Identifying and Examining the Effects of Source and Presentation on Responses to Electronic Cigarette Public Education Messages in Young Adult Vapers and Non-vapers - Part 1
Phase: NA
Conditions: Vaping
Sponsor: University of Massachusetts, Worcester

 
 
Cover Page for ClinicalTrials.gov 
 
 
Official Title:  
Responses to E-cigarette Message Source and Presentation  
 
 
 
NCT Number:  
STUDY00001220 
 
 
 
 
Document Type:  
Study Protocol 
 
 
 
 
Document Date:  
September 6, 2024 
 

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1. TITLE 
Identifying and examining the effects of source and presentation on responses to electronic 
cigarette public education messages in young adult vapers and non-vapers - Part 1 
 
2. EXTERNAL IRB REVIEW HISTORY* 
NA 
 
3. PRIOR APPROVALS: 
NA 
 
Conflict of Interest (COI):   
NA 
 
Clinical Engineering Department: 
N/A 
 
Biohazardous Agents: 
NA 
 
Radiation: 
NA 
 
Students as Subjects:  
NA 
 
Data Science Core & Recruitment Core: 
NA 
 
UMCCTS Protocol Review Committee (PRC) 
NA 
 
4. OBJECTIVES* 
The goal of the study is to conduct a crowdsourced testing to examine the effects of source and 
presentation of e-cigarette educational messages among young adults who currently vape and do 
not vape but are susceptible. The objectives are to examine young adults’ self-reported responses 
toward message source (expert vs. peer), message sidedness (one-sided vs. two-sided), and 
messages combining both (source x message sidedness) about anti-e-cigarette messages. 
Aim 1: To determine the optimal message source and presentation type for young adult vapers 
and susceptible non-vapers to increase acceptance of e-cigarette education messages and e-
cigarette harm perceptions.  
H1. Vapers will report greater message acceptance and harm perceptions than peer and two-
sided messages.  
 
Aim 1: Which message source and sidedness strategy is effective for susceptible non-vapers? 

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H1. Susceptible non-vapers will report greater message acceptance and harm perceptions to 
expert and one-sided messages.  
 
Please note that all procedures will be conducted online and there will be no direct in-person 
interaction between researchers and participants.  
 
5. BACKGROUND* 
Young adults (18-24-year-olds) in the U.S. have the highest rates of e-cigarette use (vaping),1 
with 16-19% of this population identifying as current users, 44-48% ever users, and 11-16% 
susceptible never users.2 Vaping can lead to nicotine addiction and initiation of cigarette 
smoking3–7 and is associated with cognitive and affective disorders among young adults.8 The 
U.S. Food and Drug Administration (FDA) has prioritized educating about the health harm of 
vaping among young adults. However, young adults may avoid9,10 or reject11 the current 
education messages, especially if they currently vape12–14 or perceive the messages as 
“controlling.”15 It is urgently needed to increase acceptance of e-cigarette education messages16 
to influence their e-cigarette harm perceptions and vaping behaviors.17–20 
Using a trusted source21–24 and presenting messages appropriately25,26 can increase message 
acceptance. According to persuasion theories, one’s tobacco use status may influence 
individuals’ response to a source and presentation of messages because vapers and susceptible 
non-vapers differ in their attitudes and personal relevance regarding tobacco use.25,27–29 
Unfortunately, no research has yet examined the impact of a message  source22,30 and 
presentation25,31,32 on young adults’ responses to e-cigarette education messages based on their 
vaping status. Evidence from research with cigarette smokers suggests that vapers will respond 
defensively to e-cigarette education messages, but susceptible non-vapers will not.12,33 Vapers 
may trust a tobacco health information source with similar attributes (e.g., peer young adults)29,34 
and accept messages with balanced perspectives that both present negative health effects of 
vaping and acknowledge their potential reasons for vaping (two-sided; e.g., “vaping can be 
appealing if others are using it, but it can harm your health”).25,31,35 On the other hand, 
susceptible non-vapers may trust a source with credentials (e.g., scientists) 36–38 and accept 
information-only messages (one-sided; e.g., “vaping can harm your health”).13,35 Thus, it is 
critical to understand and use a trusted source and present messages that are appropriate for 
vapers and susceptible non-vapers to optimize vaping cessation and prevention efforts, making it 
an important area of study to improve current messaging. 
The proposed research is guided by biobehavioral theories of tobacco regulatory science,39,40 
psychology,15,41 and communication.42,43 By using previously tested education messages,44 we 
will determine an optimal combination of message source and presentation type to increase 
message acceptance and e-cigarette harm perceptions. We will compare the effects of two 
sources (expert and peer) and two message presentation types (one-sided and two-sided) for 
young adult vapers and susceptible non-vapers. We will use crowdsourcing (N=800) for post-test 
self-report measures (message acceptance, harm perceptions) to determine optimal messaging. 
The goal of this study is to determine optimal message source and presentation for young adult 
vapers and susceptible non-vapers to increase message acceptance and harm perceptions using 
crowdsourcing. 
6. INCLUSION AND EXCLUSION CRITERIA* 
We will recruit 800 young adults between the ages of 18 and 24 years old (50% current vapers 
and 50% susceptible non-vapers) via Prolific crowdsourcing platform. Prolific is an on-demand, 

