A Virtual Reality Videogame for E-cigarette Prevention in Teens
Phase: NA
Conditions: E-Cig Use, Vaping
Sponsor: Yale University

 
 
IRB# 2000025177 
                    
                                    
HRP-503B – BIOMEDICAL RESEARCH PROTOCOL  
(2017-1) 
 
 
 
 
Protocol Title: A Virtual Reality Videogame for E-cigarette Prevention in Teens 
 
 
Principal Investigator: Kimberly Hieftje, PhD 
 
 
Version Date: January 27, 2020 
 
 
(If applicable) Clinicaltrials.gov Registration #:  NCT04054765 
 
 
 
INSTRUCTIONS 
 
This template is intended to help investigators prepare a protocol that includes all of the necessary information 
needed by the IRB to determine whether a study meets approval criteria. Read the following instructions 
before proceeding: 
 
1. Use this protocol template for a PI initiated study that includes direct interactions with research 
subjects. Additional templates for other types of research protocols are available in the system Library. 
 
2. If a section or question does not apply to your research study, type “Not Applicable” underneath. 
 
3. Once completed, upload your protocol in the “Basic Information” screen in IRES IRB system.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
IRB# 2000025177 
SECTION I: RESEARCH PLAN 
 
1. Statement of Purpose: State the scientific aim(s) of the study, or the hypotheses to be tested.  
 
The specific aims of Sub-study #1 are: 
 
Specific Aim #1: DEVELOPMENT: We will update our current Invite Only VR prototype into a polished videogame 
intervention using input from 4 focus groups of 5 adolescents each (n = 20), aged 12-17 and the extant literature. 
These focus groups will inform the development of the VR videogame intervention, Invite Only VR, for e-cigarette 
prevention among teens.  
 
Specific Aim #2: EVALUATION: Conduct a pilot randomized controlled trial with 300 teens ages 11-15 comparing 
the Invite Only VR intervention vs. an attention/control non-health-related VR videogame, collecting assessment 
data at baseline, post-gameplay, three months and six months to determine: 
a. 
the preliminary impact of the intervention on knowledge, intentions, perceptions, attitudes, 
social norms, self-efficacy and behaviors related to: i) initiation of e-cigarette use, ii) e-cigarette 
use cessation. 
b. 
the intervention’s acceptability and feasibility by collecting quantitative and qualitative data on 
teens’ satisfaction and gameplay experience of the intervention.  
c. 
preliminary evidence of the impact of Invite Only VR on players’ perception and experience of 
social pressure and social norm development.  
 
The specific aim for Sub-study #2 is 
 
Specific Aim #1: EVALUATION: Conduct a quasi-experimental effectiveness trial of the Invite Only VR intervention 
using a pre-post study design with 400 teens ages 11-15, collecting assessment data at baseline and post-
gameplay to determine: 
a. 
the preliminary impact of the intervention on knowledge, intentions, perceptions, attitudes, 
social norms, self-efficacy and behaviors related to: i) initiation of e-cigarette use, ii) e-cigarette 
use cessation. 
b. 
the intervention’s acceptability and feasibility by collecting quantitative on teens’ satisfaction and 
gameplay experience of the intervention.  
 
2. Probable Duration of Project: State the expected duration of the project, including all follow-up and data 
analysis activities.   
2 years 
 
3. Background: Describe the background information that led to the plan for this project. Provide references to 
support the expectation of obtaining useful scientific data. 
 
Tobacco use, including the use of e-cigarettes, is the leading cause of preventable disease and death in 
the United States1 and is linked to cancer and cardiovascular diseases.2 In 2016, 3.9 million middle/high 
school students used at least one tobacco product in the past 30 days and approximately 45% of 
middle/high school students used two or more tobacco products in the past 30 days.1 Of particular 
interest, e-cigarettes have emerged as an introductory tobacco product among youth3 due, in part, to 
their appealing flavors4-6 and perception that they are safer than other products.7-9 Given more than 
80% of adult smokers begin using tobacco products such as e-cigarettes before the age of 18,1 there is a 

 
 
IRB# 2000025177 
need to develop interventions that will help prevent e-cigarette experimentation among young 
adolescents; a population inherently vulnerable to tobacco initiation and the development of life-long 
tobacco use. 
The use of virtual reality (VR) has emerged as an effective intervention approach to addressing a 
range of health issues, including phobias, social anxiety, post-traumatic stress disorder and pain 
management. Currently, no research exists on the efficacy of evidence-based VR videogames related to 
tobacco use prevention. 
 
4. Research Plan: Summarize the study design and research procedures using non-technical language that can 
be readily understood by someone outside the discipline. Be sure to distinguish between standard of care vs. 
research procedures when applicable, and include any flowcharts of visits specifying their individual times 
and lengths. Describe the setting in which the research will take place. 
 
The goal of this research study is to conduct a randomized controlled trial of the VR-based e-cigarette prevention 
intervention, Invite Only VR, with the aim to prevent the initiation of e-cigarette use in teens by increasing their 
knowledge, decreasing their intentions to use e-cigarettes, influencing their harm perceptions and attitudes 
associated with e-cigarettes, and increasing behavioral skills associated with refusing peers involving e-cigarettes. 
Invite Only VR is an innovative, immersive intervention that may hold the promise to reducing e-cigarette 
initiation in teens. 
 
