Research Consent Form
Dana-Farber/ Harvard Cancer Center
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PROTOCOL TITLE: Phase II Study Of Parathyroid Hormone following Sequential
Unrelated Cord Blood Transplantation
DFHCC PRINCIPAL RESEARCH DOCTOR/INSTITUTION: Karen Ballen, M.D.
DFHCC SITE-RESPONSIBLE RESEARCH DOCTOR(S)/INSTITUTION(S): Joseph Antin, MD,
DFCI, David Avigan, MD, Beth Israel Deaconess
MYELOABLATIVE REGIMEN
INTRODUCTION
We are inviting you to participate in a research study. Research is a way of gaining new
knowledge. A subject is a person who is being studied by the researchers. The title of
the study is stated above. This form was created to help explain to you the nature of this
study and if you choose to participate, it will be used to document your agreement to be
part of this study.
You are being invited to take part in this study because you have an illness that can be
treated with a bone marrow or blood transplantation. Since you do not have a family
member or volunteer bone marrow donor whose immune system matches your immune
system, you are eligible to receive a cord blood transplant. Cord blood, which is
collected from the umbilical cord after a woman gives birth, contains blood stem cells,
which are cells that can grow and produce all the different parts of your blood as well as
your immune system. Since the number of stem cells that are present in 1 cord blood is
small, in this study we will transplant you with 2 cord blood units given on the same day.
This is called double or sequential cord blood transplantation. This is a newer way of
performing cord blood transplantation and may speed the recovery of normal blood
counts.
About 25 people will take part in this study through the Dana-Farber/Harvard Cancer
Center, and about 40 patients will take part overall including at several sites in the United
States.
This consent form will give you the information you will need to understand why this
study is being done and why you are being invited to participate. It will also describe
what you need to do to participate and state any possible risks, inconveniences, or
discomforts that you may have while participating. If you decide to participate, you will
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Research Consent Form
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be asked to sign this form and it will be a record of your agreement to participate. You
will be given a copy of this form.
If you do sign this consent form, you will first need to be evaluated by the study doctors
to see if you can be in the study. This is called screening. The study has eligibility
requirements that must be met. If the screening tests show you can be in the study, you
will be able to start on the study treatment. If the study doctor feels the results of these
tests show that you cannot be in the study, you will not be able to start on study
treatment. This is done for safety reasons.
We encourage you to take some time to think this over and to discuss it with your family,
friends and doctor. We also encourage you to ask questions now and at any time.
WHY IS THIS STUDY BEING DONE?
The purpose of this study is to measure the effectiveness of a drug, parathyroid hormone
or PTH, in shortening the amount of time (days to engraftment) it takes your white blood
cells to return after transplantation. Since your white blood cells help to fight infection
and infection is common after cord blood transplantation, the hope is that the PTH will
help to decrease the risk of infection after cord blood transplantation. PTH may work by
affecting the places in the bone where blood cells are made, called the stem cell niche.
This study is called a Phase II clinical trial. Phase II trials are the second step in the
development of investigational drugs. Investigational means that the drugs are still being
studied and that study doctors are trying to find out more about them. The FDA has
approved the drug parathyroid hormone for use in patients with osteoporosis (bone
thinning) but we do not yet know if PTH is useful after cord blood transplantation.
The primary purpose of this study is to test the effectiveness of the study drug, PTH, in
decreasing the number of days until your white blood cell counts return after cord blood
transplantation.
A secondary purpose of this study is to learn more about cord blood transplantation.
Since the treatments given to destroy your cancer cells, cyclophosphamide, total body
radiation, and fludarabine, the medicines to prevent graft versus host disease, tacrolimus
and cellcept, and the PTH all contribute to the return of white blood cells after transplant,
all are discussed in this consent form. It is the use of PTH in the setting of double cord
blood transplantation that is investigational.
WHAT OTHER OPTIONS ARE THERE?
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Taking part in this study is your choice. Instead of voluntarily joining this study, you
have these options:
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Double cord blood transplantation without using PTH
Standard therapy, which may consist of further chemotherapy, or transplant from
another donor source if one is available.
Transplantation that either uses a single cord blood unit or different chemotherapy
drugs.
Other investigational treatments that may be available to you, or
Getting comfort care, also called palliative care. This type of care helps reduce
pain, tiredness, appetite problems and other problems caused by the cancer. It
does not treat the cancer directly, but instead tries to improve how you feel.
Comfort care tries to keep you as active and comfortable as possible.
These treatments could be given either alone or in combination with each other.
The study doctor can tell you more about your condition and the possible risks and
benefits of the different treatments. Please talk to your study doctor about these and other
options.
WHAT IS INVOLVED IN THE STUDY?
After signing this consent form, and before you begin the study, you will need to have the
following tests or procedures to find out if you can be in the study. These tests and
procedures are part of regular cancer care and may be done even if you don’t join the
study. (If you have had some of these tests or procedures recently, they may not have to
be repeated. This will be up to your study doctor.)
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Complete physical exam and medical history
Blood test (2-3 tablespoons) for routine laboratory tests
Disease evaluation (x-rays or CT scans, for example)
Performance status assessment to see how well you are able to perform your daily
activities
Blood tests to find the best-matched cord blood units to your immune system
Blood tests (approximately 5 tablespoons) performed to assess your immune
function (blood tests that may predict your ability to fight infection)
Bone marrow aspirate and biopsy to look at your blood forming cells.
EKG or electrocardiogram – a test of the electrical function of your heart
Evaluation by a dentist
Pulmonary function tests to measure how well your lungs are performing.
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
Echocardiogram (sound wave study) of the heart, or nuclear medicine test to
measure the pumping function of your heart
If these tests show you are eligible to participate in this study and you agree to take part
in this study, you will then receive the treatment as both an inpatient and outpatient.
The study treatment consists of the following procedures:

