Personalized Feedback Programs for College Students
Phase: NA
Conditions: Alcohol Use, Unspecified
Sponsor: Virginia Commonwealth University

 
 
Title: Personalized Feedback Programs for College Students 
 
NCT #: NCT04975191 
 
Document date: 07/02/2021 
 
Document Type: Protocol 
 
 
 

 
 
7. * Select one of the following that applies to the project (selection will branch to new pages): 
Note: VCU IRB offers guidance for many types of studies, including secondary data analysis studies, internet
research, registries, EFIC, HUD, and Emergency Use protocols.
See https://research.vcu.edu/human_research/guidance.htm  
Research Project or Clinical Investigation [*most exempt, expedited, and full board research studies]
Exception from Informed Consent (EFIC) for Planned Emergency Research
Humanitarian Use of Device for Treatment or Diagnosis
Humanitarian Use of Device for Clinical Investigation
Emergency Use of Investigational Drug, Biologic or Device
Treatment Use (Expanded Access to Investigational Product for Treatment Use)
Center or Institute Administrative Grant Review
Request for Not Human Subject Research Determination (i.e. request a letter confirming that IRB review is not
required)
View: SF2 - Federal Regulations
  
Federal Regulations
1. * Is this a FDA regulated study? 
FDA regulated research includes all clinical investigations involving a test article and a human subject(s) that
has been submitted for approval to the FDA or may be submitted in the future.  
Check Yes if 
•    the study involves an IND/IDE, abbreviated IDE, IND/IDE exemption, HUD, expanded access, or is otherwise
subject to 21 CFR 56,  
•    the study involves a test article being administered or dispensed to subjects NOT according to a clinicians’
medical judgment but rather, per the study protocol, OR 
•    the study does not involve a test article but intends to provide safety or efficacy data to the FDA. 
  
  Yes No

2. * Is this study supported by the Department of Defense (DoD): 
  Yes
No
3. * Check if any of the following funding sources apply to this research (including Direct and/or Indirect
funding): 

Department of Education

Department of Justice

Environmental Protection Agency
None of the above
View: SF2 - IRB Panel Setup
  
IRB Panel Setup
1. * To which IRB is this study being submitted for review? 
VCU IRB
WCG IRB
NCI Central IRB
Advarra IRB
Other IRB
2. * Is this study transitioning to review by another IRB? 
Yes - transitioning from VCU IRB to an external IRB (WCG, CIRB, Other)
Yes - transitioning from an external IRB (WCG, CIRB, Other) to VCU IRB
No or not applicable
View: SF2 - Review Setup
  

Review Setup
1. * Select which study type best describes the majority of the study. Your response will help determine which
IRB panel should review this. 
Bio-Medical Research
Social/Behavioral/Education (SBE) Research
2. * Which option(s) best describe the way(s) this study’s procedures will be conducted? (Select all that apply.)
This information may be used by the IRB in triaging studies during an emergency. 

In-person interactions / interventions with participants
Remote interactions / interventions with participants

Secondary data/specimen analyses and no contact with study participants
3. * Does this study involve greater than minimal risk: 
  Yes No
4. * Review type requested: (subject to IRB approval): 
Full Board
Expedited
Exempt
 
The IRB has determined that the selected types of anticipated individual and social benefit apply to this study
The below information is read-only to investigators, and the categories are set by the IRB during review. All
categories will appear blank until the IRB has made a determination. If a category is not checked, it does not
apply to this study. This information may be used by the IRB in triaging studies during an emergency
situation. 
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The following information applies to studies being reviewed by the VCU IRB.
The IRB has determined that the selected Exempt and/or Expedited categories apply to this study.
The below information is read-only to investigators, and the categories are set by the IRB during review. All

categories will appear blank until the IRB has made a determination. If a category is not checked, it does not
apply to this study or the study is being reviewed by an external IRB.
5. For Expedited Studies: 
There are no items to display
  
View: SF2 - Initial Setup Complete
  
Initial Setup Complete
Protocol Progress: 
 INITIAL SETUP 
 BACKGROUND, RATIONALE & GOALS 
 RESEARCH PLAN 
 CONSENT PLAN 
 RISKS, PRIVACY & CONFIDENTIALITY 
 POPULATIONS WITH SPECIAL CONSIDERATIONS 
 INSTITUTIONAL REQUIREMENTS 
 DOCUMENTS 
 
Click Continue below to go to the next section
 
View: SF2 - Background, Rationale and Goals
  
Background, Rationale and Goals
1. * Describe the study's background and what is currently known from the scientific literature, including
citations, or upload a citation list in document upload.  Use lay language whenever possible. 
College represents a unique opportunity to intervene and have positive life-course altering health benefits for a
significant, rapidly growing (Dick et al., 2018), and increasingly diverse portion of the population (Dick & Hancock,
2015; Dick, 2018). Post-secondary enrollment is expected to grow to >24 million individuals by 2024, and college is
now considered a “pervasive” American experience (Dick, 2018). College students are entering a critical
developmental period for the establishment of health behaviors that persist into adulthood (Dick et al., 2018, Dick &
Hancock, 2015), and college represents one of the few times in an individual’s life where all primary activities – social,
career, health, and safety – are concentrated and controlled within a single setting. Accordingly, effective programs to
promote health behaviors in the college setting are needed.  
Risky substance use among college students remains one of the most widespread challenges, with 39% of students

reporting that they binge drink (Substance Abuse and Mental Health Services Administration, 2011) and 36% of
students reporting illicit drug use in the past year (Kilmer & Geisner, 2013). College students use alcohol at higher
rates than their non-college-attending peers (Schulenberg et al., 2017) and nearly half (47%) of all students meet
criteria for an alcohol or marijuana use disorder at least once in the first three years of college (Caldeira et al., 2009).
Importantly, problematic substance use is associated with serious consequences, including unwanted sexual
encounters, legal consequences, assault, injury, and suicide (Arria et al., 2013; Hingson, Zha, & Weitzman, 2009).  
The current “gold standard” for reducing risky substance use among college students is the use of brief motivational
interventions (BMIs) (Larimer & Cronce, 2002; Lee, Neighbors, Kilmer, & Larimer, 2010). BMIs aim to reduce harmful
drinking practices by providing students with information about how their drinking compares to others, recognizing
possible consequences associated with excessive alcohol use, and encouraging students to undertake new strategies
to monitor their drinking, set limits, and reduce risk. BMIs are widely used on college campuses, with one national
study finding that 62% of schools report utilizing empirically supported alcohol prevention BMI programming (Nelson,
Toomey, Lenk, Erickson, & Winters, 2010).  
Despite their widespread use and current status as the most effective available resource, a meta-analysis combining
individual participant-level data from 6,713 individuals from 17 randomized clinical trials underscored the small effect
sizes associated with BMIs and indicated a “need for the development of more effective intervention strategies'' (Huh et
al., 2015). Further, a review of interventions for college student drinking noted that “significant enhancement of
personalized feedback intervention efficacy has not been observed in over 15 years of study” (Miller, Meier, Lombardi
& Leffingwell, 2015). A second major limitation is that prevention and intervention programs for college students
historically focused exclusively on alcohol. Rates of anxiety and other mental health challenges have also been rising
in college students and it is inefficient to have programs that do not comprehensively address mental health. A
challenge for college student mental health providers is that college students rarely want to engage in “prevention
programming”. Resources on college campuses often go under-utilized. We propose to develop a program for college
students that will capitalize on the element of current prevention programming that appears to be most critical to
effectiveness: the delivery of personalized feedback to stimulate change (Cronce, Bittinger, Liu & Kilmer, 2014).
However, rather than focusing feedback on current patterns of alcohol use, we will provide personalized feedback on
underlying dispositional factors known to be related to substance use and other mental health challenges, along with
personalized recommendations and resource information tailored to the individual’s profile(s). In this way, we will utilize
findings from the basic epidemiological literature about the key personality pathways that influence substance use and
mental health to create a Personalized Feedback Program for each student. Importantly, each of the personality-
related dimensions for which we will give feedback has positive features in addition to potential challenges. Our
intervention will shift the focus from the provision of information about relative levels of substance use (what is currently
provided), and provide information about personality profiles that can contribute to health and wellness. This will help
students understand the potential strengths associated with their personalized profiles, along with potential challenges
and give them personalized resources. In this way, we aim to address several limitations of the current literature, by
focusing on something likely to be of greater interest to students (personality) in order to provide information about
resources that can support them in their college experience.  
Citation list uploaded.
2. * Describe the study hypothesis and/or research questions.  Use lay language whenever possible. 
The primary aim of this randomized controlled trial (RCT) is to preliminarily evaluate the efficacy of the Personalized
Feedback Program (PFP) as compared to an assessment only control group, a computer-delivered intervention based
on brief motivational intervention (BMI) content/principles, and a combined PFP+BMI condition. 
Hypothesis 1: Students who receive the PFP will demonstrate significantly lower rates of substance use and related
problems in comparison to students in the control condition and the BMI group at the 30-day and 3-month follow-ups. 
Hypothesis 2: Students in the PFP+BMI condition will display significantly lower rates of substance use than students
in either the PFP or BMI conditions. 

3. * Describe the study's specific aims or goals.  Use lay language whenever possible. 
The primary aim of this proposal is to conduct a preliminary test of efficacy of our newly developed innovative
prevention intervention, the Personalized Feedback Program (PFP) for college students. The PFP provides feedback
about students' unique personality-related traits and how these factors relate to wellness, general college success, and
substance use, along with personalized recommendations and resources. Preliminary efficacy will be evaluated
through a randomized controlled trial (RCT) comparing four conditions: assessment only controls, PFP, computer-
delivered intervention based on brief motivational intervention (BMI) content/principles, and PFP+BMI.
4. * Describe the scientific benefit or importance of the knowledge to be gained: 
Serving the students that are part of our university community is a critical task to ensure student success. At present,
Brief Motivational Interventions (BMIs) are implemented widely on college campuses but have demonstrated very small
effects. Accordingly, if the hypotheses in the present study are confirmed, the Personalized Feedback Program
intervention provides a substantial addition to the existing knowledge base concerning interventions for college
students. In addition, because the intervention is being implemented during college, potential benefits include the
prevention of the severe academic functioning difficulties, including school dropout. Accordingly, developing
programming to serve our students will contribute to the Quest for Distinction goal of improving student retention.
5. * Describe any potential for direct benefits to participants in this study: 
The benefits of this study may be quite substantial. The potential benefits to the subjects of this study include a better
understanding of their unique risk profile and how that relates to their potential for problematic drinking and substance
use and impairment. Additionally, participants will be given personalized recommendations for VCU-based resources
according to their profiles. Thus, they may benefit through being connected with university services early in their
college career rather than waiting for problems to arise. It cannot be promised, however, that the subjects will directly
benefit from the assessments or feedback provided through the interventions. Nominal payments will be provided for
participation in the intervention and completion of the outcome measures.
6. * Describe any potential for direct social impact in this study . For example, any engagement with specific
communities to respond to community-identified needs, or ways the study will strengthen the well-being of
the specific communities if applicable: 
There is great potential for impact on college student well-being. Risky substance use among college students is
widespread and associated with significant adverse consequences. Current prevention intervention programs have
limited effects, underscoring the need for innovative new ways to prevent college alcohol and other drug use. Our
findings have great potential to enhance the effectiveness of college student substance use prevention programming
and improve college student wellbeing.
7. Upload a supporting citation list if applicable:
  
View: SF2 - Study Population
  
Study Population
1. * Provide the maximum number of individuals that 
  1. May participate in any study interaction or intervention (Including screening, consenting, and study
activities) 
      AND/OR 