For Sub-study #1:  
 
We will conduct the proposed research for the study in two phases. Phase I consists of: (a) the continued 
development of our current Invite Only VR prototype into a polished videogame intervention using input from 4 
focus groups of 5 adolescents each (n = 20), aged 12-17 and the extant literature. These focus groups will inform 
the development of the VR videogame intervention, Invite Only VR, for e-cigarette prevention among teens 
(Specific Aim #1). In Phase II, we will conduct a randomized controlled trial with 300 teens ages 11-15 comparing 
the Invite Only VR intervention vs. an attention/control non-health-related VR videogame, collecting assessment 
data at baseline, post-gameplay, three months and six months to determine: 1) the preliminary impact of the 
intervention on knowledge, intentions, perceptions, attitudes, social norms, self-efficacy and behaviors related to 
initiation of e-cigarette use and e-cigarette use cessation, 2) the intervention’s acceptability and feasibility by 
collecting quantitative and qualitative data on teens’ satisfaction and gameplay experience of the intervention, 
and 3)preliminary evidence of the impact of Invite Only VR on players’ perception and experience of social 
pressure and social norm development.  
 
Conduct focus groups to gather data to inform refinement of the current videogame prototype, Invite Only VR. 
We will conduct 4 focus groups (5 adolescents each) to collect feedback on the game content, art, narrative, and 
characters, and gameplay mechanics.  We will use visual tools (e.g., storyboards, pictures) to facilitate the 
discussions. We will conduct the focus groups according to standard dual-facilitator procedures11. We anticipate 
that 4 focus groups will be adequate to achieve thematic saturation12. The focus groups will be conducted such 
that ideas and themes from one discussion inform discussion topics and prompts used in the next focus group. 
Participants will be compensated with a gift card for $25. Audio recordings of each session will be transcribed, 
reviewed and discussed by the research team to refine the videogame intervention. As a part of the game 
development, with parental permission we will invite selected students to the Yale recording studio on campus to 
provide voices for the videogame characters. 
 

 
 
IRB# 2000025177 
Conduct randomized controlled trial: We will enroll 300 adolescents to test Invite Only VR using a pre/post design 
to evaluate the preliminary efficacy of the videogame prototype, Invite Only VR. Participants will be randomly 
assigned to play either Invite Only VR (n=115), or receive standard care as usual (n=115). Participants will 
accumulate between 1.5-2 hours of game play over 2 sessions (approximately one week, meeting twice). 
Participants will play the Invite Only VR game on a VR headset for 45 mins to 1 hour, one to two times per week 
for 2 weeks (to accumulate up to 1.5 - 2 hours of gameplay). This total duration and number of sessions is 
consistent with those found in effective smoking prevention interventions among adolescents and with the 
amount of time adolescents play videogames13. Participants will have a 10 min break in the middle of each session 
and will be instructed that they may take additional breaks as needed.  
  
Measures. We will collect data on participant demographics at baseline. At baseline and immediately after 
gameplay, and again at 3 and 6 months post gameplay, we will collect data on intentions to initiate smoking14, 
self-efficacy for refusing offers of e-cigarettes and other tobacco products15, perceived social norms related to 
smoking16, attitudes about smoking17, and smoking behavior18 using validated questionnaires. Finally, we will 
assess satisfaction with game play and acceptability and feasibility of the intervention by collecting self-report 
data at the end of the game play period. All assessments will be conducted via face-to-face interviews with a 
research assistant and each adolescent. 
 
Study locations. For the focus groups and pilot-testing, the study will take place at one of the after-school 
programs with which the play2PREVENT Lab has ongoing partnerships including but not limited to: Wilbur Cross 
High School (which serves 1300 students from 9th to 12th grade), Hamden Youth Center (which serves roughly 75 
adolescents in the 6th through 12th grade, and the Milford Middle School District (which serves 1300 students 
the majority of whom are between the ages of 11 and 14), and LEAP (which serves over 1000 children between 
the ages of 7-18). For the randomized controlled trial, we will enroll students from the Milford Middle School 
District between the ages of 11-15.  
 
Participants, screening, and consent. In collaboration with community program staff, we will discuss the study 
with interested parents and adolescents and collect eligibility screening data. If the participant is eligible and 
interested we will proceed with the consent procedures that will differ by phase of the research. For focus 
groups, we will give information sheets to the adolescents and to their parents describing the purpose of and 
protocol for the focus groups. Parents who do not wish for their children to participate will contact the project 
director. No forms will be signed for focus groups. For the randomized controlled trial, we will obtain written, 
informed assent (adolescent) and consent (parent).  
 
In addition to paper forms for parental consent for participation in the randomized controlled study, we will also 
provide a web-based form for parents to review and electronically sign through Yale Qualtrics. 
 
For Sub-study #2: 
 
We will conduct a quasi-experimental study with 400 teens from the Seattle School District ages 11-15 of the 
Invite Only VR intervention collecting assessment data at baseline and post-gameplay to determine: 1) the 
preliminary impact of the intervention on knowledge, intentions, perceptions, attitudes, social norms, self-
efficacy and behaviors related to initiation of e-cigarette use and e-cigarette use cessation, and 2) the 
intervention’s acceptability and feasibility by collecting quantitative on teens’ satisfaction and gameplay 
experience of the intervention. 
 
