High Impact E-cigarette Advertisement Features
Phase: NA
Conditions: Vaping Behavior
Sponsor: Rutgers, The State University of New Jersey

Title: High Impact E-cigarette Advertisement Features 
NCT06704295 
Document Date: 11/01/2024 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
NON-INTERVENTIONAL/METHODOLOGICAL  
RESEARCH PROTOCOL  
(HRP-503b) 
 
 
 
 
STUDY INFORMATION 
 
§ 
Title of Project:  
High Impact E-cigarette Ad Features and Claims  
 
§ 
Principal Investigator Name 
Julia Chen-Sankey, PhD, MPP 
 
§ 
Principal Investigator Div. & Dept. 
1. Department of Health Behavior, Society and Policy, Rutgers School of Public 
Health 
2. Institute for Nicotine & Tobacco Studies, Rutgers Biomedical and Health Sciences 
 
§ 
Principal Investigator Contact Info:  
JC.Sankey@rutgers.edu 
303 George Street, Suite 500 
New Brunswick, NJ 08901 
838-932-1855 
 
§ 
Protocol Version and Date: 
v1 11/01/2024 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
Table of Contents  
Skip To Section: Hold CTRL + Click (Below) To Follow Link in Blue 
 
1.0 
Research Design 
 
1.1 
Purpose/Specific Aims 
 
1.2 
Research Significance 
 
1.3 
Research Design and Methods 
 
1.4 
Preliminary Data 
 
1.5 
Sample Size Justification 
 
1.6 
Study Variables 
 
1.7 
Specimen Collection 
 
1.8 
Data Collection 
 
1.9 
Interviews, Focus Groups, or Surveys and/or Observations 
 
 
2.0 
Project Management 
 
2.1 
Research Staff and Qualifications 
 
2.2 
Research Staff Training 
 
2.3 
Resources Available 
 
2.4 
Research Sites 
 
 
3.0 
Multi Center Research 
 
 
4.0 
Subject Considerations 
 
4.1 
Subject Selection and Enrollment Considerations 
 
4.2 
Obtaining Identifiable Information About Non-Subjects 
 
4.3 
Number of Subjects 
 
4.4 
Consent Procedures 
 
4.5 
Special Consent Populations 
 
4.6 
Economic Burden and/or Compensation For Subjects 
 
4.7 
Risks and Benefits to Subjects 
 
 
5.0 
Special Considerations 
 
5.1 
Health Insurance Portability and Accountability Act (HIPAA) 
 
5.2 
Family Educational Rights and Privacy Act (FERPA) 
 
5.3 
Code of Federal Regulations Title 45 Part 46 (Vulnerable Populations) 
 
5.4 
General Data Protection Regulation (GDPR) 
 
5.5 
NJ Access to Medical Research Act (Surrogate Consent) 
 
 
6.0 
Data Management Plan 
 
6.1 
Data Analysis 
 
6.2 
Data Security 
 
6.3 
Data and Safety Monitoring 
 
6.4 
Reporting Results 
 
6.5 
Secondary Use of Data 
 
 
7.0 
Research Repositories - Specimen and/or Data 
 
 
8.0 
Approvals/Authorizations 
 
 
9.0 
Bibliography 
 
 
 
 
 
 
 
 
 
 
 

1.0 Research Design 
 
1.1 Purpose/Specific Aims  
The overall purpose of this study is to assess the influence of e-cigarette advertisements (ads) and their 
high-impact ad features (flavor features, reduced exposure messages, and FDA-authorized claims) on 
perceptions and intentions of using e-cigarettes among young adults (ages 18-30). Using two 
randomized between-subject experiments in an online survey, the main goal of the first experiment is to 
examine the effect of viewing different flavor features (flavor name, product color that coincides with 
flavor name, flavor image, flavor sensation descriptor, and flavor choice claim) on self-reported e-
cigarette use perceptions and use intentions. The main goal of the second experiment is to examine the 
effect of viewing different e-cigarette marketing claims suggesting harm reduction (reduced exposure 
claim, FDA-authorization claims) on self-reported e-cigarette use perceptions and use intentions. 
 
