Game Plan for PrEP: A Pilot Trial of a Web-based Intervention to Help High-risk Men on PrEP Adhere to Their Medication, Reduce Alcohol Use, and Encourage Safe Sex
Phase: NA
Conditions: Human Immunodeficiency Virus Exposure, Alcohol; Harmful Use
Sponsor: Brown University

 
 
 
Official title: GamePlan for PrEP: A Pilot Trial of a Web-based Intervention to Help High-risk Men on  
PrEP Adhere to Their Medication, Reduce Alcohol Use, and Encourage Safe Sex 
NCT number: 04973267 
Document date: 05/11/2021 
 

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Brown University 
Application for Expedited / Full Board IRB Review 
 
PART 1: Name(s) and Contact Information. 
Protocol Title:  Game Plan for PrEP: A pilot trial of a web-based intervention to help high-risk men on PrEP 
adhere to their medication, reduce alcohol use, and encourage safe sex 
Principal Investigator:  Chan, Philip A., Wray, Tyler B. 
Department:  Center for Alcohol & Addiction Studies 
 
Phone number: Tyler Wray: (401) 863-6659, Philip Chan: (401) 793-2928 
Email address: tyler_wray@brown.edu, philip_chan@brown.edu 
Is this a graduate student project?* ☐ Yes  ☒ No 
If student PI, please provide the following: 
Advisor:        
Department:         
Phone number:       
Email address:       
Is this an undergraduate student project?* ☐ Yes  ☒ No 
If yes, name of undergraduate student:       
 
PART 2: Education Affirmation. 
Human Subjects CITI training is complete (PI, advisor (if student PI)): ☒  Yes ☐ No   
Good Clinical Practice (GCP) training is complete (clinical trials only): ☒  Yes ☐ No ☐ N/A   
HIPAA training is complete (if using PHI): ☒  Yes ☐ No ☐ N/A  
PART 3: Collaboration Information. 
Are there multiple sites involved with this study?  ☐  Yes   ☒ No 
If yes, list the site(s) involved:       
• If “yes,” review the Application for IRB Authorization Agreement 
PART 4: Funding Information. 
Funding Source(s):  
 If externally funded, provide the following: 
Sponsor: National Institute on Alcohol Abuse and Alcoholism  

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Project title: Applying user-centered design strategies to develop a tablet-optimized intervention to help 
high-risk men starting PrEP reduce their heavy drinking and adhere to their medication 
 
Grant / Contract #: R34AA027195 
 If funded by a specific Brown program (e.g., Mellon Mays Fellowship, Royce Fellowship, UTRA, 
OVPR Seed funds, etc.) please specify:  N/A 
 If there is no funding for the study, write "Brown" 
 
PART I. HUMAN SUBJECTS RESEARCH SCREENING 
 
Expedited / Full Board studies must meet the federal definition of “Human Subjects Research.” Answer 
the following questions to determine if your proposed study meets the federal definitions of both 
“Research” and “Human subjects.” 
 ☒ Yes   ☐ 
No 
Is this study a systematic investigation? 
 ☒ Yes   ☐ 
No 
Is the primary design intent of this study to contribute to generalizable knowledge? 
 ☒ Yes   ☐ 
No 
Is the information being obtained about living individuals? 
 ☒ Yes   ☐ 
No 
Will you collect information through some type of intervention or interaction? OR 
Will you have access to individually identifiable information? OR 
Will you have access to private information? 
 If you answered “no” to any of the above questions, your study does not meet the definition of 
“Human Subjects Research.” You are not required to submit an Application for IRB review to 
the Brown HRPP. 
 
 
PART II.  RISK ASSESSMENT & EXPEDITED ELIGIBILITY SCREENER 
 
1. Minimal Risk means that the probability and magnitude of harm or discomfort anticipated in the 
research are not greater in and of themselves than those ordinarily encountered in daily life or during the 
performance of routine physical or psychological examination or tests. 
 
Using this definition, do you believe this research presents: 
  ☐ Greater than minimal risk  
(Full Board) 
Briefly justify this selection (and proceed to Part III):  
Click or tap here to enter text. 
 ☒ No greater than minimal risk 
(Expedited) 
Briefly justify this selection (and proceed to Question 2): 
Participants will be responding to online surveys and testing for STIs/HIV, 
which are both part of everyday life.  
2. Below are Research Categories eligible for Expedited Review. Select one or more of the categories that 
are applicable to your proposed research, if any. 