 

 
 
IRB# 2000025177 
Quasi-experimental study design: With the assistance of our program partners at Seattle Schools, we will enroll 
400 adolescents to test Invite Only VR using a pre/post design to evaluate the preliminary efficacy of the 
videogame prototype. All participants will play Invite Only VR. Participants will accumulate between 1.5-2 hours of 
game play during their class or program time. Participants will play the Invite Only VR game on a VR headset for 
45 mins to 1 hour, one to two times (to accumulate up to 1.5 - 2 hours of gameplay) during their 
advisory/common time in school (non-class time). This total duration and number of sessions is consistent with 
those found in effective smoking prevention interventions among adolescents and with the amount of time 
adolescents play videogames13. Program partners will be instructed to give participants a 10 min break in the 
middle of each session and will be instructed that they may take additional breaks as needed.  
  
Measures. We will collect data on participant demographics at baseline. At baseline and immediately after 
gameplay, we will collect data on intentions to initiate smoking14, self-efficacy for refusing offers of e-cigarettes 
and other tobacco products15, perceived social norms related to smoking16, attitudes about smoking17, and 
smoking behavior18 using validated questions adapted from the Youth Risk Behavior Survey (Kann et all, 2018.)  
Finally, we will assess satisfaction with game play and acceptability and feasibility of the intervention by collecting 
self-report data at the end of the game play period. All assessments will be conducted on a secured Qualtrics 
website with instructions from school program staff. 
 
Study locations. Students will be enrolled from within the Seattle School District in Seattle, Washington. School 
program staff will select classes and teachers to participate in the study with an option to opt-out.  
 
Participants, screening, and consent. In collaboration with community program staff at Seattle School District, an 
information letter describing the study will be provided to interested parents and adolescents. Letters will be sent 
home with each child and an announcement about the letter will be emailed to parents. If the participant is 
eligible and interested, they will be enrolled in the study. If a parent or participant does not want to participate in 
the study, they may choose to opt out by contacting the school program staff.  Dr. Hieftje will call in through a live 
video-feed call through Zoom and provide a face-to face conversation with teens from classes that have been 
chosen by the school to participate in the study to describe the study and provide time for questions. Teens will 
also be provided Dr. Hieftje’s phone number to call with any additional questions or clarification.  
 
5. Genetic Testing    
N/A ☒ 
 
6. Subject Population: Provide a detailed description of the types of human subjects who will be recruited into 
this study. 
Adolescents ages 11-17 will be recruited into this study. 
 
7. Subject classification: Check off all classifications of subjects that will be specifically recruited for enrollment in 
the research project. Will subjects who may require additional safeguards or other considerations be enrolled 
in the study? If so, identify the population of subjects requiring special safeguards and provide a justification 
for their involvement. 
 
☒Children 
 
 
☒ Healthy  
 
 
☐Fetal material, placenta, or dead fetus 
☐Non-English Speaking  
☐ Prisoners 
 
 
☐Economically disadvantaged persons 
☐Decisionally Impaired  
☐ Employees 
 
 
☐Pregnant women and/or fetuses 
☐Yale Students  
 
☐ Females of childbearing potential 
 
NOTE: Is this research proposal designed to enroll children who are wards of the state as potential subjects? 

 
 
IRB# 2000025177 
Yes ☐  No ☒  
 
8. Inclusion/Exclusion Criteria: What are the criteria used to determine subject inclusion or exclusion? 
 
For the focus groups and pilot-testing, inclusion/exclusion criteria are: participants must be 12-17 years of age 
and speak English. For the randomized controlled trial, participants must be between the ages of 11-15, 
Speak English, and be able to play a mobile app-based videogame and VR videogame (willing to sit with a 
smartphone or tablet computer and/or use a VR headset for 45-60 minutes/session to play the game). 
Eligibility will be determined by the research team.  
 
9. How will eligibility be determined, and by whom?  
 
Eligibility will be determined by the research team. If a prospective participant meets the inclusion criteria, 
they will be eligible to participate in the project. 
 
10. Risks: Describe the reasonably foreseeable risks, including risks to subject privacy, discomforts, or 
inconveniences associated with subjects participating in the research.  
 
The potential risks associated with this study have to do with maintenance of the confidentiality of the 
identities of the participants enrolled in the study and information relating to them. De-identified hard copies 
of the data will be stored in locked cabinets and electronic data will be stored in secure, password-protected 
computers. Only the P.I. and other relevant research staff will have access to the data. 
 
Playing Invite Only VR may pose a potential psychological risk in that we address sensitive issues around 
tobacco use and its consequences. Research staff will be available to provide assistance to the participants, 
answer their questions, and serve as a resource if any distress or concern arises. The assessments and 
instruments may also present a potential risk given that some of the questions are sensitive in nature and 
address issues around substance use. Again, the Research staff will available to assist the participants, the 
program sites staff, and the research staff members administering the assessments if there appears to be any 
distress around the questions being asked. If participants need additional or more intensive attention, Dr. 
Kimberly Hieftje will provide consultation to the participant. 
 
Also the use of a virtual reality headset for the project may pose a slight physical risks for the participants in 
the form of dizziness, queasiness, seizures (about 1 in 4000 experience this effect), eye or muscle twitching, 
and faintness.  
 
