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CONSENT OF AN ADULT TO BE IN A RESEARCH STUDY
Participant’s Name______________________________
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
You are being asked to be in this study because you are scheduled to receive a XX transplant from a living
donor (family member or friend) or a deceased donor. To date, XX transplantation is the most effective
treatment for Disease X.
The purpose of this study is to evaluate how well Experimental Drug, an experimental drug, prevents rejection
of a transplanted XX and how safe it is to take. The Experimental Drug has not been proven to be safe or
effective in preventing a rejection of transplanted XXs by the United States Food and Drug Administration
(FDA). So far, Experimental Drug has been given to #XX subjects who were XX transplant recipients.
You will also take additional medication to prevent rejection of the transplanted XX. Commonly this treatment
involves initial short-term use of an anti-rejection medication, followed by the use of several drugs to provide
life long anti-rejection treatment. These drugs will be described later in this form.
Up to XX people will be in this study at UVA. About XX subjects are expected to participate in this study at
approximately XX study sites around the world.
Who is paying for this study?
This study is being sponsored by Sponsor Name. The University of Virginia is being paid by the sponsor to do
this study and give them the information obtained about you while performing this study.
How much time will this study take?
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The study will involve up to XX visits and will last up to X years. Most clinic visits will require about X hours
of your time. The infusion visit will require approximately X hours of your time.
What will be done if you are in the study?
A. Screening:
Before your transplant surgery and your first dose of study medication, routine tests will be performed to make
sure you are eligible and it is safe for you to participate in this study. These include:
 A physical exam with vital signs
 Review of your medical history
 Complete two quality of life questionnaires that will take about an hour to complete. These
questionnaires will ask you about how you are feeling and how your health is affecting the rest of your
life (like your ability to work, do chores around the house, etc)
 Blood tests to make sure your XX are working well (the total amount of blood will be approximately 5
teaspoons).
 Electrocardiogram (ECG) to check your heart
 Chest x-ray
 Mammogram if you are a female 40 years of age and older or with a history or risk of breast cancer, if
not done in past 6 months
 Pregnancy test for females of child bearing potential; additional pregnancy tests will be performed, and
must be negative, prior to each dose of Experimental Drug
Randomization:
If these tests show you are eligible and you agree, prior to the transplant, you will be randomly assigned (like
rolling dice) to get 1 of 3 treatments. You have an equal chance of being assigned to any one of the groups.
This study is partially blinded. This means that you will know if you are in the treatment group receiving XYZ.
But if you are assigned to a treatment group of the Experimental Drug, neither you nor your study doctor will
know what dose of Experimental Drug you are getting. This information will be made available in an
emergency.
The three treatment groups are:
1) Experimental Drug higher dose (more intensive)
2) Experimental Drug lower dose (less intensive)
3) XYZ
B. Treatment Schedule
Experimental Drug Groups
Experimental Drug is given in your vein using an IV. An IV is a small flexible tube inserted into a vein using a
needle. You will receive the infusion over X minutes.
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Regardless of whether you are assigned to “More Intensive (MI) High Dose Group” or the “Less Intensive (LI)
Low Dose Group” you will receive Experimental Drug on Days X and Day X while you are in the hospital.
Once you are discharged from the hospital after your transplant, you will also be requested to come to the
General Clinical Research Center, an outpatient infusion center on the 8th floor of the main University of
Virginia Health System Hospital, for all additional infusions at the following schedule:
 During the first year after your transplant: Weeks: [fill in]
 During the following two years after your transplant: [fill in]
When you come in for your Experimental Drug infusions, the following procedures will also occur:
 Vital signs (temperature, pulse, and blood pressure) will be taken,
 Review of any side effects or symptoms you may be having
 Blood samples (about 1 teaspoon) to test for the amount of Experimental Drug in your blood will be
drawn.
 Females of child-bearing potential will have a pregnancy test performed before each dosing of
Experimental Drug, and will continue on the study only if the test is negative.
XYZ Group
XYZ is given as a pill(s) taken twice daily by mouth.
