COMET Study 2: Effects of Cigarette and E-cigarette Flavor Restrictions on Cigarette Demand and Substitution in the Experimental Tobacco Marketplace
Phase: NA
Conditions: Tobacco Use Disorder
Sponsor: Virginia Polytechnic Institute and State University

 
 
 
Effects of Cigarette and E-cigarette flavors on Substitutability in the Experimental Tobacco 
Market Place 
NCT05110872    
03/05/2019 

20-008 Effects of Cigarette and E-cigarette flavors on Substitutability in the 
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INSTRUCTIONS: 
● Use this “TEMPLATE PROTOCOL (HRP-503)” to prepare a study protocol 
outlining your research plan.  
● Depending on the nature of your study, some major sections might not be 
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create a new paragraph wherever you need to make a change, and indicate 
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management will store the older versions of your protocol if the IRB or HRPP 
staff need to compare them during the review. 
 
PROTOCOL TITLE:  
Include the full protocol title.  
Effects of filter ventilation and e-cigarette restrictions on cigarette demand and 
substitution in the Experimental Tobacco Marketplace 
 
PROTOCOL NUMBER:   
Include the number assigned in Protocol Management (verify this has been added 
before submitting protocol to HRPP).  
 
VT IRB # 20-827 
 
PRINCIPAL INVESTIGATOR: 
Full Name and Degrees: Warren K. Bickel, PhD 
Department: Fralin Biomedical Research Institute at VTC 
Telephone Number: 540 526 2088  
Email Address: wkbickel@vtc.vt.edu 
 
FUNDING: 
 
Sponsor(s): National Institutes of Health, National Cancer Institute - grant 
5P01CA200512. 
 
Funded already or in the proposal phase?: Funded 
Is Virginia Tech the primary awardee or the coordinating center of this grant or 
contract? If not, list the primary institution: University of Minnesota. This 

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experiment is part of Project 3 of an NIH/NCI P01 Grant awarded to University of 
Minnesota (5P01CA217806-03). Virginia Tech is receiving a subcontract for 
Project 3. All of the human subject research activities for Project 3, including this 
experiment will be carried out by Virginia Tech.  
 
 
VERSION NUMBER/DATE:  
Include the version number and date of this protocol. Versions should start at 1.0. 
Version 1.0 09/30/2020 
 
REVISION HISTORY:  
Use this table to keep track of changes. Add more rows as needed. 
 
Revision 
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Table of Contents 
1.0 
Study Summary 
4 
2.0 
Objectives 
4 
3.0 
Background 
5 
4.0 
Study Endpoints 
10 
5.0 
Study Design and Statistical Analysis Plan 
10 
6.0 
Setting 
11 
7.0 
Study Intervention(s)/Investigational Agent(s) 
12 
8.0 
Procedures Involved 
13 
9.0 
Data and Specimen Long Term Storage and Use 
17 
10.0 Sharing of Results with Subjects 
19 
11.0 Study Timelines 
19 
12.0 Inclusion and Exclusion Criteria 
19 
13.0 Vulnerable Populations 
20 
14.0 Number of Subjects 
21 
15.0 Recruitment Methods 
22 
16.0 Withdrawal of Subjects 
24 
17.0 Risks to Subjects 
24 
18.0 Potential Benefits to Subjects 
26 
19.0 Data Management and Confidentiality 
27 
20.0 Provisions to Protect the Privacy Interests of Subjects 
28 
21.0 Provisions to Monitor the Data to Ensure the Safety of Subjects 
30 
22.0 Compensation for Research Related Injury 
30 
23.0 Economic Burden to Subjects 
31 
24.0 Consent Process 
31 
25.0 Process to Document Consent in Writing 
34 
26.0 Resources Available 
35 
27.0 Multi-Site Research 
36 
 
 
 

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1.0 
Study Summary 
 
Study Title 
Effects of filter ventilation and e-cigarette restrictions on 
cigarette demand and substitution in the Experimental 
Tobacco Marketplace 
Study Design 
This study uses a mixed design (within-subject repeated 
measures and between-group). Participants will be assigned 
to four different groups according to their preferred cigarette 
ventilation (ventilated and non-ventilated) and flavor 
(tobacco/menthol). Every participant will complete a few 
behavioral tasks, and make hypothetical purchases of 
tobacco products in an online store under four different 
scenarios: a) e-cigarette flavor restricted and e-cigarette 
nicotine restricted, b) e-cigarette flavor restricted and e-
cigarette nicotine restricted, c) e-cigarette flavor restricted 
and e-cigarette nicotine restricted, d) e-cigarette flavor 
restricted and e-cigarette nicotine restricted. 
Primary Objective 
To examine the effects of filter ventilation and e-cigarette 
restrictions (on flavor and nicotine concentration 
availability) on cigarette demand and substitution in the 
Experimental Tobacco Marketplace 
Secondary 
Objective(s) 
N/A 
Study Population 
Cigarette smokers 
Sample Size 
268 completers 
Research 
Intervention(s)/ 
Investigational 
Agent(s)  
A survey consisting of questionnaires and behavioral tasks.   
Study Duration for 
Individual 
Participants 
This will be a one-session study that participants will 
complete remotely including consent, ETM purchases, and 
assessments (approximately 30 minutes).  
Acronyms and 
Definitions  
ETM: Experimental Tobacco Marketplace 
FBRI: Fralin Biomedical Research Institute  
VTCRC: Virginia Tech Corporate Research Center  
 
 
2.0 
Objectives 
2.1 Describe the purpose, specific aims, or objectives of this study: 
 
Purpose: To examine the effects of filter ventilation and e-cigarette restrictions (on flavor 
and nicotine concentration) on cigarette demand and the corresponding degree to which 
e-cigarettes and other non-combustible tobacco products substitute for cigarettes. 
 

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2.2 State the hypotheses to be tested:  
 
This study is designed to better understand the effect of possible e-cigarette restrictions. 
We hypothesize that e-cigarette restrictions will decrease substitution for e-cigarettes, 
with the smallest degree of substitution when both flavors and nicotine concentration are 
restricted. 
 
3.0 
Background 
3.1 Summarize the relevant prior research on this topic and gaps in current 
knowledge within the field of study: 
 
The Food and Drug Administration (FDA) was granted authority in 2009 to establish 
tobacco product standards if those standards are reasonably expected to benefit the public 
health. One product feature that could be changed is cigarette filter ventilation. A recent 
review examined the effects of cigarette filter ventilation and concluded that filter 
ventilation, by changing how a cigarette burns, yields more mutagens and carcinogens, 
and results in greater puff volume and possibly depth of inhalation, which has led to 
increases in peripheral lung adenocarcinomas (1). This, along with the ability to 
manipulate systemic levels of nicotine by altering smoking behavior, as well as 
misconceptions about the lower toxicity of filter ventilation, may have also contributed to 
the use, appeal, and abuse liability of ventilated cigarettes. The extent to which 
commercial cigarettes are ventilated vary substantially in the market by brand, ranging 
from 0 to 80%. However, smokers compensate for the lower nicotine yields associated 
with higher ventilation by varying their puffing behavior, number of cigarettes per day, 
and blocking some portion of the ventilation holes. This compensatory behavior exposes 
smokers to more tobacco smoke constituents than would be indicated by machine 
smoking tests. Regulatory action that reduces or eliminates cigarette ventilation would 
not only reduce exposure to smoke constituents by increasing nicotine yield per cigarette, 
but also change the smoker’s experience, likely resulting in harsher taste that may be 
proportional to the ventilation in a given cigarette brand. The potentially large effect on 
taste and preference corresponding to cigarette ventilation could alter the appeal and 
abuse liability of these products and could inform regulatory actions. However, 
eliminating filter ventilation raises a variety of questions that constitute a gap in our 
knowledge and must be answered to assess the potential for adverse unintended 
consequences of removing filter ventilation. We will explore these questions within a 
behavioral economic framework. 
 
