Validation of a Video Teaching Tool for Adolescent Self Administration of Subcutaneous Depot-medroxyprogesterone
Phase: NA
Conditions: Medication Compliance, Contraception, Self-Evaluation
Sponsor: Tufts Medical Center

 
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TEMPLATE PROTOCOL INSTRUCTIONS: 
 
Use this “TEMPLATE PROTOCOL (HRP-503)”if this is an investigator-initiated study where a protocol 
document has not already been provided to you with relevant information for each applicable section 
listed in the Table of Contents (below).  
 
Depending on the nature of the research, some sections may not be applicable. If a section is not 
applicable, mark as “NA” or delete altogether. For example, research involving a retrospective chart 
review may have many sections marked as NA or deleted.   
 
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current electronic copy when making recommended changes and future modifications. 
 
Please note that underlined items in this document are hyperlinked to additional information.  
 
STUDY TITLE: Validation of a video teaching tool for Adolescent Self Administration of 
Subcutaneous depot-medroxyprogesterone 
 
STUDY SPONSOR: Amanda French, M.D. 
If there is a study sponsor, please specify. If the PI is taking on the responsibilities of the study sponsor, i.e., an 
investigator-sponsor, insert PI’s name here.  
 
PRINCIPAL INVESTIGATOR  
Refer to PI Eligibility on the Tufts Health Sciences IRB website. List only one PI: 
Name: Amanda French 
Department: obstetrics and gynecology 
Telephone Number: 781-897-0240 
Email Address: afrench1@tuftsmedicalcenter.org 
 
VERSION DATE: 7/4/21 
 
 
 
 

 
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Table of Contents – Click on the links below to go directly to the applicable section 
 
A. 
Study Schema .................................................................................................................................................3 
B. 
Introduction ....................................................................................................................................................3 
B.1 Background and Rationale ..............................................................................................................................3 
B.2 Risks to Subjects .............................................................................................................................................4 
B.3 Potential Benefits to Subjects ..........................................................................................................................5 
B.4 Alternatives .....................................................................................................................................................5 
C. 
Objectives .......................................................................................................................................................6 
D. 
Enrollment and Withdrawal............................................................................................................................6 
D.1 Inclusion Criteria .............................................................................................................................................6 
D.2 Exclusion Criteria ............................................................................................................................................6 
D.3 Withdrawal of Subjects ...................................................................................................................................7 
D.4 Recruitment and Retention ..............................................................................................................................7 
D.4.1 Local Recruitment Methods .....................................................................................................................7 
D.4.2 Study-Wide Recruitment Methods ...........................................................................................................8 
D.4.3 Payment ....................................................................................................................................................9 
D.4.4 Reimbursement ........................................................................................................................................9 
E. 
Costs to Subjects.............................................................................................................................................9 
F. 
Study Design ................................................................................................................................................10 
F.1 Study Timelines .............................................................................................................................................10 
F.2 Procedures ......................................................................................................................................................10 
F.3 Evaluations.....................................................................................................................................................12 
F.4 Collection and Storage of Human Biological Specimens (Tissue Banking) .................................................12 
G. 
Ethics and Protection of Human Subjects ....................................................................................................12 
G.1 Informed Consent Process .............................................................................................................................13 
G.2 Waiver or Alteration of Consent Process ......................................................................................................13 
G.3 International Research ...................................................................................................................................15 
G.4 Confidentiality...............................................................................................................................................15 
G.5 Screening Data Collection Form/Screening Log...........................................................................................17 
G.6 Provisions to Protect the Privacy Interests of Subjects .................................................................................17 
G.7 Provisions to Monitor the Study to Ensure the Safety of Subjects ...............................................................18 
G.8 Vulnerable Populations .................................................................................................................................19 
H. 
Adverse Event Monitoring ...........................................................................................................................23 
H.1 Definitions .....................................................................................................................................................23 
H.2 Reporting Procedures ....................................................................................................................................24 
H.3 Reportable New Information .........................................................................................................................24 
I. 
Statistical Considerations .............................................................................................................................24 
I.1 Study Endpoints ..............................................................................................................................................24 
I.2 Statistical Analysis..........................................................................................................................................24 
I.3 Number of Subjects ........................................................................................................................................25 
I.4 Data Management ...........................................................................................................................................25 
I.5 Randomization ................................................................................................................................................26 
J. 
Drugs or Devices ..........................................................................................................................................26 
K. 
Study Administration ....................................................................................................................................27 
K.1 Setting ...........................................................................................................................................................27 
K.2 Registration ...................................................................................................................................................27 
K.3 Resources Available ......................................................................................................................................28 
K.4 IRB Review ...................................................................................................................................................28 
K.5 Multi-Site Research .......................................................................................................................................28 
K.6 Community-Based Participatory Research ...................................................................................................30 
K.7 Sharing Results with Subjects .......................................................................................................................30 
L. 
References ....................................................................................................................................................30 
 

 
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A. Study Schema 
Include a diagram that provides a quick “snapshot” of the study.  For examples of study schemas, refer to the 
FDA and NIH’s Study Schema Examples document available on the IRB website:  
 
1. Prior to enrollment: Determine number of subjects to be enrolled, craft patient and doctor 
surveys.  
2. Enrollment will occur at clinic sites by calling potential subjects in advance to assess interest in 
the study. 
3. If subject expresses interest, doctor or nurse practitioner will call in the subcutaneous form of 
depot-medroxyprogesterone to pharmacy of patient’s choice, patient will pick up medication 
prior to scheduled office visit and bring medication with them to the visit. 
4. Once patient arrives in clinic with the medication in hand, informed consent / assent will be 
obtained (consent/assent will be age appropriate and involve parent or guardian if patient is 
under the age of 18).  If subject declines enrollment at this time, doctor will administer the 
medication.  
5. When patient checks into clinic, contact information for patient will be verified including phone 
number and email address. 
6. If consent is obtained, patient will be given video to watch. 
7. After video is watched, patient will then self-administer the medication injection while healthcare 
provider on research team is watching.  If there is concern that medication is not being given 
correctly, doctor/healthcare provider will step in and give the injection to ensure subject gets the 
correct medication, regardless of the success or failure of the teaching video. 
8. After injection is given, subjects will complete a survey in REDCap and study team members will 
input observational data into REDCap  
9. Approximately 12 weeks after the injection, at the time of their next scheduled office visit, 
participants will be asked complete a secondary survey via REDCap to determine frequency of 
follow up self injection. This survey will be administered in person or emailed to the subject.  
10. Data analysis will follow completion of patient enrollment.   
 
  
 
B. Introduction 
 
B.1 Background and Rationale 
1. Describe the relevant prior experience and gaps in current knowledge: Although traditionally 
administered in the clinical space, injectable contraception has been shown to be 
effective and well tolerated by adolescents when subcutaneously self-administered 
(please see question 3 below for background).  However, there is no current peer to 
peer teaching model available online, which may be a barrier to care and is particularly 
applicable during the COVID19 pandemic when a large proportion of medical care was 
abruptly moved online.    
2. Describe any relevant preliminary data: none 
       3. Provide the scientific or scholarly background for, rationale for, and significance of the research based on 
the existing literature and how it will add to existing knowledge:  
 
Means of providing health education are rapidly evolving. Telemedicine has become an important 
modality to provide healthcare and improve access, and will likely be increasingly utilized beyond the 
COVID-19 pandemic. Telemedicine can effectively provide care and counseling to all age groups, 
including adolescents (1). Studies have demonstrated that over 80 percent of adolescents between the 
ages of 11 and 18 spend one to four hours a day online (2); searches for health-related information are 
common (3). Nevertheless, adolescents may face obstacles when previously familiar aspects of their 
medical care are abruptly moved online, particularly when discussing contraception. Although 
traditionally administered in the clinical space, injectable contraception has been shown to be attractive, 
effective and well-tolerated by adolescents when subcutaneously self-administered, and can lead to 

 
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improved continuation rates (4, 5, 6). We found that remotely teaching a patient how to self-administer 
a subcutaneous injection is challenging. The provider may be in a home office, and may not have 
access to the actual medication or the supplies to demonstrate technique. The patient may struggle to 
understand verbal instruction without a visual demonstration, resulting in ineffective medication 
administration. Instructional videos currently available online are not specific to adolescents who use 
self-administered injectable contraception. Peer education can be relatable and effective for adolescent 
patients (7). We propose that self-administration of subcutaneous injectable contraception may be 
taught using a peer-to-peer video as a synchronous or asynchronous adjunct to consultation with the 
healthcare professional. Adolescents may be instructed to watch the video demonstration to help inform 
them about proper technique and ensure safe administration of their medication while at home. This 
study aims to validate an existing video as an effective teaching tool by assessing metrics such as 
clarity of the instructions, rate of error, and satisfaction with the video teaching method to our target 
population.  The video was filmed in accordance with Tufts Medical Center department of Marketing 
and Communications policies and the adolescent participant in the video was appropriately consented 
by a parent/guardian.  The video was presented as an oral abstract at the North American Society for 
Pediatric and Adolescent Gynecology Annual Meeting in March 2021.   
 
3. Describe the relevance and usefulness of the objectives: The primary objective of this study is to 
determine the validity of this teaching video for adolescents wishing to learn how to self-
administer depot-medroxyprogesterone as an alternative to receiving all injections in a 
medical office.  Having a video option for a teaching tool gives an alternative to in 
person office visits for teaching and gives more flexibility for patients and providers 
when in person visits are limited.  The secondary outcome is to determine if patients will 
continue to use the self-administration technique for future injections.   
4. Specify whether or not this is the first time the study drug, device, or intervention/procedure will be used 
in humans. If there has been experience with the study drug, device, or intervention/procedure in humans, 
detail the experience to date:        or ☒N/A, this is not the first time the study drug, device, or 
intervention/procedure will be used in humans  
5. Is there an active control group?   
☐ Yes ☒ No 
If Yes, respond to all of the following: 
a. ☐Check to confirm that the active control is an established effective intervention. If it is not, clarify 
how it is ethically justified to use this control in the study:       
b. Describe any potential bias in the selection of the active control such that there will be an unfair 
advantage for the investigational intervention. For example, is the active control treatment known to 
be significantly less effective in this study population than another treatment:       or  
☐N/A  
c. ☐Check to confirm that the sample size and the randomization ratio for this active control study is 
ethically justified with regard to the number of participants who will be exposed to the risks of the 
study. 
 