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self-service data collection. Prolific helps you recruit high quality research participants to take 
part in your study, survey or experiment (https://www.prolific.com/). Participants will be 18 and 
older and based in the United States. We will not include participants who are not fluent in 
English. Prisoners or adults who are unable to consent will not be included in the study. Pregnant 
women may be in the study if they choose, but we will not seek pregnant people to be in the 
study.  
 
We will screen for e-cigarette use susceptibility of non-vaper participants. Potential participants 
will be recruited from Prolific and directed to a screener survey. Participants are susceptible to e-
cigarette use if they respond to the tobacco use susceptibility question items (Have you ever been 
curious about using an e-cigarette? (1=Not at all curious, 5=Very curious); How likely is that 
you will try an e-cigarette, even one or two puffs, any time soon? (1=Very unlikely, 5=Very 
likely); How likely is that you will try an e-cigarette, even one or two puffs, any time during the 
next year? (1=Very unlikely, 5=Very likely); If one of your best friends were to offer you an e-
cigarette, would you use it? (1=Very unlikely, 5=Very likely) in anything other than 1=not at 
all/very unlikely. We will collect participants’ Prolific ID, a unique anonymous identifier, to 
create the list of eligible participants to participate in the 20-minute study. We expect that we 
will need 640 number of people identified as non-vapers to complete the screener and to have a 
complete sample for the 20 minute study, which will consist of susceptible non-vapers and 
vapers. 
Prolific.com provides individuals who are eligible for each of the categories we are recruiting. 
We do not need to screen the participants for this. We can just click our preferences for those in 
the study. 
 
 
7. STUDY-WIDE NUMBER OF SUBJECTS* 
NA 
 
8. STUDY-WIDE RECRUITMENT METHODS* 
NA 
 
9. STUDY TIMELINES* 
An individual’s participation in the study will be one-time for 20 minutes. We expect to 
complete the study within six months of enrolling the first participant.  
 
10. STUDY ENDPOINTS* 
The primary outcome measures include self-reported measures of message acceptance and harm 
perceptions. Secondary outcome measures include reactance, message liking, source trust, 
attitudes, and behavioral intentions.  
 
11. PROCEDURES INVOLVED* 
 
Non-vaper participants (regardless of their susceptibility) will first complete the online consent 
(i.e., STUDY00001220-Screener Consent_Fact Sheet_04.06.24.docx) and screener survey on 

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Qualtrics to determine their eligibility for susceptibility and will receive $1.00 via Prolific for 
participating in a 5-minute study. We will use the list of eligible participants from the screener 
survey, who will have been identified as susceptible, to participate in the 20-minute study, as 
described below.  
 
