Effects of Cigarette and E-cigarette Flavors on Substitutability in the Experimental Tobacco Marketplace (20-008)
Phase: NA
Conditions: Cigarette Smoking Behavior
Sponsor: Virginia Polytechnic Institute and State University

Official Title of Study: 
Effects of Cigarette and E-cigarette flavors on Substitutability in the Experimental Tobacco 
Marketplace (20-008) 
ClinicalTrials.gov Identifier (NCT Number): 
NCT06910202 
Document Type: 
Study Protocol 
Document Date: 
02/20/2025 
Principal Investigator (PI): 
Roberta Freitas-Lemos, PhD 
Sponsor/Collaborator: 
Medical University of South Carolina 
Confidentiality Statement: 
This document does not contain names of research participants. 
 

 
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Institutional Review Board 
Existing Data Research Protocol 
 
 
 
 
 
 
 
 
 
 
Note: complete this application only if this research project only involves the collection or study of existing data. Once 
complete, upload this form as a Word document to the IRB Protocol Management System: https://secure.research.vt.edu/irb  
 
 
1. DO ANY OF THE INVESTIGATORS OF THIS PROJECT HAVE A REPORTABLE CONFLICT OF 
INTEREST? (http://www.irb.vt.edu/pages/researchers.htm#conflict)  
 
 
 No  
 
 Yes, explain:       
 
 
2. IS THIS RESEARCH SPONSORED OR SEEKING SPONSORED FUNDS? 
 
 
 No, go to question 3 
 
 Yes, answer questions within table 
 
  
 
IF YES 
Provide the name of the sponsor [if NIH, specify department]: National Institutes of Health, 
National Cancer Institute 
 
Is this project receiving or seeking federal funds? 
     
 No 
     
 Yes  
 
If yes,  
 
Does the grant application, OSP proposal, or “statement of work” related to this project 
include activities involving human subjects that are not covered within this IRB 
application? 
 No, all human subject activities are covered in this IRB application 
 Yes, however these activities will be covered in future VT IRB applications, these 
activities include:       
 Yes, however these activities have been covered in past VT IRB applications, the IRB 
number(s) are as follows: 20-008, 23-825, 21-1046, 17-896 
 Yes, however these activities have been or will be reviewed by another institution’s 
IRB, the name of this institution is as follows:       
 Other, explain:       
 
Is Virginia Tech the primary awardee or the coordinating center of this grant? 
 No, provide the name of the primary institution: Medical University of South 
Carolina - MUSC 
 Yes 
 
 
 
 

 
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3. DESCRIBE THE BACKGROUND, PURPOSE, AND ANTICIPATED FINDINGS OF THIS STUDY: 
 
In 2009, the Food and Drug Administration banned all flavored conventional cigarettes except for menthol 
cigarettes. Although no such ban exists in the U.S. for E-cigarettes, such efforts have been proposed in 
several regions[1-3]. Flavors are possible objects of new tobacco control policy. Knowing whether flavors 
enhance or diminish substitution would be important in evaluating whether to support such bans on E-
cigarette flavors. A report from the first wave of the PATH study of tobacco use found that 80% of youth, 
73% of young adult and 29% of older adult smokers used flavored products[4].  They also report in that 
study that over 80% of young adults first used flavored tobacco products while the percentage was 
approximately 50% among adults.  Lastly, the prevalence of current tobacco use among adult ever-users 
was 32% higher if the first tobacco product they used was flavored [4].  Importantly, one study asked 
flavored product users what they would do if the product they used was no longer flavored, and reported 
that 75% would no longer use the product [5]. Clearly, these data show the relevance of user type in 
understanding potential policies, but also raise the question of whether removal of flavors would result in 
greater quitting and intention to quit or lead to substitution with some other product. 
Purpose: To examine the effects of e-cigarette and cigarette flavors availability on substitutability in the 
Experimental Tobacco Marketplace. 
This study is designed to better understand the effect of possible restrictions in flavored tobacco 
products. We hypothesize that flavors availability and cigarette/e-cigarette price will affect substitution 
with other tobacco products differently across groups.   
 
 
4. EXPLAIN WHAT THE RESEARCH TEAM PLANS TO DO WITH THE STUDY RESULTS: 
  For example - publish or use for dissertation 
 
The research team plans to publish these results and findings in journals and present at conferences. 
 
 
5. WILL PERSONALLY IDENTIFYING STUDY RESULTS OR DATA BE RELEASED TO ANYONE 
OUTSIDE OF THE RESEARCH TEAM?  
For example – to the funding agency or outside data analyst, or participants identified in publications with individual 
consent  
 
 No 
 Yes, to whom will identifying data be released?       
 