  2. You obtain any data/specimens about (regardless of identifiability)  
 at VCU and at other sites under the VCU IRB's oversight. See the help text for additional guidance. 
400 
2. If this is a multi-Center Project, what is the maximum anticipated number of subjects across all sites? 
3. * Provide justification for the sample size by explaining how you arrived at the expected number of
participants and why this number is adequate for answering the research questions: 
The proposed study aims to enroll a random sample of 400 freshman college students in a randomized controlled trial
(RCT). The RCT will have 4 conditions, each with 100 participants. We plan to present the study to freshmen ages 18
and older participating in the Spit for Science Baseline Survey being conducted in the Fall 2021 semester. We have
determined a limit of 400 participants to account for future study attrition in order to reach our desired sample size of
N=300 at each stage of the trial. We have previously been successful recruiting similarly sized samples of freshmen for
web-based alcohol intervention studies.  
4. * List the study inclusion criteria: 
Consent: Voluntary consent must be provided. 
Age: Students over the age of 18 may participate. 
Year in college: Newly enrolled freshmen. 
Enrollment status: Only full-time VCU students will participate. 
5. * List the study exclusion criteria: 
Age: Under the age of 18 
Year in College: A sophomore, junior or senior 
Enrollment Status: Enrolled part-time 
6. * Will individuals with limited English proficiency be included in or excluded  from this research? 
Included
Excluded - safety concerns if participants are unable to communicate with the study team
Excluded - instruments/measures only validated in English
Excluded - no prospect of direct benefit to individual participants
Excluded - minimal risk study
Excluded - lack of budget/resources for translation and interpretation [provide an explanation in next question]
Excluded - other reason [provide an explanation in next question]
7. Justify the inclusion and exclusion criteria if you are either targeting, or excluding, a particular segment of the
population / community. Provide a description of the group/organization/community and provide a rationale. 
The focus of the present (minimal risk) study is to conduct a preliminary test of efficacy of our newly developed
innovative prevention intervention, the Personalized Feedback Program (PFP) for college students. As such,
participants will only be included in the present study if they are a full-time college student. Alcohol intervention
programming is generally designed for traditional college students attending school full-time. This is not problematic
since close to 80% of the incoming freshman class each year registers for at least 9 credits and is considered full-time.
Currently the intervention is being developed with VCU students in mind and the resources provided are specific to
VCU; thus, only VCU students will be eligible to participate. We are limiting the study to college freshmen on the
premise that a college student’s first year is the most effective time to intervene given the variability in quantity and

frequency of substance use among freshmen and the fact that the proportion of people who report drinking rises
steadily across the college years. On most college campuses, substance prevention programs are delivered to
incoming freshmen, before they are exposed to increased risk following the transition. Accordingly, we want to focus
activities and outcome evaluation on freshmen to increase the potential for generalization to other college campuses.
In addition, incoming freshmen are at greatest risk for problematic alcohol use and associated consequences. Our own
work in Spit for Science and that of a previous study following a cohort of incoming freshmen also found that variables
measured at entry to university are among the strongest predictors of substance use and problems. These findings
underscore the importance of early intervention aimed at incoming freshmen, which is why we focus on this population.
Students who are considered freshmen based upon credits (e.g., withdrew from courses during first year and did not
meet credit requirements to be considered sophomores), will not be eligible, as they would comprise a unique group of
likely high risk students. We will limit enrollment to freshmen over the age of 18. This should not be difficult because
98% of incoming VCU freshmen are 18-19 years of age. 
 
View: SF2 - Background, Rationale & Goals Section Complete
  
Background, Rationale & Goals Section Complete
Protocol Progress: 
 INITIAL SETUP 
 BACKGROUND, RATIONALE & GOALS 
 RESEARCH PLAN 
 CONSENT PLAN 
 RISKS, PRIVACY & CONFIDENTIALITY 
 POPULATIONS WITH SPECIAL CONSIDERATIONS 
 INSTITUTIONAL REQUIREMENTS 
 DOCUMENTS 
 
Click Continue below to go to the next section
View: SF2 - Study Procedures
  
Study Procedures
 
1. * Describe the study hypothesis and/or research questions.  Use lay language whenever possible. 
The primary aim of this randomized controlled trial (RCT) is to preliminarily evaluate the efficacy of the Personalized
Feedback Program (PFP) as compared to an assessment only control group, a computer-delivered intervention based
on brief motivational intervention (BMI) content/principles, and a combined PFP+BMI condition. 
Hypothesis 1: Students who receive the PFP will demonstrate significantly lower rates of substance use and related

problems in comparison to students in the control condition and the BMI group at the 30-day and 3-month follow-ups. 
Hypothesis 2: Students in the PFP+BMI condition will display significantly lower rates of substance use than students
in either the PFP or BMI conditions. 
2. * Describe the study's specific aims or goals.  Use lay language whenever possible. 
The primary aim of this proposal is to conduct a preliminary test of efficacy of our newly developed innovative
prevention intervention, the Personalized Feedback Program (PFP) for college students. The PFP provides feedback
about students' unique personality-related traits and how these factors relate to wellness, general college success, and
substance use, along with personalized recommendations and resources. Preliminary efficacy will be evaluated
through a randomized controlled trial (RCT) comparing four conditions: assessment only controls, PFP, computer-
delivered intervention based on brief motivational intervention (BMI) content/principles, and PFP+BMI.
3. * Choose all types of recruitment materials that may be used and upload them below:  
E-mail invitations

Phone Solicitation scripts (i.e. cold calls or random-digit-dialing)

Flyers, Mailed Letters or Newspaper/TV/Radio Ads

TelegRAM announcements

Website text

Study-specific web sites (provide the design and text)

Social Media

EPIC MyChart Patient Portal research study descriptions

Psychology Research Participant Pool (SONA) study descriptions

Scripts for announcements made to groups

Other recruitment material

No recruitment materials
4. * Describe the study procedures/methods for identifying and recruiting participants. Address the following
three aspects of recruitment in your response.  
1. Identification of potentially eligible participants or secondary data/specimens of interest. 
     - What database(s) will be queried to identify secondary data/specimens 
     - How potential participants' contact information will be obtained 
2. Recruitment procedures to invite participation in the study (when applicable): 
     - How each of the written or verbal recruitment materials and reminders (selected above) will be used 
     - Who will contact or respond to potential participants
     - Locations where recruitment procedures will take place 
     - The timing and frequency of recruitment attempts 
3. Eligibility screening prior to consent and how those activities will be carried out (when applicable) 

See the help text for additional guidance. 
Participants will be identified by self-selection during the Spit for Science baseline survey being conducted in the Fall
2021 semester. As part of the baseline survey, participants will be asked a yes/no question about their interest in
learning more about the current spin-off study. Participants are informed that if they indicate 'yes' that their data and
contact information will be shared with the Personalized Feedback Programs for College Students study (see
document named: Spin-Off Invitation through S4S Baseline Survey). Spit for Science assigns randomly generated
coded spin-off IDs for each participant. For participants that indicate ‘yes’ to the spin-off study interest question asked
within the Spit for Science baseline survey, this spin-off ID is provided to the study project coordinator as part of the
‘turnover’ data, which includes email addresses, permanent address, phone number(s) and text permission if provided.
The information will also include responses to the baseline measures. This data sharing will occur through a VCU
approved file sharing application (like REDCap Send-It), a conditional Data Access Group (DAG) in the S4S baseline
REDCap Project and/or through a shared, 'user-assigned' Participant Tracking REDCap Project. 
When participants enter our study consent, they will be asked to provide their VCU email address, which will be used
to match the participant back to the information provided by Spit for Science, including the spinoff ID. The spin-off ID
will then be used throughout the course of the study procedures to link survey record IDs, survey data, and study data.
Should they participate in the study, all survey data will be kept separate from identifiable information. The connection
between a student email address and a particular record ID number is maintained behind the scenes in the REDCap
system and on a password-protected secure server accessible only to select study staff. This key will be kept
indefinitely on a secure server. All identifiable information from students who participate in the study will be deleted at
the end of the study.  
Once the study team receives the list of potential participants, the study team will randomize the participants across the
four conditions. All participants have an equal chance of being randomized into each of the four conditions. The study
team will then send these potential participants the “Study Enrollment Email.” This email will contain further details
about the study along with a link to this study's consent in REDCap. They will be asked to enter their VCU email
address as part of the consent process. Once they consent to participate, they will be automatically redirected to their
condition’s program. These programs are outlined in the Study Procedures section. At the conclusion of their
participation in their condition, additional contact information may be requested. Specifically, participants will be asked
to confirm their VCU email address and phone number where they can be contacted to participate in the follow-up
assessments. Additionally, if information that allows the study to carry out compensation steps was not provided
previously (e.g. the participant’s permanent address ) it will be requested at this time. While the email and mailing
address questions will be required, students are able to decline to share their phone number. 
The study survey will have a response limit of 400 respondents. Participants will be invited on a rolling basis (in
batches according to when they complete the baseline survey) until we have reached 400. Once 400 participants have
completed participation, the baseline survey will provide a message to subsequent interested participants indicating
that: "Thank you for your interest in the personalized feedback program. This study is currently full. If the study opens
enrollment in the future, we may contact you at that time to see if you are still interested. In the meantime, please keep
an eye out for more emails from Spit for Science with other opportunities to participate in research!" The study staff will
inform Spit for Science once the response limit is approaching/met and Spit for Science will remove (or alter the
information presented indicating study enrollment is full) in the baseline survey to help ensure that unnecessary
ascertainment and data sharing is avoided.  
Starting one week after the initial invitation email is sent, eligible students who have not yet enrolled in the RCT will be
sent email or text (if permission given) reminders. Reminders will be sent weekly for three weeks or until we have
achieved our desired N.  
All participants will be invited to complete follow-up assessments at two timepoints: 30 days after their initial
participation (T2) and 3 months after their initial participation (T3). At each timepoint, they will be contacted by the
study coordinator via the email address they provided on the initial survey (for content see “Intro Email/Reminder T2”
and “Intro Email/Reminder T3”). The emails will contain a link to the T2 Survey and T3 Survey respectively. The
reminder schedule will mirror the reminders for initial entry into the study. That is, starting one week after the invitation

email is sent, participants who have not yet completed the T2 (and later T3) survey will be sent email reminders. In
addition to emails, students who shared their phone numbers in the initial survey at T1 will receive reminders via text.
Reminders will be sent weekly for three weeks for each survey (for content see “Text Reminders”).  
5. * Does this study have a separate protocol document (i.e. a multisite or sponsor's protocol) that contains a
detailed description of the study's methodology? 
  Yes
No
6. * Since a separate protocol document is not uploaded, describe the proposed research using language
understandable to those IRB committee members whose expertise is not scientific. The description must
include:
1. A statement explaining the study design 
2. A detailed description of all the procedures that will be followed to carry out the study, preferably in
sequential order, and in sufficient detail that the study's methods could be replicated 
3. A description of all research measures/tests/interventions that will be used (if applicable) 
See the help text for additional guidance 
Study Design: We will conduct a preliminary test of efficacy of our newly developed Personalized Feedback Program
through a randomized controlled trial (RCT; target N = 400 freshman college students) comparing four conditions (N =
100 in each): an assessment only treatment as usual control group, Personalized Feedback Program (PFP), a
computer-delivered intervention based on brief motivational intervention (BMI) content/principles, and a combined
PFP+BMI condition.  
Study Procedure:  
Generally, participation begins during the Spit for Science baseline survey deployment. At the end of the baseline
survey, participants are provided with a brief introduction to this study and asked if they are interested in participation
and informed that if they indicate ‘yes’ that their information will be shared with the study staff so that the staff may
contact them to complete study enrollment. The first 400 participants to respond “yes” to this question will be randomly
assigned to one of the four conditions outlined below. Based on previous enrollment rates for similar studies, we
believe this will allow us to reach our desired sample size of N=300 for each stage of the trial (timepoint).  
Participants will be sent invitations from the study coordinator to their university e-mail account provided on the Spit for
Science baseline survey, with an embedded link to participate, which redirects students to the on-line study description
and consent. The consent outlines the study procedures for three timepoints: one at the time of initial consent (T1),
another 30 days after their initial participation (T2; 1-month follow-up), and a final follow-up approximately 3 months
after their initial participation (T3; 3-month follow-up). Upon completion of the on-line consent in REDCap, participants
will be redirected to the program to which they were randomly assigned. A description of the procedure at T1 for each
condition is outlined below. 
Assessment only controls (to participants in this condition, this condition will be called the ‘Resources Program’): Upon
acceptance of the consent document in REDCap, participants in the control condition will be directed to a REDCap
survey. The first page of the survey will consist of a list of resources that they can utilize as a student at VCU
containing links to the web pages associated with those resources (details on control group resource content can be
found in Description of Measures and Interventions subsection). They will then be asked to answer questions
pertaining to their future intentions regarding campus resource use, and alcohol and drug use. They will then be asked
to provide their contact information, which will be used to contact them for the remaining follow-up surveys in the study
and provide them with their compensation. Once participants complete the survey in REDCap they will automatically
be emailed the resource list from the Resources Program should they wish to revisit any information provided.
Participation for this group at T1 is expected to take ~10 minutes, but the exact length of time will vary according to
how long they spend exploring the website links for the resources provided.  

