.edu/dataclassification in
determining the data classification category selected in Question 1:
  Yes
No
3. * The PI is aware that if the study9s data is classified as Category 1, a Data Management
Plan must be submitted to and approved by VCU Information Security prior to IRB
approval. See https://ts.vcu.edu/askit/essential-computing/information-security/data-management-system/
  Yes No  
 
4. * I confirm that any use of external technology has been submitted to Information
Security in the study9s Data Management Plan. If this study uses any technology
platforms, apps, services, etc. that are maintained external to VCU or hosted by another
institution and are NOT currently listed in the DMS system as an approved service for the
storage, processing, or transmission of VCU data, I am required to have VCU Information
Security conduct a security review of that technology. I may contact infosec@vcu.edu
with questions.
I also confirm that if the study involves use of external technology and VCUHS HIPAA
data, I must also seek security review from the VCUHS Data Governance group (contact
Mary Harmon at mary.harmon@vcuhealth.org):
Yes
No
N/A - not using external technology
7. Massey Cancer Center Protocol Review and Monitoring Committee (PRMC)
For guidance, see https://www.masseycancercenter.org/research/~/link.aspx?
_id=ee49e95faa8b44d09b6e89d8e3b48b57&_z=z
1. * Does this study involve any of the following?
- Research involving patients with cancer, their families or their health care providers
- Research involving cancer screening, diagnosis or prevention
- Secondary data collected from cancer patients or their medical records
- Cancer-related surveys (e.g., attitudes about risk, prevention and treatment) of the
general population
  Yes
No
8. VCU ONETRAC Protocol Review Oversight Committees (PROCs) For guidance, see https://onetrac.vcu.edu/

1. * Does this study involve research with any of the following?
- VCU Health System patients
- VCU Health System facilities
- VCU Health System data   Yes
No
   
9. VCU Health Department of Patient Centered Services
 
1. * Does your study involve a satisfaction survey  administered to VCUHS patients (*See
Help Text):
Yes
No
Not Applicable
10. VCU Faculty-Held IND or IDE
For guidance, see https://research.vcu.edu/human-research/regulatory-affairs/.
Questions related to if you need an IND or IDE for your study should be emailed to: indide@vcu.edu. Please submit a
copy of your FDA 
submission prior to submitting to the FDA to https://redcap.vcu.edu/surveys/?s=NR7K7LR4JW.
11. VCU Health System locations
1. * Will research activities occur in patient care areas of the VCU Health System (including
at CHoR, Community Memorial Hospital, Tappahannock Hospital, VCU Medical Center and
Massey Cancer Center)?
  Yes
No
12. VCUHS Department of Pathology
Learn more about requesting and establishing an account with Pathology here:  See
https://pathology.vcu.edu/research-services/
1. * I am aware that I may need to establish a research account with VCUHS Department of
Pathology for specimen processing:
  Yes
No
2. * I have contacted VCUHS Department of Pathology to determine feasibility if my study
involves the following: 
- Storage of Microbiology isolates
- New instrumentation provided by clinical trial/study sponsor, or 
- Non-routine specimen processing (examples include but aren9t limited to the following:
addition of reagents to samples/aliquots, buffy coat processing, DNA sample processing)
Yes
No
N/A - my study does not involve any of the listed processes.
3. * If my study involves specimen retrieval from the Pathology laboratory, I have established
a process with Pathology to deidentify and retrieve specimens.
Yes
No
N/A - my study won't involve specimen retrieval from Pathology
 
 

13. VCU Institutional Biosafety Committee (IBC)
To contact the Biosafety Office see their website at:  https://research.vcu.edu/integrity-and-
compliance/compliance/regulatory-committees/
1. * Does this project involve any of the following hazardous biological agents
(<biohazardous agents=) that have NOT been FDA approved? These may include, but are
not limited to, any of the following. If you are unsure, please contact the Biosafety Office:
       - Any functional recombinant viruses (especially viruses that may integrate into the
patients9 genome).
       - Expression or administration of biological toxins.
       - Live pathogenic or potentially pathogenic organisms of plants or animals (bacteria,
fungi, wild-type viruses, parasites, etc.), that are, or potentially may be, in experimental
products.
       - Introduction or expression of rDNA or synthetic nucleic acids
       - Use of a product (e.g., monoclonal antibodies, recombinant cytokines) produced
from virally infected mammalian cells.
       - Use of a product (purified growth factors, cytokines) produced from mammals or
their cells.
  Yes No
 
 
14. VCU Radiation Safety Committee (RSC)
To contact the Radiation Safety Section see their website at: https://research.vcu.edu/integrity-and-
compliance/compliance/regulatory-committees/ 
1. * Does this study involve radiation exposure and/or scans involving radiation (e.g.: PET,
MRA, CT, DXA, nuclear medicine, etc.)?
  Yes
No
           
15. VCU Scientific Review Committee (SRC)
For guidance, see https://cctr.vcu.edu/support/consultation/scientific-review-committee/
1. * Has this human subjects protocol (not the grant application) already been reviewed by
the funder of a sponsored project (e.g. a federal, state or non-profit funding sponsor)?
  Yes
No
Based upon your responses, this study will be routed to the VCU Scientific Review Committee (SRC)
when it is submitted. After SRC review is completed, the IRB will receive the study.
16. Upload any documents requested in the questions above:
 
Document
Name
Document
VersionDate
Modified
Uploaded
By
Type
Approved
View Informed
Consent
P3 TASTE_Informed
Consent_CLEAN_1.29.2024.pdf
0.15
2/20/2024
10:22 AM
Rabia Imran Consent/Assent/Information
Sheet
Yes
View Consent -
Tool
P3TASTE_Consent_Presentation_1.29.2024.pptx 0.06
1/30/2024
1:34 PM
Rabia Imran Consent/Assent/Information
Sheet
Yes
View Social Media
Plan
P3-TASTE Social Media Plan_10.2.2023.docx
0.01
10/2/2023
3:29 PM
Caroline
Cobb Amey
Recruitment/Advertising
Yes
View Social Media
and Craigslist
Ads
P3-TASTE_facebook and craiglist
ads_10.2.2023.docx
0.01
10/2/2023
3:29 PM
Caroline
Cobb Amey
Recruitment/Advertising
Yes
View Substance
Use
CSTP Substance Use
Resources_8.11.2023.docx
0.01
8/11/2023
5:11 PM
Caroline
Cobb Amey
Other
Yes

 
Document
Name
Document
VersionDate
Modified
Uploaded
By
Type
Approved
Resources
Handout
View Subjective
Measures
P3-TASTE-Session Subjective
Measures_CLEAN_08.09.2023.doc
0.03
8/11/2023
5:10 PM
Rabia Imran Research Measure
Yes
View P3 TASTE
Advertisement
for CSTP
Website
P3 TASTE - CSTP Website Study
Description_CLEAN_08.08.2023.docx
0.05
8/11/2023
5:09 PM
Rabia Imran Recruitment/Advertising
Yes
View Presession
Symptom
Questions
P3-Presession symptom Checklist-
CLEAN_08.09.2023.docx
0.05
8/11/2023
5:08 PM
Rabia Imran Research Measure
Yes
View Baseline Self
Report Physio
Measures
P3-TASTE_Baseline forms
All_CLEAN_8.11.2023.docx
0.06
8/11/2023
5:07 PM
Rabia Imran Research Measure
Yes
View Text, Email,
Call Scripts
P3-TASTE_Phone_e-mail_text
scripts_08.09.2023_CLEAN.docx
0.10
8/11/2023
5:06 PM
Rabia Imran Study
reminders/communications
Yes
View Referral
Program Card
Template
P3_Referral program
card_06.02.2023_CLEAN.docx
0.03
6/13/2023
1:48 PM
Rabia Imran Recruitment/Advertising
Yes
View COVID-19
Questions
COVID_Questions_P3_no longer using.docx
0.02
6/13/2023
1:35 PM
Rabia Imran Other
Yes
View P3
Taste_ETM
P3-TASTE_Measures_ETM__no longer
using.docx
0.04
6/13/2023
1:35 PM
Rabia Imran Research Measure
Yes
View Tobacco
Cessation
Resources
Handout
Cessation_handout_RI_04.29.2021.pdf
0.01
2/1/2023
3:32 PM
Caroline
Cobb Amey
Other
Yes
View U54 Grant
Application
Without
Budget
U54 Grant Application BUDGET PAGES
DELETED FOR IRB.pdf
0.01
10/28/2022
2:17 PM
Rabia Imran Funding Proposal
Not
Applicable
View CP-DPT &
DPT
P3-TASTE Drug Purchase Tasks_9.2.2022.docx
0.01
10/28/2022
2:03 PM
Rabia Imran Research Measure
Yes
View CP-DPT &
DPT - Tool
DPT_CDPT presentation_10.28.2022.pptx
0.01
10/28/2022
2:03 PM
Rabia Imran Research Measure
Yes
View Subjective
Measures -
Tool
Subjective Measures
presentation_10.28.2022.pptx
0.01
10/28/2022
2:00 PM
Rabia Imran Research Measure
Yes
View Barnes
Biosketch
P3 Barnes biosketch 06.22.17.FINAL.docx
0.01
10/28/2022
1:55 PM
Rabia Imran CV/Biosketch
Not
Applicable
View Lipato
Biosketch
Lipato Biosketch.pdf
0.01
10/28/2022
1:54 PM
Rabia Imran CV/Biosketch
Yes
View Caroline Cobb
(Amey) CV
CV_Cobb_August 2022.docx
0.01
10/28/2022
1:54 PM
Rabia Imran CV/Biosketch
Yes
View Baseline
Discounting
Task - MDT
P3_TASTE_Discounting Task_11.7.2018.pdf
0.01
10/28/2022
1:54 PM
Rabia Imran Research Measure
Yes
View U54 Project 3
Grant Docs
U54_Project 3 only docs.pdf
0.01
10/28/2022
1:53 PM
Rabia Imran Funding Proposal
Not
Applicable
View CSTP Parking
Map
CSTP Parking Map.docx
0.01
10/28/2022
1:52 PM
Rabia Imran Other
Not
Applicable
View Criticare
HR/BP
Manual
Criticare_Vitalcare_506N3_-_Service_manual.pdf 0.01
10/28/2022
1:52 PM
Rabia Imran Other
Not
Applicable
View Expired Air
CO Manual
CO Monitor Manual.pdf
0.01
10/28/2022
1:51 PM
Rabia Imran Other
Not
Applicable

 
Document
Name
Document
VersionDate
Modified
Uploaded
By
Type
Approved
View Information
about Blood
Pressure
BP results P3 flux 8.22.2022.docx
0.01
10/28/2022
1:51 PM
Rabia Imran Study
reminders/communications
Yes
View CSTP
Registry
Consent and
Survey
CSTP Registry Consent Form and Questions.pdf 0.01
10/19/2022
3:27 PM
Caroline
Cobb Amey
Other
Not
Applicable
 
 

HM20025464
View: SF2 - HIPAA
ID: HM20025464
HM20025464 - Caroline Cobb Amey
Effects of Electronic Cigarette Flavors on Abuse Liability in Smokers (P3-Taste)
  
HIPAA
In order for VCUHS to meet HIPAA regulations regarding accounting of disclosures, data retention, and data destruction
requirements for PHI data obtained without patient authorization, members of the study team (including principal investigators)
are directed to consult with VCU Informatics to obtain any VCUHS data. This does not include obtaining data for which the
study team has patient authorization. [VCU Health System Authority and Affiliates Policy COMP-014] 
For data requests, including preparatory to research and research with decedents, submit a request for the desired PHI, or for
a consultation on alternate methods to obtain the data, at https://informatics.vcu.edu.
HIPAA Privacy Board Requirements
       For guidance, see https://www.vcuhealth.org/our-story/who-we-are/compliance-services/compliance-services
1. * Select the source of the Individually Identifiable Health Information. See help text for
definitions.

