Increasing Teen Access to Care Using Peer Social Networks and Mobile Health Services
Phase: NA
Conditions: Health Care Utilization
Sponsor: Children's Mercy Hospital Kansas City

 
 
 
 
Health Services/Programmatic Research 
Protocol Template 
(HRP-582 – TEMPLATE – Health Services/Programmatic Research Protocol) 
 
 
 
PROTOCOL TITLE:  
AccessKCTeen 2.0: Increasing teen access to care using peer social networks and mobile health 
services. 
PRINCIPAL INVESTIGATOR: 
Melissa Miller  
Emergency Department  
816-302-1342 
mmiller@cmh.edu 
 
IND/IDE NUMBER:  
N/A 
 
VERSION NUMBER/DATE: 
V8 09/07/2022 
V12 12/15/2023 
 
REVISION HISTORY 
 
This Revision History table is provided for the benefit of study team version control.  If 
this table will not be useful please delete it. 

 
 
 
 
 
Revision 
# 
Version Date 
Summary of Changes 
Consent 
Change? 
1 
11/4/21 
Initial submission 
 
2 
2/17/22 
Revision 
Yes 
3 
4/18/22 
• Removal of the THO arm 
• Addition of Event Day participants 
Yes 
4-7 
4/26/22 
• Peer leader compensation choice 
• Addition of data collected  
• Social Media Recruitment  
• Assent Discussion 
Yes 
8 
7/18/22 
• Addition of virtual meetings to gain feedback 
from Peer Leaders 
• Change of compensation for Peer Leader 
• Addition of notification of compensation to 
Peer Leaders  
• Addition of retroactively compensating Peer 
Leaders 
 
Yes  
9 
8/15/2022 
• Change of messaging for Peer Leader 
participants 
• Addition of risk for unsecure two-text 
messages  
  
 
 
10 
9/7/2022 
• Program activities: Mobile Unit Clinical Care 
Events  
• Research activities: Intervention Trail 
Participants (Event Day Survey) 
 

 
 
 
 
• Event Day Participant: change in wording 
from study drugs to clinical care medications 
• Table of Events for enrolled intervention trail 
participants 
• 8.0- Event Day Participants study 
medications to clinical care medications and 
Event Day Survey  
11 
11/16/2022 
• Data Collection: Record deidentified data 
from the electronic health record.   
 
 
12 
12/15/2023 
Adding community partner and letter, adding 
method to share study information with 
potential participants 
 
 
 
 

 
 
 
 
Table of Contents 
STUDY INFORMATION 
1.0 Study Summary 
2.0 Objectives 
3.0 Background 
4.0 Study Design 
5.0 Research Interventions 
SUBJECT MANAGEMENT 
6.0 Inclusion and Exclusion Criteria 
7.0 Local Number of Subjects 
8.0 Screening and Recruitment Methods 
9.0 Surveys and Psychometric Testing 
10.0 Additional Study Activities 
11.0 Follow-Up 
12.0 Genetic Analysis Information 
13.0 Sharing of Results with Subjects 
14.0 Risks to Subjects 
15.0 Potential Benefits 
16.0 Investigator Assessment of Risk/Benefits Ratio 
17.0 Payment, Reimbursement and Tangible Property Provided to Subjects 
18.0 Compensation for Research-Related Injury 
19.0 Economic Burden to Subjects 
20.0 Parental Permission and Adult Consent Process 
21.0 Assent of Pediatric Subjects 
22.0 HIPAA and Confidentiality 
23.0 Provisions to Protect the Privacy Interests of Subjects 
24.0 Withdrawal of Subjects 
DATA MANAGEMENT 
25.0 Data Collection 
26.0 Adverse Events and Unanticipated Problems 

 
 
 
 
27.0 Data Analysis 
28.0 Data and Specimen Management 
29.0 Storage/Banking of Data and Specimens for Future Research 
30.0 Provisions to Monitor the Data to Ensure the Safety of Subjects 
DATA MANAGEMENT 
31.0 Settings and Locations 
32.0 Multi-Site Research 
33.0 International Research 
ADDENDUMS 
Addendum A: Waiver of Documentation of Permission/Consent 
Addendum B: Waiver/Alteration of Permission/Assent/Consent 
Addendum C: Non-English-Speaking Subjects: N/A 
Addendum D: Surrogate Decision Maker Consent: N/A 
Addendum E: Waiver/Alteration of HIPAA Authorization 
 
 
 

 
 
 
 
STUDY INFORMATION 
1.0 
Study Summary* 
1.1  Synopsis 
 
Study Title 
AccessKCTeen 2.0: Increasing teen access to care using peer 
social networks and mobile health services.  
Study Design 
Open Clinical Trial  
Primary Objective 
To evaluate our novel multi-level intervention to increase 
access to care called TeenHealth Outreach+ (THO+).  
Secondary Objective(s) N/A 
Study Population 
• Adolescent participants: clinical trial (intervention 
trial participants as friend network or peer leader) 
and/or event day participants  
 
Up to 250 adolescent participants, including up to 40 peer 
leaders.  
Study Duration for 
Individual Participants 
Up to 7 months for adolescent clinical trial participants, 
event participants complete single survey 
Study Specific 
Abbreviations/ 
Definitions  
(SRH) Sexual and Reproductive Health 
(MH) Mental Health  
(CM) Children’s Mercy 
(MHU) Mobile Health Unit  
 
 
 

 
 
 
 
2.0 
Objectives* 
1. Purpose, specific aims or objectives:   
 
To evaluate our novel multi-level intervention to increase access to care called 
TeenHealth Outreach+ (THO+). 
2. Hypothesis to be tested/Exploratory study design:  
Adolescents receiving THO+ will report that the intervention was feasible. This 
outcome is assessed at the end of the intervention period (which will be about 6 
months after enrollment). 
Background* 
We propose research to evaluate our novel approach to increase adolescent 
access to sexual and reproductive health (SRH) and mental health (MH) care 
during and beyond the COVID-19 pandemic. As adolescents now face new and 
exacerbated access barriers, we seek to expand our work to evaluate a 
community-based intervention to ameliorate the negative impact of the 
pandemic on SRH and MH outcomes. 
In the pandemic’s wake, ambulatory clinic visits decreased by 71% for youth 
aged 7-17 years and remain uncharacteristically low. Further, mitigation efforts 
reduced youth engagement with schools and community programs, limiting 
opportunities for outreach and linkages to care. Decreased access is of particular 
concern for groups with long-standing disparities. Pre-pandemic, racial and 
ethnic minority adolescents had higher rates of sexually transmitted infections 
and unintended pregnancy and reported more persistent or severe mental 
illness. Consistent with national trends, adolescents in our pilot work reported 
increased pandemic-related stress, and many also reported sexual risk-taking. 
They also had unmet needs for SRH and MH care as typical pathways to care 
have been severed, raising concerns that existing disparities may worsen. 
One challenge in responding to COVID-19 is that novel models for care delivery, 
such as telemedicine, are less likely to be used by those with limited familiarity 
and those not already connected to care. Mobile health units (MHUs) hold 
promises to reach adolescents in need of care. However, MHUs are often hosted 
at schools. In many regions, including ours, adolescents have been physically 
absent from most schools for more than eight months. Interventions that 
leverage adolescent social networks to share health information and resources 
with peers have been successful in reducing substance use and MH risk factors. 
To build on this work, we propose engaging with peer leaders, connected to 

 
 
