Emory University IRB
IRB use only
Study No.: IRB00070965
Document Approved On: 2/19/2014
Project Approval Expires On: 1/21/2015
Emory University
Consent to be a Research Subject and HIPAA Authorization
Title: Association between Cardiovascular Risk and Preclinical Alzheimer’s Disease Pathology (ASCEND).
Principal Investigator: Whitney Wharton, PhD
Sites :Emory University Hospital, Wesley Woods Health Center, Wesley Woods Hospital
Sponsor: National Institutes of Health
Introduction
You are being asked to participate in a medical research study. This form is designed to tell you everything you need to
think about before you decide to consent (agree) to be in the study or not to be in the study. It is entirely your choice.
If you decide to take part, you can change your mind later on and withdraw from the research study. The decision to
join or not join the research study will not cause you to lose any medical benefits. If you are a member of the
Alzheimer’s Disease Research Center (ADRC), your participation in that research will also not be affected if you decide
not to participate in this study. If you decide not to participate, the health care provided to you by Emory University and
its affiliates will not be affected in any way.
Before making your decision:
 Please carefully read this form or have it read to you
 Please listen to the study doctor or study staff explain the study to you
 Please ask questions about anything that is not clear
You can take a copy of this consent form, to keep. Feel free to take your time thinking about whether you would like to
participate. You may wish to discuss your decision with family or friends. Do not sign this consent form unless you have
had a chance to ask questions and get answers that make sense to you. By signing this form you will not give up any
legal rights.
Study Overview
You are invited to participate in a study that looks at how changes in blood flow over time may affect changes in the
brain in people at risk for Alzheimer’s disease (AD). Some of the brain changes we will look at include changes in blood
flow in the brain, brain structure and volume, protein levels in spinal fluid, and your memory and thinking abilities.
Approximately 80 people will participate in this study.
Procedures
A. WHAT IS THE PURPOSE OF THIS STUDY?
The purpose of the research is to see what the relationship is between artery health in your body and brain function.
We will use brain imaging to analyze structure, blood flow and overall brain activity. In addition, we will assess artery
health by measuring blood pressure and the thickness of the walls of the arteries. We will collect fluids, such as cerebral
spinal fluid and blood, to measure markers for Alzheimer’s disease. Finally, we will conduct memory tests to determine
whether artery health is related to cognitive function. All the procedures used for these assessments will be fully
described later in this consent form.
B. WHAT WILL MY PARTICIPATION INVOLVE?
Page 1 of 12
IRB Form 10012013
Version Date: 12/16/2013
Study No.: IRB00070965
Emory University IRB
IRB use only
Document Approved On: 2/19/2014
Project Approval Expires On: 1/21/2015
Participation in this study will require you to attend three study visits. Visits happen once a year for three years. Each
annual visit can occur all in one day or we can spread the visit over two days, according to your travel and scheduling
needs. For all three visits you will need to have been fasting for at least 8 hours.
The table below shows the outline of the ASCEND study procedures by visits (Baseline, Year 1 and Year 2). The
procedures and timeline are described below.
If you are in another Alzheimer’s study such as the study titled Clinical Research in Neurology (PI: Allan I. Levey
IRB00024959), and you consented to have other Emory scientists use data from that study, then this study (ASCEND)
may use the information you gave for that study.
This includes:
•
Neurological exam information,
•
Memory and concentration tests, and
•
Any questionnaires you completed.

Genetic Information

CSF Results

Neuroimaging data

Medication history

Medical History

Family history of Alzheimer’s disease
All study participants’ information will be entered into a computer database.
ASCEND BASELINE VISIT PROCEDURES
This visit will take approximately 5.5 hours total. This visit can happen all in 1 day or take place over two days,
depending on your schedule. At your ASCEND baseline visit, you will be asked to have an MRI scan, lumbar puncture,
ultrasound scan of your arteries, and blood pressure monitoring.
