Reinforcer Pathology 1B: Decreasing the Temporal Window
Phase: NA
Conditions: Alcohol Use Disorder
Sponsor: Virginia Polytechnic Institute and State University

Decreasing the Temporal Window in Individuals with Alcohol Use Disorder (RP1B) 
NCT04128761 
02/24/2024 

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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
applicable to your research. If so, simply mark as “N/A.” For example, a simple
survey might have many sections with “N/A.”  For subsections (e.g., 1.x or 8.x)
you can mark as “N/A”if you are certain that the subsection is not applicable.
●
Once the IRB/HRPP approves your submission, your latest approved version of
the protocol will be stored in the IRB Protocol Management online system.
●
If your research plan changes and you need to modify the protocol, please submit
an amendment to Protocol Management with the requested modifications.
Download your current protocol from Protocol Management and indicate the
changes/revisions using the track changes feature in order to make review of the
modifications easier to follow. If you are unable to use track changes, please
create a new paragraph wherever you need to make a change, and indicate
“Amendment: Date” before making a change to any section. Protocol
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. 
Scarcity narratives and AUD 
PROTOCOL NUMBER: 
Include the number assigned in Protocol Management (verify this has been added 
before submitting protocol to HRPP).  
23-621
PRINCIPAL INVESTIGATOR: 
Full Name and Degrees: Warren K. Bickel, PhD and Stephen M. LaConte, PhD 
Department: Fralin Biomedical Research Institute 
Telephone Number: 540-526-2088 and 540-526-2008 
Email Address: wkbickel@vtc.vt.edu and slaconte@vtc.vt.edu 
FUNDING: 
Sponsor(s): NIAAA 
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: Yes 
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VERSION NUMBER/DATE:  
Include the version number and date of this protocol. Versions should start at 1.0. 
 
Version 6.0 - 02/26/2024 
 
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? 
1 
07/21/2023 
Updated the criteria for group randomization; 
updated inclusion and exclusion criteria; 
updated data management  
No 
2 
08/18/2023 
Updated compensation  
Yes 
3 
08/25/2023 
Included that we will collect W-9 for payment 
Yes 
4 
11/13/2023 
Change in the scarcity narrative used for 
Session 2 
No 
4 
02/26/2024 
Changed eligibility criteria to lower the 
AUDIT requirement 
No 
 
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Table of Contents 
1.0 
Study Summary 
4 
2.0 
Objectives 
4 
3.0 
Background 
5 
4.0 
Study Endpoints 
6 
5.0 
Study Design and Statistical Analysis Plan 
7 
6.0 
Setting 
7 
7.0 
Study Intervention(s)/Investigational Agent(s) 
8 
8.0 
Procedures Involved 
10 
9.0 
Data and Specimen Long Term Storage and Use 
13 
10.0 Sharing of Results with Subjects 
16 
11.0 Study Timelines 
16 
12.0 Inclusion and Exclusion Criteria 
16 
13.0 Vulnerable Populations 
17 
14.0 Number of Subjects 
18 
15.0 Recruitment Methods 
19 
16.0 Withdrawal of Subjects 
21 
17.0 Risks to Subjects 
22 
18.0 Potential Benefits to Subjects 
23 
19.0 Data Management and Confidentiality 
24 
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 
29 
23.0 Economic Burden to Subjects 
30 
24.0 Consent Process 
30 
25.0 Process to Document Consent in Writing 
33 
26.0 Resources Available 
34 
27.0 Multi-Site Research 
35 
 
 
 