PHI associated with or derived from (i.e. obtained from or entered into) VCU Health medical records or VCU
Dental Care records

Research Health Information (RHI) created or received by a study and kept solely in study records (e.g.
self reported or the result of research tests and not entered into health records)

PHI associated with or derived from (i.e. obtained from or entered into) a non-VCU HIPAA covered entity’s health
records
 

HM20025464
View: SF2 - Institutional Requirements Complete
ID: HM20025464
HM20025464 - Caroline Cobb Amey
Effects of Electronic Cigarette Flavors on Abuse Liability in Smokers (P3-Taste)
  
Institutional Requirements Complete
Protocol Progress:
w INITIAL SETUP
x BACKGROUND, RATIONALE & GOALS
y RESEARCH PLAN
z CONSENT PLAN
{ RISKS, PRIVACY & CONFIDENTIALITY
| POPULATIONS WITH SPECIAL CONSIDERATIONS
} INSTITUTIONAL REQUIREMENTS
k DOCUMENTS
Click Continue below to go to the next section
 

HM20025464
View: SF2 - Documents
ID: HM20025464
HM20025464 - Caroline Cobb Amey
Effects of Electronic Cigarette Flavors on Abuse Liability in Smokers (P3-Taste)
  
Documents
1. Upload any documents that the VCU IRB will need to conduct a review of this submission:
A list of potential documents is given in the help text.
NOTE: The delete function should only be used if an incorrect document is uploaded or added to the system AND that
document has not been reviewed and approved by the IRB. Do NOT delete documents that the IRB previously
reviewed and approved.
Once you have uploaded a document to RAMS-IRB, any changes to that document (i.e. different
versions of the same document) should be added to the IRB submission by using the Update
button. To provide updated documents, follow these steps:
  - Click the Update button located to the left of the document to be updated.
  - In the Add Document window, click the Choose File or Browse button, select the file you are adding, and
click on the Open button.
  - Click OK to close the Add Document window, and the system will upload the revised document. RAMS-IRB
will automatically provide a version number for the document.
To access previous versions of a document in RAMS-IRB you must use the History link
associated with the document.
- Click the View or Update button located to the left of the document you wish to access.
- In the Add/View Document window, click the "History" hyperlink located to the right of the file name.
- A separate window will open that shows all versions of the document that have been added to RAMS-IRB.
Click on any file name to download and view the document.
 
Document
Name
Document
VersionDate
Modified
Uploaded
By
Type
Approved
View Informed
Consent
P3 TASTE_Informed
Consent_CLEAN_1.29.2024.pdf
0.15
2/20/2024
10:22 AM
Rabia Imran Consent/Assent/Information
Sheet
Yes
View Consent -
Tool
P3TASTE_Consent_Presentation_1.29.2024.pptx 0.06
1/30/2024
1:34 PM
Rabia Imran Consent/Assent/Information
Sheet
Yes
View Social Media
Plan
P3-TASTE Social Media Plan_10.2.2023.docx
0.01
10/2/2023
3:29 PM
Caroline
Cobb Amey
Recruitment/Advertising
Yes
View Social Media
and Craigslist
Ads
P3-TASTE_facebook and craiglist
ads_10.2.2023.docx
0.01
10/2/2023
3:29 PM
Caroline
Cobb Amey
Recruitment/Advertising
Yes
View Substance
Use
Resources
Handout
CSTP Substance Use
Resources_8.11.2023.docx
0.01
8/11/2023
5:11 PM
Caroline
Cobb Amey
Other
Yes
View Subjective
Measures
P3-TASTE-Session Subjective
Measures_CLEAN_08.09.2023.doc
0.03
8/11/2023
5:10 PM
Rabia Imran Research Measure
Yes
View P3 TASTE
Advertisement
for CSTP
Website
P3 TASTE - CSTP Website Study
Description_CLEAN_08.08.2023.docx
0.05
8/11/2023
5:09 PM
Rabia Imran Recruitment/Advertising
Yes
View Presession
Symptom
Questions
P3-Presession symptom Checklist-
CLEAN_08.09.2023.docx
0.05
8/11/2023
5:08 PM
Rabia Imran Research Measure
Yes
View Baseline Self
Report Physio
Measures
P3-TASTE_Baseline forms
All_CLEAN_8.11.2023.docx
0.06
8/11/2023
5:07 PM
Rabia Imran Research Measure
Yes
View Text, Email,
Call Scripts
P3-TASTE_Phone_e-mail_text
scripts_08.09.2023_CLEAN.docx
0.10
8/11/2023
5:06 PM
Rabia Imran Study
reminders/communications
Yes
View Referral
Program Card
Template
P3_Referral program
card_06.02.2023_CLEAN.docx
0.03
6/13/2023
1:48 PM
Rabia Imran Recruitment/Advertising
Yes

 
Document
Name
Document
VersionDate
Modified
Uploaded
By
Type
Approved
View COVID-19
Questions
COVID_Questions_P3_no longer using.docx
0.02
6/13/2023
1:35 PM
Rabia Imran Other
Yes
View P3
Taste_ETM
P3-TASTE_Measures_ETM__no longer
using.docx
0.04
6/13/2023
1:35 PM
Rabia Imran Research Measure
Yes
View Tobacco
Cessation
Resources
Handout
Cessation_handout_RI_04.29.2021.pdf
0.01
2/1/2023
3:32 PM
Caroline
Cobb Amey
Other
Yes
View U54 Grant
Application
Without
Budget
U54 Grant Application BUDGET PAGES
DELETED FOR IRB.pdf
0.01
10/28/2022
2:17 PM
Rabia Imran Funding Proposal
Not
Applicable
View CP-DPT &
DPT
P3-TASTE Drug Purchase Tasks_9.2.2022.docx
0.01
10/28/2022
2:03 PM
Rabia Imran Research Measure
Yes
View CP-DPT &
DPT - Tool
DPT_CDPT presentation_10.28.2022.pptx
0.01
10/28/2022
2:03 PM
Rabia Imran Research Measure
Yes
View Subjective
Measures -
Tool
Subjective Measures
presentation_10.28.2022.pptx
0.01
10/28/2022
2:00 PM
Rabia Imran Research Measure
Yes
View Barnes
Biosketch
P3 Barnes biosketch 06.22.17.FINAL.docx
0.01
10/28/2022
1:55 PM
Rabia Imran CV/Biosketch
Not
Applicable
View Lipato
Biosketch
Lipato Biosketch.pdf
0.01
10/28/2022
1:54 PM
Rabia Imran CV/Biosketch
Yes
View Caroline Cobb
(Amey) CV
CV_Cobb_August 2022.docx
0.01
10/28/2022
1:54 PM
Rabia Imran CV/Biosketch
Yes
View Baseline
Discounting
Task - MDT
P3_TASTE_Discounting Task_11.7.2018.pdf
0.01
10/28/2022
1:54 PM
Rabia Imran Research Measure
Yes
View U54 Project 3
Grant Docs
U54_Project 3 only docs.pdf
0.01
10/28/2022
1:53 PM
Rabia Imran Funding Proposal
Not
Applicable
View CSTP Parking
Map
CSTP Parking Map.docx
0.01
10/28/2022
1:52 PM
Rabia Imran Other
Not
Applicable
View Criticare
HR/BP
Manual
Criticare_Vitalcare_506N3_-_Service_manual.pdf 0.01
10/28/2022
1:52 PM
Rabia Imran Other
Not
Applicable
View Expired Air
CO Manual
CO Monitor Manual.pdf
0.01
10/28/2022
1:51 PM
Rabia Imran Other
Not
Applicable
View Information
about Blood
Pressure
BP results P3 flux 8.22.2022.docx
0.01
10/28/2022
1:51 PM
Rabia Imran Study
reminders/communications
Yes
View CSTP
Registry
Consent and
Survey
CSTP Registry Consent Form and Questions.pdf 0.01
10/19/2022
3:27 PM
Caroline
Cobb Amey
Other
Not
Applicable
 

HM20025464
View: SF2 - Documents Complete
ID: HM20025464
HM20025464 - Caroline Cobb Amey
Effects of Electronic Cigarette Flavors on Abuse Liability in Smokers (P3-Taste)
  
Documents Complete
Protocol Progress:
w INITIAL SETUP
x BACKGROUND, RATIONALE & GOALS
y RESEARCH PLAN
z CONSENT PLAN
{ RISKS, PRIVACY & CONFIDENTIALITY
| POPULATIONS WITH SPECIAL CONSIDERATIONS
} INSTITUTIONAL REQUIREMENTS
~ DOCUMENTS
End of Application
Click Continue below to exit and submit this project
 

HM20025464
View: Bio-Medical Project Drugs
ID: HM20025464
  
Bio-Medical Project Drugs
1. * Drug:
NJOY Ace 2.4% nicotine - Menthol (flavor)
2. * Manufacturer:
NJOY LLC
3. * Select all types that apply:
 

FDA Approved and being used as approved

Marketed Drug/Biologic Exempt from IND

Investigational Drug/Biologic/Supplement used as drug

Supplement

Over the Counter Medication

Other (Drug or Compound Not Listed Above)
4. * Will the doses of drug administered and the dosing schedule match FDA approved labeling: (if
not, include all doses and dosing schedules in the Methods)
 
Yes
No
Not Applicable
5. * Select who holds the Investigational New Drug (IND) application for the drug/biologic:
 
External to VCU Sponsor or Investigator
VCU Sponsor-Investigator
VCU Sponsor who is not the Investigator
Not Required
6. Indicate the drug's IND number, if applicable. If the drug qualifies for IND exemption, enter "IND
Exempt":
  

HM20025464
View: Bio-Medical Project Drugs
ID: HM20025464
  
Bio-Medical Project Drugs
1. * Drug:
Own brand cigarettes
2. * Manufacturer:
Various Manufacturers
3. * Select all types that apply:
 

FDA Approved and being used as approved

Marketed Drug/Biologic Exempt from IND

Investigational Drug/Biologic/Supplement used as drug

Supplement

Over the Counter Medication

Other (Drug or Compound Not Listed Above)
4. * Will the doses of drug administered and the dosing schedule match FDA approved labeling: (if
not, include all doses and dosing schedules in the Methods)
 
Yes
No
Not Applicable
5. * Select who holds the Investigational New Drug (IND) application for the drug/biologic:
 