MRI Scan: The MRI scanner will be used to collect detailed pictures of your brain while you are lying still on the scanner
bed. You are asked to fast (not eat) for 12 hours prior to this procedure. Two monitors will be comfortably secured to
you to measure your pulse and respiration rates during the scan. During the scans it is essential for you to remain as still
as possible to avoid any blurring of the images. Your head will be held in place by foam padding to help you keep still
Page 2 of 12
IRB Form 10012013
Version Date: 12/16/2013
Study No.: IRB00070965
Emory University IRB
IRB use only
Document Approved On: 2/19/2014
Project Approval Expires On: 1/21/2015
during the scan. The procedure takes approximately 1 hour. We will situate you as comfortably as possible and then run
several scans that take 2-10 minutes each. In between scans, you will be able to communicate to the scan operator
through an intercom. The MRI will be performed at the Emory Center for Systems Imaging at the Wesley Woods Health
Center. Before your scan, you will be asked a series of medical history questions to make sure you are safe to go into
the scanner.
Cognitive Testing: At each of the three study visits, you will undergo about 45 minutes of cognitive testing. This will
include computerized and paper and pencil tests that will look at areas of cognitive functioning such as verbal ability,
spatial ability and memory.
Questionnaires: At this visit, you will be asked to complete 4 surveys. The surveys ask questions about your sleep habits
and problems; about your medical history and medications; about your exercise habits; and about your mood and mood
changes. The surveys are the same each time and take about a total of 30 minutes to complete.
Blood Sample: About three - four tablespoons of your blood will be drawn from a vein in your arm. This should only
take about 5 minutes.
Lumbar Puncture: A lumbar puncture is a procedure using a needle to remove spinal fluid from the lower back. For this
fasting lumbar puncture, you will be asked to lie on your side with your knees drawn as close to the chest as possible or
to sit with your arms and head resting on a table. Your lower back will then be numbed with a drug called Lidocaine.
Lidocaine will help reduce any pain that may be caused by this procedure. A thin needle (typically 1/48 of an inch wide,
and 3.5 to 4 inches long) will be placed into the space that contains the spinal fluid, which is below where the spinal cord
ends. One and a half tablespoons of spinal fluid will be removed and the needle withdrawn. If you have your lumbar
puncture for this study done at the same time as a lumbar puncture for another study, then we might draw up to 25 mLs
(about 5 teaspoons of fluid) from your back. During either of the two study visit lumbar puncture procedures, if no spinal
fluid is obtained on the first attempt, a second attempt will be made after numbing the area with Lidocaine. If the
sample of spinal fluid is not drawn correctly, you will not undergo another lumbar puncture. The lumbar puncture
procedure will take approximately 30 minutes. After the lumbar puncture is completed, you will lie on your back for
about 20 minutes.
Neurologic Exam: A physician or nurse practitioner will do a neurological and physical exam prior to the lumbar
puncture.
Ultrasound: The ultrasound is a test that involves bouncing sound beams off an artery in your arm so it can be seen on a
TV screen and measurements may be made. Sensors will be applied to your chest and stomach and a blood pressure cuff
will be placed around your lower arm and inflated for five minutes. After release of the cuff, a repeat ultrasound test of
the artery in your arm will be obtained. You will feel a squeezing sensation. The entire procedure takes about 1 hour.
Ambulatory Blood Pressure Monitoring: The ambulatory blood pressure monitoring device is non-invasive and only
mildly uncomfortable due to tightness in the arm when the cuff is inflated. When you come in for your study visit, a
study coordinator who is familiar with this process will calibrate the monitor with a manual mercury monitor. The
monitor consists of a blood pressure cuff, like you have probably seen in the doctor’s office, which is connected to a
small lightweight battery pack that can be worn on a belt or placed in your pocket. You will wear the cuff for 24 hours.
The blood pressure cuff will inflate and take your blood pressure automatically 3 times per hour while you are awake
and 1 time per hour while you are asleep. You blood pressure information will automatically be stored in the monitor
and this information will be used by the Principal Investigator and the ASCEND study team. You can wear the blood
pressure monitor home with you and do all of your normal activities, except that you should take it off to shower, bathe,
or swim. The cuff inflates 3 times per hour while you are awake, and once an hour while you are asleep. You will be
Page 3 of 12
IRB Form 10012013
Version Date: 12/16/2013
Study No.: IRB00070965
Emory University IRB
IRB use only
Document Approved On: 2/19/2014
Project Approval Expires On: 1/21/2015
asked to fill out a diary of your activities during these 24 hours. You can return the cuff or mail it back to the study team
after 24 hours.
