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HIC# Study title
Consent of an Adult to be in a Research Study
1. Participant’s Name______________________________
2. Medical Record # _______________________________
What is the Purpose of this Form?
This form will help you decide if you want to be in the research study. You need to be informed about the study
before you can decide if you want to be in it. You should have all your questions answered before you give your
permission, or consent, to be in the study. This is called an “informed consent” form because it informs you
before you sign to give your consent.
Please read this form carefully. Ask about any part you don’t understand. Then decide if you want to be in this
study. If you do want to be in the study, you will need to sign this form to give your consent. You will get your
own copy of this signed form for your records.
Introduction
The purpose of this study is to test the effectiveness of Experimental Drug in patients with moderate to severely
active XYZ disease. Experimental Drug is approved by the U.S. Food and Drug Administration (FDA) for the
treatment of high cholesterol. It has not been proven to be safe or helpful for XYZ disease.
Recent studies have shown that this type of cholesterol-lowering medicine can reduce the amount of symptoms
people have with certain inflammatory diseases, such as rheumatoid arthritis. XYZ disease is a condition
associated with XXX. We are doing this study to see if Experimental Drug can reduce the severity of XYZ
symptoms, including abdominal pain, diarrhea, and weight loss.
Up to XX participants will be enrolled in this study at UVA.
You are being asked to participate in this study because you have been diagnosed with XYZ disease, and your
symptoms are not currently under very good control with the medications you are taking for XYZ.
The study is being sponsored by the Sponsor Name. The University of Virginia is not receiving compensation
from a sponsor in exchange for your information obtained while performing this study. The study investigators
involved in this trial have no potential conflicts of interest.
Who is paying for this study?
This study is being paid for (sponsored) by Y, a for-profit drug company. The University of Virginia is being
paid by the sponsor to do this study and to give them information we collect from you and about you during the
study.
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HIC# Study title
What will be done if you are in the study?
If you choose to participate in this study, you will be asked to complete a questionnaire while you are in the
clinic to help tell us how severe your XYZ symptoms are. This should take less than X minutes of your time.
A quality-of-life survey will also be done to find out how your XYZ is affecting your life. A research
coordinator will ask you a few questions to make sure you are eligible for the study, and a brief physical exam
will be performed by a study doctor before you are enrolled in the study. Before starting the study drug, you
will have some blood drawn to test for XXX, and will also have blood drawn to check for other markers of
XYZ activity. The total amount drawn will be X tablespoons of blood. You will also be asked to donate a
sample of stool for testing. If you are a woman of childbearing age, you will be asked to provide a urine sample
to make sure you are not pregnant before starting the study. These tests are all done to make sure it is safe for
you to take Experimental Drug, and also to provide baseline blood work to compare to labs drawn when you
finish the study.
Experimental Drug is a cholesterol-lowering medicine used in the United States to treat patients with high
cholesterol. For this study, you will be given a X-week supply of Experimental Drug, and you will take one pill
with a full glass of water each day for a total of X weeks.
You should not change any of the medicines you take for your XYZ disease during the six weeks of the study.
If you are currently on X, you may not take more than X mg each day. If your physicians make any changes in
your XYZ medicines during the X weeks, you should contact the study coordinator immediately.
One of the study personnel will contact you by telephone one week, two weeks, and four weeks after starting
Experimental Drug. This is to make sure you are not having any side effects from the medicine, and to see how
your XYZ disease is doing. Phone calls will typically be in the evening, and should take less than X minutes of
your time.
At the end of X weeks, you will return to clinic and be evaluated by the study doctors, and a physical exam will
be performed while you are in the clinic. You will be asked to complete a symptom diary and questionnaire to
see how severe your XYZ symptoms are and how they are affecting your quality of life. You will also have
about X tablespoons of blood drawn to check XXX. You will also be asked to give a sample of stool to test for
evidence of active inflammation. If you are a woman of childbearing age, a urine pregnancy test will be
performed that must be negative in order for you to participate. These tests will be in addition to any testing
you might have done with your regular doctor. The clinic visit, including the interview, questionnaire, exam,
and lab testing, should take about X minutes of your time.
After you have finished taking Experimental Drug, you will be asked to come back in X weeks to have a final
set of labs, including markers of inflammation, drawn to look for any long-term effects the study medication
had on these lab values. You will also be asked to fill out a symptom diary and questionnaire like those done
the first two visits. This visit should take about X minutes of your time. In addition, you will be contacted by
one of the study personnel by phone at X months to see how your XYZ disease is doing. This phone call should
take less than X minutes of your time.
The following tests will be done on the blood collected:
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HIC# Study title
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Complete blood count: measurement of white blood cells, red blood cells, and platelets
Metabolic panel: measures how well the liver and kidneys are functioning, and measures levels of blood
salts.
Lipid panel: measurement of cholesterol levels in your blood
C- Reactive Protein: measures inflammation
Experimental Drug level: to see how your body is using the medication
When these tests are done any remaining blood will be thrown away.