B.2 Risks to Subjects 
1. List the reasonably foreseeable risks, discomforts, hazards, and/or inconveniences to the subjects related 
to their participation in the research, including risk of unintentional loss of confidentiality. Include a 
description of the probability, magnitude, duration, reversibility, and potential consequences of the risks. 
Consider physical, psychological, social, legal, and economic risks: This study aims to enroll 
subjects who have already been counselled on risks and benefits of depot 
medroxyprogesterone, have chosen to receive this medication, and have had at least 
one previously administered injection by a healthcare provider.  For these reasons the 
only intervention will be that their medication is self-administered rather than given by a 
medical provider. The risks of incorrect self-injection include bruising at the injection 
site, bleeding at the injection site, infection at the injection site, a broken needle, pain, 
and inadvertent injury. These risks are minimal and as the self-injection will be 

 
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witnessed by the study healthcare provider, any additional medical care deemed 
necessary as a result of incorrect self-injection will be immediately administered. The 
healthcare provider will also intervene if there is reasonable assumption based on the 
healthcare provider’s clinical judgement, that harm is about to occur when watching the 
patient self-inject.  If only a portion of the medication is given, an additional injection will 
be provided (which is standard practice and considered safe).  All subjects will continue 
to receive the same routine health care as if the doctor had given the injection including 
instructions to call the office or come into the office to be evaluated if any questions or 
concerns arise between appointments.  Unintentional loss of confidentiality is a minimal 
risk as exit questionnaires will be done directly through a coded REDCap survey link.  
Each patient will be given a number in the survey which will be linked to a list with the 
patient name and date of birth.  This list with identifiers will be saved into a HIPAA 
compliant Box account approved by Tufts Medical Center and only accessible by 
password by the PI and members of the research team.  This identified list will be 
destroyed by the research team after surveys have been completed per the protocol by 
Tufts Medical Center.   
2. State which study interventions may have unknown risks:       or ☒N/A  
3. State which study interventions may have risks to an embryo or fetus (if a subject is or becomes pregnant) 
or to a nursing infant of a study subject:       or ☒N/A   
4. Describe risks to people other than the participating subject, e.g., risks to family members, friends, others 
or risks to the community: or ☒ N/A   
5. Are there any risks to study investigators or staff performing the study procedures due to research with 
high risk populations (e.g. prisoners, intravenous drug users, patients with major psychiatric issues, etc.):?   
☐ Yes  ☒ No 
If Yes, respond to all of the following: 
a. Describe these risks:       
b. Describe the procedures that will be put in place to minimize these risks:       
c. Describe how these procedures are adequate for the location where study procedures will be 
performed:       
d. ☐Check to confirm that you have contacted research administration to clarify whether additional 
approvals (e.g. Security, Risk Management, etc.) are needed for the performance of this study with 
high risk populations. 
 
B.3 Potential Benefits to Subjects 
1. Describe the potential benefits that individual subjects may experience from taking part in the research. 
Include the probability, magnitude, and duration of the potential benefits: If the video is successful and 
the subject learns how to self-inject, it gives the option of not coming into the doctor’s office for every 
injection which may be more convenient.  
Note: Payments and incentives are not considered benefits in the IRB’s risk-benefit assessment; payment and 
incentives should be addressed in the payment section. 
2. ☐Check if there is no direct benefit.  
3. Describe any benefit to the population from which the subject is drawn: If this teaching video is 
deemed to be successful in teaching adolescents to self-administer the subcutaneous 
depot-medroxyprogesterone, it may be shared on other medical forums and thus benefit 
a larger audience who then also will have more flexibility and choice about how they 
receive depot medroxyprogesterone.  or ☐ N/A  
4. Describe any benefit to science, society, and humanity in general: Please see answer to #3 above.  
or ☐ N/A  
 
B.4 Alternatives 
1. Describe alternatives to participating in this research study (e.g. to decide not participate in the study, 
alternative treatments, no treatment (palliative care), etc.): Alternative is to not participate in the 

 
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study and instead receive depot medroxyprogesterone administered by the healthcare 
provider.   
2. Describe the standard clinical care that may be an alternative: Receiving the same medication by 
injection administered by a health care provider. or ☐ N/A 
3. Describe how the subject can receive the research procedures/drug/device used in this study in a non-
research setting:       or ☒ N/A 
 
C. Objectives 
1. Describe the purpose, specific aims, or objectives of the study (i.e. the reason for performing the study in 
terms of the scientific question to be answered): Primary aim of this study is to validate that this 
video, filmed specifically for an adolescent population, is effective at teaching 
adolescents how to self administer subcutaneous depot medroxyprogesterone. 
Secondary aims are to determine if the video is deemed satisfactory to the intended 
viewing audience and to determine if adolescents who watch this video will continue to 
self administer subcutaneous depot medroxyprogesterone in the future.   
Note: Specify which are the primary or secondary aims or objectives of this study as applicable. The primary 
objective is the main question. Secondary objectives are goals that will provide further information for the study.  
 
D. Enrollment and Withdrawal  
D.1 Inclusion Criteria 
1. Describe the criteria that define who will be included in the study as a numbered list:  
Subjects receiving the injection: 
1. Assigned females at birth 19 and younger seen at Tufts Medical Center or Tufts 
Children’s Hospital that have previously received at least one injection of depot 
medroxyprogesterone 
Include age eligibility including upper and lower limit. 
Indicate specifically whether you will include any of the following special populations: (You may not include members of 
the populations listed below as subjects in your research unless you indicate them in your inclusion criteria.) 
a. 
Adults unable to consent (cognitively impaired adults)  
b. Pregnant women   
c. 
Pregnant minors  
d. Minors, i.e., individuals who are not yet adults (neonates, children, teenagers)   
e. 
Wards of the state  
f. 
Non-Viable neonates  
g. Neonates of uncertain viability 
h. Prisoners 
If during the course of the study you identify a potential subject who cannot read, write or has some impairment 
that hampers consent process or documentation, follow the Policy on Subjects who Cannot Read, Write, or Have 
Some Impairment that Hampers Consent Process or Documentation. If such subjects will be excluded from the 
study, you must specify that in the “Exclusion Criteria” section below and specify the rationale for their exclusion. 
 
D.2 Exclusion Criteria 
1. Describe the criteria that define who will be excluded in the study as a numbered list:  
Subjects receiving the injection: 
1. Any patient who has never received a prior dose of depot medroxyprogesterone.   
2. Any patient who has ever self administered any injectable medication (either intramuscular 
or subcutaneous)   
3. Any patient who cannot understand written or spoken English (as the video is currently in 
English with English subtitles)  
4. Any patient under the age of 18 who does not have a parent or guardian to sign the 
consent form.  
5. Subjects who are unable to watch the video due to any circumstances (such as device 
unavailability or poor wifi signal) will be excluded. 

 
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6. Subjects who are cognitively impaired 
7. Subjects who are pregnant 
8. Wards of the state, prisoners 
    
 Describe in detail how the eligibility criteria will be assessed and satisfied (e.g., medical record review, 
physical examination): Study team members will review the clinic schedule ahead of time to 
find patients who are scheduled for depot-medroxyprogesterone injections and perform 
chart review to preliminarily determine if patients meet inclusion criteria.  These patients 
will be called via telephone and, using the script provided, will then be asked  if they 
have interest in the study.   Inclusion and exclusion criteria will be further clarified with 
verbal discussion when patients arrive in the office (for example, device availability, wifi 
signal).    
 State who will determine eligibility. Note that those who are designated to determine eligibility must have 
appropriate training, expertise, and oversight, for example a physician PI or Co-I on a biomedical study: 
Study team members Dr. French (PI), Dr. Fee and Dr. Bojko are gynecologists who 
currently provide care to patients receiving depot medroxyprogesterone and are trained 
to take care of these patients already.  These physicians are also trained to administer 
both subcutaneous and intramuscular injectable medications.  Any study team member 
added in the future must be a provider trained to care for patients receiving depot 
medroxyprogesterone injections.    
 Can study subjects participate in another research study while participating in this research study: 
☒Yes   ☐ No 
 
D.3 Withdrawal of Subjects 
1. Describe anticipated circumstances under which subjects will be withdrawn from the research without 
their consent: There is no anticipated circumstance in which subjects would be withdrawn 
without consent.  If the questionnaire is not filled out by the subject, this will be noted, as 
the provider will still be expected to fill out a separate questionnaire.  If the medication is 
not given by self administration after watching the video, the study data will reflect that 
outcome as a failure of the video to successfully teach technique.   
2. Describe procedures that will be followed when subjects withdraw or are withdrawn from the research, 
including the possibility of partial withdrawal from study intervention with continued data collection: 
Patients will revert to usual care, which is, receiving depot medroxyprogesterone 
administered by the healthcare provider.  Data collected before the point of withdraw will 
be retained.  
3. Describe any necessary safety precautions to be applied to subjects who withdraw or are withdrawn 
(tapering drug doses, evaluative x-ray, etc.):       or ☒N/A 
 
D.4 Recruitment and Retention 
 
D.4.1 Local Recruitment Methods 
Describe the following attributes of the recruitment plan for the local Tufts site:  
1. When, where, and how potential subjects will be recruited: subjects will be identified in the 
medical records and screened for eligibility, then receive a telephone call to offer 
participation prior to scheduled visit  
a. If potential subjects will be recruited by telephone, describe how many times the research 
team will attempt to call / leave a voice message: 2  
i. ☒Check to confirm that a script for both the telephone conversation and the voice 
message is included with the submission. 
b. When subjects respond to recruitment material, describe the information that will be 
provided to them about the study and the information that will be collected from subjects (e.g. 
name, telephone number, etc.). Describe also, how many times you will attempt to respond to 

 
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call the subject back / leave a voice message: Subjects will be offered participation in 
the study on the telephone.  Two attempts to call will be made.  If subject 
expresses interest, their pharmacy details will be collected and a prescription 
for the subcutaneous version of depot medroxyprogesterone will be sent to 
their pharmacy.  Subject will be instructed to pick up the medication at the 
pharmacy and bring it to their previously scheduled appointment.  Subjects 
will receive basic education from pharmacy as per SOP, so they will have 
some prior instruction on how to administer the shot on their own.   Subjects 
will be told on the phone that the doctor will discuss the consent process in 
person once they are in the office and they are free to proceed or not proceed 
with the study at that time, but if they decline, the medication will be 
administered as per standard of care. No additional recruitment calls or 
materials will be provided or sent.      
i. ☒Check to confirm that a script for both the telephone conversation and the voice 
message is included with the submission. 
2. Source of subjects (for example, patient population, local community, etc.): Subjects will be 
drawn from the existing patient population of healthcare providers on the research 
team 
3. Methods that will be used to identify potential subjects: Review in advance the schedule of 
the health care providers on the research team to identify subjects who are known 
users of depot medroxyprogesterone  
4. If print and media advertisements will be used, specify when, where, how long and frequency of the 
advertisements that will be published/aired:       or ☒ N/A 
a. ☐Check to confirm that any necessary permission will be obtained for posting/airing these 
(for example, permission to post a flyer on a bulletin board). 
5. If recruitment material is being mailed or otherwise distributed, submit the proposed material and 
describe where/how the distribution list will be obtained:       or ☒ N/A 
6. Describe how the recruitment methods described will be effective in attracting the targeted subject 
population: Patients will be asked if they want to participate, and the number of 
patients needed to complete this study is low compared to the high volume of 
patients already receiving this medication in an intramuscular form.  As there is 
general interest noted online and by anecdotal discussion in being able to give 
oneself medication, it is expected that simply asking patients if they are interested 
would be sufficient to obtain the number of subjects targeted for the study.   
7. Reminders:  
a. 
Refer to the Tufts Health Sciences IRB Policy on Direct Advertising Material for Recruitment for 
additional requirements when recruiting through social media.  
b. Submit a copy of each recruitment-related document to the IRB (including flyers, web ads, screening 
interview/questionnaires or screening scripts) for review & approval.              
c. 
For advertisements, submit the proposed final copy of the print advertisement. When advertisements 
are audiotaped or videotaped for broadcast, submit the proposed final audio/video. It is recommended 
that you submit a script of the proposed audio or video advertisement for IRB review before taping the 
final version in case revisions are needed. Once recommended changes are made, the final version is to 
be submitted to the IRB for review and approval.  
d. Postings to the Tufts Medical Center Clinical Trials website do not need to be submitted to the IRB for 
review and approval as long as information in these postings is restricted to the fields listed in the 
form. 
 