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  ☐ Category 1 
Clinical studies of drugs and medical devices only when condition (a) or (b) is met (please 
select one): 
 ☐ (a) research on drugs for which an IND application is not required. (Note: Research on 
marketed drugs that significantly increases the risks or decreases the acceptability of the 
risks associated with the use of the product is not eligible for expedited review); OR 
 
☐ (b) research on medical devices for which (i) an IDE exemption application is not 
required; or (ii) the medical device is cleared/approved for marketing and the medical 
device is being used in accordance with its cleared/approved labeling. 
 ☒ Category 2 
Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows: 
 ☒ (a) from healthy, non-pregnant adults who weigh at least 110 pounds. For these 
participants, the amounts drawn must not exceed 550 ml in an 8-week period and collection 
may not occur more frequently than 2 times per week; OR 
 
☐ (b) from other adults and children, considering the age, weight, and health of the 
participants, the collection procedure, the amount of blood to be collected, and the 
frequency with which it will be collected. For these participants, the amount drawn may not 
exceed the lesser of 50 ml or 3 ml per kg in an 8-week period and collection may not occur 
more frequently than 2 times per week. 
  ☐ Category 3 
Prospective collection of biological specimens for research purposes by noninvasive means. 
Examples may include: 
(a) hair and nail clippings in a non-disfiguring manner; 
(b) deciduous teeth at time of exfoliation or if routine patient care indicates a need for 
extraction; 
(c) permanent teeth if routine patient care indicated a need for extraction; 
(d) excreta and external secretions (including sweat); 
(e) uncannulated saliva collected either in an unstimulated fashion or stimulated by chewing 
gum base or wax or by applying a dilute citric solution to the tongue; 
(f) placenta removal at delivery; 
(g) amniotic fluid obtained at the time of rupture of the membrane prior to or during labor; 
(h) supra- and subgingival dental plaque and calculus, provided the collection procedure is 
not more invasive than routing prophylactic scaling of the teeth and the process is 
accomplished in accordance with accepted prophylactic techniques; 
(i) mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth 
washings; 
(j) sputum collected after saline mist nebulization. 
  ☐ Category 4 
   
Collection of data through noninvasive procedures (not involving general anesthesia or 
sedation) routinely employed in clinical practice, excluding procedures involving x-rays or 
microwaves. Where medical devices are employed, they must be cleared/approved for 
marketing. (Studies intended to evaluate the safety and effectiveness of the medical device 
are not generally eligible for expedited review, including studies of cleared medical devices 
for new indications.) 
Examples may include: 
 (a) physical sensors that are applied either to the surface of the body or at a distance and do 
not involve input of significant amounts of energy into the subject or an invasion of the 
subject's privacy; 
(b) weighing or testing sensory acuity; 
(c) magnetic resonance imaging; 

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(d) electrocardiography, electroencephalography, thermography, detection of naturally 
occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, 
doppler blood flow, and echocardiography; 
(e) moderate exercise, muscular strength testing, body composition assessment, and 
flexibility testing where appropriate given the age, weight, and health of the individual. 
 ☐ Category 5 
   
Research involving materials (data, documents, records, or specimens) that have been 
collected, or will be collected solely for non-research purposes (such as medical treatment 
or diagnosis). NOTE: Some research in this category may be Exempt. Review the 
categories for Exemption before selecting this option. 
 ☒ Category 6 
Collection of data from voice, video, digital, or image recordings made for research 
purposes. 
 ☒ Category 7 
Research on individual or group characteristics or behavior (including, but not limited to, 
research on perception, cognition, motivation, identity, language, communication, cultural 
beliefs or practices, and social behavior) or research employing survey, interview, oral 
history, focus group, program evaluation, human factors evaluation, or quality assurance 
methodologies. NOTE: Some research in this category may be Exempt. Review the 
categories for Exemption before selecting this option. 
 
 
 

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PART III.  RESEARCH DESIGN & METHODS 
 
THE BLUE TEXT IN THE FOLLOWING SECTIONS IS A GUIDE TO ENSURE ALL RELEVANT 
INFORMATION IS INCLUDED IN YOUR APPLICATION. YOU MAY DELETE THE BLUE TEXT 
BEFORE SUBMISSION 
 
1. Introduction and Background. In reviewing the protocol, the IRB must consider the rationale for the 
study and the importance of the knowledge that may reasonably be expected to result. 
 