External to VCU Sponsor or Investigator
VCU Sponsor-Investigator
VCU Sponsor who is not the Investigator
Not Required
6. Indicate the drug's IND number, if applicable. If the drug qualifies for IND exemption, enter "IND
Exempt":
  

HM20025464
View: Bio-Medical Project Drugs
ID: HM20025464
  
Bio-Medical Project Drugs
1. * Drug:
NJOY Ace 2.4% nicotine - Classic Tobacco (flavor)
2. * Manufacturer:
NJOY LLC
3. * Select all types that apply:
 

FDA Approved and being used as approved

Marketed Drug/Biologic Exempt from IND

Investigational Drug/Biologic/Supplement used as drug

Supplement

Over the Counter Medication

Other (Drug or Compound Not Listed Above)
4. * Will the doses of drug administered and the dosing schedule match FDA approved labeling: (if
not, include all doses and dosing schedules in the Methods)
 
Yes
No
Not Applicable
5. * Select who holds the Investigational New Drug (IND) application for the drug/biologic:
 
External to VCU Sponsor or Investigator
VCU Sponsor-Investigator
VCU Sponsor who is not the Investigator
Not Required
6. Indicate the drug's IND number, if applicable. If the drug qualifies for IND exemption, enter "IND
Exempt":
  

HM20025464
View: Bio-Medical Project Drugs
ID: HM20025464
  
Bio-Medical Project Drugs
1. * Drug:
NJOY Ace 5.0% nicotine - Menthol (flavor)
2. * Manufacturer:
NJOY LLC
3. * Select all types that apply:
 

FDA Approved and being used as approved

Marketed Drug/Biologic Exempt from IND

Investigational Drug/Biologic/Supplement used as drug

Supplement

Over the Counter Medication

Other (Drug or Compound Not Listed Above)
4. * Will the doses of drug administered and the dosing schedule match FDA approved labeling: (if
not, include all doses and dosing schedules in the Methods)
 
Yes
No
Not Applicable
5. * Select who holds the Investigational New Drug (IND) application for the drug/biologic:
 
External to VCU Sponsor or Investigator
VCU Sponsor-Investigator
VCU Sponsor who is not the Investigator
Not Required
6. Indicate the drug's IND number, if applicable. If the drug qualifies for IND exemption, enter "IND
Exempt":
  

HM20025464
View: Bio-Medical Project Drugs
ID: HM20025464
  
Bio-Medical Project Drugs
1. * Drug:
NJOY Ace 5.0% nicotine - Classic Tobacco (flavor)
2. * Manufacturer:
NJOY LLC
3. * Select all types that apply:
 

FDA Approved and being used as approved

Marketed Drug/Biologic Exempt from IND

Investigational Drug/Biologic/Supplement used as drug

Supplement

Over the Counter Medication

Other (Drug or Compound Not Listed Above)
4. * Will the doses of drug administered and the dosing schedule match FDA approved labeling: (if
not, include all doses and dosing schedules in the Methods)
 
Yes
No
Not Applicable
5. * Select who holds the Investigational New Drug (IND) application for the drug/biologic:
 
External to VCU Sponsor or Investigator
VCU Sponsor-Investigator
VCU Sponsor who is not the Investigator
Not Required
6. Indicate the drug's IND number, if applicable. If the drug qualifies for IND exemption, enter "IND
Exempt":
  

HM20025464
View: Bio-Medical Project Drugs
ID: HM20025464
  
Bio-Medical Project Drugs
1. * Drug:
NJOY Daily 6% nicotine - Menthol (flavor)
2. * Manufacturer:
NJOY LLC
3. * Select all types that apply:
 

FDA Approved and being used as approved

Marketed Drug/Biologic Exempt from IND

Investigational Drug/Biologic/Supplement used as drug

Supplement

Over the Counter Medication

Other (Drug or Compound Not Listed Above)
4. * Will the doses of drug administered and the dosing schedule match FDA approved labeling: (if
not, include all doses and dosing schedules in the Methods)
 
Yes
No
Not Applicable
5. * Select who holds the Investigational New Drug (IND) application for the drug/biologic:
 
External to VCU Sponsor or Investigator
VCU Sponsor-Investigator
VCU Sponsor who is not the Investigator
Not Required
6. Indicate the drug's IND number, if applicable. If the drug qualifies for IND exemption, enter "IND
Exempt":
  

HM20025464
View: Bio-Medical Project Drugs
ID: HM20025464
  
Bio-Medical Project Drugs
1. * Drug:
NJOY Daily 6% nicotine - Extra Rich Tobacco (flavor)
2. * Manufacturer:
NJOY LLC
3. * Select all types that apply:
 

FDA Approved and being used as approved

Marketed Drug/Biologic Exempt from IND

Investigational Drug/Biologic/Supplement used as drug

Supplement

Over the Counter Medication

Other (Drug or Compound Not Listed Above)
4. * Will the doses of drug administered and the dosing schedule match FDA approved labeling: (if
not, include all doses and dosing schedules in the Methods)
 
Yes
No
Not Applicable
5. * Select who holds the Investigational New Drug (IND) application for the drug/biologic:
 
External to VCU Sponsor or Investigator
VCU Sponsor-Investigator
VCU Sponsor who is not the Investigator
Not Required
6. Indicate the drug's IND number, if applicable. If the drug qualifies for IND exemption, enter "IND
Exempt":
  

HM20025464
View: SF_IRB_ConsentPlan_Groups
ID: HM20025464
  
Consent Groups
1. * Enter a descriptive name for this consent / assent group:
All participants
2. * Select all that apply to this consent / assent group:
 
Name

Signed Consent by Participant

Signed Parent/Guardian Permission or Legally Authorized Representative Consent

Signed Assent by Child or Decisionally Impaired Adult

Verbal/Other Indication of Assent by Child or Decisionally Impaired Adult

Short Form Consent (limited applicability)

None of the Above (select waiver below)
3. * Select all electronic signature platforms that apply to this consent / assent group:

Not using electronic signature platforms

DocuSign Part 11 (FDA regulated studies)

DocuSign (standard platform for non-FDA regulated studies)

REDCap e-Consent

iMedConsent (Veterans Affairs studies)

Other electronic signature platform
4. If Other is selected, explain:
5. * Select any waivers that apply to this consent / assent group:
 

No Waivers Requested

Waiver of All Consent or Some Elements in Consent Form

Waiver of Parental Permission or Legally Authorized Representative Consent

Waiver of All Assent by Child or Decisionally Impaired Adult

Waiver of Signature on Consent/Permission Forms (waiver of documentation of consent)

Exception from Informed Consent (for emergency research only)
6. * Select all study team role(s) that will obtain consent / assent from this group:
 

Principal Investigator

Co/Sub-Investigator

Medical or Psychological Responsible Investigator

 

Lead Student/Trainee Investigator (leading their own project)

Research Coordinator

Research Nurse

Consultant

Research Assistant

Pharmacist

Statistician

Regulatory Coordinator

Trainee/Student(working on project)

Other

N/A: Requesting Waiver of Consent
7. * Describe the consent procedures used for this group. Address each point below:
        - When and where consent will occur
        - What will be covered during the consent discussion 
        - How the consent discussion will occur (e.g. in-person, phone, video conference)
        - How you will reconfirm consent on an ongoing basis, if applicable
Consent will be obtained in a private room located at the Center for the Study of Tobacco Products (CSTP). Consent
will be obtained at in-person screening. Consent will be on-going and assumed when a participant makes and
completes follow up appointments. Participants are read the consent form aloud via a pre-recorded voice-over
Powerpoint presentation/video or in real-time by a staff member and encouraged to ask questions before signing. At
any point participants can chose not to continue with the various levels of screening for this study (the online/telephone
consent/screening and in-person consent/screening).
8. * Select the processes for minimizing any potential perception of undue influence to
participate, particularly when there is a pre-existing relationship between the participant and
the researcher (e.g. treatment provider/patient; instructor/student; supervisor/employee, etc.):

Having a 3rd person (family/friends, another study team member, etc.) present during the consent / assent
discussion

Having an independent advocate (e.g. advocate for decisionally impaired adults, wards) present during the
consent / assent discussion

Removing physical symbols of authority like white coats or police badges

Sitting down beside the participant instead of standing over them

If obtaining consent / assent in a clinical setting, letting patients sit instead of lie down (if they are able to)

Moving to a more neutral location like a conference room

Obtaining consent / assent after other services/interactions have been completed (e.g. after school or the clinic
visit)

Having a mandatory wait period for the participant to go home and think before they sign consent /assent

Sharing the consent / assent discussion between two people (i.e. a clinician might be the best person to explain
study procedures and risks, but then they could step out and let a research assistant finish the consent process)

Other protection(s) not listed here – describe below

N/A: Requesting Waiver of Consent
9. * Describe the other ways the study team will minimize any potential perception of undue
influence to participate:
The consent form emphasizes the voluntary nature of the research study and staff are well-trained to ensure
individuals understand their rights as a research participant. A copy of the consent form is given to all potential

participants to take with them. They are informed that that they can go home and/or discuss their participation with
others prior to signing the form.
10. * How much time will participants be given to make a decision:
Participants will be given as much time as necessary to consider the research study and consent form before deciding
whether or not to participate.
11. If applicable, describe the procedures for consenting children upon entering adulthood or
participants who are no longer decisionally impaired:
  

HM20025464
View: Personnel
ID: HM20025464
  
Personnel
1. * Name:
Caroline Cobb Amey
2. * Is this individual a 'COI Investigator'?
Conflict of Interest (COI) Investigator - any individual who has a level of independence and responsibility
comparable to that of the PI for the design, conduct, or reporting of research.
Anyone designated as a COI Investigator must have a current Financial Interest Report (FIR) in the Activity and
Interest Reporting System (AIRS) (https://airs.research.vcu.edu).
  Yes
No
3. * Roles:
 

Principal Investigator

Co/Sub-Investigator

Medical or Psychological Responsible Investigator

Lead Student/Trainee Investigator (leading their own project)

Research Coordinator

Research Nurse

Consultant

Research Assistant

Pharmacist

Statistician

Regulatory Coordinator

Trainee/Student(working on project)

Other
4. * Study related responsibilities:
 

Study Design

Data Collection - Lab

Data Collection - Clinical

Data Collection - Interviews/Surveys

 

Data Collection - Direct Observation

Clinical Services

Intervention Services

Data Entry

Data Coding

Data Management

Data Analysis

Project Coordination

Participant Identification

Participant Recruitment

Participant Consent

Regulatory Management

Other
5. * The PI certifies that if this individual will conduct any clinical activities as part of this study,
the individual is appropriately credentialed and privileged to practice within the institution
where the research will be conducted:
Individual has no clinical responsibilities
6. * Qualifications to carry out study related responsibilities: (you may select multiple answers)
 

Education and/or Professional Preparation

Experience - Research

Experience - Clinical

Experience - Related Skills

Trainee

Student

Other
7. Additional or Emergency Phone:
  

HM20025464
View: Personnel
ID: HM20025464
  
Personnel
1. * Name:
Andrew Barnes
2. * Is this individual a 'COI Investigator'?
Conflict of Interest (COI) Investigator - any individual who has a level of independence and responsibility
comparable to that of the PI for the design, conduct, or reporting of research.
Anyone designated as a COI Investigator must have a current Financial Interest Report (FIR) in the Activity and
Interest Reporting System (AIRS) (https://airs.research.vcu.edu).
  Yes
No
3. * Roles:
 

