Examining the Generality of Laboratory-based Findings and Their Moderators Using Diverse Samples From the International Tobacco Control (ITC) Policy Evaluation Project Cohorts - Study 3a
Phase: NA
Conditions: Cigarette Smoking, Nicotine Vaping
Sponsor: Virginia Polytechnic Institute and State University

Protocol Title: 
Examining the generality of laboratory-based findings and their moderators using diverse 
samples from the International Tobacco Control (ITC) Policy Evaluation Project cohorts (Aims 
3a and 3c) 
ClinicalTrials.gov Identifier (NCT Number): 
NCT06456671  
Protocol Number: 
24-520 
Principal Investigator: 
Roberta Freitas-Lemos, PhD 
Fralin Biomedical Research Institute at VTC 
Virginia Tech 
Funding Source: 
National Institutes of Health (NIH) 
National Cancer Institute (NCI) 
Grant Number: 5P01CA200512 
Document Version: 
Version 1.0 
Document Date: 
April 30, 2024 
Institution: 
Virginia Tech 
Fralin Biomedical Research Institute at VTC 
 

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cohorts (Aims 3a and 3c) 
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INSTRUCTIONS: 
● Use this “TEMPLATE PROTOCOL (HRP-503)” to prepare a study protocol 
outlining your research plan.  
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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.  
 
Examining the generality of laboratory-based findings and their moderators using 
diverse samples from the International Tobacco Control (ITC) Policy Evaluation Project 
cohorts (Aims 3a and 3c) 
 
PROTOCOL NUMBER:   
Include the number assigned in Protocol Management (verify this has been added 
before submitting protocol to HRPP).  
 
 
24-520 
 
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. 

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cohorts (Aims 3a and 3c) 
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Is Virginia Tech the primary awardee or the coordinating center of this grant or 
contract? If not, list the primary institution: Medical University of South 
Carolina. This experiment is part of Project 3 of an NIH/NCI P01 Grant awarded 
to the Medical University of South Carolina. 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 04/30/2024 
 
REVISION HISTORY:  
Use this table to keep track of changes. Add more rows as needed. 
 
Revision 
# 
Version Date 
Brief Summary of Changes  
(i.e., the different sections) 
Consent 
Change? 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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diverse samples from the International Tobacco Control (ITC) Policy Evaluation Project 
cohorts (Aims 3a and 3c) 
VT Research Protocol version 1.0.1 
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Table of Contents 
1.0 
Study Summary 
4 
2.0 
Objectives 
4 
3.0 
Background 
5 
4.0 
Study Endpoints 
8 
5.0 
Study Design and Statistical Analysis Plan 
9 
6.0 
Setting 
9 
7.0 
Study Intervention(s)/Investigational Agent(s) 
10 
8.0 
Procedures Involved 
12 
9.0 
Data and Specimen Long Term Storage and Use 
14 
10.0 Sharing of Results with Subjects 
16 
11.0 Study Timelines 
17 
12.0 Inclusion and Exclusion Criteria 
17 
13.0 Vulnerable Populations 
19 
14.0 Number of Subjects 
20 
15.0 Recruitment Methods 
21 
16.0 Withdrawal of Subjects 
22 
17.0 Risks to Subjects 
22 
18.0 Potential Benefits to Subjects 
24 
19.0 Data Management and Confidentiality 
25 
20.0 Provisions to Protect the Privacy Interests of Subjects 
26 
21.0 Provisions to Monitor the Data to Ensure the Safety of Subjects 
28 
22.0 Compensation for Research Related Injury 
28 
23.0 Economic Burden to Subjects 
29 
24.0 Consent Process 
29 
25.0 Process to Document Consent in Writing 
32 
26.0 Resources Available 
33 
27.0 Multi-Site Research 
34 
 
 
 

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cohorts (Aims 3a and 3c) 
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1.0 
Study Summary 
 