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1.0 
Study Summary 
 
Study Title 
Scarcity narratives and AUD 
Study Design 
Adults with Alcohol Use Disorder (AUD) will be enrolled in 
the study and complete two online sessions where the effects 
of exposure to scarcity narratives on delay discounting and 
alcohol demand will be investigated. Participants will be 
randomly assigned to one of two scarcity narrative groups 
(active or control), balanced by discounting rate and sex. 
Delay discounting and alcohol demand will be evaluated pre 
and post exposure to the narratives.  
Primary Objective 
The primary objective is to test the theory of Reinforcer 
Pathology via manipulation of the temporal window with 
exposure to a scarcity narrative. The primary outcome 
measures of this study are the extent to which scarcity 
narratives decrease an individual’s temporal window and 
increase their alcohol valuation, compared to baseline. 
Secondary 
Objective(s) 
Investigate the effects of scarcity narratives on delay 
discounting and demand in individuals with AUD 
Study Population 
Individuals with Alcohol Use Disorder (AUD) 
Sample Size 
112 
Research 
Intervention(s)/ 
Investigational 
Agent(s)  
Participants will complete two online surveys that will last 
approximately 1h each. The survey will collect data on AUD 
severity, demographics, patterns of alcohol consumption, 
DD, and alcohol demand pre and post exposure to scarcity 
narrative.   
Study Duration for 
Individual 
Participants 
The study will have a duration of two online sessions of 
approximately 1h each.   
Acronyms and 
Definitions  
AUD = Alcohol Use Disorder 
SUD = Substance Use Disorder 
DD = Delay Discounting 
RP = Reinforcer Pathology 
AI = Artificial Intelligence 
 
 
2.0 
Objectives 
2.1 Describe the purpose, specific aims, or objectives of this study: 
 
The goal of the present study is to test reinforcer pathology via manipulation of the 
temporal window (i.e., shorten the temporal window with exposure to a scarcity 
narrative). Another goal of the present study is to evaluate whether a voice recording can 
enhance the effects of a previously published scarcity narrative, compared to exposure to 
the written narrative only.  
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2.2 State the hypotheses to be tested:  
 
We hypothesize a Group (Scarcity vs. Control) x Time (baseline vs. post) interaction. 
Specifically, we expect that participants exposed to an active scarcity narrative will 
present a shorten temporal view, as measured by Delay Discounting (DD), and increase 
demand for alcohol compared to baseline, whereas the control group would not show any 
changes between baseline and post intervention measures.  
 
3.0 
Background 
3.1 Summarize the relevant prior research on this topic and gaps in current 
knowledge within the field of study: 
 
RP suggests that substance use disorders results from a short temporal window of 
reinforcer integration, as indexed by a high DD rate. Data shows that DD serves as a 
behavioral marker for addiction and a predictor for therapeutic outcomes. Furthermore, a 
short temporal window increases the valuation of brief, immediate, and intense 
reinforcers (e.g., drugs), and decreases the value of reinforcers that are less intense and 
variable over time. RP has been mechanistically tested with manipulations that both 
increase the temporal window (i.e., decreases DD), such as episodic future thinking, or 
decrease the temporal window (i.e., increases DD), such as exposure to scarcity 
narratives. Although exposure to scarcity narratives has been shown to increase DD, few 
studies have investigated its effects on alcohol valuation, as measured through demand. 
Thus, the goal of the present study is to investigate the effects of scarcity narratives on 
both DD and demand in participants with AUD.  
 
3.2 Describe any relevant preliminary data: 
 
Previous online and in-laboratory studies from our group and others have shown that 
exposure to scarcity narratives increase DD in individuals with AUD, cocaine use 
disorder, smokers, overweight, and obese population. However, empirical evidence on 
the effects of scarcity on demand and drug valuation are scarcer. 
 
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: 
 
To date, only two studies investigated the effect of scarcity narrative on DD in AUD 
population. Furthermore, only one of them included demand measures to assess alcohol 
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valuation. Thus, it is unclear how exposure to a scarcity narrative impacts both DD and 
alcohol valuation in AUD participants. In this study, we hypothesize that exposure to 
active scarcity narratives will increase DD and alcohol valuation as measured through 
demand compared to exposure to a control narrative. Specifically, we expect that 
participants exposed to an active scarcity narrative will present a shorten temporal view, 
as measured by Delay Discounting (DD), and increase demand for alcohol compared to 
baseline, whereas the control group would not show any changes between baseline and 
post intervention measures.  
 
 
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  
 
Primary: 
Change in Delay Discounting: Change in discounting rates will be compared within-
subjects across sessions and between groups. 
 
Change in Alcohol Demand: Change in alcohol demand will be compared within-subjects 
across sessions and between groups. 
 
Alcohol craving: Change in alcohol craving will be compared within-subjects across 
sessions and between groups. 
 
