Clinical trial NCT05576155
Conditions: Sex Differences
Sponsor: Anna Stanhewicz, PhD
Start date: 2022-10-03; Completion date: 2023-02-23
Enrollment: 26 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
When blood pressure changes, Angiotensin II is produced and released into the bloodstream. This substance can make blood vessels smaller (i.e., vasoconstriction) by acting through Angiotensin II type I receptors (AT1R) to increase blood pressure. Or it can increase the diameter of vessels (i.e., vasodilation) through Angiotensin II type II receptors (AT2R) to decrease blood pressure. These two receptors normally work in balance to maintain blood pressure. However, excess Angiotensin II released in the bloodstream may reduce the sensitivity of AT2Rs, leading to excessive activation of AT1Rs. This results in increased constriction which plays a major role in diseases such as high blood pressure, hardening of the arteries, and heart failure. In the body, Angiotensin II production is reduced in the presence of estrogen, as seen in pre-menopausal women. Pre-menopausal women have a greater protection against cardiovascular diseases compared to age-matched males, likely due to the protective effects of estrogen. However, the extent that estrogen may impact the sensitivity of Angiotensin II receptors in pre-menopausal is unknown.

In this study, the investigators use the blood vessels in the skin as a representative vascular bed for examining mechanisms of microvascular dysfunction in humans. Using a minimally invasive technique (intradermal microdialysis for the local delivery of pharmaceutical agents), the blood vessels in a dime-sized area of the skin are studied in healthy young women and men. As a compliment to these measurements, blood is drawn from the subjects and circulating factors that may contribute to cardiovascular health are measured.

Detailed description:

Arms: arm 1: \~1 hour of losartan is perfused through an intradermal microdialysis fiber arm 2: \~1 hour of lactated Ringer's is perfused through an intradermal microdialysis fiber
Interventions: intervention 1: Compound 21 intervention 2: Compound 21 + losartan
Intervention descriptions: intervention 1: Compound 21 + Ringer's is perfused at 10 doses increasing serially for 10 minutes each from 10\^-12 M to 10\^-3 M intervention 2: Compound 21 + losartan (43 µM) is perfused at 10 doses increasing serially for 10 minutes each from 10\^-12 M to 10\^-3 M.

Protocol documents:
Prot_SAP_000.pdf: 
 
 
 
Sex Differences in the Dilatory 
Response of Compound 21 
 
NCT05576155 
 
July 17th, 2023 



























ICF_001.pdf: 
 
 
 
Sex Differences in the Dilatory 
Response of Compound 21 
 
NCT05576155 
 
July 17th, 2023 


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INFORMED CONSENT DOCUMENT 
 
Project Title: 
Sex Differences in the Dilatory Response of Compound 21 
 
Principal Investigator: 
Anna Reid-Stanhewicz 
 
Research Team Contact: 
Kelsey Schwartz 
 
M: 319-243-0962 
 
Email: kelsey-schwartz@uiowa.edu 
 
Anna Stanhewicz, PhD 
 
W: 319-467-1731 M: 845-551-3869 
 
Email: anna-stanhewicz@uiowa.edu 
 
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 18-35 years old and have a body mass index (BMI) between 18 and 30 kg/m2.  
 
When your blood pressure decreases, your body responds by naturally producing and releasing a 
chemical called Angiotensin II into your bloodstream. This substance acts through Angiotensin II type I 
receptors (AT1R) on blood vessels causing them to become smaller in diameter (i.e., vasoconstriction). 
Angiotensin II also acts through lesser-known Angiotensin II type II receptors (AT2R) to cause your 
blood vessels to increase in diameter (i.e., vasodilation). Normally, these two receptors work in balance 
to maintain your blood pressure. Excess release of Angiotensin II may reduce the sensitivity of AT2Rs 
and increase AT1R activation, which plays a major role in cardiovascular diseases. Previous work has 
shown that Angiotensin II is reduced by estrogen in pre-menopausal women, leading to an enhanced 
effect of AT2Rs that is not seen in age-matched men. The purpose of this study is to examine the sex 
difference in young adults to Compound 21 (C21), which activates AT2Rs. We anticipate the outcomes 
of this study will aid in the understanding of mechanisms of Angiotensin II receptors in men and women 
and how AT2R activation with C21 may restore their balance. 
 