Study Title 
Examining the generality of laboratory-based findings and 
their moderators using diverse samples from the 
International Tobacco Control (ITC) Policy Evaluation 
Project cohorts (Aims 3a and 3c) 
Study Design 
This study uses a mixed design (within-subject and between-
group). Participants will complete a few behavioral 
questionnaires, and make hypothetical purchases of tobacco 
products in an online store under four different scenarios: a) 
control, b) NVPs at 1/2 market price, c) HTPs at 1/2 market 
price, and d) NPPs at 1/2 market price. 
Primary Objective 
To compare the effects of different tobacco/nicotine products 
(i.e., conventional cigarettes, NVPs, HTPs, and NPPs) on 
tobacco/nicotine purchasing and substitution in the 
Experimental Tobacco Marketplace, as a function of tobacco 
user type. 
To examine the generality of laboratory-based findings from 
a previous study that examined the same conditions across 
the US, Canada, and England. 
 
Secondary 
Objective(s) 
N/A  
Study Population 
Cigarette smokers and dual cigarette and NVP users 
Sample Size 
456 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  
NVP: Nicotine Vaping Product 
HTP: Heated Tobacco Product 
NPP: Nicotine Pouch Product 
ETM: Experimental Tobacco Marketplace 
ITC: International Tobacco Control (ITC) Policy Evaluation 
Project 
FBRI: Fralin Biomedical Research Institute  
 
 
2.0 
Objectives 
2.1 Describe the purpose, specific aims, or objectives of this study: 
 

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cohorts (Aims 3a and 3c) 
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Purpose:  
To compare the effects of different tobacco/nicotine products (i.e., conventional 
cigarettes, NVPs, HTPs, and NPPs) on tobacco/nicotine purchasing and substitution in 
the Experimental Tobacco Marketplace, as a function of tobacco user type. 
To examine the generality of laboratory-based findings and their moderators from 
Study 1 (IRB#21-1046) using diverse samples from the US, CA, and EN, from the 
International Tobacco Control (ITC) Policy Evaluation Project cohorts. 
 
2.2 State the hypotheses to be tested:  
 
The primary hypotheses are: 1) purchasing of NVPs, HTPs, and NPPs will increase as the 
price of conventional cigarettes is increased (i.e., they will all serve as substitutes), 2) 
dual cigarette/NVP users, because they are multi-tobacco users, will show greater 
substitution than exclusive cigarette smokers, and 3) country-specific factors will result in 
shifts in the profiles of substitution and product purchasing. 
 
3.0 
Background 
3.1 Summarize the relevant prior research on this topic and gaps in current 
knowledge within the field of study: 
 
Cigarettes have long been the dominant tobacco product, and the vast majority of the 
tobacco-related harm comes from their combustion.[1] In recent years, alternative 
nicotine delivery systems have been developed. These products deliver nicotine without 
combusting tobacco and are marketed as alternative products for addicted smokers.[2] In 
the previous funding period, we focused on the emergence of NVPs. In this project, we 
add two additional product classes: HTPs and NPPs. 
HTPs (sometimes called Heat Not Burn) are different from NVPs. HTPs heat 
reconstituted tobacco (tobacco not present within NVPs) at a temperature below the one 
required for combustion. Because the tobacco is not burned, exposure to harmful 
chemicals generated by cigarette smoke is substantially lower for HTPs.[3] The 
prevalence of HTP use in 2020 among current smokers and recent ex-smokers is 
estimated to be 2.7% in the US. [4] In Tokyo, where it has had the greatest success, IQOS 
captured 2.4% of the market share for tobacco, with >50% of smokers who tried the 
product switching entirely from cigarettes.[5] The limited data available on HTPs suggest 
that they are likely to serve as a substitute for conventional cigarettes.[6] Their role for 
dual cigarette/NVP users is unknown. 
NPPs contain nicotine, but no tobacco,[7] and as a result, may present reduced harm 
compared to combustible and non-combustible tobacco products, such as smokeless 
tobacco and snus. A recent pharmacokinetic study showed that the two highest doses of 
NPP (Zyn) deliver nicotine quickly and at levels similar to traditional smokeless tobacco 
products.[8] In 2020, the prevalence of NPP use among current smokers and ex-smokers 