Subjective time perception: Change subjective time perception will be compared within-
subjects across sessions and between groups. 
 
 
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.): 
 
These procedures are not more than minimal risk. 
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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): 
 
The study will use a within-between design. Adults with AUD will be randomly assigned 
to two groups (active or control), balanced by discounting rate and sex. All participants 
will provide measures for all assessments pre and post exposure to the scarcity (or 
control) narrative.   
 
 
 
 
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): 
 
Demographic characteristics will be summarized using descriptive statistics. We will 
compare outcome measures using a repeated measures ANOVA with active vs. control 
narratives as explanatory variables. Outcomes of interest include delay discounting and 
alcohol demand.  
 
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). 
● 
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. 
 
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Location of Recruitment:  
Participants will be recruited from our REDCap data base. Previously screened 
participants who have agreed to be re-contacted for other studies and that meet for the 
current experiment will be contacted via email with an invitation to participate in the 
current study.  
Location of study: 
The entirety of data collection will be conducted online. All participants will enroll on a 
voluntary basis and eletronically sign an IRB-approved consent form 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. 
 
 
Active scarcity narrative:  
" 
There was a major hurricane in my area. My car and house have been destroyed by the 
storm. My family is depending on me to come up with a solution. The storm shelters are 
full of other hurricane victims and I will have to be separated from my family to get a 
bed. I have no idea when I will see them again or how I will get food." 
 
Control scarcity narrative: "There was a minor storm in my area. Hail fell on both my 
house and car, and I have a small dent in the hood of my car. I contacted my insurance 
company, and the repair is fully covered. The earliest available appointment is next week, 
when the repair team will travel to me and fix my car while I am at work. My house 
appears to be undamaged."  
 
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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:  
 
NA 
 
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:  
 
NA 
 
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 
 
 
 
NA 
 
 
 
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8.0 
Procedures Involved 
8.1 Describe and explain the study design: 
 
Adults with alcohol use disorder will be randomly assigned to one of two scarcity 
narrative groups narrative (active vs. control), balanced discounting rate and sex. We will 
enroll approximately 160 participants in order to conclude with 112 completers (56 per 
group).  
 
The procedure will include two sessions. During the first session, participants will 
complete all the assessments via an online survey without any independent variable. 
After the first session, participants will be randomized to one of two groups. During the 
second session, participants will be initially exposed to one of the scarcity narratives 
(active vs. control). They will be asked to read the narrative while also listening to the 
narrative on audio. They will listen to either a male or female voice. The voice will be 
matched based on sex. They will be asked to vividly imagine that this narrative applies to 
them. Next, participants will complete the assessments in the presence of these narratives. 
 
All dependent variables will be measured pre and post exposure to the scarcity narrative 
for all participants. Thus, narrative effects will be measured within-subject. Comparisons 
between active and control narratives will conducted between groups.  
 
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 in our REDCap database will be contacted if they have given prior 
permission to be contacted for future studies. Participants will be screened again for 
eligibility for the current study using a Qualtrics online survey. 
Eligible participants will complete two online surveys on Qualtrics. The first survey will 
serve as the baseline. In the second survey, they will be exposed to one of the scarcity 
narratives and then they will answer the survey.  
 
 
 
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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  
 
Delay Discounting: Assesses money and alcohol (matched on utility) rewards devaluation 
as a function of delay by presenting hypothetical choices between smaller, sooner and 
larger, later rewards at a range of delays. 
Alcohol Purchase Task: Assesses alcohol demand, where participants report the quantity 
of standard alcoholic drinks they would consume across various prices. 
Alcohol Relative Reinforcement Schedule: Measures substance-related and substance-
free reinforcement. 
Alcohol Urges Questionnaire: Assesses alcohol craving. 
Alcohol Withdrawal Symptoms: Assesses alcohol withdrawal. 
Temporal perception scale: Measures the subjective perception of future proximity  
 
Contemplation Ladder: Measures readiness to change substance use 
 
The Holmes Rahe Life Stress Inventory: Assesses occurrence of stressful life events 
Obsessive Compulsive Alcohol Use Scale: Measures alcohol craving during the past 
week 
 
Reward Responsiveness Scale: Assesses reward sensitivity 
 
Stress Appraisal Measure: Assesses cognitive appraisal of an anticipatory stressful event 
 
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Expectancies and attitudes: Measures expectancies regarding intervention group 
membership assessed 
 
Experiment/Experimenter Attitudes Rating Scale: Assesses participants’ attitudes and a 
tendency to confirm arbitrary experimental hypotheses. 
 