Although the overall annual HIV incidence in the United States (US) has declined in recent 
years, the rate of new infections remains stable among men who have sex with men (MSM)1. If this 
trend continues, recent estimates show 1 in 6 MSM in the US will be diagnosed with HIV in their 
lifetimes2. However, new biomedical tools for HIV prevention could help achieve a sustained decline in 
new infections. A once-daily dose of the antiviral drug emtricitabine/tenofovir disoproxil fumarate has 
shown 99% efficacy in preventing HIV acquisition among adherent MSM in clinical trials3; 4. As a 
result, this approach, referred to as pre-exposure prophylaxis (PrEP), is being broadly implemented 
across the country5; 6. Despite its promise, concerns remain about PrEP’s potential to prevent HIV in 
“real world” settings, since its effectiveness depends on sufficient adherence and persistence to the 
drug7; 8. Although follow-up analyses of clinical trial data suggest that adherence as low as 4 doses per 
week may be protective3; 4, several effectiveness studies (open-label extensions and demonstration 
projects) have reported adherence rates below this threshold among many MSM4; 9.  
Alcohol use is a major risk factor for HIV infection among MSM10 and has harmful effects 
across the continuum of HIV care10-13. A robust literature also shows that heavy drinking affects 
adherence to antiviral medications when used to treat HIV, resulting in poorer health outcomes and 
increasing the potential for onward transmission12; 14-16. Although few published studies have 
explored alcohol’s effects specifically on PrEP adherence4; 9, we have observed a similar pattern in our 
ongoing work. In a study of high-risk MSM on PrEP (N = 40), binge drinking days (5+ drinks on a 
single day) were three times more likely to occur during PrEP dose lapses of 4 or more days (a lapse 
length that may reduce PrEP’s effectiveness4) than when adherence was more consistent. Our work also 
shows that nearly 50% of MSM prescribed PrEP at our clinic reported binge drinking in the past month, 
suggesting that this pattern of drinking is widespread. Together, these findings suggest that PrEP care 
would benefit from the integration of empirically-supported approaches to alcohol intervention. 
Recent studies17-19 including our own work shows that brief alcohol interventions based on the 
principles of motivational interviewing (BMIs) help heavy drinking MSM and people living with HIV 
reduce their alcohol use, and that these reductions in turn improve medication adherence and decrease 
viral load. However, face-to-face BMIs are often difficult to implement and scale in many settings 
because of their reliance on highly-trained counselors. Internet-facilitated interventions inspired by face-
to-face BMIs have also been shown to reduce heavy drinking among many at-risk groups20; 21, but no 
such tools have been developed for MSM on PrEP.  
In our ongoing work22; 23, we developed Game Plan, a tablet-optimized web application 
designed to help heavy drinking, HIV-negative MSM reduce their alcohol use and sexual risk behavior. 
Based on our work on BMIs24, Game Plan was designed to go beyond many existing web-based 
interventions to provide much of the same content often provided in face-to-face BMIs, including 
personalized feedback about alcohol use and health risks, normative comparisons, reflective exercises to 
enhance motivation to change, and substantive change planning components. We also employed a 
thorough user-centered design process with the goal ofbuilding a tool that was interesting and engaging 
to its intended users. In an ongoing pilot study of nontreatment-seeking, heavy drinking MSM in an HIV 
testing clinic (N = 40), 74% of those who used Game Plan set a goal to reduce heavy drinking and 
reported 25% fewer binge drinking days compared to controls over 1.8 months of follow-up conducted 

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so far. These results are promising, and suggest that web-based BMIs could provide an efficacious, 
feasible, and scalable approach to alcohol intervention in resource-limited PrEP clinics. 
 
2. Specific Aims and Study Objectives. The IRB must evaluate the objectives of the research in order to 
determine whether the risks to participants are reasonable in relation to the importance of the 
knowledge that may be gained. 
 
 
The current study will explore the preliminary efficacy of Game Plan for PrEP, a web-based 
intervention to help high-risk men on PrEP adhere to their medication, reduce their alcohol use, and 
have safe sex. To accomplish this, we will randomize 100 of MSM to receive either (1) GP4PrEP or (2) 
an attention-matched control (AC). We will use self-report measures of alcohol use collected at 1-, 3-, 
and 6-months and changes in a biomarker of alcohol use collected at baseline, 3-, and 6-months to 
explore whether GP4PrEP reduces binge drinking compared with AC. We will also use data from a 
biomarker of PrEP adherence to explore whether GP4PrEP improves PrEP adherence vs. AC. Finally, 
we will also explore whether GP4PrEP reduces STI incidence compared to AC. 
 
The aim is to explore preliminary evidence of GP4PrEP’s efficacy in reducing heavy drinking and 
improving PrEP adherence/persistence, and sexually-transmitted infection (STI) incidence among 
heavy drinking MSM who are on PrEP, but who report a recent history of missing 3 or more 
consecutive doses. 
 
 
 
  
If your study ONLY involves the use of identifiable secondary data / biospecimens, 
including coded data from which you may be able to ascertain participant identity, skip to 
PART V. Otherwise, please continue to next page. 
 
 
3. Materials, Methods and Analysis. The study design, methods and procedures must be adequately 
described in order for the IRB to understand all activities in which human subjects will participate. The 
IRB must also be able to differentiate those procedures that are performed for research purposes from 
those that are performed for routine care or evaluation. 
 
 
In order to explore its efficacy, 100 participants will be randomized to receive either the app or an 
attention-matched control (AC). We will use self-report measures of alcohol use collected at 1-, 3-, and 
6-months and changes in a biomarker of alcohol use collected at baseline, 3-, and 6-months to explore 
whether GP4PrEP reduces binge drinking compared with AC. We will also use data from a biomarker of 
PrEP adherence to explore whether GP4PrEP improves PrEP adherence vs. AC. Finally, we will also 
test whether GP4PrEP participants showed lower rates of STI incidence across the study period 
compared to AC. A baseline assessment battery will be used to collect data on alcohol and other drug 
use and factors that can affect medication adherence such as attitudes towards PrEP, barriers and 
facilitators to taking PrEP, stigma, and beliefs. Follow-up assessments will also assess a number of 
covariates that may be relevant to PrEP adherence over time, including side effects, health insurance 
coverage, financial strain, health-related quality of life, and social support. STI incidence at each 
quarterly routine PrEP care visit will also be collected by extracting this data from participants’ 
electronic medical records. At these visits, participants are tested for Chlamydia and Gonorrhea at 
genital, rectal, and oral sites, syphilis, and HIV. At-home kits to collect dried blood spot (DBS) samples 
will be sent to participants at baseline (immediately after they enroll), at 3-months, and 6-months post-
enrollment, using procedures used by several national laboratories and in several past studies. DBS 
samples will be analyzed for TFV-DP levels, a biomarker for adherence to PrEP, as well as 
phosphatidylethanol (PEth), a biomarker of alcohol consumption. At the Miriam PrEP clinic, limited 
research staff who are co-located in the clinic will inquire about PrEP patients' potential interest in 

