Harnessing Online Peer Education Online Support Intervention for COVID-19 (HOPE COVID-19)
Phase: NA
Conditions: COVID-19 Vaccination
Sponsor: University of California, Irvine

COVER PAGE
HOPE Intervention for COVID-19
NCT04376515
6/8/2021

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IMPORTANT REMINDER! In accordance with the Vice Chancellor for Research’s shutdown message, 
non-critical research has been halted. However, non-critical research that can be performed from 
home may continue. The research shutdown remains in effect consistent with California’s Executive 
Order N-33-20.  
 
Refer to the Office of Research webpage on Research Continuity for more details. 
 
Institutional Review Board 
Human Research Protections 
 
Exempt Self-Determination Tool  
 
UPDATED! Version June 2020 
UC Irvine IRB review is required for most activities that constitute engagement in human subjects 
research, as federally defined.  
 
At UCI, researchers are permitted to self-determination their exempt research without confirmation 
from the IRB. This tool is intended to help you determine and document whether the human 
subject research qualifies for exempt self-determination or requires UCI IRB Review.  
 
IMPORTANT! Should the study sponsor require evidence of IRB review for a self-determination of 
exempt research, please provide the sponsor this letter.  
 
INSTRUCTIONS: 
 
1. To get started, review Parts A & B to determine if the research is eligible for exempt self-
determination.  
2. If the research is eligible for exempt self-determination, maintain a copy of the completed 
Exempt Self-Determination Tool and any supporting documentation in your records.  
IMPORTANT! Do NOT submit the Exempt Self-Determination Tool to the IRB. 
 
a. Sign the Lead Researcher (LR) Assurance statement at the end of the Exempt Self-
Determination Tool. Obtain the Faculty Sponsor’s signature as appropriate.  
 
3. If UCI IRB Review is required, please submit a New IRB Application for exempt, expedited, or 
full committee review. For more information, please review: How To Submit Electronic IRB 
Applications for Review.        
 
If you have questions about completing the Exempt Self-Determination Tool or about the IRB 
process in general, contact the Human Research Protections staff. 
PART A:  VERIFY SELF-DETERMINIATION ELIGIBILITY 
 
The activity is eligible for exempt self-determination IF all of the statements below are true.   
 
IMPORTANT! If one or more statement below are not true then the research is not eligible for 
exempt self-determination and IRB review is required. 
 
           A.     The research IS human subject research.   
Please review the Non-Human Subject Research Determination form.  If your activity is 
non-human subject research, please complete the form and maintain it for your records.  
If your activity does not qualify as non-human subject research, please check the box to 
the left and proceed to the next check box.  
NOTE:  Graduate students dissertation research involving humans is considered human 
subject research – please check the box to the left.  

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1 When PHI is communicated inside of a covered entity, this is called a use of the information. When PHI is 
communicated to another person or organization that is not part of the covered entity, this is called a disclosure. HIPAA 
allows both use and disclosure of PHI for research purposes, but such uses and disclosures have to follow HIPAA 
guidance and have to be part of a research plan that is reviewed and approved by an Institutional Review Board (IRB). 
 
 
           B.    I am NOT a UCI undergraduate researcher.  
All UCI undergraduate research involving human subjects that meets the criteria for 
exempt review must submit for exempt confirmation through the Undergraduate Research 
Opportunities Program (UROP).   
 
          C.    The research is NOT supported by the Department of Justice (DOJ).   
Research that is funded/supported by the Department of Justice (DOJ) is not eligible for 
exemption either by Self-Determination or through submission to the IRB.  Submit a New 
IRB Application for expedited / full committee review. For more information, please review: 
How To Submit Electronic IRB Applications for Review. 
 
           D.   The research does NOT include any of the following.  
1. The use or disclosure of UCI protected health information (PHI)1 
a. Use is any sharing, employment, application, utilization, examination, or analysis 
within the entity 
b. Disclosure is any release, transfer, provision of access to, or divulging outside of 
entity 
2. A targeted recruitment of children targeted recruitment of children  
3. A targeted recruitment of adults (age 18 or older) who may not be 
legally/mentally/cognitively competent to consent  
4. A targeted recruitment of prisoners (may include parolees) 
5. A targeted recruitment of American Indian/Alaska Native tribes  
6. A targeted recruitment of undocumented people 
7. International Research 
8. A request for UCI to serve as IRB of Record for non-UCI individuals engaged in human 
subjects research.   
Note: To initiate a request for UCI to serve in this capacity, the LR must have a dual 
affiliation with the non-UCI entity and IRB review is required to formalize the reliance 
process.   
9. A study team member has a Disclosable Financial Interest 
  
IMPORTANT!  IRB approval is required to enroll any of the above listed subject 
populations. Should the study team inadvertently encounter a potential subject that 
belongs to an excluded population above, this individual may NOT be enrolled in the 
study.  
 
PART B:  VERIFY EXEMPT CATEGORIES ELIGIBLE FOR SELF-DETERMINIATION 
 
1. Please review the following Exempt categories that are eligible for self-determination. 
 
2. Check the category(ies) that apply to the research.  
 
IMPORTANT! If one or more category below are not applicable then the research is not eligible for 
exempt self-determination and IRB review is required. 

