Implementation and Examination of Contraception Care for Hospitalized Adolescents With Mental Health Disorders
Conditions: Contraception
Sponsor: Elise Berlan

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PROTOCOL TITLE: 
Evaluation of Contraception Care @ Behavioral Health Pavilion  
PRINCIPAL INVESTIGATOR: 
Name: Elise Berlan, MD, MPH  
Department/Center: Adolescent Medicine  
Telephone Number: 614-722-2450  
Email Address: elise.berlan@nationwidechildrens.org  
 
VERSION NUMBER/DATE: 
Version 2 / 10/8/2021 
 
REVISION HISTORY 
 
Revision # 
Version 
Date 
Summary of Changes 
Consent 
Change? 
1 
8/6/2021 
Change in pilot study population 
n 
2 
10/8/2021 
- 
Updated ICF information  
- 
Updated communication methods  
- 
Revised EHR study variables – 
Appendix D 
y 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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1.0 
Study Summary 
 
Study Title  
Evaluation of Contraception Care @ Behavioral Health Pavilion 
Study Design  
Longitudinal Survey Study 
Primary Objective  
1. Examine interest in receiving contraception counseling 
among female adolescents hospitalized with mental health 
disorders. 
2. Examine contraception initiation among female adolescents 
hospitalized with mental health disorders 
Secondary Objective(s)  
Examine associations between short- and medium-term outcomes 
and predictor variables among female adolescents with mental health 
disorders 
Research Intervention(s)/ 
Investigational Agent(s)   
The protocol here entitled “Evaluation of Contraception Care @ 
Behavioral Health Pavilion” describes how the investigators plan to 
examine interest in receiving contraception counseling and 
contraception initiation. 
IND/IDE #   
N/A 
Study Population  
Female adolescents 14 years and older hospitalized for mental health 
disorders at Nationwide Children’s Hospital. 
Sample Size  
N = 450 
Study Duration for 
individual participants  
5 months 
Study Specific 
Abbreviations/ 
Definitions   
LARCs: long-acting reversible contraceptives 
LGBTQ: lesbian, gay, bisexual, transgender, queer 
EHR: electronic health record 
QI: quality improvement 
NCH: Nationwide Children’s Hospital 
 
 
 
2.0 
Objectives 
2.1 The purpose of this study is to examine interest in receiving 
contraception counseling and contraception initiation female 
adolescents hospitalized with mental health disorders. 
The primary objectives of this study are to 1) Examine interest in 
receiving contraception counseling among female adolescents 
hospitalized with mental health disorders, and 2) Examine 
contraception initiation among female adolescents hospitalized with 
mental health disorders. 
Multiple secondary objectives will be investigated during the 
study. They include:   
• To assess the proportion of female adolescents hospitalized with 
mental health disorders that receive contraception counseling or 
are prescribed/initiate any contraceptive during hospital admission 
or immediately post discharge. 

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• To determine predictors of receipt of contraception counseling and 
contraception initiation among female adolescents hospitalized 
with mental health disorders 
• Assess satisfaction with and person-centeredness of contraception 
care among participants who received contraceptive counseling  
2.2 State the hypotheses to be tested: N/A  
2.3 Of note, this study is externally funded by Merck Inc. The PI has a 
conflict management plan in place approved by the compliance 
department.  
3.0 
Background 
3.1 Approximately one in five American youth have experienced severe 
impairment due to mental health disorders, with anxiety and mood 
disorders being most common among female 
adolescents.1 Mental health disorders are associated with a range of 
sexual risk behaviors and unintended pregnancy.2,3 Youth with 
mental health disorders have higher rates of condom and 
contraception non-use (especially short acting),2,4–6 earlier sexual 
debut,2 and higher fertility rates.7   
Avoiding an unwanted or unintended pregnancy is particularly 
important for women with underlying mental health disorders. 
Experiencing a pregnancy exacerbates underlying 
mental health disorders in women with mental health disorder.8 And 
children born out of an unintended pregnancy or in context of mother 
with active mental health disorder face additional risks to their 
wellbeing. Long-acting reversible contraceptives (LARCs), 
i.e., contraceptive implants and intrauterine devices, have attributes 
that may be particularly attractive to adolescents with 
mental health disorders. They are highly effective and do not require 
ongoing maintenance. However, adolescents with mental health 
disorders face multiple barriers to accessing contraception care. 
Novel solutions are needed to improve access to contraception care, 
including LARC, for adolescents with mental disorders.  
The inpatient pediatric hospitalization setting is a missed opportunity 
for improving adolescent sexual and reproductive health.9,10 Nearly 
10% of pediatric hospitalizations are for a primary mental health 
diagnosis, and mood disorders are the most common primary mental 
health diagnosis among these hospitalizations.11,12 Sexual and 
reproductive healthcare is rarely provided to hospitalized 
adolescents.    
3.2 As part of the Hospital Pediatrics: Contraceptive Access 
Collaborative QI project at Nationwide Children’s Hospital, a chart 
audit completed in December 2019 found that no adolescents 
hospitalized for mental health disorders on the Hospital Pediatrics 
service had documentation that they were screened for sexual 
activity.  