D.4.2 Study-Wide Recruitment Methods 
Is this is a multicenter study where subjects will be recruited by methods not under the control of the local 
Tufts site (e.g., call centers, national advertisements)?  
☐ Yes  ☒ No 
If Yes, respond to all of the following: 

 
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1. Methods of recruitment not under the control of the local Tufts site:  
2. When, where, and how potential subjects will be recruited:  
3. Methods that will be used to identify potential subjects:  
4. Materials that will be used to recruit subjects:  
5. Reminders:  
a. 
Refer to the Tufts Health Sciences IRB Policy on Direct Advertising Material for Recruitment for 
additional requirements when recruiting through social media.  
b. Submit a copy of each recruitment-related document to the IRB (including flyers, web ads, screening 
interview/questionnaires or screening scripts) for review & approval.              
c. 
For advertisements, submit the proposed final copy of the print advertisement. When advertisements 
are audiotaped or videotaped for broadcast, submit the proposed final audio/video. It is recommended 
that you submit a script of the proposed audio or video advertisement for IRB review before taping the 
final version in case revisions are needed. Once recommended changes are made, the final version is to 
be submitted to the IRB for review and approval.  
d. Postings to the Tufts Medical Center Clinical Trials website do not need to be submitted to the IRB for 
review and approval as long as information in these postings is restricted to the fields listed in the 
form. 
 
D.4.3 Payment  
Will subjects receive money, gifts, or any other incentive for participating in this study?  
This does not include reimbursement for expenses, which is considered in the next section.                   
☐ Yes  ☒ No 
If Yes, respond to all of the following: 
1. Describe any proposed payment or incentive for subjects (e.g. money, gifts cards, water bottles, tote 
bags, pill boxes, etc.). Include a specific description of the incentive and its value both in US and local 
currency (if international). The payment/incentive value must not be so great that it could cause undue 
influence1:  
2. Payment amount:  
3. How payment will be made (e.g., cash, check, Greenphire ClinCard). Please note, if Greenphire 
ClinCard will not be used to pay subjects, you must use a payment log to track payments to subjects 
and you must retain financial records of payments to subjects, as payments are subject to audit:  
4. To whom payment will be made (subject, parent [which one],legally authorized representative):  
5. Payment schedule: 
a. When payment will occur 
The payment schedule (amount at each time point), including details about the payment schedule and 
amount for subjects who withdraw or are withdrawn from the study:  
D.4.4 Reimbursement  
Will subjects be reimbursed for their expenses, such as travel, parking, meals, or any other study related 
costs? 
☐ Yes  ☒ No 
If Yes, respond to all of the following: 
1. What qualifies for reimbursement and whether pre-approval is needed:       
2. How subjects will be required to document expenses for reimbursement (e.g., provide receipts):       
3. How and how often subjects may request reimbursement:       
4. How reimbursement will be made (e.g., cash, check, Greenphire ClinCard). Please note, if Greenphire 
ClinCard will not be used to provide reimbursement, you must use a log to track reimbursements to 
subjects, as these reimbursements are subject to audit:       
5. The reimbursement schedule (when will subjects be reimbursed):       
 
E. Costs to Subjects 
Does the research involve any costs to subjects?  
                                                 
1 Undue influence, often occurs through an offer of an excessive or inappropriate reward or other overture in order to obtain 
compliance. For example, an investigator might promise psychology students extra credit if they participate in the research. If 
that is the only way a student can earn extra credit, then the investigator is unduly influencing potential subjects. If, however, 
she offers comparable non-research alternatives for earning extra credit, the possibility of undue influence is minimized. 

 
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☐ Yes 
 ☒ No 
If Yes, describe any costs that subjects might be responsible for due to participation in the research:  
 
F. Study Design 
 
F.1 Study Timelines 
1. Describe the duration of an individual subject’s participation in the study: Approximately 3 months 
(two separate clinic visits approximately 12 weeks apart) 
2. Describe the duration anticipated to enroll all study subjects at the Tufts study site: Approximately 6-
12 months 
3. Describe the estimated date for investigators to complete this study (complete primary analyses): 
Approximately 12-18 months 
 
F.2 Procedures 
 Summarize the research design and sequentially identify all procedures to be performed to accomplish 
the specific aims of the project. Clearly identify and distinguish procedures that are considered 
experimental, procedures that are performed exclusively for research purposes (including “extra” 
routine tests), and procedures that would occur regardless of the research (i.e., standard of care). Point 
out any procedures, situations, or materials that may be hazardous, and the precautions to be exercised 
to maintain subject safety: 1. Clinic schedules for the medical providers on the research 
team will be reviewed in advance and any patient that is under the age of 20 and 
receiving depot-medroxyprogesterone will be contacted by telephone in advance to 
offer participation in the project.  2. The telephone call will follow the attached script.  
Two attempts will be made to call patients.  3. If subject is interested in participating, a 
prescription for the subcutaneous version of depot-medroxyprogesterone will be sent to 
their pharmacy to be picked up by the subject prior to the office visit.  4. Subjects under 
18 will be instructed that they must be accompanied by a parent or guardian. At the 
office visit, written consent/assent will be obtained. 5. Subject will be shown the 
instructional video, which is approximately 3 minutes long (video submitted in attached 
word document with a link, Consent on file for actor in video).  They may view as many 
times as they want.  6. Once ready, the healthcare provider from the research team will 
observe, without giving verbal instruction, the patient give themselves a subcutaneous 
depot-medroxyprogesterone injection.  7. If at any point the provider feels that the 
subject is not performing the injection safely or correctly the healthcare provider will 
intervene to ensure that the medication is given correctly, and this will be recorded 
within the REDCap survey.  8.  After the injection is given, the subject will fill out the 
REDCap survey and study team member administering injection will input observational 
data into REDCap.  9.  Subject will be asked to repeat another questionnaire in 
REDCap at the time of the next injection which will be scheduled for 12 weeks later. The 
next visit is as per standard of care scheduling (this medication is routinely administered 
at approximately 12 week intervals). If the subject comes into the same office for the 
injection, the survey will be filled out in person. If the subject does not come in to the 
same office, a link to the follow up REDCap survey will be emailed to the subject with 
instructions on how to access the survey. Email addresses will be confirmed at the time 
of the first visit, as is routine for medical care.   
 
Please also describe the following concerning procedures: 
a. How individuals will be screened for eligibility. Specify screening that will take place prior to 
informed consent and screening that will take place after informed consent: Initial screening will 
be via review of medical charts in advance of appointments, followed by asking 

 
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subjects about inclusion and exclusion criteria verbally prior to enrollment and 
consent process.     
b. Procedures being performed to monitor subjects for safety or to minimize risks: All injections will 
be self administered in the presence of the healthcare provider on the research 
team.  If the provider feels that the subject is not following safe or proper technique, 
in their clinical opinion, the subject will be stopped and the injection will be 
administered by the trained healthcare provider.   
c. All drugs and devices used in the research, their regulatory approval status, and the purpose of their 
use: Depot-medroxyprogesterone will be the medication given, but only in the setting 
of patients who have already been counselled and agreed to treatment with this 
medication, which is FDA approved for contraception in this patient population. The 
medication is not being given for the purposes of this research, but rather for 
standard of care. Only the method of administration is being changed for this study.  
d. The source records that will be used to collect data about subjects. (Attach all surveys, scripts, and 
data collection forms.): Will attach telephone scripts that will be used to talk to patients. 
Chart reviews to determine eligibility.   A REDcap survey will be built (attached in a 
word document) 
 Is there a placebo control arm?  
☐ Yes  ☒ No  
If Yes, respond to all of the following: 
d. Describe the scientific, methodological, and medical reasons to use a placebo:       
e. Describe the care that will be given to subjects who receive placebo. If this is local standard of care, 
specify that:       
f. Describe all potential risks to the placebo group and how the risks will be minimized.       
3. Describe the following concerning  pregnancy testing and birth control: 
a. What type of pregnancy testing and how frequently will be conducted on women of reproductive 
potential.  If testing will not be conducted provide the reason: Depot medroxyprogesterone is a 
form of contraception and has been used in both subcutaneous and intramuscular 
form effectively and safely.  Subjects will only be tested for pregnancy for routine care 
reasons that are not related to the study.    
b. What birth control methods women of reproductive potential will be instructed to use. If women will 
not be instructed about acceptable methods of birth control, clarify why: Depot 
medroxyprogesterone is a form of contraception.  Subjects will receive the same 
counselling regarding contraception as all non study participants seen in the 
research team’s medical practices.     
c. What birth control methods men of reproductive potential will be instructed to use. If men will not be 
instructed about acceptable methods of birth control, clarify why: n/a - people who are not 
menstruating will not be enrolled in this study  
4. Describe the data that will be collected during the study and how the data will be obtained: Survey 
data will be entered directly into REDCap links by study participants and the healthcare 
provider on the research team. For the purpose of administering secondary surveys of 
patients that do not come into the same clinic for the second visit, the key will be 
consulted for patient names, and these charts will be accessed to obtain email 
addresses for contact purposes.  Email addresses will not be otherwise recorded or 
collected.   
a. If there are plans for long-term follow-up (once all research related procedures are complete), 
describe the data will be collected during this period: or ☒ N/A   
5. Specify which procedures, tests, visits, etc. described above are part of usual standard of care at Tufts 
and which are performed solely for research purposes: Administration of the medication is part of 
standard of care, the survey and self-administration (if done) is for research.   

 
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6. Specify which tests are routinely performed for clinical care, but are providing data for the research, and 
which tests are only performed for research purposes: n/a 
7. For Humanitarian Use Device (HUD) uses provide a description of the device, a summary of how you 
propose to use the device, including a description of any screening procedures, the HUD procedure, and 
any patient follow-up visits, tests or procedures.      or ☒ N/A   
 
F.3 Evaluations 
Will you perform any laboratory tests for this study? 
☐ Yes 
 ☒ No 
If Yes, respond to all of the following: 
1. List all laboratory tests to be done as part of the study (e.g., hematology, clinical chemistry, urinalysis, 
pregnancy testing)as follows:       
a. 
Differentiate screening laboratory test(s) from those taken after enrollment. 
b. Include specific test components and estimated volume and type of specimens needed for each test. 
c. 
List special assays or procedures required to determine study eligibility or assess the effect of the intervention 
(e.g., immunology assays, pharmacokinetic studies, images, flow cytometry assays, microarray, DNA 
sequencing). For research laboratory assays, include specific assays, estimated volume and type of specimen 
needed for each test. For procedures, provide special instructions or precautions.  
2. Describe laboratory methods to provide for appropriate longitudinal and cross-sectional comparison 
(e.g., use of consistent laboratory method throughout study, use of single, central laboratory for multi-site 
studies):       
3. If more than one laboratory will be used to perform study tests, specify which evaluations will be done by 
each laboratory:        
4. ☐Check to confirm that laboratory tests that will be performed are in compliance with Clinical 
Laboratory Improvement Amendments (CLIA) of 1988. If not, explain why:        
5. If samples will be stored for the purpose of this study, describe the preparation, handling, and storage of 
specimens, including specific time requirements for processing, required temperatures, aliquots of 
specimens, where they will be stored, how they will be labeled, and what will happen to the samples after 
the study is over (e.g. will be destroyed):        or ☐ N/A  
 
F.4 Collection and Storage of Human Biological Specimens (Tissue Banking) 
Will biological specimens be stored for future, unspecified, research?  
☐ Yes 
 ☒ No 
If Yes, respond to all of the following: 
1. Where specimens will be stored, how long they will be stored, how specimens will be accessed, and who 
will have access to the specimens:       
2. List the Protected Health Information (PHI) to be stored or associated with each specimen. If PHI will be 
gathered in the future and associated with the specimen, describe the frequency of gathering such PHI: 
       or ☐ N/A, PHI will not be stored or associated with each specimen. 
3. Procedures to release specimens, including: the process to request a release, approvals required for 
release, who can obtain specimens, and the PHI to be provided with specimens:       
4. Risks to subjects and their families associated with this collection and storage for future research use: 
      
5. Risks to groups or populations associated with this collection and storage for future research use: 
      
6. The mechanism by which the research subject can withdraw permission to use the stored specimens and 
associated PHI for future research. Indicate what will happen to the specimens and related research data 
if permission is withdrawn:       
 
Refer to the IRB’s Policy for Research Involving Collection and Storage of Human Biological Specimens for Future 
Research to ensure that all relevant information is included in the protocol. 
 