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Category 1:  Education (the following criteria must be met) 
 
Research, conducted in established or commonly accepted educational settings and specifically 
involves normal educational practices that are NOT likely to adversely impact students’ opportunity to 
learn required educational content or the assessment of educators who provide instruction. This 
includes most research on regular and special education instructional strategies, and research on the 
effectiveness of or the comparison among instructional techniques, curricula, or classroom 
management methods.   
 
Category 2:  Interactions (the following criteria must be met) 
 
Research that includes only interactions involving educational tests (cognitive, diagnostic, aptitude, 
achievement), survey procedures, interview procedures, or observation of public behavior (including 
visual or auditory recording) 2 
 
One of the following criteria must be met: 
 
  2i) The information obtained is recorded by the investigator in such a manner that the identity of  
      the human subjects CANNOT readily be ascertained, directly or through identifiers linked to the   
      subjects 
 
OR  
 
  2ii) Any disclosure of the human subjects’ responses outside the research would NOT  
       reasonably* place the subjects at risk of criminal or civil liability or be damaging to the subjects’  
       financial standing, employability, educational advancement, or reputation 
 
*Reasonably defined as with fair and sound judgment; a standard used by an ordinary, rational 
person under similar circumstances. 
 
Category 3i:  Behavioral Interventions (All of the following criteria must be met) 
 
The research involves behavioral interventions in conjunction with the collection of information from an 
adult subject through verbal or written responses (including data entry) or audiovisual recording if the 
subject prospectively agrees to the intervention and information collection 
 
The behavioral interventions are brief in duration, harmless, painless, not physically invasive, not likely 
to have a significant adverse lasting impact on the subjects, and the investigator has no reason to think 
the subjects will find the interventions offensive or embarrassing.  
 
Provided all such criteria are met, examples of such benign behavioral interventions would include 
having the subjects play an online game, having them solve puzzles under various noise conditions, or 
having them decide how to allocate a nominal amount of received cash between themselves and 
someone else. 
                                            
2 Subpart D applicable only when involving educational tests or the observation of public behavior when the investigator(s) 
do NOT participate in the activities being observed. 

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One of the following criteria must be met: 
 
  3iA)The information obtained is recorded by the investigator in such a manner that the identity of  
       the human subjects CANNOT readily be ascertained, directly or through identifiers linked to the  
       subjects 
 
OR  
 
  3iB) Any disclosure of the human subjects’ responses outside the research would NOT  
       reasonably* place the subjects at risk of criminal or civil liability or be damaging to the subjects’  
       financial standing, employability, educational advancement, or reputation 
 
*Reasonably defined as with fair and sound judgment; a standard used by an ordinary, rational 
person under similar circumstances. 
 
 
SECTION 1: STUDY INFORMATION  
 
 
 
1. Study Title:   
HOPE COVID-19 Vaccine Opinion Study 
2. Identify the funding source. Check all that apply: 
  Grant/Subaward  OR    
  Contract/Subcontract 
 
(provide details below) 
 
Prime Awardee(s): Sean Young 
 
Sponsor Name(s): NIAID 
                    
SPA Proposal or Award #(s):  5R01AI132030-05 
 
 Check here to confirm a copy of the human subjects portion of the grant is  
      available and kept on file 
 
  Department or campus funds (includes department support, unrestricted funds, start-up  
       funds, personal funds, campus program awards, etc.) 
 
  Non-cash support from manufacturer/sponsor (e.g., free drug, device, research materials)  
 
  Subject/subject's insurance/third party payer  
 
  Student project that will incur no costs. 

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SECTION 2: STUDY TEAM  
 
1. Complete the table below.   
 
2. List the Lead Researcher (LR), Co-Researchers (CR), and Research Personnel (RP) who will be 
engaged in human subject research. 
 
• 
Co-Researchers are faculty, staff, students and other academic appointees who the LR 
considers to be key personnel for conducting the research study.  These individuals work 
closely with the LR to design, conduct, and/or report on the research. 
 
• 
Personnel who are not interacting with participants for research purposes and/or who do 
not have access to identifiable private information (e.g., statisticians) are not engaged in 
human-subjects research and therefore should not be listed below. 
 
• 
IMPORTANT!  Do not list non-UCI researchers below.  To initiate a request for UCI to serve 
as the IRB of Record for non-UCI researchers, the LR must have a dual affiliation with the 
non-UCI entity and IRB review is required to formalize the reliance process.   
 