PFP: Upon acceptance of the consent document in REDCap, participants in the PFP condition will be directed to the
Personalized Feedback Program (PFP) using an embedded link in the survey (details on PFP content can be found in
Description of Measures and Interventions subsection). Immediately following completion of the PFP, students will be
directed back to REDCap to answer a brief set of survey questions related to their experiences with the program
(details on T1 post-program survey can be found in Description of Measures and Interventions subsection) and then to
provide their contact information, which will be used to contact them for the remaining follow-up surveys in the study
and provide them with their compensation. Once participants complete the survey in REDCap they will automatically
be emailed their PFP results from REDCap should they wish to revisit any information provided. Participation for this
group at T1 is expected to take ~20-30 minutes.  
BMI: Upon acceptance of the consent document in REDCap, participants in the BMI condition will be directed to a
computer-delivered intervention based on brief motivational intervention (BMI) content/principles using an embedded
link in the survey (details on BMI content can be found in Description of Measures and Interventions subsection).
Participants will be able to download their BMI feedback directly to their device. Immediately following completion of
the modified BMI program, students will be directed back to REDCap to answer a brief set of survey questions related
to their experiences with the program (details on T1 post-program survey can be found in Description of Measures and
Interventions subsection) and then to provide their contact information, which will be used to contact them for the
remaining follow-up surveys in the study and provide them with their compensation. Participation for this group at T1 is
expected to take ~20-30 minutes.  
PFP+BMI: Upon acceptance of the consent document in REDCap, participants in the PFP +BMI condition will be
directed to the Personalized Feedback Program (PFP) using an embedded link in the survey (details on PFP content
can be found in Description of Measures and Interventions subsection). Immediately following completion of the PFP,
students will be directed back to a page in REDCap thanking them for completing the PFP and introducing them to the
BMI. This page will direct participants to a computer-delivered intervention based on brief motivational intervention
(BMI) content/principles using an embedded link. Participants will be able to download their BMI feedback directly to
their device. Immediately following completion of the BMI, students will be directed back to REDCap to answer a brief
set of survey questions related to their experiences with the programs (details on T1 post-program survey can be found
in Description of Measures and Interventions subsection) and then to provide their contact information, which will be
used to contact them for the remaining follow-up surveys in the study and provide them with their compensation. Once
participants complete the survey in REDCap they will automatically be emailed their PFP results from REDCap should
they wish to revisit any information provided. Participation for this group at T1 is expected to take ~40-50 minutes.  
Approximately 30 days and 3 months post-intervention (post-intervention=after their initial participation at T1), all
enrolled participants, regardless of their initial condition, will be invited via email and reminded via email and text by the
study coordinator to complete the online Timepoint 2 (T2) and Timepoint 3 (T3) follow-up assessments. All students,
regardless of their condition will be directed to the T2 survey at T2 and the T3 survey at T3 via a link in the invitation
email and/or text (details on follow-up survey content can be found in Description of Measures and Interventions
subsection). At T2, participants will go through the survey, completing all the questions. Upon completion of the survey,
participants will be asked to provide their contact information, which will be used to contact them for the remaining
follow-up survey in the study and provide them with their compensation. At T3, participants will go through the survey,
completing all the questions. Upon completion of the survey, participants will be asked to provide their contact
information, which will be used to provide them with their compensation. Each survey is expected to take 15-20
minutes to complete. 
Description of Measures and Interventions 
Control group resource list: After providing their consent to participate, participants randomly assigned to the treatment
as usual control group will be presented with a list of resources available to them as VCU students (e.g. Writing Center,
Recreation and Well-Being, Rams Connect), etc. Each resource will link out to its respective web page. The resources
listed will match those provided throughout the Personalized Feedback Program (PFP). See attached document
“Resources for control group” for full list. 

PFP: In the PFP, students will answer items from the short UPPS-P Impulsive Behavior Scale (SUPPS-P; Lynam,
2013) which will measure impulsivity facets and the Big Five Inventory (BFI, John & Srivastava, 1999) which will
estimate participant levels of extraversion vs introversion, conscientiousness vs. lack of direction and neuroticism vs.
emotional stability. Based on their responses to these items, they will receive personalized feedback and campus
resources to help them succeed during college. Further interactive elements in the program allow them to consider
their goals, what could help them achieve those goals, and what may interfere. They are then guided through four
sample scenarios where they can select different choice options and view their outcomes. See attached document
“PFP” for the text included in the program. 
BMI: In the computer-delivered intervention based on BMI content/principles, students will answer items from the Brief
Alcohol Screening and Intervention for College Students (BASICS FLv3*) survey (currently used by the VCU Division
of Student Affairs) regarding their levels of alcohol consumption over a typical two-week period, their levels of alcohol
consumption on a peak occasion in the past three months, their experiences when they drink, things that have
happened to them in the past year as a result of their drinking, their harm reduction strategies regarding alcohol, the
money they spend on alcohol, and their demographics. They will answer further items from the Alcohol Use
Identification Test (AUDIT; Bohn, Babor, & Kranzler, 1995) regarding their alcohol consumption and its ramifications on
their lives. Participant responses to these questions will be used to generate a personalized feedback report showing
them where their consumption levels fall in comparison to other VCU students, providing a summary of their drinking
habits and alcohol-related spending habits, and details on how their alcohol use may impact their sleep and nutrition.
They are provided with their typical and peak blood alcohol content, calculated using the U.S. Dept. of Transportation,
National Highway Traffic Safety Administration's formula (National Highway Traffic Safety Administration, 1994). They
are given a risk score based on the alcohol-related harms they’ve experienced calculated using the Brief Young Adult
Alcohol Consequences Questionnaire (Kahler, Strong, & Read, 2005) as well as their score on the AUDIT. Finally, they
are given an opportunity to think through their intentions regarding future use and the support available to them 
*The survey and feedback reports at Columbia University, University of Washington, University of Northern Texas, and
University of Vermont have served as models for this intervention. Version 3.0 (2017) was developed by Nancy
Reynolds, MSPH, BASICS Director at Ithaca College, with generous input from the entire community of BASICS
professionals. The VCU BASICS survey is available at 
T1 Post-Program Survey:  
Control: The T1 post-program survey will ask questions pertaining to participants’ satisfaction and experiences with the
Resources Program. They will then be asked questions pertaining to their future intentions regarding campus resource
use, and alcohol use and drug use, as well as their risk comprehension. See attached document “Immediate Post-
Survey Control”. 
PFP: The T1 post-program survey will ask questions related to participants’ satisfaction and experiences with the
Personalized Feedback Program. They will then be asked questions pertaining to their future intentions regarding
campus resource use, and alcohol use and drug use, as well as their risk comprehension. See attached document
“Immediate Post-Survey PFP”. 
BMI: The T1 post-program survey will ask questions related to participants’ satisfaction and experiences with the BMI
Program. They will then be asked questions pertaining to their future intentions regarding campus resource use, and
alcohol use and drug use, as well as their risk comprehension. See attached document “Immediate Post-Survey BMI”. 
PFP+BMI: The T1 post-program survey will ask questions related to participants’ satisfaction and experiences with
both the Personalized Feedback Program and the BMI Program. They will then be asked questions pertaining to their
future intentions regarding campus resource use, and alcohol use and drug use, as well as their risk comprehension.
See attached document “Immediate Post-Survey PFP+BMI”. 
T2 Survey: The T2 survey will be the same as the T3 survey. It will include items from the following validated
measures: Mental Health Continuum-Short Form (MHC-SF; Keyes, 2009), Semi-Structured Assessment for the
Genetics of Alcoholism (SSAGA; Bucholz et al., 1994), Alcohol Use Disorder Identification Test (AUDIT; Bohn, Babor, &
Kranzler, 1995), Symptom Checklist-90 (SCL-90; Derogatis, Lipman, & Covi, 1973), and Alcohol: Stages of Change
(Short Form) (Laforge, Maddock, & Rossi, 1998). These items will assess well-being, alcohol use/problems, drug use,
current anxiety/depressive symptoms, and additional questions will be asked pertaining to utilization of campus

resources and risk comprehension. Additional items will be included to assess program usefulness.  
T3 Survey: The T3 survey will be the same as the T2 survey. It will include items from the following validated
measures: Mental Health Continuum-Short Form (MHC-SF; Keyes, 2009), Semi-Structured Assessment for the
Genetics of Alcoholism (SSAGA; Bucholz et al., 1994), Alcohol Use Disorder Identification Test (AUDIT; Bohn, Babor, &
Kranzler, 1995), Symptom Checklist-90 (SCL-90; Derogatis, Lipman, & Covi, 1973), and Alcohol: Stages of Change
(Short Form) (Laforge, Maddock, & Rossi, 1998). These items will assess well-being, alcohol use/problems, drug use,
current anxiety/depressive symptoms, and additional questions will be asked pertaining to utilization of campus
resources and risk comprehension. Additional items will be included to assess program usefulness.  
Secondary Data Elements: Answers to the Spit for Science baseline survey will be incorporated as study baseline data
as well. Data sharing will follow the same secure options previously described.
7. * The IRB only reviews research activities, so indicate which of the study activities are:  
  - Being performed exclusively for research purposes (i.e. they would not otherwise be done apart from this
study) VERSUS. 
  - Alterations of routine activities/procedures (e.g. the study is altering the timing, frequency, method,
location, amount, etc.) VERSUS. 
  - Being done for other purposes and whose data/results will be used secondarily in the study (e.g. standard
medical or psychological tests, routine education practices, quality improvement initiatives, etc.). 
This study is being performed exclusively for research purposes, though we anticipate that the findings will have
important implications for substance use prevention on college campuses. The primary aim of this proposal is to
conduct a preliminary test of efficacy of our newly developed innovative prevention intervention, the Personalized
Feedback Program (PFP) for college students. Preliminary efficacy will be evaluated through a randomized controlled
trial (RCT) comparing four conditions: assessment only controls, PFP, computer-delivered intervention based on brief
motivational intervention (BMI) content/principles, and PFP+BMI. 
8. If applicable, describe alternatives (research or non-research) that are available to potential participants if they
choose not to participate in this study: 
9. Upload any supporting tables or documents (e.g. protocol documents, figures/tables, data collection forms,
study communications/reminders): 
Upload ALL instruments/guides that will be used or that participants will experience (i.e. see, hear, complete),
including measures, scripts/questions to guide interviews, surveys, questionnaires, observational guides,
etc,: 
Upload ALL recruitment and screening materials, including such as ads, flyers, telephone or in-person scripts,
letters, email invitations, TelegRAM announcements, and postcard reminders, screening scripts, screening
forms, and screening measures:
View: SF2 - Project Details
  
Project Details
1. * Select all of the following types of interventions that apply to this study (selections will branch): 
Social/Behavioral interventions or experimentation / Tasks / Environmental manipulations


Deception (misleading participants through false or incomplete information)

Drug(s) / Biologics / Supplement(s) / Other Compounds (investigational products or products whose
administration is dictated by the study protocol and not per the physician's clinical judgment)

Placebos

Safety and/or effectiveness evaluation of Bio-Medical Device(s), including in-vitro diagnostic devices/assays,
mobile medical apps, and HUDs used in clinical investigations

Washout Periods

Expanded Access - Treatment Use of an Investigational Product

Medical or Surgical Procedures (eg: physical exam, clinical procedures, scans, etc)

Specimen/biological sample collection

None of the Above
2. * Select all of the following types of interactions that apply to this study (selections will branch): 
Surveys / Questionnaires /Written responses to questions (including data entry)
Active Internet data collection (i.e. using the internet to interact or intervene directly with research
participants)

Interviews / Focus Groups / Verbal responses to questions

Audio / Video recording or photographing participants

Observations

Passive Internet data collection (i.e. passively observing online behavior)

Educational Settings/Assessments/Procedures

None of the Above
3. * Select all types of secondary information and/or specimens that apply to this study (selections will branch): 
See the help text for definitions. 
Individually Identifiable Health Information (PHI or RHI)

Secondary data/specimens NOT from a research registry or repository
Information/specimens from a research registry or repository (Usage Protocol)

Information/specimens originally collected for a previous research study

Publicly available information/specimens

Government-generated or collected information that was or will be obtained for nonresearch activities [only
applicable to research conducted by or on behalf of a Federal department or agency]