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participating in the study, or will provide them with a palm card (attached) with contact information for 
the study team. If patients request them to do so, research staff will also provide patients' first names and 
email addresses to the study team. The study team will  email prospective participants a link to an online 
screening survey that will provide them with more information about the study and, if interested, will 
ask them to complete a brief survey (< 5 minutes) to assess their eligibility. All online surveys, including 
those used for screening, consent, baseline, and all follow-ups, will be collected in Qualtrics, which is 
currently approved to collect and store Level 3 data (e.g., personal health data, HIPAA-protected data, 
etc.) by Brown University’s Computing and Information Systems office. The screening survey will 
provide real-time feedback about their eligibility, and if prospective participants are eligible and 
interested, will provide further study information and ask participants to provide informed consent by 
electronically signing in a provided field. Consent information will be provided in audio or text-based 
format to ensure participant understanding. Once they provide consent, participants will then be asked to 
complete a more detailed online baseline assessment, which will take about 30-45 minutes to complete. 
After they do so, research staff will mail a DBS collection kit to the addresses participants provide. 
These kits will include a Whatman protein saver card, two personal lancets, two alcohol pads, medical 
gauze, bandages, and thorough instructions about how to provide the dried blood spot sample. A link to 
video instructions will also be included in the kit. Once the DBS card has been prepared participants will 
be instructed to let it dry in ambient air for 4 hours before enclosing the card in a sealable foil biohazard 
bag, and then seal it in a self-addressed return mailer and drop it in any USPS mailbox to ship it back to 
the research offices. Once received, DBS cards will be stored in a -20 degree freezer until the end of the 
study, when they will be shipped on dry ice to the lab for analysis. DBS cards will be marked with that 
participants' study ID number prior to being shipped to participants so that no identifying information is 
included on any materials shared with the lab. 
 
4. Participant Population. In order to approve research, the IRB must determine that the selection of 
participants is equitable and reasonably related to the purpose and aims of the research. The IRB must 
also consider whether adequate safeguards are in place to minimize any risks that are unique to 
vulnerable populations. To make this determination, the IRB must review all methods and materials 
used to contact and recruit potential participants, including letters, flyers, emails, etc. 
 
Criteria for inclusion in this study are: (1) Current male gender, (2) 18+ years old, (3) able to speak 
and read in English fluently, (4) heavy alcohol use in the past month (>5 drinks on a single occasion or 
>14 drinks in a week), (5) currently prescribed and actively taking PrEP, and (6) report missing > 3 
PrEP doses in a row at least once in the past 3 months. Those who have (1) injected drugs in the past 
year, (2) screen positive for drug-related disorders, (3) report a history or risk of complicated alcohol 
withdrawal, or (4) are currently receiving counseling or medications for alcohol or drug addiction will 
be excluded. Participants must be fluent in English to participate. The target number of participants to be 
included in the study is 100, 50 in each condition.  
 
5. Recruitment Methods 
 
Participants will be recruited a variety of ways, including social media advertisements, flyers and 
business cards, and from an existing database, in which potential participants previously expressed 
interest in participating in various research studies with Smash Labs. Examples of images and text used 
in online advertisements are attached, as well as advertising palm cards. Initial contact will involve 
participants completing an online screener to determine their eligibility for the study. If determined 
eligible, participants will consent online, and give contact info. Research staff will call to verify 
participants’ enrollment, further explain the consent and what’s expected of them in the study, and 
answer any questions the participant may have. Research staff will be trained by PI and project 
coordinator. Screening data will be destroyed after study completion.  

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6. Compensation / Reimbursement 
 
Participants will be paid $20 for viewing/interacting with the GamePlan website or control 
videos, $50 for completing both the online survey and DBS kits ($15 and $35, respectively) at baseline, 
3- and 6- months, $25 for and their 1-month online survey, with a bonus of $50 for completing all study 
procedures ($245 total possible). Participants will be paid via ClinCard. They will be mailed a ClinCard, 
and all study payment will be made within 3 business days of study activity completion.  
Some of the services participants will receive are being performed only because they are 
participating in this research study.  These ‘research only’ services include sampling a few drops of 
blood. This will be paid for by the study and will not be billed to the participant or their health insurance 
company.  
Other services they will receive during this research study are considered "routine clinical 
services" that they would have received even if they were not in the research study. Examples include 
their PrEP medication and refills, follow-up visits with their doctor every 3 months, HIV and STD 
testing at these visits, and any other laboratory tests provided as a part of monitoring their health while 
on PrEP (for example, analysis of your urine and blood). These services will be billed to their health 
insurance company, but participants’ will be responsible for paying any deductibles, co-payments, or co-
insurance that are a normal part of their health insurance plan.  If they do not have health insurance, they 
will be responsible for those costs.  
 