Principal Investigator

Co/Sub-Investigator

Medical or Psychological Responsible Investigator

Lead Student/Trainee Investigator (leading their own project)

Research Coordinator

Research Nurse

Consultant

Research Assistant

Pharmacist

Statistician

Regulatory Coordinator

Trainee/Student(working on project)

Other
4. * Study related responsibilities:
 

Study Design

Data Collection - Lab

Data Collection - Clinical

Data Collection - Interviews/Surveys

 

Data Collection - Direct Observation

Clinical Services

Intervention Services

Data Entry

Data Coding

Data Management

Data Analysis

Project Coordination

Participant Identification

Participant Recruitment

Participant Consent

Regulatory Management

Other
5. * The PI certifies that if this individual will conduct any clinical activities as part of this study,
the individual is appropriately credentialed and privileged to practice within the institution
where the research will be conducted:
Individual has no clinical responsibilities
6. * Qualifications to carry out study related responsibilities: (you may select multiple answers)
 

Education and/or Professional Preparation

Experience - Research

Experience - Clinical

Experience - Related Skills

Trainee

Student

Other
7. Additional or Emergency Phone:
  

HM20025464
View: Personnel
ID: HM20025464
  
Personnel
1. * Name:
Alison Breland
2. * Is this individual a 'COI Investigator'?
Conflict of Interest (COI) Investigator - any individual who has a level of independence and responsibility
comparable to that of the PI for the design, conduct, or reporting of research.
Anyone designated as a COI Investigator must have a current Financial Interest Report (FIR) in the Activity and
Interest Reporting System (AIRS) (https://airs.research.vcu.edu).
  Yes
No
3. * Roles:
 

Principal Investigator

Co/Sub-Investigator

Medical or Psychological Responsible Investigator

Lead Student/Trainee Investigator (leading their own project)

Research Coordinator

Research Nurse

Consultant

Research Assistant

Pharmacist

Statistician

Regulatory Coordinator

Trainee/Student(working on project)

Other
4. * Study related responsibilities:
 

Study Design

Data Collection - Lab

Data Collection - Clinical

Data Collection - Interviews/Surveys

 

Data Collection - Direct Observation

Clinical Services

Intervention Services

Data Entry

Data Coding

Data Management

Data Analysis

Project Coordination

Participant Identification

Participant Recruitment

Participant Consent

Regulatory Management

Other
5. * The PI certifies that if this individual will conduct any clinical activities as part of this study,
the individual is appropriately credentialed and privileged to practice within the institution
where the research will be conducted:
Individual has no clinical responsibilities
6. * Qualifications to carry out study related responsibilities: (you may select multiple answers)
 

Education and/or Professional Preparation

Experience - Research

Experience - Clinical

Experience - Related Skills

Trainee

Student

Other
7. Additional or Emergency Phone:
  

HM20025464
View: Personnel
ID: HM20025464
  
Personnel
1. * Name:
Thomas Eissenberg
2. * Is this individual a 'COI Investigator'?
Conflict of Interest (COI) Investigator - any individual who has a level of independence and responsibility
comparable to that of the PI for the design, conduct, or reporting of research.
Anyone designated as a COI Investigator must have a current Financial Interest Report (FIR) in the Activity and
Interest Reporting System (AIRS) (https://airs.research.vcu.edu).
  Yes
No
3. * Roles:
 

Principal Investigator

Co/Sub-Investigator

Medical or Psychological Responsible Investigator

Lead Student/Trainee Investigator (leading their own project)

Research Coordinator

Research Nurse

Consultant

Research Assistant

Pharmacist

Statistician

Regulatory Coordinator

Trainee/Student(working on project)

Other
4. * Study related responsibilities:
 

Study Design

Data Collection - Lab

Data Collection - Clinical

Data Collection - Interviews/Surveys

 

Data Collection - Direct Observation

Clinical Services

Intervention Services

Data Entry

Data Coding

Data Management

Data Analysis

Project Coordination

Participant Identification

Participant Recruitment

Participant Consent

Regulatory Management

Other
5. * The PI certifies that if this individual will conduct any clinical activities as part of this study,
the individual is appropriately credentialed and privileged to practice within the institution
where the research will be conducted:
Individual has no clinical responsibilities
6. * Qualifications to carry out study related responsibilities: (you may select multiple answers)
 

Education and/or Professional Preparation

Experience - Research

Experience - Clinical

Experience - Related Skills

Trainee

Student

Other
7. Additional or Emergency Phone:
  

HM20025464
View: Personnel
ID: HM20025464
  
Personnel
1. * Name:
Thokozeni Lipato
2. * Is this individual a 'COI Investigator'?
Conflict of Interest (COI) Investigator - any individual who has a level of independence and responsibility
comparable to that of the PI for the design, conduct, or reporting of research.
Anyone designated as a COI Investigator must have a current Financial Interest Report (FIR) in the Activity and
Interest Reporting System (AIRS) (https://airs.research.vcu.edu).
  Yes
No
3. * Roles:
 

Principal Investigator

Co/Sub-Investigator

Medical or Psychological Responsible Investigator

Lead Student/Trainee Investigator (leading their own project)

Research Coordinator

Research Nurse

Consultant

Research Assistant

Pharmacist

Statistician

Regulatory Coordinator

Trainee/Student(working on project)

Other
4. * Study related responsibilities:
 

Study Design

Data Collection - Lab

Data Collection - Clinical

Data Collection - Interviews/Surveys

 

Data Collection - Direct Observation

Clinical Services

Intervention Services

Data Entry

Data Coding

Data Management

Data Analysis

Project Coordination

Participant Identification

Participant Recruitment

Participant Consent

Regulatory Management

Other
5. * The PI certifies that if this individual will conduct any clinical activities as part of this study,
the individual is appropriately credentialed and privileged to practice within the institution
where the research will be conducted:
Yes
6. * Qualifications to carry out study related responsibilities: (you may select multiple answers)
 

Education and/or Professional Preparation

Experience - Research

Experience - Clinical

Experience - Related Skills

Trainee

Student

Other
7. Additional or Emergency Phone:
  

HM20025464
View: Personnel
ID: HM20025464
  
Personnel
1. * Name:
Nicoleta Gaitan
2. * Is this individual a 'COI Investigator'?
Conflict of Interest (COI) Investigator - any individual who has a level of independence and responsibility
comparable to that of the PI for the design, conduct, or reporting of research.
Anyone designated as a COI Investigator must have a current Financial Interest Report (FIR) in the Activity and
Interest Reporting System (AIRS) (https://airs.research.vcu.edu).
  Yes
No
3. * Roles:
 

Principal Investigator

Co/Sub-Investigator

Medical or Psychological Responsible Investigator

Lead Student/Trainee Investigator (leading their own project)

Research Coordinator

Research Nurse

Consultant

Research Assistant

Pharmacist

Statistician

Regulatory Coordinator

Trainee/Student(working on project)

Other
4. * Study related responsibilities:
 

Study Design

Data Collection - Lab

Data Collection - Clinical

Data Collection - Interviews/Surveys

 

Data Collection - Direct Observation

Clinical Services

Intervention Services

Data Entry

Data Coding

Data Management

Data Analysis

Project Coordination

Participant Identification

Participant Recruitment

Participant Consent

Regulatory Management

Other
5. * If other responsibility is selected, explain:
Provide medical safety supervision/consultation
6. * The PI certifies that if this individual will conduct any clinical activities as part of this study,
the individual is appropriately credentialed and privileged to practice within the institution
where the research will be conducted:
Yes
7. * Qualifications to carry out study related responsibilities: (you may select multiple answers)
 

Education and/or Professional Preparation

Experience - Research

Experience - Clinical

Experience - Related Skills

Trainee

Student

Other
8. Additional or Emergency Phone:
  

HM20025464
View: Personnel
ID: HM20025464
  
Personnel
1. * Name:
Rabia Imran
2. * Is this individual a 'COI Investigator'?
Conflict of Interest (COI) Investigator - any individual who has a level of independence and responsibility
comparable to that of the PI for the design, conduct, or reporting of research.
Anyone designated as a COI Investigator must have a current Financial Interest Report (FIR) in the Activity and
Interest Reporting System (AIRS) (https://airs.research.vcu.edu).
  Yes
No
3. * Roles:
 

Principal Investigator

Co/Sub-Investigator

Medical or Psychological Responsible Investigator

Lead Student/Trainee Investigator (leading their own project)

Research Coordinator

Research Nurse

Consultant

Research Assistant

Pharmacist

Statistician

Regulatory Coordinator

Trainee/Student(working on project)

Other
4. * Study related responsibilities:
 

Study Design

Data Collection - Lab

Data Collection - Clinical

Data Collection - Interviews/Surveys

 

Data Collection - Direct Observation

Clinical Services

Intervention Services

Data Entry

Data Coding

Data Management

Data Analysis

Project Coordination

Participant Identification

Participant Recruitment

Participant Consent

Regulatory Management

Other
5. * The PI certifies that if this individual will conduct any clinical activities as part of this study,
the individual is appropriately credentialed and privileged to practice within the institution
where the research will be conducted:
Individual has no clinical responsibilities
6. * Qualifications to carry out study related responsibilities: (you may select multiple answers)
 

Education and/or Professional Preparation

Experience - Research

Experience - Clinical

Experience - Related Skills

Trainee

Student

Other
7. Additional or Emergency Phone:
  

HM20025464
View: Personnel
ID: HM20025464
  
Personnel
1. * Name:
Augustus White
2. * Is this individual a 'COI Investigator'?
Conflict of Interest (COI) Investigator - any individual who has a level of independence and responsibility
comparable to that of the PI for the design, conduct, or reporting of research.
Anyone designated as a COI Investigator must have a current Financial Interest Report (FIR) in the Activity and
Interest Reporting System (AIRS) (https://airs.research.vcu.edu).
  Yes
No
3. * Roles:
 

Principal Investigator

Co/Sub-Investigator

Medical or Psychological Responsible Investigator

Lead Student/Trainee Investigator (leading their own project)

Research Coordinator

Research Nurse

Consultant

Research Assistant

Pharmacist

Statistician

Regulatory Coordinator

Trainee/Student(working on project)

Other
4. * Study related responsibilities:
 

Study Design

Data Collection - Lab

Data Collection - Clinical

Data Collection - Interviews/Surveys

 

Data Collection - Direct Observation

Clinical Services

Intervention Services

Data Entry

Data Coding

Data Management

Data Analysis

Project Coordination

Participant Identification

Participant Recruitment

Participant Consent

Regulatory Management

Other
5. * The PI certifies that if this individual will conduct any clinical activities as part of this study,
the individual is appropriately credentialed and privileged to practice within the institution
where the research will be conducted:
Individual has no clinical responsibilities
6. * Qualifications to carry out study related responsibilities: (you may select multiple answers)
 

Education and/or Professional Preparation

Experience - Research

Experience - Clinical

Experience - Related Skills

Trainee

Student

Other
7. Additional or Emergency Phone:
  