Eligible participants will complete an online consent (STUDY00001220-Consent_Fact 
Sheet.v3.013124.docx) and tobacco use questions on a Qualtrics survey before random 
assignment to one of four experimental conditions in a 2 (Source: expert and peer) X 2 
(Presentation: one-sided and two-sided) design. First, participants will view the source 
description within their assigned condition and view 18 random-ordered messages. See 
Appendix A. Copies of the messages. They will rate each message for perceived message 
effectiveness (PME),45 a widely used measure of message acceptance by the FDA’s tobacco 
health communication campaigns.46,47 They will also rate e-cigarette harm perceptions,48 
psychological reactance (resistance to the message),49 message liking,50,51 and source trust.52 The 
process will repeat 18 times, once for each message. Afterwards, participants will complete 
posttest survey questions about their demographics, attitudes about vaping,46 and behavioral 
intentions to vape.53 We will check manipulation of the source manipulation by asking 
participants to indicate the source of the message they saw after the first three messages. After 
completing the study, they will receive $4.00 via Prolific per its policies for participating in a 20-
minute survey. At the end of the study, participants will be extensively debriefed about the 
hypothetical nature of the message source and the health harm of using any tobacco products, 
provided with an information sheet about the health effects of e-cigarettes and resources for the 
Quitlines across the U.S. See Appendix B-1 and B-2 for information about nicotine health harms 
and resources to quit. They will also complete a questionnaire assessing their understanding of 
the information regarding quitting resources. At the end of the survey, each participant is given a 
unique code to input into Prolific to receive compensation. We will double-check responses on 
our end of the survey and approve them to compensate participants. 
 
12. DATA AND SPECIMEN BANKING* 
We will not collect any information directly linked to the identity of individual subjects. It is 
possible that IP addresses may be collected. We will de-identify the dataset by removing IP 
addresses. The data will be stored in UMass Chan Medical School OneDrive indefinitely and 
will be accessible to the PI and the research coordinator. De-identified dataset will be available 
to other researchers upon request.   
 
13. Data Analysis and Management* 
Scores for each measure will be summed and averaged across all messages for each vaping status 
population. A multi-attribute decision-making MADM framework54 will be used to produce a 
dataset containing data on participant response to each message with source + presentation type. 
Crowdsourced data will be merged with the Study part 2 data (psychophysiological testing) to 
rank messages and determine optimal message type.  
 
Once the crowdsourced and psychophysiological data collection is complete, we will use the 
MADM framework54 to determine the optimal combination of message source and presentation 
type. We will create a decision matrix in which each row represents a message type (source + 
presentation) and each column (attribute) represents a construct via the crowdsourced and 

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psychophysiological studies. Each message type will receive an average score for each self-
report (e.g., message acceptance, harm perceptions) and psychophysiological measure (e.g., heart 
rate, skin conductance, eye-tracking) for each vaping status. The overall rank for each message 
type will be calculated by taking the average of ranking scores of the crowdsourced and 
psychophysiological data across the measures within each message type. Each measure will be 
equally weighted, as a previous study using MADM has indicated no differences in ranks when 
weighting psychophysiological or self-report measures differently.54 We will use statistical 
software (e.g., Stata, SPSS, R) to conduct analysis.  
 
14. PROVISIONS TO MONITOR THE DATA TO ENSURE THE SAFETY OF SUBJECTS* 
The study presents minimal risk to participants for participating in the study. However, there is a 
possibility of the breach of confidentiality. Participants can opt out of the survey at any time 
during the study. Additionally, participants’ identities will never be revealed. Names, addresses, 
email addresses, or any other identifying information will not be collected. Participants are 
identified by a unique, randomly generated code at the end of the survey only to ensure they have 
completed it and are compensated. 
 
15. WITHDRAWAL OF SUBJECTS WITHOUT THEIR CONSENT* 
NA 
 
16. RISKS TO SUBJECTS* 
Risks to subjects involve being uncomfortable answering questions about tobacco use or seeing 
messages about negative health effects of using e-cigarettes. 
 
17. POTENTIAL DIRECT BENEFITS TO SUBJECTS* 
NA 
 
18. VULNERABLE POPULATIONS* 
• Students or employees: Students or employees of the University of Massachusetts 
Medical School will be eligible to enroll. Contacts with the study participants will be for 
assessment purposes only.  
• Adults unable to consent: They are ineligible to participate. 
• Subjects who are not yet adults (infants, children, teenagers): Individuals under the 
age of 18 are ineligible to participate.  
• Pregnant women: Pregnant women may be included in this research study. These 
requirements will be followed: No inducements, monetary or otherwise, will be offered to 
terminate a pregnancy. Individuals engaged in the research will have no part in any 
decisions as to the timing, method, or procedures used to terminate a pregnancy. 
Individuals engaged in the research will have no part in determining the viability of a 
neonate. 
• Neonates of uncertain viability or non-viable neonates: NA 
• Prisoners: We will not enroll or conduct research procedures with individuals that are 
known to be prisoners. We will not obtain any information regarding participants’ 
incarceration status. 
 