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3.3 Adolescents are interested in learning about sexual and reproductive 
health and receiving sexual and reproductive healthcare in the 
hospital setting regardless of age, gender, and prior sexual 
experiences.13,14 Two studies of pediatric hospitalists found that the 
majority of those physicians felt that sexual and reproductive 
services are appropriate for hospitalized adolescents, with high 
support for referrals and starting contraception in the hospital.15,16 
Numerous barriers to inpatient provision of contraceptives/sexual 
reproductive healthcare were endorsed, including: concerns about 
follow up after discharge, lack of knowledge about confidentiality, 
lack of knowledge about contraception, interference with the 
treatment plan, time constraints, and pregnancy risk in LGBTQ 
youth. Riese et al.14 conducted a trial of an interactive patient-facing 
electronic sexual health module and found that it was acceptable to 
adolescents and their parents, and that most participants requested a 
sexual health service after completing the module. (The most 
requested service was viewing a contraception video made by this 
PI.)  
4.0 
Study Endpoints 
4.1 The primary endpoints are interest in contraception and 
contraception initiation. Secondary endpoints are location of 
contraception counseling and initiation, and contraceptive method 
choice. 
5.0 
Study Intervention/Investigational Agent 
5.1 
The protocol here entitled “Evaluation of Contraception Care @ 
Behavioral Health Pavilion” describes how the investigators will examine 
interest in receipt of contraception counseling and initiation among 
female adolescents hospitalized with mental health disorders. 
 
6.0 
Procedures Involved* 
6.1 
 This is an observational study. The study components include 
participant surveys, EHR data extracts related to sexual and reproductive 
health, and statistical process control charts for quality improvement 
analyses. Three surveys will be administered to participants, the first at 
the time of enrollment, the second immediately after discharge, and the 
third four months after discharge.   
6.2 
Potential participants will be approached during their admission at 
NCH and invited to participate in the study. If they are interested in 
participation, they will complete an electronic informed consent via 
redcap, all study participants will receive a copy of their consent via e-
mail. If the participant is 14 years old the coordinator will be required to 
obtain verbal consent from the parent or guardian via Information Sheet. 
After the consent process is completed, they will fill out the first study 
survey while they are admitted to the hospital (see Appendix A). The 

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subsequent two surveys will be sent electronically via their preferred 
communication method , which will be determined at enrollment. After 
the last survey is completed the subject will have completed their portion 
of the study. This is a study with adolescents as the study population and 
there will be little parental involvement, there are concerns regarding 
study retention. We will be providing texts as a communication option for 
the participants as we believe this will be most successful. If a participant 
chooses this as their preferred contact method. In order to text 
participants, we will be utilizing Twilio, an NCH approved application. 
Study staff will review responses on the following questions on the 
baseline survey: if the participant indicates they would like to a) learn 
more about, b) initiate or change contraception methods, and c) desire for 
privacy for contraception care. Study staff will notify the patient’s 
clinical team if any of these are positive. 
On the day of discharge, or the first business day after discharge if 
participant is discharged during the weekend or a holiday, study staff will 
send the second survey (see Appendix B) to the participants who 
indicated interest in contraception counseling and initiation via their 
preferred communication method. The patient will have 1 month to 
complete the survey. They will receive weekly reminders if the surveys is 
incomplete, and after 1 month the participant will be considered lost to 
follow up for the first follow-up survey. The third survey (see Appendix 
C) will be sent to the participants who indicated interest in contraception 
counseling and initiation 4 months after the patient is discharged from the 
hospital. Again, the participant will be provided the survey link via their 
preferred contact method and given 1 month to complete the survey and 
study staff will provide weekly reminders until completion. Completion 
of the third survey indicates the patient has completed their portion of the 
study. After 1 month, if the third survey is incomplete, the patient will be 
considered lost to follow up.   
Additionally, routine data pulls from the electronic health record (EHR) 
will be generated to gather supplementary data not collected from the 
subject surveys (see Appendix D).  
To ensure optimal readability, prior to the start of the enrollment period 
for the study we will be sending the surveys through the health literacy 
department. We will also pilot the surveys to 10-15 adolescent patients, 
ages 14 years and older, we would like to do this in order to get feedback 
on survey design, so that we can make necessary changes before 
enrollment starts. These patients may be approached in the Adolescent 
Medicine Clinic or may be children of NCH employees or other 
colleagues.  
6.3 
 We do not anticipate any risks associated with enrollment in the 
study. All PHI and sensitive information recorded for research will only 
be available to study staff. Additionally, we will be requesting waived 
parental consent for participants 15 and older to mitigate any potential 
conflict between parent and participant due to the sensitive nature of this 