This study includes the use of four research drugs in a nickel-sized area of skin on your arm. They are 
losartan, C21, Lactated Ringer’s solution, and sodium nitroprusside. These drugs are considered 
investigational, which means that they have not been approved by the U.S. Food and Drug 
Administration for this use. 
 


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HOW MANY PEOPLE WILL PARTICIPATE? 
Approximately 44 people will take part in this study conducted by investigators at the University of 
Iowa.  
 
HOW LONG WILL I BE IN THIS STUDY? 
If you agree to take part in this study, your involvement will last for approximately 2 weeks depending 
on your availability. 
 Screening Visit 
 
up to 1 hour 
 Study Visit 
 
 
up to 4 hours 
 
In the event of an experimental failure (e.g. equipment stops working, power outage in the building 
during study visit, etc.) you may be asked to repeat a trial. The decision to repeat a trial is up to you. If 
you do repeat a trial, you will be compensated for that additional trial. 
 
WHAT WILL HAPPEN DURING THIS STUDY? 
Screening Visit: 
The researchers will measure your height, weight, blood pressure, and heart rate.   
 You will fill out a participant information survey and health history questionnaire. You can skip 
any questions that you do not want to answer.  
 Women will submit a urine sample for a pregnancy test. 
We will use the information collected during the screening visit to determine if you are eligible to 
continue in the study, and to analyze our data in the study. 
 
Study Visit (Microdialysis Experiment ): 
Before you arrive: 
If you have any questions about the study, please contact us right away. You will be asked to fast 
3 hours prior to your appointment, avoid caffeine 12 hours prior, avoid alcohol and any forms of 
heavy exercise 24 hours prior, and avoid supplements and over-the-counter medications on the 
morning of the experiment visit. Do not stop taking medications as prescribed by your physician. 
 
Women who complete the study will be tested during the early follicular phase of the menstrual 
cycle (1-7 days after the onset of menses) or during the placebo phase of an oral contraceptive. 
You will schedule with the research team to make sure you are scheduled during the right time. 
 
When you arrive: 
The researchers will meet you at the entrance of the Field House and walk with you to the lab 
space (528 FH) for the blood draw and experiment. The blood draw involves approved laboratory 
personnel drawing 15 ml (~1 Tbsp) of blood from a vein in your arm. We save some of the blood 
in the research lab to analyze later. 
 
Measurements: 
Blood Pressure, Heart Rate: We measure blood pressure and heart rate throughout the 
experiment. We apply three sticky tabs to the skin of your chest. The tabs connect to an 
electrocardiogram (ECG) machine that records heart rate. During the experiment, we can 
measure blood pressure in one of two ways. 
A) We inflate a cuff on your upper arm while we listen at the inside of your elbow with a 


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stethoscope, or 
B) An automated machine inflates a cuff on the upper arm and uses a sensor in the cuff to 
measure blood pressure. 
 
Skin Blood Flow, Skin Temperature: We measure skin blood flow and skin temperature 
throughout the experiment. We tape a thin probe and its holder over two sites on your forearm. 
The thin probe measures skin blood flow with a weak laser light (Laser Doppler Flowmetry). 
The holders measure skin temperature. We control the temperature of the holders. The holders 
start at 33⁰C (91⁰F). 
 
Microdialysis (MD): 
Overview: Microdialysis (MD) involves placing very thin plastic tubing between the layers of your 
skin. The largest part of the tubing is about 6 times the diameter of a human hair. We pump fluid 
like that found in your body’s tissues (lactated Ringer’s solution) through the thin tubing. The thin 
tubing acts like the very small blood vessels in your skin. There is an exchange of substances 
between the fluid in the tubing and the fluid in the surrounding tissue. During the experiment, we 
add substances to the fluid in the tubing. The substances can only reach a 2.5 cm2 (0.4 inch2), 
nickel-sized area of skin. 
 