Optional test: "Additional Test Y"
If Additional Test Y is being scheduled by your regular doctor, we will ask you if we may obtain biopsy
samples for research purposes in addition to the samples that are being taken as part of your standard of care
during the Additional Test Y. We want to know the amount of inflammation that is present. This will not lead
to any significant additional risks of having the Additional Test Y. If your doctor does not feel that the
Additional Test Y is clinically necessary, we may ask you to have the Additional Test Y done for the purposes
of the study.
This is an optional part of the study, meaning it is not required. Patients who have Additional Test Y before
starting Experimental Drug will be asked to undergo a repeat Additional Test Y in X weeks to get biopsy
samples and to see whether Experimental Drug helped heal the inflammation. This Additional Test Y is also
optional, but if it is done you will be paid $X for your time and effort.
What are the risks of being in the study?
The risks of this study include a small chance of developing X while taking Experimental Drug. In earlier
studies, the risk of this happening was less than X percent, a value similar to placebo, and the liver test
elevations usually resolved after stopping Experimental Drug.
A small number of patients (less than 0.1 percent) may develop muscle damage while taking Experimental
Drug. The muscle damage usually causes problems like muscle weakness, pain, or cramps. In very rare
instances, the muscle damage associated with Experimental Drug has led to kidney failure, and even death.
Patients who are taking certain medications, including other cholesterol-lowering medications, may be at
increased risk of developing muscle problems while taking Experimental Drug, and will not be allowed in the
trial. Patients with poor kidney function may be at increased risk of developing muscle problems with
Experimental Drug and will not be allowed in the trial.
While Experimental Drug has not been found to cause problems during pregnancy, medications similar to it
have caused skeleton formation problems in animals. Experimental Drug and similar medications should not be
taken by women who are pregnant or who are trying to become pregnant.
Risks associated with the Additional Test Y:
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HIC# Study title
If you agree to undergo Additional Test Y, you may be exposed to some risk from the procedure. The overall
risk of having a complication from Additional Test Y is around 0.1 percent. Risks can include having a reaction
to (list risks here).
Finally, there is a potential risk of delaying alternative treatment for your XYZ disease while you are in this
study. You may, however, withdraw from the study at any time if you wish to pursue alternative treatment if
you or your doctor feels it is necessary.
Only you can take the study drug. Do not share it with anyone else. It must be kept out of reach of children and
persons who may not be able to read or understand the label.
Risks of having your blood drawn:
Having blood drawn may cause:
 pain (common),
 a bruise (sometimes),
 fainting or passing out (not very often), and
 infection (rare).
If the people doing the study are exposed to your blood or body fluids in a way that could give them a disease,
your blood may be tested. The tests might check for:
 hepatitis,
 HIV (Human Immunodeficiency Virus), or
 other infections.
You and the person exposed would be told the test results. However, your name would be kept private. If your
test is positive for hepatitis or HIV, we will tell you how to find counseling. You may want help in
understanding what the results mean for you.
Risks of taking blood with a catheter:
Sometimes the catheter stops working. In order to get the blood we need, we may have to stick you with
another needle.
In addition, it is possible in any experiment that side effects, which are not now known, could occur.
Precautions will be taken to prevent harmful side effects. You should contact your study doctor or research
coordinator if you think you are having side effects related to the study.
If you are pregnant, we want you to tell us and we will not include you in the experiment, because to do so
might be harmful to your unborn baby. We also want you to avoid getting pregnant during this study and for
one month following the study. We expect you to use an effective method of birth control during this time. If
you should become pregnant in spite of taking precautions, please immediately contact the investigator whose
phone number is listed on this form and he/she will provide you with information and/or resources for your
consideration.
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HIC# Study title
Could you be helped by being in the study?
If you participate in this study, you may experience improvement in your XYZ disease symptoms. The
improvement in symptoms may only last for as long as you take the study medicine, which is X weeks. The
treatment you receive may prove to be more effective than other available treatments. The Additional Test Y
at week X and week X may provide information to your doctors about the severity of inflammation which will
allow them to make better treatment decisions regarding your care. We do not guarantee or promise, however,
that you will receive any of these benefits.
What are your other choices if you do not join the study?
Often, the treatment for your condition would be to use stronger or more potent medicines to treat your XYZ
disease, typically steroids or other medications that suppress your immune system.
However, in order to see if Experimental Drug can help improve your XYZ symptoms, we must necessarily
delay customary treatment, which would be to avoid the use of high dose steroids and to not make any changes
in the medicines you are taking for XYZ disease.
Other alternatives to participating in this study include enrolling in another study evaluating other experimental
treatments for XYZ disease. In certain patients, surgery may be another alternative treatment.
Another alternative is not to participate in this study.
Will you be paid for being in this study?
You will receive $XX for participating in and completing this study. You will receive an additional $XX if you
decide to undergo the Additional Test Y at week X and at week X. You should expect to receive your payment
approximately X week/month after completion of the study. If you participate in but do not complete the study,
you will receive $X for completing the initial screening questionnaire, blood work, and study diary, and $X for
finishing the X week course of study drug.