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study. Please see appendices A, B, and C and D for survey and data 
collection forms.  
6.4 
Once a participant enrolls in the study, they will then be prompted 
to complete the baseline survey (Appendix A).  
Follow-up surveys will be completed by the participants that indicated 
interest in contraception counseling or initiation immediately following 
their discharge and an additional survey will be sent 4 months after 
discharge (Appendices B & C).  
 
Additionally, EHR data will be collected (Appendix D) for information 
the participant may not be able to answer (insurance status, previous test 
results, unit census, etc.) 
 
EHR data will be pulled to create variables for analysis and statistical 
process control charts to examine predictors of and receipt of 
contraception-related care among female adolescents 14 and older 
hospitalized for mental health disorders  
 
7.0 
Data and Specimen Banking* 
7.1 The data will be kept for 3 years after completion of the study in 
order to complete data analysis. Through this time period the data 
will be kept on a password protected spreadsheet in a secure shared 
drive, only study staff will have access. At this time all data will be 
de-identified to ensure subject privacy.   
7.2 List the data to be stored or associated with each specimen: N/A 
7.3 No data containing PHI will be released. However, de-identified 
study data will need to be reported back to the study sponsor.  
8.0 
Sharing of Results with Subjects* 
8.1 At the completion of data analysis, we plan to send each participant a 
short letter outlining study findings and how their participation in the 
study has helped the hospital. We would like to do this to show the 
importance of research at Nationwide Children’s Hospital.   
9.0 
Study Timelines 
• 
From enrollment to the last follow-up survey subjects’ 
participation will span 5 months. 
• 
It is estimated to take about 18 months to enroll 450 subjects. 
10.0 Inclusion and Exclusion Criteria* 

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10.1 The study coordinator will screen for eligible patients each morning 
by checking the census in the EHR of specified behavioral health 
units. The coordinator will enter the charts of patients that appear to 
eligible for the study to determine whether they meet inclusion 
criteria.  
10.2 Inclusion criteria: female adolescents, 14 years and older, admission 
to the following units – Psychiatric Units (BHP7B and 8A), Youth 
Crisis Stabilization Unit, Psychiatric Crisis Department Extended 
Observation Care Unit and patients with mental health disorders 
admitted to Hospital Pediatrics 3 service awaiting a psychiatric 
bed/disposition.   
Exclusion criteria: wards of state, unable to consent due to mental 
health disorder, serious medical conditions, non-English 
speaking, intellectual disability, and known pregnancy.   
10.3 Indicate specifically whether you will include or exclude each of the 
following special populations: 
• Individuals who have not yet reached the age of legal 
consent will be required to complete study consent. We will 
be submitting the form to waive parental consent for 
participants 15 and older as the study questions are 
sensitive and may impede ability to enroll participants with 
requirements for parental consent. We will require verbal, 
parental consent for potential participants who are 14 years 
of age. We will provide the parent or guardian with a study 
Information Sheet. 
• Pregnant women will be excluded from eligibility in the 
study. However, if a participant becomes pregnant during 
the study she will not be required to withdraw, as the only 
study procedures are questionnaires. 
 