 
6. WILL THE RESEARCH TEAM COLLECT AND/OR BE PROVIDED PARTICIPANT IDENTIFYING 
INFORMATION (E.G., NAME, CONTACT INFORMATION, VIDEO/AUDIO RECORDINGS)? 
 
 No, go to question 7 
 Yes, answer questions within table 
 
  
IF YES 
Describe if/how the study will utilize study codes: All participant data, including electronic data, 
will be stored in secure places to protect confidential participant information. Secured places 
will include locked filing cabinets, locked rooms accessible only to study personnel, and/or 
password-protected databases. Moreover, all data will be quality controlled in preparation for 
data analyses. All discrepancies in data entry will be checked against the raw data source, 
and the correct data entry will be used. All data entered into spreadsheets and databases will 
be coded by participant ID number and not by name (i.e., first and last name). 
 

 
3 
If applicable, where will the key [i.e., linked code and identifying information document (for instance, 
John Doe = study ID 001)] be stored and who will have access? All entered data will be backed up on 
secure password-protected servers. Computers used in the studies will also be password 
protected, accessible only by study personnel. 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. 
 
Note: the key should be stored separately from subjects’ completed data documents and accessibility 
should be limited. 
 
 
 
7. HOW WILL DATA BE STORED TO ENSURE SECURITY (E.G., PASSWORD PROTECTED 
COMPUTERS, ENCRYPTION) AND LIMITED ACCESS? 
 
To secure study data computer databases will have coded identifiers, only ID numbers will be used, data 
will be kept in secure locations and/or in locked offices. The study team will have access to data that 
participants' identities could be readily ascertained, such as in screening information and previous 
participant payment information. Participants names, however will not be used during any data analysis 
nor will they be part of any published results. Only authorized study personnel will have access to 
screening and payment information. 
The only key connecting participants' data ID to their identities is in REDCap, which is accessible only to 
trained personnel and is accessed via secure log in.  
 
 
8. WHO WILL HAVE ACCESS TO STUDY DATA? 
 
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.  
 
 
9. DESCRIBE THE PLANS FOR RETAINING OR DESTROYING STUDY DATA:  
 
Data collected from this study will be retained and destroyed in accordance with state and federal law that 
requires a 5-year retention period following study closure. 
 
 
10. FROM WHERE DOES THE EXISTING DATA ORIGINATE? 
 
The existing data comes from Qualtrics survey responses and our Experimental Tobacco Marketplace 
dataset collected under VT IRB 20-008. 
 
 
11. PROVIDE A DETAILED DESCRIPTION OF THE EXISTING DATA:  
 
Data for this project is comprised Qualtrics survey data and data from our Experimental Tobacco 
Marketplace. All data were collected under VT IRB 20-008, including obtaining informed consent. 
 
 
12. IS THE SOURCE OF THE DATA PUBLIC? 
 
 
 No, go to question 13 

 
4 
 
 Yes, you are finished with this application 
 
 
13. WILL ANY INDIVIDUAL ASSOCIATED WITH THIS PROJECT (INTERNAL OR EXTERNAL) 
HAVE ACCESS TO OR BE PROVIDED WITH EXISTING DATA CONTAINING INFORMATION 
WHICH WOULD ENABLE THE IDENTIFICATION OF SUBJECTS: 
 
§ Directly (e.g., by name, phone number, address, email address, social security number, student ID number), or 
§ Indirectly through study codes even if the researcher or research team does not have access to the master list 
linking study codes to identifiable information such as name, student ID number, etc 
or 
§ Indirectly through the use of information that could reasonably be used in combination to identify an 
individual (e.g., demographics) 
  
     
 No, collected/analyzed data will be completely de-identified  
     
 Yes,  
 
If yes, 
 
Research will not qualify for exempt review; therefore, if feasible, written consent must be obtained from 
individuals whose data will be collected / analyzed, unless this requirement is waived by the IRB. 
 
Will written/signed or verbal consent be obtained from participants prior to the analysis of collected 
data? Yes, signed consent has been obtained 
 
 
 
 
 
 
 
This research protocol represents a contract between all research personnel associated with the project, 
the University, and federal government; therefore, must be followed accordingly and kept current.  
 
Proposed modifications must be approved by the IRB prior to implementation except where necessary 
to eliminate apparent immediate hazards to the human subjects.  
 
Do not begin human subjects activities until you receive an IRB approval letter via email. 
 
It is the Principal Investigator's responsibility to ensure all members of the research team who collect 
or handle human subjects data have completed human subjects protection training prior to handling or 
collecting the data. 
 
 
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