Please be aware that if you owe the state of Virginia any money for unpaid taxes, fines, child support, etc., the
money will be withheld by the state and will be used towards payment of these obligations. This payment may
be reported to the IRS as taxable income.
Will being in this study cost you any money?
You will not have to pay anything to enroll in this study. This includes all blood draws and if you agree to
participate in the Additional Test Y, you will not be charged for either the week X or week Y.
What if you are hurt in this study?
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HIC# Study title
If you are hurt as a result of being in this study, we have no plans to pay you for lost wages, disability, or
discomfort. Treatment for an injury directly resulting from the research procedure that is not covered by your
insurance will be provided free of charge at the University of Virginia. If you have any questions, you should
talk to PI name at PI phone number.
You do not waive any liability rights for personal injury by signing this form.
What happens if you change your mind?
Participation in this study is entirely voluntary. The University of Virginia cannot require you to participate in
this study and sign this authorization in order for you to receive health care, except for the treatment directly
related to this research study. You may choose not to participate or you may enter the study and withdraw at
any time. There is no penalty for withdrawing. Neither your decision to participate in this study nor your
decision to stop and withdraw from the study after you have decided to participate will affect your health care in
any other way. Of course, we will tell you anything we learn during the study that may help you decide whether
to continue participating, or that is important to your overall health.
You may be withdrawn from the study without your permission at any time by the investigator or the sponsor
conducting this study. Some situations in which this might occur are if you do not follow the instructions given
to you or if the investigator feels your safety is at risk if you continue in the study.
How will your personal information be shared?
The UVa researchers are asking for your permission to gather, use and share information about you for this
study. If you decide not to give your permission, you cannot be in this study, but you can continue to receive
regular medical care at UVA.
If you sign this form, we may collect any or all of the following information about you:
o Personal information such as name, address, date of birth, social security number
o Your medical records and test results from before, during and after the study from any of your doctors or
health care providers (including mental health care and substance abuse records, and HIV/AIDS records)
o Information needed to bill others for your care
Who will see your private information?
o The researchers to make sure they observe the effects of the study and understand its results
o People or committees that oversee the study to make sure it is conducted correctly
o People who pay for the study, including insurance companies
o Tax reporting offices (if you are paid for being in the study)
o People who evaluate study results, which can include sponsors that make the drug or device being studied,
researchers at other sites conducting the same study, and government agencies that provide oversight such
as the Food and Drug Administration (FDA)
The information collected from you might be published in a medical journal. This would be done in a way that
protects your privacy. No one will be able to find out from the article that you were in the study.
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HIC# Study title
What if you sign the form but then decide you don't want your private information shared? You can
change your mind at any time. Your permission does not end unless you cancel it. To cancel it, please send a
letter to the researchers listed on this form. Then you will no longer be in the study. The researchers will still
use information about you that was collected before you ended your participation. UVa researchers will do
everything possible to protect your privacy. However, they will need to share your information with people
who may not have to follow the rules described above. Some of those people may be allowed to share/release
your information without your permission.
A copy of this consent form will be put in your medical record. (This is not the same as the record of this
research study.) This means that everyone who is allowed to see your records will be able to find out that you
are in this study. This is done so your regular doctors will know what drugs or treatment you are getting in the
study. If you have other health problems during the study, they will be able to treat you properly.
Contact Information
Please contact the people listed below to:
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Learn more about the study
Ask about the way the study is done or about treatments
Report an illness, a research related injury, or other problem (you may also need to tell your regular doctors)
Leave the study before it is finished
Report a concern about the study
Principal Investigator name:
Address:
Telephone:
What if you have a concern about a study?
You may also report a concern about a study or ask questions about your rights as a research subject by
contacting the Institutional Review Board listed below.
University of Virginia Institutional Review Board for Health Sciences Research
PO Box 800483
Charlottesville, Virginia 22908
Telephone: 434-924-2620
Fax: 434-924-2932
When you call or write about a concern, please give as much information as you can. Include the name of the
study leader, the IRB-HSR Number (at the top of this form), and details about the problem. This will help
officials look into your concern. When reporting a concern, you do not have to give your name.
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HIC# Study title
Conclusion
Please check one of the following:
______
You agree to be contacted after the completion of this study for follow up information.
_____
You do not agree to be contacted after the completion of this study for follow up information.
_____
You agree to undergo Additional Test Y at week X and week X and have biopsies taken for the
purposes of the study.
_____
You do not agree to undergo Additional Test Y at week X and week X and have biopsies taken
for the purposes of the study.
What does your signature mean?
Before you sign this form, please ask questions about any part of this study that is not clear to you. When you
sign below, you are saying you understand the information we gave you about the study and in this form. If you
sign the form it means that you agree to be in the study.
______________________
PARTICIPANT
(SIGNATURE)
________________________
PARTICIPANT
(PRINT)
_______
DATE
______________________________
PERSON OBTAINING CONSENT
(SIGNATURE)
_____________________________
PERSON OBTAINING CONSENT
(PRINT)
________
DATE
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