12 Informed Consent - Xanax

FOR IRB USE ONLY
APPROVED BY: IRB-01
IRB ID #: 201303743
APPROVAL DATE: 07/25/13
EXPIRATION DATE: 04/04/14
OMB Control Number: 0925-XXXX
Expiration Date: XX/XX/XXXX
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not return the completed form to this address.

INFORMED CONSENT IN-PERSON SCREENING - XANAX
Project Title:
Quantification of Behavioral and Physiological Effects of Drugs Using a Mobile
Scalable Device: Study 2
Principal Investigator:

Timothy Brown

Research Team Contact:

Timothy Brown, (319) 335-4785

This consent form describes the research study to help you decide if you want to participate. This form
provides important information about what you will be asked to do during the study, about the risks and
benefits of the study, and about your rights as a research subject.
 If you have any questions about or do not understand something in this form, you should ask
the research team for more information.
 You should discuss your participation with anyone you choose such as family or friends.
 Do not agree to participate in this study unless the research team has answered your
questions and you decide that you want to be part of this study.
WHAT IS THE PURPOSE OF THIS STUDY?
This is a research study. We are inviting you to participate in this research study because you are
between the ages of 18 and 40 years, with a valid driver’s license for two years, drive a minimum of
5,000 miles per year, and are in good health.
The purpose of this research study is to explore the usefulness of the Mobile Alertness Memory Profiler
(M-AMP) assessment in detecting the effect of certain drugs on driving performance. The M-AMP is an
inexpensive, non-invasive assessment that assesses alertness, attention, and memory. This study will
evaluate the M-AMP assessment by comparing the measure before and after subjects have taken Xanax,
a benzodiazepine usually taken by prescription.

HOW MANY PEOPLE WILL PARTICIPATE?
Approximately 26 people will take part in this study conducted by investigators at the University of
Iowa.

FOR IRB USE ONLY
APPROVED BY: IRB-01
IRB ID #: 201303743
APPROVAL DATE: 07/25/13
EXPIRATION DATE: 04/04/14

HOW LONG WILL I BE IN THIS STUDY?
If you agree to take part in this study, your involvement will last for three visits, one screening visit,
approximately 45 minutes in length and two study visits that will be separated by 2-7 days and will last
approximately 5-6 hours in length, starting at 8:00 AM.

FOR IRB USE ONLY
APPROVED BY: IRB-01
IRB ID #: 201303743
APPROVAL DATE: 07/25/13
EXPIRATION DATE: 04/04/14

WHAT WILL HAPPEN DURING THIS STUDY?
Visit 1 (Screening Visit)
Upon arrival at NADS, study staff will verbally review this document with you, answer any questions
you may have about the study, provide you time to read this document and, if you agree to participate,
obtain your written consent. You will receive a copy of this signed Informed Consent Document.

First you will be asked to provide a urine sample for a drug screen test. If you are female, the urine
sample will also be tested for pregnancy.
If your drug screen test or pregnancy test comes back positive, your test results will remain confidential.
However, you will be ineligible to continue in the study.
If you continue to be eligible to participate in the study, you will be asked to complete a questionnaire
about general demographic information, your driving record, driving behavior, and driving history. If
you are eligible to continue, you will be asked to drive two short 5-8 minute practice drives on the
simulators. After your drives, you will be asked to complete a questionnaire about how you feel. A
medical professional will then conduct a physical and psychological evaluation. If you continue to be
eligible to be in the study, study staff will set up an appointment for your next two study visits. You will
then be asked to arrange for third party transportation to and from NADS on both study visit days. In
the event that you are unable to arrange for third party transportation, taxi transportation will be
arranged for you by study staff at no cost to you.
Visits 2 and 3 (Study Visits)
For these visits, you will be asked to consume either Xanax or a Xanax placebo. You will receive both
study drugs, but you will be randomly assigned to the order in which you receive them. You will have a
50/50 chance of receiving Xanax at the first visit and the placebo at the second and vice-versa. This
means that the order in which you receive the study drug will be determined purely by chance, like flipping a
coin.

You will be instructed to minimize caffeine usage in the 24 hours preceding your visits.
 No caffeine within two hours of going to bed the night before your visit
 No more than one 8 ounce cup of caffeinated beverage no later than 6 AM the day of your visit.
You will also be asked to refrain from alcohol for the 24 hours preceding each visit, and to get between
seven and nine hours of sleep the night before each visit.
For these visits, you must continue to meet study eligibility. You will be asked to provide a urine
sample for a urine drug screen test and a pregnancy test for females. If your drug screen test or
pregnancy test comes back positive, your test results will remain confidential. However, you will be
ineligible to continue in the study.