3. If there is a Faculty Sponsor (FS), they must be listed below, as they must be identified to provide 
oversight and guidance to the LR. If there is collection of identifiable information, the Faculty 
Sponsor should be designated as having access to the identifiable information.  
Role 
Name, 
Title & 
Degrees 
Department & UCI 
Affiliation -  Faculty, 
Staff, Graduate or 
Undergraduate 
Student 
Recruit 
 
Informed 
Consent 
Process 
 
Interact 
with 
Participant 
 
Access 
Participant 
Identifiable 
Information 
 
Analyze 
Participant 
Identifiable 
Information 
LR 
Sean 
Young, 
PhD, MS 
 Faculty  
 Staff  
 Grad Student  
 Undergrad  
 Other UCI:  
Type Here 
 N/A  
 Yes  
 No 
 N/A  
 Yes  
 No 
 N/A  
 Yes  
 No 
 N/A  
 Yes  
 No 
 N/A  
 Yes  
 No 
FS 
Type 
Here 
 Faculty  
 Other UCI: 
 
Other UCI:  
Type Here 
 N/A  
 Yes  
 No 
 N/A  
 Yes  
 No 
 N/A  
 Yes  
 No 
 N/A  
 Yes  
 No 
 N/A  
 Yes  
 No 
 CR  
 RP 
Dominic 
Arjuna 
Ugarte, 
MD, MBA 
 Faculty  
 Staff  
 Grad Student  
 Undergrad  
 Other UCI:  
Type Here 
 N/A  
 Yes  
 No 
 N/A  
 Yes  
 No 
 N/A  
 Yes  
 No 
 N/A  
 Yes  
 No 
 N/A  
 Yes  
 No 
 CR  
 RP 
Lidia 
Flores, 
BA 
 Faculty  
 Staff  
 Grad Student  
 Undergrad  
 Other UCI:  
Type Here 
 N/A  
 Yes  
 No 
 N/A  
 Yes  
 No 
 N/A  
 Yes  
 No 
 N/A  
 Yes  
 No 
 N/A  
 Yes  
 No 

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SECTION 3: WHAT IS YOUR RESEARCH QUESTION? 
 
1. State the hypothesis or primary objective of the research. Include a rationale for conducting the 
study.  [Maximum length = 250 WORDS]    
This study seeks to utilize our previously tested Harnessing Online Peer Education (HOPE) online 
community intervention to connect peer leaders with healthcare personnel and frontline essential workers 
choosing not to receive the COVID-19 vaccine. Over the 4-week intervention we aim to teach participants 
about the risks of COVID-19 and the benefits of the COVID-19 vaccine. 
 
The peer community leader model, which teaches community popular opinion leaders about how to 
disseminate behavior change messages throughout the community, has been proven to increase 
prevention behaviors in things like HIV prevention. Social networks, such as Facebook.com may be a 
cost-effective platform for scaling these models. Our research team has employed our HOPE intervention 
previously, for example, in populations who are high risk for HIV/AIDS and in populations suffering from 
anxiety due to COVID-19. Following that same model, we will modify it to help combat the current low 
rates of COVID-19 vaccination, with some places experiencing as high as 50% of healthcare personnel 
refusing to receive the COVID-19 vaccine. If we are able to increase the rates of COVID-19 vaccination, it 
will show potential as a useful tool to aid in future public health crises and vaccination campaigns. 
2. COVID-19: Does this research include a focus on SARS-CoV-2/COVID-19 (Coronavirus)? 
   NO   
 
   YES: Please consider whether Ancillary Committees for COVID-19 Research apply.  
 
SECTION 4: SUBJECT POPULATION  
 
Complete the table below. Specify the maximum number of individual-level information to be 
accessed/analyzed within each cohort and in total across all cohorts.  
 CR  
 RP 
Romina 
Romero, 
PhD, 
MPH 
 Faculty  
 Staff  
 Grad Student  
 Undergrad  
 Other UCI:  
Type Here 
 N/A  
 Yes  
 No 
 N/A  
 Yes  
 No 
 N/A  
 Yes  
 No 
 N/A  
 Yes  
 No 
 N/A  
 Yes  
 No 
 CR  
 RP 
Desirée 
Fehmie, 
MPH, 
MSc 
 Faculty  
 Staff  
 Grad Student  
 Undergrad  
 Other UCI:  
Type Here 
 N/A  
 Yes  
 No 
 N/A  
 Yes  
 No 
 N/A  
 Yes  
 No 
 N/A  
 Yes  
 No 
 N/A  
 Yes  
 No 
 CR  
 RP 
Parvati 
Singh, 
PhD 
 Faculty  
 Staff  
 Grad Student  
 Undergrad  
 Other UCI:  
Postdoc 
 N/A  
 Yes  
 No 
 N/A  
 Yes  
 No 
 N/A  
 Yes  
 No 
 N/A  
 Yes  
 No 
 N/A  
 Yes  
 No 
To add more study team members, click into this space, then click the new + button on the right 
5. If applicable, specify which members of the above study team will be responsible for interacting 
with non-English speaking participants. 
NA: English speaking participants only 

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Category/Group 
(e.g., students in School or Course, consumers 
on website, people being observed at location) 
Age Range 
(e.g., adults 18 and over) 
Maximum Number 
of Subjects  
American Adult in phase 1a or 1b of COVID-19 
vaccine rollout who have refused to receive the 
COVID-19 vaccine 
18+ years old 
120 
Type Here 
Type Here 
Type Here 
To add more categories/groups, click into this space, then click the new + button on the right 
 
Total:120 
 
SECTION 5: RECRUITMENT METHODS   
 
1. Indicate which recruitment methods will be utilized. Check all that apply:  
 
IMPORTANT! Advertisements must adhere to UCI Recruitment Guidelines. Various templates are 
available on the HRP webpage Application and Forms (see sub-section HRP and then Recruitment 
Templates).  
 