19. MULTI-SITE RESEARCH* 

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NA 
 
20. COMMUNITY-BASED PARTICIPATORY RESEARCH* 
NA 
 
21. SHARING OF RESEARCH RESULTS WITH SUBJECTS* 
Results of this research may be shared with other researchers upon request. We will not collect 
information linked to the identity of individual subjects. Additionally, dataset will be de-
identified to remove any identifying information, such as IP addresses, prior to sharing with 
other researchers. 
 
22. SETTING 
The study will take place online via Prolific, an online crowdsourcing platform. Participants may 
participate in the survey in any setting (e.g., home, library, computer lab) with computer or 
mobile devices with Internet access. The research team will conduct data entry and analysis from 
Albert Sherman building. It is possible that the research team conducts data entry and analysis 
outside the campus (e.g., research team members’ home). In such cases, they will be using the 
UMass Medical computer with the UMass Medical Secure network.” 
 
23. RESOURCES AVAILABLE 
The PI and postdoctoral fellow are responsible and accountable for the implementation of the 
study in accordance with the proposed plan. The postdoctoral fellow is responsible for obtaining 
the informed consent. The PI and the postdoctoral fellow hold a doctoral degree and has 
extensive human subjects research experience including the conduct of a variety of studies 
relevant to the current study. The postdoctoral fellow will devote 50% of their time to ensure the 
launch and completion of this study, as well as data cleaning, analysis, and dissemination. 
The PI and/or postdoctoral fellow will meet with any staff member involved with this research 
via Zoom and in person to ensure that they are fully informed about the protocol and the research 
procedures. Furthermore, the PI and/or postdoctoral fellow will meet with the staff members at 
least once a week to review their specific duties and functions (e.g., setting up study, data 
analysis).   
 
24. LOCAL RECRUITMENT METHODS 
We will recruit U.S. young adults (N=800; 18-24 years) identified as vapers (n=400) and 
susceptible non-vapers (n=400) to collect self-report measures. Vapers are defined as those who 
have vaped in the past 30 days,2,55 and susceptible non-vapers are defined as those who have 
never vaped, or those who have ever vaped but not in the past 30 days, but are susceptible to use 
as determined by the Susceptibility to Use Tobacco Products questionnaire.56 We will use 
Prolific, a crowdsourcing platform.57 Prolific is optimal for this type of behavioral experiment58 
because it allows a rapid collection of high quality data.57 Our team has successfully recruited 
participants and completed studies using Prolific.59,60 Using an online convenience sample has 
yielded comparable results with probability samples in prior tobacco survey research studies.61,62 
We will use Prolific’s screening features to recruit participants based on their vaping status 
(vapers and susceptible non-vapers), age (18-24 years), English fluency, and location (U.S.). We 
will use all data assurance measures (e.g., attention checks, manual review, bot inspection) for 
data quality, as we have done in past crowdsourced studies.59,63 Participants sign up to be on the 

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Prolific platform as participants and can self-select what studies they want to participate in. 
However, the study will not use advertisements to directly recruit participants for this study. 
Participants who complete the study will receive $4.00 via Prolific per its policies for 
participating in a 20-minute survey. This study will not be advertised specifically to recruit 
UMass Chan students. It is possible that UMass Chan students who signed up to be on the 
Prolific platform might participate in the study. 
 
25. LOCAL NUMBER OF SUBJECTS 
800 individuals who are age between 18 and 24 years old, speak English, current residents of the 
United States will participate in the study.  
 
26. CONFIDENTIALITY  
Questionnaire data will be collected using the Qualtrics data collection system via Prolific. IP 
addresses will not be collected. No identifiable data will be collected via the Qualtrics research 
system. Data will be collected anonymously with no direct or indirect link or awareness of who 
participated in the study. All data will be stored on a secure UMass Chan server. Data will be 
password protected and stored for seven years, then destroyed as is the standard in the health 
communication field. 
 