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diverse samples from the International Tobacco Control (ITC) Policy Evaluation Project 
cohorts (Aims 3a and 3c) 
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was estimated to be 0.7% in the US. [4] The most recent Nielsen data show that sales 
from these products are sharply on the rise. However, given that NPPs are oral nicotine 
products, rather than inhaled products like NVPs and HTPs, whether NPPs would 
effectively substitute for cigarettes or NVPs among cigarette smokers or dual users is 
unknown. Further, the strength of substitution for NPPs relative to NVPs and HTPs is 
unknown. Thus, utilization of NPPs in the ETM may provide data about substitutability 
that is prescient for understanding the implications of these products for tobacco control. 
1. National Center for Chronic Disease Prevention and Health Promotion (US) Office on 
Smoking and Health. The Health Consequences of Smoking—50 Years of Progress: A 
Report of the Surgeon General. Atlanta (GA): : Centers for Disease Control and 
Prevention (US) 2014. https://www.ncbi.nlm.nih.gov/pubmed/24455788 
2. Zeller M, Hatsukami D, Strategic Dialogue on Tobacco Harm Reduction Group. The 
Strategic Dialogue on Tobacco Harm Reduction: a vision and blueprint for action in the 
US. Tob Control 2009;18:324–32. doi:10.1136/tc.2008.027318 
3. IQOS. https://www.pmi.com/smoke-free-products/iqos-our-tobacco-heating-system 
(accessed 23 Jun 2020). 
4. Li L, Borland R, Cummings KM, et al. Patterns of non-cigarette tobacco and nicotine 
use among current cigarette smokers and recent quitters: Findings from the 2020 ITC 
Four Country Smoking and Vaping Survey. Nicotine Tob Res Published Online First: 8 
March 2021. doi:10.1093/ntr/ntab040 
5. Caputi TL. Industry watch: heat-not-burn tobacco products are about to reach their 
boiling point. Tob Control 2016;26:609–10. doi:10.1136/tobaccocontrol-2016-053264 
6. Adriaens K, Van Gucht D, Baeyens F. IQOSTM vs. e-Cigarette vs. Tobacco Cigarette: 
A Direct Comparison of Short-Term Effects after Overnight-Abstinence. Int J Environ 
Res Public Health 2018;15. doi:10.3390/ijerph15122902 
7. Robichaud MO, Seidenberg AB, Byron MJ. Tobacco companies introduce ‘tobacco-
free’ nicotine pouches. Tob Control Published Online First: 21 November 2019. 
doi:10.1136/tobaccocontrol-2019-055321 
8. Lunell E, Fagerström K, Hughes J, et al. Pharmacokinetic comparison of a novel non-
tobacco-based nicotine pouch (ZYN®) with conventional, tobacco-based Swedish snus 
and American moist snuff. Nicotine Tob Res Published Online First: 22 April 2020. 
doi:10.1093/ntr/ntaa068 
 
 
3.2 Describe any relevant preliminary data: 
 
The Experimental Tobacco Marketplace (ETM) [1], 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. Different policies have been examined with 
this methodology in adult smokers, as part of the previous funding period. Study 1 