 This study involves no direct contact with participants (i.e., passive observation of public behavior or 
secondary use of information). Skip to SECTION 6. 
 
   Online Advertisements – Including Social Media      
   Radio / Television Advertisement               
 
   Newspaper Advertisement                                        
   Flyers                                        
 
   Letters or Emails                                                       
  Phone Call                                                   
 
   Other (specify): Type Here 
2. Describe when, where, by whom and how potential participants will be approached.  
3. If posting on your Facebook page or other social media sites, please explain.   
4. If you will recruit by e-mail, phone, etc., explain how the researcher will obtain the participants’ 
contact information. 
Participants in both the control and intervention group will be recruited through online advertisements on 
Facebook, Google ads, our Facebook page, and online forums like Reddit. We may also contact healthcare 
organizations, hospital departments, and academic institutions by phone or email asking them to send 
emails with information about the study to any frontline essential workers through a mailing list. 
Advertisements will be designed to recruit healthcare personnel and frontline essential workers who have 
refused to receive the COVID-19 vaccine. Participants who click on the ads or links on the forums will be 
routed to a website/survey (such as Qualtrics) where they are screened online for eligibility with our 
questionnaire. Those who visit our Facebook page may have the option to interact with a chat box that will 
eventually route potential participants to the website/survey as above. 
 
Inclusion criteria: 
1. Adults, 18+ years old, who are competent to give informed consent 
2. English speakers only 
3. U.S. Resident 
4. Part of phase 1a or 1b of COVID-19 vaccine rollout – healthcare personnel and frontline essential 
workers (employment verified through LinkedIn profile or similar) 
5. Uses social media and/or online communities greater than twice per week 
6. Has, or is willing to accept a friend request and group invite from our Facebook social media page 
7. Has not received a COVID-19 vaccine and does not have medical conditions or other circumstances 
preventing them from receiving one 

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Phase 1a includes healthcare personnel such as physicians, nurses, technicians, therapists, pharmacists, 
administrative staff, environmental services staff, students, and other trainees. 
Phase 1b includes frontline essential workers such as fire fighters, police officers, corrections officers, 
food and agricultural workers, United States Postal Service workers, manufacturing workers, grocery store 
workers, public transit workers, and those who work in the educational sector (teachers, support staff, and 
daycare workers.) 
See CDC recommendations for further details: https://www.cdc.gov/coronavirus/2019-
ncov/vaccines/recommendations.html 
 
Those who do not qualify to participate in the study will see a web page that thanks them for their interest 
and tells them that they are not qualified to participate at this time and that their data will not be used and will 
be destroyed to protect their confidentiality. Those who are unqualified will not be able to access the 
Informed Consent Information Sheet. If eligible, potential participants will be sent a brief description of the 
study and the Informed Consent Information Sheet. If they would like to participate in the study they will be 
asked to continue with the consent process. By clicking continue, they will have implied consent to the study 
and be routed to a webpage where they can provide an email address and phone number for future contact, 
as well as begin the baseline survey. After survey completion, they will be instructed to friend request our 
HOPE Study Facebook profile or be provided a link to join the group. 
 
After 1) consenting to the study (by clicking continue), 2) friending us on Facebook, 3) completing a baseline 
survey, and 4) joining our private Facebook group (they will be randomly assigned to a group and group 
request will be sent to them), participants will be officially enrolled in the study. 
 
If participants have yet to friend us or join our private group, we will email them a reminder and/or call them 
every 24 hours until the invitation is accepted. 
In the event that a participant has trouble friending us on Facebook, participants may alternatively be sent a 
link to join the Facebook group. 
If the baseline survey is not completed after 48 hours, we will attempt to reach the participant by phone 
every day until we successfully make contact. We may call them multiple times per day up to a maximum of 
3 attempts. 
 
Peer Leader Recruitment: 
Up to 30 peer leaders will be recruited using online advertisements as above, as well as by direct message 
of healthcare personnel or frontline essential worker that has shared a picture of their vaccine card or 
vaccination sticker online, for example on Reddit. Advertisements will be designed to recruit people who are 
social online (e.g., chat frequently online, create TikTok videos, etc.) and report having received the COVID-
19 vaccine. Potential peer leaders who click on the ads will be routed to a website/survey (such as Qualtrics) 
where they are screened online for eligibility with our questionnaire. 
 
Inclusion criteria: 
1. Adults, 18+ years old, who are competent to give informed consent 
2. English speakers only 
3. U.S. Resident 
4. Part of phase 1a or 1b of COVID-19 vaccine rollout - healthcare personnel and frontline essential 
workers (employment verified through LinkedIn profile or similar) 
5. Uses social media and/or online communities greater than twice per week and is active on TikTok or 
Instagram (ideally with at least 10,000 followers) 
6. Has, or is willing to accept a friend request and group invite from our Facebook social media page 
7. Has received a COVID-19 vaccine 
 
Phase 1a includes healthcare personnel such as physicians, nurses, technicians, therapists, pharmacists, 
administrative staff, environmental services staff, students, and other trainees. 
Phase 1b includes frontline essential workers such as fire fighters, police officers, corrections officers, 
food and agricultural workers, United States Postal Service workers, manufacturing workers, grocery store 
workers, public transit workers, and those who work in the educational sector (teachers, support staff, and 
daycare workers.) 