11.0 Vulnerable Populations 
11.1 This study intends to enroll children, a special population, and will 
accordingly adhere to additional protections specified under 45 CFR 
Part 46 Subpart D – Additional Protections for Children Involved as 
Subjects in Research (45 CFR Part 46.401-
409). The study presents no more than minimal risk, we are 
requesting a waiver of parental consent for participants 15 years and 
older. For participants that are 14 years old, verbal parental consent 
will be obtained. In order to facilitate the participation of youth who 
may not have disclosed diagnosis and treatment of an STD or 
contraceptive decisions, to remain consistent with standard of 
clinical care, and to prevent undo conflict or unsafe situations with 
guardians regarding the nature of these topics, we request a waiver 

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of parental consent. However, we will be requiring informed consent 
to completed by participants as we believe adolescents 14 years of 
age and older obtain the knowledge and maturity to consent to this 
study, especially due to the minimal risk associated.   
12.0 Local Number of Subjects 
12.1 It is expected that 450 participants will be recruited for the study. 
12.2 It is expected that 1,000 adolescents will be eligible for the study 
from 2021-2023. We estimate that 45% will agree to participate. 
13.0 Recruitment Methods 
13.1 Subjects will be recruited 2021 – 2023. The research coordinator will 
screen specific inpatient units or services at Nationwide Children’s 
Hospital as identified by the PI, specifically psychiatric units or units 
where patients with a mental health diagnosis are generally admitted. 
Each day the coordinator will screen the hospital census for these 
units to determine admitted patients that meet inclusion criteria. If 
there is a question, the research coordinate will confer with the 
patient’s psychiatric healthcare provider and/or PI. The coordinator 
will then approach the patient to determine if they are interested in 
participation. If they express interest, the research coordinator will 
confirm inclusion/exclusion criteria and then consent the subject.   
13.2 Patients will be identified through the hospital census, of specified 
units, for admitted patients. A HIPAA waiver will be completed in 
order to access minimal information to identify potential 
participants.   
13.3 The research coordinator will screen each day from the hospital 
census of specified units. They will then complete a brief chart 
review to ensure the patient does meet criteria for the study. 
13.4 Upon enrollment the subject will be provided with a ClinCard for 
study compensation. Those who pilot the surveys will receive a one-
time compensation of $20. For those enrolled in the full study, at the 
time of completion of the enrollment survey $50 will be added to the 
card. At the time of completion of the two subsequent follow-up 
surveys $25 will be added for each survey. Subjects can earn up to 
$100 for their participation. The study is externally funded by 
Merck. 
14.0 Withdrawal of Subjects* 
14.1 Participation in the study is always voluntary, so subjects can decide 
to withdraw at any time by notifying the research coordinator. There 
are no instances that would require the study team to withdraw a 
subject as there are no risks to participating in the study. 
14.2 Describe any procedures for orderly termination: N/A 

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14.3 If a subject decides they would like to withdraw they will receive no 
further contact from study staff, this includes follow-up surveys as 
well as the memo at study completion. Any data collected prior to 
the withdraw will be kept and de-identified to protect the subject, 
unless they request all of their information be removed from the 
study.   
15.0 Risks to Subjects* 
15.1 There is minimal risk associated with this study. There is a risk of 
the subject’s parent or guardian learning of the subject's participation 
study. Additionally, the study surveys do ask some sensitive 
information; to mitigate any discomfort they may be associated with 
these questions we will be requesting to waive parental consent, so 
that the subject is more comfortable participating in the study. 
16.0 Potential Benefits to Subjects* 
16.1 It is important for researchers and clinicians to better understand the 
sexual and reproductive healthcare needs of adolescents with mental 
health disorders, an area that has received little research and clinical 
interest. Adolescents, themselves, will benefit as care protocols are 
informed with scientific evidence derived from researching them 
directly.   
17.0 Data Management* and Confidentiality 
17.1 Describe the data analysis plan, including any statistical procedures 
or power analysis. 
For our first objective, the dependent variables are interest in 
receiving contraception counseling during a hospital stay and 
interest in starting a contraceptive during a hospital stay.  
• We will examine interest in receiving contraception 
counseling during hospitalization among female 
adolescents hospitalized with mental health disorders by 
assessing the proportion of participants who answer yes to 
the following survey question “Interest in learning more 
about contraception during your hospital stay”. 
• We will examine interest in initiating contraception during 
hospitalization among female adolescents hospitalized with mental 
disorders by assessing the proportion of participants who answer 
yes to the following question “Interest in starting a contraceptive 
during your hospital stay”. 
• We will perform univariate descriptive analyses on all variables. 
• We will perform bivariate analysis to explore the relationship 
between variables “Interest in learning more about contraception 
during your hospital stay” and “Interest in starting a contraceptive 
during your hospital stay” using 2 X 2 contingency tables. 

