Download Sleep Consent

Date: March 26, 2015
Principal Investigator: Grace Pien, MD
Application No.: NA-00093511
Approved March 26, 2015
If you are using Epic for this study, fax a copy
of the signed consent form to 410-367-7382.
Patient I.D. Plate
RESEARCH PARTICIPANT INFORMED CONSENT AND PRIVACY
AUTHORIZATION FORM
Protocol Title:
Maternal Sleep and the Developing Fetus
Application No.:
NA-00093511
Sponsor:
NIHNICHD
Principal Investigator: Grace Pien, MD
Johns Hopkins Allergy and Asthma Center, Rm 5B 77
5501 Hopkins Bayview Circle
Baltimore, MD 21224
Phone: (443) 287-3313
Fax: (443) 287-3312
1.
What you should know about this study:







You are being asked to join a research study. This consent form explains the research study and your
part in the study.
Please read it carefully and take as much time as you need.
Ask your study doctor or the study team to explain any words or information in this informed
consent that you do not understand.
You are a volunteer. If you join the study, you can change your mind later. You can decide not to
take part or you can quit at any time. There will be no penalty or loss of benefits if you decide to quit
the study.
During the study, we will tell you if we learn any new information that might affect whether you
wish to continue to be in the study.
If you receive routine medical treatment (including medical or laboratory tests) in the study or if you
are taking part in the study at the Clinical Research Unit, information about your research study
participation will be included in your medical record, which is used throughout Johns Hopkins.
Doctors outside of Johns Hopkins may not have access to this information. You can ask the research
team to send this information to any of your doctors.
When Johns Hopkins is used in this consent form, it includes The Johns Hopkins University, The
Johns Hopkins Hospital, Johns Hopkins Bayview Medical Center, Howard County General Hospital,
Johns Hopkins Community Physicians, Suburban Hospital, Sibley Memorial Hospital and All
Children’s Hospital.
Page 1 of 8
Combined Informed Consent/Authorization October 2013 Version 14
Date: March 26, 2015
Principal Investigator: Grace Pien, MD
Application No.: NA-00093511
Approved March 26, 2015

2.
The Johns Hopkins School of Medicine Institutional Review Board (IRB) sometimes reviews studies
that are conducted at other institutions. These other institutions are solely responsible for conducting
the study safely and according to the protocol that the Johns Hopkins IRB has approved. Information
about how to contact the investigator at the institution that is responsible for the study is included in
this form. When another institution is conducting the study, the word “we” in this consent form may
include both Johns Hopkins and the participating institution.
Why is this research being done?
This research is being done to learn about how sleep in pregnant women affects their babies’ reactions
and responses. We are examining responses in the baby while the mother sleeps to find out whether
fetuses are affected by the mother’s sleep. We are also examining the baby’s responses during the
daytime to determine whether associations that occur while the mother sleeps have an effect on the fetus
during the daytime.
Women who are at least 18 years of age, have a body mass index of at least 30 kg/m2 and are pregnant
with their first baby may join the study. Women with serious medical conditions, who smoke cigarettes
or who perform shift work may not be eligible to participate.
How many people will be in this study?
We are planning to include a total of 150 women in this research study.
3.
What will happen if you join this study?
If you agree to be in this study, we will ask you to do the following things. These procedures are all
study procedures and are not part of your standard care.
At about 28 weeks of pregnancy:
You will come to our Fetal Neurodevelopment Unit located within the Johns Hopkins Prenatal
Diagnosis and Treatment Center. We will do a short ultrasound scan to take some measurements of
your fluid and blood flow, see what position the baby is in, and give you some photographs. We will
also take your blood pressure and weigh you. After this, your baby's heart rate and movement will be
measured for 50 minutes using standard fetal assessment equipment. During this time, your own heart
rate, breathing, skin conductance (a measure of moisture in your skin) and contractions will also be
recorded.
You will be asked to complete questionnaires that will assess your sleep habits and daytime sleepiness,
daily behaviors and functioning, and medical history. They will take 20-30 minutes to complete.
Between 34 and 37 weeks of pregnancy:
You will return to our Fetal Neurodevelopment Unit located within the Johns Hopkins Prenatal
Diagnosis and Treatment Center. We will repeat the same procedures as done at the first visit.