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See CDC recommendations for further details: https://www.cdc.gov/coronavirus/2019-
ncov/vaccines/recommendations.html 
 
As this is a time-sensitive study, peer leaders might be enrolled based on these criteria; however, if time 
permits, they might also be called and secondarily screened to see whether they are social, communicative, 
and seem to have leadership qualities based on things like past volunteer experiences. Enrolled peer 
leaders will be asked to participate in 3 online training sessions of approximately 2-3 hours each where they 
learn how to interact with participants. Session 1 will focus on COVID-19 epidemiology; session 2 on 
benefits of the vaccine, as well as fears and myths surrounding the vaccine, and session 3 on the logistics of 
the study. Peer leaders who complete the training will be paid $20 per week in Amazon gift cards for 
emailing us a tracking form by the weekly deadline that documents their efforts attempting to communicate 
with participants during the course of the study. 
 
Methods: 
Participants will be randomly assigned to an intervention or control group (each group will have 
approximately 30 participants and approximately 6 peer leaders (depending on recruitment and people that 
may drop out)). There will be 5 control groups and 5 intervention groups total. Those in the control group will 
be assigned to a private and hidden Facebook group and told they can interact with each other as they wish. 
Those in the intervention group will be assigned to peer leaders, also in a private and hidden Facebook 
group, with each participant assigned to have approximately 2-3 peer leaders. Facebook groups will also 
become hidden once all group participants are in the group. The intervention will take place over 4 weeks, 
with a possible week 0 before the study officially starts to allow peer leaders and participants to become 
accustomed to each other and the Facebook group features. Each week of the intervention, peer leaders will 
reach out to participants by posting on the online group forum, either text, images, or videos and sending 
direct messages to participants, attempting to promote COVID-19 vaccination through comforting and 
educational information/content of their choice. Every 2 weeks through the end of the study, participants in 
both conditions will be invited to email us to receive information about and receive related resources for 
COVID-19 vaccination, such as pamphlet on vaccination information. At the end of the 4-week intervention, 
participants will complete the final survey. Participants will be paid $15 in Amazon gift cards for the baseline 
survey, $20 in Amazon gift cards for the final survey, and $15 in Amazon gift cards for providing proof of 
vaccination if applicable. Participants should expect about 4-6 weeks after completing respective tasks 
before receiving compensation. Participants will be contacted by phone and/or email to remind them to 
complete surveys as discussed above for the baseline survey. 
 
All analyses will be conducted in R (version 4.1.2) We will assess the effect of the HOPE intervention on the 
primary outcome (whether a participant requested vaccine information during the study), and the secondary 
outcome (whether a participant got the vaccine during the study). We will adjust for race (dichotomized by 
Caucasian vs other), age (above vs. below 40), sex from birth, education (bachelor or below vs. grad school 
or above), and ethnicity (Latino vs. other). 
The intervention effect on the primary outcome will be assessed using logistic mixed effects models or 
generalized estimating equations.  
The intervention effect on the secondary outcome will be assessed using generalized estimating equations 
with an exchangeable correlation structure ([2]), which accounts for the clustering by Facebook group. 
Engagement in the study is defined as participants that posted, commented, voted, or reacted to anything 
within a given week. 
 
 
 
SECTION 6: PARTICIPANT COMPENSATION  
 
Will participants be compensated? 
 
IMPORTANT! Compensation should be offered on a prorated basis when the research involves 
multiple sessions. Additional considerations are required when using lotteries, raffles, and 
drawings, see UCI Lottery Guidance. For additional information about researcher's/department's 
responsibilities and current Accounting procedures, see UCI Policy Sec. 701-03. 

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 Participants will not be compensated. Skip to SECTION 7. 
    
 Participants will be compensated, address the following: 
     
Amount of Payment: Participants will be compensated $15 for the baseline survey, $20 for completing the 4-
week survey, and an additional $15 if they show proof of at least the first dose of vaccination (send us 
picture of vaccine card). Up to a total of $50.  
 
Peer Leaders will be compensated $20 for each week they turn in their complete response sheet on time. 
Total of $80 if all response sheets are turned in complete and on time. 
 
Method:  
 Cash     
 Check     
 Extra credit     
 Gift card: Amazon Gift Card    
 Other: Type Here 
 
Schedule:  
 After each study visit     
 At the end of study     
 Other : Type Here 
 
SECTION 7: INFORMED CONSENT PROCESS  
 
1. Identify the specific steps for obtaining consent.   
 
IMPORTANT! For additional information, see Guidance for Consenting Process. Templates are 
available on the HRP webpage Application and Forms (see sub-section HRP, Consent Forms). 
  No consent process will take place (i.e., no contact with participants) Skip to SECTION 8. 
 