 
 
trusted community organizations, to share tailored information about SRH, MH, 
and novel, community-based, care sources within their networks. 
 Study Design 
Study Design: Open Clinical Trial 
PROGRAM ACTIVITIES: 
AccessKCTeen 2.0 is an outreach program that deploys Children Mercy’s Staff and Mobile Unit 
into the community to increase access to SRH and MH care and resources. AccessKCTeen 2.0 
will focus on education, peer leaders, and community partnership.  All events are optional for 
adolescents to attend. 
Mobile Unit Demonstration Events: The CM mobile unit will go to community sites where 
members of the CM AccessKCTeen team will do the following: provide education on 
telemedicine, SRH, and MH, answer questions on accessing care, SRH, and MH, and help 
adolescents get registered for telemedicine or other care at CM.  
Mobile Unit Clinical Care Events: The CM mobile unit go to community sites where members of 
the CM AccessKCTeen team will provide direct clinical services, such as testing for infections or 
pregnancy, birth control counseling, and birth control. 
Any teen can attend these events. If they choose to attend an event, they must enroll in our 
Event Day Survey, to receive clinical medications (e.g., emergency contraception, birth control 
pills, birth control patch) or testing as this is a requirement for pharmacy documentation.  This 
survey will ask for contact information which is required to track clinical medications and 
provide testing results. 
THO+: Teens as part of a friend network, where peer leaders in each network work with health 
professionals and trusted adults to connect adolescents in their networks to health information 
and sources for care.  
RESEARCH ACTIVITIES:  
INTERVENTION TRIAL PARTICIPANTS:  
All adolescents will have access to THO+ activities and materials shared by the peer 
leaders. 
All adolescents will be asked to complete an eligibility screening survey and baseline 
survey online or in-person. They will complete short surveys at 2, 4 and 6 months via 
Twilio text, call, or email.  
PEER LEADER 

 
 
 
 
We will enroll up to 40 Peer Leaders. In addition to the above activities (under 
intervention trial participant), if a teen is a “peer leader” they will attend a training 
session in-person or online with our study team to learn about sexual and mental health 
information and how to share information with their friends (like text or social media). 
The peer leaders will answer the same surveys described above and will be asked about 
their Peer Leader experience and how they are sharing the study health information. 
The Peer Leader will complete check-ins online, in-person, or through text message to 
gain feedback on their participation.  
EVENT DAY TRAIL PARTICIPANTS  
Adolescents not already in the trial as interventional trail participants who attend 
demonstration and clinical care and have received clinical medications or testing.  They 
have the option to be consented for a single survey.  
 
3. Table of Events for enrolled intervention trial participants:  
 
 
 
Completed 
at 
enrollment 
Mobile unit 
event 
(optional) 
Completed 
after 
enrollment 
Eligibility Screen (Survey Measures Interventional 
Subjects and Mobile Unit Event) 
X 
X 
 
Informed Consent 
X 
X 
 
Contact Information (Survey Measures 
Interventional Subjects) 
X 
 
 
Baseline Survey (Survey Measures Interventional 
Subjects) 
X 
 
 
Event Day Survey (administration of clinical cares to 
possibly include clinical care medicine and testing) 
 
X 
 
2-month Follow-up survey (Intervention Measures) 
 
 
X 
4-month Follow-up survey (Intervention Measures) 
 
 
X 
6-month Follow-up survey (Intervention Measures) 
 
 
X  
 
Research Interventions* 
4. Description:  

 
 
 
 
o This intervention will examine the impact peer leaders have in mobilizing their networks 
to engage in health events and care for MH and SRH. We will examine intervention 
feasibility. We will examine our primary outcome through surveys. 
 
SUBJECT MANAGEMENT 
6.0 
Inclusion and Exclusion Criteria* 
2.  
1. Eligibility Criteria:  
 
(1) INTERVENTION TRIAL PARTICIPANTS (ADOLECENTS)  
Inclusion Criteria 
o Aged 14-18 years and 364 days old  
a. Exclusion Criteria 
o Younger than 14 years old or older than 18 years and 364 days at the time of enrollment 
o Does not speak/understand English 
o Not recruited from an already nominated or enrolled adolescent  
 
(2) Event Day Trail PARTICIPANTS (ADOLECENTS) 
Inclusion Criteria 
o Aged 14-18 years and 364 days old 
o Exclusion Criteria 
o Younger than 14 years old or older than 18 years and 364 days at the time of enrollment 
o Does not speak/understand English 
      
 
2. Equitable Selection:  
1. Adolescents within the social networks of enrolled adolescents will be selected 
for our sample population since peer networks heavily influence adolescents’ 
health behavior choices. Peer networks that diffuse reliable information and 
positively influence norms have efficacy in connecting under-resourced 
adolescents to care.  

 
 
 
 
3. Vulnerable Populations: Check any vulnerable populations that are being 
targeted for enrollment into the study: (Members of the following populations 
may not be included as participants in the research unless selected here.) 
☐ Children/Minors (under 7 years of age) 
☒ Children/Minors (7-17 years of age) 
☐ Neonates (infants less than 30 days old) 
☐ Neonates of Uncertain Viability (infants less than 30 days old) 
☐ Non-Viable Neonates (infants less than 30 days old) 
☐ Wards of the State 
☐ Fetuses 
☐ Pregnant Women  
☐ Adults with impaired decision-making capacity        
☐ CM Employees 
☐ CM Students/Residents/ Fellows 
☒ Economically or Educationally Disadvantaged Persons 
☐ Prisoners 
 
Children/Minors (7-17 years of age): Our research involves no more than minimal risk to 
children aged 7-17 years. To participate in this research study, adolescent participants 
must be between the ages of 14-18 years and 364 days of age. For adolescents this age, 
guidelines from national medical organizations support allowing for waiver of parental 
permission for minimal risk studies to support adolescent autonomy and since teens 
have the capacity to understand and consent for research studies. Adolescents will be 
provided as much time as they want to make their decision and can involve a trusted 
adult if they so choose. Further, state laws enable adolescents to have access to 
confidential SRH and MH care and to make decisions regarding their care.  Because of 
this, we are requesting a waiver of parental permission to help maintain confidentiality 
around sensitive health care and to follow best practices to support adolescent 
autonomy. 
 
Economically or Educationally Disadvantaged Persons: Our research is designed to address 
health disparities; thus, we involve communities experiencing these disparities such as those 

 
 
 
 
that are economically disadvantaged. We are mindful of the history of abuse experienced by 
some of these communities regarding research participation. We will follow best practices for 
engaging in research with disadvantaged communities which include involving community 
members in research design and implementation (as planned for our community action boards) 
and acknowledge the important contributions of community members by providing appropriate 
gift cards or tokens of appreciation (refreshments) and bringing the study findings back to 
stakeholders. 
 
7.0 
Local Number of Subjects 
1.  
1. We will enroll up to 250 adolescents in the trial. Of these, up to 40 will be asked to 
participate as peer leaders.  
 
8.0 
Identification and Recruitment of Potential Participants* 
2.  
1. Identification of Potential Participants:   
How will participants be identified? (Check all that apply) 
 
☐ Chart reviews  
 
☐ By their treating physician who will then provide the study team’s contact 
information to the potential subject/family 
☐ By their treating physician who will obtain patient/family permission to share contact 
information with the study team 
☒ By a partnering community-based organization who will then provide the study 
team’s contact information to the potential subject/family  
INTERVENTION TRIAL PARTICIPANTS: 
Community organizations and partners will be given a paper or digital flyer (titled 
Peer Leader Flyer) about the program and see if any adolescents are interested. 
They will then let a study team member know which adolescents would like to 
be in the study. A study member will approach the interested adolescents to see 

 
 
 
 
if they would like to be a part of the study. After interested adolescents are 
enrolled, adolescents will turn to their social networks to recruit more 
adolescents to participate in the trial. After networks are formed, networks in 
the THO+ arm will nominate a peer leader to work with our team to disseminate 
health information related to SRH and MH.  
Event Day Participants 
Community organizations and partners will host our team and may share 
information through their own networks. A study team member will approach 
teens who are interested in receiving clinical care medications or testing at 
events. If they choose to receive clinical care services they must enroll as an 
Event Day participant.  
We will create a QR code that community partners may share with potential 
event day participants. Once scanned, the code will reveal this text:  
Get healthy with Children’s Mercy!  
We hope to talk with you about our study to learn about getting care on a mobile health unit.  
Your health and your voice matter!  
 