 
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. Only study personnel will have access to the survey and 
collected data.  
 
8.5 Who will transcribe or code audio and/or video recordings?: 
 
NA 
 
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)  
 
 
NA 
 
 
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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:  
 
NA 
 
 
 
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 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), stored in a master ID 
log. The master ID log will be stored in REDCap and Qualtrics, which are HIPAA 
compliant. Additionally, all entered data will be backed up on secure password-protected 
servers. Computers used in the studies will also be password protected, and accessible 
only by study personnel. Computers and password-protected servers used for this study 
are Virginia Tech secured and managed. We will provide certification of IRB approvals 
of the study protocol to NIDA prior to enrolling study participants. VT 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. Data will be stored for three years following publication in accordance with 
NIH policy. Individuals on the IRB approved protocol will have access to data in long 
term storage.  
 
 
9.2 For specimens, list the data to be stored or associated with each 
specimen: 
 
NA 
 
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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. Participant data 
collected in this project will be de-identified and made available if requested. We will 
also share the analysis results. 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. 
Raw data will be made available upon request after the dissemination of results. 
Access Criteria:           
Data requests will be reviewed by the principal investigators 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: 
 
All screened participants are assigned study IDs that are thereafter associated with all 
collected data. The electronic de-identified data is stored on the Bickel shared server 
which is password protected and only accessible to members of the research team on the 
VT IRB approved protocol.  
Study ID and identifiers (i.e., name, email, age, and demographics) will be available 
together electronically only in the pre-screener in Qualtrics. Specifically, we will use a 
pre-screener survey in Qualtrics to collect demographic and other screening criteria to 
decide the participant's eligibility to enroll in the study. After completing the pre-
screener, the participant will be assigned an ID. If eligible to enroll in the study, they will 
receive that ID by email together with the link to the surveys. They will use this ID to 
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authenticate their access to the two surveys of the study. They will not have to provide 
any PII during the surveys following the pre-screen. Throughout the remaining of the 
study, the only personal information linked to their ID will be their email which will be 
needed to send the survey links and process the payments. Data will be stored in 
Qualtrics and only authorized people will have access to the data in Qualtrics.  
If data need to be downloaded from Qualtrics, those data will be stored in password-
protected folders and only the participant's ID will be included in the file. No other PII 
will be stored together with the participants' responses to the surveys.    
 
 
 
 
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 
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☐ 
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 any results with the study participants. In the event of incidental 
findings, we will follow the established protocol highlighted in the NIDA Data and 
Safety Monitoring Plan (DSMP) for the R01 associated with this project. 
 
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. 
 
The study will last two online sessions of approximately 1h each. 
 
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:  
 
We will use a study-specific pre-screening online survey that will occur prior to enrolling 
participants into the study, in order to effectively decrease attrition in our studies by 
ensuring that participants meet all inclusion/exclusion criteria prior to enrolling into the 
randomized study. 
 
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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 will require that participants: 
(1) demonstrate high-risk or harmful drinking (AUDIT>15; i.e., 16 or higher); (2) be 21 
years old or older, (3) have a desire to quit or cut down on their drinking, but do not have 
proximate plans to enroll in treatment for AUD during the study period 
 
Exclusion criteria include: (1) having a current unmanaged psychotic disorder, (2) 
reporting current pregnancy or lactation, (3) having dementia 
 
 
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 
 
Vulnerable subjects, such as individuals with cognitive impairments, minors, prisoners, 
and pregnant women will be excluded.  
 
 
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 
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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. 
 
 
 This research study will not include any vulnerable populations.  
 
 
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):  
 
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In the preliminary data, we observed effect sizes ranging from ηp2 = .027 to ηp2 = .074. 
Thus, we selected a medium effect size (f = 0.25) to inform sample size of the current 
study. A total of 112 participants will complete the study (56 participants per group), 
assuming a type 1 error rate of 0.01 to account for multiple comparisons, 95% statistical 
power, and pre- and post-measure correlation of 0.25, based on an ANOVA comparing 
the intervention at sessions 1 and 2. 
 