Behavioral economic demand analyses can be used to understand the level of motivation 
to consume a product on either an individual or small group level, including cigarettes 
(2,3). This level of analysis allows for experimental manipulations to be made on 
variables of interest. By quantifying how consumption decreases as costs increase to 
obtain and consume a product, important indices of demand are obtained. These indices 
can be grouped into two main measures of consumption, demand intensity and demand 

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elasticity, which are associated with use level and dependence severity (3,4,5,6). Demand 
intensity is the amount of the commodity consumed when available at very low cost 
(approaching free), and demand elasticity quantifies the degree to which the individual is 
willing to increase monetary or effort-based expenditures to maintain the same level of 
consumption as costs increase. Elasticity of demand has been shown to be a characteristic 
of the drug itself and independent of drug dose for many drugs including nicotine (2,7,8). 
While drug demand plotted as a function of unit price has been often shown to be a 
function of the total drug consumed, some of our prior research with cigarette demand 
calls this conclusion into question. A prior study we conducted (9) compared 
conventional cigarettes to denicotinized cigarettes. We found that, if these denicotinized 
cigarettes were the only tobacco product available, the denicotinized cigarettes had 
comparable demand to nicotinized cigarettes. If both were available, however, 
participants preferred the nicotinized cigarettes. This suggests that cigarette demand is 
not strictly regulated by nicotine dose, and that there is substantial abuse liability 
associated with other aspects of cigarettes (e.g., sensory components) apart from any 
nicotine content. Relevant to this point and the current application, we conducted a pilot 
study, where conventional ventilated cigarette smokers purchased either their usual 
cigarettes (ventilated) or their usual cigarettes with the filter vents blocked. When each 
cigarette type was available alone in separate sessions, demand for both products was 
very similar. However, in a separate session in which both cigarette types were available 
concurrently at equivalent unit prices, ventilated cigarettes were clearly preferred at all 
prices. These findings suggest that to fully understand the abuse liability of cigarettes will 
require that they are studied in contexts where other products are available (e.g., 
substitution). 
 
Substitution is defined as an increase in the consumption of a constant-priced product 
while the cost of a different commodity is increased. For example, we have shown that as 
the price of conventional cigarettes is increased and its consumption decreased, the 
consumption of nicotine gum increased even though its price remained constant (10). 
Substitution defines one end of a continuum of interactions between two commodities. At 
the other end of that continuum, commodities can also function as complements. 
Complementarity refers to the decreased consumption of a constant-priced product in 
response to an increase in the price of a different commodity. For example, the research 
team has previously shown that as the price of cigarettes increased, consumption of 
coffee decreased even though its price remained constant (11). Between these two 
extremes is independence, which occurs when changes in the price of one commodity 
have little or no effect on consumption of another commodity where price has remained 
unchanged. Substitution, complementarity, and independence are measured by cross-
price elasticity of demand and are represented by values that are positive, negative, or 
near zero, respectively. Studies to date have almost exclusively examined only pairs of 
products and, in even fewer cases, three concurrently available commodities. For 
example, in one of our studies smokers had access to conventional cigarettes, 
denicotinized cigarettes, and nicotine gum13. When the price of conventional cigarettes 
increased, consumption of both denicotinized cigarettes and nicotine gum increased even 
though their prices were fixed. Thus, denicotinized cigarettes and nicotine gum 
functioned as substitutes for conventional cigarettes. Indeed, by concurrently using both 

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products, the smoker could reproduce both the central and sensory effects of standard 
cigarettes by consuming the denicotinized cigarette (i.e., sensory effects) and nicotine 
gum (i.e., central effects). Importantly, denicotinized cigarettes functioned as a better 
substitute than gum (the use of denicotinized cigarettes increased the most). This effect 
could not have been predicted from the individual demand curves with these 
commodities. Only when they were measured together did these complex interactions 
emerge. Lastly, in this experiment consumption of conventional cigarettes was greatest 
when it was the only available product, and was least when denicotinized cigarettes or 
both alternatives were available. This finding demonstrates that cigarette demand was 
altered by the presence of alternative products and that under some conditions multiple 
products will be used concurrently. However, this and similar studies are constrained by 
arbitrary circumstances of the laboratory, such as required nicotine deprivation, 
constrained consumption of a product (e.g., 1 cigarette puff per self-administration), long 
and numerous sessions (e.g., one, 3-hour session for each price examined). As such, these 
methods cannot and do not come close to replicating the ever more complex tobacco 
marketplace and underscore the gap in the understanding of how to examine these 
relationships among a large number of products that approximate the real world.  
 
To address this methodological gap and to inform how various products may interact, we 
have developed and tested a novel method called the Experimental Tobacco Marketplace 
(ETM). The ETM is a systematic extension of similar marketplace methods used with 
other consumer products (e.g., food marketplaces used in obesity and other nutrition-
related research). In experimental marketplaces, multiple products are available and the 
experimenter controls the prices for each. These marketplaces can be either physical or 
virtual stores (similar to online retailers) and permit the examination of price effects and 
an assessment of degree of substitution or complementarity in consumer behavior under 
conditions that approximate naturalistic settings. One such study (12) examined foods 
purchased by mothers when less healthy foods were taxed (increased price) and healthier 
foods were subsidized (decreased price). These authors found that taxing less healthy 
food reduced caloric intake and proportion of calories from fat, while increasing the 
amount of protein consumed. Alternatively, subsidizing healthier foods did not change 
the macronutrient profile of foods purchased while increasing energy intake. In a review 
of this emerging area of nutritional research, Epstein and colleagues noted that “price 
changes modify purchases of targeted foods, but research on the overall nutritional 
quality of purchases is mixed because of substitution effects” (p. 789; (13)). This 
statement suggests the importance of exploring regulatory options in complex 
marketplaces. The ETM developed by the investigative team is similar to an online store, 
that displays pictures, information, and prices for several tobacco/nicotine products. In a 
recent study of ours (14), smokers were endowed with an amount of money comparable 
to their weekly tobacco purchases. They then made tobacco product purchasing decisions 
while the price of conventional cigarettes was varied and the price of 5 other tobacco 
products remained constant. Purchasing decisions from one, randomly selected cigarette 
price was actualized and smokers were provided the products purchased and any unspent 
account balance. Smokers returned one week later to report tobacco/nicotine use and 
return unused products for a refund. Cigarette consumption decreased as a function of 
price. As the price of cigarettes increased, consumption of snus, electronic cigarettes, and 

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nicotine lozenges showed the greatest substitution. Importantly, this approach moves 
beyond the constraints of previous laboratory studies by permitting the study of 
tobacco/nicotine preference and consumption under conditions that typically occur in 
most smokers’ lives, including not being nicotine deprived, consuming the products in 
their natural environment, selecting the products they wish from a large number of 
products, and consuming the products while engaging in normal daily activities. 
 
In this experiment, we will ascertain the impact of e-cigarette restrictions (on flavor and 
nicotine concentration availability) on cigarette demand and substitution in the ETM 
across a range of cigarette prices to model the effect of ventilation. We will assess these 
measures in each of four smoker subtypes: unventilated menthol smokers, ventilated 
menthol smokers, unventilated non-menthol smokers, ventilated non-menthol smokers. 
For this purpose, ventilated and unventilated cigarettes will be defined as ≥20% and 
<10% filter ventilation, respectively. Thus, in this experiment, we will examine whether 
the effects of e-cigarette restrictions differ by smoker subtype.  
 
 
References 
 
1. Song M, Benowitz N, Berman M, ...et al. Cigarettes filter ventilation and its 
relationship to increasing rates of lung adenocarcinoma (under review). 
2. Bickel, W. K., DeGrandpre, R. J., Hughes, J. R. & Higgins, S. T. Behavioral 
economics of drug self-administration. II. A unit-price analysis of cigarette smoking. J. 
Exp. Anal. Behav. 55, 145–154 (1991). 
3. MacKillop, J. et al. Further validation of a cigarette purchase task for assessing the 
relative reinforcing efficacy of nicotine in college smokers. Exp. Clin. Psychopharmacol. 
16, 57–65 (2008). 
4. Murphy, J. G., MacKillop, J., Tidey, J. W., Brazil, L. A. & Colby, S. M. Validity of a 
demand curve measure of nicotine reinforcement with adolescent smokers. Drug Alcohol 
Depend. 113, 207–214 (2011). 
5. MacKillop, J. et al. Latent structure of facets of alcohol reinforcement from a 
behavioral economic demand curve. Psychopharmacology 203, 33–40 (2008). 
6. MacKillop, J. et al. Alcohol demand, delayed reward discounting, and craving in 
relation to drinking and alcohol use disorders. J. Abnorm. Psychol. 119, 106–114 (2010). 
7. Hursh, S. R. & Roma, P. G. Behavioral economics and empirical public policy. J. Exp. 
Anal. Behav. 99, 98–124 (2013). 
8. Hursh, S. R. & Winger, G. Normalized demand for drugs and other reinforcers. J. Exp. 
Anal. Behav. 64, 373–384 (1995). 
9. Shahan, T. A., Bickel, W. K., Madden, G. J. & Badger, G. J. Comparing the 
reinforcing efficacy of nicotine containing and de-nicotinized cigarettes: a behavioral 
economic analysis. Psychopharmacology 147, 210–216 (1999). 
10. Johnson, M. W. & Bickel, W. K. The behavioral economics of cigarette smoking: 
The concurrent presence of a substitute and an independent reinforcer. Behav. Pharmacol. 
14, 137–144 (2003). 