☐ By a partnering community-based organization who will obtain patient/family 
permission to share contact information with the study team 
☒Self-refer in response to IRB approved advertisements or websites 
☐ Through Cerner or other CM sources (e.g. databases, billing records, pathology 
reports, admission logs, etc.) May involve access of records by individuals not involved 
in the patient’s care. 
☐ List of candidates provided through the Data Report Request Form  
☒ Registry of individuals interested in research opportunities   
INTERVENTION TRIAL PARTICIPANTS: 
Community organizations and members of our CAB can give study staff a list of 
interested adolescents who we can contact to participate in this program.  
☒Past subject list 
☐ Participants will roll-over from another research study: Study #_______________ 
☒ Other: __  

 
 
 
 
2. Pre-Screening prior to HIPAA Authorization 
Will any of the identification methods checked above involve access to 
Protected Health Information (PHI) prior to obtaining HIPAA 
Authorization? 
☐ Yes 
 
☒ No 
If yes, a “Partial Waiver of HIPAA Authorization” is required.  Be sure to make this selection in 
the “HIPAA & Confidentiality” section below and complete Addendum E: Waiver/Alteration of 
HIPAA Authorization 
3. Recruitment of Potential Subjects:   
1. Describe when, where, and how potential participants will be recruited.  
INVERVENTION TRIAL PARTICIPANTS: Community organizations and partners will be given a 
paper or digital flyer (titled Peer Leader Flyer) about the program and see if any adolescents are 
interested. They will then let a study team member know which adolescents would like to be in 
the study. A study member will approach the interested adolescents to see if they would like to 
be a part of the study. After interested adolescents are enrolled, adolescents will turn to their 
social networks to recruit more adolescents to participate in the trial. After networks are 
formed, networks will nominate a peer leader to work with our team to disseminate health 
information related to SRH and MH.  
A Children’s Mercy social media account will be used in accordance to CMH requirements if 
needed to facilitate follow-ups for AccessKCTeen surveys, and to inform Peer Leaders of 
AccessKCTeen events for them to share with their peer networks for recruitment.  
a) ADOLESCENT INTERVENTION TRIAL PARTICIPANTS: We will develop a digital or paper 
flyer (titled Peer Leader Flyer) about participation in this research study that will be 
distributed to our community partners and enrolled adolescents.  
o Adolescents will not be contacted more than three times for initial study 
participation. For each follow-up survey, study staff will make up to three attempts 
to reach these teens by phone, text (reminder of appointment for survey through 
Twilio/Spark or CM approved messaging), and/or email. 
b) ADOLESCENT EVENT PARTICIPANTS: We will recruit adolescents using paper or digital 
information sheets on the day of the event. We will create a QR code that community 
partners may share with potential participants. The text will read: 
Get healthy with Children’s Mercy!  
We hope to talk with you about our study to learn about getting care on a mobile health unit.  
Your health and your voice matter!  
  

 
 
 
 
9.0 
Surveys and Psychometric Testing: 
• 
Describe any surveys or psychometric testing that will be conducted as part of the study. 
Address whether the instruments used have been previously validated. 
o INTERVENTION TRIAL PARTICIPANTS: Surveys include: 
▪ (Titled Survey Measures Interventional Trial Participants) Eligibility 
Screen, contact form, baseline survey 
▪ (titled Survey Measures Intervention Trail Participant): 2, 4, 6 follow-up  
▪ Event Day Survey Measures (optional).  
▪ Surveys will include both closed-ended and open-ended questions (see 
table below). When possible, we will use previously validated measures. 
▪ Peer Leaders in the THO+ arm will complete check-ins by text message, 
on-line or in-person.  
 
o ADOLESCENT EVENT PARTICIPANTS: Survey (titled Event Day Survey Measures) at 
the event day survey (optional).  
 
 
Feasibility constructs (Bowen et al.) and sample measures 
Construct 
Source 
Sample Measure* 
Acceptability - How do 
stakeholders react? 
Adolescent 
Satisfaction**; Recommend to friends**;  
 
 
Demand - To what extent 
is the intervention likely to 
be used? 
Adolescent 
Likelihood to use again**; proportion of friends who would 
use 
 
 
Implementation - To what 
extent can the 
intervention be 
implemented as planned? 
Adolescent 
Engagement**; “What toolkit ideas worked well/not so 
good?” 
 
 
Study 
Record# 
Fidelity to peer leader training, engagement, attendance 
Practicality - What factors 
make intervention 
delivery challenging or 
facilitate delivery? 
Adolescent 
Ease of talking with friends about health** 
 
 
Study 
Record# 
Field notes 

 
 
 
 
Integration - To what 
extent can intervention be 
integrated within 
community? 
 
Adolescent 
Frequency of network health information exchange** “What 
was it like to learn about SRH/MH health at community 
partner?”  
 
 
Expansion - To what 
extent can model be 
expanded? 
Adolescent 
Openness to vaccine information using intervention** 
 
 
Limited efficacy - Does 
the intervention show 
promise? 
Adolescent,  
Study/Medic
al Record# 
Health care utilization (yes/no; also where accessed, what 
type);74 new patient registration (yes/no); care-seeking 
intention** 
 
*Appendix has complete list of closed- and open-ended items; **Likert responses range from 1 (“strongly 
disagree”) to 5 (“strongly agree”); #Additional assessments: proportion enrolled, attendance for study 
activities  
 
 
• 
List the names of each instrument (survey, questionnaire, test, etc). Upload copies of any 
surveys, psychometric tests, or other instruments that will be administered for research 
purposes in the myIRB application, Other Attachments section.   
o We will submit the following attachments: 
▪ INTERVENTION TRIAL PARTICIPANTS: Survey Measures for intervention 
participants (titled Survey Measures Interventional Trial Participants) 
includes Eligibility Screen, Contact Information and Baseline Survey, 
(titled Survey Measures Interventional Trial Participants), includes 2, 4, 6 
Follow-Up Survey and Event Day Survey Measures (optional) 
▪ ADOLESCENT EVENT PARTICIPANTS: Survey Measures for Event Day 
Participants includes Eligibility Screen, Contact Information (titled Event 
Day Survey Measures)  (optional).  
 
10.0 Additional Research Activities 
N/A 
11.0 Follow-up 
c) INTERVENTION TRIAL PARTICIPANTS: Adolescents will interact with us for 6 months as 
this is the duration of the intervention period. After enrollment, adolescents will 
complete a follow-up survey at 2, 4, and 6 months. Study staff will make up to three 

 
 
 
 
attempts to contact the participant and the follow-up survey will be administered via 
phone call, text message (Twilio/Spark) or Email. 
d) Event Day Participants: N/A 
 
12.0 Genetic Analysis Information 
13.0 Sharing of Results with Subjects 
3.  
1. Describe whether results (study results or individual subject results, such as 
results of investigational diagnostic tests, genetic tests, or incidental findings) will 
be shared with participants or others (e.g., primary care physicians) and if so, 
describe how the results will be shared. See Research Documentation in the 
Electronic Health Record for details on what must be included in the EMR. 
We intend to share study results with participants and community partners 
through informational meetings and flyers and other forms of communication 
used by partners (email, newsletters). 
We intend to share study results in the academic community though 
presentations and a peer-reviewed publication. 
We will share only aggregated results, never any individual subject results.  
14.0 Risks to Subjects* 
• Risk of emotional distress: Participants may experience increased stress over survey 
questions asking about mental or sexual health. However, we feel this risk is minimal 
and will include information in the consent process that reminds participants that they 
are not required to answer questions that make them feel uncomfortable. We will have 
a list of other community resources for participants needing services. During the 
consent process, we will inform participants that most of the information they share 
during the study will be kept confidential except in rare cases where their safety is at 
risk or mandated reporting is in effect. 
• Risk of Unsecure two-way texting: Participants and member of the community have a 
risk of breach of confidentiality when using two-way messages. Information security is a 
top priority for both the investigators and the hospital. When any PHI (name, address, 
date of birth etc.) or sensitive information is received through an unsecure two-way 
messaging platform, a member of the research team will contact the participants or 
members of the community directly by phone call to gather all information on a secure 
platform. 