Dr. Stevens and the research coordinator (postdoctoral fellow) will be responsible for file 
maintenance. Participant consent form and survey and data will be stored on a password 
protected storage on a UMass Chan Medical secured network. Files will be reviewed once per 
week to ensure all documentation is securely stored. 
 
27. PROVISIONS TO PROTECT THE PRIVACY INTERESTS OF SUBJECTS 
All study activities will be conducted in a private setting. Subjects will be told that they can skip 
any question they wish. 
 
28. COMPENSATION FOR RESEARCH-RELATED INJURY 
This research presents minimal risk. No funds have been set aside for compensation. 
 
29. ECONOMIC BURDEN TO SUBJECTS 
None. 
 
30. CONSENT PROCESS 
Informed consent will be obtained using a Fact Sheet. All members of the research team will be 
trained in Human Subjects and HIPAA policies and procedures and the handling of data to 
ensure confidentiality in order to obtain Institutional Review Board (IRB) approval from UMass 
Chan. Researchers’ contact information (phone and email) will be provided with study 
description for participants to ask questions.   
 
31. PROCESS TO DOCUMENT CONSENT IN WRITING 
We will use a Fact Sheet to indicate that we will not document consent in writing since the 
research is minimal risk and involves no procedures that require a signature outside of the 
research context. 
 

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32. DRUGS OR DEVICES 
NA  
 
 
References 
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Direct Comparison of Smokers’ and Nonsmokers’ Psychophysiological and Self-Report 
Responses to Secondhand Smoke Anti-Tobacco PSAs. Health Commun. 2020;35(8):925-
934. doi:10.1080/10410236.2019.1598741 
2. Grandpre J, Alvaro EM, Burgoon M, Miller CH, Hall JR. Adolescent reactance and anti-
smoking campaigns: a theoretical approach. Health Commun. 2003;15(3):349-366. 
doi:10.1207/S15327027HC1503_6 
3. LaVoie NR, Quick BL, Riles JM, Lambert NJ. Are Graphic Cigarette Warning Labels an 
Effective Message Strategy? A Test of Psychological Reactance Theory and Source 
Appraisal. Commun Res. 2017;44(3):416-436. doi:10.1177/0093650215609669 
4. Fitzsimons GJ, Lehmann DR. Reactance to Recommendations: When Unsolicited Advice 
Yields Contrary Responses. Mark Sci. 2004;23(1):82-94. 
5. Pham N, Mandel N, Morales AC. Messages from the Food Police: How Food-Related 
Warnings Backfire among Dieters. J Assoc Consum Res. 2016;1(1):175-190. 
doi:10.1086/684394 
6. Pechmann C. Predicting When Two-Sided Ads Will Be More Effective than One-Sided 
Ads: The Role of Correlational and Correspondent Inferences. J Mark Res. 
1992;29(4):441-453. doi:10.2307/3172710 
7. O’Keefe DJ. How to Handle Opposing Arguments in Persuasive Messages: A Meta-
Analytic Review of the Effects of One-Sided and Two-Sided Messages. Ann Int Commun 
Assoc. 1999;22(1):209-249. doi:10.1080/23808985.1999.11678963 
8. Paek HJ, Hove T. Risk Perceptions and Risk Characteristics. Oxford Research 
Encyclopedia of Communication. doi:10.1093/acrefore/9780190228613.013.283 
9. Schmidt AM, Ranney LM, Pepper JK, Goldstein AO. Source Credibility in Tobacco 
Control Messaging. Tob Regul Sci. 2016;2(1):31-37. doi:10.18001/TRS.2.1.3 
10. Case KR, Lazard AJ, Mackert MS, Perry CL. Source Credibility and E-cigarette 
Attitudes: Implications for Tobacco Communication. Health Commun. 2018;33(9):1059-
1067. doi:10.1080/10410236.2017.1331190 
11. Guttman N, Peleg H. Public Preferences for an Attribution to Government or to Medical 
Research Versus Unattributed Messages in Cigarette Warning Labels in Israel. Health 
Commun. 2003;15(1):1-25. doi:10.1207/S15327027HC1501_1 
12. Zagona SV, Harter MR. Credibility of source and recipient’s attitude: Factors in the 
perception and retention of information on smoking behavior. Percept Mot Skills. 
1966;23(1):155-168. doi:10.2466/pms.1966.23.1.155 