MD Probe Insertion: We place a tight band around your arm so we can easily see your veins. For 
each MD site, we make pairs of pen-marks 2.5 cm (1 inch) apart and away from veins. The MD 
tubing enters and exits your skin at the marks. We remove the tight band. We clean your arm with 
an orange-colored fluid and alcohol. We place an ice bag on your arm for 5 minutes to numb your 
skin. Then we insert a thin needle into your skin at each entry mark. The needle’s tip travels 
between the layers of skin for 2.5 cm (1 inch). It leaves your skin at the matching exit mark. We 
thread the MD tubing through the needle. Next, we withdraw the needle leaving the tubing in your 
skin. We prepare all MD sites in this manner. Any redness of your skin subsides in about 60 – 120 
minutes. 
 
Microdialysis Experiment Protocol: 
Summary:  We prepare 2 MD sites as described above. Initially, Lactated Ringer’s only flows 
through all probes. Then the investigational agents are added to the Lactated Ringer’s flowing 
through MD probe 2 for 60 minutes. After those 60 minutes, we record baseline measurements for 
both sites (20 minutes). After we have collected baseline data, we change the fluid flowing through 
each microdialysis fiber at 10-minute intervals. Each perfusion will include a progressively higher 
concentration of C21. After the last amounts of C21 have been added, all MD sites are then 
warmed to 43°C (108°F) to perform Maximal Skin Blood Flow. At the same time, the 
researchers switch the fluids at all sites to Ringer’s + Sodium Nitroprusside (SNP) for about 30 
minutes. This causes blood vessels at the MD sites to dilate or enlarge as much as they can. Finally, 
we remove the MD probes and apply a sterile dressing. If desired, we can place a bag of ice on your 
arm for 10 minutes to reduce any bruising that may occur. We remove all instrumentation and 
measure your blood pressure and heart rate before you leave. 
 
The 2 MD sites are: 
C21 Dose Response:  
 
Probe 1. Lactated Ringer’s only 
 
 
 
 
 
Probe 2. Lactated Ringer’s + Losartan 


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Tissue/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. Your sample, information, and/or data may be placed in a central 
repository or other national repositories sponsored by the National Institutes of Health or other Federal 
agencies. If this happens, it will be stripped of identifiers (such as name, date of birth, address, etc).  
Other qualified researchers who obtain proper permission may gain access to your sample and/or data 
for use in approved research studies that may or may not be related to in the purpose of this study.   
 
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 
studies may provide additional information that will be helpful in understanding cardiovascular disease, 
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 tests, or discoveries that could be patented and 
licensed.  In some instances, these may have potential commercial value and may be developed by the 
Investigators, University of Iowa, commercial companies, organizations funding this research, or others 
that may not be working directly with this research team.  However, donors of blood do not retain any 
property rights to the materials.  Therefore, there are no plans to provide financial compensation to you 
should this occur. 
 
Your blood will be stored with a code which may be linked to your name and date of birth.  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 Anna Stanhewicz (319-467-1732, anna-stanhewicz@uiowa.edu).  
However, if some research with your blood has already been completed, the information from that 
research may still be used.  
 
Please place your initials in the blank next to Yes or No for each of the questions below: 
 
My blood may be stored/shared for future research in cardiovascular disease. 
 
_____ Yes  
_____ No 
 
My blood may be stored/shared for future research for any other purpose. 
 
_____ Yes  
_____ No 
 
WILL I BE NOTIFIED IF MY STUDY VISIT RESULT(S) IN AN UNEXPECTED FINDING?   
The results from the skin blood flow data we collect in this research study are not the same quality as 
what you would receive as part of your routine health care. The results will not be reviewed by a 
physician who normally reads such results. Due to this, you will not be informed of any unexpected 
findings. The results of your study will not be placed in your medical record with your primary care 
physician or otherwise. If you believe you are having symptoms that may require care, you should 
contact your primary care physician. 
 