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11. Bickel, W. K., Hughes, J. R., De Grandpre, R. J., Higgins, S. T. & Rizzuto, P. 
Behavioral economics of drug self-administration. Psychopharmacology 107, 211–216 
(1992). 
12. Epstein, L. H., Dearing, K. K., Roba, L. G. & Finkelstein, E. The influence of taxes 
and subsidies on energy purchased in an experimental purchasing study. Psychol. Sci. 21, 
406–414 (2010). 
13. Epstein, L. H. et al. Experimental research on the relation between food price changes 
and food-purchasing patterns: a targeted review. Am. J. Clin. Nutr. 95, 789–809 (2012). 
14. Quisenberry, A. J., Koffarnus, M. N., Hatz, L. E., Epstein, L. H. & Bickel, W. K. The 
Experimental Tobacco Marketplace I: Substitutability as a Function of the Price of 
Conventional Cigarettes. Nicotine Tob. Res.(2015). doi:10.1093/ntr/ntv230 
15. Benowitz, N. L. & Others. Compensatory smoking of low-yield cigarettes. National 
Cancer Institute. Risks associated with smoking cigarettes with low machine yields of tar 
and nicotine. Smoking and Tobacco Control Monograph No 13, 39–63 (2001). 
16. Frost, C. et al. The tar reduction study: randomised trial of the effect of cigarette tar 
yield reduction on compensatory smoking. Thorax 50, 1038–1043 (1995). 
17. Robinson, J. C., Young, J. C., Rickert, W. S., Fey, G. & Kozlowski, L. T. A 
Comparative Study of the Amount of Smoke Absorbed From Low Yield (‘Less 
Hazardous’) Cigarettes Part 2: Invasive Measures. Br. J. Addict. 78, 79–87 (1983).      
 
3.2 Describe any relevant preliminary data: 
 
The Experimental Tobacco Marketplace (ETM) [6], a novel method recently developed, 
permits estimates of the effects of new policies and products on consumption and 
substitution in the tobacco marketplace. This methodology places the mix of products, 
prices, and specific policies under experimental control so as to provide estimates of 
novel policies obtained under conditions that simulate “real world” circumstances. This 
approach provides insight into how a given policy may alter consumption, preferences, 
and substitution among tobacco products. As part of this grant, one previous study has 
examined the effect of removing filter ventilation on nicotine product consumption. 
Preliminary analysis shows that exposure to unventilated cigarettes might decrease 
demand for ventilated cigarettes and increase substitution for unventilated cigarettes. The 
manuscript is currently in preparation.  
 
6. Bickel WK, Pope DA, Kaplan BA, et al. Electronic cigarette substitution in the 
experimental tobacco marketplace: A review. Prev Med 2018;117:98–106. 
doi:10.1016/j.ypmed.2018.04.026 
 
3.3 Based on the existing literature, provide the scientific or scholarly 
rationale for and significance of your research and how will it add to 
existing knowledge: 
 

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No study to date has experimentally examined the effects of e-cigarette restrictions on 
demand for unventilated and ventilated cigarettes and substitution for other tobacco 
products. The rationale for this specific proposal is to explore prospectively the possible 
consequences of e-cigarette restrictions on consumption and substitution with tobacco 
products among ventilated and unventilated smokers. The results might inform tobacco 
control policies. 
4.0 
Study Endpoints 
4.1 Describe the primary and secondary study endpoints. See links below for 
discussion of study endpoints and how they may differ from study 
objectives. These are most common in clinical trials but are sometimes 
applicable to other types of biomedical research, as well as social, 
behavioral, or educational research. See link below for a discussion. 
https://docs.google.com/document/d/1Wocz7K7a0hCQJPPO_khh5l1
SQQjhGDDGHzcOPRHR5Tw/edit?usp=sharing  
 
Substitutability: all groups will be compared to assess whether substitutability 
with tobacco products occurs as a function of different flavor and nicotine 
restrictions and cigarette price. 
 
4.2 Describe any primary or secondary safety endpoints. These should be 
included for all studies that are greater than minimal risk. (Minimal risk: 
The probability and magnitude of harm or discomfort anticipated in the 
research that are not greater in and of themselves than those ordinarily 
encountered in daily life or during the performance of routine physical or 
psychological examinations or tests.): 
 
This study will recruit adults who regularly smoke cigarettes. This study’s procedures are 
not designed to increase daily nicotine use and we do not anticipate any increased risk to 
participants directly from this study. 
 
5.0 
Study Design and Statistical Analysis Plan 
5.1 Describe the basic study design/approach (e.g., qualitative study using five 
focus groups of first year students to describe assimilation into the 
university community; randomized controlled trial of a behavioral change 
intervention to increase dietary intake of whole grains; pre- post-test 
evaluation of new pedagogical techniques to improve adult literacy): 
 
In a one-session study, participants will complete assessments and purchase tobacco 
products in a hypothetical ETM. All participants will complete four ETM conditions, all 
of which include five trials assessing different prices of their preferred cigarette. In each 

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ETM condition, participants will purchase tobacco/nicotine products for a 7-day 
period. Unventilated and ventilated cigarettes, as well as a range of other products (i.e., 
lozenges, snus, gums, and dip), will be always available. Availability of e-cigarettes will 
vary according to the following conditions: 
A) Nicotine restricted and flavor restricted 
B) Nicotine unrestricted and flavor restricted 
C) Nicotine restricted and flavor unrestricted 
D) Nicotine unrestricted and flavor unrestricted 
Participants will be exposed to these restriction conditions across purchasing scenarios in 
a counterbalanced order.  
 
5.2 Describe corresponding data analysis plan/approach (e.g., content analysis 
of focus group transcripts; descriptive analysis followed by linear 
regression modeling; nonparametric analysis of pre- and post-test 
measures): 
 
The analysis of each group will assess whether substitutability occurs as a function of 
different e-cigarette conditions. The relationship between consumption and condition will 
be modeled according to: 
𝑦𝑖𝑗= 𝜇+ 𝛼𝑖+ 𝜏𝑗+ 𝜀𝑖𝑗, 
where 𝑦𝑖𝑗 represents the average log consumption for the ith e-cigarette restriction and 
the jth subject, 𝛼𝑖 is the effect of the ith condition on log consumption, 𝜏𝑗 is the effect of 
the jth subject, 𝜀𝑖𝑗 is the error term,  i=1, 2, 3, 4 and j=1,…,n.   
 
Additionally, all the groups will be compared to assess whether substitutability occurs as 
a function of different e-cigarette conditions. The relationship between consumption and 
condition will be modeled according to: 
𝑦𝑖𝑗𝑘= 𝜇+ 𝛼𝑖∗𝑏𝑗+ 𝜏𝑘+ 𝜀𝑖𝑗𝑘, 
where 𝑦𝑖𝑗𝑘 represents the average log consumption by condition for the ith e-cigarette 
restriction, in the jth smoking status and the kth subject, 𝛼𝑖 is the effect of the ith 
condition on log consumption, 𝑏𝑘 is the effect of the jth group on log consumption 𝜏𝑘 is 
the effect of the kth subject, 𝜀𝑖𝑗𝑘 is the error term,  i=1, 2, 3, 4, j=1, 2, 3, 4 and k=1,…,n.  
 
Additional analyses might be conducted.   
 
 
6.0 
Setting 
6.1 Describe the sites or locations where your research team will conduct the 
research.  Consider each of the items listed below: 
● 
Identify where your research team will identify and recruit potential 
subjects. 
● 
Identify where the team will perform the research procedures. 
● 
Describe the composition and involvement of any community 
advisory board(s). 

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● 
For research conducted in other locations, describe: 
o 
Site-specific regulations or customs affecting the research at 
those locations. 
o 
Local scientific and ethical review structure at those locations.  
Examples include work in other cultures or ethnic groups 
(within or outside of the U.S.) and work with churches. The 
HRPP will provide additional guidance for international 
research. 
 
Recruitment: This study will use a contracted survey firm panel, Ipsos Public Affairs, 
LLC, which contains approximately 60,000 members via an address-based sampling 
methodology from the U.S. Postal Service’s database. Adults from sampled households 
are invited to join this panel. Panel members will be recruited and screened by Ipsos 
Public Affairs, LCC to complete an online session.  
Location of study: The research procedures will be performed remotely. The study 
consent and survey will be prepared by our VT team. Recruitment will be conducted by 
the Ipsos Public Affairs, LCC and closely monitored by our team. All participants will 
enroll on a voluntary basis and consent electronically prior to study participation. 
 