G. Ethics and Protection of Human Subjects 

 
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G.1 Informed Consent Process 
Will subjects be required to provide informed consent? 
☒ Yes 
 ☐ No 
If Yes, respond to all of the following: 
1. Where the consent process will take place (e.g. a private clinic room): Privately, in the medical 
clinic prior to watching the instructional video. 
2. Anticipated amount of time a potential subject will have to make a decision about participation in the 
study: Subjects will be aware of the study approximately 1-2 days prior to their scheduled 
appointment. They will be given the consent / assent forms in person once they arrive in 
the office.  They will be given as much time as they prefer to ask questions and make a 
decision prior to their appointment so as not to disrupt the flow of the clinic.   
3. Processes to ensure ongoing consent throughout the study: Research team members will ensure 
consent forms are signed just prior to watching the video.   
4. Role of each research team member involved in the informed consent process (Please note, in general, for 
studies designated by the IRB as greater than minimal risk, a physician PI or Co-I must perform the 
informed consent process with subjects. A study coordinator/clinical research associate may not consent 
subjects. A study coordinator/clinical research associate may assist with this process; however, the PI or 
Co-I should be present to discuss the study with the subject and answer questions, and the PI or Co-I 
should sign the ICF documenting that s/he has performed the informed consent process with the subject 
and the subject understands the study.): Consents will be signed with the PI/Co-Is on the 
research team only.  
5. ☒ Check to confirm you will follow “SOP: Informed Consent Process for Research (HRP-090)”.  
If not, answer all of the following: 
a. Steps that will be taken to minimize the possibility of coercion or undue influence:       
b. Steps that will be taken to ensure subjects’ understanding:       
c. Describe in detail any other changes that differ from the SOP:       
6. ☐ Check to confirm that Non-English speakers will be enrolled using interpreters and IRB approved 
Short Forms per the IRB’s Short Form policy. If IRB approved Short Forms will not be used, describe 
which languages the consent will be fully translated into, who will conduct the consent interview, use of 
interpreters, use of IRB approved translated documents, etc.:       
7. If non-English speakers are not eligible (excluded from enrollment) for this study, provide the ethical and 
scientific justification, including whether this would be equitable. For example, if non-English speakers 
are eligible for the study and could potentially benefit from participation, it would not be equitable to 
exclude them: Our video at this time is in spoken English with English subtitles only.   
Providing different languages for the video prior to validation as a teaching tool is not 
practical. If the video is validated in English, newer versions in different languages may 
be considered with the assistance of medical interpreters to ensure the verbiage is 
appropriate.   
 
Refer to the IRB Short Form Policy on the IRB website for information about enrolling non-English speakers 
including how to reach medical interpreters. 
8. ☒Check to confirm you will follow “SOP: Written Documentation of Consent (HRP-091)”. If not, 
describe how consent will be documented in writing:       
9. ☐Check to confirm you will follow “SOP: Remote Consent Process (HRP-092)” if there is ever a 
situation where consent will not be obtained in person. If you will follow a different process if there is 
ever a situation where consent will not be obtained in person, describe:       or ☒ N/A. 
 
G.2 Waiver or Alteration of Consent Process 
This applies for studies where informed consent will not be obtained, required information will not be disclosed, or the 
research involves deception. 
1. Is a waiver or alteration of the consent process being requested for this study?  
☒ Yes  ☐ No 

 
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If Yes, respond to all of the following: 
a. Provide the rationale for the waiver: Patient charts will be reviewed to determine eligibility 
for the study, but this screening step will not alter medical care. It is necessary to 
determine eligibility in order to contact appropriate candidates for the study, and to 
ensure that the subcutaneous form of depot medroxyprogesterone is prescribed so 
that when patient arrives in the office, the choice to participate in the study is 
available.  If charts cannot be prescreened, it cannot be guaranteed that the 
appropriate medication will be available and this will limit the enrollment process.  
Having a preliminary consent for the screening process is unduly onerous to 
potential study subjects as there is no alteration in clinical care regardless of which 
form of depot medroxyprogesterone they bring to the office.  Patients receiving 
depot medroxyprogesterone administered by the doctor are already being called 
routinely in advance of their appointments to confirm pharmacy information and to 
confirm they will be bringing the correct medication to the appointment.   
b. How the waiver or consent alteration will NOT adversely affect the rights and welfare of subjects: 
Determination of eligibility criteria only by pre-screening charts will not alter medical care in any 
way.  Having the subcutaneous form of depot medroxyprogesterone does not commit the subjects to 
participation in the study.  The subcutaneous and intramuscular forms of the medication 
can be given interchangeably by the doctor.    
c. How the research could NOT practicably be carried out without the waiver or alteration: It is not 
practical to consent for chart review to determine eligibility as patients are at home 
and the phone call prior to an appointment to confirm pharmacy information is 
already routinely performed.     
d. How, subjects will be provided with additional pertinent information after participation.  If subjects 
will not be provided this information after participation, explain why: Complete consent for the 
actual study will be reviewed while the potential subjects are physically in the office 
space and at that time all questions will be reviewed. Any additional information will 
be provided at this time, prior to signing of the consent and assent forms 
 
2. Is a waiver of the consent process being requested for parents for research involving children?  
 
☐ Yes  ☒ No 
If Yes, respond to all of the following: 
a. The rationale for this waiver:       
b. How the research could NOT practicably be carried out without the waiver or alteration:        
c. How this waiver is an appropriate substitute to parental consent for protecting the children who will 
participate as subjects in the research:       
 
d. ☐ Check to confirm that the waiver is consistent with Federal, State, and local laws. 
 
3. Is a waiver of the consent process for planned emergency research being requested?  
☐ Yes  ☒ No 
If Yes, respond to all of the following: 
a. How the subjects are in a life-threatening situation:       
b. How available treatments are unproven or unsatisfactory:       
c. How the collection of valid scientific evidence, which may include evidence obtained through 
randomized placebo-controlled investigations, is necessary to determine the safety and effectiveness 
of particular interventions:       
d. Clarify how the appropriate animal and other preclinical studies that have been conducted, and the 
information derived from those studies and related evidence that supports the potential for the study 
drug, device, or procedure to provide a direct benefit to the individual subject:       
e. How the research could not practicably be carried out without the waiver:       
f. How obtaining informed consent is not feasible because:  

 
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i. Subjects will not be able to give their informed consent as a result of their medical condition 
(describe why):       
ii. The study drug, device, or procedure must be administered before consent from the subjects’ 
legally authorized representatives can be obtained (describe why):       
iii. There is no reasonable way to identify prospectively the individuals likely to become eligible 
for participation in the research (describe why):       
g. The length of the potential therapeutic window based on scientific evidence:       
h. ☐Check to confirm that the research team will attempt to contact a legally authorized representative 
for each subject within that window of time and, if feasible, ask for consent within that window rather 
than proceeding without consent. Note that at continuing review, you will need to report to the IRB 
the efforts made to contact legally authorized representatives or subject’s family member if a legally 
authorized representative is not available. 
i. 
☐Check to confirm that if the subject dies before a legally authorized representative or family 
member can be contacted, information about the research will be provided to the subject’s legally 
authorized representative or family member, if feasible. 
j. 
☐Check to confirm that if a legally authorized representative or family member is told about the 
research and the subject’s condition improves, the subject will also to be informed as soon as 
feasible. 
k. The consultation (including, where appropriate, consultation carried out by the IRB) with 
representatives of the communities in which the research will be conducted and from which the 
subjects will be drawn:       
l. 
The public disclosure to the communities in which the research will be conducted and from which the 
subjects will be drawn, prior to initiation of the research, of the plans for the investigation and its 
risks and expected benefits:       
m. The public disclosure following completion of the research to apprise the community and researchers 
of the study, including the demographic characteristics of the research population, and its results: 
      
n. The procedures to inform, at the earliest feasible opportunity, each subject, or if the subject remains 
incapacitated, a legally authorized representative of the subject, or if such a representative is not 
reasonably available, a family member, of the subject’s inclusion in the research, the details of the 
investigation and other information contained in the ICF, and that he or she may discontinue the 
subject’s participation at any time without penalty or loss of benefits to which the subject is otherwise 
entitled:       
 
G.3 International Research 
Refer to the IRB’s International Research Checklist and International Research Guidance and include all 
relevant information described in those documents in this protocol: N/A 
 
G.4 Confidentiality 
Data and specimens should be stored in a secure location only accessible by the research team. The PI must ensure that 
study documents are stored in a manner that protects the privacy of subjects and the confidentiality of study data. 
1. State where the study records, both electronic and/or paper documents including signed ICFs/assent 
forms, will be retained during the study (state the location for original document plus any copies that are 
made, e.g., if a copy of the ICF will be retained in the subject’s medical record): A key containing the 
link between coded REDcap responses and patient names will be kept separately in a 
password protected HIPAA compliant Box account set up through Tufts Medical Center.  
The REDCap does not collect any identifiers and each subject will have a unique 
sequential code attached to their survey. This will only be accessed by the study team 
and will be destroyed at the completion of the study.  The Key and any downloaded 
REDCap coded data will have two different passwords. Paper consent forms will be 
stored in a folder in a locked cabinet in a locked office that will only be accessible by Dr. 
Fee and Dr. French (PI).   