WILL YOU KEEP MY NAME ON FILE FOR PARTICIPATION IN FUTURE STUDIES? 
If you consent, we may contact you to participate in future studies with our laboratory group. We will 
keep your name, sex, race/ethnicity, birthdate, and contact information for this purpose. Participating in 


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this study does not mean that you are obligated to participate in any future studies. A separate consent 
document would be signed for future studies.   
 
May we keep your name, race/ethnicity, birthdate, pregnancy history, and contact info to contact you for 
future studies?   
 
Please place your initials in the blank next to Yes or No for each of the questions below: 
 
_____ Yes 
_____ No 
 
 
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, associated with being in this 
study.  
 
Microdialysis:  The risks are less than that for a blood draw because microdialysis uses only a small, 
local area of skin. In contrast, a blood draw involves not only skin, but also large blood vessels and 
blood. You are likely to have some pain and bruising like that from a blood draw. However, we use ice 
to numb your arm when we insert the tubing. Also, the small needle reduces pain when we insert the 
tubing. You are not likely to have pain after the tubing is in place. You may feel a little pain when we 
remove the tubing from your skin. Needles make some people feel lightheaded or cause them to faint. 
You may feel lightheaded or faint during the placement or the removal of the fibers. Although rare, the 
tubing could break as we remove it from the skin. Then we remove the tubing still in your skin by 
pulling on the other end of it. This presents no added risk for you. Even more rare, the tubing could 
break so that a piece of the tubing is left under your skin. In this case, we treat any tubing still in your 
skin like a splinter. We stop any mild bleeding with mild pressure and sterile gauze. Infection is 
possible. We keep the risk of infection very small by using sterile techniques and supplies like those 
used with blood draws. We apply a sterile bandage to the site after the experiment. We tell you how to 
take care of the site.   
 
Fluid flowing through the tubing:  The substances flowing through the tubing only go to a 2.5 cm2 
(0.4 inch2) area of skin at each tubing site. The amount that enters the skin is very small. However, there 
is a chance of having a bad reaction to the substances. This reaction could produce redness, itching, rash, 
and/or swelling. A worse reaction could also cause fever, breathing problems, changes in pulse, 
convulsions, and/or fainting. We and other researchers have used these substances with microdialysis in 
skin. There have been no reports that these substances caused bad reactions. If a bad reaction should 
occur, we summon medical help. 
 
Losartan, C21, SNP:  These substances stop or mimic the action of your body’s natural chemicals upon 
the blood vessels in the skin. A small amount of these substances enters the skin around the tubing. This 
only affects the blood flow in the vessels in that nickel-sized area of skin. The effect of these substances 
in your skin is gone within an hour after the experiment. There are no individual risks associated with 
the substances used with microdialysis. There is a slight chance of allergic reaction to these substances, 
which could produce redness, itching, rash, and/or swelling. 


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Losartan – causes blood vessels to constrict (get narrow). 
Compound 21 (C21) – causes blood vessels to dilate (get wider). 
Sodium Nitroprusside (SNP) – causes blood vessels to dilate as much as they can. 
 
Lactated Ringer’s Solution:  This fluid is similar to the natural fluids in your skin. This fluid contains 
salt, potassium, lactate, and chloride. The acid content is like that in your body’s natural fluids. A bad 
reaction to this fluid is highly unlikely, but could produce redness, itching, rash, and/or swelling.. 
 
Laser Doppler Flowmetry:  Weak lasers can hurt your eye if you stare into the light for a long time.  
We do not turn on the laser until the probes are taped to a surface. The tape may irritate your skin. 
 