11. Minimizing Risks: Describe the manner in which the above-mentioned risks will be minimized. 
 
A number of precautions will be actively integrated into the research procedures to protect the 
confidentiality and anonymity of all participants. All research staff and the staff and volunteers participating in 
the intervention will be required to complete training in research ethics. Data collection forms will be 
designated by ID numbers only. A separate master file of names, addresses, contact persons, and telephone 
numbers, along with the study ID numbers will be maintained in a locked file cabinet in the P.I.’s research 
offices. All data entry and analyses will be completed with ID numbers only. The study will be explained to 
others, such as the guardian/parent and program staff as a study of child development that will focus on 
promoting healthy behaviors. In instances in which data are requested from other sources or it is beneficial to 
the participant to provide information to another individual or agency (e.g. medical personnel) this will only 
be done with the written permission of the guardian/parent on a “Release of Information” form stipulating 

 
 
IRB# 2000025177 
who the information is provided to, or received from. The research staff will follow standard confidentiality 
procedures for research programs.  
 
To minimize possible physical risks associated with the project, per the health and safety manual for the 
virtual reality headsets, participants will not be allowed to use the virtual reality headsets while they are tired, 
sleep impaired, if they have digestive problems, are under emotional stress or anxiety or suffering from a 
cold, flu, headache, migraine or earache. Additionally, participants using the virtual reality headsets will be 
required to take a 10-15 min break for every 30 mins of game play. 
 
Furthermore, throughout their gameplay experience, to help minimize risk participants utilizing the VR 
headsets will be asked about how they are physically feeling. If the participant’s answer indicates that they 
are experiencing any of the adverse physical symptoms, the research staff will immediately stop gameplay.  
 
In the unlikely event that a participant involved with the study experiences a serious medical or psychological 
complication, that requires further attention, this would be reported to Dr. Hieftje who will then determine if 
further consultation is required without divulging the name of the individual, if this appeared appropriate and 
necessary. Dr. Hieftje would then be responsible for ensuring that the needs of the individual were addressed.  
 
12. Data and Safety Monitoring Plan: Include an appropriate Data and Safety Monitoring Plan (DSMP) based on 
the investigator’s risk assessment stated below. (Note: the HIC will make the final determination of the risk to 
subjects.) 
 
a.  
What is the investigator’s assessment of the overall risk level for subjects participating in this 
study? Minimal risk 
b. 
If children are involved, what is the investigator’s assessment of the overall risk level for the 
children participating in this study? Minimal risk 
c. 
Include an appropriate Data and Safety Monitoring Plan. Examples of DSMPs are   
available here http://your.yale.edu/policies-procedures/forms/420-fr-01-data-and-safety-
monitoring-plans-templates for 
i. Minimal risk 
ii. Greater than minimal 
 
The principal investigator is responsible for monitoring the data, assuring protocol compliance, and 
conducting the safety reviews quarterly. During the review process, the principal investigator will evaluate 
whether the study should continue unchanged, require modification/amendment, or close to enrollment.  
 
The principal investigator or the Human Investigative Committee (HIC) have the authority to stop or suspend 
the study or require modifications. 
 
This protocol presents minimal risks to the subjects and Unanticipated Problems Involving Risks to Subjects or 
Others (UPIRSOs), including adverse events, are not anticipated.. In the unlikely event that such events occur, 
Reportable Adverse Events (which are events that are serious or life-threatening and unanticipated (or 
anticipated but occurring with a greater frequency than expected) and possibly, probably, or definitely 
related) or Unanticipated Problems Involving Risks to Subjects or Others that may require a temporary or 
permanent interruption of study activities will be reported immediately (if possible), followed by a written 
report within 5 calendar days of the Principal Investigator becoming aware of the event to the IRB via the RNI 
submission process in IRES IRB and any appropriate funding and regulatory agencies. The investigator will 
apprise fellow investigators and study personnel of all adverse events that occur during the conduct of this 
research project through regular study meetings and via email as they are reviewed by the principal 

 
 
IRB# 2000025177 
investigator. We will use procedures to detect and respond to adverse events that ensure prompt discovery 
of any adverse events and to minimize their effects. There is adequate surveillance and protections to 
discover adverse events promptly and keep their effects minimal. Data and safety monitoring procedures in 
this study include collection and monitoring of paper-based questionnaires and an organizational structure of 
clearly defined tasks assigned to all research personnel involved in the conduct of this study. We will keep a 
thorough record of research activities and completion of scheduled assessments. 
 
d. For multi-site studies for which the Yale PI serves as the lead investigator: 
i. How will adverse events and unanticipated problems involving risks to subjects or others be 
reported, reviewed and managed? Write here 
ii. What provisions are in place for management of interim results? Write here 
iii. What will the multi-site process be for protocol modifications? Write here 
 
13. Statistical Considerations: Describe the statistical analyses that support the study design.  
 
Statistical procedures and models for analyzing data have been selected according to the research 
hypotheses being investigated and the types of data available. In general, we will use two-tailed tests 
and p-values smaller than 0.05 will be considered to indicate statistical significance. When necessary, 
however, we will use appropriate adjustment of the level of significance (alpha) to account for multiple 
statistical tests. All statistical analyses will be conducted on an intention-to-treat sample using either 
SPSS/SAS statistical packages. Baseline characteristics will be analyzed using descriptive statistics. 
  