 
7.0 
Study Intervention(s)/Investigational Agent(s) 
7.1 Describe the study interventions (including behavioral interventions) and/or 
investigational agents (e.g., drugs or devices) to be used in this study.  Consider 
each of the items listed below:  
● 
Drug/Device Handling: If the research involves drugs or devices, 
describe your plans to store, handle, and administer the drugs or 
devices so that they will be used only on subjects, and only by 
authorized investigators. 
● 
Describe whether any of the following will be used: microwaves, X-
rays, DEXA scans, general anesthesia, or sedation 
● 
If control of the drugs or devices used in this protocol will be 
accomplished by following an established, approved organizational 
SOP (e.g., Research Pharmacy SOP for the Control of 
Investigational Drugs, etc.), please reference the SOP in this section. 
 
This study does involve experimental manipulation of nicotine/tobacco product price 
and availability on a hypothetical online store to understand consumer's behavior. No 
drugs or devices will be provided to participants.  
 
7.2 List the name of all drugs (including any vitamins, supplements, herbs, or 
nicotine) to be used in the study.  Indicate whether they have FDA 
approval, and list any limitations for their use:  

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N/A  
 
7.3 List all devices, how they will be used, their purpose in the study, and if 
they will be used in a manner consistent with their approved uses. If they 
will be used in ways that are not yet FDA approved, indicate whether they 
need an IDE or a determination that they are exempt from the IDE 
Determination. If a determination of significant risk or non-significant risk 
is needed for any of the devices, include the researcher’s recommendation 
for each of those devices:  
 
N/A 
 
7.4 If the drug is investigational (has an IND) or the device has an IDE or a 
claim of abbreviated IDE (non-significant risk device), include the 
following information: 
● 
Identify the holder of the IND/IDE/abbreviated IDE. 
● 
Explain procedures followed to comply with sponsor requirements 
for FDA regulated research for the following: 
 
Applicable to: 
FDA Regulation 
IND Studies 
IDE studies 
Abbreviated 
IDE studies 
21 CFR 11 
X 
X 
 
21 CFR 54 
X 
X 
 
21 CFR 210 
X 
 
 
21 CFR 211 
X 
 
 
21 CFR 312 
X 
 
 
21 CFR 812 
 
X 
X 
21 CFR 820 
 
X 
 
 
 
N/A 
 
 
 
8.0 
Procedures Involved 
8.1 Describe and explain the study design: 
This study uses a mixed design (within-subject repeated measures and between-group).  
In a one-session survey, participants will complete assessments and purchase tobacco 
products in a hypothetical ETM. All participants will complete four ETM conditions, all 
of which include approximately five trials assessing different prices of their preferred 

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cigarette. In each ETM condition, participants will purchase tobacco/nicotine products for 
a 7-day period. Unventilated and ventilated cigarettes, as well as a range of other 
products (e.g., lozenges, snus, gums, and dip), will always be available. Availability of e-
cigarettes will vary according to the experimental conditions:  
A) Nicotine restricted and flavor restricted 
B) Nicotine unrestricted and flavor restricted 
C) Nicotine restricted and flavor unrestricted 
D) Nicotine unrestricted and flavor unrestricted 
 
Participants will be exposed to these conditions across purchasing scenarios in a 
counterbalanced order. 
 
We will assess these measures in each of four smoker subtypes: unventilated menthol 
smokers, ventilated menthol smokers, unventilated non-menthol smokers, ventilated non-
menthol smokers. For this purpose, ventilated and unventilated cigarettes will be defined 
as ≥20% and <10% filter ventilation, respectively. 
 
Every participant will complete questionnaires on a computer, tablet or cell phone. 
 
8.2 Provide a description of: 
● 
All research procedures being performed  
● 
If the study has more than one procedure, session, and/or subject 
population, describe each procedure, session, and/or study 
population separately. For complex studies, you are encouraged to 
include a figure or chart. 
 
 
Participants will complete a one session study including consent and behavioral tasks 
(ETM and smoking-related assessments).  
 
A Qualtrics survey will administer: 
1) the electronic informed consent; 
     Participants will read through the informed consent and consent will be implied with 
submission of the assessment at the end or the survey. 
2) smoking-related assessments  
     a) timeline follow back, to assess previous month recent smoking, e-cigarette use and 
consumption of nicotine products, and to determine ETM budget   
     b) tobacco use history, exposure and preferences questions; 
     c) the Fagerstrom Test of Nicotine Dependence for cigarettes and the Heaviness of 
Smoking Index for e-cigarettes to assess dependence.  
3) the ETM; 
     Participants will make hypothetical purchases of tobacco products to use throughout 
the next 7 days. Participants will complete a total of 20 purchasing trials each for 7 days' 
worth of products. They will be exposed to 4 conditions with their preferred cigarettes 
increasing in price. The following conditions will be presented in a randomized order: 
 

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Conditions 
E-Cigarette 
Nicotine restricted 
Nicotine unrestricted 
E-
Cigarette 
Flavor 
restricted 
E-cigarette nicotine 
restricted and E-cigarette 
flavor restricted 
E-cigarette nicotine 
unrestricted and E-cigarette 
flavor restricted 
Flavor 
unrestricted 
E-cigarette nicotine 
restricted and E-cigarette 
flavor unrestricted 
E-cigarette nicotine and 
unrestricted E-cigarette 
flavor unrestricted 
 
In the E-Cigarette Flavor Restricted, only tobacco flavors will be available. In the E-
Cigarette Flavor Unrestricted, a variety of flavors will be available. In the E-Cigarette 
Nicotine Restricted, only low nicotine concentration will be available. In the E- Cigarette 
Nicotine Unrestricted, a variety of nicotine concentration will be available.  
A range of other tobacco products will be available across conditions, such as snus, 
lozenge, gum, and dip. 
 
 
8.3 Describe: 
● 
Procedures or safeguards intended to reduce the probability and 
magnitude of risks. (For example: Reducing the risk of injury in a 
virtual reality study either by having the subjects sit during the study 
or by providing an obstacle-free space for walking.) 
● 
Be sure to describe all drugs and devices used in the research, when 
they will be administered or used, and their purpose.  
● 
Methods used to collect data about subjects. Please upload all data 
collection forms to Protocol Management. Some common examples 
are: 
● Screening questionnaires  
● Survey(s), including online surveys 
● Demographic questionnaire(s) 
● Interview guide(s), e.g., questions or pool of questions for semi-
structured interviews  
● Focus group guide(s) 
● Other documents used to collect data  
 
 
Participation in this study is completely voluntary and participants may choose not to 
participate at any time.  
Panel members from IPSOS Public Affairs, LLC complete profile surveys that contain 
demographic questions available to investigators. IPSOS will provide demographics data 
from study completers. 
 

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Specific information and data for this study will be collected from a self-reported survey. 
Examples of the assessments described in section 8.2 are attached. 
 
 
8.4 What data will you collect during the study and how you will obtain them? 
Please include descriptions of electronic data collection, database 
matching, and app-based data collection: 
 
All of the survey and questionnaire data will be collected using Qualtrics, an online 
survey platform used to develop, administer, and collect participant data in a secure 
password protected database.  
All tasks can be performed on a computer, tablet or cell phone. Only study personnel will 
have access to the collected data. 
 
8.5 Who will transcribe or code audio and/or video recordings?: 
 
N/A 
 
8.6 Include a description of any deception to be used in the study. Include 
justification for the use of deception (why the deception is necessary), 
describe the debriefing process, and describe how the study meets all the 
following criteria  for alteration of consent (deception is considered an 
alteration of informed consent): 
• The research involves no more than minimal risk to the subjects 
• The alteration will not adversely affect the rights and welfare of the 
subjects 
• The research could not practicably be carried out without the 
alteration/deception 
• (Optional but encouraged in most cases) Subjects will be provided with 
additional pertinent information after participation (i.e., debriefing for 
studies involving deception)  
 
 
N/A 
 
 
8.7 If the study involves long-term follow-up (once all research related 
procedures are complete), describe what data will be collected during the 
follow up period and when it will occur:  
 
N/A 

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9.0 
Data and Specimen Long Term Storage and Use 
9.1 If you will store data or specimens for future use, describe where you will 
store the data or specimens, how long they will be stored, and how and by 
whom the data or specimens will be accessed: 
 
All participant electronic data, will be stored in secure places to protect confidential 
participant information. Secured places will include password-protected databases 
accessible only to study personnel. Additionally, all data will be backed up on secure 
password-protected servers. Moreover, all data will be quality controlled in preparation 
for data analyses. 
Data collected from this study will be retained and destroyed in accordance with the 
center's policy that requires a 3-year retention period following final publication of the 
data. 
IRB regulations will be strictly adhered to in the conduct of the proposed research. 
Specifically, prior to implementation of any protocol changes, amendments will be 
submitted to the IRB for approval. 
 