 
7. Potential Research Risks / Discomforts to Participants. In order to approve the research, the IRB 
must consider the risks posed to participants by the research and any efforts to mitigate those risks. The 
IRB needs to determine that the risks have been both minimized and are reasonable in relation to the 
anticipated benefits to participants, as well as to the importance of the knowledge that may be gained. 
The IRB will also consider whether the informed consent process provides potential participants with an 
accurate and fair description of the risks or discomforts. 
During this study, some of the questions we will ask are about sex, alcohol and drug use, and 
other sensitive behaviors. These questions might make participants uncomfortable or embarrassed. This 
discomfort is usually rare and very mild.  
Participation in this study, as well as any information you provide us during the study, is 
confidential. To safeguard confidentiality, we store all data that participants provide us in secure 
locations and in password-protected and encrypted files, and after the study is over, we destroy any 
information that could identify participants (e.g., your name, phone, email).  However, there is a risk 
that a data breach during the study may result in the loss of confidentiality. To minimize this risk, the 
systems we use to collect data throughout the study meet very high standards for security and are 
routinely checked for flaws. We also do not store any information that could identify participants in the 
programs we use to collect data from them online.  
Participants may experience problems as a result of taking PrEP or while undergoing any 
medical procedure done as part of the typical course of monitoring their use of PrEP (e.g., HIV/STD 
testing/treatment). However, participants may experience these even if they chose not to join the study, 
since these are a result of taking PrEP and not the study procedures themselves. See data security 
assessment below.  
 
8. Potential Benefits of the Research. NOTE: Compensation for participation is not a benefit and 
should not be included in this section. In order to approve this research, the IRB must determine that 
the potential benefits to research participants are reasonable in relation to the potential risks. Very 

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often, research at Brown does not include potential direct benefits to participants, but may only benefit 
society as a whole by helping researchers. 
 
There are no direct benefits to participants, but this study will be contributing to general medical 
knowledge.  
 
PART IV.  INFORMED CONSENT 
 
Informed consent is a process, not just a form. The IRB must ensure the informed consent process clearly 
discloses and facilitates the understanding of all information needed to make an informed decision to 
participate while promoting the voluntariness of participation. 
 
Please use the Brown consent / assent templates and related guidance on the HRPP Forms & Templates page 
to develop your consent forms. 
 
1. Describe the informed consent process: 
 
Informed consent will be obtained online as part of the usual onboarding sequence for enrolled 
participants. This process will involve first providing the information contained in the consent in brief, 
bulleted segments, and providing the full consent information in audio format (for those who choose it). 
The full consent form will then be displayed and participants will be invited to download and/or save a 
copy for their records. Participants will then provide informed consent by electronically signing in a 
provided field. 
 
 2. Facilitate Understanding 
 
Participants will be asked to read the bulleted list of consent items, before being shown the consent 
document in its entirety and given a downloadable copy. They will then be asked to digitally approve 
their consent. Participants can email, call, or text study staff at any time during the study with questions.  
 
3. Documentation 
 
Researchers will document all consent using an online Qualtrics survey, see measures document 
attached.  
 
4. Additional Considerations 
      
 
N/A 
 
PART V. USE OF SECONDARY DATA / BIOSPECIMENS  
 
For research that involves the use of identifiable secondary data / biospecimens, including coded data 
from which you may be able to ascertain participant identity.  
If your research does not involve identifiable secondary data / biospecimens, proceed to PART VI. 
DATA SECURITY ASSESSMENT 
1. From what source(s) will you acquire or access the data / biospecimens? 
 
 
N/A 
 

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2. Describe the type(s) of data and date range(s) of the data you will use and the characteristics of the study 
research population (e.g., age range, sex, and any other pertinent demographic information.) 
 
N/A 
 
4. HIPAA and Protected Health Information (PHI): 
 
•  Please review the HIPAA Privacy Rule Guidance for Brown University Researchers.   
 
• If the research involves the use of PHI from a HIPAA-covered entity, describe how authorization from 
participants to access and use their information will be obtained.  
 
• Complete Appendix G. Use of Protected Health Information (PHI) for Research and include with this 
application. 
 
5. Do any of the source(s) require a Data Use Agreement (DUA) or other Agreement that requires institutional 
signature to obtain, access or use the data / biospecimens? ☐ Yes   ☒ No 
 
If “yes,” please include a copy of the Agreement(s) with this submission and also follow the Data Use 
Agreement review and signature processes. 
 