We anticipate a 70% retention rate; thus, to achieve a final sample size of 112, we 
anticipate consenting 160 participants.  
 
 
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: 
 
NA 
 
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: 
 
We cannot accurately estimate the total number of potential participants we expect to 
screen. However, as described above, we anticipate enrolling 160 participants in order to 
complete a total of 112 participants. Additionally, the first few participants enrolled in the 
study may be pilots. 
 
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 all sessions unless they withdraw from the study. 
 
 
15.0 Recruitment Methods 
15.1 Describe when, where, and how you will recruit potential subjects: 
 
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Participants will be recruited from our REDCap data base. Previously screened 
participants who have agreed to be re-contacted for other studies will be contacted via 
email with an invitation to participate in the current study.  
 
 
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): 
 
Participants will be recruited from our REDCap database. Previously screened 
participants who have agreed to be re-contacted for other studies will be contacted via 
email with an invitation to participate in the current study. 
 
15.3 Describe the methods that you will use to identify potential subjects: 
 
We will check our current REDCap database, composed of participants that have 
screened in REDCap for other studies in our lab, and look for participants who: 1) have 
agreed to be re-contacted for future studies, and 2) reported alcohol use. We will then 
send out an email about the new study with a new REDCap screener link. All 
prospective participants will be required to fill out the new screener before enrolling for 
the current study to assure they meet all the inclusion criteria for the 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 
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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A template of the invitation email is attached. 
 
Compensation. Participants will be compensated for each survey completed and will 
receive a study completion bonus if they complete both sessions. Compensation will be 
provided via online gift cards. Participants will be required to complete an online W-9 
form in order to receive the payment.  
 
Session 1: $15  
Session 2: S20 
Study completion bonus: $5 
 
 
16.0 Withdrawal of Subjects 
16.1 Describe circumstances under which you anticipate subjects could be 
withdrawn from the research without their consent: 
 
Participants may be withdrawn from the research without their consent if they become 
ineligible based on inclusion/exclusion criteria or learning of a contraindication for 
continuing, or if they demonstrate inconsistent responding during baseline assessment.  
 
16.2 If applicable, describe any procedures for orderly termination (e.g., 
discontinuation of a study drug or debriefing after a behavioral 
intervention): 
 
If a participant is withdrawn from the study, he or she will be informed that we have 
collected all the data required from their participation. If a participant is withdrawn or 
voluntarily discontinue, their compensation for the study will be pro-rated accordingly. 
 
 
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): 
 
If a participant is withdrawn or discontinued, they will be withdrawn from the entire 
study. 
 
 
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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 
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 are minimal risks involved in participation, including: 
1. Adverse emotional reactions: These reactions may be related to some of the research 
tasks. Participants may also feel uncomfortable disclosing personal information such as 
drug use history. 
2. Loss of confidentiality: The research team will employ every effort to maintain 
participant confidentiality, however the loss of confidentiality is a potential risk, 
specifically associated with the collection, storage, and transmission of data via an app. 
 
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.) 
 
NA 
 
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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: 
 
NA 
 
17.4 If applicable, indicate which procedures might have risks to an embryo or 
fetus should the subject be or become pregnant: 
 
NA 
 
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): 
 
NA 
 
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: 
 
Participants may benefit from education about research participation. The project 
involves minimal risk to confidentiality or other personal rights or to physical or 
emotional health. The results from this behavioral economic study will inform the 
development of new treatments for cocaine use. Thus, in general, the expected benefits 
outweigh the very minimal risks to participants. 
 
 
18.2 If applicable, specify that there are no anticipated direct benefits for 
participants:  
 
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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: 
 
All staff involved in the conduct and/or monitoring of this study will have completed the 
Virginia Tech (VT) Human Subject Protection Training. Documentation of training will 
be maintained by the VT Institutional Review Board (IRB). VT 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. The PI will be responsible for continuous data and safety monitoring of all 
participants enrolled in this study. 
 