9.2 For specimens, list the data to be stored or associated with each 
specimen: 
 
N/A 
 
9.3 Describe the procedures to release data or specimens outside of the 
research team, including the process to request a release, approvals 
required for release, who can obtain data or specimens, and what data 
will be provided with specimens: 
 
Investigators will adhere to all NIH requirements regarding data sharing. Only de-
identified participant data collected will be shared for analysis outside of the study team. 
As part of this process, all investigators will be required to agree to the following 
conditions: 1) will adhere to the reporting responsibilities; 2) will not redistribute the data 
beyond the requesting individual and named collaborators; 3) will give appropriate 
acknowledgement; 4) will not use the data for commercial purposes; and 5) will obtain 
appropriate ethical approvals. 

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Results from research conducted will be shared and disseminated, including: regular 
project meetings, annual meetings, symposia, workshops, and/or conferences for related 
groups. Manuscripts will be written and submitted for publication in peer-reviewed 
journals/conferences, following the NIH Public Access Policy guidelines. All necessary 
ethical approvals will be obtained. 
 
 
Data requests will be reviewed by the principal investigator and data will be shared with 
the expectation of acknowledgment of funding source and primary study team. 
 
9.4 Describe the identifiers to be included with stored data or specimens, as 
well as any key or code that could be used to make them identifiable. 
Describe where the code will be stored, who will have access to it, and 
when it will be destroyed: 
 
The VTC study team will not have access to any identifiers. Participants will be recruited 
and assigned a study ID by IPSOS Public Affairs, LLC, that are thereafter associated with 
all collected data. The electronic de-identified data is stored on the shared servers which 
are password protected. 
 
9.5 Please select the identifiers you will obtain (whether directly from 
participants or from another source), including but not limited to: 
 
☐ 
Name 
☐ 
Geographical subdivisions smaller than a state, including street address, 
city, county, precinct, zip code, and equivalent geocodes (note, the initial 
three digits of a zip code are not considered identifiable) 
☐ 
Elements of dates (except year) for dates directly related to an individual, 
including birth date, admission date, discharge date, date of death, and 
single year of age over 89 and all elements of dates (including year) 
indicative of such age (note, such ages and elements may be aggregated 
into a single category of age 90+) 
☐ 
Phone numbers 
☐ 
Fax numbers 
☐ 
Electronic mail addresses (e-mail) 
☐ 
Social Security numbers 
☐ 
Medical record numbers 
☐ 
Health plan beneficiary numbers 
☐ 
Account numbers 
☐ 
Certificate/license numbers 
☐ 
Vehicle identifiers and serial numbers, including license plate numbers 
☐ 
Device identifiers and serial numbers 

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☐ 
Web Universal Resource Locators (URLs) 
☐ 
Internet protocol (IP) address numbers 
☐ 
Biometric identifiers, including finger and voice prints (audio recording) 
☐ 
Full face photographic images and any comparable images (including 
video recording) 
☐ 
Student record number or identification number   
☐ 
User name for online or computer accounts 
☐ 
Any other unique identifying number, characteristic, or code (note this 
does not mean the unique code assigned by the investigator to code the 
data): Click here to explain.   
 
10.0 Sharing of Results with Subjects 
10.1 Describe whether you will share results (study results or individual subject 
results, such as results of investigational diagnostic tests, genetic tests, or 
incidental findings) with subjects or others (e.g., the subject’s primary care 
physician). If so, describe how you will share the results and include this 
information as part of the consent document. Upload materials you will use 
to explain the results to subjects: 
 
We will not share study results or individual results directly with the study participants or 
others. 
 
11.0 Study Timelines 
11.1 Describe: 
● 
The duration of an individual subject’s participation in the study (for 
example, 1 hour, 2-4 weeks, 3-5 years). 
● 
The amount of time expected to enroll all study subjects (weeks, 
months, years, etc.) 
● 
The amount of time expected for the investigators to complete this 
study including primary data analyses. 
 
Participant's schedule: the participation of one subject is expected to take approximately 
30 minutes in a single session.  
 
Study timeline: enrollment and data collection are expected to take about 1 month.  
 
The study team has projected this study to take approximately 1 year to complete 
enrollment, data collection and data analysis.  
 
12.0 Inclusion and Exclusion Criteria 

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12.1 Describe how you will screen individuals for eligibility. When will 
screening occur and what procedures will you use? Upload any screening 
scripts or surveys to Protocol Management:  
Participants will be first screened by IPSOS Public Affairs, LLC, for regular tobacco use. 
Cigarette smokers will be invited to participate in this study and have access to a survey 
link. Participants will then be screened to verify specific eligibility criteria for this study 
with questions about number of cigarettes smoked per day and cigarette brand and type.  
12.2 Describe the eligibility criteria that define who will be included and who 
will be excluded from enrollment for each procedure of your study. 
Include any geographic criteria (e.g., Virginia Tech undergraduate 
students, a national sample of adults with engineering degrees, minors 
aged 8-12 in the New River Valley, university faculty in Virginia and 
Paris, France): 
 
Inclusion criteria for signing consent will require that participants: 
    Be at least 21 years old 
    Smoke cigarettes daily (≥ 10 cigarettes/day) 
    Smoke ventilated or unventilated cigarettes ( ≥20% and <10% filter ventilation, 
respectively) 
 
There will be no additional exclusion criteria for this study. 
  
 
12.3 Indicate specifically whether you will include or exclude each of the 
following special populations: (You may not include members of these 
populations as subjects in your research unless you indicate them in the 
description of your subject population.) 
● 
Minors, as defined by state law where the study is performed 
(infants, children, teenagers) 
● 
Pregnant women (can be included in minimal risk studies by 
mentioning in section 13.1) 
● 
Prisoners (including all incarcerated individuals) 
● 
Adults not capable to consent on their own behalf 
 
This study will focus on cigarette smokers. We will not include individuals under the age 
of 21 in compliance with Federal law. Minors, prisoners, and adults not capable to 
consent on their own behalf will not be part of  the recruitment. Pregnant women will not 
be excluded and might be invited for this study. 
 
13.0 Vulnerable Populations 

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13.1 If the research involves individuals who are vulnerable to coercion or 
undue influence, please describe additional safeguards you will include to 
protect their rights and welfare. Consider the applicable items listed 
below: 
● 
If the research involves Virginia Tech students, indicate whether 
these are students of any of the investigators. If so, describe whether 
the activities will take place during class time as part of the 
curriculum and the steps you will take to reduce the possibility that 
students feel obliged to participate in order to improve their course 
grade. The HRPP can provide further guidance as needed. Describe 
whether you will request access to student records (e.g., SAT, GPA, 
GRE scores). 
● 
If the research involves employees of Virginia Tech or the research 
sponsor, describe steps you will take to ensure that the employees 
are freely participating and describe how their data will be 
protected from inspection by their supervisors.  
● 
If the research involves Virginia Tech NCAA athletes, you must 
obtain approval from the athletic department.  
● 
For research involving Montgomery County Public Schools, you 
must obtain county approval (after obtaining contingent Virginia 
Tech approval). Other locales have different requirements; please 
check on these and describe here. Approval is typically granted by 
the superintendent, principal, and classroom teacher (in that order). 
Approval by an individual teacher is insufficient. School approval, in 
the form of a letter or a memorandum should be uploaded as a 
supporting document. 
● 
If the research involves pregnant women, review “CHECKLIST: 
Pregnant Women (HRP-412)” to ensure that you have provided 
sufficient information in this protocol. 
● 
If the research involves prisoners, review “CHECKLIST: Prisoners 
(HRP-415)” to ensure that you have provided sufficient information 
in this protocol. 
● 
If the research involves persons who have not attained the legal age 
for consent to treatments or procedures involved in the research 
(minors), review the “CHECKLIST: Minors (HRP-416)” to ensure 
that you have provided sufficient information in this protocol. 
● 
If the research involves cognitively impaired adults, review 
“CHECKLIST: Cognitively Impaired Adults (HRP-417)” to ensure 
that you have provided sufficient information in this protocol. 
 
 
Pregnant women might participate in the study if they meet the inclusion criteria, 
although pregnant women will not be directly recruited because of their status. 
There are no procedures in this study that can represent a threat to their rights or 
welfare.   
 

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14.0 Number of Subjects 
14.1 Indicate the total number of subjects to be enrolled and how this number 
was determined (e.g., sample size calculation [show], number of available 
subjects in a finite pool, number of tests funding award would allow):  
 
In this experiment, we request 268 participants for all four groups which will allow 
detection of effect size f=0.24 with 90% power using alpha =0.05 type I error rate and a 
within subject correlation of 0.5. According to Cohen's 1988 conventions, this is a 
medium effect size (f=0.24). This calculation was done using G*Power assuming a 
repeated measures ANOVA testing a within-between subject effect for the 4 conditions 
(e-cigarette flavor and nicotine restrictions). 
 