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• We will explore associations with dependent variables and 
predictor variables by performing bivariate analyses of “Interest in 
learning more about contraception during your hospital stay” and 
“Interest in starting a contraceptive during your hospital stay” with 
predictor variables from surveys and EHR variables using Chi 
square for categorical variables and Students T-test for continuous 
variables. 
• We will regress significant predictor variables (p < 0.1) on 
dependent variables to determine predictors of “interest in 
receiving contraception counseling during your hospital stay” and 
“interest in starting a contraceptive during your hospital stay”. 
For our second objective the dependent variables are 
contraceptive prescription/initiation during hospitalization and 
contraceptive prescription/initiation following discharge. 
• We will create derived variables: 
o Initiation any contraceptive (in hospital, in BC4Teens 
clinic, none) 
o Initiation preferred contraceptive (in hospital, in BC4Teens 
clinic, none)  
o Time interval (days) between enrollment and contraception 
prescription/initiation 
o Initiation of contraceptive not preferred contraceptive (in 
hospital, in BC4Teens) 
• We will perform univariate descriptive analyses on all variables. 
• We will examine contraception initiation all among participants by 
assessing the proportion of participants who initiate any 
contraceptive in the a) hospital setting, b) in BC4Teens clinic, and 
c) either hospital or BC4Teens clinic. 
• We will examine contraception initiation all among participants by 
assessing the proportion of participants interested in contraception 
care who initiate any contraceptive in the a) hospital setting, b) in 
BC4Teens clinic, and c) either hospital or BC4Teens clinic. 
• We will examine how time between enrollment and Initiation any 
contraceptive varies by location of contraception 
prescribing/initiation using Student’s T test.   
• We will also perform the 3 analyses above on the variable “initiate 
preferred contraceptive” 
• We will examine the type of contraceptive method 
prescribed/initiated in the a) hospital setting, b) in the BC4Teens 
clinic setting, and c) either hospital of BC4Teens clinic 
• We will examine variation in type of contraceptive method 
prescribed/initiated between the hospital setting and the BC4Teens 
clinic setting using Chi square.  
• We will explore associations with dependent variables and 
predictor variables by performing bivariate analyses of “initiation 

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any contraceptive” and predictor variables from surveys and EHR 
variables using Chi square for categorical variables and Students 
T-test for continuous variables. 
• We will regress significant predictor variables (p < 0.1) on 
dependent variables to determine predictors of initiation any 
contraceptive. 
• To better understand personal and system-level differences in 
initiation of contraception during hospitalization and in BC4Teens 
clinic, we will examine differences in demographics, survey 
variables of interest, and EHR variables of interest between 
participants who initiate “any contraceptive during hospitalization” 
and initiate “any contraceptive in BC4Teens clinic” using Chi 
square.  
• To better understand personal and system-level differences in 
initiation of preferred contraceptive and not-preferred 
contraceptive we will examine differences in demographics, survey 
variables of interest, and EHR variables of interest between 
participants who initiate “preferred contraceptive” and initiate “not 
preferred contraceptive” using Chi square. 
• Statistical process control methods will be used to evaluate trends 
in contraceptive contraception counseling for hospitalized female 
adolescents with mental health disorders. 
• Statistical process control methods will be used to evaluate 
trends in contraceptive initiation for hospitalized female 
adolescents with mental health disorders. 
• Statistical process control methods will be used to evaluate 
trends in initiation of contraceptive implant for hospitalized 
female adolescents with mental health disorders. 
17.2 The enrollment survey as well as follow-up surveys will be collected 
in RedCap. The database is a secure data management platform that 
only study staff will have access to. When the data is exported it will 
all be de-identified. Additionally, there will be quarterly data pulls to 
gather additional patient information. The data will be stored on a 
password-protected spreadsheet that only study staff have access to. 
At the completion of data collection the spreadsheet will be de-
identified for purposes of analysis. At this time, the only PHI will be 
stored on an enrollment log to serve as a master list of all 
participants, this will also be password protected with access only 
provided to the study staff. 
17.3 Describe any procedures that will be used for quality control of 
collected data. 
• When enrollment begins the EHR data will be gathered 
more frequently to ensure that the process is obtaining 
accurate information. During this time the coordinator will 