HM20025464
View: Personnel
ID: HM20025464
  
Personnel
1. * Name:
Rose Bono
2. * Is this individual a 'COI Investigator'?
Conflict of Interest (COI) Investigator - any individual who has a level of independence and responsibility
comparable to that of the PI for the design, conduct, or reporting of research.
Anyone designated as a COI Investigator must have a current Financial Interest Report (FIR) in the Activity and
Interest Reporting System (AIRS) (https://airs.research.vcu.edu).
  Yes
No
3. * Roles:
 

Principal Investigator

Co/Sub-Investigator

Medical or Psychological Responsible Investigator

Lead Student/Trainee Investigator (leading their own project)

Research Coordinator

Research Nurse

Consultant

Research Assistant

Pharmacist

Statistician

Regulatory Coordinator

Trainee/Student(working on project)

Other
4. * Study related responsibilities:
 

Study Design

Data Collection - Lab

Data Collection - Clinical

Data Collection - Interviews/Surveys

 

Data Collection - Direct Observation

Clinical Services

Intervention Services

Data Entry

Data Coding

Data Management

Data Analysis

Project Coordination

Participant Identification

Participant Recruitment

Participant Consent

Regulatory Management

Other
5. * The PI certifies that if this individual will conduct any clinical activities as part of this study,
the individual is appropriately credentialed and privileged to practice within the institution
where the research will be conducted:
Individual has no clinical responsibilities
6. * Qualifications to carry out study related responsibilities: (you may select multiple answers)
 

Education and/or Professional Preparation

Experience - Research

Experience - Clinical

Experience - Related Skills

Trainee

Student

Other
7. Additional or Emergency Phone:
  

HM20025464
View: Personnel
ID: HM20025464
  
Personnel
1. * Name:
Mary Bridgman
2. * Is this individual a 'COI Investigator'?
Conflict of Interest (COI) Investigator - any individual who has a level of independence and responsibility
comparable to that of the PI for the design, conduct, or reporting of research.
Anyone designated as a COI Investigator must have a current Financial Interest Report (FIR) in the Activity and
Interest Reporting System (AIRS) (https://airs.research.vcu.edu).
  Yes
No
3. * Roles:
 

Principal Investigator

Co/Sub-Investigator

Medical or Psychological Responsible Investigator

Lead Student/Trainee Investigator (leading their own project)

Research Coordinator

Research Nurse

Consultant

Research Assistant

Pharmacist

Statistician

Regulatory Coordinator

Trainee/Student(working on project)

Other
4. * Study related responsibilities:
 

Study Design

Data Collection - Lab

Data Collection - Clinical

Data Collection - Interviews/Surveys

 

Data Collection - Direct Observation

Clinical Services

Intervention Services

Data Entry

Data Coding

Data Management

Data Analysis

Project Coordination

Participant Identification

Participant Recruitment

Participant Consent

Regulatory Management

Other
5. * The PI certifies that if this individual will conduct any clinical activities as part of this study,
the individual is appropriately credentialed and privileged to practice within the institution
where the research will be conducted:
Yes
6. * Qualifications to carry out study related responsibilities: (you may select multiple answers)
 

Education and/or Professional Preparation

Experience - Research

Experience - Clinical

Experience - Related Skills

Trainee

Student

Other
7. Additional or Emergency Phone:
  

HM20025464
View: Personnel
ID: HM20025464
  
Personnel
1. * Name:
Melody Falter
2. * Is this individual a 'COI Investigator'?
Conflict of Interest (COI) Investigator - any individual who has a level of independence and responsibility
comparable to that of the PI for the design, conduct, or reporting of research.
Anyone designated as a COI Investigator must have a current Financial Interest Report (FIR) in the Activity and
Interest Reporting System (AIRS) (https://airs.research.vcu.edu).
  Yes
No
3. * Roles:
 

Principal Investigator

Co/Sub-Investigator

Medical or Psychological Responsible Investigator

Lead Student/Trainee Investigator (leading their own project)

Research Coordinator

Research Nurse

Consultant

Research Assistant

Pharmacist

Statistician

Regulatory Coordinator

Trainee/Student(working on project)

Other
4. * Study related responsibilities:
 

Study Design

Data Collection - Lab

Data Collection - Clinical

Data Collection - Interviews/Surveys

 

Data Collection - Direct Observation

Clinical Services

Intervention Services

Data Entry

Data Coding

Data Management

Data Analysis

Project Coordination

Participant Identification

Participant Recruitment

Participant Consent

Regulatory Management

Other
5. * The PI certifies that if this individual will conduct any clinical activities as part of this study,
the individual is appropriately credentialed and privileged to practice within the institution
where the research will be conducted:
Individual has no clinical responsibilities
6. * Qualifications to carry out study related responsibilities: (you may select multiple answers)
 

Education and/or Professional Preparation

Experience - Research

Experience - Clinical

Experience - Related Skills

Trainee

Student

Other
7. Additional or Emergency Phone:
  

HM20025464
View: Personnel
ID: HM20025464
  
Personnel
1. * Name:
Carrico
2. * Is this individual a 'COI Investigator'?
Conflict of Interest (COI) Investigator - any individual who has a level of independence and responsibility
comparable to that of the PI for the design, conduct, or reporting of research.
Anyone designated as a COI Investigator must have a current Financial Interest Report (FIR) in the Activity and
Interest Reporting System (AIRS) (https://airs.research.vcu.edu).
  Yes
No
3. * Roles:
 

Principal Investigator

Co/Sub-Investigator

Medical or Psychological Responsible Investigator

Lead Student/Trainee Investigator (leading their own project)

Research Coordinator

Research Nurse

Consultant

Research Assistant

Pharmacist

Statistician

Regulatory Coordinator

Trainee/Student(working on project)

Other
4. * Study related responsibilities:
 

Study Design

Data Collection - Lab

Data Collection - Clinical

Data Collection - Interviews/Surveys

 

Data Collection - Direct Observation

Clinical Services

Intervention Services

Data Entry

Data Coding

Data Management

Data Analysis

Project Coordination

Participant Identification

Participant Recruitment

Participant Consent

Regulatory Management

Other
5. * The PI certifies that if this individual will conduct any clinical activities as part of this study,
the individual is appropriately credentialed and privileged to practice within the institution
where the research will be conducted:
Individual has no clinical responsibilities
6. * Qualifications to carry out study related responsibilities: (you may select multiple answers)
 

Education and/or Professional Preparation

Experience - Research

Experience - Clinical

Experience - Related Skills

Trainee

Student

Other
7. Additional or Emergency Phone:
  

HM20025464
View: Personnel
ID: HM20025464
  
Personnel
1. * Name:
Elizabeth Ogunleye
2. * Is this individual a 'COI Investigator'?
Conflict of Interest (COI) Investigator - any individual who has a level of independence and responsibility
comparable to that of the PI for the design, conduct, or reporting of research.
Anyone designated as a COI Investigator must have a current Financial Interest Report (FIR) in the Activity and
Interest Reporting System (AIRS) (https://airs.research.vcu.edu).
  Yes
No
3. * Roles:
 

Principal Investigator

Co/Sub-Investigator

Medical or Psychological Responsible Investigator

Lead Student/Trainee Investigator (leading their own project)

Research Coordinator

Research Nurse

Consultant

Research Assistant

Pharmacist

Statistician

Regulatory Coordinator

Trainee/Student(working on project)

Other
4. * Study related responsibilities:
 

Study Design

Data Collection - Lab

Data Collection - Clinical

Data Collection - Interviews/Surveys

 

Data Collection - Direct Observation

Clinical Services

Intervention Services

Data Entry

Data Coding

Data Management

Data Analysis

Project Coordination

Participant Identification

Participant Recruitment

Participant Consent

Regulatory Management

Other
5. * The PI certifies that if this individual will conduct any clinical activities as part of this study,
the individual is appropriately credentialed and privileged to practice within the institution
where the research will be conducted:
Individual has no clinical responsibilities
6. * Qualifications to carry out study related responsibilities: (you may select multiple answers)
 

Education and/or Professional Preparation

Experience - Research

Experience - Clinical

Experience - Related Skills

Trainee

Student

Other
7. Additional or Emergency Phone:
  

HM20025464
View: SF_IRB_Summary_Document
ID: HM20025464
Add Document
1. * Document Name:
Informed Consent
2. * Type:
Consent/Assent/Information Sheet
3. * File:

P3 TASTE_Informed Consent_CLEAN_1.29.2024.pdf(0.15)   
 

HM20025464
View: SF_IRB_Summary_Document
ID: HM20025464
Add Document
1. * Document Name:
Consent - Tool
2. * Type:
Consent/Assent/Information Sheet
3. * File:
P3TASTE_Consent_Presentation_1.29.2024.pptx(0.06)   
 

HM20025464
View: SF_IRB_Summary_Document
ID: HM20025464
Add Document
1. * Document Name:
Social Media Plan
2. * Type:
Recruitment/Advertising
3. * File:
P3-TASTE Social Media Plan_10.2.2023.docx(0.01)   
 

HM20025464
View: SF_IRB_Summary_Document
ID: HM20025464
Add Document
1. * Document Name:
Social Media and Craigslist Ads
2. * Type:
Recruitment/Advertising
3. * File:
P3-TASTE_facebook and craiglist ads_10.2.2023.docx(0.01)   
 

HM20025464
View: SF_IRB_Summary_Document
ID: HM20025464
Add Document
1. * Document Name:
Substance Use Resources Handout
2. * Type:
Other
3. * File:
CSTP Substance Use Resources_8.11.2023.docx(0.01)   
 

HM20025464
View: SF_IRB_Summary_Document
ID: HM20025464
Add Document
1. * Document Name:
Subjective Measures
2. * Type:
Research Measure
3. * File:
P3-TASTE-Session Subjective Measures_CLEAN_08.09.2023.doc(0.03)   
 

HM20025464
View: SF_IRB_Summary_Document
ID: HM20025464
Add Document
1. * Document Name:
P3 TASTE Advertisement for CSTP Website
2. * Type:
Recruitment/Advertising
3. * File:
P3 TASTE - CSTP Website Study Description_CLEAN_08.08.2023.docx(0.05)   
 

HM20025464
View: SF_IRB_Summary_Document
ID: HM20025464
Add Document
1. * Document Name:
Presession Symptom Questions
2. * Type:
Research Measure
3. * File:
P3-Presession symptom Checklist-CLEAN_08.09.2023.docx(0.05)   
 

HM20025464
View: SF_IRB_Summary_Document
ID: HM20025464
Add Document
1. * Document Name:
Baseline Self Report Physio Measures
2. * Type:
Research Measure
3. * File:
P3-TASTE_Baseline forms All_CLEAN_8.11.2023.docx(0.06)   
 

HM20025464
View: SF_IRB_Summary_Document
ID: HM20025464
Add Document
1. * Document Name:
Text, Email, Call Scripts
2. * Type:
Study reminders/communications
3. * File:
P3-TASTE_Phone_e-mail_text scripts_08.09.2023_CLEAN.docx(0.10)   
 