Blood Pressure:  The researchers measure blood pressure with the method used in a doctor’s office and 
they can use a machine. A cuff inflates on the upper arm. As the cuff slowly deflates, the researchers 
listen with a stethoscope at the bend in the elbow or the machine takes a reading. During the short time 
the researchers inflate the cuff, your arm may feel numb or tingly. The cuff could cause mild bruising. 
   
Povidone Iodine:  Researchers and hospitals use this orange-colored fluid to clean the skin. You could 
have a bad reaction if you are allergic to iodine. You need to inform us if you have this allergy. In this 
case, we use only alcohol instead. A bad reaction could cause redness, itching, rash, and/or swelling. A 
worse reaction could also cause fever, breathing problems, changes in pulse, convulsions, and/or 
fainting. 
 
Blood Draw:  Blood draws often cause mild pain, bruising, swelling, or bleeding. There is also a slight 
chance of infection or a small clot. If you are nervous about needles, your blood pressure and heart rate 
may increase for a little while. You may also feel lightheaded, sick to your stomach, or may faint. Using 
the same techniques used in hospitals keeps the chance of infection minimal.  
 
Tape and sticky disks:  The tape or sticky disks could cause a rash. During screening, you tell us if you 
are sensitive to tape. If a disk sticks very strongly, removing the disk could cause an abrasion like a rug-
burn on your skin. An abrasion can feel tender or slightly painful and can increase risk of infection.  If 
you are sensitive to tape, you may have an increased chance for abrasion. If you get an abrasion, 
antibiotic ointment and a sterile bandage are applied. We tell you how to take care of the site.  
 
Medical screening:  You may feel shy about giving health information. The staff collects the 
information in a private and professional manner. You may feel shy about being measured. You may 
request someone of the same sex to conduct the screening. 
 
Initial screening form:  Only members of our lab group use this form. We use the form to help decide 
whether you are a good candidate for the study. You may feel shy about answering questions. You may 
request someone of the same sex to ask you the questions. We collect the information in a private and 
professional manner. We keep the completed form confidential and secure. 
 
ECG Heart Rate:  This machine measures the electrical activity of your heart. You have 3 wires from 
the machine taped to spots on your chest. There have been no adverse effects. The tape may irritate. 
 
Local heating:  We measure the temperature of your skin under the holders. During heating, the skin 


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Page 7 of 10 
feels very warm but will not hurt. The heating makes the skin under the holder red like when you take a 
hot bath. The redness goes away within several hours. Some people may be more sensitive to heating. If 
your arm feels too hot, tell us, and we will reduce or stop the heating. 
 
Latex:  Some gloves and medical materials are made of latex rubber. You will inform us if you are 
allergic to latex and decline to participate in the study.  
 
There is a risk of loss of confidentiality if your information or your identity is obtained by someone 
other than the investigators, but precautions will be taken to prevent this from happening.  The 
confidentiality of your electronic data created by you or by the researchers will be maintained to the 
degree permitted by the technology used. Absolute confidentiality cannot be guaranteed. 
 
WHAT ARE THE BENEFITS OF THIS STUDY? 
We don’t know if you will benefit from being in this study. 
 
However, we hope that, in the future, other people might benefit from this study because this research 
will help us understand how blood vessels respond to Compound 21. 
 
WILL IT COST ME ANYTHING TO BE IN THIS STUDY? 
You will not have any costs for being in this research study. You/your insurance company will remain 
responsible for your regular clinical care. 
 
WILL I BE PAID FOR PARTICIPATING? 
You will be paid for being in this research study. You may need to provide your address if a check will 
be mailed to you. You will be given a parking pass for time involved at the study and screening visits. 
 
Experimental visit: $60 per visit ($15/microdialysis probe + $7.50/hour for completing the experiment) 
 
Pro-rating: You can receive payment for experiments not completed. We will pay an amount of money 
equal to the part completed. For instance, if you complete half of the Experimental visit, you receive 
$15.00 for each probe inserted plus $7.50 for each hour you completed. We may ask you to repeat a 
trial. If you agree to repeat a trial, you receive payment for the repeated trial as stated above. 
 