Fasting: Prior to all three study visits, you are required to fast. This means refraining from food and over-the-counter
medications for 8 hours prior to each study visit. After you have completed all procedures that require you to fast, we
will feed you breakfast or lunch. There are some risks associated with fasting. If you experience any of the following
symptoms, please contact researchers and discontinue your fast: shakiness, nervousness, sweating, dizziness or lightheadedness, sleepiness, confusion, difficulty speaking, anxiety, or weakness. You should not delay taking your
prescription medications longer than indicated by your doctor. We may need to alter your study visit schedule to ensure
that you don’t delay taking your medications outside of the clinically prescribed window. Additionally, we will need to
discuss your prescriptions, including how frequently you are expected to take your medications, so that we may
schedule your visit appropriately. You must also bring your prescribed medications with you to your study visit, so you
may take them after your study visit.
Pregnancy Screening: Although there is no evidence that MRI scans can cause harm to a fetus, there may be risks to a
fetus that are not known at this time. For these reasons, this study is not approved for the enrollment of pregnant
women. Thus, if you are a woman and are premenopausal (still having menstrual periods) you will be asked to undergo
a pregnancy test at your Baseline and Year 2 visits – which are the visits when you will have an MRI.
ASCEND YEAR ONE VISIT PROCEDURES
This visit will take approximately 2 hours and will take place at the Emory University Hospital. At this visit, we will update
your medical and medication history and you will be asked to repeat the surveys about your exercise, mood, and sleep.
We will perform a routine physical exam. You will be asked to repeat the vascular ultrasound procedure. This procedure
will be the same as your Baseline visit and will take about 60 minutes. This visit also involves taking memory tests
similar to the tests you took during your first visit. You will also be asked to repeat the blood pressure monitoring
portion of this study by again wearing the blood pressure cuff for 24 hours and keeping a diary of your activities during
this time. You can bring the monitor and activity diary back to Emory or mail it back.
ASCEND YEAR TWO VISIT PROCEDURES
This visit will be almost identical to your Baseline (first) visit. This is the final visit for the study and will take about 5
hours. Like the Baseline visit, procedures can be done all in one day, or over the course of several days, according to
your schedule and travel needs. At this visit (Year 2), you will be asked to have an MRI scan, lumbar puncture, ultrasound
scan of your arteries, physical exam, blood pressure monitoring and neuropsychological testing. The vascular ultrasound
tests require you to fast from food, beverages, and over the counter medications for 8 hours prior to the visit. Drinking
water is permitted. We will provide lunch for you afterward. The final study procedures take about 5.5 hours to
complete.
Additional Procedures:
Tissue Banking: In the future, there may be genetic or laboratory tests to identify memory disorders and/or dementia.
By storing a small sample of your cerebrospinal fluid and your blood for future tests, researchers may be able to find or
study these new markers and genes. Your spinal fluid will be stored indefinitely in a freezer with designated for this
study. If you want to have your sample removed from the tissue bank, you can write to our program with your request.
The stored vials of blood and spinal fluid will be marked with a code and not your name. The code linking the sample to
your information will be kept separately.
There have been many advances in the ways in which DNA and CSF can be studied. Some of these new ways of studying
DNA and proteins can only be done by non-Emory researchers because they have some of the most advanced
Page 4 of 12
IRB Form 10012013
Version Date: 12/16/2013
Study No.: IRB00070965
Emory University IRB
IRB use only
Document Approved On: 2/19/2014
Project Approval Expires On: 1/21/2015
technologies. We are asking your permission to allow your DNA, blood, and CSF samples to be shared with other
researchers when that is the best way to advance scientific knowledge and public health. When samples are shared, we
will provide these samples to researchers without personal identifying information, such as your name, address, or
Social Security number. Organizations will be required to treat the data or samples as strictly confidential, and agree not
to share data or samples with other parties. By signing this consent form, your blood and CSF may be used by Emory and
non-Emory researchers for research purposes. Researchers may only use the blood for the specifically approved
purpose. They may not keep any leftover samples for other purposes. They must either return any unused remaining
samples or dispose of the sample if so instructed by our research group. You will not be able to retrieve your samples or
information about them. If you chose to have your sample withdrawn, no further testing will be done and your sample
will be destroyed. Results of any analysis that have already been performed, however, will remain part of the study
records.
Since this research is federally funded, the funding agency may require further distribution of the data and samples. The
information might be transmitted over the internet to researchers outside this study, including researchers outside of
the United States. In addition, the data and samples might be held in a database maintained by the National Institutes of
Health or other federal agencies. Information about you would only be shared in a coded manner so that you would not
be directly identifiable.