We will evaluate the efficacy of Invite Only VR at reducing initiation of e-cigarette use (primary 
outcome). We will test the hypothesis that individuals who play Invite Only VR will be less likely to report 
the initiation of e-cigarette use in comparison to the control condition. We will conduct a longitudinal 
analysis using a linear mixed models approach to compare participants in the intervention group to 
participants in the control group on e-cigarette use from baseline across all follow-up assessments. An 
advantage of mixed models is that participants with missing data need not be excluded as all available 
data are used in estimating parameters. We will also use logistic regression models to determine if any 
relevant baseline variables are associated with rates of initiation of e-cigarette use (constructed as a 
binary outcome (Yes/No). We plan to evaluate the prognostic significance of a small set of predictor 
variables (e.g., knowledge, intentions, perceptions, attitudes, social norms, and self efficacy) and use 
them as covariates in the primary analysis.  
 
SECTION II: RESEARCH INVOLVING DRUGS, BIOLOGICS, RADIOTRACERS, PLACEBOS AND DEVICES 
 
 
A.  RADIOTRACERS 
☒N/A 
B.  DRUGS/BIOLOGICS    ☒N/A 
B.  DEVICES 
 ☒ 
 
1. 
Are there any investigational devices used or investigational procedures performed at Yale-New Haven 
Hospital (YNHH) (e.g., in the YNHH Operating Room or YNHH Heart and Vascular Center)?  ☐Yes   ☐No    
 
 If Yes, please be aware of the following requirements: 
 

 
 
IRB# 2000025177 
A YNHH New Product/Trial Request Form must be completed via EPIC: Pull down the Tools tab in the EPIC Banner, 
Click on Lawson, Click on “Add new” under the New Technology Request Summary and fill out the forms 
requested including the “Initial Request Form,” “Clinical Evidence Summary”, and attach any other pertinent 
documents. Then select “save and submit” to submit your request;   AND 
 
Your request must be reviewed and approved in writing by the appropriate YNHH committee before 
patients/subjects may be scheduled to receive the investigational device or investigational procedure. 
 
2. Background Information: Provide a description of previous human use, known risks, and any other factors 
that might influence risks. If this is the first time this device is being used in humans, include relevant data on 
animal models.  
Write here 
3. Source:  
a) Identify the source of the device to be used. Write here 
b) Is the device provided free of charge to subjects? ☐Yes   ☐No     
 
 
4. Investigational device accountability:  State how the PI, or named designee, ensures that an investigational 
device is used only in accordance with the research protocol approved by the HIC, and maintains control of 
the investigational device as follows: 
 
a) Maintains appropriate records, including receipt of shipment, inventory at the site, dispensation or use 
by each participant, and final disposition and/or the return of the investigational device (or other 
disposal if applicable): Write here 
b) Documents pertinent information assigned to the investigational device (e.g., date, quantity, batch or 
serial number, expiration date if applicable, and unique code number): Write here 
c) Stores the investigational device according to the manufacturer's recommendations with respect to 
temperature, humidity, lighting, and other environmental considerations: Write here 
d) Ensures that the device is stored in a secure area with limited access in accordance with applicable 
regulatory requirements: Write here 
Distributes the investigational device to subjects enrolled in the IRB-approved protocol: Write here 
 
SECTION III: RECRUITMENT/CONSENT AND ASSENT PROCEDURES  
1. Targeted Enrollment: Give the number of subjects: 300 for sub-study 1; 400 for sub-study #2 
a. Targeted for enrollment at Yale for this protocol: 300; 400 
b. If this is a multi-site study, give the total number of subjects targeted across all sites: n/a 
 
2. Indicate recruitment methods below.  Attach copies of any recruitment materials that will be used. 
☒ Flyers 
☐ Internet/web postings 
☐ Radio 
☒ Posters 
☐ Mass email solicitation 
☐ Telephone 
☐ Letter 
☐ Departmental/Center website 
☐ Television 
☐ Medical record review*  
☐ Departmental/Center research boards 
☐ Newspaper 
☐ Departmental/Center newsletters 
☐ Web-based clinical trial registries 
☐ Clinicaltrails.gov  
☐ YCCI Recruitment database 
☐ Social Media (Twitter/Facebook):  
 
☐ Other:  
 
 

 
 
IRB# 2000025177 
 
* Requests for medical records should be made through JDAT as described at 
http://medicine.yale.edu/ycci/oncore/availableservices/datarequests/datarequests.aspx 
 
3.  Recruitment Procedures:  
a. Describe how potential subjects will be identified. SEE BELOW 
b. Describe how potential subjects are contacted. SEE BELOW 
c. Who is recruiting potential subjects? SEE BELOW 
 
For sub-study #1 
Participation in this study will be strictly voluntary, confidential and non-discriminatory. Participants will be 
enrolled while they are on-site at one of the participating programs. The study will be advertised via posters 
and flyers located and circulated at the two community centers with which we have partnered. Potential 
participants will meet with the Research Assistant to discuss participation in the study. For the RCT, If the 
participant is interested, the Research Assistant will discuss the study with their guardian/parent and obtain 
informed written assent from the participant and written informed consent from their guardian/parent. For 
the focus groups, the Research Assistant will discuss the study with their guardian/parent and obtain verbal 
assent from the participant and verbal consent from their guardian/parent Participants will be provided with 
an age-appropriate description of the study and told about what they might expect. In describing the study to 
the participant, the purpose of the study will be described as “finding out how kids can make choices that are 
healthier for them”. In describing the study to the guardian/parent, we will indicate that the study will focus 
on promoting healthy behaviors in adolescence and on providing strategies to assist adolescents in making 
decisions about the many challenges they face; particularly as they relate to avoiding tobacco use. If a 
participant or their guardian/parent indicates that they do not wish to participate, there will be no further 
involvement in the study. We will also obtain agreement from the appropriate administrator at the 
participating program. 
 