 
 
 
 
• Risk of breach of confidentiality: There is potential for loss of confidentiality. 
Information security is top priority for both the investigators and the hospital. We 
believe that all identifying and clinical information will be secure, and a security breach 
is highly unlikely to occur. We will store participants’ names and contact information on 
a REDCap project accessible only to the study team. Name and contact information will 
be kept on a separate REDCap instrument within the main project and marked as 
“identifiers”. Thus, data downloaded for analysis will not include any identifying 
information, and all names and phone numbers will be destroyed at the end of the 
study.   
We believe the risks involved in this study are minimal. 
o If applicable, indicate which activities may have risks to the subjects that are 
currently unforeseeable. 
N/A 
o If applicable, indicate which activities may have risks to an embryo or fetus, 
should the participant be or become pregnant. 
N/A 
o If applicable, describe risks to others who are not participants (e.g. pregnant 
partner of a male subject) 
N/A 
15.0 Potential Benefits* 
• Describe the potential of any direct benefits that individuals may experience from taking 
part in the research. Include the probability, magnitude, and duration of the potential 
benefits as this will be useful to the IRB in making their risk/benefit determination. 
There may be no direct benefits to participating in this study. Some 
participants may benefit from learning about health information and care 
sources in their community. 
• Describe the potential of any benefits to society/science or others related to the possible 
knowledge gained. 
The knowledge gained from this study will help inform future local efforts 
aimed to connect teens in Kansas City to the healthcare they need and 
will inform the wider scientific/public health community of opportunities 
and effective strategies for integrating peer leader and mobile health 
intervention models. 
16.0 Investigator Assessment of Risk/Benefits Ratio*  

 
 
 
 
16.1 
Please provide an assessment of risk and benefits in the table below.  Note, the 
IRB makes the final determination based upon responses in the two preceding 
sections. 
 
Select as applicable: 
Pediatric Risk Category: 
☒ 
Category 1  Research not involving greater than minimal risk  
(45 CFR §46.404 and 21 CFR §50.51)   
☐ 
Category 2 
Research involving greater than minimal risk but 
presenting the prospect of direct benefit to the 
individual subjects. (45 CFR §46.405 and 21 CFR 
§50.52) 
☐ 
Category 3 
Research involving greater than minimal risk and no 
prospect of direct benefit to individual subjects, but 
likely to yield generalizable knowledge about the 
subject's disorder or condition.  
(45 CFR §46.406 and 21 CFR §50.53) 
☐ 
Category 4 
Research not otherwise approvable which presents 
an opportunity to understand, prevent, or alleviate a 
serious problem affecting the health or welfare of 
children. (45 CFR §46.407 and 21 CFR §50.54) 
Select if applicable: 
Adult Risk Category: 
☒ 
Not Greater than Minimal Risk 
☐ 
Greater than Minimal Risk 
 
 
17.0 Payment, Reimbursement and Tangible Property provided to subjects*  
Is payment, reimbursement, or tangible property part of the study?  
☒ Yes                 ☐ No (If No, delete the following subsections) 
• Payment to Subjects: If providing payment for participation (e.g., cash equivalent 
for participation, payment for time off work), select the form of payment: 
 
☒   Greenphire/ClinCard (will be used for in 
☒ Gift Card: (Merchant:_Rybbon electronic cards will be used as a primary 
compensation method. Physical Target/Walmart cards may be used for teens that 
prefer physical gift cards over electronic) 
☐ Other: __________ 
 

 
 
 
 
Note: “Gift Card” and “Other” options require approval by Research Administration. Upon 
submission in myIRB, ORI staff will initiate the Research Administration approval process. 
 
Payment Schedule: Describe the payment schedule (if the payment schedule is involved, 
consider using a table to display this information) including: 
Intervention Trial Participants: Adolescents will have an opportunity to receive up to 
$60. They will be given a $30 gift card after completing the baseline survey. A $10 gift 
card will be given for each follow-up survey that is completed at 2, 4, and 6 months after 
enrollment.  
Peer Leaders: Teens can choose to earn an additional $225 for being a peer 
leader or they can choose to earn up to 30 hours of academic volunteer or 
community service hours.  
Teens that choose to earn an additional $225 for being a peer leader will receive 
$100 for Peer Leader Training, $25 recruiting the first teens to the research study 
and $ 5 for each teen recruited after the first teen (Maximum of $50 for 10 
additional friends enrolled), and  they will get up to $5 for each text message 
check-in or virtual meeting check-in ($50 for up to 10 check-ins).  
 
All Peer Leaders enrolled prior to protocol version 7.18.2022 will be contacted 
via phone and notified of compensation changes. The notification of change of 
compensation for Peer Leader participants will be documented in REDCap under 
the note section.  For those who have already enrolled more than one friend will 
be retroactively compensated following the new compensation changes.  
Teens can earn up to 30 hours of academic volunteer or community service hours for 
participating in the training, Peer Leader virtual meeting check-ins, helping study staff to 
prepare for events (inventory, setup and takedown), attending events, text message 
check ins, and recruiting other teens to enroll in the study. 
For teens who choose academic volunteer or community service hours, they must 
follow the guidelines of their academic institutions to ensure the hours gained through 
AccessKCTeen 2.0 would count towards their requirement. If their academic institution 
does not allow the volunteer or community service hours, they have the option to join 
the research study and earn up to $225 (as listed above) for their participation. 
Teens will have the flexibility to change the type of compensation received, (up to $225 
or Academic Community Service Hours) at any time during the study.   
  
Event day Participants: Adolescents will have an opportunity to receive study 
medications and/or testing. At demonstration events, they may receive emergency 

 
 
 
 
contraception for future use. At clinical events, they may receive contraception (emergency 
contraception, depo-provera, birth control pills/patch) and/or testing for pregnancy/sexually 
transmitted infections. 
 
• Tangible Property: If providing tangible property or any item of value given for 
participation (e.g., a toy, a tote bag, a water bottle, an electronic device), describe: 
• The item(s) to be offered to research participants at some of the mobile unit events 
include the following:  
• Demonstration event: 
Emergency Contraception Plan B (Levonorgestrel) for future use 
• How and when will the item(s) be distributed 
This item will be given to any research participant who feels the need to have it 
after a mobile unit event (optional)  
• The estimated total maximum value of the item(s). 
$19  
• Clinical event: 
• Emergency Contraception Plan B (Levonorgestrel); birth control pills/patch/depo 
shot, testing for pregnancy and/or sexually transmitted infection. 
• How and when will the item(s) be distributed 
These items will be given to any research participant who wants to start 
medication or get tested at a clinical event (optional)  
• The estimated total maximum value of the item(s). 
Emergency contraception = $19 
birth control pills = $78.80 
birth control patch= $113.60 
depo shot= $37.81 
testing for pregnancy =$15.26 
testing for Chlamydia=$115.33 
Testing for Gonorrhea=$24.69 
 

 
 
 
 
• If the estimated total maximum value of payment and/or tangible property 
provided to an individual subject may exceed $600, include plans for the collection 
of Social Security Number (SSN) or Individual Tax Identification Number (ITIN) per 
CM policy. 
18.0 Compensation for Research-Related Injury 
4.  
o If the research involves more than Minimal Risk, describe the available 
compensation in the event of research related injury. NOTE: For industry 
sponsored studies, this must match the agreed upon language in the Clinical 
Trial Agreement (CTA). 
N/A 
 
19.0 Economic Burden to Subjects 
5.  
o Describe any costs that participants may be responsible for because of 
participation in the research. This may include transportation to 
appointments, time away from work, parking, additional lab tests, et cetera. 
N/A 
 
20.0  Parental Permission and Adult Consent Process* 
 
20.1 
Indicate below all methods of Permission/Consent that will be used in this 
study.   
• If the study includes multiple study groups, be sure to indicate which method is being 
used with each group. 
• If requesting a Waiver of Documentation, a complete Waiver, or an Alteration, 
complete the required regulatory addendum noted below.   
 