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13. Villanti AC, LePine SE, West JC, et al. Identifying message content to reduce vaping: 
Results from online message testing trials in young adult tobacco users. Addict Behav. 
2021;115:106778. doi:10.1016/j.addbeh.2020.106778 
14. Cuccia AF, Patel M, Kierstead EC, Evans WD, Schillo BA. Associations of e-cigarette 
industry beliefs and e-cigarette use and susceptibility among youth and young adults in 
the United States. Drug Alcohol Depend. Published online October 27, 2021:109126. 
doi:10.1016/j.drugalcdep.2021.109126 
15. Rohde JA, Noar SM, Prentice-Dunn H, Kresovich A, Hall MG. Comparison of Message 
and Effects Perceptions for The Real Cost E-cigarette Prevention Ads. Health Commun. 
2021;36(10):1222-1230. doi:10.1080/10410236.2020.1749353 
16. Graham AL, Amato MS, Cha S, Jacobs MA, Bottcher MM, Papandonatos GD. 
Effectiveness of a Vaping Cessation Text Message Program Among Young Adult e-
cigarette Users: A Randomized Clinical Trial. JAMA Intern Med. 2021;181(7):923-930. 
doi:10.1001/jamainternmed.2021.1793 
17. England KJ, Edwards AL, Paulson AC, Libby EP, Harrell PT, Mondejar KA. Rethink 
Vape: Development and evaluation of a risk communication campaign to prevent youth 
E-cigarette use. Addict Behav. 2021;113:106664. doi:10.1016/j.addbeh.2020.106664 
18. Hair EC, Kreslake JM, Rath JM, Pitzer L, Bennett M, Vallone D. Early evidence of the 
associations between an anti-e-cigarette mass media campaign and e-cigarette knowledge 
and attitudes: results from a cross-sectional study of youth and young adults. Tob 
Control. Published online July 21, 2021. doi:10.1136/tobaccocontrol-2020-056047 
19. Gramlich J. Young Americans are less trusting of other people – and key institutions – 
than their elders. Pew Research Center. Accessed January 4, 2022. 
https://www.pewresearch.org/fact-tank/2019/08/06/young-americans-are-less-trusting-of-
other-people-and-key-institutions-than-their-elders/ 
20. Rainie L, Perrin A. Key findings about Americans’ declining trust in government and 
each other. Pew Research Center. Accessed January 4, 2022. 
https://www.pewresearch.org/fact-tank/2019/07/22/key-findings-about-americans-
declining-trust-in-government-and-each-other/ 
Appendix A. Copies of the messages 
 
* Before seeing each message, participants will view one of the four directions below according 
to their assigned source condition. 
Condition 
Expert 
Peer 
Expert 1 
Government 
health org 
Expert 2 
Medical school 
researcher 
Peer 1 
Young adults 
Peer 2 
Influencers 
Directions 
Imagine that a 
world-renowned 
Imagine that 
your doctor 
Imagine that 
your best friend 
Imagine that a 
social media 

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scientist wrote 
this message. 
wrote this 
message. 
wrote this 
message.. 
influencer that 
you follow wrote 
this message.  
 