Other Results: You may have been asked to participate in this study because you are enrolled in another Alzheimer’s
disease study. We ask that results of this study (ASCEND) including, brain images, blood samples, and CSF samples be
made available to other ADRC scientists so that the results of multiple studies can be combined and compared across
time. These prior and future results include neuropsychological testing (i.e. memory testing), laboratory tests, surveys,
ultrasound and blood pressure measures, medical history (including family history of AD), brain imaging and fluid
biomarkers. Combining information across studies could potentially increase the value of your participation beyond
what is learned in any individual study and help researchers learn more about aging and Alzheimer’s disease.
Ambulatory Blood Pressure Results:
Ambulatory (24 hour) blood pressure monitoring is the one of the most comprehensive ways to get an accurate idea of
what your blood pressure really is. This method has been shown to be better than clinical reading that you normally
receive when you go to a regular doctor’s appointment. If you choose to, we will provide you with a detailed summary
of your blood pressure results that we will collect as a part of this study. You are free to take these results home and
share them with your doctor.
Potential Risks:
Risks of MRI: Some people should not participate in MR studies. These include persons with shrapnel or certain metallic
implants, such as prostheses, or aneurysm clips, or persons with electronic implants, such as cardiac pacemakers or
implanted hearing devices. The magnetic field generated by the MR machine can cause a displacement or
malfunctioning of these devices. There are no other known risks to body tissues associated with the magnetic field
strength used in this study. Some participants report some anxiety or claustrophobia in the MR scanner since the head
must be placed fully inside the scanner tube. If anxiety or claustrophobia occurs, please let us know and we will stop the
scan and bring you out of the scanner. In addition, fatigue and physical discomfort are possible. The MRI scanner makes
a great deal of noise when taking images. To minimize the level of noise, you will be fitted with disposable earplugs or
headphones to wear during the procedure. These may be a bit uncomfortable to wear, and will not eliminate all sound,
so that communication with you is still possible.
Risks of Fasting: All three study visits will require you to be fasting. There are some risks associated with fasting. If you
experience any of the following symptoms, please contact researchers and discontinue your fast: shakiness,
nervousness, sweating, dizziness or light-headedness, sleepiness, confusion, difficulty speaking, anxiety, or weakness.
Page 5 of 12
IRB Form 10012013
Version Date: 12/16/2013
Study No.: IRB00070965
Emory University IRB
IRB use only
Document Approved On: 2/19/2014
Project Approval Expires On: 1/21/2015
Risk of Blood Draw: We will collect a blood sample at all 3 visits. Blood draws can cause mild pain in the arm and may
cause bruising, infection, and occasional fainting.
Risks of Lumbar Puncture (LP). Approximately 22-25 milliliters (1 ½ Tbs) of spinal fluid may be taken during each LP and
your body will make up for the loss. During the procedure, you may have temporary pain and discomfort in your back.
The most common complication of spinal fluid collection is a headache. When done in most clinical settings, headache
occurs in about 10 out of every 100 people who have the procedure. On the other hand, the number of people who get
headaches is less than 2 out of every 100 people when a special needle is used. This special needle is used for spinal fluid
collection in every lumbar puncture in this study.
Drinking a lot of fluids before the spinal fluid collection may also help prevent headaches, and drinks with caffeine may
help treat headaches from spinal fluid collections. We will call you the day after your spinal fluid collection to see if you
have any side effects.
During the spinal fluid collection, about 13 out of every 100 people feel brief electric shocks if the needle touches a
nerve. Damage to the nerves that come off the spinal cord can rarely occur. In 1 out of every 150,000 people, bleeding
from a broken blood vessel can cause a pocket of blood. If the procedure is performed at the improper level, the needle
may injure the spinal cord. A doctor does a physical exam before the spinal fluid collection to make sure you have no
neurological conditions that would make spinal fluid collection unsafe.
Lidocaine: Lidocaine is the drug used to numb the lower back before the collection of spinal fluid. There are rare cases
of allergic reactions to lidocaine, such as redness and swelling of the skin. If you have had a previous reaction to
lidocaine, please inform study personnel right away.
Risks of Questionnaires: During tasks that involve memory, you may become bored, fatigued, or frustrated by their
difficulty. There are no physical risks to these tests. Some of the questions you will be asked on the questionnaire are
personal and may make you feel embarrassed. You may skip any questions you do not feel comfortable answering, but it
is important for you to give your best effort.