HM20025464
View: SF_IRB_Summary_Document
ID: HM20025464
Add Document
1. * Document Name:
Referral Program Card Template
2. * Type:
Recruitment/Advertising
3. * File:
P3_Referral program card_06.02.2023_CLEAN.docx(0.03)   
 

HM20025464
View: SF_IRB_Summary_Document
ID: HM20025464
Add Document
1. * Document Name:
COVID-19 Questions
2. * Type:
Other
3. * File:
COVID_Questions_P3_no longer using.docx(0.02)   
 

HM20025464
View: SF_IRB_Summary_Document
ID: HM20025464
Add Document
1. * Document Name:
P3 Taste_ETM
2. * Type:
Research Measure
3. * File:
P3-TASTE_Measures_ETM__no longer using.docx(0.04)   
 

HM20025464
View: SF_IRB_Summary_Document
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Overall Research Strategy. In 2009, FDA began regulating some tobacco products and, in 2016, extended its 
regulatory authority to others, including electronic cigarettes (ECIGs). ECIGs heat a liquid that usually contains 
nicotine; users inhale the resulting aerosol. Regulating tobacco products is challenging, in part because a 
potential health-promoting regulation can have unintended consequences that impact public health negatively. 
For example, requiring “tar” and nicotine yields on cigarette packs was intended to provide health-promoting 
information to smokers, but drove some of them to switch to “low yield” cigarettes instead of quitting smoking, 
thus increasing their risk of tobacco-caused disease (NCI, 2001). As FDA considers future regulatory actions 
on the variety of products now under its jurisdiction, it may benefit from data-driven models that allow it to 
predict efficiently and accurately the population-level consequences of the potential action it is considering. For 
this reason, the Center for the Study of Tobacco Products (CSTP) proposes four projects with an integrative 
theme of impact analysis, drawing on our established expertise in the scientific domains of tobacco product 
toxicity, user behavior, and addiction/abuse liability. Our vision is to provide FDA with tools that can be used to 
guide regulation development. Importantly, to realize this vision, we do not require foreknowledge of potential 
FDA regulatory action or any tobacco regulatory changes. Rather, our approach involves identifying three 
potential regulatory actions (described below) and then examining hypotheses about those actions under the 
controlled conditions of Projects 1-3. Results will be used to generate population-level predictions about 
current ECIG user behavior, and Project 4 will use a prospective cohort survey to test those predictions at the 
population level. We also propose an Administrative Core, a Career Enhancement Core, and a Contextual 
Knowledge Core that will inform Projects 1-4 (see “Administrative Structure”, Fig 1, in Administrative Core). 
A. Overall Significance. FDA’s authority to regulate tobacco products arises from the Family Smoking 
Prevention and Tobacco Control Act that states that a primary goal of tobacco regulation is to protect public 
health. This “public health standard” requires FDA to consider how regulation will influence the risks and 
benefits to tobacco product users and non-users. Among other things, FDA must be cognizant of regulatory 
impact on the likelihood of cessation and transitions across tobacco products for current users, and the 
likelihood of initiation of tobacco use among non-users. These issues are relevant to all tobacco products, and 
particularly salient for ECIGs as their popularity increases. For example, among US high school students, in 
whom past 30-day ECIG use was 16% in 2015 – up 900% from 2011 – ECIGs are more popular than tobacco 
cigarettes (USDHHS, 2016). Among young adults ages 18-24, ECIG prevalence is 13% (USDHHS, 2016) and 
they are as common among never smokers as among current smokers (Schoenborn & Gindi, 2016). As the 
Surgeon General noted, “E-cigarette use among U.S. youth and young adults is now a major public health 
concern” (USDHHS, 2016, p. vii). Addressing this public health concern through regulation will be challenging 
for at least two reasons. First, ECIGs are a class of products that evolve constantly and vary greatly in many 
characteristics, such as liquid nicotine concentration, device power, and liquid flavors (USDHHS, 2016). These 
characteristics can influence ECIG effects including toxicant emissions (e.g., Breland et al., 2017) and also can 
influence ECIG abuse liability (i.e., increased likelihood of persistent use and dependence; Carter et al., 2009). 
Second, ECIG user behavior is variable. Puff behavior (i.e., puff topography, including puff number and 
duration) helps to determine the amount nicotine delivered to the user and thus ECIG subjective effects (e.g., 
Hiler et al., in press). Potential FDA regulatory action intended to influence ECIG effects in users and initiation 
in non-users must therefore account for variability in product characteristics and user behavior.  
If FDA is to understand how tobacco product regulation will influence the risks and benefits to users and non-
users, it may benefit from robust scientific methods that predict how variability in product characteristics and 
user behavior will influence the impact of regulatory action. To understand the benefit of predicting regulatory 
impact, consider the European Union’s (EU’s) Tobacco Products Directive 2014/40/EU that limits ECIG liquids 
to no more than 20 mg/ml nicotine to allow “for a delivery of nicotine that is comparable to the permitted dose 
of nicotine derived from a standard cigarette…”. (http://ec.europa.eu/health/tobacco/products_en). The 
intended consequence of this directive is clear: limiting liquid concentration to ≤20mg/ml is supposed to limit 
nicotine delivery to the user such that delivery does not exceed that of a tobacco cigarette. However, the 
directive does not account for variability in product characteristics that work against its intent and, in fact, may 
increase public health risk. Device power (measured in watts, or W) influences ECIG nicotine emissions (Talih 
et al., 2015; Sleiman et al., 2016): early ECIG models were powered at 10 W or less, but current models 
achieve 150 W or more (Wagener et al., 2017). Recent data from a small convenience sample demonstrate 
that 10 puffs from high power ECIGs (mean=70 W) filled with only 4 mg/ml nicotine liquid (on average) can 
attain and sometimes exceed the nicotine delivery of a tobacco cigarette (Wagener et al., 2017). Use of these 
Contact PD/PI: EISSENBERG, THOMAS EVAN
Research Strategy                                                                                             
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“third generation” ECIGs is on the rise (e.g., Barrington-Trimis et al., 2017), and early results reveal that, 
relative to lower power devices, they can produce more carcinogenic volatile aldehydes (Gillman et al., 2016; 
El-Hellani et al., 2016), lead users to consume more nicotine-containing liquid (Wagener et al., 2017; Etter, 
2016; Sleiman et al., 2016), and, due to their ability to deliver nicotine so effectively, likely have greater abuse 
liability. These results suggest that, when higher power devices are available, the intended consequences of 
the EU directive are unlikely to be realized and unintended consequences are likely because users can buy 
high power devices that produce more toxicants (i.e., increase toxicity), lead users to consume more liquid 
(i.e., alter behavior) and deliver nicotine more efficiently (i.e., increase abuse liability), even when paired with 
liquids ≤20 mg/ml nicotine. The ability to predict the consequences of regulatory action might help FDA craft 
regulations that meet their intent without increasing product toxicity, altering user behavior, and enhancing 
product abuse liability. Indeed, if FDA had scientific methods that could predict these population-level 
outcomes in advance, these methods could be used to generate objective data to guide the development of 
potential regulation. Then, by the time data-guided regulations are enacted, they will have been crafted to 
maximize intended effects and minimize unintended consequences. Our goal with this application is to provide 
these methods to FDA. To do so, we examine, under controlled conditions, hypotheses related to three 
potential regulatory actions: limiting liquid nicotine concentration, constraining nicotine flux (nicotine yield/unit 
time), and reducing flavor availability. We then use results from this controlled condition testing to generate 
predictions about how these potential regulatory actions might impact the population, and then test these 
predictions at the population level. Note that no new regulations need be in place for us to meet these goals.  
What model are we using for impact analysis?  There are a number of important outcomes to consider when 
attempting to predict the impact of potential tobacco product regulation, and not all can be considered at once. 
We focus on outcomes from three key domains: product toxicity (Project 1), user behavior (Project 2), and 
abuse liability (Project 3). Toxicity is relevant because, at a minimum, a regulation should not increase tobacco 
product toxicant emissions, and regulated changes in toxicant emissions can drive use of one product over 
another. User behavior is relevant because people may adapt to a regulated product in a way that defeats 
regulatory intent or increases product toxicity. Abuse liability is relevant because it is a key determinant of the 
extent to which current users will maintain persistent tobacco product use and, importantly, also may help 
determine transitions from one class of products (e.g., ECIGs) to another (e.g., tobacco cigarettes); it may also 
be predictive of tobacco initiation and persistent use among current non-users. Because toxicity, behavior, and 
abuse liability can interact (e.g., longer puffs can increase delivery of nicotine and other toxicants, thus 
influencing abuse liability as well as health effects) we emphasize a transdisciplinary approach in which these 
issues are considered simultaneously (see Fig 1, next page). We expand on each of these topics below.  
Understanding product toxicity can help predict population-level effects. One powerful way to study tobacco 
product toxicity is to analyze emissions under controlled conditions. For example, to understand cigarette 
toxicity, cigarette smoke constituents were analyzed and found to contain many toxicants (USDHHS, 2010), 
including highly carcinogenic TSNAs. TSNAs can be controlled through manufacturing modifications 
(Chamberlain & Chortyk, 2015), leading to regulatory measures that have resulted in lower population-level 
TSNA exposure (e.g., Czoli & Hammond, 2017; Xia et al., 2011). Similarly, for waterpipe, smoke constituents 
have been analyzed and many cigarette smoke toxicants are found in waterpipe smoke (e.g., WHO, 2015). An 
analog of this approach that simulates the oral cavity has been applied to smokeless tobacco (e.g., Delvadia et 
al., 2012). Thus, analyzing toxicant emissions is relevant to an array of FDA-regulated tobacco products.  
We and others have begun using this approach for ECIGs in ways that can inform regulation by analyzing the 
content of ECIG aerosols produced under controlled conditions (Bekki et al., 2014; Mikheev et al., 2016; 
Soussy et al., 2016). Results reveal fewer toxicants in ECIG aerosol relative to cigarette smoke (e.g., Margham 
et al., 2016), and also make clear that many factors influence ECIG nicotine and other toxicant emissions. As 
might be expected, ECIG nicotine emission is related directly to liquid nicotine concentration and it also is 
related to device power and puff duration (e.g. Talih et al., 2015). In fact, our nicotine emission analyses led us 
to develop a physics-based mathematical model that takes into account device, liquid, and puff variables and 
allows us to predict the amount of nicotine emitted/unit time (i.e., nicotine “flux”, in µg/sec, R2=0.72; Talih et al., 
2016a). We have suggested that nicotine flux may be an important regulatory consideration (e.g., Shihadeh & 
Eissenberg, 2015), in that speed of drug delivery is a key factor in abuse liability (e.g., Henningfield & Keenen, 
1993). Building on this suggestion, FDA might develop product standards that specify a range of nicotine flux 
values that approach but do not exceed the nicotine delivery of a tobacco cigarette: product standards are 
Contact PD/PI: EISSENBERG, THOMAS EVAN
Research Strategy                                                                                             
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squarely in the purview of FDA’s authority to regulate tobacco product manufacturing. These flux standards 
could be attained by products that limit key characteristics like maximum and minimum wattage, liquid nicotine 
concentration, and puff duration (e.g., the device turns off after detecting a 3-sec puff, and does not allow 
another puff for 20 seconds). However, such standards must also take into account the observation that 
device, liquid, and puff variables are relevant to ECIG emissions of non-nicotine toxicants. For example, 
increasing ECIG power from 4.1 to 8.8 W approximately tripled volatile aldehyde emissions (Sleiman et al., 
2016; see also Wang et al., 2017; Havel et al., 2016; Geiss et al., 2016) and, in another study, increasing 
power from 4.3 to 10.8 W more than doubled furan emissions (Soussy et al., 2016). Also, increasing ECIG 
power from 6 to 13 W increased emissions of the carcinogen benzene 100-fold (Pankow et al., 2017). These 
results suggest that, if nicotine flux is used as a regulatory target, care must be taken: there may be some flux 
conditions that meet the nicotine target and that also emit more non-nicotine toxicants relative to other 
conditions that meet the same target. Another factor that influences ECIG toxicant emissions involves 
flavorants (e.g., Soussy et al., 2016; Behar et al., 2016). In some cases, flavorant inhalation could have health 
consequences (e.g., Farsalinos et al., 2015; Leigh et al., 2016). In sum, one way to understand tobacco 
product toxicity is to produce emissions under controlled conditions and analyze their content. These methods 
have been used to understand toxicity of cigarettes, waterpipes, and smokeless tobacco, and are being 
applied to understanding toxicity of ECIGs. Extant data indicate that factors that influence ECIG nicotine and 
other toxicant emissions include liquid nicotine concentration, device power, puff duration, and liquid flavorants. 
Figure 1: Model for predicting potential regulatory impact. A Contextual Knowledge Core informs Projects 1-3 about common ECIG 
wattages, nicotine concentrations, and flavors as well as do-it-yourself (DIY) flavor recipes/methods; it also informs Project 4’s 
respiratory effects and dependence assessment. Projects 1-3 will test hypotheses concerning three potential regulatory actions. Project 
1 tests hypotheses regarding the toxicant content of ECIG aerosols, Project 2 tests hypotheses regarding user behavior and toxicant 
exposure, and Project 3 tests hypotheses regarding abuse liability. Project 1-3 results are used to generate predictions regarding 
population-level phenomena. Project 4 uses a prospective cohort survey to test predictions, examining relationships between device 
power and nicotine concentration, nicotine flux and dual use and respiratory symptoms, and flavor availability and DIY flavor mixing.  
Contact PD/PI: EISSENBERG, THOMAS EVAN
Research Strategy                                                                                             
 Page 125