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also do manual chart reviews to ensure the data reports are 
providing the same information. As the study progresses 
the data extraction will occur less frequently; however, the 
study coordinator will be required to chart review 5 patients 
to ensure the data is still intact.  
17.4 Describe how data will be handled study-wide: 
•  During data collection surveys will be stored 
within RedCap, a secure data management platform. The 
data pull variables will be kept in a password protected 
excel spreadsheet. Once the data collected period is over 
the RedCap data will be merged onto the password 
protected spreadsheet. At this time the data will be de-
identified and a separate participant master list containing 
PHI will be kept separately. Only study staff will have 
access to the PHI.   
• Data will be stored for three years after the data collection 
period is complete, this will allow for data analysis to take 
place.   
• Only study staff included on the IRB will have access to 
the data. When the data is analyzed and given to the 
biostatistician it will be completely de-identified.   
• OSU staff associated with the 
study will receive study reports. The data will be 
transmitted via secure transfer through approved 
electronical modalities. NCH study staff will be responsible 
for ensuring all data is de-identified prior to sending as well 
as ensuring secure transfer is successful.   
•  The sponsor, Merck, has requested quarterly reports as a 
part of this study. Data transfer will occur electronically 
through Merck’s grant management website. Any study 
subject level data will be coded with a number and no PHI 
will be included.  
 
18.0 Provisions to Protect the Privacy Interests of Subjects 
18.1 As research is completely voluntary the study coordinator will fully 
review the informed consent with the participant, at any time they 
can decide they do not want to participate and forgo their enrollment. 
If a patient consents to participate they will be made aware that they 
may skip any question on the study surveys that they do not feel 
comfortable answering. At the end of study collection period we will 
de-identify their responses and keep a separate master list of 
participants.   

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18.2 Subjects will be informed that they may skip any portion of the study 
that they do not feel comfortable with. They will also be informed 
that they may withdraw from the study at any time with no 
consequence to their standard of care treatment. The survey 
questions may be viewed as sensitive and patients may be 
uncomfortable disclosing information such as sexuality, birth control 
knowledge or sexual activity with their parent or guardian. The 
population for the study is ages 14 and up and we believe that 
subjects have the cognitive maturity to decide whether or not to 
participate in the study. Accordingly, we will be requesting to waive 
parental consent for this study. 
18.3 All sources of information will be outlined in the consent form, so 
that the potential survey subject is aware and can make 
an informed decision. Most of the data will be self-reported from the 
study surveys. Other demographic and health data will need to be 
gathered from the patient’s EHR to ensure quality data, this 
data includes information the patient may be unable to report at the 
time of baseline survey, such as insurance status, 
administrative hospital census data, results of sexually transmitted 
infection testing, and hospital encounter diagnoses.   
19.0 Economic Burden to Subjects 
19.1 Patients will not accrue any additional costs from participating in 
this study, as the only procedures are three surveys.  
20.0 Consent Process 
20.1 Indicate whether you will you be obtaining consent, and if so 
describe: 
• 
The consent process will take place at the patient’s bedside 
during their admission.  
• 
After reviewing the consent with the subject, the research 
coordinator will ask if they have any questions. There will not 
be an official waiting period; however, if they would like time 
to think about participation that will be granted.  
• 
When a participant indicates they would like to learn more 
about the study, informed consent will be reviewed with the 
subject by the research coordinator. Potential participants will 
be educated on the purpose of the study as well as any risks or 
benefits associated with their participation. The informed 
consent will contain all study processes as well as the measures 
that will be taken to ensure any data collected will be kept 
confidential. They will also be made aware that they can 
discontinue their participation at any time as research is 
completely voluntary.  
• 
This study is important because little is known about the sexual 
and reproductive healthcare needs of female adolescents with 
mental health disorders. The principle of justice supports the 

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inclusion of these minor adolescent females, who are often 
excluded from sexual health research, in this project. We 
request to waive parental consent for this study, as the study 
presents no more than minimal risk. We are concerned that 
requiring parental consent will decrease participation in 
this project because parents may object to the sensitive nature 
of the survey content, and it has been demonstrated that fewer 
adolescents enroll in research about sexual health topics when 
parental consent is required19 We are also concerned 
that requiring parental consent would potentially oversample 
youth with positive parent-child communication about 
sexuality, which would negatively impact our 
study. We believe that our target population can reason as 
adults and to perceive the possibility of the negative 
consequences of their actions. Moreover, the criteria for 
competence have moved from biological age towards 
individual children's experiences and 
understanding20,21. Moreover, minor adolescents in the State of 
Ohio and at Nationwide Children’s are permitted to consent 
to many sexual healthcare services, including contraception 
care at age 15 and older within Nationwide Children's Hospital. 
In summary, we believe they are capable of and should be able 
to consent to participate in research that will inform this care.   
• 
Whether you will be following “SOP: Informed Consent 
Process for Research (HRP-090).” If not, describe: 
o 
The study coordinator will be tasked with completing the 
informed consent with each participant to ensure 
continuity. They will be thoroughly trained on the 
informed consent process. Additionally, if the protocol 
and consent are modified, they will be required to 
complete additional training prior to consenting 
additional patients.   
o 
In total we estimate the consent process will take 20-30 
minutes, this includes time for participant questions.   
o 
All risks and benefits will be discussed in full with each 
participant.   
o 
The research coordinator will ensure that they review 
each section in full with the participant. They will also 
periodically pause to ensure the participant does not have 
additional questions. Prior to signing of the consent, the 
participant will be reminded that research is completely 
voluntary and that they may withdraw at any time during 
the study with no consequence to their standard of 
care. Each participant will be provided with a copy of 
their consent via e-mail after signing so that they may 
review the study at any time, this will also contain contact 
information for the study staff if questions arise. 