A. Objectives  
Objective 1: To assess if exposure to e-cigarette ads with flavor features and reduced harm 
claims will result in greater positive perceptions and increased e-cigarette use intentions than 
exposure to e-cigarette ads without these features.  
B. Hypotheses / Research Question(s) 
Hypothesis 1: Exposure to e-cigarette ads with flavor features and reduced harm claims will 
result in greater positive perceptions and increased e-cigarette use intentions than exposure 
to e-cigarette ads without these features.  
Hypothesis 2: The positive effect of exposure to e-cigarette ads with flavor features on e-
cigarette use intentions will be moderated by participants’ tobacco-use status.  
 
1.2 Research Significance  
There has been a rise in e-cigarette use with nicotine among U.S. young adults in recent years.1 Among 
those aged 19-30, past 12-month nicotine vaping increased from 13.7% in 2017 to 25.3% in 2023, while 
past 30-day nicotine vaping rose from 6.1% in 2017 to 18.7% in 2023.1 This is concerning, given that e-
cigarette use during young adulthood among those who are naïve to tobacco products can lead to 
nicotine addiction and may increase the risks of developing more harmful tobacco-use behaviors that 
can lead to respiratory diseases, cardiovascular diseases, and cancer later in life.2,3 On the other hand, 
young adults who smoke cigarettes may benefit from using e-cigarettes to quit smoking, as switching 
from cigarettes to e-cigarettes could reduce their exposure to harmful chemicals before they become 
vulnerable to the severe health effects of long-term cigarette smoking.4 E-cigarette marketing plays a 
key role in shaping the perceptions and use intentions of e-cigarette products among young adults of 
varying tobacco use behaviors.5–7 In our previous research, we found that exposure to flavor features, 
such as fruit flavor names, images, etc., is influential in increasing positive product perceptions and use 
interests.8–11This is unsurprising considering the availability of e-cigarettes in non-tobacco flavors is 
commonly cited as a key reason for e-cigarette initiation and use among young people.12 However, it is 
unclear which specific flavor features (e.g., flavor names, colorful product packing that coincide with the 
product flavor [e.g., red for strawberry, green for apple], flavor images, flavor sensation claims) may be 
particularly appealing to young adults. It is also unknown which combinations of various flavor features 
appearing on an ad together are especially influential in changing perceptions and use intentions. In 
addition, various potential marketing claims related to reduced harm from e-cigarette use, including 
reduced exposure claim and FDA-authorized claims may also alter the perceptions and use intentions 
of the products. Additional research is needed to address significant gaps regarding which the impact 
of those features and claims used in e-cigarette ads among young adults with varying tobacco use 
behaviors and to inform regulatory decision-making. Regulatory decision-making related to e-cigarette 
flavor features on ads is important for helping to reduce the use of e-cigarettes with non-tobacco 
flavorings that may expose young people to aerosols containing compounds of respiratory toxicity.13  
 
1.3 Research Design and Methods 
To assess the impact of those features and claims, we will administer two separate randomized 
experiments through this online survey project where subjects will be assigned to one of six e-
cigarette ad conditions (experiment 1) and one of the six e-cigarette ad conditions (experiment 2). The 
survey will include a series of questions about subjects’ sociodemographic backgrounds, health 

conditions, tobacco use history and dependence, and tobacco use environment. Static images of 
mock e-cigarette ads will be created based on publicized ads in brand company websites and emails.  
A. Research Procedures 
Young adult subjects will be recruited from online study panels administered by Qualtrics. 
Qualtrics will send out a brief description of the study for young adult recruitment (see 
Attachment A). Those who are interested in participating will first receive a screening survey 
(see Attachment B) to ensure eligibility. Those who are eligible will move on to the informed 
consent page (see Attachment C) and those who agree with the consent will proceed to 
complete the study survey (see Attachment D). In the survey, subjects will first answer a 
series of questions about demographics, health conditions, tobacco use history and 
dependence, and tobacco use environment. Afterward, for experiment 1, subjects will be 
randomly assigned to one of six conditions where they will be exposed to an e-cigarette ad 
either featuring an e-cigarette product that may or may not include high-impact flavor 
features. Condition 1 (control condition) will not include any high-impact flavor features and 
conditions 2-6 will include at least one high-impact flavor feature (flavor name, product color 
that coincides with flavor name, flavor sensation descriptor, and flavor choice claim). 
Attachment E includes stimuli for each experimental condition. Each ad will also include other 
ad features (e.g., nicotine warning label, generic marketing claim) to help increase ad 
authenticity. The conditions are: 
• 
Condition 1: Black product with tobacco flavor name 
• 
Condition 2: Black product with strawberry flavor name 
• 
Condition 3: Colorful (strawberry color) product with strawberry flavor name 
• 
Condition 4: Colorful (strawberry color) product with strawberry flavor name + 
strawberry image 
• 
Condition 5: Colorful (strawberry color) product with strawberry flavor name + 
strawberry image + strawberry flavor sensation descriptor 
• 
Condition 6: Colorful (strawberry color) product with strawberry flavor name + 
strawberry image + strawberry flavor sensation descriptor + flavor choice claim 
 