No secondary data/specimens will be used

 
View: SF2 - Behavioral Intervention Details
  
Behavioral Intervention Details
1. * Describe the duration of the social/behavioral intervention, task, or environmental manipulation: 
The randomized controlled trial (RCT) will compare four conditions:  
Assessment only controls will not receive a social/behavioral intervention. They will receive a list of resources at VCU
(e.g. Writing Center, Recreation and Well-Being, Rams Connect) with hyperlinks to their respective websites, but they
are not required to engage with them in any way.  
Personalized Feedback Program (PFP) condition: All participants in this condition will complete the PFP. The PFP is
estimated to take approximately 20 minutes, though exact time will depend on the extent to which the participant
wishes to engage with each section of the program.  
Brief Motivational Intervention (BMI) condition: All participants in this condition will complete a computer-delivered
intervention based on BMI content/principles. The BMI is designed to be similar in time to the PFP and is estimated to
take approximately 20 minutes to complete. 
PFP+BMI condition: All participants in this condition will complete both the PFP and the BMI. The PFP is estimated to
take approximately 20 minutes, though exact time will depend on the extent to which the participant wishes to engage
with each section of the program. The BMI is designed to be similar in time to the PFP and is estimated to take
approximately 20 minutes to complete. Thus the total duration expected is 40 minutes. 
2. * Describe any potential harms or discomforts that participants could experience during the intervention: 
There is no more than minimal risk associated with participation in this study. Potential risks may be psychological in
nature as associated with participation in the Personalized Feedback Program and/or the computer-delivered
intervention based on brief motivational intervention content/principles. However, we believe that potential for this kind
of distress is minimal. Subjects will be advised to complete the programs only when they have sufficient privacy and
they will be reminded regularly that participation is voluntary and they can withdraw from the study at any time during
the process. 
All information gathered is treated under the Human Subjects Review Board guidelines of confidentiality of patient
records. This study’s utilization of questionnaires to evaluate psychopathology, functioning, and substance use poses a
minimal risk to participants. Rating scale measures such as the ones proposed for this study are frequently used in
studies of college students. One possible complication from administration of these measures is boredom or symptoms
of anxiety surrounding the disclosure of personal information. A second potential risk is that confidentiality could be
breached; we take extensive measures to ensure data security. 
3. * Will the intervention be physically invasive or painful? 
  Yes
No
4. * Describe the impact the intervention will have on participants, including the nature and duration of any
impact(s): 

If the hypotheses in the present study are confirmed, the Personalized Feedback Program (PFP) provides a substantial
addition to the existing knowledge base concerning interventions to promote success and well-being in college
students. Potential benefits include the prevention of harm related to higher-risk substance use, including detrimental
impacts to academic success and retention. We expect that all students who participate in the PFP (either through the
PFP condition or the PFP+BMI condition) will receive some benefit from learning about their traits and the strengths
and challenges associated with their personality profiles. We anticipate that this will help them make more informed
choices during their college years. Students will also receive information about recommended university resources for
them, which could help them connect to university services and experience associated benefits. We expect that all
students who participate in the BMI (either through the BMI condition or the PFP+BMI) will receive some benefit from
receiving information about about how their drinking compares to others, how to recognize possible consequences
associated with excessive alcohol use, and new strategies to monitor their drinking, set limits, and reduce risk. In
addition, results of this study will help inform and improve the future education of college students.
5. * In the investigator's opinion, is there any reason to think that the participants will find the intervention
offensive or embarrassing? Explain why or why not. 
There is no reason to expect the PFP intervention will be offensive or embarrassing to participants. It contains
personality-related items that are routinely used in research. Additionally, we do not believe the BMI intervention will be
offensive or embarrassing to participants. BMIs are mandated on college campuses across the country and are
considered the current “gold standard” for reducing risky substance use among college students.
View: SF2 - Active Internet Data Collection
  
Active Internet Data Collection
1. * Describe the platform/technology chosen for collecting the data and transmitting data securely over the
internet.  Give the rationale for selecting this technology. 
Following participation in the Spit for Science baseline survey conducted in the Fall 2021 semester, participants will
complete ratings of substance use and associated problems at 2 additional timepoints: 30 days after their initial
participation (T2) and 3 months after their initial participation (T3). All the outcome measures will be completed on-line
via survey using REDCAP (Research Electronic Data Capture) which significantly increases feasibility and the
likelihood ratings are returned in a timely manner (i.e., as compared to mail or in-person visits). The consent for each
survey will also be administered using REDCap. REDCap is a secure, web-based application designed exclusively to
support data capture for research studies. REDCap provides: 1) an intuitive interface for data entry (with data
validation); 2) audit trails for tracking data manipulation and export procedures; 3) automated export procedures for
seamless data downloads to common statistical packages (SPSS, SAS, Stata, R); 4) procedures for importing data
from external sources; and 5) advanced features, such as branching logic and calculated fields. The REDCap project
(http://project-redcap.org/) was initiated at Vanderbilt University and includes more than 200 active institutional partners
from CTSA, GCRC, RCMI funded institutions, including MUSC, and others through a collaborative international
consortium. The REDCap application is currently in production use or development buildstatus for more than 11,080
studies with over 20,110 end-users spanning numerous research focus areas. REDCap was approved by the VCU
Information Security Officer in 2010 as an electronic data capture (EDC) tool to collect and manage sensitive data.
Accessing REDCap Database is accomplished via a secure LDAP-based web authentication process. Only VCU
faculty, staff and sponsored VCU students and VCU affiliates may be granted access to REDCap Database. Off
campus connectivity to REDCap database must be done via a secure VCU VPN connection. Application level security
includes project level user permissions, event logging, and de-identification capabilities which facilitate the export and
exchange of data in a coded manner. All REDCap data are stored on VCU University Computing Center (UCC)
database servers which are backed-up and maintained following VCU best practices. REDCap will be managing the
system that supports this project, the PI and research staff will be responsible for identifiable data collection,
management, user rights, determining who has access and all related logistics related to data collection and reporting.

The data collected will be secured via REDCap on a secure MySQL database server at the UCC. The UCC hosts a
dedicated server to store REDCap data within this MySQL database. The system will be configured to restrict access
to identifiers via user permissions and resulting access controls to data entry forms, reports, and/or export functions.
The identifiable data will only be available to the Registry team. Technical controls will be placed on the identifiable
data and user permissions limiting access to this information (to view or export) will be in place. Access to the
identifiable data will be restricted by password protection. REDCap uses LDAP (Lightweight Directory Access Protocol)
authentication. A typical LDAP server is a simple network-accessible database where an organization stores
information about its authorized users and what privileges each user has. Only designated registry staff will have
access to the identifiable data. The UCC has implemented Tivoli Storage Manager Software to provide advanced
backup capabilities for backing up of the disk and database storage. The Tivoli Storage Manager Software is a
centralized, policy-based, enterprise class, data backup and recovery package. The software enables the user to insert
objects not only via backup, but also through space management and archive tools. It also allows retrieval of the same
data via similar restore, recall, and retrieve methods. This product is part of the IBM TotalStorage suite of products and
is unrelated to Tivoli Framework. Backups will be made to a high capacity Automatic Tape Library (ATL) which is IBM
software allowing servers to do backup to disk without having to re-write or replace popular tape. All backups will have
the same restricted password protected access. Further, all computer data will be protected by institution and industry
standard antivirus best practices will be adhered to. In addition to the VCU UCC firewalls REDCap will have GreenSQL
layered between the application and the database. GreenSQL is an Open Source database firewall used to protect
databases from SQL injection attacks. GreenSQL works as a proxy for SQL commands and has built in support for
MySQL & PostgreSQL. The logic is based on evaluation of SQL commands using a risk scoring matrix as well as
blocking known db administrative commands (DROP, CREATE, etc). GreenSQL is distributed under the GPL license.
All data will have 256-bit encryption (SSL) creating a secure transmission from respondent to server. Further, Stunnel
is incorporated between the application and database servers. 
At T1, for those in the PFP condition, the secure REDCap consent will transfer the participant to the Personalized
Feedback Program (PFP) application, passing a randomly-generated de-identified opaque handle. The PFP
application will record time-stamped participant responses and interactions, and associate these with the deidentified
opaque handle. Upon completion, the PFP application will return the participant to REDCap to complete the survey. All
identifiable information will remain entirely within the secure REDCap application server. At no time will the PFP
application store identifiable information.  
At T1, for those in the BMI condition, the secure REDCap consent will transfer the participant to the computer-delivered
intervention based on brief motivational intervention (BMI) content/principles, passing a randomly-generated de-
identified opaque handle. The BMI application will record time-stamped participant responses and interactions, and
associate these with the deidentified opaque handle. Upon completion, the BMI application will return the participant to
REDCap to complete the survey. All identifiable information will remain entirely within the secure REDCap application
server. At no time will the BMI application store identifiable information.  
At T1, for those in the PFP+BMI condition, the secure REDCap consent will transfer the participant to the Personalized
Feedback Program (PFP) application, passing a randomly-generated de-identified opaque handle. The PFP
application will record time-stamped participant responses and interactions, and associate these with the deidentified
opaque handle. Upon completion, the PFP application will take the participant back to REDCap. In REDCap
participants will be asked to access the BMI application via an embedded link. Similarly to the PFP, the BMI application
will record time-stamped participant responses and interactions, and associate these with the deidentified opaque
handle. Upon completion, the BMI application will return the participant to REDCap to complete the survey. All
identifiable information will remain entirely within the secure REDCap application server. At no time will the PFP or BMI
applications store identifiable information. 
At T1, those in the control condition will remain in REDCap for the entirety of their participation at this time. 
2. * Describe how data will be linked or  unlinked to identifiers including email addresses, names, and/or IP
address. 
Obtaining Identifiers from the Spit for Science Registry: 

Spit for Science assigns randomly generated coded spin-off IDs for each participant. For participants that indicate ‘yes’
to the Spit for Science Registry spin-off study interest question asked within the Spit for Science baseline survey
launching in Fall semester 2021, this spin-off ID is provided to the study project coordinator as part of the ‘turnover’
data, which includes email addresses. The study will use the VCU email provided by the participant to the study to
match to the Spit for Science spin-off ID. The spin-off ID will then be used throughout the course of the study
procedures to link survey record IDs, survey data, and study data. Should they participate in the study, all survey data
will be kept separate from identifiable information. The connection between a student email address and a particular
record ID number is maintained behind the scenes in the REDCap system and on a password-protected secure server
accessible only to select study staff. This key will be kept indefinitely on a secure server. All identifiable information
from students who participate in the study will be deleted at the end of the study.  
Spit for Science uses randomly generated coded identifiers for each participant. For those participants that say ‘yes’ to
the study, then data related to the participant will be connected and shared with the spin-off study ID. The study will
only have access to identifying information for as long as required to complete the study procedures after which they
will remove or permanently delete personally identifying data and only retain a coded identifier.  
Once a student completes the study survey, his/her responses are recorded and are associated with a coded number
generated by the study, on a remote, secure server. Access to this server is limited to select study staff. Study staff will
strip all identifying information (email address, permanent address) from the survey data and link the survey
information to the de-identified dataset. Once the survey is completed, participants will be compensated electronically.  
At the conclusion of all study procedures, the study will provide its dataset, with the spin-off ID, to Spit for Science. The
S4S Database Administrator will replace the spin-off ID with the Spit for Science ID to allow for future de-identified data
matching. 
VCU investigators use computers that are in compliance with institutional policies (e.g., up-to-date software and
antivirus protection), and conduct their work in private offices that would limit the opportunity for study information to be
disclosed to unauthorized individuals. We reconfirm that VCU investigators will not attempt to re-identify any of the
individuals who are part of the dataset being collected. All data will be kept strictly confidential. All data sent to the
investigators for analysis will be de-identified. Investigators will never have access to any identifiable student
information.  
3. * Is there an alternative method for completion of the data collection other than the internet? 
  Yes
No
4. * Describe how individuals will be able to skip or not answer particular questions.  If any questions are
mandatory, provide justification. 
In each of the post-program surveys conducted at Timepoint 1, as well as the follow-up surveys delivered at
Timepoints 2 and 3, participants who do not want to answer particular questions can select the response option “I
choose not to answer.”  
Students will not have the option to skip anything in the Personalized Feedback Program (though there is a “neither
agree nor disagree” neutral option for each question) to ensure that they complete the entire program and receive their
correct personalized feedback. 
Students will not have the option to skip anything in the BMI condition to ensure that they complete the entire program
and receive their correct personalized feedback. 
 