After completing the maternal-fetal heart rate monitoring, a member of the research team will escort you
to the sleep laboratory. The sleep lab is located in the Johns Hopkins Bayview Clinical Research Unit.
We will provide you with dinner. You will stay overnight in a private room.
Page 2 of 8
Combined Informed Consent/Authorization October 2013 Version 14
Date: March 26, 2015
Principal Investigator: Grace Pien, MD
Application No.: NA-00093511
Approved March 26, 2015
We will ask you to go to sleep at your usual bedtime. You will be able to sleep until your usual wake
time in the morning. We will place five electrodes on your abdomen in order to record the heart rate
signal of both you and your baby while you sleep. In addition, we will apply monitors to make the
following measurements while you sleep:







Brain waves
Muscle activity
Breathing
Heart rate
Eye movement
Oxygen level in the body
Body position
Brain waves will be measured using 6 electrodes that will be pasted to your head. Muscle activity will
also be measured using electrodes. These will be attached under your chin and to the front of your lower
legs. Breathing will be measured with soft belts wrapped around your chest and your abdomen and by
using temperature sensors placed under your nose. Two heart rate sensors will be placed in your chest
area. Eye movements will be recorded by placing electrodes outside of your eye sockets. Oxygen level
will be measured using an oximeter. This device clips to your index finger. Body position will be
determined using a small box attached to a belt that wraps around your torso.
None of these measuring devices or sensors involve breaking the skin or drawing blood. All
measurements are non-invasive. The study continues throughout the night. If you need help at any
time, the technician will be close by. You will be discharged home in the morning. After completing
these assessments, your sleep study will be analyzed.
If this sleep study shows that you have severe sleep apnea, you will be offered evaluation and treatment
at the Johns Hopkins Sleep Disorders Centers. If you decide to use therapy with nasal Continuous
Positive Airway Pressure (CPAP) or another treatment, you may continue to participate in the study.
You may also continue to participate in the study if you choose not to use therapy.
After the baby is born:
After you have delivered your baby, we will review your chart for information about the pregnancy,
such as whether you developed complications including high blood pressure or diabetes. We will also
review the chart to see if your baby had any problems immediately following delivery, such as low birth
weight.
How long will you be in the study?
You will be in this study until you deliver your baby. You may give consent at any point before the first
study visit. The first study visit will take place at about 28 weeks of pregnancy. The second study visit
will take place between 34 and 37 weeks of pregnancy.
Incidental Findings
Page 3 of 8
Combined Informed Consent/Authorization October 2013 Version 14
Date: March 26, 2015
Principal Investigator: Grace Pien, MD
Application No.: NA-00093511
Approved March 26, 2015
The information we collect during this research study will be reviewed by a qualified person. There is a
possibility that we will notice a problem in your baby’s amniotic fluid or heart rate patterns or in your
blood pressure that we did not expect. This is what is called an “incidental finding.”
We will let you know if we see such an incidental finding. Depending on the type of incidental finding,
we may contact you by mail or by phone. In the case of a potential serious emergency, someone may go
to your home.
A qualified person (usually a member of the research team) will talk to you if there is an incidental
finding. You do not have an option to decline information about an incidental finding.
If you want, we will give information about this incidental finding to your primary doctor or we will
refer you to an appropriate doctor for further evaluation.
 An incidental finding may cause you to feel anxious.
 Since an incidental finding will be part of your medical record, it may affect your current or
future life or health insurance coverage. This risk will vary depending on the type of insurance
plan involved.
The costs for any care that will be needed to diagnose or treat an incidental finding would not be paid for
by this research study. These costs would be your responsibility.
Future Contact
We would like your permission to contact you about other studies that you may be eligible for in the
future.
Please check box and sign to indicate your choice below:
YES  ________________________
Signature of Participant
NO 
__________________
Signature of Participant
4.
What are the risks or discomforts of the study?
We don’t expect there to be any risks for taking part in this study. The brief ultrasound scan is not
meant to diagnose problems, but in the event that we notice something of concern, such as too little or
too much amniotic fluid, we will let you and your physician know. This may result in the need for you
to have additional testing by your provider; any costs for additional testing would need to be covered by
your insurance or yourself.