We chose to assess strawberry as the product flavor in these ads because it is a commonly 
marketed and available e-cigarette flavor14,15 in the retail environment, and one of the most 
frequently mentioned e-cigarette flavors among users on social media sites.16–18 Strawberry 
has also been cited as one of the most appealing,14,19 and highly rated20 e-cigarette flavors 
among users. It is therefore a flavor commonly used in e-cigarette research, including 
laboratory experiments, to assess user perceptions, use intentions, and use behaviors.14,15,20  
 
During the experiment, subjects will be required to view each ad for a minimum of 10 
seconds and will then answer questions about their intentions and perceptions of using the e-
cigarette products shown in each ad.  
 
For experiment 2, subjects will be randomly assigned to one of six conditions where they will 
be exposed to an e-cigarette ad with or without reduced exposure claims, FDA-authorized 
claims, and scientific facts about FDA-authorized claims. Attachment E includes stimuli for 
each experimental condition. 
 
• 
Condition 1: E-cigarette ad without any claims  
• 
Condition 2: E-cigarette ad with reduced exposure claim  
• 
Condition 3: E-cigarette ad with reduced exposure claim and FDA-authorized claim 
• 
Condition 4: E-cigarette ad with reduced exposure claim, FDA-authorized claim, and 
scientific facts about FDA-authorization 
• 
Condition 5: E-cigarette ad with FDA-authorized claim  
• 
Condition 6: E-cigarette ad with FDA-authorized claim and scientific facts about FDA-
authorization 
 

During the experiment, subjects will be required to view each ad for a minimum of 10 
seconds and will then answer questions about their intentions and perceptions of using the e-
cigarette products shown in each ad.  
 
After completing the survey questions, subjects will view debriefing messages about the harm 
of tobacco and e-cigarette use. The debriefing messages will also include information about 
how the tobacco industry targets young people with appealing advertisements and a list of e-
cigarette and cigarette cessation resources for those who need quitting support.  
 
B. Duration for Study and Each Subject  
It will take subjects approximately 20 minutes to complete the entire survey.  
 
1.4 Preliminary Data 
This study is informed by preliminary data from several of our previous projects. For instance, our 
previous online heatmap experiment study,8 eye tracking studies,9,10 and in-depth interviews11 all 
provide information about the most impactful e-cigarette marketing features in changing perceptions 
and use interests among young adults of various tobacco use behaviors. In our online heatmap 
experiment, we found that noticing fruit flavors and fruit images in e-cigarette ads was associated with  
e-cigarette product appeal and switching interest among young adult dual-users of e-cigarettes and 
cigarettes.8 Noticing price promotions was also associated with e-cigarette product appeal, but no 
other features were influential in increasing participants’ interest in completely switching to e-
cigarettes.8 In our eye-tracking study assessing cartridge-based e-cigarette product features in print 
ads, we found that overall, longer dwell time for multiple flavor choice descriptions (choice of fruit, 
menthol, tobacco flavors) was positively associated with e-cigarette appeal, and a shorter entry time 
for fruit flavor descriptions was associated with positive e-cigarette use expectancies.9 Similarly, in our 
eye-tracking study assessing disposable e-cigarette product features in social media marketing, 
attention to fruit/candy descriptors (names and promotional claims for fruit and candy flavors) 
generated product use interest among young adults who smoke.10 Our interviews that followed the 
eye-tracking study for cartridge-based e-cigarette products revealed that young adults who do not use 
tobacco and those who smoke cigarettes generally noticed fruit and multiple flavors in the ads, which 
were seen as appealing and were reported to generate product use interest because of bright colors, 
sensory appeal, and a variety of flavor options.11 Based on the findings from these studies, it is 
important to further assess the influence of flavor features in e-cigarette ads to understand which 
flavor features, or which combination of flavor features together, are most impactful in changing 
perceptions and use interests.  
 