Waiver of Documentation of Permission/Consent 
Permission/Consent form provided but signature will NOT be obtained (e.g. verbal consent) 
Must complete Addendum A: Waiver of Documentation of Permission/Consent 

 
 
 
 
 
☐ Waiver of written documentation of permission of parent/LAR for pediatric 
participants N/A 
     
☒ Waiver of written documentation of consent of adult participants  
Study group(s) to which this method applies: We will obtain verbal consent for any 
participants who are aged 18 or older upon enrollment. This includes adolescents that 
may be 18 years and 364 old upon enrollment and adult stakeholder participants.  
☒ Waiver of written documentation of consent of participants turning 18  
Study group(s) to which this method applies: (Active Participants) Any adolescent 
turning 18 during the study participation still actively participating in study activities. In 
the case a participant turns 18 from the time of the baseline survey through the time of 
the follow-up surveys, we will complete verbal adult informed with that participant 
before the 2, 4, 6-month follow-up call.  
 
 
Waiver or Alteration of Permission/Consent 
Adult consent will NOT be obtained, or you propose to alter a required element of consent. 
Must complete Addendum B: Waiver of Permission/Assent/Consent 
 
☒ Waiver/Alteration of permission of parent/LAR for pediatric participants 
Study group(s) to which this method applies: All parents of adolescents between the 
ages of 14-17.  
☐ Waiver/Alteration of consent of adult participants 
Study group(s) to which this method applies:  
☒ Waiver of consent of participants turning 18 
Study group(s) to which this method applies: (Non-Active Participants) Adolescent participants 
that turn 18 during the study and have completed study activities for the continued access to 
and use of identifiable data. 

 
 
 
 
 
Additional Methods 
☐ Obtaining permission/assent/consent of non-English speaking parents or participants 
Must compete Addendum C: Non-English Speaking Subjects 
Study group(s) to which this method applies: 
☐ Surrogate decision maker consent form adults not capable of consenting for 
themselves 
Must complete Addendum D: Surrogate Decision Maker Consent 
Study group(s) to which this method applies: 
 
20.2  Permission/Consent/Consent at 18 Discussion: If selected options for “Written” or 
“Waiver of Documentation” above, describe below how the informed 
permission/consent discussion will be conducted. Describe: 
• Where and when the discussion will take place. 
• Steps that will be taken to minimize the possibility of coercion or undue influence. 
• Any supplemental materials that will be used to enhance the discussion (e.g. 
videos, sent, educational pamphlets).  
• Any measures that will be taken to ensure that parent(s)/LAR have adequate 
time to ask questions and decide if they will permit their child to participate in 
the study (e.g., providing a copy of permission form in advance of visit). 
• How comprehension of the permission form will be verified (e.g. teach back). 
• If obtaining permission via telephone, confirm CM research policy will be 
followed.   
• Process to ensure ongoing consent during the study. 
 
Intervention Trial Participants: 
For adolescents, we will review a study information sheet in-person  or online (titled 
Study Information Letter for Intervention Participants). This info sheet will be 
available for the participant to keep. We will use a teach-back method to ensure 
participant understanding and ensure that the participant has the opportunity to ask 
questions before agreeing to participate. 
 

 
 
 
 
20.3 Documentation of Permission/Consent/Consent at 18:  If selected “Written” 
options above, explain how informed permission will be documented.  Describe: 
• Whether CM Research Policy “10.04 Obtaining Permission/ Assent/ Consent” and 
“Research Documentation in the Electronic Health Record” will be followed.  If 
not, describe whether and how permission of the parent(s)/LAR will be 
documented in writing. 
• Whether e-Consent will be used to document permission (non-FDA regulated 
studies only).   
N/A 
 
20.4 Identification of participants turning 18: Explain the process for tracking 
participants to ensure that consent is obtained to continue participation once they turn 
18 years of age. 
 
INTERVENTION TRIAL PARTICIPANTS: We will build a REDCap alter to indicate to study 
staff on the Event Daysurvey (optional) and on the Survey Measures Interventional Trial 
Participants follow-up surveys whether the adolescent has turned 18 since the baseline 
survey according to their date of birth. If yes, we will proceed with adult consent 
processes and record having done so in the REDCap survey. If the participant attends a 
mobile unit event and has turned 18, they will be re-consented in-person at the event. If 
they have turned 18 by the follow-up surveys, they will be re-consented over the phone.  
21.0 Assent of Pediatric Subjects 
 
21.1 
Select the option(s) that apply to the study: 
 
☐ Obtaining assent of pediatric participants is NOT POSSIBLE due to: 
☐ The capability of the participants (considering the ages, maturity, physical and/or 
psychological state) is so limited that they cannot reasonably be consulted. 
☐ The intervention or procedure involved in the research holds out a prospect of 
direct benefit that is important to the health or well-being of the participants and 
is available only in the context of the research. 
 

 
 
 
 
☐ Obtaining assent of pediatric participants is NOT PRACTICLE given the context of 
this study (e.g., minimal risk, no direct contact with subjects). 
Must complete Addendum B: Waiver/Alteration of Permission/Assent/Consent 
 
☒ Assent of pediatric participants WILL BE SOUGHT following assessment of ability to 
assent: Waiver of written documentation of assent of pediatric participants (ages 14-17)  
. 
 
 
21.2 Assessment of Ability to Assent: If seeking assent from pediatric subjects, describe 
how the ability to assent will be determined.   
 
Intervention Trial Participants: Adolescents will have to be at least 14 years of age or 
older to participate. Study staff will determine ability to provide assent in similar 
manner as with adult consent. 
 
21.3 Assent Discussion: If seeking assent from pediatric participants, explain how the 
assent discussion will be conducted. Describe: 
• Where and when the discussion will take place. 
• Steps that will be taken to minimize the possibility of coercion or undue influence. 
• Any age-appropriate supplemental materials that will be used to enhance the 
discussion (e.g., videos, eConsent, educational pamphlets).  
• Any measures that will be taken to ensure that pediatric participants have 
adequate time to ask questions and decide if they want to participate in the 
study. 
• How comprehension of the study will be verified (e.g., teach back). 
• If obtaining assent via telephone, confirm CM research policy will be followed.   
• Process to ensure ongoing assent during the study. 
The minor adolescents (ages 14-17) will be asked to provide verbal assent after the 
study is explained in detail in person. We will follow best practice guidelines established 
for adolescent participation in health research. This includes building a research team 
that is specially trained to work with adolescents, using age-appropriate language that is 
easy to understand and allowing adolescents ample time to consider participation and 

 
 
 
 
ask questions. We will clearly state that participation is voluntary. Potential adolescents 
will be asked if they understood the information and if they have any questions. 
 
For those adolescents who enroll virtually they will be provided with the study 
information sheet (titled Study Information Letter for Intervention Participants) from 
our REDCap to review by themselves. If the participant has any questions about the 
study, they can contact the PI listed on the information sheet or the research staff over 
the phone to ask questions prior to completing the study. If the adolescent does not 
have any questions about the study, they will use REDCap to agree to the study. 
 
21.4 Documentation of Assent or Inability to Assent: If seeking assent from pediatric 
participants, explain how assent, or a determination of inability to assent, will be 
documented.  Describe: 
• Whether CM Research Policy “10.04 Obtaining Permission/ Assent/ Consent” and 
“Research Documentation in the Electronic Health Record” will be followed.  If 
not, describe whether and how assent, or inability to assent, will be documented 
in writing. 
• Whether e-Consent will be used to document assent (non-FDA regulated studies 
only).   
 