Once you are discharged from the hospital after your transplant, you will also be required to come to the
University of Virginia Health System Transplant Clinic for all your study visits at the following schedule:
 Weeks: fill in
 Months: fill in
When you come into clinic for study visits, the following procedures will occur:
 Vital signs (temperature, pulse, and blood pressure) will be taken,
 Any side effects or symptoms you may be having will be recorded,
 Blood samples (about 1 teaspoon) will be obtained at every visit to monitor the amount of XYZ in your
body
 Females of child-bearing potential will also have a pregnancy test performed at each visit and will
continue in the study only if the test is negative
 After month X, your physician or the study coordinator will contact you every month to follow-up on
your progress when you are not seen for a clinic visit
For All Participants
Everyone participating in this study will also receive the following approved medications, to be taken as
instructed by the study doctor:
Drug 1
Given as IV infusion on Day X
Drug 2
Given as pill(s) taken by mouth every day, starting on Day
X. This may also be given as an IV if necessary
immediately after your transplant
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Drug 3:
Immediately after your transplant, while you
are still in the hospital, Drug 3 will be give as an IV
infusion on Day X.
All of these drugs have been approved by the FDA and are used as the current standard of care in XX
transplant patients
You may also receive other approved anti-rejection medications such as [fill in] if specified by the study doctor.
In addition, approved medications to prevent serious infections may be given to you for at least X months after
your transplantation.
You will be closely monitored throughout this study and if your doctor suspects rejection, additional tests,
including blood work and sonograms are likely to be performed.
For all participants
 Standardized blood pressure monitoring will occur every X months during the first year, then at months
X, Y, and Z. You will be asked to sit and rest for 10 minutes before your blood pressure is taken. Your
blood pressure will then be repeated. If you take medication to lower your blood pressure you will need
to hold your morning dose on visit days when standardized blood pressure monitoring is done.
 Blood tests (about X teaspoons) to monitor your XX function will be obtained at every study visit.
 Blood samples (about X teaspoons) to test for the development of antibodies to your donor XX will be
obtained X times during the study and whenever you experience any episode of suspected rejection.
 Blood tests (about 2 teaspoons) to check on the development of diabetes or cholesterol problems will be
performed approximately every X months during the first year, then every X months during year X.
 Special XX clearance test to measure your XX function
Your responsibilities
It is important that you adhere to the visit schedule as directed by your study doctor and plan to stay until all
procedures are completed.
At each visit:
 You will be asked how you feel
 You must tell your study doctor of any new medication that you are taking while you are in the study
 Women of child-bearing potential must use a medically acceptable method of birth control during the
study, and for X weeks after the last dose of study medication
 If you are a male, you must inform your study doctor if your partner becomes pregnant.
 You will have to bring back empty study medication packages and all unused study medication (for
patients in the XYZ treatment group only)
If you want to know about the results before the study is done:
This study is not meant to find out if you have any other disease or problem.
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The study leader will tell you if any research results are important to your health during the study. That
information is important for you to know, because it may help you decide whether you want to continue being
in this study.
We cannot tell you any other information until the results have been studied. At that time you can ask for more
information.
If we take any blood or tissue:
Blood, tissue biopsies and urine samples collected will be tested to measure:
 XX function (at every visit)
 Your blood counts including white blood cells (help fight infection), red blood cells (help carry oxygen
to your body), and platelets (help in clotting your blood).
 Blood test to check the amount of sugar, fat and proteins that show signs of rejection will be measured.
 Pregnancy test must be done within XX hours before study drug is administered and at each visit,
(serum sample only for the first dose of study drug)
 Special clearance test to measure your XX function
 Biopsies of your XX will be performed (during transplant and X years after transplant and if your doctor
suspects that you may be experiencing an episode of acute XX rejection)
 Blood testing for the amount of study drug in your blood
 Blood tests to check your body’s capacity to make antibodies will be done up to XX days before your
transplant.
You will have a total of X tablespoons of blood drawn at each visit. A total of approximately X tablespoons of
blood will be drawn during your XX-month participation in this study.
What are the risks of being in this study?
We do not know if the study drug, Experimental Drug, is a better treatment than the drugs that we now use.
XYZ is an effective anti-rejection medication, however, its use is associated with adverse side effects including
high blood pressure, diabetes, high cholesterol, and scarring of the transplanted XX. These factors can increase
the risk of heart-related diseases (such as a heart attack) and loss of function in the XX. For these reasons,
alternative anti-rejection drugs, which may have fewer adverse side effects, are being developed to prevent
rejections. Experimental Drug is an investigational drug that is being developed for this purpose.
In a small one year long study we found some hopeful results that the study might be less toxic to the XX than
XYZ but we do not know if this is true for longer periods of time. We also need to know if the study drug
causes cancers. In the small study, X out of XX of the patients in the more frequent dose (more intense dose)
Experimental Drug group were diagnosed with tumors. None of the patients in the less frequent dose (less
intense dose) Experimental Drug group developed cancers and X out of XX patients in the XYZ treatment
group developed cancers.