Additionally, including all four groups together will provide more than sufficient power 
assuming a repeated measures ANOVA testing a within-between subject effect 
for 4 groups (between-factor; smoking preferences) and 4 conditions (within-subject; e-
cigarette restriction). 
 
14.2 If this is a multi-site study, indicate the number of subjects to be enrolled 
at this site and the total to be enrolled from all sites: 
 
N/A 
 
14.3 If applicable, indicate the number of potential subjects you expect to 
screen for enrollment, and the number of subjects you will need to 
complete the research procedures: 
 
As stated previously, the survey will be conducted using the IPSOS web-enabled 
KnowledgePanel®, a probability-based panel designed to be representative of the U.S. 
population. We anticipate screening around 3,250 participants in order to complete a total 
of 268 participants. 
 
14.4 If the study has more than one procedure, indicate the total number of 
subjects to undergo each procedure separately: 
 
All participants will undergo one entire study session unless they withdraw consent. 
 
15.0 Recruitment Methods 
15.1 Describe when, where, and how you will recruit potential subjects: 

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The survey will be conducted using the IPSOS web-enabled KnowledgePanel®, a 
probability-based panel designed to be representative of the U.S. population. Initially, 
participants are chosen scientifically by a random selection of telephone numbers and 
residential addresses by IPSOS. Persons in selected households are then invited by 
telephone or by mail to participate in the web-enabled KnowledgePanel. For those who 
agree to participate, but do not already have Internet access, Ipsos provides at no cost 
a laptop/netbook and ISP connection. People who already have computers and Internet 
service are permitted to participate using their own equipment. Panelists are sent 
emails throughout each month inviting them to participate in research. Cigarette smokers 
will be invited to participate in this study and receive unique log-in information for 
accessing this study's survey online. Panelists will receive up to two (2) email reminders 
will be sent to non-responders to encourage response.  
 
15.2 Describe the source of subjects (for example, clinic patients with specific 
conditions, students in the library, community members at a gathering, or 
members of a local gym): 
 
As stated above, the survey will be conducted using the IPSOS web-enabled 
KnowledgePanel®, a probability-based panel designed to be representative of the U.S. 
population. Initially, participants are chosen scientifically by a random selection of 
telephone numbers and residential addresses by IPSOS. 
 
15.3 Describe the methods that you will use to identify potential subjects: 
 
IPSOS Public Affairs will first screen cigarette smokers based on the information on their 
KnowledgePanel. Participants that meet this criterion will receive an invite to participate 
in this study.    
 
15.4 Describe materials that you will be use to recruit subjects. Attach copies 
of these documents with this protocol in Protocol Management and be 
sure to include the IRB protocol number on each document.  
● For flyers, attach the final copy of printed flyers.  
● For Virginia Tech News, Facebook postings and ads, newspaper ads, 
websites, MTurk/SONA/online survey systems, etc., attach the final 
wording and graphics to be used.  
● For email recruitments, please include the subject line.  
● For advertisements meant for audio broadcast, please submit the 
wording of the advertisement prior to taping (to avoid having to re-
record with approved language) and submit the final recorded version 
for IRB review before use.  
● Describe any compensation to subjects. Separate compensation into 
appropriate categories, such as: reimbursement for expenses, time and 

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effort, and additional incentives for study participation.  For each 
category, specify the amount (including any pro-rated amount), schedule, 
and method of payment. 
 
Recruitment email template is attached.  
 
Participants will be paid through IPSOS Public Affairs, LLC upon completion of our 
survey. VT will pay the survey firm a flat rate per participant that we want to recruit. 
Participants are redirected to our study from the survey firms and after completion of our 
study, they are redirected back to the survey firms where they receive information about 
their remuneration and a reminder that they will be paid via existing survey firm 
infrastructure. Participants will receive from 5,000 points ($5 cash-equivalent) to 10,000 
points ($10 cash-equivalent) for qualifying and completing a 30- or 40-minute survey 
depending on the median time of completion. These are the standard incentives for a 
survey of this length.  It is possible that the panel firm recommend increasing the 
incentive in order to achieve targets if survey uptake is lower than anticipated. 
 
16.0 Withdrawal of Subjects 
16.1 Describe circumstances under which you anticipate subjects could be 
withdrawn from the research without their consent: 
 
Every participant who gives their consent will have the opportunity to complete the 
study. 
 
16.2 If applicable, describe any procedures for orderly termination (e.g., 
discontinuation of a study drug or debriefing after a behavioral 
intervention): 
 
N/A 
 
16.3 Describe procedures that you will follow when subjects withdraw from the 
research, including partial withdrawal from procedures with continued 
data collection (e.g., participant declines to continue with regular blood 
draws, but continues with periodic behavioral questionnaires): 
 
Participants can stop completing the survey without submitting it at any time. In this case, 
a participant will be withdrawn from the entire study. 
 
17.0 Risks to Subjects 

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17.1 List the reasonably foreseeable risks, discomforts, hazards, or 
inconveniences to the subjects related the subjects’ participation in the 
research. Include for the IRB’s consideration a description of the 
probability, magnitude, duration, and reversibility of the risks. Consider 
physical, psychological, social, legal, privacy, and economic risks. Do not 
indicate “No risk” or “N/A.” Instead, for studies with very low risk (e.g., 
anonymous online questionnaire on a mundane topic) indicate “The 
investigators are not aware of any risks from participation in this study.” 
or “No more than risks than are found in everyday life.” The example 
consent form presents a tabular method for risk information, which you 
can also use here. Common risk types include: 
● Physical (e.g., potential for pain, discomfort, infection) 
● Psychological (e.g., potential for stress, discomfort, and/or 
embarrassment) 
● Social (e.g., potential for discrimination or stigmatization and 
disruption of personal and family relationships) 
● Legal (e.g., potential for disclosure of illegal activity, negligence) 
● Privacy (e.g., potential for personal information being accessed, used, 
or disclosed without the subjects’ knowledge or consent, breach of 
confidentiality/security) 
● Economic (e.g., potential for individuals to lose access to economic 
services, employment, insurability) 
 
There will be no direct costs for participation, although there are risks.  
 
1. Possible embarrassment: This may result from answering questions that participant 
considers sensitive. Some of our questions will ask for information about substance use.  
 
2. Possible discomfort: There is also the possibility that participant may become bored or 
frustrated during the research sessions. 
 
3. Loss of confidentiality: The research team will employ every effort to maintain 
participant confidentiality, however the loss of confidentiality is a potential risk. 
 
Due to the investigative nature of this study, there may be other risks that are currently 
unknown. 
 
17.2  Indicate the measures you will use to minimize risks and monitor subjects 
for safety. (e.g., asking a subject at regular intervals to rate how they are 
feeling from 1 to 10, or to slowly crouch in order to check their balance.) 
 
Informed Consent. All consenting methods will be conducted electronically using 
standard operating procedures. All participants will enroll on a voluntary basis and read 

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an IRB-approved consent form prior to study participation. Consent to participate in this 
study will be implied with submission of the assessment. 
 
Protections against risk. Participants will be free to withdraw from the study at any time.  
 
The risks enumerated above will be addressed by the following: 
1. Possible embarrassment: Participants may discontinue at any time. 
 
2. Possible discomfort: Participants can take breaks, if desired.  
 
3. Loss of confidentiality: The use of study ID for participants will protect 
confidentiality. Password protected computer databases will have coded identifiers. 
Master databases linking subject names to study ID are only available through survey 
firm. VT will have no access.  
 
17.3 If applicable, indicate which procedures might have risks to the subjects 
that are currently unforeseeable. This will be rare, and usually applicable 
when testing a new drug or device or a new use of an existing drug or 
device: 
 
N/A 
 
17.4 If applicable, indicate which procedures might have risks to an embryo or 
fetus should the subject be or become pregnant: 
 
N/A 
 
17.5 If applicable, describe risks to others who are not subjects (e.g., collection 
of sensitive health data that might affect sexual partners if disclosed, 
mandatory reporting of abuse, DNA testing that might affect family 
members or relationships): 
 
N/A 
 
18.0 Potential Benefits to Subjects 
18.1 Describe the potential benefits that individual subjects might experience 
from participating in the research. Include the probability, magnitude, and 
duration of the potential benefits, as this will be useful to the IRB’s 
risk:benefit analysis. Do not include benefits to society or others. Do not 

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list monetary or non-monetary compensation for participation, as this is 
not a benefit These should be included in section 2 or 3 of this document: 
 
Participants will not directly benefit from participating in this study. However, the current 
study may help identify effective methods of assessing the use of tobacco products as 
well as policy changes, which may help the health of people in the future.   
 