FOR IRB USE ONLY
APPROVED BY: IRB-01
IRB ID #: 201303743
APPROVAL DATE: 07/25/13
EXPIRATION DATE: 04/04/14

If you continue to be eligible to participate in the study, your height and weight will be measured and
recorded, and you will be asked to complete a questionnaire about your sleep habits in the last 24 hours
and your food intake within the last 4 hours. If you remain eligible to continue, you will be fitted with
an EEG monitoring device. This device is a non-intrusive wireless recording device that is worn on
your head. It also has a single lead that researchers will place on your chest. Researchers will apply a
gel to your scalp before fitting you with the EEG device. It wirelessly records brain activity as well as
data about electrical activity from your heart and head movement data. You will then complete a 45
minute Mobile Alertness Memory Profiler (M-AMP) Assessment which involves three tests.
1. The first is a multiple choice vigilance task that requires you to identify a predetermined target
from amongst three objects.
2. The second task is divided into an eyes open task and an eyes closed task. The eyes open task
requires you to press a button each time an image appears on the screen. The eyes closed task
requires you to press a button each time you hear an auditory tone.
3. The third task is an image recognition task in which you will be presented a set of images and
then asked to indicate whether images from another set were in the original set you were shown.
4. A medical professional will obtain a blood sample of 4mL (less than a teaspoon) by individual
needle stick.
You will then be escorted to the driving simulator and asked to drive for 35 minutes. The drive consists
of urban, freeway, and rural roadways.
You will be asked to complete questionnaires about your current sleepiness level before and after the
study drive, and questionnaires about how you feel after the drive and your experience driving the
simulator.
After completing the questionnaires, you will be escorted back to the prep room where you will be
provided either the Xanax or Xanax placebo with a glass of water. After thirty minutes you will
complete another Mobile Alertness Memory Profiler (M-AMP) Assessment. After the assessments, a
medical professional will obtain a blood sample by individual needle stick of 4 mL(less than a teaspoon)
for a laboratory test. The collected blood sample will be used only for study purposes; to assess how
quickly the medication was metabolizing. Next you will again be escorted to the driving simulator for
another 35 minute drive followed by the same set of questionnaires. After completing the drive and the
questionnaires, you will be escorted back to the prep room where you will complete a final Mobile
Alertness Memory Profiler (M-AMP) Assessment. Then the EEG monitoring device will be removed
from your head, the medical professional will obtain a final blood sample of 4 mL(less than a teaspoon)
by individual needle stick, and you will be transported home.
You may skip any questions that you do not wish to answer on the questionnaires.
Blood/Data Storage for Future Use
As part of this study, we are obtaining blood samples from you. We would like to study your blood in
the future, after this study is over.
The tests we might want to use to study your blood may not even exist at this time. Therefore, we are
asking for your permission to store your blood so that we can study them in the future. These future

FOR IRB USE ONLY
APPROVED BY: IRB-01
IRB ID #: 201303743
APPROVAL DATE: 07/25/13
EXPIRATION DATE: 04/04/14

studies may provide additional information that will be helpful in understanding the effects of Xanax,
but it is unlikely that what we learn from these studies will have a direct benefit to you. It is possible
that your blood might be used to develop products or tests that could be patented and licensed. There
are no plans to provide financial compensation to you should this occur.
If you agree now to future use of your blood, but decide in the future that you would like to have it
removed from future research, you should contact Dr. Timothy Brown at 319-335-4785. However, if
some research with your blood has already been completed, the information from that research may still
be used.

Audio /Video Recording
All driving trials will be recorded on video.
The simulator contains sensors that measure vehicle operation, vehicle motion, and your driving actions.
The system also contains video cameras that capture images of the forward visual scene while you drive.
These sensors and video cameras are located behind you in such a manner that they will not affect you
or obstruct your view while driving. Your likeness will not be recorded unless you turn around to face
the cameras. The information collected using these sensors and video cameras are recorded by research
staff for analysis, and may be used as described in the Confidentiality section below. Access to the
videos will be restricted to members of the research team and will be maintained with the engineering
data to support future analysis of the data.

Future Studies
We will keep on file your name and information about you, including birth date, contact phone numbers,
and the annual mileage you drive each year. In the future, we may contact you to see if you would be
willing to complete questionnaires, interviews, or drives for future studies. Agreeing to participate in
this study does not obligate you to participate in future studies. You would be asked to give a separate
consent for any future studies.