All patients receiving a transplant have risk of rejecting the new XX. Anti-rejection medications will be given
to help resolve these rejections. The risks associated with the surgery itself as well as the standard of care antirejection drugs will be discussed with you by your physician.
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Risks of all anti-rejection drugs
 Increased risk of infection
 Post-transplant lymphoproliferative disorder (PTLD) – a tumor of white blood cells
 Increased risk of cancer
 Risk of infection with vaccinations
Risks associated with XYZ include:
 XX dysfunction
 Low white blood cells that could lead to infection
 Tremor
 Low levels of magnesium in the blood
 High blood pressure
 High cholesterol (fat level)
 Diabetes
 Increased hair growth
 Increased gum growth over the teeth
Certain drugs and herbal products may interfere with XYZ treatment, leading to increased risk of
rejection or increased side effects. In particular, taking St. John’s wort while being treated with XYZ
could result in rejection of transplanted organ and graft loss.
Drug 2
 Anemia (low red blood cells)
 Leukopenia (low white blood cells)
 Diarrhea
Drug 3
 Fluid build-up
 Facial swelling
 Weight gain
 Increased appetite
 High blood pressure
 Muscle weakness
 Bone problems
 Fragile skin
 Wound healing problems
 Mental problems
Risks associated with Experimental Drug include:
 pulmonary edema (fluid in the lungs) and
 proteinuria (protein in the urine)
 Post Transplant Lymphoproliferative Disorder – a tumor of white blood cells
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Risks of Vaccinations post transplant:
Due to the risk of infection, you should not receive any live vaccination during the course of the study.
Similarly, the chicken pox and live oral polio vaccine(s) should not be given to anyone living in your home due
to the rare risk of transmitting the infection to you. If vaccinations with any of the live virus vaccines are
recommended for yourself or household contacts during the course of the study and up to three months
following the last dose of study medication, you should discuss the risks and alternatives with your personal and
research physicians.
Risks With Procedures
Clearance test (performed X times during the study)
 Allergic reactions to iodine (trouble breathing, rash)
 Pain or redness with needle injection
 Pain or redness with blood draw
XX biopsy performed once during transplant surgery, at month X, and possibly on an “as needed” basis
 Pain at the site of biopsy
 Bleeding
 Need for blood transfusion (rare)
 Loss of XX (rare)
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).
Please ask the study doctor if you have more questions about the side effects. If you experience these or any
other symptoms, please notify your study doctor or study staff.
Risk for Women of Childbearing Potential
If you are pregnant or if you are breastfeeding, then we want you to tell us. You will not be able to be in this
study, because to be in the study might hurt your unborn baby. We also want you to not get pregnant during
this study and for X weeks after the study. You should use a safe method of birth control during this time. If
you have questions about a safe method of birth control, please ask the study leader. If you do become
pregnant, suspect pregnancy, if you have a change in your menstrual cycle, in your contraception method or if
you need to take another medication, please tell the study leader right away and he/she will give you more
information.
The sponsor will not be responsible for providing routine medical care relating to your pregnancy. In the case of
a pregnancy, your study doctor will ask you to agree to allow access to your medical records and to the medical
records of your infant for a minimum of X weeks after delivery.
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Laboratory and animals studies have been done to test for any possible risks to the unborn, but the results do not
necessarily translate to humans.
If you are in the treatment group receiving XYZ, you should not share this drug with anyone. Keep it out of
reach of children and persons not able to read or understand the label.
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.
Other unexpected risks:
In addition to the risks listed above, the study drug and procedures may have unknown side effects. You may
have side effects that we do not expect or know to watch for now. All drugs have the risk of causing an allergic
reaction that, if not treated promptly, could be life threatening. It is important that you report any and all
symptoms or possible reactions to your study doctor. You will be monitored for side effects by study staff and
the study doctor may decide that you should be withdrawn from the study.
Could you be helped by being in this study?
There is no guarantee that you will benefit from participating in this research. If the study drug is effective, you
may benefit from increasing the life of your XX transplant. Information obtained from your participation in this
study may help you and others in the future. We do not promise that you will be helped by being in this study.
What are your other choices if you do not join this study?
You do not have to be in this study to be treated for your illness or condition or to receive a XX transplant. If
you choose not to be in this study, you will have the usual treatment, which includes [explain usual treatment.]
Your study doctor will discuss these options with you.
New findings
All new findings discovered during this study, which may reasonably influence your willingness to continue
participation in this study, will be provided to you when they become available.
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Will you be paid for being in this study?