The Co-PIs and the IRB 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 meeting in which all study personnel, including the Co-PIs, 
will be in attendance. Issues pertaining to participant safety also will be addressed at 
these meetings. Moreover, the Co-PIs and the Senior Research Associate Project 
Manager will meet on a regular basis to discuss these topics further.  
 
 
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  
 
The study will obtain existing data on participant contact information collected during 
screens in REDCap.  
 
19.3 Describe the steps that you will take to handle and secure study data 
during data collection, storage, use, and transmission.  Include 
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information about training of study staff, authorization of access, 
password protection, encryption, physical controls, certificates of 
confidentiality, separation of identifiers and data, etc.: 
 
Access to study data will be limited to study personnel who have completed human 
subjects research protections and Good Clinical Practice trainings and who have been 
delegated the responsibility of data collection, management, or analyses by the PI.  
All screened participants are assigned study IDs that are thereafter associated with all 
collected data, whether paper or electronic. The electronic de-identified data is stored on 
the Bickel shared server which is password protected. Non-electronic data that is 
collected is stored in participant specific binders identified only by study ID. These 
binders are stored in a locked file room inside a locked office within ARRC. . Study ID 
and identifiers (i.e., name, email, age, and demographics) will be available together 
electronically only in the pre-screener in Qualtrics, a widely used secure web-based 
application. Specifically, we will use Qualtrics to collect demographic and other 
screening criteria for eligibility for study enrollment. This service is password protected 
and has been approved by Virginia Tech IRB.  
Personally identifiable information (PII) and Protected Health Information (PHI) is 
strongly guarded at all points in the study procedures.   
All online data collection will be completed using the participant’s ID, and will not 
require entering any PII. 
 
As the survey is computerized, self-administered, and directly entered into the secure 
server, only authorized researchers will have access to assessment survey responses.  
  
Study laptops will be password protected with an encrypted file system.   
 
 
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): 
 
NA 
 
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? 
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● 
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? 
 
 
Answers to the study questions, demographic data, contact information, and primary 
records (i.e., PII and/or PHI) will be stored in a secure HIPAA compliant data storage 
environment managed by Virginia Tech for a period of 3 years after the publication of the 
primary data analysis in accordance with the National Institutes of Health (NIH) 
guidelines. The files will be deleted from storage at the designated time. 
 
Data will be used exclusively for research purposes and will be collected online via 
Qualtrics. Data will be stored on Qualtrics and will be only available for download/export 
by people with authorized access to the surveys. 
 
Data will be encrypted during transfer between the HIPAA compliant data storage 
environment and remote computers. Computers used in the study will be password-
protected, and data will be accessible only by study personnel.  
 
 
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):  
 
Data will be collected and stored securely on the Qualtrics server, a commercial 
subscription service for implementing and executing tasks and questionnaires on any 
device with a modern Internet browser, including mobile and desktop computer devices. 
The computerized survey will collect only data that is needed to support analytic 
objectives and all results presented will be in aggregate form where no individual can be 
identified.  
  
The study team will comply with all Health Insurance Portability and Accountability Act 
(HIPAA) Health IT guidelines and policies. The study team will store participant PII 
(e.g., contact information) on a HIPAA compliant data storage environment that is 
appropriate for PHI and managed by Virginia Tech. The study staff will have access to 
this information, on a strictly need-to-know basis.    
     
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All online data collection will be completed using the participant’s ID, and will not 
require entering any PII.   
   
The online assessment data are saved automatically on secure servers. Data will be 
encrypted during transfer to and from the secure servers.   
    
As the survey is computerized, self-administered, and directly entered into the secure 
server, only study staff will have access to assessment survey responses.  
   
Destruction of Study Data:  
Primary records (i.e., PII and/or PHI) will be stored in a secure HIPAA compliant data 
storage environment managed by Virginia Tech for a period of 3 years after publication 
of the primary 3-year data analysis in accordance with the National Institutes of Health 
(NIH) guidelines. The files will be deleted from storage at the designated time 
 
    
Participants will have substantial control over the location where they will take the online 
survey.  
 
 
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): 
 
The survey will be completed online in a location with sufficient privacy chosen by the 
participant. Participants will be reminded before starting the online survey that they may 
stop participation at any time without penalty.  
 