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Subjects who are not yet adults (infants, children, teenagers) 
• 
For this study a chart review will be completed in order to 
determine if a patient is eligible to participate. The included 
population are those 14 years and older. This will also be 
verified at the bedside.   
• 
We are requesting to waive parental consent for this study and 
allow participants to consent for themselves if they are 15 years 
or older. Participants who are 14 will require verbal consent 
from parent or guardian, via information sheet, prior to their 
enrollment in the study. Participants will be the only party 
completing study surveys, the parents will not.  
• 
No one other than the participant will have the ability 
to provide informed consent for this study. Exclusion 
parameters such as inability to consent due to mental health 
diagnosis or acute illness are in place to protect the subjects.   
 
21.0 Process to Document Consent in Writing 
21.1 We would like to waive parental consent but obtain informed 
consent from the participants directly. The patient population is 14 
years of age and up and we believe that the population can consent 
for themselves due to the nature of the study, survey only.  
 
22.0 Setting 
22.1 Describe the sites or locations where your research team will 
conduct the research. 
• 
The research coordinator will be responsible for identifying 
and recruiting new subjects. They will screen the census each 
morning to determine patients that meet criteria. All 
recruitment activities will take place at NCH units as specified 
in the inclusion criteria.  
• 
The enrollment questionnaire will be completed by the subject 
during their admission at NCH. The follow-up surveys will be 
sent to participants electronically after admission for them to 
complete on their own time; they will have one month to 
complete the follow-up surveys.   
23.0 Resources Available 
23.1 Describe the resources available to conduct the research: For 
example, as appropriate: 
• 
We conservatively estimate that the demand for inpatient 
hospitalization will be equally present in 2021 and 2022 as it 
was in 2019.We estimate that at least 1000 adolescents eligible 

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for our study will be admitted to Nationwide Children's 
Hospital following units – Psychiatric Unit, Youth Crisis 
Stabilization Unit, Psychiatric Crisis Department Extended 
Observation Care Unit and Hospital Pediatrics service. We 
estimate that 45% will agree to participate in our study. A 
demonstration that at least 25% of this sample is interested in 
contraception care during hospitalization will be notable 
• 
A span of 2 years will be dedicated to study recruitment. The 
time devoted during that span may vary based upon eligible 
patients per day as well as follow-up survey schedules.  
• 
All research processes will be carried out on the unit at the time 
of enrollment. The only exception is verbal consent from the 
parent or guardian of those who are 14. In those cases, consent 
may be obtained verbally via telephone after receipt of the 
study information sheet. The follow-up surveys will be sent 
electronically, and subjects will complete them on their own 
time.  
• 
We do not anticipate any medical or psychological distress as a 
result of this study; however, at the time of enrollment subjects 
will be admitted so they will have access to all medical and 
psychological services that NCH provides. 
• 
All study staff are required to complete all research training 
(CITI and NCH specific human subjects training) prior to 
being added to the IRB. Additionally, staff will be required to 
undergo study specific education before involvement in study 
procedures. All education will be tracked on a training log. If 
there are any changes made to the IRB all staff will also be 
required to review the changes. The dates of training will be 
available in the study Training Log.  
 