1.5 Sample Size Justification 
There will be 3,000 subjects enrolled in the study. Our previous studies using a similar study design 
examining the influence of e-cigarette marketing features used sample sizes of approximately 3,000 to 
obtain sufficient power for detecting differences in product perceptions and use interest with small to 
moderate effect sizes. Other studies have shown that 500 subjects per group (6 randomizing 
conditions) will provide sufficient power to detect differences in perceptions and use intentions after 
viewing varying ad features as well as the moderating effect of tobacco-use status on those 
associations.  
 
1.6 Study Variables 
A. Independent Variables, Interventions, or Predictor Variables 
The predictor variable will be subjects’ conditions they are assigned to for the two experiments. 
 
B. Dependent Variables or Outcome Measures 
For both experiments, four groups of outcome measures will be used. See the Survey attachment 
for detailed measures  
1. Ad appeal 
2. E-cigarette use intentions 
3. E-cigarette risk perceptions  
4. E-cigarette outcome expectancies 

 
1.7 Specimen Collection 
 
A. Primary Specimen Collection 
§ 
Types of Specimens: N/A 
§ 
Annotation: N/A 
§ 
Transport: N/A 
§ 
Processing: N/A 
§ 
Storage: N/A 
§ 
Disposition: N/A 
 
B. Secondary Specimen Collection 
§ 
Types of Specimens: N/A 
§ 
Annotation: N/A 
§ 
Transport: N/A 
§ 
Storage: N/A 
§ 
Disposition: N/A 
 
1.8 Data Collection 
 
A. Primary Data Collection 
§ 
Location: The survey will be programmed online, via Qualtrics, an online survey platform.  
§ 
Process of Data Collection: Data collection will be managed by Qualtrics, and young adult 
subjects will be recruited from Qualtrics’ existing study panels.  
§ 
Timing and Frequency: The survey will be a one-time occurrence estimated to take 
approximately 20 minutes. 
§ 
Procedures for Audio/Visual Recording: N/A 
§ 
Study Instruments: The survey is included with this application (see Attachment D). The 
study survey will assess tobacco-using history, perceptions about tobacco products and 
tobacco use, perceptions of e-cigarette ads with various features and claims, intentions 
perceptions of using the products in these ads, and subject demographics.  
§ 
Ethnographic Studies, Interviews, Or Observation: N/A 
§ 
Subject Identifiers: Data will be collected from young adult subjects online who are 
registered users of Qualtrics survey panels. Qualtrics takes extensive measures to ensure that 
all registered members’ privacy and personal information are treated confidentially and kept 
secure. For this study, all data will be de-identified and anonymous to the PI and no personal 
information will be released to the PI. We will set up the Qualtrics survey in a way to not 
collect subjects’ PI addresses using the Anonymous Response features, in order to collect 
completely anonymous survey responses. At the beginning of the survey, Qualtrics will 
generate a random Subject ID. 
B. Secondary Data Collection  
§ 
Type of Records: N/A 
§ 
Location: N/A 
§ 
Inclusion/Exclusion: N/A 
§ 
Data Abstraction Form(s): N/A 
 
1.9 Interviews, Focus Groups, Surveys, and/or Observations  
 
A. Administration 
§ 
Timing and Frequency 
See Section 1.8A. 
§ 
Location 
See Section 1.8A. 
§ 
Procedures For Audio And Visual Recording 
N/A  
§ 
Person Identifiers 

N/A 
 
B. Study Instruments 
§ 
Evaluation Instrument Details 
See Section 1.8A. 
§ 
Study Instruments For Ethnographic Studies 
N/A 
§ 
Oral Histories Or Interviews General Framework 
N/A 
§ 
Referral Information 
N/A 
  
 
2.0 Project Management 
 
2.1 Research Staff and Qualifications 
Dr. Julia Chen-Sankey, PhD, MPP, Assistant Professor, Institute for Nicotine & Tobacco Studies and 
Rutgers School of Public Health, PI of this project, is an experienced researcher with expertise in 
tobacco product marketing influence among young adults. Specifically, Dr. Chen-Sankey has led 
several projects examining attention to specific marketing features of tobacco vape product ads and 
associations with product perceptions and use intentions among young adults. Dr. Chen-Sankey has 
also conducted online survey studies using subjects recruited through research companies such as 
Qualtrics. The PI will be involved in the study design, implementation, and data analysis and has 
completed relevant IRB/CITI trainings. 
 