The electrodes used to monitor you and your baby’s heart rate are similar to those used for heart rate
measurement in people who are not pregnant. The electrodes do not put electricity into your body. We
will need to rub your skin before we put them and this may be slightly uncomfortable. It is possible that
the adhesive on them will leave small marks on your abdomen or scalp for a short time after they are
removed.
Page 4 of 8
Combined Informed Consent/Authorization October 2013 Version 14
Date: March 26, 2015
Principal Investigator: Grace Pien, MD
Application No.: NA-00093511
Approved March 26, 2015
There are no apparent risks involved in measuring sleep or breathing functions. The electrodes used for
sleep study monitoring are identical to those used to monitor sleep in people who are not pregnant. They
do not put electricity into your body. You may have a slight skin reaction to the jelly we use to paste the
electrodes to your scalp. This occurs rarely. The electrode application procedures are sometimes mildly
uncomfortable.
You may get tired or bored when we are asking you questions or you are completing questionnaires.
You do not have to answer any question you do not want to answer.
There is the risk that information about you may become known to people outside this study. To protect
against this, the study information will be kept in password-protected computers in locked rooms
accessible only to study staff.
5.
Are there risks related to pregnancy?
There are no known risks to the fetus from either the heart rate monitoring or the sleep monitoring. This
research may hurt an embryo or fetus in ways we do not currently know.
6.
Are there benefits to being in the study?
There is no direct benefit to you from being in this study. If you take part in this study, you may help
others in the future.
7.
What are your options if you do not want to be in the study?
You do not have to join this study. There is no penalty if you choose not to join the study. If you do not
join, your care at Johns Hopkins will not be affected.
8.
Will it cost you anything to be in this study?
No.
9.
Will you be paid if you join this study?
You will receive reimbursement for your time participating in the study, up to $200 total if you complete
both study visits. You will receive $25 for completing the first daytime visit and $175 following the
overnight sleep study.
You will receive reimbursement when the procedures are completed and after submission of your forms
to the business office. If you are not able to complete all of the study procedures, you will be reimbursed
for the completed procedures only.
You may be required to provide your social security number to be paid for taking part in this study.
Federal tax law requires that you report your research payments when you file your taxes. If your total
payments from Johns Hopkins exceed $600 per year, Johns Hopkins will report these payments to the
Internal Revenue Service and you will receive a 1099-MISC form from us.
10.
Can you leave the study early?



You can agree to be in the study now and change your mind later.
If you wish to stop, please tell us right away.
Leaving this study early will not stop you from getting regular medical care.
Page 5 of 8
Combined Informed Consent/Authorization October 2013 Version 14
Date: March 26, 2015
Principal Investigator: Grace Pien, MD
Application No.: NA-00093511
Approved March 26, 2015
If you leave the study early, Johns Hopkins may use or give out your health information that it has
already collected if the information is needed for this study or any follow-up activities.
11.
Why might we take you out of the study early?
You may be taken out of the study if:
 Staying in the study would be harmful.
 You have not followed instructions.
 The study is cancelled.
 There may be other reasons to take you out of the study that we do not know at this time.
If you are taken out of the study early, Johns Hopkins may use or give out your health information that it
has already collected if the information is needed for this study or any follow-up activities.
12.
How will your privacy be protected?
We take protection of your confidentiality very seriously and store your records in a locked location that
only some members of the research team can access. When we analyze or publish the results, we will
use a number instead of your name and never report information on individual people.
We have rules to protect information about you. Federal and state laws and the federal medical Privacy
Rule also protect your privacy. By signing this form you provide your permission, called your
“authorization,” for the use and disclosure of information protected by the Privacy Rule.
The research team working on the study will collect information about you. This includes things learned
from the procedures described in this consent form. They may also collect other information including
your name, address, date of birth, and information from your medical records. This could include
information about HIV and genetic testing, or treatment for drug or alcohol abuse or mental health
problems.
The research team will know your identity and that you are in the research study. Other people at Johns
Hopkins, particularly your doctors, may also see or give out your information. We make this information
available to your doctors for your safety.
People outside of Johns Hopkins may need to see or receive your information for this study. Examples
include government agencies (such as the Food and Drug Administration), safety monitors, other sites in
the study and companies that sponsor the study.