 
 
 

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PART VI. DATA SECURITY ASSESSMENT 
 
1. Will you be collecting biospecimens? 
☒ Yes   ☐ No 
If “yes,” please review the Institutional Biosafety Committee (IBC) webpage. A 
supplemental IBC review may be required. 
2. Do the study data / biospecimens include identifiers? Video and audio recordings are considered 
identifiable. 
☒ No 
If “no,” I affirm that I have read and will abide by the Level 1 Risk Minimum Security 
Standards: ☒ Yes   ☐ No  
 
Proceed to Question #3. 
☐ Yes    
If “yes,” answer the following questions. 
 
A. Describe the identifiers associated with the data / biospecimens. 
 
B. Justify why identifiers are required to conduct the research. 
Click or tap here to enter text. 
 
C. Described the proposed research use of the identifiable data / biospecimens. 
Click or tap here to enter text. 
 
D. Self-classify the Risk Level of these data / biospecimens (select the highest level of risk 
for all data / biospecimens being collected). 
     ☐ Level 2 Risk 
     ☐ Level 3 Risk 
3. How will study data / biospecimens be collected? 
   ☐ Brown desktop 
   ☐ Laptop 
   ☒ Departmental server 
   ☒ CIS managed server 
   ☒ Brown Qualtrics 
   ☐ REDCap; Please describe what instance of REDCap is being used (Brown does not have an instance of  
        REDCap): Click or tap here to enter text. 
   ☐ Amazon Mechanical Turk (MTurk) 
   ☐ Text messaging  You must complete the Text messaging section after completing Qs 3 – 5. 
   ☐ Mobile App (on tablet, iPad, Phone)  You must complete the Mobile App section after completing Qs 
3-5. 
   ☐ Zoom  
   ☐ Digital records (audio / videoconferencing tools, digital photographs); please describe the tool: Click or 
tap here to enter text. 
   ☐ Paper records (including physical photographs). Please describe, including how you will securely store 
        the paper records:   Click or tap here to enter text. 
   ☐ Web-based site / survey / other tool not listed above  You must complete the Web-based Other section 
after completing Qs 3 – 5. 

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   ☐ Other; please describe:  
Click or tap here to enter text. 
 
 
4. Who will have access to the study data / biospecimens? 
   ☐ A. Brown PI only. How will unauthorized access by others be prevented? 
Click or tap here to enter text. 
 
   ☒ B. Brown PI and other Brown research team members. How will unauthorized access by others be 
prevented? 
Brown login credentials require the use of 2-step verification. Only approved staff will have access to 
study data.  
 
   ☐ C. Data will be shared with research collaborators external to Brown. This data sharing intent must be  
            described as part of your consent process / form. Please describe how you will securely share / transfer 
the data outside of Brown:  
            Click or tap here to enter text. 
 
Note that an Outgoing Data Use Agreement is required when sharing identifiable data external to 
Brown. Please follow the procedures outlined here. You do not need to submit a copy of a DUA to the 
HRPP. This will be linked by the ORI administratively. 
 
5. Where will the study data / biospecimens be stored? 
   ☒ Departmental server 
   ☒ CIS managed server 
   ☐ Stronghold 
   ☐ Campus file storage 
   ☐ REDCap  
   ☐ Other. Please describe: Click or tap here to enter text. 
 
6. If traveling with your data, describe how your data will be secured. 
N/A 
7. For how long will you retain identifiable data / biospecimens? How will you destroy identifiers when 
no longer required? 
Identifiers will be destroyed at the conclusion of study procedures.  
 
8. Text Messaging (only complete if instructed above.) 
A. Are you using the current text messaging service available on the device? 
☐ Yes   ☐ No 
 
If “no,” you must also complete the Mobile App section. 
B. Whose device will be used? ☐ Participant’s personal phone   ☐ Brown-issued phone 

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C. Content of messaging: (If brief, insert here; otherwise, please provide as an attachment) 
D. Is the communication one-way or two-way? ☐ One-way   ☐ Two-way 
9. Mobile App (only complete if instructed above.) 
A. Name of the mobile app: Click or tap here to enter text. 
B. Has this site / tool been reviewed by CIS IT Security?  
☐ Yes   ☐ No 
If “no,” answer the following: 
a) Who created the site / tool (vendor name or off the-shelf app creator name)? 
Click or tap here to enter text. 
b) Where is it hosted?  
Click or tap here to enter text. 
c) Is the site / tool scanned for security vulnerabilities? ☐ Yes   ☐ No 
d) What version of software is being used, if applicable: ☐ N/A or  
Click or tap here to enter text. 
e) How are the data encrypted? 
Click or tap here to enter text.  
C. Whose device will be used? ☐ Participant’s personal phone   ☐ Brown-issued phone 
If Participant’s person phone: 
a. How is the app downloaded to the device?  
Click or tap here to enter text. 
b. Is a password or PIN required for the app? ☐ Yes   ☐ No 
D. Will data be stored on the device for any period of time? 
☐ Yes   ☐ No 
 
a. If “yes,” please describe (i.e., queue on phone and then transmitted to server):  
    Click or tap here to enter text. 
 
b. Is the app data encrypted on the device? ☐ Yes   ☐ No 
E. Device features mobile app can access ☐ N/A 
   ☐ Device ID and call information 
   ☐ Identity 
   ☐ Contacts   
   ☐ Camera 
   ☐ SMS or chat 
   ☐ Storage 
   ☐ Device and application history 
   ☐ Phone 
   ☐ Photo / media / files 
   ☐ Microphone 
   ☐ Location 

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   ☐ Other; please describe: Click or tap here to enter text. 
 