WHAT ARE THE RISKS OF THIS STUDY?
You may experience one or more of the risks, indicated below, from being in this study. In addition to
these, there may be other unknown risks, or risks that we did not anticipate being associated with this
study.
One risk involves the possibility of discomfort associated with simulator disorientation. This can occur
as a consequence of driving the simulator. Previous studies with similar driving intensities and
simulator setups produced few disorientation effects. When effects were reported, they were usually
mild to moderate and consisted of slight uneasiness, warmth, or eyestrain for a small number of
participants. These effects typically last for only a short time, usually 10-15 minutes, after leaving the
simulator. You may quit driving at any time if you experience any discomfort.
If you ask to quit driving as a result of discomfort, you will be allowed to quit at once. You will then be
escorted to a separate room where you can sit and rest. A beverage and snack will be offered. A trained

FOR IRB USE ONLY
APPROVED BY: IRB-01
IRB ID #: 201303743
APPROVAL DATE: 07/25/13
EXPIRATION DATE: 04/04/14

staff member will determine when you will be allowed to leave. If you show few or no signs of
discomfort, you will be transported home.
If you experience anything other than slight effects, a follow-up call will be made to you 24 hours later
to ensure you’re not feeling ill effects.
Xanax also presents a risk for side effects. The risks for taking a single dose of Xanax are:
 Drowsiness
 Dizziness
 Low Energy
 Altered Interest in Having Sexual Intercourse.
The risk of blood sampling is pain, tenderness, bruising, or bleeding at the needle puncture site, and
transient lightheadedness or dizziness.
Some people find the application of the gel for the EEG device to be uncomfortable or inconvenient as it
has to be washed out of the hair after participating.

WHAT ARE THE BENEFITS OF THIS STUDY?
You will not benefit from being in this study.
However, we hope that, in the future, society might benefit from this study because the information
might provide a better understanding of how to detect drugs being used by drivers. This may allow the
development and refinement of new technologies that could minimize drugged driving-related crashes in
the future.

WILL IT COST ME ANYTHING TO BE IN THIS STUDY?
You will not have any costs for being in this research study.
WILL I BE PAID FOR PARTICIPATING?
You will be paid for being in this research study. You will need to provide your social security number
(SSN) in order for us to pay you, if you proceed past the screening visit. If you do, you may choose to
participate without being paid if you do not wish to provide your social security number (SSN) for this
purpose. You may also need to provide your address if a check will be mailed to you. If your social
security number is obtained for payment purposes only, it will not be retained for research purposes.
If you agree to participate in this study, you will be paid $275 if you complete all study visits and
procedures. If you withdraw or your participation ends, your compensation will be pro-rated as follows:

FOR IRB USE ONLY
APPROVED BY: IRB-01
IRB ID #: 201303743
APPROVAL DATE: 07/25/13
EXPIRATION DATE: 04/04/14

Visit 1 (Screening)
Visit 2
Visit 3
Total (complete all visits)

$ 25
$ 115
$ 135
$ 275

In the event that you fail to meet the study criteria at any visit (e.g., the drug screen, pregnancy screen,
sleep requirements, and alcohol/caffeine restrictions) you will be paid only $10 for the visit.

WHO IS FUNDING THIS STUDY?
The National Institute on Drug Abuse (NIDA), part of the National Institutes of Health (NIH) is funding
this research study. This means that the University of Iowa is receiving payments from NIH to support
the activities that are required to conduct the study. No one on the research team will receive a direct
payment or increase in salary from NIH for conducting this study.

WHAT IF I AM INJURED AS A RESULT OF THIS STUDY?
 If you are injured or become ill from taking part in this study, medical treatment is available at the
University of Iowa Hospitals and Clinics.
 The University of Iowa does not plan to provide free medical care or payment for treatment of any
illness or injury resulting from this study unless it is the direct result of proven negligence by a
University employee.
 If you experience a research-related illness or injury, you and/or your medical or hospital insurance
carrier will be responsible for the cost of treatment.

WHAT ABOUT CONFIDENTIALITY?
We will keep your participation in this research study confidential to the extent described in this
document and permitted by law. However, it is possible that other people such as those indicated below
may become aware of your participation in this study and may inspect and copy records pertaining to
this research. Some of these records could contain information that personally identifies you.
 federal government regulatory agencies,
 Representatives of Advanced Brain Monitoring involved in the research
 Auditing departments of the University of Iowa, and
 the University of Iowa Institutional Review Board (a committee that reviews and approves
research studies)

You will be assigned a study number which will be used instead of your name to identify all data
collected for the study. The list linking your study number and your name will be stored in a secure