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diverse samples from the International Tobacco Control (ITC) Policy Evaluation Project 
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examined the impact of e-liquid nicotine strength and showed that the substitutability 
between cigarettes and NVPs increased as a function of e-liquid strength. The 24mg/mL 
strength resulted in the greatest substitutability  (p<0.001; f=1.05).[2] Study 2 examined 
cigarette taxes and e-liquid subsidies. It showed that cigarette taxes decreased cigarette 
purchases (p=0.005; f=0.45).[3] Interestingly, e-liquid subsidies had no effects on 
cigarette purchases, but increased e-liquid purchases (p=0.013; f=0.44). Study 3 used a 
hypothetical ETM and replicated the taxes and subsidies conditions from Study 2 among 
exclusive cigarette smokers and dual cigarette/NVP users in an international context as 
part of the ITC survey. Analysis of country-specific differences have yet to be explored, 
however, the US cohort replicates the findings of the lab-based ETM. Note, the effects of 
taxes on cigarette purchases observed in Studies 2 and 3 replicate and demonstrate the 
generality of our findings as related to prior econometric analysis of the impact of 
national and state taxes.[4] This replication provides an example of reverse translational 
research demonstrating that the ETM can reflect effects observed in larger 
populations.[5] Study 4 investigated the effects of NVP use in smoke-free environments 
on product choice. The results suggest that permitting NVP use in the workplace 
increased e-liquid purchase on average (p<0.001; f=0.56), but nicotine concentration had 
no effect on e-liquid demand intensity. Cigarette demand was unaltered across 
conditions.[6] This study suggests that allowing NVP use in the workplace may increase 
the demand for e-liquid without affecting purchases of conventional cigarettes.  
Collectively, and importantly for the proposed study, our ETM work shows that the 
substitution between products is dependent upon several factors (nicotine strength, price 
of the substitutable product, and the type and number of products in the marketplace). In 
these studies, we change the price as an expeditious, effective, and quantifiable method to 
promote change. With that change, we can ascertain the likelihood that smokers will 
defend their consumption or substitute it for another product. In doing so, we can 
estimate the consequences of a policy constraint before implementation. 
In study 1 conducted in the laboratory, we confirmed that: 1) purchasing of NVPs, HTPs, 
and NPPs increased as the price of conventional cigarettes was increased (i.e., they will 
all serve as substitutes), 2) the effect was largest when those alternative products were at 
a reduced price (1/2 MP - conditions replicated in this study). 
  
 
1. 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 
2. Pope DA, Poe L, Stein JS, et al. Experimental tobacco marketplace: substitutability of 
e-cigarette liquid for cigarettes as a function of nicotine strength. Tob Control Published 
Online First: 18 April 2018. doi:10.1136/tobaccocontrol-2017-054024 
3. Pope DA, Poe L, Stein JS, et al. The Experimental Tobacco Marketplace: Demand and 
Substitutability as a Function of Cigarette Taxes and E-Liquid Subsidies. Nicotine Tob 
Res under review. 
4. Chaloupka FJ, Grossman M, Bickel WK, et al. The Economic Analysis of Substance 
Use and Abuse: An Integration of Econometric and Behavioral Economic Research. 
Published Online First: 1 January 1999.https://www.nber.org/books/chal99-1.pdf 
(accessed 7 Aug 2020). 

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5. Shakhnovich V. It’s Time to Reverse our Thinking: The Reverse Translation Research 
Paradigm. Clin Transl Sci 2018;11:98–9. doi:10.1111/cts.12538 
6. Freitas Lemos R, Stein JS, Pope DA, Brown J, Feinstein M, Stamborski KM, Tegge 
AN, Heckman BW, Bickel WK. E-liquid Purchase as a Function of Workplace 
Restriction in the Experimental Tobacco Marketplace. Exp Clin Psychopharmacol; 
Advance online publication. https://doi.org/10.1037/pha0000444 
 
 
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: 
 
An important aim of tobacco control is to reduce demand for the most harmful products. 
No study to date has experimentally compared the effects of conventional cigarettes, 
NVPs, HTPs, and NPPs on tobacco/nicotine purchasing and substitution. A priori 
knowledge of substitutability across novel and widely used tobacco products may 
forecast the impact of policies on product switching.  
 
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: cigarettes, NVPs, HTPs, and NPPs will be compared to assess 
substitutability as a function of tobacco user type across different regulatory 
environments. 
 
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.): 
 

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This study will recruit adults/young adults who regularly smoke cigarettes and who 
regularly smoke cigarettes and use NVPs. 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): 
 
This study uses a mixed design (within-subject and between-group). Participants will 
complete a few behavioral questionnaires, and make hypothetical purchases of tobacco 
products in an online store under four different scenarios: a) control, b) NVPs at 1/2 
market price, c) HTPs at 1/2 market price, d) and NPPs at 1/2 market price. 
 