5. If not including children, describe any procedures used to verify that research participants are adults. 
This research will not include children. All participants will be confirmed incoming VCU freshmen who will be attending
university full-time. Students must be 18 or older to participate in the Spit for Science project. Additionally, as part of
their consent, participants will acknowledge that they are 18 years of age or older. 98% of incoming VCU freshmen are
18-19 years of age, so we do not foresee difficulty ensuring our sample is of the age required. 
 
View: SF2 - Secondary Data/Specimen Details
  
Secondary Data/Specimen Details
1. * Describe the source(s) and nature of the information/specimens being obtained. This response should: 
  a. Identify where the data/specimens will come from (e.g., another researcher's registry, pathology lab,
commercial source, medical records, etc.); and 
  b. List what types of specimens will be obtained (when applicable); and/or 
  c. List all data elements that will be obtained (when applicable). A data collection form or other
documentation may be uploaded and referenced here. 
Participants will be identified by self-selection during the Spit for Science baseline survey being conducted in the Fall
2021 semester. As part of the baseline survey, participants will be asked a yes/no question about their interest in
learning more about the current spin-off study (the contents of this question can be found in the attached document
"Baseline Survey Interest Question"). Participants are informed that if they indicate 'yes' that their contact information
will be shared with the Personalized Feedback Programs for College Students study. The contact information and spin-
off IDs will be provided to the study coordinator by the Spit for Science Registry. This data sharing will occur through a
VCU approved file sharing application (like REDCap Send-It), a conditional Data Access Group (DAG) in the REDCap
Project and/or through a shared, 'user-assigned' Participant Tracking Project. Additionally, the study will make use of
participants’ survey responses on the Spit for Science baseline survey being conducted in the Fall 2021 semester.
Data will be shared with the present study in accordance with Spit for Science Registry's Standard Operating
Procedures. Spit for Science will provide access to the de-identified phenotypic (survey) dataset.  
2. * Describe whether any agreement exists between you and data/specimen provider that states you will never
have access to the ability to identify the participants (i.e. access to identifiers or the code key) and that you
will not attempt to re-identify individuals. 
Investigators will complete the de-identified data-sharing agreement, following the Spit for Science protocol. After the
DSA has been approved, the investigators will be granted access to the de-identified dataset for participant ID
selection.  
The de-identified Spit for Science data contains a participant or registry ID that will be used for participant selection. All
participants from which the selection will be drawn are part of the Registry and have completed the Spit for Science
baseline (parent) consent and survey conducted in the Fall 2021 semester. Spit for Science then assigns these
participants a second randomly generated unique ID called a spin-off ID. This spin-off ID will be used to track
participation outcomes and acts as an indirect identifier that Spit for Science can link back to the participant within the
registry. The contact information and the spin-off IDs of individuals who indicate they are interested in participating in or
learning more about the study will be shared (using a secure file sharing application, like VCU FileLocker or a
participant tracking project within REDCap) with the study project coordinator. Following the conclusion of study
procedures, identifiable information is not retained by the study nor does the study have the mechanism to match Spit
for Science generated IDs back to identifiable information. Furthermore, the PI of the spin-off study will sign an
Agreement that indicates they will not have access to names or other participant identifying information.

3. * When the information/specimens were originally collected, did individuals provide consent for secondary
research use of their data/specimens (i.e. consent to another research study or to a research registry)? 
  Yes
No
4. * Provide name(s) of the registry/repository being accessed. 
Spit for Science Registry
5. * Site having responsibility for the management of this registry/repository: 
VCU
Non-VCU
6. If the registry / repository is located at VCU, provide the IRB number for the registry / repository. 
HM13352
7. * Is the original consent form that participants signed upon entry into the registry /repository available? 
  Yes
No
8. If NO above, describe in detail the allowed uses of the data information/specimens as outlined in the registry /
repository consent.  Be sure to describe any stipulations or limitations on the use. 
The data information we will be collecting for this study will come from the Spit for Science Baseline Survey to be
conducted in Fall 2021. This baseline study is currently awaiting IRB approval for an amendment, and thus the consent
document has not been delivered to participants or approved by the IRB as of yet. We will upload the baseline consent
to this application as soon as it is IRB approved.
 
View: SF2 - Costs to Participants
  
Costs to Participants
1. * Select all categories of costs that participants or their insurance companies will be responsible for: 
Participants will have no costs associated with this study

Study related procedures that would be done under standard of care

Study related procedures not associated with standard of care

Administration of drugs / devices


Study drugs or devices

Other
 
View: SF2 - Compensation
  
Compensation
1. * Describe any compensation that will be provided including: 
   1. total monetary amount 
   2. type (e.g.,  gift card, cash, check, merchandise, drawing, extra class credit) 
   3. how it will be disbursed 
T1: 
All participants who complete the condition they have been assigned to and post-program survey at time point 1 (T1;
beginning of fall semester 2021) (resources program, Personalized Feedback Program (PFP), brief motivational
intervention (BMI), or PFP+BMI) will receive a $25 Amazon e-gift card. 
T2: 
All participants who complete the follow-up assessment at time point 2 (T2; 30 days post initial participation) will
receive a $20 e-Amazon gift card. 
T3:  
All participants who complete the follow-up assessment at time point 3 (T3; approx. 3 months post initial participation)
will receive a $20 Amazon e-gift card. 
Bonus: 
All participants who complete all 3 surveys will receive an additional $20 Amazon e-gift card at the conclusion of their
participation at T3. 
2. If compensation will be pro-rated, explain the payment schedule. 
3. * Will Social Security Numbers be collected for compensation purposes only? 
  Yes
No
 
View: SF2 - Contingency Plan
  
Contingency Plan

This page will be used by the IRB in the event that an institution-wide emergency situation arises that requires
contingency plans. 
A contingency plan describes the alternative procedures that a study would want to use in case of an emergency that
prevented normal study activities from occurring. It is a form of adaptive protocol. It enables the VCU IRB to quickly
approve alternative study activities along with criteria for when those activities would or would not be put into effect.
For example, in 2020, some studies had a COVID-19 Contingency Protocol approved that described alternative
remote procedures that they would switch to whenever the University restricted in-person research activities.
In all studies, investigators are strongly encouraged to plan prospectively and build flexibilities into their regular
protocols (regardless of whether an emergency situation exists) as well as think about what they would do in an
emergency situation. For example, windows for timed study visits, ranges instead of exact values, flexibilities in
inclusion criteria, etc. Flexibility and adaptations that are built into the protocol will reduce the number of changes
that have to be submitted to the IRB and should reduce the number of incidents of deviations and noncompliance by
investigators.
Further instructions and smartform questions on this page will be released from the IRB in the event of such an
institution-wide emergency situation. 
 
View: SF2 - Research Plan Complete
  
Research Complete
Protocol Progress: 
 INITIAL SETUP 
 BACKGROUND, RATIONALE & GOALS 
 RESEARCH PLAN 
 CONSENT PLAN 
 RISKS, PRIVACY & CONFIDENTIALITY 
 POPULATIONS WITH SPECIAL CONSIDERATIONS 
 INSTITUTIONAL REQUIREMENTS 
 DOCUMENTS 
 
Click Continue below to go to the next section
 
View: SF2 - Consent Process
  
Consent Process

1. * List all consent groups: 
 
Group
Types Waivers
Roles
Roles
-
Other
Electronic
Signatures Consent
Coercion Decision Re-
Consent
View All
participants
None
of the
Above
(select
waiver
below)
Waiver of Signature
on
Consent/Permission
Forms (waiver of
documentation of
consent)
N/A:
Requesting
Waiver of
Consent
 
Not using
electronic
signature
platforms
In the
baseline Spit
for Science
Survey
delivered in
the Fall
semester of
2021,
participants
will be asked
if they are
interested in
participating
in our study.
Those who
say "Yes" to
the
interested
question will
be asked if
their
information
can be
shared with
our study.
Those who
say "Yes" to
the data
sharing
question will
receive the
"Study
Enrollment
Email" from
our study
coordinator.
This email
contains a
link to the
Study
Consent
document.
Participants
are able to
review the
consent,
close the
Participation
in this study
is voluntary.
All interested
participants
will be
reminded in
the consent
document
that their
participation
is voluntary
and that they
can withdraw
from the
study at any
time without
penalty.
Consent will
only be done
electronically,
thereby
further
reducing
participants'
chances of
feeling
coerced. The
consent
document
will be
presented
online at the
time and
place desired
by each
individual.
Each
individual is
able to
review the
consent, take
time to
consider it
and/or ask
any
questions,
The study
consent
process is
conducted
on-line,
meaning
participants
can take as
much time
as they
need to
make a
decision.
 

 
Group
Types Waivers
Roles
Roles
-
Other
Electronic
Signatures Consent
Coercion Decision Re-
Consent
window, and
open it again
at any time
prior to their
participation.
Participants
will not be
able to
participate in
any of the
programs or
answer any
survey items
without
giving
consent to
participate in
the study. If
participants
do not
consent to
participate
after reading
the consent,
they will not
be contacted
about the
study again.
Once
participants
do consent
to participate
in the study,
they will be
automatically
taken to the
program to
which they
have been
randomized
followed by
the brief set
of follow-up
questions
(Post-
Program
Survey).
and return to
the
document to
provide their
consent or
not.

2. Upload any consent / assent documents:
 
View: SF2- Waiver of Documentation of Consent
  
Waiver of Documentation of Consent
Consent groups that require a waiver of documentation (i.e. consent form not signed): 
Group
Types Waivers
Roles
Roles
-
Other
Consent
Decision Status
Change
All
participants
None of
the
Above
(select
waiver
below)
Waiver of Signature
on
Consent/Permission
Forms (waiver of
documentation of
consent)
N/A:
Requesting
Waiver of
Consent
 
In the baseline Spit for Science Survey
delivered in the Fall semester of 2021,
participants will be asked if they are
interested in participating in our study.
Those who say "Yes" to the interested
question will be asked if their information
can be shared with our study. Those who
say "Yes" to the data sharing question will
receive the "Study Enrollment Email" from
our study coordinator. This email contains
a link to the Study Consent document.
Participants are able to review the
consent, close the window, and open it
again at any time prior to their
participation. Participants will not be able
to participate in any of the programs or
answer any survey items without giving
consent to participate in the study. If
participants do not consent to participate
after reading the consent, they will not be
contacted about the study again. Once
participants do consent to participate in
the study, they will be automatically taken
to the program to which they have been
randomized followed by the brief set of
follow-up questions (Post-Program
Survey).
The study
consent
process is
conducted
on-line,
meaning
participants
can take as
much time
as they
need to
make a
decision.
 
1. * Select which of the following applies to the consent groups used in this study: 

(1) The only record linking the participant and the research would be the consent document and the principal risk
would be potential harm resulting from a breach of confidentiality. Each participant will be asked whether the
participant wants documentation linking the participant with the research, and the participant's wishes will govern
(2) The research presents no more than minimal risk of harm to participants and involves no procedures
for which written consent is normally required outside of the research context


(3) The subjects or legally authorized representatives are members of a distinct cultural group or community in
which signing forms is not the norm, that the research presents no more than minimal risk of harm to subjects
and provided there is an appropriate alternative mechanism for documenting that informed consent was
obtained
2. * Explain how your selection above applies to this study: 
The proposed consent process occurs completely online and the online consent protocol provides potential participants
the opportunity to take the time they need to read the consent and decide whether or not they want to provide
consent/participate in the study. An online consent process also decreases participant burden for a study that is
ultimately completed online. 
Before enrolling in the study, participants will be provided full consent information online. Participants will then be
asked if they understand and are willing to participate in this research. They must indicate their consent and confirm
their consent before being able to participate in the study. 
This research involves no procedures for which consent is typically required outside the research setting. This study
consists mostly of surveys in which students answer questions about themselves, their substance use, their behavioral
and emotional wellbeing, and their college experiences. Outside the research setting, surveys are not typically
something for which consent is required.  
The Personalized Feedback Program is also minimal risk. There is no reason to expect the intervention will be
offensive or embarrassing to participants. It contains personality-related items that are routinely used in research.
Additionally, we do not believe the BMI intervention will be offensive or embarrassing to participants. BMIs are
mandated on college campuses across the country and are considered the current “gold standard” for reducing risky
substance use among college students. 
 