 
The same methods used to understand tobacco product toxicity also can help generate predictions regarding 
population-level effects of potential tobacco product regulation. For example, consider again Directive 
2014/40/EU that limits ECIG liquid nicotine concentration to ≤20 mg/ml. If FDA contemplated similar action, 
one approach to predict its effects would be to examine ECIG emissions under relevant controlled conditions. 
These conditions could involve varying liquid nicotine concentration as well as other factors such as device 
power and puff duration. Based on limited data available now, higher powered devices paired with lower 
nicotine liquids likely emit nicotine in amounts that exceed a tobacco cigarette (e.g., Talih et al., 2015). 
Moreover, these pairings of high power/low nicotine likely lead to greater non-nicotine toxicant production (El-
Hellani et al., 2016) and aerosolize more liquid (e.g., Sleiman et al., 2016). At the population level, this pattern 
suggests that individuals who use higher power ECIGs consume more aerosolized liquid and may also report 
more adverse events (e.g., respiratory symptoms) due to greater toxicant inhalation. Next, consider regulating 
nicotine flux within a target range (e.g., Shihadeh & Eissenberg, 2015) and a study that examines ECIG 
toxicant emissions across that range. A given nicotine flux standard can be met in numerous ways, including 
decreasing liquid nicotine concentration while increasing power, but increased power can increase non-
nicotine toxicant emissions. Thus, users of some products that can meet the flux standard might be exposed to 
more toxicants than others who use different products that also can meet that same standard. At the 
population level, this observation suggests that users of high power/low nicotine combinations will experience 
more adverse events than would users of low power/high nicotine combinations even though both achieve 
similar nicotine flux. Finally, consider a regulation that reduces the availability of ECIG liquid flavors. ECIG 
users are known to engage in do-it-yourself (DIY) flavor mixing (e.g., Farsalinos et al., 2014; Etter, 2016), and 
decreased flavor availability may increase DIY likelihood. Common DIY flavors can be mixed in the lab and the 
toxicity of their aerosols evaluated under controlled conditions. To the extent that DIY liquids produce more 
aerosolized toxicants than others, DIY liquid users might be expected to report more adverse events. Each of 
these potential regulatory actions are reasonable policy approaches to ECIGs, and each of the predicted 
population-level effects are possible consequences of them. Examining the effects of these potential regulatory 
actions on product toxicity is the work of our Project 1. What is missing is some way of testing population-level 
predictions to determine if they represent real-world phenomena. We return to this topic two pages down. 
Understanding user behavior can help predict population-level effects. One powerful way to study tobacco user 
behavior is with the methods of the clinical lab, where tobacco users are presented with various products under 
controlled conditions and key outcomes such as subjective effects, topography (e.g., puff volume and 
duration), and nicotine delivery are measured. There is a large literature detailing this approach using 
cigarettes (Hammond et al., 2005; Rose & Behm, 2004, Collins et al., 2010), waterpipe (e.g., Blank et al., 
2011; Leavens et al., 2017; WHO, 2015), smokeless tobacco (e.g., Hatsukami et al., 2011, Lemmonds et al., 
2005; Gire & Eissenberg, 2000; Lunell & Curvall, 2011), and non-cigarette products that emit aerosol (e.g., 
Breland et al., 2002; Lopez et al., 2016a). Results are too numerous to detail, but demonstrate, for example: 1) 
that “low-yield” cigarettes cause smokers to take longer and larger puffs that influence nicotine and other 
toxicant delivery (e.g., Djordjevic et al., 2000); 2) that, relative to a cigarette, a waterpipe session is associated 
with puffs that are 10 times larger, carbon monoxide exposure that is 4 times greater, and nicotine exposure 
that does not differ (e.g., Cobb et al., 2011); 3) that smokeless tobacco product pH influences nicotine delivery 
and physiological response (Pickworth et al., 2014) and 4) that smokeless tobacco products marketed to 
cigarette smokers fail to suppress aversive tobacco abstinence effects in smokers (e.g., Blank & Eissenberg, 
2010; Cobb et al., 2010). Thus, measures of user behavior are relevant to a broad array of FDA-regulated 
products (i.e., inhaled and oral). They are also predictive of real-world behavior (e.g., Breland et al., 2002). 
We and others have begun informing ECIG regulation by studying the factors that influence ECIG user 
subjective response, puffing behavior, and nicotine exposure (e.g., Cox et al., 2016; Dawkins & Corcoran, 
2014; Eissenberg, 2010; Hajek et al., 2015; Papaseit et al., 2017). For example, the effects of nicotine liquid 
concentration have been examined in several studies (e.g., St. Helen et al., 2016; Vansickel & Eissenberg, 
2013). In two studies where liquid nicotine concentration was manipulated systematically, 16 smokers (Lopez 
et al., 2016c) and 16 ECIG users (Ramôa et al., 2016) completed 10-puff use bouts with a 7.3 W device loaded 
with 0, 8, 18, or 36 mg/ml nicotine liquid. Results demonstrated that plasma nicotine concentration increased 
with liquid nicotine concentration, but nicotine delivery was greater for experienced ECIG users. For example, 
at 36 mg/ml, mean post-bout plasma nicotine was 30.2 ng/ml (SD=20.0) for ECIG users (Ramôa et al., 2016a) 
compared to 17.0 ng/ml (SD=17.9) for smokers (Lopez et al., 2016c). This result may be explained by the 
Contact PD/PI: EISSENBERG, THOMAS EVAN
Research Strategy                                                                                             
 Page 126

 
finding that experienced ECIG users took longer puffs (e.g., at 36 mg/ml, mean puff duration was 4.0 s for 
ECIG users and 2.3 s for cigarette smokers). In a study that compared subjective effects, puff topography, and 
nicotine delivery across experienced ECIG users and ECIG-naïve cigarette smokers, the magnitude of a 
variety of subjective effects also increased as nicotine concentration increased (as did plasma nicotine 
concentration), with between group differences in subjective effects (including tobacco/nicotine abstinence 
symptom suppression), plasma nicotine concentration, and puff topography (Hiler et al., in press). These same 
outcomes can be used to examine the effects of potential FDA regulation. 
Results from clinical lab studies in which user behavior is measured can help generate predictions regarding 
the population-level effects of potential tobacco product regulation. For example, if a clinical lab study in which 
device power and nicotine concentration are manipulated reveals that low power/low nicotine combinations fail 
to suppress aversive nicotine abstinence symptoms and increases puff duration and volume, a regulation that 
limits nicotine concentration might be predicted to cause ECIG users either to take longer, larger puffs from 
their current device, or switch to higher powered devices that emit more aerosol, with a resulting increase in 
daily liquid consumption. Similarly, if a study in which flux is manipulated reveals that high flux conditions 
deliver nicotine and suppress abstinence symptoms effectively while low flux conditions do not, then high flux 
conditions may be more associated with population-level exclusive ECIG use and low flux conditions with 
population-level dual ECIG/cigarette use. Likewise, if a clinical lab study in which flavor is manipulated reveals 
that preferred flavors are associated with greater abstinence symptom suppression and nicotine delivery, ECIG 
users at the population level might be expected to either report more abstinence symptoms and consume less 
liquid when their preferred flavor is unavailable, or find ways to attain that preferred flavor regardless of its 
availability (e.g., DIY flavor mixing). Thus, behavioral outcomes can help predict population-level phenomena. 
This topic is the work of our Project 2. There remains a need to test population-level predictions to determine if 
they represent real-world phenomena. We return to this topic at the bottom of the next page. 
Understanding abuse liability can help predict population-level effect. Cigarette smokers know that smoking is 
lethal, but quitting is difficult because they self-administer the dependence-producing drug nicotine with every 
toxicant-laden puff. For this reason, understanding dependence/addiction is a key element in treating and 
preventing tobacco use (USDHHS, 2010). Doing so requires an understanding of drug reinforcement: how 
rewarding a drug is and how likely it is to sustain persistent use and dependence (e.g., IOM, 2012; Hanoch et 
al., 2017). The likelihood that a given drug’s reinforcement value will lead to persistent use and dependence is 
part of its overall “abuse liability” (e.g., Carter & Griffiths, 2009), and this abuse liability concept has been 
applied to tobacco (Carter et al., 2009). There is a growing understanding that combustible tobacco cigarettes 
lie at the upper end of the reinforcement continuum among drugs of abuse (e.g., IOM, 2012). The issues raised 
by the application of abuse liability to tobacco product regulation have been articulated and include (but are not 
limited to) a product’s ability to promote switching to that product and cessation of a more harmful one; dual 
use of the less and more harmful products; and relapse in current exclusive users of the less harmful product 
to occasional or exclusive use of the more harmful one (IOM, 2012): “All of these outcomes can be logically 
related to the [product’s] reinforcing value … (how rewarding it is).” (IOM, 2012; p.149). These issues are of 
particular importance for regulation of ECIGs that are sometimes used exclusively by former cigarette smokers 
who have switched to ECIGs but are more often used by current tobacco smokers in conjunction with tobacco 
cigarettes (i.e., dual use; USDHHS, 2016). Critically, important methods for predicting a tobacco product’s 
abuse liability include lab-based behavioral economic indicators of demand for a single product and 
substitution between products (IOM, 2012). One of the most policy-relevant behavioral economic predictors of 
tobacco product abuse liability is own-price elasticity of demand. Elasticity provides an index of a tobacco 
product’s value to a user. For example, users who are less elastic will be less responsive to policies that make 
tobacco products harder to obtain. Thus, lower elasticity is a predictor of higher abuse liability (Hursh & Roma, 
2013; Hursh & Winger, 1995; Hursh & Silberberg, 2008; Carter et al., 2009). By extension, assessing a 
tobacco product’s value means measuring how much users are willing to pay to consume that product as well 
has how hard they are willing to work for it, and results can be used to predict population-level abuse liability. 
Moving beyond a single product, the economic relationship between two products (e.g., cigarettes and ECIGs) 
can be described using measures of cross-price elasticity, categorized along a continuum. Consider the case 
of two tobacco products whose reinforcing values are similar. Policies or regulations that make one product 
more difficult to obtain without influencing the other will result in users substituting away from the first by 
reducing their consumption and towards the second by increasing their consumption. Thus, regulatory action 
Contact PD/PI: EISSENBERG, THOMAS EVAN
Research Strategy                                                                                             
 Page 127