18.2 If applicable, specify that there are no anticipated direct benefits for 
participants:  
 
There are no anticipated direct benefits for participation in this study. 
 
19.0 Data Management and Confidentiality 
19.1 Describe procedures that you will use for quality control to ensure validity 
of collected data: 
 
The PI will oversee monitoring of the data collection procedures. These procedures will 
be reviewed regularly in a number of settings. For instance, issues pertaining to data 
validity and integrity will be addressed formally during regularly scheduled study 
personnel meetings in which all study personnel, including the PI, will be in attendance.  
 
19.2 Describe any existing data or biospecimens you will obtain as part of this 
study. Include:  
● 
Variables or samples to be obtained  
● 
Source of the data or specimens 
● 
Your authorization to access or receive the data or biospecimens 
● 
Whether the data or biospecimens are publicly available 
● 
Whether the data or specimens you receive will contain identifiers  
 
Survey firm will only provide demographics data from completers. See "Standard 
Demographics" attached. No biospecimens will be obtained. 
 
19.3 Describe the steps that you will take to handle and secure study data 
during data collection, storage, use, and transmission.  Include 
information about training of study staff, authorization of access, 

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password protection, encryption, physical controls, certificates of 
confidentiality, separation of identifiers and data, etc.: 
 
To secure study data computer databases will have coded identifiers, only ID numbers 
will be used and data will be kept in secure locations. Access to study data will be limited 
to study personnel who have completed the IRB Human Subjects Training and who have 
been delegated the responsibility of data collection, management, or analyses by the PI.  
In addition, this project is included in the NIH grants' certificate of confidentiality. 
 
 
19.4 For multi-site studies, describe how data or specimens will be handled 
and secured for each site (e.g., central or disseminated data storage, data 
coordinating center): 
 
N/A 
 
19.5 Describe the plan for data disposition following the conclusion of the 
study (e.g., long term maintenance of data, data destruction methods).  
● 
What information will be included in the long term storage of data 
or specimens? 
● 
How long will the data or specimens be stored? 
● 
Where and how data or specimens will be stored? 
● 
Who will have access to the data or specimens during long term 
storage? 
● 
Who is responsible for receipt or transmission of the data or 
specimens? 
● 
How will data or specimens be shared or transported? 
● 
When and how will personal identifiers be destroyed? 
 
 
As stated previously, data collected from this study will be retained and destroyed in 
accordance with the center's policy that requires a 3-year retention period following final 
publication of the data. 
 
 
20.0 Provisions to Protect the Privacy Interests of Subjects 
20.1 Describe the steps that you will take to protect subjects’ privacy interests. 
“Privacy interest” refers to a person’s desire to place limits on with whom 
they interact or to whom they provide personal information (e.g., 
collecting the minimal amount of private information required to complete 
the study, protecting the data once it is obtained):  
 

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No private information will be collected in this study. Private information is collected and 
protected by IPSOS Public Affairs, LLC. Procedures to keep all other the information 
safe are described in section 9.4. 
 
20.2 Describe steps that you will take to make subjects feel at ease with the 
research situation in terms of the questions being asked and the 
procedures being performed. “At ease” does not refer to physical 
discomfort, but the sense of intrusiveness a subject might experience in 
response to questions, examinations, and procedures (e.g., use of a same 
gender investigator to place sensors on the torso, a private changing area 
if clothing must be changed, sensitivity when discussing  pregnancy testing 
with subjects, making it clear on surveys that participants can discontinue 
at any time, not asking questions about private or sensitive issues unless 
necessary for the research): 
 
Participants will voluntarily complete the study in the place of their choice on their own 
time using a computer, tablet or cell phone. All participants are informed that their 
information is confidential. 
 
20.3 Describe how you plan to access existing sources of information about the 
subjects (e.g., medical records, grades) and how you will protect 
participant privacy through the data security plan: 
 
The VT team will provide IPSOS with study's IDs from participants that completed the 
survey. IPSOS will then provide demographics from their knowledge panel.  No private 
information will be exchanged. 
 
20.4 Describe any required reporting that might occur as a result of your 
research questions, study populations, and data collection methods. 
Examples for Virginia and Virginia Tech include: 
• Any suspicions (e.g., circumstantial, disclosed) of child abuse (physical, 
emotional, sexual) and neglect  
• Sexual discrimination and/or sexual violence that involves a student 
• Disclosure or signs of intention to harm oneself (i.e., suicidal ideation 
and/or plan) 
• Disclosure or signs of desire to harm others (i.e., homicidal ideation 
and/or plan) 
• Suspected abuse, neglect or exploitation of vulnerable adults (e.g., 
individuals with a disability, elderly persons) 
 

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We do not expect any required reporting to occur as a result of our research questions and 
data collection methods.  
 
 
21.0 Provisions to Monitor the Data to Ensure the Safety of Subjects 
Safety monitoring is required when research involves greater than minimal risk 
and is sometimes appropriate for other studies. 
21.1 Describe: 
● 
The plan to periodically evaluate the data collected regarding both 
harms and benefits to determine whether subjects remain safe  (e.g., 
periodic reporting to the IRB, establishing a data monitoring 
committee, reporting data monitoring committee findings to the IRB 
and the sponsor). 
● 
What data you will review, including safety data, unexpected events, 
and data that show the ability to produce the intended results. 
● 
How the safety information will be collected (e.g., with case report 
forms, at study visits, by telephone calls with subjects). 
● 
The frequency of data collection, including when safety data 
collection starts. 
● 
Who will review the safety data and with what frequency. 
● 
The statistical tests for analyzing the safety data to determine 
whether harm is occurring. 
● 
Any conditions that will trigger an immediate suspension of the 
research (e.g., a serious adverse event). 
 
 
N/A 
 
 
22.0 Compensation for Research Related Injury 
22.1 If the research involves more than minimal risk to subjects, describe the 
available compensation in the event of research-related injury, if any: 
 
N/A 
 
22.2 Provide a copy of contract language, if any, relevant to compensation for 
research-related injury. At Virginia Tech, this is most common for 
sponsored research: 
 
N/A 

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23.0 Economic Burden to Subjects 
23.1 Describe any costs that subjects might be responsible for because of 
participation in the research, including any uncompensated costs for items 
such as transportation, missed work, and childcare: 
 
There are no costs to participate in this study.  
 
24.0 Consent Process 
24.1 Indicate the process by which you will obtain consent for study 
participation. Please upload all consent, parental permission, and assent 
forms, documents, and scripts referenced in this section to Protocol 
Management. 
Describe the following: 
● 
Where the consent process will take place (e.g., clinic waiting area, 
classroom, online) 
● 
The time interval between sharing the consent information with the 
prospective subject and obtaining consent. For lab, interview, and 
focus group studies, the Virginia Tech IRB prefers that subjects have 
at least 24 hours to review the consent form and study information 
before the appointment where consent will be obtained. For simple 
online survey studies, you can typically present the consent 
information immediately before subjects begin participation. 
● 
If applicable, processes to ensure ongoing consent or assent (e.g., 
for multiple sessions; for research in which a minor will turn 18 
during the study; for longitudinal research with minors who will 
later be asked to provide or affirm their assent). 
● 
Please review “SOP: Informed Consent Process for Research (HRP-
090)” for recommended procedure. Describe your process, being 
sure to include: 
o 
The name and role of all study personnel who will be trained 
and certified by the PI to conduct the consent process 
o 
The time that will be devoted to the consent discussion 
o 
Steps that you will take to minimize the possibility of coercion 
or undue influence 
o 
Steps that you will take to gauge or ensure the subjects’ 
understanding 
 

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An invitation to participate in this study will be sent to participants during recruitment. If 
they are interested in completing the study, they will be provided with a link to the survey 
and will be able to read the informed consent and give their consent electronically. 
 
Consent will take place on the internet and through the portal in which the survey will be 
administered. That is, we will include detailed information about the nature of the study 
prior to the assessment beginning. The potential participant will be instructed to read that 
information and by continuing with the assessment give consent. Furthermore, because 
we are obtaining the sample through a survey firm, these particular participants will have 
already been informed about this study and will have the opportunity to express interest 
or decline not only at the time the assessment is administered, but also when they are 
being recruited. 
Non-English Speaking Subjects 
● 
Indicate what language(s) other than English are understood by 
prospective subjects or representatives. 
● 
If non-English speakers will be recruited, describe the process you 
will use to ensure that the oral and/or written consent information 
provided will be in a language that they understand.  
● 
If you translate consent forms and study materials, please provide a 
certified translation of the form as well as the certification 
document. 
● 
Indicate the spoken language that study personnel obtaining consent 
will use. Describe how you will assess fluency of personnel obtaining 
consent to ensure that the translation is accurate. 
 