Messages with Sidedness Manipulation 
One-sided 
Two-sided 
Sleek design hides a deadly truth that can harm 
your health. Vapes contain ingredients that can 
cause cancer. 
You may want to vape because of the sleek 
design. But these cool looks hide a deadly truth. 
Vapes contain ingredients that can cause 
cancer.  
Vapes have ingredients that cause lung disease 
and cancer that are not “just vapor.” 
You may want to vape because you may think 
it’s “just vapor.” But that’s not true. Vapes have 
ingredients that cause lung diseases and 
cancer.  
Most vapes have formaldehyde, a toxic 
chemical. You wouldn't drink formaldehyde. 
Why would you vape it?  
You may want to vape because you don’t think 
it’s bad for you. But don’t vape. Most vapes 
have formaldehyde, a toxic chemical. You 
wouldn’t drink formaldehyde. Why would you 
vape it? 
You may have trouble breathing from vaping. 
Vape flavors may cause lung damage 
Vapes come in cool flavors that can make you 
want to vape. But these flavors can cause lung 
damage and trouble breathing.  
Chemicals in these vape flavors can hurt your 
lungs. 
Tempting flavors like cinnamon roll and very 
vanilla can make you want to vape. But in 
truth? Chemicals in these vape flavors can hurt 
your lungs. 
Chemicals in these vape flavors can cause cell 
and lung damage. 
We get why you may want to vape. Vapes come 
in flavors like sugar and spice and everything 
nice. But NOPE. Chemicals in vapes can cause 
cell and lung damage. 
People who vape are more likely to have signs 
of depression. What a vibe check. 
You may want to vape for cool vibes. But don’t 
trade it with your mental health. People who 
vape are more likely to have signs of 
depression. What a vibe check. 
The coughing caused by lung damage from 
vaping? Not a good look. 
You may want to vape because Influencers 
make vaping look cool. But don’t be tricked by 
social media. The coughing caused by lung 
damage? That’s not a good look. 
You know what will never be cool? The lung 
damage caused by vaping.  
You may want to vape because vaping is going 
viral. But you know what will never be cool? 
The lung damage caused by vapes. 
Vape addiction is REAL. If you’ve been extra 
salty lately, that might be nicotine withdrawal.  
You may want to vape for good mood. But 
vaping can make you feel worse. Have you or 

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your friends been extra salty lately? That might 
be nicotine withdrawal. Vape addiction is REAL. 
Nicotine addiction means losing your 
independence. Don’t get chained to your vape.  
You may feel free when you’re vaping. But 
nicotine addiction means losing your 
independence. Don’t get chained to your vape. 
Take a hard pass at catchy terms like “JUUL 
Buzz.” It just means nicotine addiction.  
Seeing catchy terms like “JUUL Buzz” can make 
you want to vape. But that just means nicotine 
addiction. Hard pass. 
Don't get hooked by the flavors. Some pods 
have as much nicotine as a whole pack of 
cigarettes. 
The flavors can make you want to vape. But 
don’t get hooked by the flavors. Some pods 
have as much nicotine as a whole pack of 
cigarettes. 
You’re not just vaping flavor. Don’t get hooked. 
Some pods contain as much nicotine as 20 
cigarettes. 
You may want to vape because vape companies 
say that you're just vaping flavor. But don’t get 
hooked. Some pods contain as much nicotine as 
20 cigarettes.  
Most vape products contain nicotine. Don't get 
hooked by the flavors. Nicotine addiction won't 
give you much of a choice. 
The limitless flavors can make you want to 
vape. But don't get hooked. Most vape 
products contain nicotine. Nicotine addiction 
won't give you much of a choice.  
JUUL pods contain nicotine - as much as a pack 
of cigarettes. Do your friends get salty if they 
haven't had a hit? That's nicotine addiction.  
It may be fun to hit that vape with your friends. 
But do your friends get salty if they haven’t had 
a hit? That’s nicotine addiction. JUUL pods 
contain nicotine - as much as a pack of 
cigarettes. 
Nicotine addiction makes people moody and 
hard to be around, which really kills the vibe. 
You may want to hit that vape with your 
friends. But vaping with friends leads to fighting 
with friends. Nicotine addiction makes people 
moody and hard to be around, which really kills 
the vibe. 
Don’t trade nicotine addiction to be on trend. 
You’ll be hooked forever. 
You may want to vape because it’s today’s big 
thing, but you’ll be hooked forever. Don’t trade 
nicotine addiction to be on trend. 
 

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Template Revised 12/21/2020 
Appendix B-1. 
Health harm of nicotine 
Thank you for taking our survey.  
E-cigarettes are not safe. If you vape e-cigarettes, you could be inhaling seriously addictive 
levels of nicotine. Nicotine in tobacco can damage your brain, increase the chance of having a 
heart attack, and decrease your immune system. Any tobacco products – including e-cigarettes, 
cigarettes, e-cigarettes, smokeless tobacco like dip, cigars, cigarillos, hookah, roll-your-own – 
are always dangerous. The only safe tobacco is NO tobacco. For more information about the 
harms of tobacco and nicotine, please visit:  
https://therealcost.betobaccofree.hhs.gov/vapes 
 
https://www.thetruth.com/breathofstressair?cid=vap_search_googlepaidsearch_truth_brand_BOS
A&gad=1&gclid=CjwKCAjwtuOlBhBREiwA7agf1mx8urYu2Ws_aoxOKuvW7id_4yUBQItPrS
cQfVuvxlnwzL-cQrkQ4xoCefIQAvD_BwE 
 