View: SF2 - Consent Plan Complete
  
Consent Plan Complete
Protocol Progress: 
 INITIAL SETUP 
 BACKGROUND, RATIONALE & GOALS 
 RESEARCH PLAN 
 CONSENT PLAN 
 RISKS, PRIVACY & CONFIDENTIALITY 
 POPULATIONS WITH SPECIAL CONSIDERATIONS 
 INSTITUTIONAL REQUIREMENTS 
 DOCUMENTS 
 
Click Continue below to go to the next section
 
View: SF2 - Risks, Discomforts, Potential Harms and Monitoring

  
Risks, Discomforts, Potential Harms and Monitoring
1. * Describe the risks of each research procedure to participants or others. For each identified risk, provide an
assessment of the anticipated seriousness and likelihood of the risk. Some examples of possible risks include
but are not limited to:
Physical risks (e.g. bodily harms or discomforts, side effects, etc.)
Psychological risks (e.g. emotional, mental, or spiritual harms or discomforts, changes to thoughts,
beliefs, or behaviors, etc.)
Research data risks (e.g. loss of confidentiality and privacy)
Social or legal risks (e.g. impacts on relationships or reputation, legal or criminal justice actions for self
or others, etc.)
Financial risks (e.g. impacts on income, employability, or insurability, loss of services, etc.)
Other risks (e.g. unforeseeable risks of experimental procedures, risks related to particular study
designs (randomization, washout, placebo, withholding care/services, deception), etc.)
See the help text for additional guidance.
There is no more than minimal risk associated with participation in this study. Potential risks may be psychological in
nature as associated with participation in surveys and personality-related assessments. However, we believe that the
potential for this kind of distress is minimal. Subjects will be advised to complete the surveys, and if applicable, the
Personalized Feedback Program and/or the computer-delivered intervention based on Brief Motivational Intervention
(BMI) content/principles only when they have sufficient privacy and they will be reminded regularly that participation is
voluntary and they can withdraw from the study at any time during the process. Should participants experience
emotional distress and/or concerns about their emotional health or substance use while completing the surveys,
Personalized Feedback Program or the computer-delivered intervention based on BMI content/principles, they will be
given the contact information for University Counseling Services at 828-6200. There is someone on call all day, every
day, all year long. 
There are no more than minimal risks involved in this study, however all research participation might involve loss of
privacy or confidentiality. Standard practices will be used to protect participant confidentiality and personal information,
including removing identifiers from all survey and program data collected, using only numbers to identify participant
data, and keeping all data files securely stored.  
Students may decline to participate given the sensitive nature of the questionnaire items (i.e., voluntary disclosure of
recent alcohol consumption in spite of being underage for consuming alcohol; however, we note that the content of the
questionnaires is generally similar to the content of the Spit for Science project, which has successfully been employed
with >12,000 VCU students). 
Loss of confidentiality: With all research participation, there is a risk that personal information obtained from research
participants will be mishandled, and confidentiality may be compromised. Participation in this study is voluntary. 
2. * Describe how each of the risks/harms/discomforts identified above will be minimized: 
It is explicitly stated in the consent document that the subject can choose to withdraw or not to participate at any point

in the study. Subjects will also be fully informed of the potential risks involved prior to soliciting formal consent to
participate. The goal of this project is to ensure that all college students who complete the prevention program will
receive adequate feedback and information about relevant university resources. Participants will be encouraged to
reach out to their university counseling/health services if they experience distress during the study. Standard practices
will be used to protect participant confidentiality, including removing identifiers from all data collected, using only
numbers to identify participant data, and keeping all data files when not in use in a locked filing cabinet behind a locked
office. REDCap, the survey tool that will be utilized for this project, has many security measures in place to prevent
against the inappropriate release of survey data and information. REDCap will be used to contact participants via
email, collect survey responses, and record survey completion. To provide an additional layer of protection to
participants, the collection of direct identifiers (VCU email address, permanent address) will be assessed separately
from the general surveys. All identifiable information will only be saved on a Monroe Park campus-based VCU
approved secure server (the server is HIPAA compliant for security set up, the shared folder will only be browseable
and accessible by the authorized registry personnel, each authorized person has their own account to log on server
through VCU Web VPN then work on the shared folder). The key will be password protected. Only the study project
coordinator and select project staff will know the password.  
At T1, for those in the PFP condition, the secure REDCap consent will transfer the participant to the Personalized
Feedback Program (PFP) application, passing a randomly-generated de-identified opaque handle. The PFP
application will record time-stamped participant responses and interactions, and associate these with the deidentified
opaque handle. Upon completion, the PFP application will return the participant to REDCap to answer a brief set of
survey questions related to their experiences with the program. All identifiable information will remain entirely within the
secure REDCap application server. At no time will the PFP application store identifiable information.  
At T1, for those in the BMI condition, the secure REDCap consent will transfer the participant to the computer-delivered
intervention based on brief motivational intervention (BMI) content/principles, passing a randomly-generated de-
identified opaque handle. The BMI application will record time-stamped participant responses and interactions, and
associate these with the deidentified opaque handle. Upon completion, the BMI application will return the participant to
REDCap to answer a brief set of survey questions related to their experiences with the program. All identifiable
information will remain entirely within the secure REDCap application server. At no time will the BMI application store
identifiable information.  
At T1, for those in the PFP+BMI condition, the secure REDCap survey will transfer the participant to the Personalized
Feedback Program (PFP) application, passing a randomly-generated de-identified opaque handle. The PFP
application will record time-stamped participant responses and interactions, and associate these with the deidentified
opaque handle. Upon completion, the PFP application will take the participant back to REDCap. In REDCap
participants will be asked to access the BMI application via an embedded link. Similarly to the PFP, the BMI application
will record time-stamped participant responses and interactions, and associate these with the deidentified opaque
handle. Upon completion, the BMI application will return the participant to REDCap to answer a brief set of survey
questions related to their experiences with the programs. All identifiable information will remain entirely within the
secure REDCap application server. At no time will the PFP or BMI applications store identifiable information 
At T1 those in the control condition will remain within the secure REDCap application server for the entirety of their
participation at this timepoint.  
All participants regardless of their initial condition will remain within the secure REDCap application server for the
entirety of the follow-up surveys at T2 and T3. 
3. * Describe any potential risks or harms to a community or a specific population based on study findings (e.g.
information that could be stigmatizing or derogatory): 
We do not believe the study poses any additional risks to any specific population. The study investigators initially took
a number of steps to ensure that all study materials would be acceptable to multiple groups and populations, and we
will continue to make every effort to reduce any potential risks or harms to our participants. Our research team has
extensive experience working with young adults and presenting findings in a manner that is useful to the population

being studied. Additionally, Co-I Trisha Saunders, Associate Director of the Health and Wellness Promotion Center
(“The Well”, changing to RecWell this upcoming year) at VCU, was instrumental in designing both the Personalized
Feedback Program and the computer-delivered intervention based on BMI content/principles and selecting their
language. She will continue to play a role in presenting the findings in a positive and empowering way to students. She
has worked with students for over 5 years in the Well at VCU, worked in a similar role for 5 years at another university,
and is highly adept at working with and conducting outreach for this population.  
Within the Personalized Feedback Program, the names of all personality types were specifically chosen to reduce any
stigma traditionally associated with that trait. All personality types start with “the good” things about them, and we
emphasize that there are pros and cons associated with each of the different types. While we will be informed by
students’ generated personality types when looking at differences in response to the intervention and behavior
changes following the intervention, we will not be presenting these findings in a derogatory way. 
We intend for our recruitment methods to ensure we have a diverse sample of students with varying traits.  
4. Where appropriate, discuss provisions for ensuring necessary medical, professional, or psychological
intervention in the event of adverse events to the subjects: 
The goal of this project is to ensure that all college students who complete the Personalized Feedback Program will
receive adequate feedback and information about university resources that can support them. Participants will be
encouraged to reach out to their university counseling/health services if they experience distress during the study.  
5. * Describe criteria for when the investigator would withdraw an individual participant from the study; such as
safety or toxicity concerns, emotional distress, inability to comply with the protocol, etc.: 
Participants will be withdrawn from the study if they do not follow the instructions outlined in the protocol and informed
consent form. Additionally, students can withdraw at any time by contacting the study coordinator (either via email or
phone) and request this. This staff will verify what level of withdrawal they desire at the time of withdrawal (e.g. do they
want their past data removed or do they just not want to participate in assessments at future time points). After a
student has withdrawn completely, they will never be contacted by this study again. 
6. * Summarize any pre-specified criteria that would trigger the investigator/sponsor/monitoring committee to
stop or change the study protocol due to safety concerns: 
None. This study assesses aspects of behavior that are routinely assessed. We do not collect any information that
might necessitate stopping the study protocol. 
Data and Safety Monitoring 
Data and safety monitoring is a system for checking the study’s data at regular intervals over the study period
to identify and address issues that could affect the safety of research participants. This requirement is in
accordance with 45 CFR 46.111.
The purpose of data and safety monitoring plan is to set forth study team procedures for
monitoring/addressing:
- Participant safety (physical, psychological, etc.) 
- Data validity 
- Early stopping (termination) based upon changes in risks and benefits.
7. * Indicate if this study will have a Data Safety Monitoring Board (DSMB) or a Data Safety Monitoring Plan
(DSMP): [Required for all greater than minimal risk studies] 

DSMB

DSMP
No DSMB/DSMP [Note: This response is not applicable for greater than minimal risk studies]

 
View: SF2 - Privacy
  
Privacy
Privacy refers to an individual’s right to control how others view, record, or obtain information about them. When
privacy is violated it can involve such things as
Being asked personal questions in a public setting;
Being publicly identified as having a particular characteristic or diagnosis;
Being seen entering a place that might be stigmatizing;
Being photographed, videotaped or observed without consent;
Disclosure of personal information to unauthorized people
Privacy is not the same as confidentiality because privacy protections apply to people, and confidentiality
protections apply to data. Confidentiality protections should be described on the Data Confidentiality page of this
form, not here.
Instructions for this page:
Select all the applicable ways that the research team will protect participants' privacy throughout the course of the
study. Not all will be applicable to every study.  
To elaborate on any response, also click the “Other Protections” checkbox to provide further explanation in the last
free-text question. 
Read the entire page before filling out the form. 
 
1. * Protections when conducting one-on-one in-person interventions or interactions (for groups see Q2 below): 

Conducting study activities in locations that maximize privacy (limited people around, closing doors, drawing
drapes around beds, monitoring voice volume, etc.)

Verifying identity before discussing personal information.

Asking the participant if they are comfortable answering questions in that location

Asking the participant if they are comfortable with having other people present (if any)

Moving away from other people when conducting activities in public spaces or offering a private space

Offering other options of ways to respond to sensitive questions (i.e. pointing, clicking, or writing) if
uncomfortable verbally responding


Using generic signs on research rooms and spaces, particularly for research on stigmatizing or sensitive topics

Other protections not listed in this question – describe below
N/A – study has no in-person interventions or interactions with participants
 
2. * Protections when conducting group interventions or interactions: 

Conducting study activities in locations that maximize privacy (limited people passing by, closing doors,
monitoring voice volume, etc.)

Moving to a more private area to answer questions or to discuss concerns

Discussing privacy with the participants and the importance of not talking outside the group about what other
people say during the group session

Allowing participants to use a pseudonym or limiting use of individuals’ names during the group activity

Asking everyone in a public group setting (e.g. classrooms, workshops) to turn something in (blank or filled) so
participants do not have to self-identify when turning in materials

Collecting paper forms in a closed box or envelope rather than passing to others or leaving in an open area

Limiting participant identifiers that would be visible on paper documents (i.e. using study IDs instead of direct
identifiers)

Allowing people to distance themselves from other participants during group activities

Offering other options of ways to respond to sensitive questions (i.e. pointing, clicking, or writing instead of
speaking)

Using generic signs on research rooms and spaces, particularly for research on stigmatizing or sensitive topics

Ensuring non-participating individuals are not captured on recordings or in photos

Other protections not listed in this question – describe below
N/A – study has no group interventions or interactions
 
3. * Protections when conducting remote interventions or interactions (e.g. phone, text, video-conference, tele-
health, online, etc.): 
Conducting study activities in locations where study staff can maximize their own privacy (limited
people around, closing doors, monitoring voice volume, etc.)