F. Will a third-party have access to research data through this app? ☐ Yes   ☐ No 
G. Is data transmitted by the device?  
☐ Yes   ☐ No 
If “yes,” how is it encrypted in transit?  
Click or tap here to enter text. 
H. Are phone numbers or mobile identification numbers stored with the data? ☐ Yes   ☐ No 
10. Web-based Other (only complete if instructed above.) 
A. Name of the site / tool: Click or tap here to enter text. 
B. Has this site / tool been reviewed by CIS IT Security?  
☐ Yes   ☐ No 
If “no,” answer the following: 
a. Who created the site / tool (vendor name or off the-shelf app creator name)? 
      Click or tap here to enter text. 
b. Where is it hosted?  
     Click or tap here to enter text. 
c. Is the site / tool scanned for security vulnerabilities? ☐ Yes   ☐ No 
d. What version of software is being used, if applicable: ☐ N/A or 
     Click or tap here to enter text.  
e. How are the data encrypted?  
    Click or tap here to enter text. 
C. Is informed consent being obtained via this site / tool?  
☐ Yes   ☐ No 
If “yes,” how is re-identification prevented?  
Click or tap here to enter text. 
D. Does the technology allow for the explicit exclusion of the collection of IP address of the participant’s 
connection?  
☐ Yes   ☐ No 
If “yes,” will you use this option to exclude the collection of IP address? 
☐ Yes   ☐ No 
 
Brown Qualtrics: CIS has pre-vetted Brown Qualtrics for collection/storage of up to Risk Level III data. Qualtrics is the preferred 
survey tool for all Brown research data collection. 
 
REDCap: Brown does not currently have its own instance of REDCap. Access to REDCap through a Lifespan collaborator must be 
explicitly identified. 
 
Data collection: The expectation is that data collection devices will only store data during active data collection. Data must then be 
transitioned to more secure long-term storage solutions. 
 
Departmental/CIS managed servers: If data are collected/entered directly onto a Departmental or CIS managed server, you must 
ensure that the server meets the security standards described in the Minimum Security Standards for Servers based on the Risk Level 
of the data identified in 1D. 
 

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PART VII.  APPENDICES  
 
Please complete & attach the following Appendices to this Application, as applicable. 
 Incl.      N/A  
☐ 
☒ 
Appendix A. Children as Subjects 
To be attached when minors are included as participants [please be aware of the age of 
majority for your specific research site(s)] 
☐ 
☒ 
Appendix B. Prisoners as Subjects 
To be attached when prisoners are included as participants. 
☐ 
☒ 
Appendix C. Use of Drugs 
To be attached when the research includes the use of FDA-regulated or unregulated drugs. 
☐ 
☒ 
Appendix D. Use of Devices 
To be attached when the research includes the use of FDA-regulated or unregulated devices. 
☐ 
☒ 
Appendix E. Prescription Drug / Medication Management 
To be attached when study procedures include administering prescription medications to 
study participants. 
☐ 
☒ 
Appendix F. Mental Health Safety Plan 
To be attached when participants may experience significant emotional distress, or be at risk 
of themselves or others. 
☐ 
☒ 
Appendix G. Use of Protected Health Information (PHI) for Research 
To be attached when study procedures include a plan to access, use or disclose Protected 
Health Information (PHI) of participants.  
☐ 
☒ 
Appendix H. International Research 
 To be attached when study involves human subjects research outside the United States.  
☐ 
☒ 
Appendix I. Advisor Appendix 
To be attached when a graduate or medical student is the Principal Investigator. 
 
 
PART VIII. ATTACHMENTS 
 
Please attach the following materials to this Application for Expedited / Full Board IRB Review, as 
applicable. 
 
  Incl.      N/A  
☐ 
☒ 
Additional Investigator COI  
☐ 
☒ 
Application for IRB Authorization Agreement (IAA) 
☒ 
☐ 
Data collection materials (questionnaires, surveys, interview scripts, etc.) 
☐ 
☒ 
Data Safety Monitoring Plan 
☐ 
☒ 
Data Use Agreement from data provider(s) 
☐ 
☒ 
DSMB Charter Template 
☐ 
☒ 
HIPAA Authorization 
☒ 
☐ 
Informed consent documents / scripts 
☐ 
☒ 
Permissions, approval documents, and/or support letters  

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☒ 
☐ 
Recruitment materials (emails, flyers, letters, scripts, posters, brochures, etc.) 
☐ 
☒ 
Request for Approval to Serve as Principal Investigator on a Human Subjects Research 
Application 
☐ 
☒ 
Other: Click or tap here to enter text. 
 