For this mature group of minors (ages 14-17), we wish to document assent or inability to 
assent similarly to how we will document adult consent. Study staff conducting assent 
will document within REDCap that the participant indicated they understood all study 
procedures, had the ability to answer questions, and agreed to participate. However, we 
will not be collecting signatures. 
 
 
22.0 HIPAA and Confidentiality 
 
HIPAA regulations apply to this study if the data used or accessed relates to: 
The past, present or future physical or mental health or condition of an individual; The 
provision of health care to an individual; OR The payment for the provision of health care. 
 

 
 
 
 
22.1 
HIPAA Authorization  
Select all applicable methods of HIPAA Authorization that apply to this study.   
☐ Full Written HIPAA Authorization will be obtained (within the p/a/c form or 
standalone form) 
 
☐ Partial Waiver of HIPAA Authorization (e.g., waiver for recruitment and pre-screening 
purposes only) 
Must complete Addendum E: Waiver/Alteration of HIPAA Authorization 
 
o Describe the PHI for which use, or access is necessary for research. 
 
☒ Alteration of HIPAA Authorization (some but not all required elements of an 
Authorization are present, e.g., signature will not be obtained) 
Must complete Addendum E: Waiver/Alteration of HIPAA Authorization 
 
• Describe which proposed elements to be altered. 
 
We will not obtain a signature from adolescents 
 
☐ Waiver of HIPAA Authorization (authorization will NOT be obtained) 
 
☐ If Other, explain: 
 
22.2 
Indicate how the research team will protect the confidentiality of 
subjects’ data during storage, use, and transmission (e.g., training, 
authorization of access, password protection, encryption, physical controls, 
and separation of identifiers and data [master list]). Remember: Sensitive CM 
data, including research data, must be stored on a file server on the CM 
network domain – not on a workstation hard drive.  

 
 
 
 
We will store all data in REDCap on a CM secured device. Signatures on paper 
will not be obtained to avoid obtaining written PHI.  
 
22.3 
State whether a Certificate of Confidentiality has been issued for this 
study.  Certificates are automatically issued for NIH funded research per NIH 
policy. For non-federally funded research involving identifiable, sensitive 
information, investigators may apply for a Certificate if desired.  See the NIH 
website on Certificates of Confidentiality for more details. 
 
This study is funded by the NIH and therefore is automatically provided a 
certificate of confidentiality. 
 
23.0 Provisions to Protect the Privacy Interests of Subjects* 
23.1 
Describe the steps that will be taken to protect subjects’ privacy during 
recruitment and while obtaining permission/assent/consent.  For example, best 
practice is to obtain permission/assent/consent in a separate area where a private 
conversation can be had. If this is not possible, be sure to explain what steps will be 
taken to provide as much privacy as possible. 
 
Assent/consent will be collected one-on-one in-person or virtually with all adolescents. 
For adolescents, study staff will make sure potential adolescent participants have access 
to privacy remotely or in-person.  
 
 
 
23.2 
Describe what steps you will take to make the subjects feel at ease with the 
research situation in terms of the questions being asked and the procedures being 
performed. “At ease” does not refer to physical discomfort, but the sense of 
intrusiveness a subject might experience in response to questions, examinations, and 
procedures. 
Adolescents will be contacted by study staff with experience working with adolescent 
research participants. They will be told about the study and given as much time as 
necessary to decide if they want to participate. We will ensure that adolescents know 
they are free to choose whether to participate in all study-related activities and surveys. 

 
 
 
 
 
23.3 
Indicate how the research team is permitted to access any sources of 
information about the participants and how the research team will protect the 
confidentiality of the data. 
We will input all survey data into REDCap that is on a secured server.  
24.0 Withdrawal of Subjects* 
24.0 Describe anticipated circumstances under which participants will be withdrawn 
from the research without their consent. 
N/A 
24.1 Describe procedures that will be followed when participants are withdrawn 
from the research, including data retention plans or partial withdrawal from 
procedures with continued data collection. 
For adolescents that do not complete the follow-up surveys, we will still use their 
baseline data for analysis. Their contact information will be destroyed after the third 
attempt to reach them. 
 
DATA MANAGEMENT 
25.0 Data Collection* 
6.  
1. Provide a general description of the types or categories of data that will be 
collected during the study (e.g., lab test results, procedure outcomes, length of 
stay, questionnaires, surveys).  Details on identifiable data and sensitive data will 
be described below:  
o Survey data through REDCap 
o For those receiving Clinical Care there will be data collection for feasibility of the mobile 
unit for the following: Biological Sex of Patient, Age of Patient, Participation in 
Pregnancy test, STI testing for gonorrhea/chlamydia (urine), and STI testing for HIV and 
Syphilis (blood). Results for the following: pregnancy test, STI test results for 
gonorrhea/chlamydia/HIV/syphilis (urine and blood). Record of if birth control was 
received and which type. Record of Condoms taken.  Record if referral to Children’s 
Mercy Hospital Adolescent or Teen Clinic was given. All services are optional for teens.  
All information collected will be de-identified.  
2. Describe the source of the data and how that data will be obtained.  

 
 
 
 
• All data will be collected directly from participants by entry into redcap via ipad, phone 
call, text (Twilio), or email.   
3. Sensitive Data: If collecting or accessing sensitive data which may pose legal, 
economic, or reputational harm, please specify here. 
N/A 
4. Identifiable Data: To minimize risks, only the minimum necessary identifiable 
data should be accessed and/or recorded. Indicate below which identifiable data 
elements will be accessed only versus which data elements will be recorded, i.e., 
written down for the purposes of this research study.   
Names, phone number, and email addresses will be recorded for the purposes of 
the 2-, 4- and 6-month follow-up phone calls. We will also record phone 
numbers to send text messages to engage peer leaders. Date of birth will be 
recorded to assess the age of intervention trial participants. Zip codes will be 
recorded to identify if we are serving economically, or disadvantage youth based 
on their location.  
 
a) Name/Initials 
☐ Accessed only 
☒ Recorded 
b) All elements of date (except year) directly 
related to an individual (e.g. date of birth, 
admission date, discharge date, date of 
death) 
☐ Accessed only 
☒ Recorded 
c) Medical record number 
 ☒Accessed only 
☒ Recorded 
d) Account number 
☒ Accessed only 
☐ Recorded 
e) Health plan identification number 
☐ Accessed only 
☐ Recorded 
f) Social Security Number 
☐ Accessed only 
☐ Recorded 
g) Device identifiers and serial number 
☐ Accessed only 
☐ Recorded 
h) Certificate/License number 
☐ Accessed only 
☐ Recorded 
i) Telephone number 
☐ Accessed only 
☒ Recorded 
j) Fax number 
☐ Accessed only 
☐ Recorded 
k) Email addresses 
☐ Accessed only 
☒ Recorded 
l) Web addresses (URLs); Internet IP addresses 
☐ Accessed only 
☐ Recorded 
m) Street address, city, county, precinct, zip 
code or equivalent geographical codes 
☐ Accessed only 
☒ Recorded 
n) Full face photographic images and any 
comparable images 
☐ Accessed only 
☐ Recorded 
o) Biometric identifiers, including finger and 
voice print 
☐ Accessed only 
☐ Recorded 
p) Vehicle identifiers and serial numbers, 
including license plate number 
☐ Accessed only 
☐ Recorded 

 
 
 
 
q) Any other unique identifying number, 
characteristic or code that may help identify 
individual participants including their initials 
(e.g. student or employee ID number) 
☐ Accessed only 
☐ Recorded 
r) Elements of date, including year, for persons 
90 years or older 
☐ Accessed only 
☐ Recorded 
s) Other: 
☐ Accessed only 
☐ Recorded 
 
26.0 Adverse Events and Unanticipated Problems* 
Intervention Trial Adolescent Participants: In the unlikely occurrence of an adverse event 
or unanticipated problem, we will follow established practices for adolescents engaged 
in minimal risk research. It is possible that some of the intervention content may make 
some participants feel uncomfortable. We will clearly announce multiple times 
throughout the intervention duration that participation is voluntary, and adolescents 
may skip parts if they prefer. We have trained staff who are skilled in discussing 
sensitive topics like sexual health and mental health. While unlikely, someone may share 
information about a serious health risk to themselves or others (I.e., thoughts of hurting 
oneself).  Our team has experience with these serious conditions and will work with 
community partner leaders and the parent or guardian to establish a safe care plan that 
may include referral to the CM emergency department for urgent evaluation.  
 