Leaving/sending generic messages that avoid using study and participant identifiers, such as names, study
titles, clinics, study topics, etc.
Obtaining permission prior to sending text messages

Advising the participant to move to a location where they are comfortable answering questions and will not be
overheard
Advising online participants to complete the activity at a time and location where they will be
comfortable answering questions

Ensuring non-participating individuals are not captured on recordings or in photos


Offering other options of ways to complete the activity (i.e. online, paper, phone) if more privacy is desired
Offering a way to save and return later to the online activity if privacy is compromised

Other protections not listed in this question – describe below

N/A – study has no remote interventions or interactions with participants
 
4. * Protections when mailing study materials to/from participants: 

Obtaining permission to mail study materials

Confirming/verifying the accuracy of addresses before mailing items

Ensuring the participant is able to personally receive mailed materials and has a way to protect their own privacy
if they do not want others to know they are receiving research communications (i.e. notifying participants of
when to expect it)

Using return address labels and document headers that avoid study identifiers, such as study names, clinics,
study topics, etc.

Avoiding or limiting use of participant identifiers and health information on mailed documents (i.e. using study
IDs instead of direct identifiers)

Providing a return mailing address label or pre-addressed envelope to ensure returned items are sent to the
correct address

Communicating receipt of mail from participants and/or asking them to notify you when they mail it to ensure
study documents are not lost in transfer

Offering other options of ways to complete the activity (i.e. by phone or online) if desired

Other protections not listed in this question – describe below
N/A – not mailing any materials to/from participants
 
5. * Protections when analyzing or disseminating study data *Applicable to all studies*: 
Working only in locations where the study team can ensure privacy (not working in close proximity to
non-study personnel, closing doors, closing/putting away documents/files before leaving, etc.)
Securing physical materials only in locations that ensure privacy (access limited to authorized study
personnel)
Only sharing data/specimens in accordance with the Sharing Plan outlined in this smartform

Obtaining explicit parental permission before disseminating or sharing recordings or photos of children

Blurring/redacting/hiding faces and other identifiable features/marks (tattoos, scars, birthmarks, distinctive voice,
etc.) in recordings or photos prior to disseminating or sharing

Other protections not listed in this question – describe below
 

6. * If “other protections” was selected in one or more of the questions above, describe all the other way(s) that
the research team will protect participants' privacy. See the help text for additional guidance. 
To protect participants’ privacy during the recruitment phase of the project, potential participants will be able to review
information about the present study (including all consent documents) and decide whether they wish to participate in a
setting of their choosing, at their own pace, and they will be able to contact the project coordinator by email with any
further questions prior to consenting and participating on their own at a convenient time. 
We have been automatically issued a Certificate of Confidentiality (CoC) from the National Institutes of Health to
further protect the privacy of our subjects. The CoC will protect the researchers and institution from being compelled to
disclose information that would identify our subjects and help achieve the research objectives and promote
participation in our study by assuring confidentiality and privacy to our participants.
 
View: SF2 - Data Confidentiality and Storage
  
Data Confidentiality and Storage
Confidentiality refers to the way private, identifiable information about a participant or defined community is
maintained and shared. It describes how the study’s research materials (data, specimens, records, etc.) are protected
from unauthorized access. 
Instructions for this page:
Select all the ways that the research team will keep the study materials and data confidential throughout the course
of the study. Not all will be applicable to every study.  
To elaborate on any response, also click the “Other Protections” checkbox to provide further explanation in the last
free-text question. 
Read the entire page before filling out the form.
1. * Protections for paper research materials: 

Maintaining control of paper documents at all times, including when at an off-campus location

Limiting or avoiding use of participant identifiers on paper documents (i.e. using study IDs instead of direct
identifiers)

Storing paper documents in a secure location accessible only to authorized study personnel

Promptly transcribing, scanning, or abstracting data from paper into electronic platforms with destruction of the
paper copy

Proper destruction of paper records (and obtaining prior permission when required) in accordance with VCU
Records Management policies

Other protection not listed in this question – describe below
N/A – no paper research materials
2. * Protections for research specimens: 

Maintaining control of specimens at all times, including when at an off-campus location


Storing specimens in a secure location accessible only to authorized study personnel

Labeling specimens with subject ID or other coded information instead of direct identifiers

Final destruction of specimens will be devoid of any identifiable information

Other protection not listed in this question – describe below
N/A – no research specimens
3. * Protections for electronic files/data - See https://ts.vcu.edu/about-us/information-security/data-management-
system/ 
*Required for all studies* Use VCU-approved methods of data storage, transmission, and transfer (see
https://dms.vcu.edu)
Remotely accessing VCU network storage to store data when at off-campus locations
Ensuring unauthorized individuals who might share a device do not have access to study materials (e.g.
individual logins, separate accounts)
Using VCU-approved data collection tools and apps (e.g. REDCap) and storing exported analysis files in
VCU-approved storage locations (see https://dms.vcu.edu)

When using non-VCU-approved electronic data collection tools, storage locations, data transfer platforms, and
mobile apps (e.g. Dropbox, Box, Survey Monkey, Fitbits, novel apps): • consulting with VCU Information Security
on proper data management (see https://ts.vcu.edu/askit/essential-computing/information-security/); • advising
participants about the terms of use and privacy policies of those sites/apps; • limiting or avoiding use of
identifiers; and • removing data promptly from the external location after transferring it to a VCU storage location
De-identifying the research data by replacing subjects’ names with assigned subject IDs
Storing the study’s linkage key in a password-protected and VCU-approved storage location (see
https://dms.vcu.edu)
When analyzing particularly sensitive information, using computers that are unconnected from the
internet.
Proper destruction of electronic records (and obtaining prior permission when required) in accordance
with VCU Records Management policies

Other protection not listed in this question – describe below
4. * Protections for computers and research devices/apps provided for participant use by the study: 

Transferring data promptly from the device/app to a VCU storage location

Setting strong passwords on computers and research devices (when applicable)

When providing devices or mobile apps to children, informing parents about the settings and how to manage
them (if applicable), internet access, and any other installed apps on the device
Other protection not listed in this question – describe below

N/A – no computers or devices/apps being provided for participant use
5. * Protections for email/online communications 
Only using VCU/VCU Health email addresses for study-related communications


Only using VCU/VCU Health–approved methods of teleconferencing or video conferencing (e.g. Zoom) (for
studies involving HIPAA, contact VCU or VCU Health Information Security [as appropriate] about HIPAA-
compliant systems)

Other protection not listed in this question – describe below

N/A – no email/online communications
6. * If "other protections" was selected in one or more of the questions above, specify where this study’s paper
and electronic research data and/or physical specimens will be stored and how they will be secured from
improper use and disclosure. 
For Q4: The Personalized Feedback Program (PFP) is a web application hosted on a publicly-accessible web server,
accessed via the participant's personal web browser. The PFP web application (and associated server) does not
receive or store any personally-identifying information. The PFP web application provides all (de-identified) recordings
of participant interactions to the VCU-controlled REDCap server for secure storage. 
For Q3: For recruitment from the Spit for Science Registry, Spit for Science will only share information with the study
and vice versa using a secure file sharing application, like REDCap Send-It or VCU FileLocker or through a limited
access REDCap project. 
The surveys will be administered using REDCap, and email addresses and phone numbers will never be stored with
subject data. All identifiable information will remain entirely within the secure REDCap application server. At no time will
the Personalized Feedback Program application or the computer-delivered Brief Motivational Intervention application
store identifiable information. Consent forms and surveys will be administered using REDCap. REDCap is a secure,
web-based application designed exclusively to support data capture for research studies. REDCap provides: 1) an
intuitive interface for data entry (with data validation); 2) audit trails for tracking data manipulation and export
procedures; 3) automated export procedures for seamless data downloads to common statistical packages (SPSS,
SAS, Stata, R); 4) procedures for importing data from external sources; and 5) advanced features, such as branching
logic and calculated fields. The REDCap project (http://project-redcap.org/) was initiated at Vanderbilt University and
includes more than 200 active institutional partners from CTSA, GCRC, RCMI funded institutions, including MUSC, and
others through a collaborative international consortium. The REDCap application is currently in production use or
development buildstatus for more than 11,080 studies with over 20,110 end-users spanning numerous research focus
areas. REDCap was approved by the VCU Information Security Officer in 2010 as an electronic data capture (EDC)
tool to collect and manage sensitive data. Accessing REDCap Database is accomplished via a secure LDAP-based
web authentication process. Only VCU faculty, staff and sponsored VCU students and VCU affiliates may be granted
access to REDCap Database. Off campus connectivity to REDCap database must be done via a secure VCU VPN
connection. Application level security includes project level user permissions, event logging, and de-identification
capabilities which facilitate the export and exchange of data in a coded manner. All REDCap data are stored on VCU
University Computing Center (UCC) database servers which are backed-up and maintained following VCU best
practices. The UCC database servers are located on the VCU Medical School Campus. This facility houses many
critical campus servers in a Tier 2 level data center, which provides redundant capacity for cooling and power supply
for the IT equipment. All servers are physically secured, follow appropriate multilevel access control protocols, and
maintain long term data security via daily and monthly backup/restore procedures. All users are connected to a TCP/IP
local area network within VCU webvpn network or customized IP registered by specific users. Desktop resources,
network storage, and email systems are protected from virus attacks via antivirus software that is automatically
updated weekly. Desktop PCs and campus networks are behind appropriate firewalls. Desktops and their
corresponding network resources follow appropriate multilevel access protocols; network data storage availability is
assured via nightly and monthly archival procedures.  
We have been automatically issued a Certificate of Confidentiality (CoC) from the National Institutes of Health to
further protect the privacy of our subjects. The CoC will protect the researchers and institution from being compelled to
disclose information that would identify our subjects and help achieve the research objectives and promote
participation in our study by assuring confidentiality and privacy to our participants. 

7. * If research data that contains any of the 18 HIPAA identifiers will be released to person(s) or group(s) outside
of the VCU study team or the PI's department, identify the data recipient(s) along with their VCU department or
other institutional or organizational affiliation(s).
N/A
8. * Select all identifiers that will be collected as part of this study (including for recruitment, data gathering, data
analysis, etc.), even if the data will eventually be anonymized: 
Names
Geographic Locators Below State Level

Social Security Numbers

Dates (year alone is not an identifier)

Ages over 89 (age under 89 is not an identifier)
Phone Numbers

Facsimile Numbers
E-mail Addresses

Medical Record Numbers

Device Identifiers

Biometric Identifiers

Web URLs

IP Addresses

Account Numbers

Health Plan Numbers

Full Face Photos or Comparable Images

License/Certification Numbers

Vehicle ID Numbers

Other Unique Identifier

No Identifiers

Employee V#
9.   * If the study will code (i.e. de-identify) the research data by replacing subjects’ names with assigned subject
IDs, explain the following aspects of the coding process: 
- The process for how subject IDs will be generated/assigned (e.g. random, sequential) 

- Whether there will be a key that links the subject ID with direct identifiers. 
If a key will be created, describe 
- The place where the key will be stored 
- The role(s) of all individuals who will have access to the key 
- When the key will be destroyed 
See the help text for guidance.   
All students who accept the consent document will be assigned a randomly generated ID in REDCap. This ID will be
linked securely within REDCap to their de-identified data and separately with their preferred email address. A copy of
this key will be stored on a password protected computer only accessible to the project coordinator. The key will be
destroyed at the conclusion of the study. 
 Spit for Science Registry staff assign a randomly generated spin-off ID to each participant associated with this study.
For participants that indicate ‘yes’ to being interested in participating in the study, Spit for Science provides the study
project coordinator with the spin-off ID as part of the ‘turnover’ data, which also includes email addresses, permanent
address, phone number(s) and text permission if provided. The information will also include responses to the baseline
measures. The spin-off ID will be used as an indirect identifier for tracking recruitment/enrollment steps and participant
statuses., The spin-off ID continues to be used throughout the course of the study until all data collection is completed.
At the end of data collection procedures and compensation, the study will remove/destroy identifying information from
their own records. The next step is for the Spit for Science Registry to replace the spin-off ID. To accomplish this, the
study project coordinator would then provide their de-identified study dataset (using a secure platform like VCU
FileLocker or REDCap SEND-IT) to the Spit for Science Registry so that the Spit for Science programmer could
append the Spit for Science ID (registry/participant ID) assigned to the participant when they joined the registry and
remove the spin-off ID from the data. This dataset, with the updated coded identifier will be shared back to the study
project coordinator using the same secure platform options. This allows the study to use the registry/participant ID to
match to the existing Spit for Science data to which access has already been granted through existing data use
agreements. Unless otherwise noted, Spit for Science retains all its coded identifiers indefinitely. Spit for Science does
not share the key that would allow these identifiers to be merged back with personally identifying information. 
View: SF2 - Data Retention
  