Risks of Blood Pressure Cuff: The blood pressure monitoring device is non-invasive and the most common complaint is
potential discomfort due to the blood pressure cuff inflating. If this occurs, you simply can take off the cuff.
Risks of Blood Vessel Function Tests: The brachial artery ultrasound is safe and only mildly uncomfortable due to
tightness in the arm when the cuff is inflated. We will use ultrasound to painlessly bounce sound beams off of your heart
to determine how much blood is flowing out of it. We will place a pencil-like sensor gently against the inside your elbow
and record a blood pressure signal from your pulse. This measure is also painless and is non-invasive.
Risk of Breach of Confidentiality: Because your personal information will be retained, there is a small possibility that
your information could become available to unauthorized persons. This risk is a concern because of the sensitivity of
some of the study data. If your employer or a potential employer became aware of these results, it could lead to the
loss of your job or make it harder to get a new one, or insurance. While there are laws against this, the laws do not apply
to everyone and are difficult to enforce.
Page 6 of 12
IRB Form 10012013
Version Date: 12/16/2013
Study No.: IRB00070965
Emory University IRB
IRB use only
Document Approved On: 2/19/2014
Project Approval Expires On: 1/21/2015
Benefits
You are not expected to benefit directly from participating in this study. Your participation in this research study may
benefit other people in the future by helping us learn more about the disease process of Alzheimer's disease.
Compensation
You will not be offered payment for being in this study.
Possible Discovery of Unanticipated Findings: When lab work or brain scans are performed for research, there is a
chance of finding something unexpected, given your health history. Unexpected findings can be medically important, or
medically unimportant. Findings that are medically important have clear clinical significance and are those for which
treatment might be available, and for which we generally know the risks of non-treatment.
You will only be informed of findings with clear clinical significance which may be revealed during the imaging
procedure, artery ultrasound or lab work. This is information that you should share with your doctor as it has been
deemed important to your individual health care. You will not be informed of findings judged as medically
unimportant by our clinicians.
In order to assist us in interpreting the results of your lab work or brain scans, we are also seeking permission to review
your medical records if you are or have been a patient at this hospital.
There may be benefits to learning such results (early detection and treatment of a medical condition), but there are risks
as well (problems with getting insurance or a job, or feeling worried about a finding for which no treatment is required
or appropriate). Please note that any further clinical care or tests you receive from your doctor might lead to costs
incurred by you or your insurance company. The research team and Emory University will not reimburse you for those
additional tests.
You may also choose to have your physician informed of any findings of clear clinical significance that we report to you
by initialing the box below. Please note, however, that if you choose to have your physician informed of findings of
clinical significance, that report will likely be placed in your medical records. We will discuss this with you at the time you
are informed.
Please indicate your preference by signing your initials on the appropriate line:
______
Please inform me and my doctor of findings of clinical significance.
______
Please only inform me. Do not inform my doctor of findings of clinical significance.
Name of Physician to Contact
Name of primary physician_______________________________________________________
City or clinic ___________________________________________________________________
Page 7 of 12
IRB Form 10012013
Version Date: 12/16/2013
Study No.: IRB00070965
Emory University IRB
IRB use only
Document Approved On: 2/19/2014
Project Approval Expires On: 1/21/2015
Health Care Provider ____________________________________________________________
Confidentiality: Emory will keep any research records that it creates private to the extent that this is required to do so
by law. Whenever possible, a study number, rather than your name, will be used on study records. Additionally, paper
files will be stored in a locked cabinet when not in use. Your data will be coded with a specific study number and only
authorized study personnel will have access to individually identifiable data. To the extent permitted by law, your
identity and your participation in this study will remain confidential. Your information will not be disclosed to anyone
who is not listed in this consent form without your written permission.
Study records can be opened by court order. They also may be provided in response to a subpoena or a request for the
production of documents.
Any data or samples leaving Emory will be coded. Researchers at Emory might need to know your identity in order to
match your information and samples with the information we collect from you in other studies that you participate in.
Medical Records
Emory does not control results from tests and procedures done at other places, so these results will not be placed in
your Emory Healthcare medical record. They will likely not be available to Emory Healthcare to help take care of you.