FOR IRB USE ONLY
APPROVED BY: IRB-01
IRB ID #: 201303743
APPROVAL DATE: 07/25/13
EXPIRATION DATE: 04/04/14

location and will be accessible only to the researchers at the University of Iowa. All records and data
containing confidential information will be maintained in locked offices or on secure password protected
computer systems that are accessible to the researchers, the study sponsor, and its agents. It is possible
that persons viewing the video data may be able to identify you. If we write a report or article about this
study, we typically describe the study results in a summarized manner so that you cannot be identified
by name.
The engineering data collected and recorded in this study (including any performance scores based on
these data) will be analyzed along with data gathered from other participants. These data may be
publicly released in final reports or other publications or media for scientific (e.g., professional society
meetings), regulatory (e.g., to assist in regulating devices), educational (e.g., educational campaigns for
members of the general public), outreach (e.g., nationally televised programs highlighting traffic safety
issues), legislative (e.g., data provided to the U.S. Congress to assist with law-making activities), or
research purposes (e.g., comparison analyses with data from other studies). Engineering data may also
be released individually or in summary with that of other participants, but will not be presented publicly
in a way that permits personal identification, except when presented in conjunction with video data.
The video data (video image data recorded during your drive) recorded in this study includes your
video-recorded likeness and all in-vehicle audio including your voice (and may include, in some views,
superimposed performance information). Video and in-vehicle sounds will be used to examine your
driving performance and other task performance while driving. Video image data (in continuous video
or still formats) and associated audio data may be publicly released, either separately or in association
with the appropriate engineering data for scientific, regulatory, educational, outreach, legislative, or
research purposes (as noted above).
The simulator data are captured and stored on hard drives located within a limited access area of the
NADS facility. Access to simulator data is controlled through permissions established on a per-study
basis.
If we write a report or article about this study or share the study data set with others, we will do so in
such a way that you cannot be directly identified.

IS BEING IN THIS STUDY VOLUNTARY?
Taking part in this research study is completely voluntary. You may choose not to take part at all. If
you decide to be in this study, you may stop participating at any time. If you decide not to be in this
study, or if you stop participating at any time, you won’t be penalized or lose any benefits for which you
otherwise qualify.

What if I Decide to Drop Out of the Study?
If you decide to leave the study early, we ask you to contact Kayla Smith 319-335-4672 as soon as you
decide not to participate.

FOR IRB USE ONLY
APPROVED BY: IRB-01
IRB ID #: 201303743
APPROVAL DATE: 07/25/13
EXPIRATION DATE: 04/04/14

Will I Receive New Information About the Study while Participating?
If we obtain any new information during this study that might affect your willingness to continue
participating in the study, we’ll promptly provide you with that information.

Can Someone Else End my Participation in this Study?
Under certain circumstances, the researchers might decide to end your participation in this research
study earlier than planned. This might happen if you fail the drug screen, for females, if you are
pregnant while participating, or if you do not meet the requirements for the study. Additionally, your
participation may end if you fail to operate the research vehicle in accordance with the instructions
provided or if there are technical difficulties with the driving simulator.
WHAT IF I HAVE QUESTIONS?
We encourage you to ask questions. If you have any questions about the research study itself, please
contact: Dr. Timothy Brown, (319) 335-4785. If you experience a research-related injury, please
contact: Dr. Timothy Brown (319) 335-4785.
If you have questions, concerns, or complaints about your rights as a research subject or about research
related injury, please contact the Human Subjects Office, 105 Hardin Library for the Health Sciences,
600 Newton Rd, The University of Iowa, Iowa City, IA 52242-1098, (319) 335-6564, or e-mail
[email protected]. General information about being a research subject can be found by clicking “Info for
Public” on the Human Subjects Office web site, http://hso.research.uiowa.edu/. To offer input about
your experiences as a research subject or to speak to someone other than the research staff, call the
Human Subjects Office at the number above.

This Informed Consent Document is not a contract. It is a written explanation of what will happen
during the study if you decide to participate. You are not waiving any legal rights by signing this
Informed Consent Document. Your signature indicates that this research study has been explained to
you, that your questions have been answered, and that you agree to take part in this study. You will
receive a copy of this form.

Subject's Name (printed):

Do not sign this form if today’s date is on or after EXPIRATION DATE: 04/04/14.

(Signature of Subject)

(Date)

FOR IRB USE ONLY
APPROVED BY: IRB-01
IRB ID #: 201303743
APPROVAL DATE: 07/25/13
EXPIRATION DATE: 04/04/14

Statement of Person Who Obtained Consent
I have discussed the above points with the subject or, where appropriate, with the subject’s legally
authorized representative. It is my opinion that the subject understands the risks, benefits, and
procedures involved with participation in this research study.

(Signature of Person who Obtained Consent)

(Date)