In addition to paper forms for parental consent for participation in the randomized controlled study, we will 
also provide a web-based form for parents to review and electronically sign through Yale Qualtrics. 
 
For sub-study #2 
Participation in this study will be strictly voluntary, confidential and non-discriminatory. Participants will be 
enrolled while they are on-site at one of school classrooms in Seattle Schools. For the quasi-experimental 
study, information sheets will be provided to the adolescents and parents about the study.. If a parent does 
not wish their child to participate, they can call the designated school program staff to opt out.  An email will 
also be provided later to all student’s parents about the study as a second means of ensuring the letter 
reaches the parents. If a participant or their guardian/parent indicates that they do not wish to participate, 
there will be no further involvement in the study.  
 
The PI from the research team (Dr. Hieftje) will Zoom in to each classroom to discuss the study with students 
over video and consent them into the research. In addition to the opportunity to contact the PI with questions 
during recruitment, students will have the time to ask questions regarding the study and will be provided with 
a phone number to speak with Dr. Hieftje directly if they desire. Parents will also be provided a phone number 
in the verbal consent sheet so that they may contact her directly with questions or more information. 
 
 
4. Assessment of Current Health Provider Relationship for HIPAA Consideration: 

 
 
IRB# 2000025177 
Does the Investigator or any member of the research team have a direct existing clinical relationship with any 
potential subject?  
☐Yes, all subjects 
☐Yes, some of the subjects 
☒No 
 
If yes, describe the nature of this relationship. Write here 
5. Request for waiver of HIPAA authorization: (When requesting a waiver of HIPAA Authorization for either the 
entire study, or for recruitment purposes only.  Note: if you are collecting PHI as part of a phone or email 
screen, you must request a HIPAA waiver for recruitment purposes.) 
Choose one:  
☐ For entire study  
☐ For recruitment/screening purposes only  
☐ For inclusion of non-English speaking subject if short form is being used and there is no translated HIPAA 
research authorization form available on the University’s HIPAA website at hipaa.yale.edu. 
 
i. Describe why it would be impracticable to obtain the subject’s authorization for use/disclosure of this 
data: Write here 
 
ii. If requesting a waiver of signed authorization, describe why it would be impracticable to obtain the 
subject’s signed authorization for use/disclosure of this data: Write here 
 
The investigator assures that the protected health information for which a Waiver of Authorization has been 
requested will not be reused or disclosed to any person or entity other than those listed in this application, except 
as required by law, for authorized oversight of this research study, or as specifically approved for use in another 
study by an IRB. 
 
Researchers are reminded that unauthorized disclosures of PHI to individuals outside of the Yale HIPAA-Covered 
entity must be accounted for in the “accounting for disclosures log”, by subject name, purpose, date, recipients, 
and a description of information provided.  Logs are to be forwarded to the Deputy HIPAA Privacy Officer. 
 
6. Process of Consent/Assent: Describe the setting and conditions under which consent/assent will be obtained, 
including parental permission or surrogate permission and the steps taken to ensure subjects’ independent 
decision-making.  
 
Sub-study #1 
 
Participation in this study will be strictly voluntary, confidential and non-discriminatory. Participants will be 
enrolled while they are on-site at one of the participating programs. The study will be advertised via posters 
and flyers located at the two listed community sites. Potential participants will meet with the Research 
Assistant to discuss participation in the study. If the participant is interested, the Research Assistant will 
discuss the study with their guardian/parent. We will provide the adolescents and their parents with an age-
appropriate description of the study and told about what they might expect.  In describing the study to the 
participant, the purpose of the study will be described as “finding out how kids can make choices that are 
healthier for them”. In describing the study to the guardian/parent, we will indicate that the study will focus 
on promoting healthy behaviors in adolescence and on providing strategies to assist adolescents in making 
decisions about the many challenges they face; particularly as they relate to tobacco use. For the focus 

 
 
IRB# 2000025177 
groups we will employ waived signature of consent. Parents who do not wish for their children to participate 
will contact the project director. For the evaluation, we will obtain informed written assent from the 
participant and written informed consent from their guardian/parent. For both phases, if a participant or their 
guardian/parent indicates that they do not wish to participate, there will be no further involvement in the 
study. We will also obtain agreement from the appropriate administrator at the participating program. 
 
In addition to paper forms for parental consent for participation in the randomized controlled study, we will 
also provide a web-based form for parents to review and electronically sign through Yale Qualtrics. 
 
 
Sub-study #2 
 
Participation in this study will be strictly voluntary, confidential and non-discriminatory. Participants will be 
enrolled while they are on-site at one of the participating school programs. For the quasi-experimental study, 
verbal information sheets will be provided to the adolescents and parents about the study with a waiver of 
documentation of consent .  
 
The PI from the research team (Dr. Hieftje) will Zoom in to each classroom to discuss the study with students 
over video. Students will have the time to ask questions regarding the study and will be provided with a phone 
number to speak with Dr. Hieftje directly if they desire. Parents will also be provided a phone number in the 
verbal consent sheet so that they may contact her directly with questions or more information. Participants 
will be provided with an age-appropriate description of the study and told about what they might expect and 
may opt out if they desire. In describing the study to the participant, the purpose of the study will be described 
as “finding out how kids can make choices that are healthier for them”.  
 