Kathryn La Capria, MPH, Research Associate, Institute for Nicotine & Tobacco Studies, research 
assistant and project manager of this project, will assist in data collection and research support 
throughout the life of the project.  
 
Siyan Meng, MA, Research Assistant, Institute for Nicotine & Tobacco Studies, will assist in data 
analysis and manuscript writing.  
 
Research Staff Training 
All study members who are involved in this study have completed relevant IRB/CITI trainings and will 
receive specific trainings on this study protocol. All study team members will be provided with a copy 
of the protocol. There will be weekly project meetings where specific procedures and individual tasks 
will be discussed in full detail to ensure that the study team is following the protocol. 
. 
2.2 Resources Available 
We will use Qualtrics, offered through Rutgers, to program, host, and administer the online survey. 
Qualtrics will also use their study panels for subject recruitment. This is a resource available to Rutgers 
faculty (https://oit.rutgers.edu/qualtrics).  
 
The PI has access to various statistical analysis programs (SPSS, SAS, STATA) through their work at 
the Rutgers Institute for Nicotine & Tobacco Studies. 
 
2.4 Research Sites 
The Rutgers Institute for Nicotine & Tobacco Studies will serve as the administrative base for this 
project. Research activities (i.e., data storage and data analysis) will be conducted using 
computers/servers located in the study team’s Rutgers office space at the Rutgers Institute for 
Nicotine & Tobacco Studies (303 George Street, Suite 500, New Brunswick, NJ.)  
 
3.0 Multi Center Research 
N/A 
4.0 Subject Considerations 
 

4.1 Subject Selection and Enrollment Considerations  
 
A. Method to Identify Potential Subjects 
Subjects will be registered Qualtrics study panel members. Potential subjects will initially review a 
brief description of the study (see Attachment A), and those who are interested in participating will 
proceed to the eligibility screening questions assessing their age and tobacco use history (see 
Attachment B). If eligible, they will then be directed to the online consent form (see Attachment 
C).  
 
B. Recruitment Details 
In Spring 2025, subjects will be recruited via Qualtrics’ online study panels. Potential subjects who 
see and choose to complete our task (i.e., study) will complete it using Qualtrics’ survey platform. 
Recruitment is anticipated to take approximately three weeks.  
 
C. Subject Screening 
§ 
Inclusion Criteria 
Three groups of young adult subjects (ages 18-30) will be included in the study. The first 
group is those who are exclusive cigarette smokers (n=1000), defined as those who have 
smoked at least 100 cigarettes in their lifetime and have smoked at least one cigarette in the 
past 30 days but have not used e-cigarettes in the past 30 days. The second group is those 
who are dual users of cigarettes and e-cigarettes (n=1000). Those in this group have smoked 
more than 100 cigarettes in their lifetime and have smoked a cigarette and also used an e-
cigarette in the past 30 days. The third group is those who are non-tobacco users (n=1000), 
defined as those who have never used any tobacco product before or have never “regularly” 
used tobacco products before and are currently not using any tobacco products (in the past 
30 days).  
§ 
Exclusion Criteria 
Any subjects not meeting the inclusion criteria described in 4.1.C will be excluded from the 
study. Individuals will be further excluded if they do not provide consent to participate in the 
study. 
 
D. Privacy Protections 
Our survey will be publicized via Qualtrics (see Attachment D) to their registered study panel 
members. The screening questions (see Attachment B) pertain solely to demographics and tobacco 
use history and do not request any personally identifiable information. The PI will not receive the 
responses to the screening questions from Qualtrics if the subjects do not agree with the consent 
form or do not complete the survey.  
 
4.2 Obtaining Identifiable Information About Non-Subjects 
      N/A 
 
4.3 Number of Subjects 
 
A. Total Number of Subjects 
 
3,000 
B. Total Number of Subjects If Multicenter Study 
N/A 
C. Feasibility 
Based on prior studies conducted by the research team using a research company with study 
panels and other similar online sample providers, we anticipate that the recruitment of eligible 
subjects will take approximately three weeks.  
 