Sources:  
U.S. Department of Health and Human Services (n.d.). The Real Cost. 
https://therealcost.betobaccofree.hhs.gov/vapes 
 
Mishra A, Chaturvedi P, Datta S, Sinukumar S, Joshi P, Garg A. Harmful effects of nicotine. 
Indian J Med Paediatr Oncol. 2015;36(1):24-31. doi:10.4103/0971-5851.151771 
 
Appendix B-2. 
 
Quit vaping or support someone in their quit attempt 
My Life, My Quit 
 
My Life, My Quit™ is a specially designed program to help young people quit vaping or other 
tobacco products. My Life, My Quit™ provides five free and confidential coaching sessions by 
phone, live texting, or chat with a specially-trained youth coach. You can text “Start My Quit” to 
36072 or call toll-free 1-855-891-9989 for real-time coaching.  You can also 
visit mylifemyquit.com to sign up online, chat with a live coach, get information about vaping 
and tobacco, and activities to help them quit. The program can send out materials and a 
certificate at the end of the program. 
This is Quitting 
 
This is Quitting powered by truth® is a texting program for young people who want to quit 
vaping. It is a free, confidential 60-day program during which participants receive texts with 
information, tips, and support. They receive daily text messages to help them prepare to quit and 
supportive texts from young people who have been through the program and know what it’s like 
to quit. They can also text COPE, SLIP, STRESS, or MORE at any time for instant support, or 

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Template Revised 12/21/2020 
MASSINFO for information specific to Massachusetts.  Young people can sign up even if you 
they aren’t ready to quit – the texts they receive will give them strategies and practice quits to 
help build confidence and help them feel ready to quit. 
To enroll in the program, youth text “VapeFreeMass” to 88709.  Youth can also connect with 
their school nurse, counselor, or coach to help get them started. 
Parents and other adults can also text QUIT to 202-899-7550 to sign up to receive text messages 
designed specifically for parents of vapers. 
Source: National Jewish Health (2023). MyLifeMyQuit. https://www.mylifemyquit.com/ 
eIRB Section 7.0 Attachments Upload Checklist 
Follow How to Manage Files in eIRB and upload the following items as applicable to your 
submission. This checklist is provided for your convenience and is not a requirement for review. 
 
 
Investigator Study Plan 
 
Sponsor protocol 
 
Research portion of the grant 
 
Human subjects portion of the grant 
 
Written approvals from ancillary reviews (Clinical Engineering, COI, IBC, PRC, RSC, 
Students as Subjects, etc.) 
 
Recruitment materials such as flyers, brochures, posters, scripts of radio ads, etc. 
 
Data collection sheets, case report forms, etc. 
 
Surveys, measures, instruments, etc. 
 
Measures to assess capacity to consent 
 
DMC or DSMB charter 
 
Data safety monitoring plan 
 
Adverse event log 
 
Investigator brochure or package insert for drugs  
 
Instructions for use or approved FDA labeling for devices 
 
Sponsor justification or FDA documentation for non-significant risk device study  
 
IND or IDE documentation 
 
Patient information sheet for Humanitarian Use Device 
 
Approval order for Humanitarian Use Device 
 
Product labeling for Humanitarian Use Device 
 
HIPAA waiver 
 
HIPAA authorization 
 
Authorization to contact form 
 
Consent form(s) 
 
Assent forms(s) 
 
Fact sheet(s) 
 
Multi-site communication plan 
 
Study staff training plan 
 
SOPs or Manuals of Operations 

INVESTIGATOR STUDY PLAN - REQUIRED 
 
 
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Template Revised 12/21/2020 
 
Screening log 
 
Compensation log 
 
Certificates of translation or translator attestations 
 
Data use agreements, memoranda of understanding,  
 
Documentation of data/specimen anonymity (i.e., provider will never break the code)