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Emory University IRB
IRB use only / Document Approved On: 2/2/2017EMORY UNIVERSITY
ASSENT FORM FOR MINOR SUBJECTS
Study Title: A Biosocial Pilot Study of Stress and Unintended Pregnancy During Adolescence and Young Adulthood
Public Study Name: Stress and Young Women’s Health
Principal Investigator: Kelli Stidham Hall, PhD MS
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This page to be filled out by research team at time assent is obtained:
Subject’s Age: _____years
Subject’s Name: ______
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• This child is 11 to 17 years old — must obtain subject’s signature on page 2 of assent form to document assent
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• In my opinion, this child is unable to provide informed assent for non-age-related reasons, and the PI for this study has been informed of this determination.
● Reason(s):______
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Signature of person soliciting assent (if above box is checked) Date Time
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EMORY UNIVERSITY/CHILDREN’S HEALTHCARE OF ATLANTA
ASSENT FORM FOR MINOR SUBJECTS
Study Title: A Biosocial Pilot Study of Stress and Unintended Pregnancy During Adolescence and Young Adulthood
Public Study Name: Stress and Young Women’s Health
Principal Investigator: Kelli Stidham Hall, PhD MS
INFORMATION ABOUT THIS STUDY:
● Why are you being asked to be in this study?
o You have been asked to join this study because you are a girl between the ages of 15 and 24 that lives in the Atlanta area.
● Why is this study taking place?
o The research team wants to understand how stress impacts the health and wellbeing of adolescent girls and young women. This study is a smaller project that will be used to develop a larger study regarding stress and young women’s health in the future.
● What will happen to you if you take part in the study?
o At the first visit, you will be asked a series of questions that relate to your health, your daily life, and your personal characteristics. You will then fill out shorter, monthly surveys for the next two years. You will be asked to give small samples of hair and blood spots at the first visit. The total time in the research project will be two years. For your participation in all of the research activities, you could earn up to $260.
● Will any part of the study cause pain?
o You may feel some pain or discomfort when giving the biological samples and maybe for a short period after. This could also cause bruising which may be painful for a short time.
● Will any part of the study make me feel uncomfortable?
o Some of the questions we ask talk about sensitive topics, so this may cause you to feel uncomfortable. You may skip any questions that make you feel extremely uncomfortable and you do not wish to answer without penalty or judgment.
● Who can you ask if you have questions about this form?
o You may discuss with the research assistant any concerns or questions you have about the form or the research project.
o You may also call the research staff at 404-857-2703 or email at .
o The Principal Investigator is Dr. Kelli Hall who can be reached at 404-727-1369 or email at .
● Can you change your mind about being in the study at any time?
o Yes, if at any point over the next three years, you may withdraw from the study and we will not collect any more data from you. To do this, you will need to contact the study team by email () or phone (404-857-2703).
● Do you have to be in this study even if you don’t want to?
o No, you don’t have to participate if you do not want to. You also don’t have to answer any questions you are not comfortable with or give any biological samples if you don’t want to.
● Optional Study:
o You may be asked to participate in an additional research study. In this study, we would ask you to complete a urinary hormone monitoring kit to understand how stress impacts your hormone levels. We will use this information to help inform the methods we use in a future study. You do not have to agree to be in this part of the study to participate in the other activities of the research study.
For subjects 15 to 17 years old: if you agree to be in this study, please sign your name below.
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Signature of 15 to 17-year-old Subject Date Time
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Signature of person soliciting assent of 15 to 17-year-old Subject Date Time
For subjects 15 to 17 years old: if you agree to be in the sub-study, please sign your name below.
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Signature of 15 to 17-year-old Subject Date Time
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Signature of person soliciting assent of 15 to 17-year-old Subject Date Time
IRB Form: 04082014 Version Number: 1 Version date: 08/02/2016 / Version Number: 2 Version date: 01/04/2017