7.  
1. Monitoring: Describe the process for monitoring participants and data to 
identify adverse events and other unanticipated problems. 
 
Intervention Trial Participants: Study staff will review study data every month for any 
adverse events.  
 
2. Reporting:  Confirm Policy 5.11 Reportable Events of the CM Research Program 
Policies and Procedures will be followed in regards to reporting adverse events 
and other unanticipated problems to the CM IRB. If deviating from, or expanding 
upon this policy, explain why the approved policy would not suffice for this study 
and the rationale for deviating/expanding 
 
 

 
 
 
 
27.0 Data Analysis* 
8.  
1. Describe the data analysis plan, including any statistical procedures or power 
analysis. 
Describe how the sample size for the study was determined (e.g. formal sample 
size calculation, convenience sampling). To minimize the risks associated with a 
possible breach of confidentiality, appropriate sample size calculations limit the 
amount of patient data being recorded to the amount necessary to answer the 
research question. 
Quantitative data: We will conduct descriptive analysis with inferential and 
graphical exploratory analytic techniques, presenting mean, median, and 
interquartile range [continuous variables] and frequency and percentage 
[categorical variables]. We will examine outliers and/or influential points, 
perform bivariate analyses to assess relationships, and summarize group data. 
We will use SAS 9.4 (SAS Institute Inc., Cary, NC, USA); the significance level will 
be 0.05. For our primary outcome, we calculate the proportion in each arm with 
any health care utilization at 6 months. We use logistic regression to assess 
intervention effect on utilization and explore differences in other outcomes. 
Models will include covariates to adjust for variables (e.g., sex, age) that may 
increase precision. We will explore heterogeneity of effects with stepwise 
addition on interaction terms to examine moderation by sex, age, or 
engagement. If >20% of data is missing, we will use complete cases 
or imputation, based on missingness pattern. 
28.0 Data and Specimen Management* 
9.  
1. Data Management: Describe how data will be handled, including: 
▪ What information will be included with the data? 
• Intervention Trial Participants: Survey information included as 
data will be questions from our eligibility screen, baseline 
survey, Event Day Survey Measures(optional) and 2-, 4-, and 6-
month follow-up. We will ask adolescents about their health 
behaviors as well as some demographics to describe the group 
(age, gender identity, race). Attendance at study-related 
events, training, and group sessions will be included as data. 
• Event day Participants: Survey information included as data 
will be questions from our eligibility screen, and Event Day 
Survey Measures (optional). For those receiving Clinical Care 

 
 
 
 
the information included as data: Participation in Pregnancy 
test, STI testing for gonorrhea/chlamydia (urine), and STI 
testing for HIV and Syphilis (blood). Results for the following: 
pregnancy test, STI test results for 
gonorrhea/chlamydia/HIV/syphilis (urine and blood). Record 
of if birth control was received and which type. Record if 
referral to Children’s Mercy Hospital Adolescent or Teen Clinic 
was given. All services are optional to teens.  
 
▪ How the data will be collected and stored. (e.g., REDCap, Excel, paper forms) 
• All data will be directly accessible and stored securely via 
REDCap at CMKC.  
▪ How long will the data be stored?  
• Contact information for teens that would like to participate in 
future research will be kept for 5 years and then destroyed. 
For teens that do not want to participate in future research, 
we will destroy contact information as soon as the study is 
completed.  De-identified data will be stored in accordance 
with CMRI guidelines and will be deleted once IRB project is 
closed  
▪ Who will have access to the data? 
• CM study team, students from the University of Kansas 
Medical Center (KUMC) and University of Missouri – Kansas 
City (UMKC) will have access. A reliance will be obtained from 
both institutions.  
▪ Who is responsible for receipt or transmission of the data?   
• Trained CM research team members and students from the 
University of Kansas Medical Center (KUMC) and University of 
Missouri – Kansas City (UMKC) 
▪ Methods for transferring data. 
• All data that is shared will be de-identified using a secure data 
transfer system. 
2. Specimen Management:  
N/A                                                                                                                                                                                          
3. Biosafety Information 
Will this study involve handling, transporting, or shipping any potentially 
hazardous biological material at/from a Children’s Mercy location (e.g., 
blood, stool, saliva, tissue)? 

 
 
 
 
☐ Yes 
☒ No 
Will this study involve processing any potentially hazardous biological 
material at a Children’s Mercy location (e.g., blood, stool, saliva, tissue)? 
☐ Yes 
☒ No 
If processing potentially hazardous biological materials, where will this work 
be conducted? 
☐ Pediatric Clinical Research Unit (PCRU) 
☐ Children’s Mercy Research Institute labs (mySafety ID#: __________) 
☐ Other location 
If “Other location,” identify the location and mySafety ID# of the 
corresponding IBC protocol: 
Location: ____________________ 
mySafety ID#: ___________________________  
 
29.0 Storage/Banking of Data and Specimens for Future Research 
 
N/A 
 
10. 
30.0 Provisions to Monitor the Data to Ensure the Safety of Subjects 
This section is required when research involves more than Minimal Risk to 
participants. 

 
 
 
 
N/A: Our study involves no more than minimal risk to participants  
11. 
 
STUDY MANAGEMENT 
31.0 Setting & Locations* 
12. 
o Describe the sites or locations where the research will be conducted. 
o Research may be conducted in a variety of settings including the community, within 
CMRI, virtually on Microsoft TEAMS, as well as at mobile unit events at community 
partner locations.    
Identify where research procedures will be performed including any non-CM 
affiliated locations.  For any non-CM affiliated locations, upload a letter of 
support in myIRB which states that the site is aware that research will be 
conducted on their premises. 
o Community Partners: 
a) Mattie Rhodes Center 
                    148 North Topping Ave 
                    Kansas City, MO 64123 
b) Front Porch Alliance 
     3210 Michigan Ave 
     Kansas City, MO 64109 
 
 
 
Describe the composition and involvement of any community advisory board. 

 
 
 
 
o For intervention refinement we will form a Community Action Board (CAB) to 1) 
refine proposed content,2) generate strategies for outreach (e.g., social media), 
education (e.g., group sessions), and support to inform peer leader training, 3) guide 
toolkit development (described below), 4) confirm sites to host the MHU for care 
and telemedicine demonstrations, 5) inform outcome measures. We will meet 
(virtually/in-person) biweekly then monthly (or as needed) during implementation. 
The CAB will be composed of key stakeholders from the community including about 
10 adults and about 10 teens. The CAB participants are not engaged in research. 
▪ For research conducted outside of CM and its affiliates describe: 
• Regulations or customs affecting the research  
▪ N/A 
• The local scientific and ethical review structure 
▪ N/A 
▪ Describe the availability of medical or psychological resources that subjects might 
need as a result of taking part in the study. 
 
32.0 Multi-Site Research 
13. 
1. Students: Describe any student involvement in the protocol (only when a reliance 
is necessary). Remove section or mark ‘n/a’ if students are not involved.  
o Student from KUMC will assist with recruitment, enrollment, and data collection 
through survey administration. They will also assist with data analysis and 
dissemination.  
2. Study-Wide Number of Subjects:  If this is a multicenter study, indicate the total 
number of participants to be accrued across all sites. Additionally, list out the 
enrollment numbers planned for each site.  
• N/A 
 
33.0 International Research 
14. 
1. Describe any research conducted internationally by CM investigators that is part 
of this study. If research is conducted internationally, the project must also have 
been approved by the local equivalent of an IRB before it can receive final 
approval from the CM IRB.  When there is no equivalent board or group, 
investigators must rely on local experts or community leaders to provide 
approval. Upload related correspondence in myIRB. Contact ORI at irb@cmh.edu 

 
 
 
 
to discuss further as there is a great deal of variation in requirements 
internationally and this assessment can take some time. 
• N/A 
 
 

 
 
 
 
Addendum A: Waiver of Documentation of Permission/Consent 
 
Regulatory Criteria: To qualify for a waiver of documentation of parental permission or adult 
consent, the study must fit into at least one of the three scenarios below. Indicate which 
scenario(s) applies. 
 