 
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2. State where study records will be retained when the study has been closed (long-term storage): The 
paper consent forms will be stored in the locked cabinet in the locked office following 
Tufts data retention policies.  Identifiable data that is entered into the HIPAA compliant 
Box account will not be stored long term and will not be accessed by anyone other than 
the research team.  Data will be destroyed at the culmination of the study.   
3. State who, in addition to the research team, will have access to the study files, data, and/or specimens: 
Only Dr. French and Dr. Fee will have access to the consent forms.  Study files in Box 
will be accessed only by the research study team for the duration of the study.  Nobody 
other than the research team will have access to this data.   
4. Will data (or specimens) be sent outside of Tufts Medical Center or Tufts University and/or sent between 
Tufts Medical Center and Tufts University?   
☐ Yes  ☒ No 
If Yes, respond to all of the following: 
a. 
 Describe the nature of the data/specimens to be transferred:            
b. State to whom or what entity the data/specimens will be transferred:            
c. Confirm that you have consulted with Tufts MC Research Administration or Tufts University 
Technology Transfer to determine whether an agreement is needed to permit the transfer of 
data/specimens, and one of the following is true: 
i. 
☐ An agreement (e.g. contract, Clinical Trial Agreement, Collaboration Agreement, 
Data Use Agreement (DUA), or Material Transfer Agreement (MTA)) has been or will 
be established that will cover any transfer of data/specimens, and the agreement will be 
executed prior to any transfer. 
ii. 
☐ Research Administration or Technology Transfer has determined that an 
agreement is not needed for this research.  (Research Administration/OVPR should 
make this determination, not the Investigator.) 
iii. 
☐ A determination from Research Administration/Technology Transfer is still pending. 
(The study cannot be approved by the IRB until Research Administration/Technology 
Transfer makes a determination, but it can be approved prior to the execution of an 
agreement.)  
5. Explain how data and/or specimens will be transported (e.g. fax, mail, delivery, email, etc.): REDCap 
data will be de-identified and kept within the REDCap tool.  Box data will be kept 
electronically and in separate password protected files accessible only by study team 
members through online access.  Paper consent forms will be transported by study 
team members to the locked cabinet detailed above.  No data will leave Tufts Medical 
Center.   
6. Explain how data and/or specimens will be coded. Specify if there is a key to the code that matches the 
subjects’ study identification number with their name and who, in addition to the research team, will have 
access to it: The key with patient names will have a number assigned to each name that 
corresponds to the number in the REDCap survey.  This key will be kept in a password 
protected Box account set up through Tufts Medical Center and nobody aside from the 
research team will have access.    
7. Explain whether confidential genetic information will be collected from subjects:       or ☒ N/A   
8. Explain whether audio/videotapes and/or photographs of subjects could potentially identify the study 
subject. If so, indicate who will have access to (be able to view) these item, in addition to the research 
team, and how long the videotapes or photographs will be retained for the study and what the plan is for 
their destruction:       or ☒ N/A   
9. ☒Check to confirm that study records will be retained for the timeframe described in the record retention 
policy of the “SOP – Records Retention Timeframe – Investigators”.  If they will not, describe the record 
retention plan for this study:        
10. ☒Check to confirm that you will follow the “Confidentiality and Data Security Guidelines for Electronic 
Research Data” for electronic data.  If not, describe how your plan differs from these guidelines:       
11. A Certificate of Confidentiality will be issued (for NIH studies) or obtained: ☐Yes   ☒N/A   

 
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CoCs protect the privacy of research subjects by prohibiting disclosure of identifiable, sensitive research information 
to anyone not connected to the research except when the subject consents or in a few other specific situations. NIH 
funded researchers are automatically issued a CoC through their award. Other Department of Health and Human 
Services (HHS) agencies issue CoCs to researchers they fund. Researchers not funded by HHS can apply to NIH or 
the FDA as appropriate to request a CoC for HHS-mission relevant research, i.e., research involving collection of 
information that, if disclosed, could have adverse consequences for subjects or damage financial standing, 
employability, insurability, or reputation. For more information, refer to refer to the NIH website. 
 
G.5 Screening Data Collection Form/Screening Log  
This section specifically refers to data collected about potential subjects who are screened, but have not signed consent, 
for example potential subjects whose medical record is reviewed to see if they are potentially eligible, potential subjects 
who respond to a telephone screening call where the research team records information about the potential subject, etc. 
In this section “Screening Data / Screening Log” refers to any form of data collection on potential subjects who have not 
yet signed consent. For more information, refer to https://privacyruleandresearch.nih.gov/clin_research.asp. 
 
Will a screening data/screening log be used in this research study?  
☐ Yes 
 ☒ No 
If Yes, respond to all of the following: 
1. ☐ Check to confirm you have submitted the Screening Data Collection Form / Screening Log to the IRB.  
2. Review the following and provide information about the Screening Data / Screening Log and how it will 
be used (check all that apply): 
a. ☐ De-identified Screening Log will be provided to and/or viewed by the Study Sponsor (the log does 
not record any HIPAA identifiers or contain protected health information (PHI)). 
i. Explain how the Screening Log will be “distributed to” or viewed by the study Sponsor, i.e., 
how the Screening Log be e-mailed, sent to and /or viewed by the study Sponsor:       
b. ☐ Identifiable Screening Log that will not be distributed or viewed outside of the institution 
(although the Screening Log will record HIPAA identifiers, the Screening Log will not leave the 
institution.) 
i. Specify the identifiers that will be collected (e.g. date of admission or clinic visit, medical 
record #, and reason the person was not eligible for the study):       
c. ☐ Identifiable Screening Log that will be distributed or viewed outside of the institution.   
Consider whether these identifiers could be removed from the Screening Log. It might be possible to 
eliminate HIPAA identifiers or use a screened subject identifier code and maintain a separate key to 
the code so no PHI will leave the institution.  
If it is necessary to include HIPAA identifiers in the screening log, address the following:  
i. The rationale for including HIPAA identifiers in the Screening Log:       
ii. A plan for protecting the privacy and confidentiality of screened subjects. Screened subjects 
might or might not be enrolled in the research study, and since screened subjects will not 
have consented to the use of their PHI for research purposes, it is especially important to 
protect their privacy and confidentiality.  The plan should include keeping identifiers to a 
minimum, and keeping the Screening Log in a secure location (password protected computer 
location only accessible by the research team or a locked file cabinet in a locked office, only 
accessible by the research team):       
 
Note: A Screening Data Collection Form / Screening Log that contains identifiers and/or PHI must NOT be sent to the 
study Sponsor UNLESS the IRB has granted a waiver of consent/authorization for this component of the study (or unless 
the investigator has obtained IRB approved consent and research authorization from each study subject whose name is 
on the log.) 
 
G.6 Provisions to Protect the Privacy Interests of Subjects 
In this section, “privacy” refers to persons and their interest in controlling the access of others to themselves. For example, 
based on their privacy interests, people want to control:  
 
 
The time and place where they give information 
 
The nature of the information they give 
 
The nature of the experiences that are given to them 

 
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 
Who receives and can use the information 
 
Persons might not want to be seen entering a place that might stigmatize them, such as a pregnancy counseling center that 
is clearly identified as such by signs on the front of the building. What is private depends on the individual and can vary 
according to gender, ethnicity, age, socioeconomic class, education, ability level, social or verbal skill, health status, legal 
status, nationality, intelligence, personality, and the individual’s relationship to the researcher. Protecting the privacy 
interests of a young child might mean having a parent present at a session with a researcher. Protecting the privacy 
interests of a teenager might mean having a parent absent.  
1. Describe the steps that will be taken to protect subjects’ privacy interests (e.g. ensuring that discussion of 
the study will take place in a private area where subjects cannot be overheard): The consent for the 
study will be done in a private clinic room where medical care is provided.  Watching the 
video and completing the questionnaire will also be done in a private clinic room. 
Subject and guardian/parent will have the room to themselves while answering 
REDCap. The study doctor will be present during drug administration.  
2. Describe the steps that will be taken 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 or might not experience in response to 
questions, examinations, and procedures (e.g. ensuring that subjects are comfortable with the research 
team members performing the study procedures): Patients will be given a choice between 
participating in the study to perform self injection, or to get the injection from the 
healthcare provider which is their usual care.  The choice to participate or to receive 
usual care will be entirely up to the patients, as the medication is the same and the 
health care plan overall does not change depending on who gives the injection (patient 
or healthcare provider).   
 
G.7 Provisions to Monitor the Study to Ensure the Safety of Subjects 
1. Describe the plan to periodically evaluate the data regarding both harms and benefits to assess subject 
safety as follows: 
a. The data that will be reviewed, including safety data, untoward events, and efficacy data: As there 
is no new medication being given, untoward side effects or issues regarding safety 
with this medication during the study are not anticipated.  Self administered 
subcutaneous injections are also widely accepted as safe practice.  If unexpected 
issues arise, the PI will assess.   Data will be collected on failed attempts at self 
injection as part of the REDCap survey.  Failed self administered attempts at 
injection will be followed immediately by provider injection so as to ensure that the 
patients get the medication appropriately.   
b. Who will review the data: Dr. Bojko, Fee and French.   
c. How the safety information will be obtained and documented (e.g., case report forms, by telephone 
calls with participants, printouts of laboratory results, etc.): telephone or in person discussion 
with patients 
d. The frequency of data collection, including when safety data collection starts: Data collection will 
be ongoing 
e. The frequency or periodicity of review of cumulative data: Data collection will be reviewed 
every 3 months 
f. The statistical tests for analyzing the safety data to determine whether harm is occurring: There is 
no anticipated harm from this study (see a above). If an adverse event is reported 
the study PI will do a root-cause analysis to assess the nature of the event and why 
it happened. Any event will be reviewed so there is no need for statistical testing. 
g. Any conditions that trigger an immediate suspension of the research or other action for the research: 
none 
The plan might include establishing a data monitoring committee which addresses all the above.  
2. Describe the entity responsible for monitoring the data, and their respective roles (e.g., the investigators, 
the research sponsor, a coordinating or statistical center, an independent medical monitor, a Data and 

 
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Safety Monitoring Board (DSMB) /Data Monitoring Committee (DMC), and/or some other entity, and the 
timeframe for reporting events to this entity: The PI and study team   
3. A copy of the DSMB/DMC Charter if the study is enclosed with the submission: ☐Yes   ☒N/A 
 
G.8 Vulnerable Populations 
If the research involves individuals who are vulnerable to coercion or undue influence, describe the rationale for their 
inclusion and the additional safeguards included to protect their rights and welfare. 
1. Can or will pregnant women be enrolled?   
☐ Yes  ☒ No 
If Yes, respond to all of the following: 
a. Describe any preclinical studies, including studies on pregnant animals, and clinical studies, 
including studies on non-pregnant women, that have been conducted that provide data for assessing 
potential risks to pregnant women and fetuses:       
b. Are there any risk to the fetus from the study interventions or procedures.  If yes, describe:       or 
☐No, there are no risks to the fetus from the study interventions or procedures 
c. Do the study interventions or procedures hold out the prospect of direct benefit for the woman or the 
fetus. If yes, describe:       or ☐No, the study interventions or procedures do not hold out the 
prospect of direct benefit for the woman or the fetus.  
d. If there is no prospect of benefit to the fetus, clarify whether the risk to the fetus is NOT greater than 
Minimal Risk, and whether the purpose of the research is the development of important biomedical 
knowledge which cannot be obtained by any other means:       or ☐ N/A   
e. The biomedical knowledge that is expected to result from this research for this population:       
f. How any risk of this research is the least possible for achieving the objectives of the research: 
      
g. How mothers providing consent are informed of the reasonably foreseeable impact of the research on 
the fetus or neonate:       
h. ☐Check to confirm that no inducements, monetary or otherwise, will be offered to terminate a 
pregnancy and that in the case of a fetus, the fetus is not the subject of a planned abortion. 
i. 
☐Check to confirm that individuals engaged in the research will have no part in any decisions as to 
the timing, method, or procedures used to terminate a pregnancy or in determining the viability of a 
neonate. 
 