Emory does not have control over any other medical records that you may have with other healthcare providers. Emory
will not send any test or procedure results from the study to these providers. If you decide to be in this study, it is up to
you to let your health providers know.
If you receive care through Emory Healthcare, some information from this study will be included in your existing medical
record. If you do not already receive health care through Emory Healthcare, a record will be created for you.
This means that if you receive health care from Emory Healthcare, your Emory Healthcare providers will see that you
took part in a research study. You are participating in a study as a normal healthy volunteer (i.e., you are at risk for
Alzheimer’s disease, but you don’t have it), the title and purpose of the research study you are taking part in will not
appear in the electronic medical record and you will be identified as a healthy volunteer to help protect your privacy.
Some of the results of the procedures or tests performed for the study will be recorded in your electronic medical
record and others will not. Results that would not link you to Alzheimer’s disease or results that are not considered
sensitive information will be placed in your electronic medical record, such as nursing documentation, results of blood
work, and the results of cell counts performed after the Lumbar Puncture.
Study results that would link you to Alzheimer’s disease or are considered sensitive information will not be placed in
your electronic medical record without your consent.
This means that if you have Emory Healthcare care providers, they may be able to discover the results of those study
tests that are put in your electronic medical record. Because the procedures being done for this study are being done for
research purposes only, the study team does not plan on reporting the results back to you unless they suggest a clinical
concern. However, because the results of your tests are resulted in your Emory Healthcare record, your usual health
care providers may follow up with you regarding the tests. If your health care providers discover your results and want
to perform additional follow up tests, that is up to them. If your Emory Healthcare care provider asks you why you
visited an Emory Healthcare facility, such as the ACTSI, and had procedures or tests done, you can simply state that you
participated in a research study and do not need to share the details of the study.
Page 8 of 12
IRB Form 10012013
Version Date: 12/16/2013
Study No.: IRB00070965
Emory University IRB
IRB use only
Document Approved On: 2/19/2014
Project Approval Expires On: 1/21/2015
If you have any questions about what information will go into the electronic medical record created for you, ask the
study team for more information.
The MRI images and spinal fluid samples collected in this study will be coded with unique participant numbers. This
coding means no one except study personnel will know your identity and test results. Only tests with numbers (no
names) are sent to outside laboratories for analysis.
The information collected from you during this study will be used by the researchers and research staff at Emory
University and the Emory University ADRC and its affiliates for this study. It may also be shared with others at Emory and
outside Emory. The results of this study may also be used for medical and scientific publications, but you will not be
identified personally.
If you enroll in another Alzheimer’s disease - related study, we may share the relevant data and tissue collected in this
study with the research staff who work on the other study. We offer this as an option to reduce some of the hassles of
research participation. The other study’s consent form describes how information will be used in that study, and with
whom it will be shared..
Others at Emory University and its affiliates who may need to use your health information in the course of this
research:
•
•
Emory University regulatory and research oversight boards and offices
• Accounting and billing personnel at Emory University
Research support services staff at Emory University and its affiliates
Others outside of Emory University and its affiliates who may receive your health information in the course of this
research:



The sponsor of the study (National Institutes of Health/National Institute on Aging)
Other researchers conducting work relevant to dementia or aging
Research oversight and regulatory agencies, such as the Food and Drug Administration (FDA)
The researchers will not be looking at the results of these test and procedures to make decision about your personal
health or treatment. However, if we find evidence of a clinically meaningful problem during one of your procedures, we
will notify you and your primary care physician if you so choose. For this study, those items include: neuroimaging,
cognitive testing, physical exam, pregnancy testing and lumbar puncture.
Authorization to Use and Disclose Protected Health Information
The privacy of your health information is important to us. We call your health information that identifies you, your
“protected health information” or “PHI.” To protect your PHI, we will follow federal and state privacy laws, including the
Health Insurance Portability and Accountability Act and regulations (HIPAA). We refer to all of these laws as the “Privacy
Rules.” Here we let you know how we will use and disclose your PHI for the study.