  Oral / Implied informed consent will be obtained – No signature is required (e.g., completion of 
a survey electronically) 
 
IMPORTANT!  
• 
Customize the Study Information Sheet template. 
 
• 
If obtaining consent online, participants should: 
o View the Consent/Study Info Sheet prior to participation 
o Be prompted to verify they meet the eligibility criteria, and  
o Indicate their willingness to participate in the research (e.g., click “Yes”). 
 
  Written (signed) informed consent will be obtained – A signature is required.   
 
IMPORTANT! Customize the Informed Consent Document template. 
2. Will this study include Non-English Speaking Participants?   
 Only individuals who can read and speak English are eligible for this study. 
 
 The English version of the consent materials will be translated for non-English speaking participants. 
An interpreter will be involved in the consenting process.  
UNCOMMON 

11 of 17 
3. If study team members will approach their own students or employees: 
a. 
Explain what precautions will be taken to minimize potential undue influence or coercion. 
  
b. 
Explain how compromised objectivity will be avoided. 
 
c. 
When prospective medical students, residents or fellows are included, it is expected that 
a statement be added to the Study Information Sheet indicating that their agreement to 
participate will have no impact on their current or future positions/ opportunities at UCI.  
This is particularly relevant if the Lead Researcher is also in a position to make hiring or 
appointment determinations.  The following is a suggested text that may be used: 
 
“Refusing to participate will not impact current or future residency or fellowship 
opportunities or your ability to progress at UCI.”  
 
IMPORTANT! UCI expects that appropriate provisions are in place to engage with this potentially 
vulnerable population. See HRPP Policy (#40) for more information on this topic. In addition, visit the 
HRPP webpage on this topic. 
 The study team will not approach their own students or employees. 
 
 The study team will approach their own students or employees: 
 
a. Specify how undue influence or coercion will be minimized. Check all that apply:  
 
 The student's experimental results, performance, or any confidential information will not be 
given to whomever is grading the student, except for stating whether the student participated 
or not.  If this is not feasible, then the student's experimental results, performance, or any 
confidential information will not be accessed until after grades have been posted.  
 
 The student's participation must not be required for course credit to be given. Instructors who 
wish to involve students in simulations of human experimentation and course-assigned data 
collection for educational purposes only (as opposed to research purposes) may require such 
participation as part of the class requirements. 
 
 Other; specify: Type Here 
 
b. Specify how compromised objectivity will be avoided: Type Here 
4. Will this study include access to (both UCI and non-UCI) student records?   
 
IMPORTANT! Researchers interested in accessing UCI Student Records for research purposes are 
directed to the UCI Registrar website on Confidentiality of Students Records. The disclosure of 
information from student records is governed in large measure by the Federal Family Educational 
Rights and Privacy Act of 1974, by the State of California Education Code, and by University policy 
and procedures implementing these laws. Generally, documentation of informed consent is required 
to access private student information. 
  The study team will not access student records 
 
 The study team will access student records and evidence of FERPA3 compliance has been / will be  
obtained (and on file) from the local school/district site or the UCI Registrar prior to the initiation of 
research. 
                                            
3 34 CRF 99: Family Educational Rights and Privacy Act (FERPA) applies to this research. 

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5. Will this study involve Deception or Incomplete Disclosure?   
 
IMPORTANT! Per Federal regulations, the use of deception or incomplete disclosure may only be 
exempt (and considered for a Self Determination of Exemption at UCI) if the (prospective) subject 
authorizes the deception through a prospective agreement to participate in research in 
circumstances in which the subject is informed that he or she will be unaware of or misled regarding 
the nature or purposes of the research.  If advanced disclosure is not possible, submit an 
Application to the IRB for Expedited review.  
  There is no deception or incomplete disclosure involved. 
 
   There is deception or incomplete disclosure and consent materials will include an initial disclosure to 
prospective subjects that he or she will be unaware of or misled regarding the nature or purposes of 
the research and a subsequent debriefing upon conclusion of the research. 
 
SECTION 8: RESEARCH PROCEDURES  
 
1. Specify where the research procedures will take place (e.g. Irvine High School, Starbucks, UCI 
Douglas Hospital – Cardiac Care Unit, UCI Main Campus – Hewitt Hall, etc).  
 
2. If research will be conducted at non-UCI locations, confirm whether Letters of Permission or 
other documentation are required. See Guidance for Letter(s) of Permission and Template Letter 
of Permission. 
Location(s) of research procedures: All research procedures will be conducted online. 
 
 Check here to confirm Letter(s) of Permission has been / will be obtained for non-UCI private  
      locations and kept on file.   
3. List the data collection procedures in chronological order using the table format below.  
 
Procedure and/or 
the Data Collection 
Instrument 
 
Is the 
Procedure/ 
Instrument 
already 
being 
completed 
as part of a 
program 
evaluation 
or an 
educational 
activity? 
 
Is the 
Procedure/ 
Instrument a 
standardized 
measure? 
 
 
List the 
frequency and 
the time 
required for 
participants to 
complete the 
Procedure/ 
Instrument 
 
Describe the 
setting where 
data collection 
will take place  
 
Confidentiality: 
Are participant 
identifiers (IDs) 
recorded 
during data 
collection?   
 