4.4 Consent Procedures 
 
A. Consent Process 
§ 
Location of Consent Process 

The consent process will take place online, via the Qualtrics platform.  
§ 
Ongoing Consent 
N/A 
§ 
Individual Roles for Researchers Involved in Consent 
The researchers will program the consent form into the start of the online study.  
§ 
Consent Discussion Duration 
Consent will be obtained through an online form, so there will be no set duration for the 
discussion.  
§ 
Coercion or Undue Influence 
The online consent document will specify that the prospective subjects are not required to 
participate and may exit the study at any time.  
§ 
Subject Understanding 
The online consent process will explain the nature of the study experience before requesting 
consent for participation. The consent form (see Attachment C) will thoroughly convey the 
nature of the study and communicate potential risks involved with participation and the 
voluntary nature of participation. The form will also provide contact information for the PI and 
the Rutgers IRB so that subjects may ask further questions about the study, their 
participation, and their rights as subjects. 
§ 
Protecting Privacy 
The study will not request any personally identifiable information during the consent process; 
if Qualtrics collects such information, the researchers of the study will not be able to accept it.  
 
B. Waiver or Alteration of Consent Process  
 
§ 
Waiver or Alteration Details 
N/A 
§ 
Destruction of Identifiers 
N/A 
§ 
Use of Deception/Concealment 
N/A 
a. Minimal Risk Justification 
N/A 
b. Alternatives 
N/A 
c. Subject Debriefing 
N/A 
 
C. Documentation of Consent 
§ 
Documenting Consent 
N/A 
§ 
Waiver of Documentation of Consent (i.e., will not obtain subject’s signature) 
All aspects of the study procedures will be done online. We request a waiver of documented 
consent. All potential subjects will be shown an online consent form describing the study and 
its voluntary nature, the confidentiality and privacy of their responses, and providing contact 
information for the study PI. The consent form will state that by clicking the “I agree” button at 
the bottom of the page, they will have provided their consent. Only after clicking “I agree” will 
they advance to the study survey. These are typical consent methods used for online survey 
studies and will allow us to make sure all data are de-identified and anonymous. 
 
4.5 Special Consent/Populations 
 
A. Enrolling Minors-Subjects Who Are Not Yet Adults  
§ 
Parental Permission 
N/A 
§ 
Non-Parental Permission 
N/A 

§ 
Assent Process 
N/A 
§ 
Documentation of Assent 
N/A 
§ 
Reaching Age of Majority During Study 
N/A 
 
B. Enrolling Wards of the State 
N/A 
§ 
Research Outside of NJ Involving Minors 
N/A 
 
C. Enrolling Non-English-Speaking Subjects 
N/A 
§ 
Process for Non-English-Speaking Subjects 
N/A 
§ 
Short Form Consent for Non-English Speakers 
N/A 
 
D. Enrolling Adults Unable to Consent / Decisionally Impaired Adults 
N/A 
§ 
Assessing Adult Capacity to Consent 
N/A 
§ 
Selecting a Surrogate & Consent Process 
N/A 
§ 
Subject Assent 
N/A 
§ 
Selecting a Witness to the Surrogate Consent Process  
N/A 
§ 
Removing a Subject 
N/A 
 
E. Special Consent Considerations 
N/A 
 
4.6 Economic Burden and/or Compensation for Subjects 
 
A. Expenses 
Other than participation time, which is expected to be brief, there is no cost associated with 
participation in this survey.  
B. Compensation/Incentives 
Subjects will be compensated with points that could be redeemed for cash. 
 
 
C.  Compensation Documentation 
Subjects who receive the compensation will receive points that could be redeemed for cash per 
Qualtrics’ policy and therefore, compensation documentation will be documented by Qualtrics. 
 
4.7 Risks of Harm/Potential for Benefits to Subjects 
 
A. Description of Subject Risks of Harm  
The risk of harm to all study subjects is minimal. This study involves standard survey 
procedures, and the information obtained is recorded in such a manner that human subjects 
cannot be identified directly. Although the survey collects some information about behaviors 
that might be considered sensitive, including sexual orientation, the dataset contains no 
personal identifiers. In the unlikely event of a data breach, reported behaviors could not be 