 
 
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): 
 
A within-between subject analysis of variance (ANOVA) will test for differences in 
substitution and demand measures between user types (exclusive cigarette smokers and 
dual cigarette/NVP users) and relative price scenario (e.g., ½ market price for HTPs). We 
will test for the interaction between the relative price scenarios and each user type, 
suggesting a difference in how each user type responds to price scenarios. In addition, we 
will add a covariate for country. Moreover, we will use other tobacco related measures 
collected by the ITC primary survey to understand the possible influence of these 
variables on purchasing in the ETM. Order effects will be included in all models to 
account for the balanced Latin square design for counterbalancing the ETM conditions 
within the session. We will perform post-hoc contrasts to compare user types, based on 
our hypotheses. 
 
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. 

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cohorts (Aims 3a and 3c) 
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● 
Identify where the team will perform the research procedures. 
● 
Describe the composition and involvement of any community 
advisory board(s). 
● 
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: The sample that we plan on using for this study, which is to be conducted 
online in 3 different countries, will be recruited and screened by contracted survey firms. 
The ITC project has conducted cohort studies in the past of tobacco users and we will use 
their databases to recruit the sample needed for this study. Specifically, participants from 
the US, Canada, and England will be recruited and screened by IPSOS Public Affairs, 
LLC, Leger Marketing, and Ipsos UK, respectively. Participants who complete the main 
ITC survey, will be invited to complete a bonus survey online that incorporates both the 
assessment and ETM trials described in this protocol.  
 
Location of study: The research procedures will be performed remotely. The study survey 
will be prepared by our VT team. Recruitment will be by the survey firms mentioned 
above 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. 
 
 

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This study does involve experimental manipulation of nicotine/tobacco product price and 
availability in 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:  
 
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 

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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 
cigarette. In each ETM condition, participants will purchase tobacco/nicotine products for 
a 7-day period.  
ETM conditions include:  
a) control (NVPs, HTPs, and NPPs at market price),  
b) NVPs at 1/2 market price,  
c) HTPs at 1/2 market price, and  
d) NPPs at 1/2 market price. 
 
Participants will be exposed to these conditions across purchasing scenarios in a 
counterbalanced order. 
 
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 who meet inclusion criteria will be invited to participate and will be 
redirected from the main ITC survey to a bonus survey that will include questionnaires, 
smoking-related assessments, and ETM purchasing trials.  
 
A Qualtrics survey will administer: 
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) e-cigarette use and perceptions 
     c) tobacco awareness (for NVP, HTP, and NPP) 
     d) intention to transition or quit 
3) the ETM; 

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     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: 
 
a) control (NVPs, HTPs, and NPPs at market price,  
b) NVPs at 1/2 market price,  
c) HTPs at 1/2 market price, and  
d) NPPs at 1/2 market price. 
 
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.  
Demographic questions answered in the main survey are available to investigators upon 
request to the ITC team.  
 
 
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.  

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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 
 
 
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 

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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 for at least 5 years following study 
closure. Identifiers will be destroyed 3 years 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. 
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: 
 

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The VTC study team will not have access to any identifiers. Participants will be recruited 
and assigned a study ID by the survey firms 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 
☐ 
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 

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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 3 months.  
 
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 
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 the ITC project after completion of the main survey. 
Eligible participants will be invited to participate in this study and have access to a 
survey link.  
 