2. Can or will the research involve neonates of uncertain viability or non-viable neonates?  
☐ Yes  ☒ No 
If Yes, respond to all of the following: 
a. Any preclinical and clinical studies that have been conducted that provide data for assessing 
potential risks to neonates:       
b. The important biomedical knowledge that will be developed from this research and why it cannot be 
obtained by other means:       
c. Whether there will be added risk to the neonate resulting from the research:       
d. How individuals providing consent are informed of the reasonably foreseeable impact of the research 
on the neonate:       
e. No person shall perform or offer to perform an abortion where part or all of the consideration for 
said performance is that the fetal remains may be used for experimentation or other kind of research 
or study: ☐Yes   ☐ N/A  
f. No person shall knowingly sell, transfer, distribute or give away any fetus or neonate for a use which is in 
violation of Massachusetts General Laws Chapter 112 Section 12J: ☐Yes   ☐ N/A   
g. Individuals engaged in the research will have no part in determining the viability of a neonate:  
☐Yes   ☐ N/A   
h. For non-viable neonates, the vital functions of the neonate will not be artificially maintained and that 
the research will not terminate the heartbeat or respiration of the neonate: ☐Yes   ☐ N/A   

 
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i. 
For neonates of uncertain viability, the research holds out the prospect of enhancing the probability of 
survival of the neonate to the point of viability, and any risk is the least possible for achieving that 
objective: ☐Yes   ☐ N/A  
 
3. Can or will subjects who are not yet adults (neonates, children, teenagers) be enrolled?  
☒ Yes  ☐ No 
If Yes, respond to all of the following: 
a. ☒Check to confirm that you will follow “SOP: Legally Authorized Representatives, Children, and 
Guardians (HRP-013)” to determine whether a prospective subject has or has not attained the legal 
age for consent to treatments or procedures involved in the research under the applicable law of the 
jurisdiction in which the research will be conducted. (e.g., individuals under the age of 18 years).  If 
this SOP will not be followed, describe how this (attainment of legal age for consent or not) will be 
determined:        
b. How permission to participate in the study will be obtained from the parents or legal guardians: 
Written consent forms will be signed in person by parent/guardian as well as assent 
forms will be reviewed and signed in person by the subject.   
c. The assent process of children as follows: 
i. Any waiting period available between informing the prospective subject and obtaining the 
assent: no 
ii. Any process to ensure ongoing assent: Subjects may opt out of the study anytime.  
Assent will be confirmed before both the first and second visit.   
iii. Research team members involved in the assent process: PI/Co-Is   
iv. How long children will have to consider study participation: They will be notified 
several days prior to their appointment and will be able to ask questions and 
consider participation on the day of the appointment prior to signing assent.  
They can opt out anytime during the study.    
v. Steps that will be taken to minimize the possibility of coercion or undue influence: Patient 
will have the choice to opt out at any time. 
vi. Steps that will be taken to ensure the subjects’ understanding: Assent forms will be 
given and healthcare provider will explain verbally, with ample opportunity for 
subjects to ask questions.   
vii. If assent will not be obtained from children, specify why: n/a 
viii. If children reach 18 years of age while in the study describe the following: 
1) The plan to obtain written informed consent from the subject at age 18 years: There is 
a consent form for those 18 and over – subjects will be re-consented if 
they turn 18 between their two appointments.  
2) Who will be responsible for managing the plan: Healthcare providers on the 
research team.  
3) Where the consent discussion will take place: In the clinical office space at the 
time of their medical appointments.   
4) What will happen if the subject cannot be located to provide consent at age 18 years: n/a 
 
4. Can or will minors who are:  
i) 
married, widowed, divorced; or  
ii) 
the parent of a child; or  
iii) 
a member of any of the armed forces; or  
iv) 
pregnant or believes herself to be pregnant; or  
v) 
living separate and apart from his/her parent or legal guardian, and is managing his/her own 
financial affairs  
be approached for study participation for either themselves or their child?  
☒ Yes  ☐ No 
If Yes, respond to all of the following: 

 
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a. How will it be determined that this population has the capacity to consent for this study.  Please note 
that the circumstance of parenthood, pregnancy, etc. may not mean that the person has the same 
capacity of an adult who can understand the risks, benefits, and alternatives for indicated care. Thus, 
sound and sensitive clinical judgment that is attentive to both the minor’s rights and the minor’s 
actual competence and needs must be considered, and is to include a determination as to whether 
involvement of family or other adults familiar to the minor is necessary and appropriate: The 
subjects will only be approached if they are already receiving this medication and 
have already consented to using it.  The only intervention in this study will be the 
patient’s choice about self administration of the medication which will be explained 
verbally and with written consent forms with the opportunity to ask questions and opt 
out any time. Study doctor is observing application of shot, so subject will be 
stopped from self-administering if doctor feels subject cannot administer safely.  
b. How informed consent will be executed with this population in a way that allows for independent and 
thoughtful decision-making: Consent will be approached in the same way as for all 
subjects.  If parent or guardian signature is required due to age of patient, and is not 
available, then the patient may not participate in the study.   
c. Any additional steps or procedures that will be used when performing informed consent with this 
population: no  
 
Refer to Massachusetts state law (MGL Chapter 112, Section 12F) for more information about this population.  
Please note, the statute applies to clinical care and should be applied to research only as applicable. 
 
 
5. Can or will wards of the state and/or children at risk of becoming wards of the state be enrolled (this 
includes foster children or any child that is in state custody)?            
☐ Yes  ☒ No 
If Yes, respond to all of the following: 
a. Justification for recruiting and enrolling this population:  
b. Any additional details about the recruitment methods to be used. If the same recruitment methods 
previously described in the protocol will be used, then state that:  
c. Any additional details about the informed consent process to be used. If the same informed consent 
process for enrolling minors previously described in the protocol will be used, then state that:  
d. How it will be ensured that the appropriate person(s) grants permission for each ward to participate 
in the research:  
e. How the research team will know if there has been a change in guardianship status during the course 
of the research and how permission will be obtained from the new guardian:  
f. ☐Check to confirm that documentation of review by the Department of Children and Families (DCF) 
for this study has been submitted to the IRB. 
g. If the study is greater than minimal risk, describe the following or ☒ N/A, study is not greater than 
minimal risk:  
i. Whether the research is related to their status as wards OR if the research is conducted in 
schools, camps, hospitals, institutions, or similar settings in which the majority of children 
involved as subjects are not wards:       
ii. How an advocate will be appointed for each child who is a ward, in addition to any other 
individual acting on behalf of the child as guardian or in loco parentis:       
iii. The background and experience of the advocate to act in the best interests of the child for the 
duration of the child’s participation in the research:       
iv. ☐ Check to confirm that the advocate will not be associated in any way (except in the role as 
advocate or member of the IRB) with the research, the investigator(s), or the guardian 
organization. 
Refer to the IRB’s Wards of the State policy for additional information on enrolling wards of the state. 
 
6. Can or will cognitively impaired adults (adults with impaired-decision making capacity) or adults who 
may lose the capacity to consent be enrolled?  
☐ Yes  ☒ No 

 
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If Yes, respond to all of the following: 
a. Whether the research holds out a prospect of direct benefit to the individual subject that is 
unavailable outside the research context:        
b. Why the objectives of the study cannot be met by enrolling subjects who are able to give consent: 
      
c. ☐Check to confirm that this study is NOT prohibited by law. 
d. The process to determine whether or not the individual is capable of consent:        
e. Who will determine if the subject is able to provide informed consent:       
f. How it will be determined whether the subject is able to provide informed consent:       
g. When and how often (even after obtaining informed consent) it will be determined whether the subject 
is able to provide informed consent:       
h. List the individuals from whom permission will be obtained if the subject cannot provide informed 
consent. Prioritize the list (e.g., durable power of attorney for health care, court appointed guardian 
for health care decisions, spouse, and adult child.):       
i. ☐Check to confirm that for research conducted in MA, you have reviewed “SOP: Legally 
Authorized Representatives, Children, and Guardians (HRP-013)” and are aware of which 
individuals in MA meet the definition of “legally authorized representative.” 
ii. For research conducted outside of MA, provide information that describes which individuals 
are authorized under applicable law to consent on behalf of a prospective subject to their 
participation in the procedure(s) involved in this research. One method of obtaining this 
information is to have a legal counsel or authority review your protocol regarding the 
definition of “legally authorized representative” in “SOP: Legally Authorized Representatives, 
Children, and Guardians (HRP-013)”:       
i. 
If it is possible that subjects may regain capacity to provide informed consent during the study, 
describe how frequently this will be assessed and state that subjects will be consented to the study in 
the event that they regain capacity to provide informed consent:       or ☐ N/A  
j. 
Describe the process for assent of the subjects as follows: 
i. Whether assent will be required of all, some, or none of the subjects. If some, specify which 
subjects will be required to assent and which will not:       
ii. If assent will not be obtained from some or all subjects, an explanation of why not:       
iii. Whether assent of the subjects will be documented and the process to document assent. The IRB 
allows the person obtaining assent to document assent on the consent document and does not 
routinely require assent documents and does not routinely require subjects to sign assent 
documents:       
k. Provide a description of how the patient will be informed of the potential risks and benefits of the 
study and any procedures associated with its use:       
l. 
☐Check to confirm that subjects will be withdrawn if they appear to be unduly distressed at any time 
during the study.  
 
7. Can or will prisoners be enrolled?   
☐ Yes  ☒ No 
If Yes, respond to all of the following: 
a. Any possible advantages accruing to the Prisoner through his or her participation in the research, 
when compared to the general living conditions, medical care, quality of food, amenities and 
opportunity for earnings in the prison, are not of such a magnitude that his or her ability to weigh the 
risks of the research against the value of such advantages in the limited choice environment of the 
prison is impaired:        
b. Whether the risks involved in the research are commensurate with risks that would be accepted by 
non-Prisoner volunteers:        
c. Procedures for the selection of subjects within the prison which are fair to all Prisoners and immune 
from arbitrary intervention by prison authorities or Prisoners. Unless the Principal Investigator 
provides to the Board justification in writing for following some other procedures, control subjects 

 
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must be selected randomly from the group of available Prisoners who meet the characteristics needed 
for that particular research project:        
d. ☐Check to confirm that parole boards will not take into account a Prisoner’s participation in the 
research in making decisions regarding parole, and each Prisoner is clearly informed in advance 
that participation in the research will have no effect on his or her parole.  
e. ☐Check to confirm that a letter of support from the Prison this research will be conducted in has 
been submitted to the IRB.  
f. If follow-up examination or care of subjects after the end of their participation is required, describe 
the provision for such examination or care, taking into account the varying lengths of individual 
Prisoners’ sentences, and for informing subjects of this fact:       
 
8. Can or will students and/or employees be targeted for enrollment in this research?  
☐ Yes  ☒ No 
If Yes, respond to all of the following: 
a. Justification for specifically targeting recruitment efforts to enroll students and/or employees:       
b. How potential coercion will be eliminated:       
c. Recruitment methods to be applied specifically to students and/or employees. If the same recruitment 
methods previously described in the protocol will be used, then state that:       
d. Additional safeguards included to protect the rights and welfare of students and employees:        
e. Protections to ensure that a subject’s decision about participation and/or early withdrawal from the 
study will not affect his/her status as a student or employee:        
f. ☐Check to confirm that you have submitted a letter from the appropriate institutional official (e.g., 
Department Chair, Dean, Vice-President) who oversees the students and/or employees attesting to 
the fact that the employee’s or student’s participation in the research is acceptable and that coercion 
has been minimized. 
 
9. Transgender Subjects: Are you recording sex or gender for your study? 
☐ Yes  ☒ No 
a. Is there a scientific and/or safety rationale for collecting information on whether a subject is 
transgender? ☐ Yes ☐ No 
If Yes, respond to all of the following: 
i. Provide the scientific/safety rationale for collecting information on whether a subject is 
transgender:         
ii. Are transgender individuals eligible for participation in this study? ☐ Yes ☐ No 
If No,  Provide the scientific or safety rationale for excluding transgender or gender 
nonconforming individuals:        
    Note: Transgender subjects may not be excluded unless there is a scientific or subject safety 
rationale for doing so. 
iii. ☐ Check to confirm that relevant questions for transgender and gender nonconforming 
individuals have been incorporated into relevant study documents (i.e. protocol eligibility, 
screening forms, demographic questionnaires, surveys), per the website guidance. 
If no, there is no scientific or safety-related rationale for needing to identify sex or gender for your study, and you 
will not collect information on transgender and gender nonconforming people’s identification.  
 