As an additional protection against the risk of loss of confidentiality, we will use only ID 
numbers and keep all data in password-protected databases.  
 
 
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: 
 
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All data will be encrypted and stored in password-protected secure server at ARRC.  
 
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 will report any disclosure or signs of intention to harm oneself (i.e., suicidal ideation 
and/or plan). In the event of this disclosure study staff will follow ARRC’s SOP related 
to suicidal ideation.  
 
 
 
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). 
 
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Data quality assurance and confidentiality: 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 subject ID number and not by 
name (i.e., first and last name), stored in a master ID log. Additionally, 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. We will provide 
certification of IRB approvals of the study protocol to NIDA prior to screening study 
participants. VT 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.  
 
The MPIs and the IRB will oversee monitoring of the aforementioned 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 each week during a 
weekly study personnel meeting in which all study personnel, including the MPIs, will be 
in attendance. Issues pertaining to participant safety also will be addressed at these 
meetings.  Moreover, the MPIs and the Senior Research Associate Project Manager will 
meet on a monthly basis to discuss these topics further. In consultation with the IRB and 
NIDA, the study will be stopped if there is clear evidence of harm. 
 
 
 
 
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: 
 
NA 
 
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: 
 
NA 
 
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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: 
 
To the extent possible, we will attempt to minimize obstacles to participation by 
optimizing our data collection platform for both desktop and mobile devices.  
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 
 
The consent process will occur online. Participants will indicate their consent 
electronically prior to starting the survey. Thus, the consent process may occur at any 
participant-chosen location. Participants will have the opportunity to read and review 
the ICF document that will explain the nature of the study, its purpose, procedures, 
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expected duration, and the benefits and risks involved in study participation. Participants 
will be given ample time to carefully consider whether they want to participate.   
  
After screening, eligible participants will receive a link via email. When following the 
link, the first page of the survey will display the full version of the consent and 
participants will be asked to check a box indicating that they consent in order to continue 
to the survey. Participants will be told that they should feel free to discuss participation 
with relatives, friends, and primary care physicians. Participants will also be informed of 
their right to stop participating in the study at any time without penalty. ICF will also 
include the contact information available to them should they have any questions 
throughout the study.  
  
The electronic consent will be available at the beginning of each online 
survey and participants will be reminded that they may stop participating in the study at 
any time without penalty. 
 
 
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. 
 
 
NA 
 
 
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). 
 
NA 
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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-
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.  
 
 
NA 
 
 
Adults Unable to Consent  
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● 
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-
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.  
 
NA 
 
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: 
 
Prior to beginning the survey, participants will electronically agree to participate in the 
study by checking a box after being presented with the full version of the ICF in 
Qualtrics.   
 
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): 
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Consent to participate is indicated by pressing a button for an online questionnaire – after 
the consent information is presented and before the questionnaire begins. 
 
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: 
 
The study will obtain consent, but not document consent in writing. The consent script 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 PI’s primary focus is overseeing research efforts and will devote sufficient time to 
supervise the study.   
We have a history of successful recruitment of individuals in recovery from AUD. All 
participants will enroll on a voluntary basis and electronically sign an IRB-approved 
informed consent form prior to study participation. In addition, we have more than 
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sufficient numbers of participants in our current REDCap database to recruit an adequate 
number of participants for the current study.  
Contact methods that were previously successful in previous studies will be used to 
recruit for this study. Participants will be allowed to answer the surveys at a time and 
location of their convenience in an attempt to minimize barriers to participation and 
increase retention and survey completion.  
 
The PI’s office and Virginia Tech facilities reside on the 3rd floor of the Fralin 
Biomedical Research Institute (FBRI) and consists of several laboratories for clinical 
research. Office space for the PI, co-investigators, project manager, post-doctoral 
associates, and graduate students is provided in the FBRI.   
  
This is a minimal risk observational study.  In the unlikely event of any medical 
emergencies, study representatives will call 911 regardless of whether it is related to the 
study. If a participant reports depression or suicidal thoughts to any study representative, 
the participant will be provided with information about relevant resources (i.e., suicide 
hotlines and/or call 911, if appropriate).  
 
 
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. 
NA 
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