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 

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aged 8-12 in the New River Valley, university faculty in Virginia and 
Paris, France): 
 
 A sample of 456 adults participants from the US, EN, and CA will complete the study 
(76 smokers and 76 dual users from each of the three countries). 
Eligibility (filters:) 
Smokers only must satisfy the following criteria: 
a. From CA, US, or EN (country=CA, EN, or US) 
b. At least 21 years old (ageSD>20) 
c. Smoking daily (FR309v=10) 
d. Smoking mostly or about equal amounts of factory-made cigarettes (vs. Roll Your 
Own) (FR300=1-3) 
e. Does not currently vape (EC309v=40-70) 
 
Dual users must satisfy the following criteria: 
a. From CA, US, or EN (country=CA, EN, or US) 
b. At least 21 years old (ageSD>20) 
c. Smoking daily (FR309v=10) 
d. Smoking mostly or about equal amounts of factory-made cigarettes (vs. Roll Your 
Own) (FR300=1-3) 
e. Vapes Daily (EC309v=10) 
 
There will be no additional exclusion criteria for this study. 
 
Based on our prior experience with the ITC, we should be able to fill the requested 
sample size. 
 
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 laws. 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. 

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13.0 Vulnerable Populations 
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. 
 
 

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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. 
 
 
 
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):  
 
Our sample size is based on repeated measures within-between interaction ANOVA 
design using a small effect size (f=0.1) to account for increased variability in the 
population and 80% power. Note the effect sizes observed in preliminary data collected 
from laboratory based studies ranged from f=0.29 to f=1.05. Given that the products (i.e., 
NVP and HTPs) used in these experiments are untested and we are sampling from a more 
diverse population, we conservatively selected a small effect size of f=0.1.  In order to 
account for multiple testing, we will control for five comparisons; therefore, we use an 
alpha of 0.01. We require n=456 (76/cohort) participants to complete the study when 
using repeated measures with 6 cohorts (3 countries x 2 user type) and 2 measurements 
per participant. Attrition is not included in these final sample sizes because the study will 
be completed in one session. Note that this Aim includes more than two measurements 
per participant, but only two were considered in the calculations to maximize power. 
 
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: 
 
Every participant who completes the main survey will be screened for the bonus study 
and invited to participate. We will use a quota system to assess if more participants of 
that specific tobacco user type are needed. A total of 456 participants will complete the 
study. 
 
14.4 If the study has more than one procedure, indicate the total number of 
subjects to undergo each procedure separately: 

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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: 
 
Participants who complete the main ITC survey and meet eligibility criteria will be 
invited to complete a bonus survey. 
 
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 source will be the ITC cohorts.  
 
15.3 Describe the methods that you will use to identify potential subjects: 
 
ITC completers who meet eligibility criteria will see an invite to a bonus survey at the 
end of the main survey. 
 
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 
effort, and additional incentives for study participation.  For each 
category, specify the amount (including any pro-rated amount), schedule, 
and method of payment. 
 

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Invitation is attached.  
 
Compensation: Participants will be paid through the survey firms upon 
completion of our survey. The survey firms are paid a flat rate per participant; 
when participants finish our survey, the firm pays the participants according to 
their own policies and protocols. Participants will be paid approximately $8 USD 
or equivalent value, $8CAD or equivalent in panel points or Air Miles or 
Aeroplan reward miles, or in England the standard points provided to their 
panelists.  
 
 
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 
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 

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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 
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.  

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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 
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: 
 

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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, 
password protection, encryption, physical controls, certificates of 
confidentiality, separation of identifiers and data, etc.: 
 

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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 for at least 5 years 
following study closure. Identifiers will be destroyed 3 years 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):  
 
No private information will be collected in this study. Private information is collected and 
protected by the survey firms. Procedures to keep all other the information safe are 
described in section 9.4. 

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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 the ITC with study's IDs from participants that completed the 
survey. The ITC will then provide demographics and any other requested measures 
collected in the main survey. 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) 
 
 
We do not expect any required reporting to occur as a result of our research questions and 
data collection methods.  
 

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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 
 
An invitation to participate in this study will be sent to participants who complete the 
main ITC survey. If they are interested in completing the study, they will be redirected to 
a bonus survey and will be able to read specific information about the study. Consent for 
the bonus survey will be implied with submission of the survey. 

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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.   
 
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). 
o 
For research conducted in 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 “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. 
 
 

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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: 
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.  
 
 

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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. 
 
Click here to provide a response.