WHO IS FUNDING THIS STUDY? 
This study is being funded by the National Heart, Lung, and Blood Institute (NHLBI) of the National 
Institutes of Health. This means that the University of Iowa is receiving payments from NHLBI 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 NHLBI 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.  


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 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 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,  
 U.S. Food and Drug Administration  
 auditing departments of the University of Iowa, and the University of Iowa Institutional Review 
Board (a committee that reviews and approves research studies  
 
To help protect your confidentiality, we will limit the use and sharing of your personal research 
information to people who have a need to review this information. We keep the list that matches your 
name with your code number in a locked file or password protected file on a computer in a room that is 
locked when unoccupied. Only authorized members of the lab have access to the list. We label your 
research records with your code number and keep them in a locked file or password protected computer 
in a room that is locked when unoccupied. We label your research samples with your code number only.   
 
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. 
 
The University of Iowa Hospitals and Clinics generally requires that we document your participation in 
research occurring in a University of Iowa Health Care facility. This documentation will be in either 
your medical record or a database maintained on behalf of the institution reflecting that you are 
participating in this study. The information included will provide contact information for the research 
team as well as information about the risks associated with this study. We will keep this Informed 
Consent Document in our research files; it will not be placed in your medical record chart. 
 
WILL MY HEALTH INFORMATION BE USED DURING THIS STUDY? 
The Federal Health Insurance Portability and Accountability Act (HIPAA) requires University of Iowa 
Health Care to obtain your permission for the research team to access or create “protected health 
information” about you for purposes of this research study.  Protected health information is information 
that personally identifies you and relates to your past, present, or future physical or mental health 
condition or care.  We will access or create health information about you, as described in this document, 
for purposes of this research study.  Once University of Iowa Health Care has disclosed your protected 
health information to us, it may no longer be protected by the Federal HIPAA privacy regulations, but 
we will continue to protect your confidentiality as described under “Confidentiality.” 
 
We may share your health information related to this study with other parties including federal 
government regulatory agencies, the University of Iowa Institutional Review Boards and support staff, 
and the U.S. Food and Drug Administration.   
 
You cannot participate in this study unless you permit us to use your protected health information.  If 
you choose not to allow us to use your protected health information, we will discuss any non-research 


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Page 9 of 10 
alternatives available to you.  Your decision will not affect your right to medical care that is not research 
related. Your signature on this Consent Document authorizes University of Iowa Health Care to give us 
permission to use or create health information about you. 
 
Although you may not be allowed to see study information until after this study is over, you may be 
given access to your health care records by contacting your health care provider. Your permission for us 
to access or create protected health information about you for purposes of this study has no expiration 
date. You may withdraw your permission for us to use your health information for this research study by 
sending a written notice to: Anna Stanhewicz, 410 Field House, 225 South Grand Avenue, Iowa City, IA 
52242. However, we may still use your health information that was collected before withdrawing your 
permission. Also, if we have sent your health information to a third party, such as the study sponsor, or 
we have removed your identifying information, it may not be possible to prevent its future use.  You will 
receive a copy of this signed document. 
 
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. 
 
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 become pregnant, if the researcher decides to end 
the study early, or if for any reason the researcher decides that it is no longer safe for you to continue. 
 
WHAT IF I HAVE QUESTIONS? 
We encourage you to ask questions.  If you have any questions about the research study itself, please 
contact: Anna Stanhewicz (319)467-1732 or Kelsey Schwartz (319)243-0962. If you experience a 
research-related injury, please contact: Anna Stanhewicz (319)467-1732. 
 
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 
irb@uiowa.edu. 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 


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Page 10 of 10 
receive a copy of this form. 
 
Subject's Name (printed):  __________________________________________________________ 
 
 
 
 
__________________________________________ 
_______________________________ 
(Signature of Subject)  
 
 
 
 
(Date) 
 
 
 
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)