 
aiming to influence the demand for one tobacco product will affect substitution in consumption for other 
tobacco products that are considered by users to have similar reinforcing value. Importantly, these patterns 
within and across tobacco products can be assessed in the lab and results can be used to predict product 
abuse liability at the population-level.  
Lab-based testing with behavioral economic indicators has been used to examine normal cigarettes (Griffiths 
et al., 1996), very low nicotine cigarettes (Tucker et al., 2017), waterpipe (Salloum et al., 2015), and smokeless 
tobacco (Stein et al., 2017). For example, when smokers responded to a cigarette purchase task (CPT; it 
models tobacco consumption), purchases declined as cigarette price increased, with measures of own-price 
elasticity and the maximum amount participants were willing to pay corresponding to their nicotine dependence 
and daily smoking (MacKillop et al., 2008). Similarly, when demand for cigarettes and several substitutes (i.e., 
smokeless tobacco; medicinal nicotine) was assessed using purchase tasks, results revealed lower demand 
elasticity for cigarettes compared to all alternatives (O’Connor et al., 2014). This pattern suggests that 
changing smokers’ cigarette availability would do little to influence demand for alternative nicotine sources 
(O’Connor et al., 2014). Another study estimated measures of demand for smokeless tobacco, as compared to 
cigarettes and nicotine gum, and demand for smokeless tobacco was significantly more elastic than for 
cigarettes (Stein et al., 2017). Thus, predicting tobacco product abuse liability using behavioral economic 
indicators in a lab setting is relevant to an array of FDA-regulated products (i.e., inhaled and oral) and may 
help explain user transitions across products, dual use, and exclusive use of one product over another. 
We and others have begun using lab-based behavioral economic tasks to predict ECIG abuse liability (e.g., 
Grace et al., 2015; Copp et al., 2015; Czoli et al., 2016). For example, we compared smokers’ choices for own-
brand cigarette puffs, ECIG puffs, and money using a multiple-choice procedure (MCP) in which participants 
choose between puffs from a product and increasing dollar values (Vansickel et al., 2012). Smokers were 
willing to pay more for puffs from their own-brand cigarette than from ECIGs and they valued 10 ECIG puffs at 
3 cigarette puffs. This pattern suggested lower abuse liability for these ECIGs relative to tobacco cigarettes. In 
another study with different ECIGs a similar pattern was observed (McPherson et al., 2016). One limitation of 
these studies is that they used early-model ECIGs that did not deliver nicotine effectively. More recently, we 
used the MCP and CPT among ECIG-naïve smokers to predict the abuse liability of ECIGs with a known 
nicotine delivery profile. Participants’ willingness to pay for ECIGs was generally lower than for their own-brand 
tobacco cigarettes but these differences varied by ECIG liquid flavor (Barnes et al., 2017). Relatedly, another 
recent study demonstrated that young adult ECIG users will work harder for puffs from an ECIG loaded with 
flavored vs unflavored liquid, consistent with the notion that flavors likely increase ECIG abuse liability 
(Audrain-McGovern et al., 2016). Overall, these results demonstrate that behavioral economic tasks are a 
powerful tool to understand the abuse liability of ECIGs across potential regulatory conditions. 
Results from lab-based behavioral economic studies can help generate predictions about population-level 
abuse liability in response to potential tobacco product regulation. For example, if a lab-based study in which 
device power and nicotine concentration are manipulated systematically predicts that lower power/nicotine 
combinations have lower abuse liability (i.e., participants exhibit greater price sensitivity), we would expect that, 
at the population-level, nicotine-dependent ECIG users will be more likely to seek out and buy higher power 
devices to maintain nicotine intake. Similarly, if a lab-based study in which nicotine flux is manipulated 
systematically reveals that flux is related directly to willingness to pay/work and inversely to price sensitivity 
and therefore predicts higher abuse liability, we would expect higher flux to be associated with more persistent 
use and greater nicotine dependence at the population level. Likewise, if a lab-based study examining abuse 
liability in which flavor is manipulated while nicotine flux is held constant reveals that participants are willing to 
pay more/work harder for their preferred flavor, we would expect that exclusive ECIG users will seek ways to 
attain that preferred flavor regardless of its availability on the market (e.g., DIY mixing). Thus, results from lab-
based studies that employ behavioral economic indicators of abuse liability can be used to make population-
level predictions regarding tobacco user behavior. This topic is the work of our Project 3.  What is missing is 
some way of assessing population-level predictions of abuse liability generated in the lab in order to determine 
if those predictions represent real-world phenomena. We now turn to this topic. 
How can predictions regarding population-level impact be tested?  Many approaches have been used to 
evaluate the effects of enacted regulation. Quasi-experimental studies are often employed, with outcomes 
assessed before and after a jurisdiction enacts a regulation (Cook & Campbell, 1979; Borland, 1997). Stronger 
Contact PD/PI: EISSENBERG, THOMAS EVAN
Research Strategy                                                                                             
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designs compare outcomes before and after enactment across jurisdictions that did and did not enact the 
regulation, as epitomized by The International Tobacco Control (ITC) study (Thompson et al., 2006; Borland et 
al., 2009; Yong et al., 2017). ITC is multi-country and longitudinal and regularly assesses multiple measures 
related to regulatory constructs. While powerful policy evaluation tools, one limitation of these designs is that 
the regulation must already be in place, and then the regulation must be changed if it is not achieving its 
intended effects or has harmful unintended consequences. Simulation models can predict regulatory impact. 
For example, the SimSmoke model has been used to predict the impact of tobacco control policies on smoking 
prevalence and smoking attributable deaths (e.g., Levy et al., 2007; 2016). Modeling can also predict 
outcomes under different assumptions in the absence of requisite data (e.g., estimating the impact of ECIGs 
on smoking patterns; Levy et al., 2017). Monte Carlo simulations have been used to predict cigarette and ECIG 
use behaviors under different policy scenarios (e.g., Kalkhoran et al., 2015). A limitation of simulation models is 
that while they start with some actual data (e.g., effect size of a policy on smoking prevalence; prevalence of 
ECIG use), calculations are based on a range of assumptions that may or may not reflect real-world 
phenomena. The Population Assessment of Tobacco and Health (PATH) is a great resource for monitoring 
regulatory impact. It is a nationally representative longitudinal cohort study of U.S. youth and adults who are 
interviewed annually (Hyland et al., 2016). However, because PATH is nationally representative, it is not an 
efficient mechanism to gather detailed data from users of a specific product (e.g., ECIGs) when prevalence in 
the general population is relatively low. It also lacks many measures relevant to testing the impact of a 
potential regulation pertaining to a specific product (e.g., ECIG power). 
We propose a data-driven method that will test population-level predictions generated by controlled testing 
using measures of product toxicity, user behavior, and abuse liability. We will recruit a cohort of ~1200 regular 
ECIG users and assess over time their device characteristics (wattage, voltage, resistance), liquid 
characteristics (nicotine concentration, PG/VG ratio, flavors), amount liquid consumed, price of current 
device/liquid, dependence (ECIG/tobacco cigarette), frequency of DIY flavor mixing, and respiratory symptoms.  
A sub-group of respondents will undergo puff topography measurement so that nicotine flux may be calculated. 
Importantly, predictions are tested by looking for anticipated associations at the population level (e.g., low 
nicotine liquids will be paired with high power devices and accompanied by greater dependence and 
respiratory symptoms). Thus, our testing does not require any new regulatory action. Also, while we are testing 
predictions we will also collect other data relevant to regulation, such as the rates at which ECIG users change 
their devices, nicotine concentration, and flavors. We also will use PATH data to explore our hypotheses, to the 
extent possible, particularly examining patterns of use and use behaviors among recent ECIG initiators.  By 
comparing the sociodemographic distribution of our sample of regular ECIG users to the sociodemographic 
distribution among PATH ECIG users, we will be able to generate population-level estimates of our findings. 
Summary. FDA’s public health standard requires consideration of whether a potential regulation will meet its 
health-promoting intent without leading to harmful unintended consequences. This consideration, we suggest, 
should include empirical testing of the potential regulation’s effects on product toxicity, as well as user behavior 
and behavioral economic indicators of abuse liability in relevant populations. We speculate that results from 
this empirical testing will inform FDA regarding likely population-level consequences. Because this notion is 
speculative, we propose testing it at the population level using a longitudinal survey of ECIG users and 
outcomes such as adverse health consequences, product consumption, dependence, and product switching. 
To the extent that population-level data support predictions generated by controlled testing, FDA will have at its 
disposal a model that can be used to shape, refine, and predict the effects of potential regulatory action.  
B. Overall Rationale. This effort will provide a transdisciplinary model with which empirical data from several 
domains can help FDA to predict the extent to which potential tobacco product regulation is likely to meet the 
mandated “public health standard”. As discussed, this standard requires FDA to consider how regulation will 
influence the risks and benefits to tobacco product users and non-users. We argue that this consideration of 
risks and benefits is best done prior to regulation taking effect, and is best informed by rigorous science that 
includes testing of product toxicity, user behavior and behavioral economic indicators of abuse liability. We 
have mentioned one case where regulation took effect without informative empirical data: labeling of cigarette 
packs with “tar” and nicotine yields. In this case, unintended consequences (product switching instead of 
cessation) and subsequent harm are well-documented (NCI, 2001). The model we propose offers a 
mechanism with which FDA can ensure future regulation has the health-promoting consequences that are 
intended and not harmful ones that are unintended. In addition to meeting the scientific goal of testing the 
Contact PD/PI: EISSENBERG, THOMAS EVAN
Research Strategy                                                                                             
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