H. Adverse Event Monitoring 
H.1 Definitions 
Define adverse events (AEs), serious adverse events (SAEs), and unanticipated problems for your study: No 
serious adverse events are anticipated.  The only intervention in the study is to self 
administer an injection versus receiving the same injection from a healthcare provider.  
There is a risk that the subject may not properly give themselves the injection, but this is a 
minor risk that may also occur when a healthcare provider gives injections and is easily 
remedied by having the healthcare provider give an additional injection.  If an additional 
injection is given, the risk of side effects from the medication is minimal, and the therapeutic 

 
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benefit is the same as if a single injection is given.  This practice of repeating an injection 
on the same day at the same clinic appointment if there is concern for incomplete 
administration of medication for depot medroxyprogesterone is common and accepted 
practice when this medication is administered by healthcare providers.  Risks of 
administering an injection include bleeding, bruising, unintentional injury, broken needle, 
infection.  All of these are minor risks that will be attended to with routine medical care. 
 
H.2 Reporting Procedures 
1. Describe the protocol-specific reporting procedures, including who will be responsible for each step 
(e.g., PI, Data Coordinating Center, Medical Monitor), which forms should be completed, timeframes for 
reporting, how reports will be distributed, and what follow-up is required: If medication is not 
correctly self administered this data will be entered into the REDcap survey by the 
healthcare provider and is part of the data being collected.  In addition, this will be 
documented in the patient’s medical record as part of routine medical care.    
2. Include specific details of reporting procedures for: 
a. Deaths, life-threatening events, pregnancies: not anticipated  
b. Other SAEs:        
c. Other AEs:        
d. Other UPs:        
Ensure that the reporting procedures meet the reporting requirements of the FDA, NIH, OHRP, sponsor, study leadership 
and any other regulatory body that applies to the study, as applicable.  
 
H.3 Reportable New Information 
☒Check to confirm that reportable new information will be reported to the IRB per the Tufts Health Sciences 
IRB’s Reportable New Information policy. If your reporting plan to the IRB differs from the IRB’s policies, 
please describe it in detail or specify where this information is in the protocol:       
 
I. Statistical Considerations 
 
I.1 Study Endpoints 
1. Describe the primary and secondary study endpoints: The primary outcome for this study is 
successful or not successful (i.e.,1/0) self administration of depot-medroxyprogesterone 
by study participants. A secondary outcome is understanding whether or not study 
participants will continue to use self administered injections in the future. In addition to 
these quantifiable outcomes, the study will also collect feasibility information, such as 
ease of identifying eligible study participants, potential participants willingness to 
consent, or participants willingness to pick up the prescribed medication prior to an in-
person appointment.  
2. Describe any primary or secondary safety endpoints:       
 
I.2 Sample Size Justification Statistical Analyses 
1. Describe the statistical analyses that will be performed for this study:  This is a pilot study, 
designed to understand the feasiblity of larger scale studies, including those with a 
comparisong group, in the future. Key questions include the statistical properties of the 
dependent variables, including response rates for survey items and the injection 
success rate. The analysis will be descriptive, looking at the completeness of the survey 
data, correlation among survey items, and the injection success rate (to help inform 
future power analysis, among other things). We will also assess concordance between 
the observing physician and the patient on the success of the injection using a kappa 
statistic. Finally, we will compare injection success based a patient's assesement of 
willingness to continue using self injection in the future.       After the initial survey, a 

 
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second survey will be given to participants approximately 12 weeks later, to see if 
participants self inject a second time.   
2. Provide a sample size justification:  Since this is a treatment group-only pilot study, formal 
power analysis was not conducted. We are targeting 30 participants to better 
understand how many teenagers complete all steps in the study process (i.e., meet 
study criteria, consent, pick up medication, attend appointment, attempt injection, 
complete surveys). The team will make efforts to understand study drop-out at each 
stage. We also want to better understand the relationship between key covariates, such 
as convinence of home injection, and the outcome.      
 
I.3 Number of Subjects 
1. Specify the number of subjects to be enrolled in total across all sites:  or ☒ N/A this is not a multicenter 
study. 
2. Specify the number of subjects to be enrolled at the Tufts site. Subjects who sign an ICF are considered 
“enrolled”. For studies that have a separate screening ICF, this number is the number of subjects who 
sign a screening ICF: 50   
a. Provide the rationale for enrolling this number of subjects at the Tufts site: it is anticipated 
that 50 will need to be enrolled to achieve 30 to complete the study 
b. Estimate the number of subjects expected to be enrolled at the Tufts site (i.e. sign the screening or 
study ICF) as well as the number needed to complete the study at the Tufts site: 50 enrolled, 30 
complete 
c. If a large number of withdrawals and/or dropouts is expected, explain why: not expected 
 
I.4 Data Management 
1. Describe the data analysis plan, including descriptions of the data:       
The data are survey results, collected and stored in the Tufts instance of RedCAP. Each encounter will 
result in two surveys: one from the patient and one from the clinician. Each survey will have a unique 
identifier for the provider and an encrypted identifier for the patient.  
 
Descriptive analysis will start with data completeness. Next, we will look at the frequency of all variables, 
including the patient’s self-assessment of a complete injection with the provider’s assessment of the 
injection. We will look at the correlation between self-perception of a successful injection and age, 
assessment of the video and self-reported intent to do self-injection in the future. We will also assess the 
degree to which patients and providers agree on the quality of the injection (kappa statistics to assess 
concordance on injection success).   
2. Describe the steps that will be taken to secure the data (e.g., training, authorization of access, password 
protection, encryption, physical controls, certificates of confidentiality, and separation of identifiers and 
data) during storage, use, and transmission: All data entered into REDCap will be coded.  
Subjects will be given numbers by the REDCap survey, and these numbers will be 
assigned in the sequential order the subjects complete the surveys.  These numbers will 
be linked to their names, and the key will be kept in a password protected online file in a 
HIPAA secure Box file created by Tufts Medical Center.  Only research team members 
will have access to this file.  The file will be destroyed at the end of the study.  Consent 
forms will be kept in a locked cabinet in a locked office accessible only by Dr. Fee and 
Dr. French.  
3. Describe any procedures that will be used for quality control of collected data:       
One challenge with data collection is making sure the provider survey and patient survey are correctly 
linked. To test this, the team will review a random 5 cases and make sure the date, time and provider 
match. During the analysis, we will see if any surveys are incomplete. If yes, we’ll seek to understand any 
patterns. For example, are teens in a specific age group leaving items blank? Are patients see at a 
particular time of day or by a specific clinician skipping items. This type of information will be used to 
decide if incomplete surveys can be used in the analysis.  

 
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To ensure data integrity, downloads from RedCAP will be dated and carefully managed to make sure 
incomplete data sets are not used for analysis. Only members of the study team will have access to the 
analytic file and results will be reviewed by multiple team members. All final tables will clearly show the 
number of cases involved in the analysis and identify the analytic data set used to generate results.  
 
4. Describe how data and specimens will be handled study-wide as follows:  
a. What information will be included in that data or associated with the specimens: Each survey 
will be given a number by REDCap, and this number will be recorded and linked to 
the patient’s name.  The key that has the names and numbers will be stored in a 
HIPAA compliant password protected Box account for the PI and only research 
team members will have access to this Box account.   
b. Where and how data or specimens will be stored: There will be no specimens.  Data will be 
stored electronically in the REDCap surveys which are coded.  The key matching 
survey numbers and patient names will be stored in a HIPAA compliant Tufts 
Medical Center Box account.  Paper consent forms will be kept in a locked cabinet 
in a locked office accessible only to Dr. Fee and Dr. French.   
c. How long the data or specimens will be stored: Paper consent forms will be stored for at 
least 7 years.   REDCap surveys will only contain de-identified information.  The 
key linking survey numbers to patient names will be in a secure Box account that 
will be destroyed at the completion of the study and data analysis.   
d. Specify who will have access to the data or specimens: only members of the research team 
e. Specify who is responsible for receipt or transmission of the data or specimens: Dr.s Fee, French 
and Bojko 
f. Specify how data and specimens will be transported: study data will not be transported and 
will not leave Tufts. 
g. Specify the plan for study data retention and storage (accounting for research team turnover): 
Electronic data will be stored online with password protection.  If the specified 
locked cabinet becomes unavailable for storage of the paper consent forms, plans 
will be made with Ms. Iyer to obtain a different secure locked location within the 
obstetrics and gynecology department for storage.    
  
I.5 Randomization  
Will subjects be randomized?  
☐ Yes 
 ☒ No 
If Yes respond to all of the following: 
1. Describe the randomization procedures, including the ratio of subjects randomized to each study arm: 
       
2. Describe the blinding procedures       or ☐N/A the study will not be blinded. 
 
J. Drugs or Devices 
1. Will the research involve drugs?   
☐ Yes  ☒ No 
If Yes, respond to all of the following: 
 
 If the drug is investigational (has an IND) identify the holder of the IND:       
 Describe your plans to store, handle, and administer study drugs so that they will be used only on 
subjects and be used only by authorized investigators (if the control of the drugs used in this protocol will 
be accomplished by following an established, approved organizational SOP (e.g., Research Pharmacy SOP for 
the Control of Investigational Drugs, etc.), please reference that SOP in this section):       
 Who on the research team, in addition to the Principal Investigator, will be accountable for drug(s): 
      
 Who will interface with the pharmacy:       

 
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 If pre-printed orders will be created to obtain study drug(s) from the pharmacy, describe the 
procedures for reviewing and verifying the accuracy of the pre-printed orders prior to their being 
implemented:       or ☐N/A, there are no pre-printed orders  
 If computerized order sets are created and/or infusion devices need to be programmed to administer 
an investigational drug, indicate the mechanism to pre-review and verify their accuracy, including 
who will be involved in this process from the research team, pharmacy, and nursing:       or  
☐N/A, there are no computerized orders sets and/or infusion devices.  
 The study drug or procedure (including beneficial health care procedures) will be available to 
subjects after participation in the study: ☐Yes   ☐N/A    
 There are medications or other substances that should not be taken while participating in the study. A 
list of these are incorporated into the ICF or submitted to the IRB as a subject handout: ☐Yes   ☐N/A  
 
Handouts or instructions sheets that will be given to subjects on how to administer study drug(s) have 
been submitted to the IRB: ☐Yes   ☐N/A 
 
2. Will the research involve devices?   
☐ Yes  ☒ No 
If Yes, respond to all of the following: 
 If the device has an IDE or a claim of abbreviated IDE (non-significant risk device) identify the 
holder of the IDE/Abbreviated IDE:       
 Describe your plans to store, handle, and administer study devices so that they will be used only on 
subjects and be used only by authorized investigators (if the control of the devices used in this protocol 
will be accomplished by following an established, approved organizational SOP, please reference that SOP in 
this section):       
 Specify who will be responsible for the costs of implantation or placement of the device in subjects’ 
bodies?:       or ☐N/A, the device will not be implanted or placed in the body. 
 Specify who will be responsible for the costs of removing the device from subjects’ bodies?       or 
☐N/A, the device will not be removed from the body. 
 Specify the cost of the device and who will be responsible for the cost:        or ☐N/A, the device 
will be provided free of charge. 
 Who on the research team, in addition to the Principal Investigator, will be accountable for device(s): 
      
 Who will interface with the sponsor:       
 The study device or procedure (including beneficial health care procedures) will be available to 
subjects after participation in the study: ☐Yes   ☐N/A    
 
Handouts or instructions sheets that will be given to subjects on how to use study device(s) have been 
submitted to the IRB: ☐Yes   ☐N/A 
 
K. Study Administration 
K.1 Setting 
 Describe the sites / locations where your research team will conduct the research: Sites will be where 
the healthcare providers in the research team currently see patients and include Tufts 
Medical Center, Boston MA. Tufts Pediatric Specialty Centers in Woburn, Chelmsford 
and Lawrence.    
 The research will take place at an international site, and the International Research Guidance and 
International Checklist were utilized: ☐ Yes   ☒ N/A  
 
K.2 Registration 
1. Describe the steps the research team will take to ensure that a subject is appropriately enrolled or 
registered in the study prior to receiving any study intervention (e.g. describe and submit any protocol 
eligibility checklist that will be used, specify who on the research team will confirm eligibility and that 

 
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consent was documented, etc.): Eligibility criteria and consents will be reviewed on the same 
day as the video is shown and the medication is given.   
 