24.0  Protected Health Information Recording 
 
1.0 
Indicate which subject identifiers will be recorded for this research. 
☒  Name 
☒  Complete Address 
☒  Telephone or Fax Number 
☐  Social Security Number (do not check if only used for ClinCard) 
☒  Dates (treatment dates, birth date, date of death) 
☒  Email address , IP address or url 
☒  Medical Record Number or other account number 
☐  Health Plan Beneficiary Identification Number 
☐  Full face photographic images and/or any comparable images (x-rays) 
☐  Account Numbers 
☐  Certificate/License Numbers 
☐  Vehicle Identifiers and Serial Numbers (e.g. VINs, License Plate Numbers) 

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☐  Device Identifiers and Serial Numbers 
☐  Biometric identifiers, including finger and voice prints 
☐  Other number, characteristic or code that could be used to identify an 
individual 
☐  None (Complete De-identification Certification Form) 
 
2.0   
Check the appropriate category and attach the required form* on the Local 
Site Documents, #3. Other Documents, page of the application.  (Choose one.) 
☒  Patient Authorization will be obtained. (Include the appropriate HIPAA 
language (see Section 14 of consent template) in the consent form OR attach 
the HRP-900, HIPAA AUTHORIZATION form.) – All participants will 
complete an ICF and those under 15 will require parent/guardian to review the 
information sheet 
☒  Protocol meets the criteria for waiver of authorization. (Attach the HRP-901, 
WAIVER OF HIPAA AUTHORIZATION REQUEST form.) – for screening 
purposes only  
☐  Protocol is using de-identified information. (Attach the HRP-902, DE-
IDENTIFICATION CERTIFICATION form.) (Checked "None" in 1.0 above) 
☐  Protocol involves research on decedents. (Attach the HRP-903, RESEARCH 
ON DECEDENTS REQUEST form.) 
☐  Protocol is using a limited data set and data use agreement. (Contact the 
Office of Technology Commercialization to initiate a Limited Data Use 
Agreement. 
 
3.0    How long will identifying information on each participant be maintained? 
3.1 Identifiable information will be kept for 6 years for purposes of data analysis. 
However, this information will be coded and stored separately.  
 
4.0 
Describe any plans to code identifiable information collected about each 
participant. 
4.1 At the time of enrollment all patients will be given a subject ID number, after 
the data collection period is over the PHI will be removed from the study data 
and stored separately in a password protected document.   
 
5.0 
Check each box that describes steps that will be taken to safeguard the 
confidentiality of information collected for this research: 
☒   Research records will be stored in a locked cabinet in a secure location  
☒   Research records will be stored in a password-protected computer file  
☒  The list linking the assigned code number to the individual subject will 
be   maintained separately from the other research data  
☒  Only certified research personnel will be given access to identifiable subject 
information  
 
6.0 
Describe the provisions included in the protocol to protect the privacy 
interests of subjects, where "privacy interests" refer to the interest of 
individuals in being left alone, limiting access to them, and limiting access to 

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their information. (This is not the same provision to maintain the 
confidentiality of data.) 
6.1 The subjects will only have one in-person encounter with study staff, at the 
time of enrollment. All other contact will be via their preferred contact 
method (phone call, text or e-mail). Participants will only be contacted at the 
study time points directly after discharge and 4 months after. Study staff will 
reach out a total of 4 times until the surveys have been completed. After the 
4th contact attempt the participant will be considered lost to follow-up. EHR 
data pulls will be completed for newly enrolled patients to gather additional 
information (Appendix D). Aside from these encounters subjects as well as 
their information will not be accessed.  
 
Confidential Health Information 
 
1.0 
Please mark all categories that reflect the nature of health information to be 
accessed and used as part of this research. 
 
☒  Demographics (age, gender, educational level) 
☒  Diagnosis 
☒  Laboratory reports 
☐  Radiology reports 
☐  Discharge summaries 
☒  Procedures/Treatments received 
☒  Dates related to course of treatment (admission, surgery, discharge) 
☐  Billing information 
☒  Names of drugs and/or devices used as part of treatment 
☒  Location of treatment 
☒  Name of treatment provider 
☐  Surgical reports 
☒  Other information related to course of treatment 
☐  None 
 
2.0 
Please discuss why it is necessary to access and review the health information 
noted in your response above. 
2.1 
Important research study endpoints and outcomes, as well as predictor 
variables, will only be available as patient-level health information 
available in the EHR, this includes information such as hospital unit 
census data, insurance status, disposition of outpatient encounters, medical 
diagnoses, and prescription or initiation/discontinuation of contraception.  
 
3.0 
Is the health information to be accessed and reviewed the minimal necessary to 
achieve the goals of this research?  ☒ Yes    ☐ No 
 
4.0 
Will it be necessary to record information of a sensitive nature?  ☒ Yes   ☐ No 

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5.0 
Do you plan to obtain a federally-issued Certificate of Confidentiality as a means 
of protecting the confidentiality of the information collected?  ☐ Yes   ☒ No 
 
 
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