In describing the study to the guardian/parent, we will indicate that the study will focus on promoting healthy 
behaviors in adolescence and on providing strategies to assist adolescents in making decisions about the many 
challenges they face; particularly as they relate to avoiding tobacco use. If a participant or their 
guardian/parent indicates that they do not wish to participate, there will be no further involvement in the 
study. If a parent does not wish their child to participate, they can call Kimberly Hieftje (PI), who will then 
notify the school. Students may remove themselves when the experiment starts if their assent or 
parental consent has not been provided.  
 
For students that have opted out of the study, they will work on other assignments provided by the teacher.  
 
 
7. Evaluation of Subject(s) Capacity to Provide Informed Consent/Assent: Indicate how the personnel obtaining 
consent will assess the potential subject’s ability and capacity to consent to the research being proposed.  
This research does not involve subjects with limited decision-making capacity. Parents and adolescents will be 
provided with an age-appropriate description of the study and told about what they might expect.  In 
describing the study to the participant, the purpose of the study will be described as “finding out how kids 
can make choices that are healthier for them”. In describing the study to the guardian/parent, we will indicate 
that the study will focus on promoting healthy behaviors in adolescence and on providing strategies to assist 
adolescents in making decisions about the many challenges they face; particularly as they relate to tobacco 
use. For focus groups, we will employ waived signature of consent. Parents who do not wish for their children 
to participate will contact the project director. For the randomized controlled trial, we will obtain informed 
written assent from the participant and written informed consent from their guardian/parent. 
 

 
 
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8. Non-English Speaking Subjects: Explain provisions in place to ensure comprehension for research involving 
non-English speaking subjects. If enrollment of these subjects is anticipated, translated copies of all consent 
materials must be submitted for approval prior to use.  
 
Non-English Speaking Subjects will not be able to participate in this project. 
 
As a limited alternative to the above requirement, will you use the short form* for consenting process if you 
unexpectedly encounter a non-English speaking individual interested in study participation and the translation of 
the long form is not possible prior to intended enrollment?  YES ☐  NO ☒ 
 
Note* If more than 2 study participants are enrolled using a short form translated into the same language, then 
the full consent form should be translated into that language for use the next time a subject speaking that 
language is to be enrolled. 
 
Several translated short form templates are available on the HRPP website (yale.edu/hrpp) and translated HIPAA 
Research Authorization Forms are available on the HIPAA website (hipaa.yale.edu). If the translation of the short 
form is not available on our website, then the translated short form needs to be submitted to the IRB office for 
approval via modification prior to enrolling the subject.   Please review the guidance and presentation on use of 
the short form available on the HRPP website. 
 
If using a short form without a translated HIPAA Research Authorization Form, please request a HIPAA waiver in 
the section above.  
 
9. 
Consent Waiver: In certain circumstances, the HIC may grant a waiver of signed consent, or a full waiver 
of consent, depending on the study. If you will request either a waiver of consent, or a waiver of signed consent 
for this study, complete the appropriate section below.   
 
☐Not Requesting any consent waivers  
 
☒Requesting a waiver of signed consent: 
☒ Recruitment/Screening only (if for recruitment, the questions in the box below will apply to 
recruitment activities only) 
☒ Entire Study (Note that an information sheet may be required.) – For focus group participation 
and sub-study #2.  
 
 
  
  ☐ Requesting a waiver of consent: 
 For a waiver of signed consent, address the following: 
• Would the signed consent form be the only record linking the subject and the research?  YES ☐  NO ☐  
• Does a breach of confidentiality constitute the principal risk to subjects? YES ☐  NO ☐ 
  
 OR 
• Does the research pose greater than minimal risk? YES ☐    NO☒  
• Does the research include any activities that would require signed consent in a non-research context? YES ☐   
NO ☒  

 
 
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☐ Recruitment/Screening only (if for recruitment, the questions in the box below will apply to 
recruitment activities only) 
☐ Entire Study   
 
 
 
 
 
 
 
SECTION IV: PROTECTION OF RESEARCH SUBJECTS 
 
    Confidentiality & Security of Data: 
1. What protected health information (medical information along with the HIPAA identifiers) about subjects will 
be collected and used for the research?   Name, Address, Telephone Number, Email Address 
 
2. How will the research data be collected, recorded and stored? All data collected from the assessments will 
be entered directly into the secure web-based system, OnCore, which is Yale’s enterprise-wide data 
management system. Research staff will enter the data into the OnCore system. For the more sensitive 
information collected, the participant will enter these data. To assess acceptability and feasibility, 
directly following completion of the intervention, we will collect quantitative and qualitative data on 
the intervention participants’ experiences of the game intervention. 
 
3. How will the digital data be stored? ☐CD  ☐DVD  ☐Flash Drive  ☐Portable Hard  Drive   ☒Secured Server  
☐Laptop Computer  ☐Desktop Computer  ☐Other 
 
4. What methods and procedures will be used to safeguard the confidentiality and security of  the identifiable 
study data and the storage media indicated above during and after the subject’s participation in the study?  
 
Data will be stored in Yale’s secured online data collection system, OnCore. Paper assessments will be kept in 
a locked filing cabinet in the PI’s office. 
 