Data Retention
1. * Select all of the ways that individually identifiable information obtained during pre-screening and/or
screening will be handled for individuals who DO NOT qualify for the study: 

Immediately destroy the information and identifiers (no data collected)

Immediately destroy the identifiers connected with the data (anonymization)

Store until the end of study & then destroy

Use as "screening failure" data by members of the study team

Provide to others outside of the research team (with the participant's permission)

Request permission from participant to maintain and use the identifiable information

Other
N/A - study does not require screening procedures
2. If Other, explain how the information will be handled. 
There are no eligibility requirements outside of participation in the Spit for Science baseline survey delivered in the Fall
semester of 2021. All participants in the baseline survey will be eligible to participate in our study until we have reached
our desired N.
3. * Will participants be able to withdraw their data (paper, electronic, or specimens) from the study (e.g. ask that
it be destroyed or returned) if they no longer wish to participate? (FDA-regulated studies should select No -
see help text) 
  Yes
No
4. If Yes , describe the process (oral, written, email, letter, etc.) that  participants should use to request
withdrawal of their data/specimens. Identify if there is a timepoint when withdrawal will no longer be an option
and/or if the amount of data that can be withdrawn is reduced at different points in the study. 
Participation in the current study is completely voluntary. Those who wish to participate can stop at any time.
Participants are also provided with the project coordinator's study email address and can contact them at any time to
withdraw participation and/or request that their data be destroyed.
5. * What will happen to the research materials (e.g. data, specimens, documents, etc.) when the research has
been completed? 
Stored indefinitely with identifiers removed
Stored indefinitely with identifiers attached
Destroyed at the end of study once the minimum time required for data retention has been met per VCU Data
Retention Policy and/or sponsor retention requirements
Destroyed when notified by sponsor but not less than the minimum time required for data retention per VCU
Data Retention Policy
Other
 
View: SF2 - Sharing Plan
  
Sharing Plan
This page addresses times when investigators may be required to share information about participants or may desire
to share their research information/specimens with the aim of advancing science. This page creates a plan for when

and how information/specimens could be shared. 
Try to anticipate all reasonably foreseeable sharing so that the consent document can also reflect that information.
However, it is acceptable to amend this page later and explain either how re-consent of previously and currently
enrolled participants will occur or why re-consent should not be required. 
The IRB reviews this page against the consent document (if one exists) to demonstrate the ethical principle of
Respect for Persons by confirming that plans for sharing do not go against what participants would understand
about the use of their data/specimens. 
The IRB also ensures there are adequate protections for the privacy of participants and the confidentiality of
participants' data/specimens when data is shared with others. 
1. * Is it likely investigators could discover information about child/elder abuse or neglect that would require
mandatory reporting by the investigators or staff? 
The Code of Virginia requires that most medical personnel and all employees of institutions of higher
education report suspected child/elder abuse or neglect. 
  Yes
No
2. *  Is it likely investigators could discover a previously unknown reportable disease or condition that would
require mandatory reporting by the investigators or staff (i.e., HIV , coronavirus, hepatitis, etc.)? 
  Yes No
3. * Will the sponsor or investigator obtain a Certificate of Confidentiality for this study? 
Certificates of Confidentiality  (CoC) are issued by the National Institutes of Health (NIH), the FDA and CDC to
protect identifiable research information from forced disclosure. All human subject research studies
regardless of funding can qualify to receive a CoC. A CoC is automatically issued for research that was
ongoing on December 13, 2016. or initiated after that date. For more information, see
https://humansubjects.nih.gov/coc/ 
No - Will not obtain CoC for this study
Yes - CoC has been obtained or issued automatically
Yes - CoC request is pending
Yes - Plan to submit request for CoC and will amend study/ICF once status of request is known
4. * Select the way(s) that individual-level information or biospecimens (including DNA) may be used by the VCU
PI or VCU study team for other future research projects (i.e. analyses beyond/apart from the aims of this
study)? 
See help text for definitions. 


Will use directly identifiable information or specimens. 
(‘Directly identifiable’ means that identifiers like name, medical record number, social security number, etc. are
included in/attached to the dataset/specimens. Maintaining identifiable data for future research is treated as a
registry by the VCU IRB. The IRB must approve the new research use in an amendment to this study or as part
of a new study before the project is initiated. You will be asked more questions about this on a later page)

Will use de-identified or indirectly identifiable information or specimens. 
(‘De-identified’ means that a linkage/key code exists that links identifiers to data/specimens. When the
researcher holds both the data and the key, the VCU IRB considers the subjects to be readily identifiable.
Maintaining identifiable data for future research uses is treated by the IRB as a registry. The IRB must approve
the new research use in an amendment to this study or as part of a new study before the project is initiated. You
will be asked more questions about this on a later page)

Will use anonymized information or specimens. 
(‘Anonymized’ means that 1) no linkage/key codes exist that link identifiers to data/specimens; and 2) subjects
cannot be readily identified, i.e. no direct or indirect identifiers or identifiable combinations of variables. The VCU
IRB considers uses of anonymized data/specimens to not be human subject research.)

Will use aggregate results (summary-level results), not individual-level information or specimens. 
(The VCU IRB considers uses of aggregate data to not be human subject research because there are no
individual subjects.)

Will contribute to an existing registry or repository 
(You will be asked more questions about this on a later page.)
Will not use information/specimens for purposes beyond this study.

Not sure and will submit an amendment when known

Other use(s) of individual-level information in a way not listed above
5. * Select the way(s) the VCU PI/study team may share individual-level information or biospecimens (including
DNA) with other researchers who are not on this study team (i.e. for analyses beyond/apart from the aims of
this study).   
See help text for definitions. 

Will share directly identifiable information or specimens with other researchers. 
(‘Directly identifiable’ means that identifiers like name, medical record number, social security number, etc. are
included in/attached to the dataset/specimens. Maintaining identifiable data for future research uses is treated
by the VCU IRB as a registry. The data recipient’s use of identifiable data would require them to obtain IRB
review. You will be asked more questions about this on a later page.)


Will share de-identified or indirectly identifiable information or specimens with other researchers. 
(‘De-identified’ means that a linkage/key code exists that links identifiers to data/specimens. The VCU
researcher maintains the key but does not share it with any other researchers. The recipient’s use of de-
identified data/specimens may not be human subject research if there is documentation that the key will never
be shared with the recipient, but they should check with their own IRB about review requirements. You will be
asked more questions about this on a later page.)

Will share anonymized information or specimens with other researchers. 
(‘Anonymized’ means that 1) no linkage/key codes exist that link identifiers to data/specimens; and 2) subjects
cannot be readily identified (i.e. no direct or indirect identifiers or identifiable combinations of variables). The
VCU IRB considers uses of anonymized data/specimens by other researchers to not be human subject
research, but the recipient should check with their own IRB about review requirements.)

Will only share aggregate results (summary-level results), not individual-level information or specimens. 
(The VCU IRB considers uses of aggregate data to not be human subject research because there are no
individual subjects. The data recipient should check with their own IRB about review requirements.)

Will contribute to an existing registry or repository (You will be asked more questions about this on a later page.)

Will submit data to an NIH genomic data repository (You will be asked more questions about this on a later
page.)
Will not share information/specimens with other researchers.

Not sure and will submit an amendment when known

Other sharing of individual-level information with other researchers
6. * The Principal Investigator certifies that after the study has been closed with the VCU IRB, the following
conditions will be met whenever individual level research information and/or specimens are used or shared: 
  - The identities of participants who are represented in the dataset/specimens will not be readily ascertainable
or otherwise re-identifiable by the recipient; 
  - If a linkage/code key is created, it will be maintained at VCU and not shared with the recipient under any
circumstances; 
  - The PI will have no knowledge that the remaining information could be used alone or in combination with
any other information to identify the individuals represented in the data; and 
  - The PI agrees to abide by this sharing plan even after the study has been closed with the VCU IRB. 
Yes
No
N/A - No sharing will occur
7. If the Certificate of Confidentiality has been obtained by the PI, upload it here:
 

View: SF2 - Pertinent and Incidental Findings
  
Pertinent and Incidental Findings
1. * Is it likely investigators could discover a participant's previously unknown condition (e.g. pregnancy,
disease, suicidal thoughts, wrong paternity, genetic results, or other findings that may be of importance to
health or well-being) or if a participant is engaging in illegal or reportable activities: 
  Yes
No
2. * Describe what possible pertinent or incidental findings stemming from research-only procedures may be
discovered. 
It is possible that participants may disclose the use of illegal substances and/or underage drinking.  
3. * Explain what actions or procedures research personnel should take to inform the PI of such a discovery : 
Research personnel will not take any action if participants disclose the use of illegal substances or underage drinking.
One aim of this study is to understand the impact of our newly developed innovative prevention intervention, the
Personalized Feedback Program (PFP) on substance use among college students. Thus, the nature of the study
requires that we ask participants about their current and past substance use. Participants will be encouraged to reach
out to their university counseling/health services if they experience distress during the study.  
4. * Will findings be disclosed to participants and/or any other person/group outside of the study team? 
  Yes
No
5. If pertinent and/or incidental findings will not be disclosed, explain why not: 
One aim of this study is to preliminarily evaluate the efficacy of the Personalized Feedback Program (PFP) in reducing
risky substance use among college students as compared to an assessment only control group, a computer-delivered
intervention based on brief motivational intervention (BMI) content/principles, and a combined PFP+BMI condition.
Thus, the nature of the study requires that we ask participants about their current and past substance use. If we were
to share any incidental findings, this could jeopardize the comfort and safety of potential participants to answer the
survey honestly.  
 
View: SF2 - Risk Benefit Complete
  
Risk Benefit Complete
Protocol Progress: 
 INITIAL SETUP 
 BACKGROUND, RATIONALE & GOALS 

 RESEARCH PLAN 
 CONSENT PLAN 
 RISKS, PRIVACY & CONFIDENTIALITY 
 POPULATIONS WITH SPECIAL CONSIDERATIONS 
 INSTITUTIONAL REQUIREMENTS 
 DOCUMENTS 
 
Click Continue below to go to the next section
 
View: SF2 - Populations with Special Considerations
  
Populations with Special Considerations
1. * Check all participant groups that will be either 
  a) Specifically included in this study or 
  b) Discernable in the research data/specimens. 
  (Selections will branch) 

Children

Emancipated minors

Wards of the State

Pregnant women or fetuses

Neonates or Post-delivery Materials

Prisoners

Decisionally Impaired Adults
VCU / VCUHS students or trainees

VCU / VCU Health System employees

Individuals with limited English proficiency

Active military personnel

Student populations in K-12 educational settings or other learning environments

Members of a federally recognized American Indian and Alaska Native tribe


None of the Above
  
2. Additional considerations for student populations: 
* Select all who will be research participants in the study: 
VCU Students

K-12 Students

Parents/Guardians of Students

Teachers

Administrators

Other
3. If applicable, describe any alternative activities for students (including VCU students) who choose not to
participate in the research. 
4. * Describe how the study will minimize the possibility of coercion to participate. 
We prevent undue coercion to participate by providing participants with the opportunity to decline participating in the
study even after they initiate the consent process. Recruitment will only be done electronically, thereby further reducing
participants' chances of feeling coerced. In addition, participants will have the opportunity to seek additional information
about participating in the study. In the electronic consent document the decision to consent or to decline consent is
presented at the end of the consent document with the following statement: ‘‘I have been provided with an opportunity
to read the consent form carefully. All of the questions that I wish to raise concerning this study have been answered.
Do you consent to participate in this research study? ‘Yes’ or ‘No’.’ In addition, the consent document will be available
and individuals will be encouraged to download a copy for their own records. The study email will be available in the
consent document. Individuals who are uncertain about whether they want to participate will therefore have the
opportunity to contact the coordinator with questions about the study. 
          
          
View: SF2 - Populations with Special Considerations Section Complete
  
Populations with Special Considerations Section Complete
Protocol Progress: 
 INITIAL SETUP 
 BACKGROUND, RATIONALE & GOALS 
 RESEARCH PLAN 
 CONSENT PLAN 
 RISKS, PRIVACY & CONFIDENTIALITY 
 POPULATIONS WITH SPECIAL CONSIDERATIONS