We cannot do this study without your authorization to use and give out your information. You do not
have to give us this authorization. If you do not, then you may not join this study.
We will use and disclose your information only as described in this form and in our Notice of Privacy
Practices; however, people outside Johns Hopkins who receive your information may not be covered by
this promise or by the federal Privacy Rule. We try to make sure that everyone who needs to see your
information keeps it confidential – but we cannot guarantee that your information will not be redisclosed.
The use and disclosure of your information has no time limit. You may revoke (cancel) your permission
to use and disclose your information at any time by notifying the Principal Investigator of this study by
Page 6 of 8
Combined Informed Consent/Authorization October 2013 Version 14
Date: March 26, 2015
Principal Investigator: Grace Pien, MD
Application No.: NA-00093511
Approved March 26, 2015
phone or in writing. If you contact the Principal Investigator by phone, you must follow-up with a
written request that includes the study number and your contact information. The Principal
Investigator’s name, address, phone and fax information are on page one of this consent form.
If you do cancel your authorization to use and disclose your information, your part in this study will end
and no further information about you will be collected. Your revocation (cancellation) would not affect
information already collected in the study, or information we disclosed before you wrote to the Principal
Investigator to cancel your authorization.
13.
Will the study require any of your other health care providers to share your health
information with the researchers of this study?
As a part of this study, the researchers may ask to see your health care records from your other health
care providers.
14.
What other things should you know about this research study?
a. What is the Institutional Review Board (IRB) and how does it protect you?
The Johns Hopkins Medicine IRB is made up of:
 Doctors
 Nurses
 Ethicists
 Non-scientists
 and people from the local community.
The IRB reviews human research studies. It protects the rights and welfare of the people taking part
in those studies. You may contact the IRB if you have questions about your rights as a participant or
if you think you have not been treated fairly. The IRB office number is 410-955-3008. You may
also call this number for other questions, concerns or complaints about the research.
b. What do you do if you have questions about the study?
Call the principal investigator, Dr. Pien, at (443) 287-3313. If you wish, you may contact the
principal investigator by letter or by fax. The address and fax number are on page one of this
consent form. If you cannot reach the principal investigator or wish to talk to someone else, call the
IRB office at 410-955-3008.
c. What happens to Data that are collected in the study?
Johns Hopkins and our research partners work to understand and cure diseases. The data you provide
are important to this effort.
If you join this study, you should understand that you will not own your data, and should researchers
use them to create a new product or idea, you will not benefit financially.
Page 7 of 8
Combined Informed Consent/Authorization October 2013 Version 14
Date: March 26, 2015
Principal Investigator: Grace Pien, MD
Application No.: NA-00093511
Approved March 26, 2015
15.
What does your signature on this consent form mean?
Your signature on this form means that:
 you understand the information given to you in this form
 you accept the provisions in the form
 you agree to join the study
You will not give up any legal rights by signing this consent form.
WE WILL GIVE YOU A COPY OF THIS SIGNED AND DATED CONSENT FORM
___________________________________________________________________________________________________________
Signature of Participant
(Print Name)
Date/Time
___________________________________________________________________________________________________________
Signature of Person Obtaining Consent
(Print Name)
Date/Time
NOTE: A COPY OF THE SIGNED, DATED CONSENT FORM MUST BE KEPT BY THE PRINCIPAL INVESTIGATOR;
A COPY MUST BE GIVEN TO THE PARTICIPANT; IF YOU ARE USING EPIC FOR THIS STUDY A COPY MUST BE
FAXED TO 410-367-7382; IF YOU ARE NOT USING EPIC A COPY MUST BE PLACED IN THE PARTICIPANT’S
MEDICAL RECORD (UNLESS NO MEDICAL RECORD EXISTS OR WILL BE CREATED).
ONLY CONSENT FORMS THAT INCLUDE THE JOHNS HOPKINS MEDICINE LOGO CAN BE USED TO OBTAIN
THE CONSENT OF RESEARCH PARTICIPANTS. IF THIS CONSENT FORM DOES NOT HAVE A JOHNS HOPKINS
MEDICINE LOGO, DO NOT USE IT TO OBTAIN THE CONSENT OF RESEARCH PARTICIPANTS.
Page 8 of 8
Combined Informed Consent/Authorization October 2013 Version 14