PHI that will be Used/Disclosed:
The PHI that we will use and/or disclose (share) for the research study includes
 Medical information about you including your medical history and present/past medications
 Results of exams, procedures and tests you have before and during the study
 Laboratory test results
 Neuroimaging results
Page 9 of 12
IRB Form 10012013
Version Date: 12/16/2013
Study No.: IRB00070965



Emory University IRB
IRB use only
Document Approved On: 2/19/2014
Project Approval Expires On: 1/21/2015
Neuropsychological testing results
Results of the lumbar puncture
Vascular function testing results
Authorization to Use PHI is required to Participate:
By signing this form, you give us permission to use and share your PHI as described in this document. You do not have to
sign this form to authorize the use and disclosure of your PHI. If you do not authorize the use and disclosure of your PHI
for the study, then you may not participate in the research study or receive research-related treatment. You may still
receive non-research related treatment.
Expiration of Your Authorization
This authorization will not expire because it is a research study.
Revoking Your Authorization
If you sign this form, at any time later you may revoke (take back) your permission to use your information. If you want
to do this, you must write to:
At that point, the researchers would not collect any more of your PHI. But they may use or disclose the information you
already gave them so they can follow the law, protect your safety, or make sure that the study was done properly and
the data is correct. If you revoke your authorization you will not be able to stay in the study.
Other Items You Should Know
Not all people and entities are covered by the Privacy Rules. HIPAA only applies to health care providers, health care
payers or health care clearinghouses. If we disclose your information to people who are not covered by the Privacy
Rules, including HIPAA, then your information won’t be protected by the Privacy Rules. People who do not have to
follow the Privacy rules can use or disclose your information with others without your permission if they are allowed to
do so by the laws that cover them
To maintain the integrity of this research study, you generally will not have access to your PHI related to this research
until the study is complete. When the study ends, and at your request, you generally will have access to your PHI that
we maintain in a designated record set. A designated record set is data that includes medical information or billing
records that your health care providers use to make decisions about you. If it is necessary for your health care, your
health information will be provided to your doctor.
We may remove identifying information from your PHI. Once we do this, the remaining information will not be subject
to the Privacy Rules. Information without identifiers may be used or disclosed with other people or organizations and/or
for other purposes besides this study.
In Case of Injury
If you get ill or injured from being in this study, Emory would give/arrange for you to have urgent or emergent health
care. However, Emory University, Emory University Hospital, the Emory Clinic, Wesley Woods, Inc., National Institute of
Health, National Institute on Aging – Alzheimer’s Disease Center, Woodruff Health Sciences Center, National Institute of
Environmental Health Sciences, Center for Neurodegenerative Disease, the Packard ALS Center, Consolidated Anti-Aging
Consortium, and the Emory University Research Committee have not set aside funds to pay for this care or to
compensate you
If you believe you have been injured by this research, you should contact Dr. Whitney Wharton at 404.728.6918.
Page 10 of 12
IRB Form 10012013
Version Date: 12/16/2013
Study No.: IRB00070965
Emory University IRB
IRB use only
Document Approved On: 2/19/2014
Project Approval Expires On: 1/21/2015
Costs
There are no costs, research or standard of care related, associated with the study.
There will be no costs to you for participating in this study, other than basic expenses like transportation. You will not be
charged for any of the research activities.
Withdrawal from the Study
You have the right to leave a study at any time without penalty.
The researchers and sponsor also have the right to stop your participation in this study without your consent if:
 They believe it is in your best interest;
 You were to object to any future changes that may be made in the study plan;
 or for any other reason.
Contact Information
Contact Dr. Whitney Wharton at 404.728.6918
 if you have any questions about this study or your part in it,
 if you feel you have had a research-related injury or a bad reaction to the study drug, or
 if you have questions, concerns or complaints about the research
Contact the Emory Institutional Review Board at 404-712-0720 or 877-503-9797 or irb@emory.edu:
 if you have questions about your rights as a research participant.
 if you have questions, concerns or complaints about the research.
 You may also let the IRB know about your experience as a research participant through our Research Participant
Survey at http://www.surveymonkey.com/s/6ZDMW75.
Page 11 of 12
IRB Form 10012013
Version Date: 12/16/2013
Study No.: IRB00070965
Emory University IRB
IRB use only
Document Approved On: 2/19/2014
Project Approval Expires On: 1/21/2015
Consent
Please print your name and sign below if you agree to be in this study. By signing this consent form, you will not give up
any of your legal rights. We will give you a copy of the signed consent to keep.
Name of Subject
Signature of Subject
Date
Time
Signature of Person Conducting Informed Consent Discussion
Date
Time
__________________________________________________________
Name of Person Conducting Informed Consent Discussion
Page 12 of 12
IRB Form 10012013
Version Date: 12/16/2013