You will receive $X for each visit for your time and travel expenses, which is a total of $XX for YY visits. If
you leave the study before completing all visits, you will be paid for each completed visit. You will receive
payment within approximately X months after your last visit.
You will also receive free medication for X years or until the end of your participation in the study (you may
decide to end participation or participation may be ended by the researcher or the sponsor).
If you owe the state of Virginia for unpaid taxes, fines, child support, etc., the state can use the money you earn
in this study to pay those debts. Even if this happens, the money you earn may be reported to the IRS as taxable
income.
Will being in this study cost you any money?
All study related clinic visits, physical examinations, study drug (Experimental Drug or XYZ), laboratory tests,
electrocardiograms, x-rays, and any other procedures associated with the conduct of this study will be provided
at no charge to you. You and/or your insurance company will be responsible for covering the costs of the X.
You or your insurance company will also be responsible for paying for your usual tests and care that would be
done if you were not in this study.
Taking part in this study may also lead to added costs to you and/or your insurance company. You may wish to
check with your insurance company before the study starts to determine which of these charges they will cover
or if a pre-authorization is required. Ask your insurance company what they will cover and if they require you
to get their permission before we treat you.
What if you are hurt in this study?
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. If you are hurt in the study in a way that is unexpected (meaning in a way that is not listed in the
risks part of this form), the sponsor, or your insurance company may pay for your treatment. If they do not pay,
University of Virginia will treat you free of charge. If you have questions about what will be covered if you are
hurt in the study, talk to the study leader. You do not give up any legal rights by signing this form.
If you suffer a physical injury as a direct result of administration of the sponsor’s investigational study drug or
any properly performed medical procedures required by the written study plan, you will be reimbursed for
reasonable and necessary medical expenses you actually incur to treat that injury (to the extent those costs are
not paid by your insurance or other third party coverage), provided that medical expenses will not be
reimbursed if your injury is attributable to (a) your failure to follow instructions contained in this informed
consent or otherwise communicated to you by study staff; or (b) the natural progression of your underlying
disease.
You may obtain such medical care in the same manner as you would ordinarily obtain other medical treatment.
Treatment for an unexpected injury directly resulting from the research study that is not covered by the sponsor
or your insurance will be provided free of charge at the University of Virginia.
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What happens if you change your mind?
You can change your mind about being in the study any time. It is always up to you. You can choose not to join
in the first place. Or you can choose to stop during the study. You do not have to be in this study to get services
you can normally get at the University of Virginia.
The study leader will tell you if any research results are important to your health during the study. That
information is important for you to know, because it can help you decide whether you want to continue being in
this study. You can change your mind at any time.
Even if you do not change your mind, the study leader or the sponsor of this study can take you out of the study.
This might happen if the study leader is concerned about your health. Or it might happen if you do not follow
instructions given to you.
 An adverse event, injury or medical condition which may place you at risk of further complications if you
continue to participate
 Failure to take the study medication as instructed
 Failure to keep your scheduled appointments
 Cancellation of the entire study by the sponsor
 The targeted number of subjects needed for study have entered the treatment phase
 It is in your best interest
 The sponsor stops the study early
 Other administrative reasons
If you decide to stop being in the study, we will ask you to return to the clinic for the following tests:
 ECG (electrocardiogram),
 physical exam with vital signs, and
 laboratory tests
 you will be asked about your general health, any new medications you are taking
 and you will be asked to complete both quality of life questionnaires
Approximately X months after taking your last dose of study medication, a visit will be scheduled {insert
timeframe} for laboratory tests and questions about your health.
Even if you have stopped the study treatment, you will be asked to return to the clinic after your transplant
for an ECG, physical exam, vital signs, and laboratory tests.
If you agree, a biopsy will be scheduled {insert timeframe}.
 If you do not agree to return to the clinic for these study visits, you will be contacted by phone to see
how you are.
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.
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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
o Blood samples if you agree to provide them for genetic testing or future research
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.
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.
Contact Information
Please contact the people listed below to:





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:
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.
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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.
Conclusion
Please check one of the following:
______
You agree to be contacted after this study is done for follow up information or to be asked to be
in other studies.
_____
You do not agree to be contacted after this study is done for follow up information or to be asked
to be in other studies.
For Women of Childbearing Potential, if applicable
The information on pregnancy prevention for Women of Childbearing Potential has been reviewed with me.
Please confirm by signature:_____________________________ Date: _____________
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)
______________________________
PERSON OBTAINING CONSENT
(SIGNATURE)
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DATE
_____________________________
PERSON OBTAINING
CONSENT
(PRINT)
________
DATE
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