 
 
 
 
 
 
EXAMPLE: 
ABC Satisfaction Survey 
via Amazon Turk 
 
 N/A  
 Yes  
 No 
 N/A  
 Yes  
 No 
Survey will be 
completed 3x 
during the 
academic year.  
Takes no more 
than 20 mins. to 
complete 
Amazon 
Mechanical 
Turk 
 No IDs   
 Code with  
     link to IDs 
 Yes IDs 
Online Screener 
 N/A  
 Yes  
 No  
 N/A  
 Yes  
 No  
Takes a couple 
minutes to 
complete. 
Internet 
 No IDs   
 Code with  
     link to IDs 
 Yes IDs 

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Baseline Survey 
 N/A  
 Yes  
 No  
 N/A  
 Yes  
 No  
Takes 15 
minutes to 
complete 
Internet 
 No IDs   
 Code with  
     link to IDs 
 Yes IDs 
4-Week Survey 
 N/A  
 Yes  
 No  
 N/A  
 Yes  
 No  
Takes 15 
minutes to 
complete 
Internet 
 No IDs   
 Code with  
     link to IDs 
 Yes IDs 
Proof of Vaccination 
 N/A  
 Yes  
 No  
 N/A  
 Yes  
 No  
If participant 
reports receiving 
the vaccine, 
participants may 
text/email us a 
picture of their 
vaccine card. 
Internet/Phon
e 
 No IDs   
 Code with  
     link to IDs 
 Yes IDs 
To add more procedures/data collection instruments, click into this space, then click the new + button  
4. Will any of the study procedures include collecting photographs, audio recordings 
and/or video recordings?  
 No photos, audio or video recordings will be taken.   
 
 Photos, audio or video recordings will be taken. Text regarding the photos or recordings will be included 
in the consent document and specific permission to record identifiers will be obtained from participants.   
Check all that apply: 
 Facial image will be in video or photo 
 
 Participants’ names will be collected or recorded in either video, photo or audio recording 
 
 Collecting photographs, as well as audio and video recordings will be optional for the participant 
 
  Other: Type Here  
 
 
SECTION 9: CONFIDENTIALITY OF RESEARCH INFORMATION 
 
1. How will how information be stored and secured? Check all that apply: 
 
Questions regarding best practices for data security and/or privacy may be addressed to UCI 
Information Security and Privacy at security@uci.edu. 
  Information will be maintained electronically. Information will be password protected and maintained in  
an encrypted format. Researchers may access UCI-contracted data sharing and storage tools through 
UCI OIT. 
 
  Information will be maintained in hard copy. Information will be stored in a locked area that is not 
accessible to non-study team members. 
 
  Other; specify:  Type Here 
2. Will any participant identifiers be retained in the research records (i.e., for recruitment, consent, 
analysis, and/or compensation)? Check all that apply: 

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  No participant identifiers will be retained.  
 
  Participant identifiers will be retained as selected below:  
 Names 
 
 Phone or fax number  
 Web URLs   
 
 Email Address  
 
 Postal address                
 IP address numbers 
 
 
 Facial Photos/Images  
 Other unique identifier (specify): Facebook Username 
 
 
3. Will a code be used to link participant identifiers with the research information?  
  No participant identifiers will be retained. 
 
  Participant identifiers will be retained; check one of the following: 
 
  A code will be used. Participant identifiers will be kept separately from the information, linked by 
the code. 
 
  A code will not be used. Participant identifiers will be kept separately from the information. 
 
  A code will not be used. Participant identifiers will be kept directly with the information. 
4. Specify how long ALL participant identifiers will be retained.  This includes the identifiers 
stored in paper format, stored electronically, video/audio recordings, photographs, etc. 
  No participant identifiers will be retained  
 
  Participant identifiers will be retained as selected below:  
 
  Destroyed after recruitment/consent process  
  Destroyed after data collection 
  Destroyed after compensation 
  Destroyed after data analysis 
  Destroyed after publication/presentation or end of study 
  Maintained indefinitely for undefined future research 
5. Will identifiable information be disclosed in publications and/or presentations? 
  No  
 
  Yes: Identifiable information will be shared. Text regarding the disclosure will be included in the consent 
document specific permission to disclose identifiers will be discussed with participants.   
 Check here to confirm that Release Form will be obtained from each participant and kept 
on file  

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6. Will information be shared with other researchers outside of the study team (i.e., UCI / non-UCI 
researchers) for purposes within the scope of the current study? 
 
IMPORTANT! 
• 
When transferring data to a non-profit, please contact Grace J. Park at parkgj@uci.edu. 
• 
When transferring data to a for-profit, please contact the Industry Contract Officer at UCI Beall 
Applied Innovation assigned to your department. 
• 
When transferring tangible research material to an organization, please contact UCI Beall Applied 
Innovation at MaterialTransfer@uci.edu. 
 No  
 
 Yes: Text regarding the information sharing will be included in the consent document and  
       specific permission to share information will be discussed with participants.   
 
 Check one of the following: 
 
 Only de-identified information will be shared (i.e. research subjects cannot be identified by other 
researcher)  
 
 Check here to confirm that study team will remove ALL of the identifiers listed in 
Section 9.2 above prior to distribution.  
 