linked to individual subjects. Participation in this study poses no serious physical, 
psychological, or social risks to subjects. Given that all data collected will be anonymous, 
participation in the study does not put the subject at legal risk or civil liability. Subjects will be 
exposed to images of e-cigarette ads, but these ads are ones that could be encountered in 
daily life in stores and/or via marketing. Therefore, young adult subjects could have already 
encountered e-cigarette ads through various channels of ad exposure. During the study, if 
subjects feel uncomfortable with a question, they can quit the survey at any time. There is 
some risk in showing ads to non-users because the ads could stimulate or increase their 
interest in these products (as they might in real life). However, these exposures are very brief, 
and young adults are already exposed to those ads in their everyday lives. Precautions will 
also be taken to minimize these risks by showing subjects health education messages at the 
end of the survey about the harms of tobacco and e-cigarette use. The debriefing messages 
will also include information about how the tobacco industry targets young people with 
appealing advertisements and a list of e-cigarette and cigarette cessation resources for those 
who need quitting support.  
§ 
Existing Condition/Disorder 
N/A 
§ 
Additional Considerations 
a. N/A 
b. N/A 
§ 
Minimizing Risks 
As described above, the study will expose young adult subjects to e-cigarette ads, which 
might increase their interest in using the products. Precautions will also be taken to minimize 
these risks by showing subjects messages at the end of the survey about the harm of e-
cigarette use. The debriefing messages will also include information about tobacco industry 
targeting through appealing advertisements and a list of e-cigarette and cigarette cessation 
resources for those who need quitting support.  
§ 
Certificate of Confidentiality  
This is an NIH-funded study and will automatically be issued a Certificate of Confidentiality 
(CoC) from NIH. 
§ 
Risks of Harm to Non-Subjects 
N/A 
 
B. Potential Direct Benefits to Subjects 
There are no known direct benefits to subjects, however, subjects may experience other benefits, 
such as the personal satisfaction of knowing they have contributed to a research project.  
 
 
5.0 Special Considerations 
 
5.1 Health Insurance Portability and Accountability Act (HIPAA) 
      N/A 
 
5.2 Family Educational Rights and Privacy Act (FERPA) 
      N/A 
 
5.3 Code of Federal Regulations Title 45 Part 46 (Vulnerable Populations) 
N/A 
A. Special Populations 
N/A 
 
5.4 General Data Protection Regulation (GDPR) 
       N/A 
 
5.5 NJ Access to Medical Research Act (Surrogate Consent) 
      N/A 

 
6.0 Data Management Plan 
 
6.1 Data Analysis 
We will use linear regressions to assess the associations between experimental conditions and various 
outcomes described above. We will add the interaction terms to the regression models to test the 
interactive effects of tobacco-use status and the experimental effect. We will also provide estimates of 
participant characteristics and assess their even distributions across conditions.  
 
6.2 Data Security 
By design, the identity of the subjects recruited via the research company’s study panels is 
anonymous to the PI. Survey response data collected through Qualtrics is absent of all identifying data 
(e.g., name, birth date, e-mail address). All data collected from this study will be deleted by the PI 
within 90 days of study closure.  
6.3 Data and Safety Monitoring 
 
A. Data/Safety Monitoring Plan 
N/A (research does not pose greater than minimal risk of harm to subjects.) 
 
B. Data/Safety Monitoring Board Details 
N/A (research does not pose greater than minimal risk of harm to subjects.) 
 
6.4 Reporting Results 
 
A. Subject Results Reporting 
N/A 
 
B. Aggregate Results 
N/A 
 
C. Professional Reporting 
Upon data collection and analysis, we plan to share results with the scientific community through 
conference presentations and publication in scholarly journals. 
 
D. Clinical Trials Registration, Results Reporting and Consent Posting 
N/A 
 
6.5 Secondary Use of the Data    
There are no plans for secondary use of data. 
 
7.0 Research Repositories – Specimens and/or Data 
All data collected will be retained by the PI and available within the electronic databases of the Rutgers 
Institute for Nicotine & Tobacco Studies.   
 
8.0 Approvals/Authorizations 
N/A 
 
9.0 Bibliography 
 
1. Patrick ME, Miech RA, Johnston LD, O’Malley PM. Monitoring the Future Panel Study Annual Report: 
National Data on Substance Use among Adults Ages 19 to 65, 1976-2023. Institute for Social 
Research, University of Michigan; 2024:208. 

2. National Academies of Sciences E, Division H and M, Practice B on PH and PH, et al. Harm 
Reduction. National Academies Press (US); 2018. Accessed November 7, 2022. 
https://www.ncbi.nlm.nih.gov/books/NBK507185/ 
3. National Center for Chronic Disease Prevention and Health Promotion (US) Office on Smoking and 
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