K.3 Resources Available 
 Describe the roles/tasks of each research team member here (or alternatively, you may submit any 
current Delegation of Authority Log you may have which already has this information completed):  
Members of the research team Dr.s Fee, French and Bojko will all be responsible for 
reaching out to patients, reviewing consent, watching patients administer the injections, 
ensuring study participants fill out the surveys and filling out surveys themselves.  In 
addition they will be responsible for keeping data and analyzing data.  Ms. Iyer will 
assist with administrative support, such as assistance in building a REDCap survey, and 
may assist with data analysis.   
 Describe the qualifications (e.g., training, experience) of the PI and research team to perform their roles. 
Provide enough information for the IRB to determine the PI and research team are qualified to conduct 
the proposed research. Alternatively, you can submit the current CVs for the research team instead: Dr.s 
Fee, French and Bojko are all trained in gynecology care including administration of 
subcutaneous and intramuscular injections as well as trained to counsel and care for 
patients taking depot medroxyprogesterone.   
 Describe the coverage plan to address any issues (including subject safety issues) that occur while the PI 
is away and/or unavailable. The research team member designated to serve as the acting PI in the PI’s 
absence should have similar training and expertise as the PI: The PI will be available, in case of 
emergency, Dr. Fee is a fellow receiving advanced training in pediatric and adolescent 
gynecology and will be able to contact the PI.    
 Describe the process to ensure the research team members have adequate oversight and are adequately 
trained regarding the protocol, study procedures, and their roles and responsibilities: See above. 
 Medical or psychological resources that subjects might need, such as for emergencies or medical issues, 
are available for the study: ☐Yes   ☒ N/A 
 
K.4 IRB Review 
1. ☒Check to confirm that an appropriate IRB registered with the OHRP, will review and approve this 
study.   
2. ☒Check to confirm that any amendments to the protocol or informed consent documents will be reviewed 
and approved by the IRB prior to use, unless required to eliminate an apparent immediate hazard to 
subjects.    
    
K.5 Multi-Site Research 
Is this a multi-site study where Tufts is the sponsor, primary grant recipient, or coordinating site?: 
☐ Yes 
 ☒ No 
If Yes, describe the Study Management Plan, including: 
You can also provide corresponding sections from Manual of Operations in the below.  
1. Complete the following for each site: 
 
List the name of 
each site 
Address 
Name of Site 
PI 
Name of IRB 
overseeing the 
research at each 
site 
Telephone #  of 
IRB Contact 
Person (if Tufts 
is not the IRB of 
record) 
Site’s FWA # 
Research Activity 
that will occur at 
each site (if they will 
do all the activities 
described in the 
protocol state that) 
      
      
      
      
      
      
      
      
      
      
      
      
      
      
      
      
      
      
      
      
      
      
      
      
      
      
      
      
      
      
      
      
      
      
      
 

 
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a. ☐Check to confirm that documentation of each site’s IRB approval letter will be submitted to the 
Tufts Health Sciences IRB prior to initiating any research activity at that site. 
b. ☐Check to confirm that Tufts Health Sciences IRB is serving as the IRB of record for any site, and 
a Form 10 (IAA/IIA) has been submitted for each site to request Tufts Health Sciences IRB assume 
IRB oversight for the research or ☐N/A, Tufts Health Sciences IRB is not serving as the IRB of 
record for any site 
i. 
☐ Check to confirm Tufts Health Sciences IRB will serve the HIPAA Privacy Board for 
this study. If no, please clarify:       
ii. 
☐ Check to confirm that Conflict of Interest (COI) management plans from relying 
intuitions will be provided to Tufts Health Sciences IRB when applicable.   
iii. 
☐ Check to confirm that Local Context Survey was completed by each relying site and 
included with this submission. 
iv. 
If there are additional state laws and/or local requirements that should be considered by 
the Reviewing IRB (e.g., mandatory reporting to state health authorities, child abuse 
reporting, child pregnancy results), please provide details      or ☐N/A 
c. ☐Check to confirm each site will be provided with all relevant sIRB policies. 
d. ☐Check to confirm each site will complete the File Review Checklist and Participant File 
Checklist self-audit tools as part of the annual continuing review.  If they will not, describe the 
mechanism for review / audit of sites:       
Refer to the Tufts Health Sciences IRB website for more information about requests to cede/assume IRB 
review. 
2. The plan for preparing and submitting the study materials for continuing review, submitting 
modifications and submitting site specific materials to the sIRB:       
3. The plan for tracking IRB approval of documents and consent forms for each site:       
4. Name of the sponsor and Contract Research Organization (CRO):       or ☐N/A, there is no sponsor 
or CRO for this study. 
5. The training that will be provided to the enrolling sites’ staff prior to protocol implementation at that 
study site and throughout the course of the study. Include the type of training, e.g., study meetings, 
teleconferences, etc., as well as who will provide the training and how it will be documented:        
6. The plan for ensuring: 
a. All sites have the most current version of the protocol and consent forms:        
b. Amendments to the Coordinating Center’s template protocol and template consent forms will be 
communicated to all sites:       
7. The plan for collection and management of data from all sites. Specify if Tufts’ data will be shared 
outside of Tufts (e.g., with other investigators, sponsor, etc.) and how the data will be shared (e.g. how 
data will be received from and distributed to other sites as needed).  If available, please provide the 
Data Sharing Plan or Policy; if not, describe how each will safeguard data, including secure 
transmission of data, as required by local information security policies:        
a. ☐Check to confirm all local site investigators will conduct the study in accordance with applicable 
federal regulations and local laws. 
8. The plan to manage and/or monitor each site’s study conduct including enrollment, research events, 
withdrawals and protocol deviations: 
a. Describe how the Coordinating Center will monitor each site’s study conduct during the different 
phases of the study (e.g. remotely, in-person visits, reports, etc.):       
b. Describe whether monitoring visits will be conducted. If so, how often? What will the site 
monitoring visits entail?:       
9. The plan for processing, reporting and evaluating interim results, unanticipated problems, protocol 
violations, deviations, and serious adverse events from all sites to the IRB, funder, and federal agencies 
(e.g. FDA):       
10. The plan for handling of the investigational product (drug/device/biologic) at each site (if applicable) 
as follows: 
a. Describe how they will be provided to each enrolling site:       
b. Describe how dispensing will be monitored:       

 
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c. Describe what investigational product accountability procedures will be implemented:       
11. The procedures for study closures and early site termination:       
a. Describe any collaborations not described above, such as Tufts investigators with multiple 
affiliations that would engage other institutions in research (e.g., Tufts is paying another institution 
for the research, the research is being conducted on behalf of another institution):       or ☐N/A 
 
K.6 Community-Based Participatory Research 
Note: “Community-based Participatory Research” is a collaborative approach to research that equitably involves all 
partners in the research process and recognizes the unique strengths that each brings. Community-based Participatory 
Research begins with a research topic of importance to the community, has the aim of combining knowledge with action 
and achieving social change to improve health outcomes and eliminate health disparities. 
Can or will this study involve community-based participatory research?  
☐ Yes 
 ☒ No 
If Yes, respond to all of the following 
1. Describe the communities that will be involved in this research:       
2. Describe the composition and involvement of any community advisory board:       
3. Describe the involvement of the community in the design, protocol development, informed consent 
process, access to data and samples, and conduct of the research       
4. Describe the plans on dissemination and publication of study results which are in agreement with the 
community:       
 
K.7 Sharing Results with Subjects 
Will results (overall study results or individual subject results, such as results of investigational diagnostic 
tests, genetic tests, or incidental findings) be shared with subjects or others (e.g., the subject’s primary care 
physician or the subject’s treating physician)?   
☐ Yes 
 ☒ No 
If Yes, respond to all of the following: 
 Rationale for sharing these results:       
 How results will be shared:       
 For individual subject results, specify if subjects have the option to opt-in or opt-out of receiving these 
results or allowing these results to be shared with others:       
 Any referral policies (i.e. for confirmation of any individual subject results):        
 ☐Check to confirm that testing of research specimens is being conducted in a laboratory certified (CLIA-
approved) to conduct diagnostic testing. If patient-specific research results are reported from the 
laboratory and those results will or could be used for the diagnosis, prevention, or treatment of any 
disease or impairment, or the assessment of the health of human beings, the laboratory must be CLIA 
certified. 
 If the research tests are experimental or of unknown or unproven clinical significance and the results will 
be provided to the source individual or physician or placed in the source individual’s medical record, 
provide the rationale for this:       
 
L. References  
Provide a list of references for all citations included in the protocol  
 
1. Wang CJ, Ma J, Zuckerman B, Car J. The Opportunities for Telehealth in Pediatric Practice and 
Public Health. Pediatr Clin North Am. 2020 Aug;67(4):603-611. doi: 10.1016/j.pcl.2020.03.001. 
PMID: 32650856 
2. Strasburger VC, Jordan AB, Donnerstein E. Health effects of media on children and 
adolescents. Pediatrics. 2010 Apr;125(4):756-67. doi: 10.1542/peds.2009-2563. Epub 2010 Mar 
1. PMID: 20194281. 
3. Park E, Kwon M. Health-Related Internet Use by Children and Adolescents: Systematic Review. 
J Med Internet Res. 2018 Apr 3;20(4):e120. doi: 10.2196/jmir.7731. PMID: 29615385; PMCID: 
PMC5904452 

 
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4. Kennedy CE, Yeh PT, Gaffield ML, et al. Self-administration of injectable contraception: a 
systematic review and meta-analysis.  BMJ Global Health 2019;4:e001350. 
5. Williams RL, Hensel DJ, Fortenberry JD. Self-administration of subcutaneous depot 
medroxyprogesterone acetate by adolescent women. Contraception. 2013 Sep;88(3):401-7. doi: 
10.1016/j.contraception.2012.11.019. Epub 2013 Jan 4. PMID: 23294549; PMCID: 
PMC3745808. 
6. Cameron ST, Glasier A, Johnstone A. Pilot study of home self-administration of subcutaneous 
depo-medroxyprogesterone acetate for contraception. Contraception. 2012 May;85(5):458-64. 
doi: 10.1016/j.contraception.2011.10.002. Epub 2011 Nov 12. PMID: 22079602. 
7. Patton GC, Sawyer SM, Santelli JS, Ross DA, Afifi R, Allen NB, Arora M, Azzopardi P, Baldwin 
W, Bonell C, Kakuma R, Kennedy E, Mahon J, McGovern T, Mokdad AH, Patel V, Petroni S, 
Reavley N, Taiwo K, Waldfogel J, Wickremarathne D, Barroso C, Bhutta Z, Fatusi AO, Mattoo 
A, Diers J, Fang J, Ferguson J, Ssewamala F, Viner RM. Our future: a Lancet commission on 
adolescent health and wellbeing. Lancet. 2016 Jun 11;387(10036):2423-78. doi: 
10.1016/S0140-6736(16)00579-1. Epub 2016 May 9. PMID: 27174304; PMCID: PMC5832967.