 Identifiable information will be shared  
 
Name of other researcher/entity:  Type Here 
 
List of all identifiers to be shared:  Type Here 
 
Provide justification for why it is necessary to share identifiers: Type Here 
 
 Check here to confirm that all appropriate data use agreements will be finalized 
before sharing. 
7. Will information be shared, used again, or stored for undefined future research purposes 
beyond the scope of the current study? 
 
  No  
 
 Yes: Text regarding the information sharing will be included in the consent document and  
       specific permission to share information will be discussed with participants.   
 
 Check one of the following: 
 
   No subject identifiers will be retained by the study team beyond initial collection (i.e. information 
cannot be linked to an individual). Requests for de-identified information will be managed by the 
UCI study team.  
 
 Check here to confirm that all appropriate data use and/or materials transfer 
agreements will be finalized before sharing. 
 
   De-identified information will be retained and managed in an established non-UCI biorepository 
(i.e. not managed by the UCI study team). Specify the non-UCI biorepository:  Type Here 
 
 Check here to confirm that all appropriate data use and/or materials transfer 
agreements will be finalized before sharing. 
 

16 of 17 
   Other; specify: Once results are published, only deidentified information will be retained and 
managed by the study team. Requests for de-identified information will be managed by the UCI 
study team. 
8. Indicate how long research information and/or biospecimens will be retained.  
 
IMPORTANT! In accordance with UCOP policy, information/biospecimens must be retained for 10 
years after the end of the calendar year in which the research is completed, unless otherwise 
specified in the award agreement. 
Choose the longest retention period applicable: 
 
  There is no contract or award associated with this research. Information/biospecimens will be retained  
       for 10 years after the end of the calendar year in which the research is completed. 
 
  The contract or award associated with this research requires that information/biospecimens be retained   
       for the following period; specify time frame: Type Here 
 
  The study is conducted under an IND or an IDE investigation, information/biospecimens will be retained  
       for two years after an approved marketing application. If approval is not received, the        
       information/biospecimens will be kept for 2 years after the investigation is discontinued and the FDA is  
       notified per FDA sponsor requirements. 
 
  This research includes the potential for future undefined research using information/biospecimens which  
       will be stored and maintained indefinitely. 
 
  Other; specify timeframe and provide rationale: Type Here 
 
 
 

17 of 17 
SECTION 9: LEAD RESEARCHER ASSURANCE 
 
 
The Lead Researcher (and Faculty Sponsor – if applicable) assure the following.  
As Primary Lead Researcher and Faculty Sponsor, we have ultimate responsibility for the performance of 
this study, the protection of the rights and welfare of the human subjects, and applicable UCI policies, as 
well as state statutes for research involving human subjects.  
 
We hereby assure or acknowledge the following:  
 
1. 
The information provided in this application is accurate to the best of my knowledge.  
 
2. 
All named individuals on this project have read the procedures outlined in the protocol, are aware of 
and have reviewed relevant HRPP Policies and Procedures and understand  their role on the study.  
 
3. 
All named individuals on this project have completed the required electronic educational research 
tutorials and have been made aware of the "Common Rule" (45 CFR Part 46) and acknowledge the 
importance of the Belmont Principles - Respect for Persons, Beneficence and Justice in conducting 
research involving human participants. Also UCI has signed the Federalwide Assurance (FWA) that 
is available for review on the Human Research Protections (HRP) website.   
 
4. 
Minor changes to the research that do not increase risk to participants, or significantly alter the study 
aims or procedures, such as the addition or removal of students researchers, do not require 
additional self-confirmation of exemption or approval from the IRB. Major changes that increase risk 
or constitute substantive revisions to the research including procedural changes will require a new 
self-confirmation of exemption or approval from the IRB. 
 
5. 
When conducting research at a non-UCI location outside of California (but within the United States), 
Lead Researchers must comply with the requirements and policies of the location and State laws 
regarding human research procedures.  
 
6. 
When collaborating with another entity (e.g., another UC, CHOC, CSUF, or a local school district), 
the collaborators who are engaged in human research activities are responsible for securing their 
own (non-UCI) IRB exemption/approval.  
 
7. 
The Exempt Self-Determination, consent documents including recruitment materials and data 
collection materials will be maintained by the Lead Researcher or Faculty Sponsor for 10 years 
beyond the completion of the research. If you will cease your affiliation with UCI during this 10 year 
period and intend to transfer your identifiable data to a new institution, please notify your Faculty 
Sponsor and Department to determine whether this is permissible.  
 
8. 
This research study is subject to routine monitoring by the Human Research Protections (HRP) unit 
of the Office of Research.  Through the Education Quality and Improvement Program (EQUIP) 
program, HRP staff conduct periodic quality improvement monitoring and educational outreach. 
Please sign below, indicating that you agree with the above. 
 
 
 
 
 
 
 
 
 
Lead Researcher’s Signature 
6/8/2021 
 
 
Date 
 
 
 
 
 
 
 
 
 
Faculty Sponsor’s Signature (if applicable) 
 
 
 
 
Date