PART IX. CONFLICT OF INTEREST  
 
The Brown University Conflict of Interest Policy for Officers of Instruction and Research (“COI Policy”) 
defines the term “Investigator” as “the project director or principal investigator and any other person, 
regardless of title or position (e.g., full or part-time faculty member, staff member, student, trainee, 
collaborator, or consultant), who is responsible for the design, conduct, or reporting of sponsored 
research.” 
Using this definition of “Investigator,” please ensure that all Investigators on this protocol answer questions 
(1) and (2) below. Attach additional sheets for any Investigators who are not the PI; additional sheets are 
available on the HRPP website. 
☐ 
I am affiliated with Rhode Island School of Design and will abide by policies and 
procedures set forth by my institution.  
1. Have you completed a conflict of interest disclosure (i.e. COI Reporting Form) within the past 12 months 
and is it accurate and up-to-date as of the time of this submission, as required by Brown’s COI Policy? (If 
you have not completed this disclosure, access the InfoEd system here.) 
☒ Yes   ☐ No 
If “no,” please do so before submitting this Application 
2. Do you have a significant financial interest (SFI) that is related to this research protocol?   
“Related” could mean the research involves products, technology, intellectual property, or services made, 
owned, or provided by the entity/ies in which you have an SFI. It could also mean that the SFI could be 
affected by the proposed research or its results.     
 
☐ Yes   ☒ No 
If “yes,” please identify the SFI and explain the relatedness:  
Click or tap here to enter text. 
3. Do you have a faculty advisor or other Brown investigators working on this study? 
 
☐ Yes   ☒ No  
Additional COI sheets for Investigators are attached to this Application. 
 
 
 
PART X. PRINCIPAL INVESTIGATOR AGREEMENTS & 
RESPONSIBILITIES  
 
 A. Conduct of the Research 
1. I accept responsibility for the ethical conduct of this research and protection of participants as set 
forth in the Belmont Report, Common Rule, and Brown University policies. 
2. I accept responsibility for ensuring this research is conducted in accordance with: 
a) Sound research design and methods; 
b) The parameters of the research plan and activities described in this Application; 
c) The applicable terms of the grant, contract, or other signed funding agreements; 
d) Applicable laws and regulations, including those protecting the rights, safety and welfare of 
human subjects. 

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3. I certify that I am, or my faculty advisor is, sufficiently qualified by education, training and 
experience to assume responsibility for the proper conduct of this research. I accept 
responsibility for ensuring that all member of the research team have or will complete human  
4. subjects CITI training before any work with participants or identifiable data / biospecimens 
begins. 
5. I accept responsibility to personally conduct and/or directly supervise this research. I certify that 
I have sufficient time and resources to properly conduct and/or supervise this research. 
 
B. Ensuring and Maintaining Compliance 
1. I will comply with relevant regulatory and institutional reporting requirements, including Brown 
University’s Reportable Events Policy.  
2. I understand that it is my responsibility to ensure that any research personnel, including myself, 
responsible for the design, conduct or reporting of the research declares any conflicts of interest 
related to this research. I will ensure that any changes that impact my or other research 
personnel’s answers to the questions in PART IX. Conflict of Interest, are reported promptly to 
Brown’s HRPP. 
3. I will ensure that prospective agreement and/or informed consent is obtained and a copy is 
provided to participants, when appropriate. 
4. If there are changes to the research described in this Application for Expedited / Full Board IRB 
Review that may impact the study’s classification as Full Board or Expedited research, I will 
promptly notify the Brown HRPP of such changes. 
5. I will notify the Brown HRPP when I have completed all activities involving human subjects or 
identifiable participant data or identifiable biospecimens. 
6. I will maintain approval, as applicable, with collaborative parties, including approvals from other 
countries or jurisdictions. 
7. I will cooperate with any post-approval monitoring or auditing of study activities and/or study 
records as requested and/or required by the Brown ORI, the Brown IRB, funding entities, 
sponsors, and/or any federal or state regulatory agencies. 
 
C. Study records, Reports and Documentation 
1. I will comply by Brown’s Research Data and Research Materials Management, Sharing and 
Retention Policy. 
2. I will maintain all research protocol materials and consent materials for the duration of this 
study. 
3. I will maintain research records for at least three years following the end of this research, or for a 
longer length of time if specified in applicable regulations or sponsor requirements. I will take 
measures to prevent accidental or premature destruction of these records. 
4. I will abide by all terms of any Data Use Agreement (or equivalent agreement) related to this 
study, including those agreed to electronically (through an online attestation). 
5. I will ensure that the data security measures for acquisition, collection, transfer and use of study 
data described in PART VI. of this Application are adhered to by all members of the research 
team.  
 
                
By my signature below, I certify that I have read and agree to uphold all of the Agreements and 
Responsibilities in PART X. 
 
 
 
 
Principal Investigator signature:    
 
 
 
Date:  5/11/2021 
 

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=============================================================================== 
 
 
For IRB Use Only 
 
Signature of the IRB:  
 
Date of IRB approval: Click here to enter a date.