☐ The only record linking the participant and the research would be the permission/consent 
form and the principal risk is potential harm resulting from a breach of confidentiality. 
Each parent/LAR or adult participant will be asked whether they want documentation linking 
the participant with the research, and the parent/LAR’s or adult subject’s wishes will govern. 
 
OR 
 
☒ The research presents no more than minimal risk of harm to participants and involves no 
procedures for which written parental permission or adult consent is normally required 
outside of the research context. 
 
OR 
 
☐ The parent(s)/LAR or adult participants are members of a distinct cultural group or 
community in which signing forms is not the norm, the research presents no more than 
minimal risk of harm to subjects and an appropriate alternative mechanism for documenting 
that informed parental/LAR permission or adult consent was obtained will be provided. 
Describe the alternative mechanism provided: 

 
 
 
 
Addendum B: Waiver/Alteration of Permission/Assent/Consent: Waiver of parental permission of 
adolescent and Waiver of adult consent at age 18 (Non-Active Participants) Adolescent participants that 
turn 18 during the study and have completed study activities for the continued access to and use of 
identifiable data. 
 
What’s the difference between a “waiver” and an “alteration” of parental permission, child 
assent, or adult consent?   
 
A “waiver” of parental permission, child assent, or adult consent is when all 9 required 
elements of permission/consent are waived. If the IRB approves a waiver, then the study team 
does not need to obtain the parental permission or adult consent in order to include a 
participant in the study. 
 
An “alteration” of parental permission, child assent, or adult consent is when one or more of 
the 9 required elements are waived because they are not relevant to the research activity. If 
the IRB approves an alteration, then the study team must still obtain parental permission or 
adult consent in order to include a participant in the study, but certain elements may not be 
required in the form/discussion. 
 
 
 
NOTE: If requesting a waiver of parental/LAR permission because parental permission is not a 
reasonable requirement to protect the subjects [e.g. research on neglected or abused children], 
contact irb@cmh.edu to discuss additional regulatory requirements. 
 

 
 
 
 
Regulatory Criteria: To qualify for a waiver or alteration of parental permission or adult 
consent, ALL of the following must apply.  Explain how the study meets each of the regulatory 
criteria below.   
 
Criteria 
Explain how the study meets the criteria 
The research involves no more 
than minimal risk to the 
subjects 
Adolescents will be completing confidential surveys. Risks 
are minimal and mitigated by the option to skip any 
question that they do not want to answer and by the 
confidentiality procedures we have in place to protect 
personal information.  
 
 
The research could not 
practicably be carried out 
without the requested 
waiver/alteration (i.e., explain 
why the study could not be 
done if 
permission/assent/consent 
were required) 
Adolescents will be recruited virtually or in-person where 
parents may not be present. Also, some teens would not 
want to participation if we could not maintain privacy on 
the potentially sensitive research topics. Requiring parental 
permission would mean many teens interested and eligible 
would not be able to participate. This could lead to sample 
bias and inaccurate study findings and ultimately could 
cause harm to adolescents.   
 
Additionally, assent was obtained utilizing the Information 
Sheet.  Continued access to and use of identifiable data is 
needed to meet the study aims for participants that turn 18 
during the study and have completed study activities.    
If the research involves using 
identifiable private 
information or identifiable 
biospecimens, the research 
could not practicably be 
carried out without using such 
information or biospecimens 
in an identifiable format 
Because of the 2, 4, 6-month follow-up survey, we will need 
to collect at least one form of contact information (phone 
number, email). 
 
Additionally, continued access to and use of identifiable 
data is needed to meet the study aims for participants that 
turn 18 during the study and have completed study 
activities.    
The waiver/alteration will not 
adversely affect the rights and 
welfare of the subjects 
We have no reason to believe that this waiver will adversely 
affect the rights of participants. On the contrary, we believe 
it will protect their rights, as teens may be more 
comfortable participating in a study about sexual and 
mental health without the involvement of their parents. 
 
The Waiver will not adversely affect the rights of non-active 
participants that turn 18 during the study as assent was 
obtained utilizing the Information Sheet.  

 
 
 
 
Whenever appropriate, the 
subjects or legally authorized 
representatives will be 
provided with additional 
pertinent information after 
participation 
Because our participants are older minors (14 and up) we 
are including in the assent everything that would be 
typically included in an adult consent form.  We believe not 
providing study information to parents participating in a 
study about their sexual and mental health, may protect 
teen rights and privacy without the involvement of their 
parents. They may choose to share their decision with 
parents and trusted adults. 
 
Whenever appropriate, the subjects or legally authorized 
representatives will be provided with additional pertinent 
information after participation 
 
Proposed Alteration (if applicable):  
 
N/A 
 
 
Addendum E: Waiver/Alteration of HIPAA Authorization 
 
 
What’s the difference between a “waiver” and an “alteration” of HIPAA Authorization? 
 
A “waiver” of HIPAA Authorization is when the requirement to obtain authorization is 
completely waived. If the IRB approves a waiver then the study team does not need to obtain 
HIPAA Authorization in order to include a subject in the study. 

 
 
 
 
 
An “alteration” of HIPAA Authorization is when one or more of the required elements of 
authorization are waived.  If the IRB approves an alteration then the study team must still 
obtain HIPAA Authorization in order to include a subject in the study, but certain elements may 
not be required in the form/discussion. 
 
 
 
Regulatory Criteria: To qualify for a waiver/alteration of HIPAA Authorization, ALL of the 
following must apply to a study. Explain how the study meets each of the regulatory criteria 
below.   
 
Criteria 
Explain how the study 
meets the criteria 
The use or disclosure of PHI involves no 
more than minimal risk to the privacy of 
individuals based upon the following:  
o Plan to protect PHI from improper 
use and disclosure: 
o Plan to destroy PHI at the earliest 
opportunity, unless there is a 
health or research justification for 
retaining the PHI: 
o Assurance that PHI will not be 
reused or disclosed to any other 
person or entity: 
 
a. PHI will only be kept in 
the REDCap project, 
accessible only to 
authorized members of 
the study team  
b. We will remove all PHI 
from the REDCap database 
after the last contact. 
Names and contacts of 
participants that indicate 
they would like to be 
contacted for future 
research will be stored in a 
separate secure database 
away from study 
materials. 
c. PHI will not be reused or 
disclosed to any other 
person or entity 
 
The research cannot 
practicably be conducted 
We have requested an 
alteration for HIPPA 

 
 
 
 
without the 
waiver/alteration, i.e. 
explain why a signature for 
HIPAA Authorization 
cannot be obtained. 
Authorization to reduce 
stress and anxiety that 
could potentially occur if 
adolescents are asked to 
provide signature for 
minimal risk study. 
Participants may choose 
not to participate which 
could affect the sample 
size and bias results for 
the research.  
Some teens may have 
distrust in medical 
research based on a long 
history of abuse 
perpetrated against 
marginalized populations. 
In order to improve 
communication and 
reduce anxiety for this 
minimal risk study, we 
seek this alteration. 
The research cannot 
practicably be conducted 
without access to and use 
of the PHI, i.e. explain why 
access to PHI is needed for 
this study. 
Names, phone numbers 
and emails are needed in 
order to contact the 
survey participant for the 
follow-up surveys and to 
send educational 
messages to the peer 
leaders throughout the 
study.