Non-English speakers will not be recruited. 
Waiver or Alteration of Consent Process (consent will not be obtained, 
required information will not be disclosed, or the research involves 
deception) 
● 
Review the “CHECKLIST: Waiver or Alteration of Consent Process 
(HRP-410)” to ensure you have provided sufficient information for 
the IRB to make these determinations (i.e., that it meets the criteria 
for a waiver or alteration of the consent process). 
 
N/A 
 
Subjects who are not yet adults (minors: infants, children, teenagers) 
● 
Describe the criteria that you will use to determine  legal age for 
consent to treatments or procedures involved in the research under 
the applicable law of the jurisdiction in which the research will be 
conducted (e.g., in Virginia, individuals under the age of 18 years). 

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o 
For research conducted in Virginia, review “SOP: Legally 
Authorized Representatives, Minors, and Guardians (HRP-
013)” to determine which individuals in the state meet the 
definition of “minor.” 
o 
For research conducted outside of the state, please describe 
the legal requirements for the definition of “minor.”  
● 
Describe the process for obtaining parental permission.  
o 
Permission from one parent is acceptable for studies that 
involve no greater than minimal risk OR involve greater than 
minimal risk but present the prospect of direct benefit to the 
minor subject. 
o 
Permission from both parents is required in all other 
cases (unless one parent is deceased, unknown, 
incompetent, or not reasonably available, or when only 
one parent has legal responsibility for the care and 
custody of the minor). 
● 
Describe whether you will obtain permission from individuals other 
than parents or Legally Authorized Representatives, and if so, who 
will be allowed to provide permission. Describe the process you will 
use to determine these individuals’ authority to consent to the 
minor’s general medical care. 
● 
Indicate whether you will obtain assent from all, some, or none of 
the minors. If you will obtain assent from some minors, indicate 
which minors will be required to assent. Consider chronological age 
and intellectual capacity when determining who will be required to 
provide assent (e.g., infants are unable to assent. However, 
teenagers are likely able to read and sign an assent form). 
● 
When assent of minors is obtained, describe whether and how you 
will document it.  Will minors sign an assent form or give verbal 
assent? 
● 
Attach parental permission and minor assent forms or scripts in 
Protocol Management.  
 
 
N/A 
 
 
Adults Unable to Consent  
● 
Describe the process you will use to determine whether an individual 
adult is capable of consent. 
● 
List the individuals from whom you will obtain permission in order 
of priority (e.g., durable power of attorney for health care, court 
appointed guardian for health care decisions, spouse, and non-
minor child). 
o 
For research conducted in the Virginia, review “SOP: Legally 
Authorized Representatives, Minors, and Guardians (HRP-

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013)” to determine which individuals in the state meet the 
definition of “legally authorized representative.” 
o 
For research conducted outside of Virginia, please describe 
the legal requirements for obtaining permission from a legally 
authorized representative in the state where the research will 
occur. 
● 
Describe the process for assent of the subjects. 
o 
Indicate whether you will require assent from all, some, or 
none of the subjects. If some, indicate which subjects will be 
required to assent and which will not. 
o 
If you will not obtain assent from some or all subjects, please 
provide justification for not obtaining assent. 
o 
Describe whether and how you will document assent.  
 
N/A 
 
25.0 Process to Document Consent in Writing 
25.1 Consult “SOP: Written Documentation of Consent (HRP-091)” for 
recommended procedures, and describe whether and how consent of the 
subject will be documented in writing: 
 
Consent will not be documented in writing.  
 
25.2 If the research presents no more than minimal risk of harm to subjects and 
involves no procedures for which written documentation of consent is 
normally required outside of the research context, you can request that the 
IRB waive the requirement to obtain written documentation of consent 
(e.g., consent to participate is indicated by pressing a button for an online 
questionnaire – after the consent information is presented and before the 
questionnaire begins): 
 
As stated above, consent will take place on the internet and through the portal in which 
the survey will be administered. That is, we will include detailed information about the 
nature of the study prior to the assessment beginning. The potential participant will be 
instructed to read that information and by continuing with the assessment give consent. 
 
25.3 If you will document consent in writing, attach a consent document with 
places for signatures. If you will obtain consent, but not document consent 
in writing, please attach the consent script or text. Review “CHECKLIST: 

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Waiver of Written Documentation of Consent (HRP-411)” to ensure that 
you have provided sufficient information. You should use “TEMPLATE 
CONSENT DOCUMENT (HRP-502)”to create the consent document or 
script: 
 
Electronic informed consent is attached. 
 
 
26.0 Resources Available 
26.1 Describe the resources available to conduct the research. For example, as 
appropriate: 
● 
Describe the PI’s availability to supervise the research. 
● 
Justify the feasibility of recruiting the required number of suitable 
subjects within the agreed recruitment period. For example, how 
many potential subjects do you have access to? What percentage of 
those potential subjects do you need to recruit? 
● 
Describe the time that you will devote to conducting and completing 
the research. 
● 
Describe your facilities. 
● 
Describe the availability of medical or psychological resources that 
subjects might need as a result of an anticipated or unanticipated 
consequence of participation in the research. 
● 
Describe your process to ensure that all persons assisting with the 
research are adequately informed about the protocol, the research 
procedures, and their duties and functions (e.g., training plans, 
detailed study notebooks). 
 
The organizational structure of the study team involves overall leadership by Dr. Warren 
Bickel, who will assume full responsibility for all aspects of the project, including design 
and participant eligibility. Dr. Bickel will oversee study procedures. He will also oversee 
and delegate to the Co-Investigators and other study team members the responsibility of 
monitoring data collection. Behavioral data analysis will be overseen by Dr. Bickel and 
conducted by the Co-Is and the Statistician.  
All staff involved in planning and monitoring of this study will have completed the IRB 
Human Subject Protection Training and Good Clinical Practice Training. Documentation 
of training will be maintained.  
 
Participants will be recruited through a survey firm panel which contains approximately 
60,000 members via an address-based sampling methodology from the U.S. Postal 
Service’s database. 
 

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All methods and measures will be conducted using standard operating procedures. All 
participants will enroll on a voluntary basis and read an IRB-approved consent form prior 
to study participation. Consent to participate in this study will be implied with submission 
of the assessment. 
 
This survey will be administered remotely and participants will not be required to visit 
our facilities.  
Study team meet on a regular basis and any issues will be discussed and addressed all 
study personnel, including the PI. 
 
27.0 Multi-Site Research 
Contact the HRPP for multi-site research (involving multiple institutions) and 
the details required for this section will be provided. Otherwise, indicate N/A. 
 
N/A 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Principal Investigator: Warren K. Bickel 
IRB# and Title of Study: 20-827 
Sponsor: NIH/NCI 
 
You are invited to participate in a research study.  This form includes information about 
the study and contact information if you have any questions. 
 
WHAT SHOULD I KNOW? 
 
This survey is being conducted by the Addiction Recovery Research Center at the Fralin 
Biomedical Research Institute at Virginia Tech Carilion.  The study will help researchers 
understand choice behavior in buying different types of tobacco and nicotine products. 
 
If you decide to participate in this study, you will complete a survey. As part of the study, 
you will complete questions about: 
your current tobacco/nicotine use and preferences 
how you might purchase tobacco/nicotine products under different scenarios. You will be 
asked to browse our online store of tobacco/nicotine products and make a series of 
hypothetical purchases under different price scenarios. Although the purchases you will 
make in the study are not real, please answer all questions as if you were actually making 
the purchases. When completing these questions, you will only be able to enter in 
numbers using your keyboard. 
 
The study should take approximately 30 minutes of your time, and you’ll receive 5,000 
bonus points if you qualify and complete the survey. 
We do not anticipate any risks from completing this study. 
 
You can choose whether to be in this study or not.  If you volunteer to be in this study, 
you may withdraw at any time without consequences of any kind.  The investigator may 
withdraw you from this research if circumstances arise which warrant doing so.   
CONFIDENTIALITY 
 
Your responses are anonymous. No personally identifiable information will be provided 
to Virginia Tech. 

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Any data collected during this research study will be kept confidential by the researchers.  
WHO CAN I TALK TO? 
 
If you have any questions or concerns about the research, please feel free to contact the 
KnowledgePanel Panel Member Support at 800-782-6899. You are not waiving any legal 
claims, rights or remedies because of your participation in this research study.  If you 
have questions regarding your rights as a research participant, contact the Virginia Tech 
HRPP Office at 540-231-3732 (irb@vt.edu). 
Your consent to participate in this research is implied with submission of the assessment.  
 
Please print out a copy of this information sheet for your records.