All portable devices must contain encryption software, per University Policy 5100.  If there is a technical reason a 
device cannot be encrypted please submit an exception request to the Information Security, Policy and Compliance 
Office by clicking on url http://its.yale.edu/egrc or email it.compliance@yale.edu 
 
5. What will be done with the data when the research is completed? Are there plans to destroy the identifiable 
data? If yes, describe how, by whom and when identifiers will be destroyed. If no, describe how the data and/or 
identifiers will be secured. Data collected in the study will reside in our computerized database and electronic 
storage mechanisms. All data analyses will be performed under approved HIC protocols. 
 
6. If appropriate, has a Certificate of Confidentiality been obtained? Write here 
For a full waiver of consent, please address all of the following: 
• 
Does the research pose greater than minimal risk to subjects?   
☐ Yes If you answered yes, stop. A waiver cannot be granted.   
☐ No 
• 
Will the waiver adversely affect subjects’ rights and welfare? YES ☐    NO☐ 
• 
Why would the research be impracticable to conduct without the waiver? Write here 
• 
Where appropriate, how will pertinent information be returned to, or shared with subjects at a later date? 
Write here 

 
 
IRB# 2000025177 
 
SECTION V: POTENTIAL BENEFITS 
 
Potential Benefits: Identify any benefits that may be reasonably expected to result from the research, either to 
the subject(s) or to society at large. (Payment of subjects is not considered a benefit in this context of the risk 
benefit assessment.)  
Potential benefits expected from the result of this research include a better understanding on how the use of 
videogame technology may influence health behaviors in young adolescents that impact their health and well-
being. Specifically, this research will help to inform the sparse research available on the use of virtual reality to 
influence behaviors and social perceptions in adolescents. 
 
         SECTION VI: RESEARCH ALTERNATIVES AND ECONOMIC CONSIDERATIONS 
1. Alternatives: What other alternatives are available to the study subjects outside of the research?  
Not participating in the study 
2. Payments for Participation (Economic Considerations): Describe any payments that will be made to subjects, 
the amount and schedule of payments, and the conditions for receiving this compensation. 
 
We will compensate focus group participants and participants who participate in pilot testing with gift cards 
with monetary value of $25. Voice over participants will receive a gift card valued at $30.  
 
3. Costs for Participation (Economic Considerations): Clearly describe the subject’s costs associated with 
participation in the research, and the interventions or procedures of the study that will be provided at no cost 
to subjects.  
 
No costs to subjects will be incurred. 
 
4. In Case of Injury: This section is required for any research involving more than minimal risk, and for minimal 
risk research that presents the potential for physical harm (e.g., research involving blood draws). 
 
a. Will medical treatment be available if research-related injury occurs? Write here 
 
b. Where and from whom may treatment be obtained? Write here 
c. Are there any limits to the treatment being provided? Write here 
d. Who will pay for this treatment? Write here 
e. How will the medical treatment be accessed by subjects? Write here   
IMPORTANT REMINDERS 
 
Will this study have a billable service?  Yes ☐  
 No☒ 
 
A billable service is defined as any service rendered to a study subject that, if he/she was not on a study, would 
normally generate a bill from either Yale-New Haven Hospital or Yale Medical Group to the patient or the patient’s 
insurer. The service may or may not be performed by the research staff on your study, but may be provided by 
professionals within either Yale-New Haven Hospital or Yale Medical Group (examples include x-rays, MRIs, CT 
scans, specimens sent to central labs, or specimens sent to pathology). Notes: 1. There is no distinction made 
whether the service is paid for by the subject or their insurance (Standard of Care) or by the study’s funding 
mechanism (Research Sponsored). 2. This generally includes new services or orders placed in EPIC for research 
subjects.  
 

 
 
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If answered, “yes”, this study will need to be set up in OnCore, Yale’s clinical research management system, for 
Epic to appropriately route research related charges. Please contact oncore.support@yale.edu 
 
Are there any procedures involved in this protocol that will be performed at YNHH or one of its affiliated entities?  
Yes ☐  No ☐  
 
If Yes, please answer questions a through c and note instructions below.   
a. Does your YNHH privilege delineation currently include the specific procedure that you will perform? Yes ☐  No 
☐ 
b. Will you be using any new equipment or equipment that you have not used in the past for this procedure? Yes 
☐  No ☐ 
c. Will a novel approach using existing equipment be applied? Yes ☐  No ☐ 
  
If you answered “no” to question 4a, or "yes" to question 4b or c, please contact the YNHH Department of 
Physician Services (688-2615) for prior approval before commencing with your research protocol. 
 
IMPORTANT REMINDER ABOUT RESEARCH AT YNHH  
Please note that if this protocol includes Yale-New Haven Hospital patients, including patients at the HRU, the 
Principal Investigator and any co-investigators who are physicians or mid-level practitioners (includes PAs, APRNs, 
psychologists and speech pathologists) who may have direct patient contact with patients on YNHH premises 
must have medical staff appointment and appropriate clinical privileges at YNHH. If you are uncertain whether 
the study personnel meet the criteria, please telephone the Physician Services Department at 203-688-2615. By 
submitting this protocol as a PI, you attest that you and any co-investigator who may have patient contact has a 
medical staff appointment and appropriate clinical privileges at YNHH. 
 
 
 
 
 
 
 
 
 
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