Intravenous (IV) Catheter: As an outpatient, before your transplant, an
intravenous (IV, meaning in your vein) catheter will be placed in one of the large
veins in your upper chest underneath the collarbone. It will reduce the need for
frequent needle punctures in your arm. A separate consent form will need to be
signed for this procedure, which describes the actual placement of the device in
detail. This catheter will stay in place throughout your transplant, approximately
1 to 2 months (longer if there is a continued need for the catheter). It will be used
for drawing blood, receiving blood products and IV medications, and for
transplanting the cord blood units.

Conditioning Therapy: This is the chemotherapy portion of your treatment. It
consists of two intravenous medications, given through the intravenous catheter,
and radiation therapy treatments. The information below will use a negative
symbol in front of each day that is before your transplant.
o You will receive the drug, fludarabine, IV for three days (Days –6,-5,-4)
before your transplant.
o You will receive the drug, cyclophosphamide, IV for two days (Days –5,4) before your transplant.
o You will receive radiation therapy treatments, called total body radiation
(TBI) twice daily for three days (Days-3,-2,-1) and once on the morning of
your transplant day (Day 0).
Both these drugs and the TBI are given to help destroy your cancer, as well as
suppress your immune system to allow the cord blood cells to survive and
reproduce.

Immunosupression Therapy: Starting 3 days before your transplant and every
day for 6-9 months after your transplant, you will receive the drugs tacrolimus
and mycophenolate mofetil (MMF). You will take both of these drugs either by
mouth or by IV through the intravenous catheter twice daily. If you vomit a pill
right after taking it, the dose will be repeated. These drugs are used to prevent
graft versus host disease (GVHD), a serious complication of transplantation. You
will be taking these drugs for several months after the transplant.
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Infusion of Cord Blood Units: After you complete your conditioning therapy
(chemotherapy and radiation treatments), you will have your transplant. Each
cord blood unit will be thawed and washed in our laboratory and given to you
through your central venous catheter. The cord blood units will be given to you
2-5 hours apart. To help with cell count recovery (return of cell counts to
normal), you will be given the medication G-CSF starting on day five after your
transplant, until your white blood cells recover. G-CSF is a growth factor that
will be used to speed up the recovery of white blood cells after your transplant.

Parathyroid Hormone: Starting on Day 1 after your transplant, you will receive
PTH daily through several injections just under the skin (“subcutaneous”
injection). PTH is given to help aid engraftment and to help re-strengthen the
immune system.
o The dose you take on Day +1 will be increased on Day +2, and again for
Day +3. Once established, the dose will remain the same from Day +4 to
Day +29.
o PTH will initially be given in the hospital. If you are discharged and still
need PTH, you can come to the outpatient clinic to receive the injection,
or you may take it at home with the help of a visiting nurse or a family
member. You and/or a family member will be trained in the technique of
subcutaneous injection.

Supportive care/transfusions: You will be treated with antibiotics to prevent
infection. You may receive transfusions of red blood cells (blood cells that carry
oxygen) and platelets (blood cells that prevent bruising and bleeding). After you
recover from the transplant, you will have repeat CT scans and x-rays, along with
bone marrow aspirates and biopsies to assess your cancer. Often these tests are
done as routine care after transplant.
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Blood Tests: You will have blood drawn frequently (about 3 tablespoons per day)
to test whether your donor’s immune cells have engrafted or taken in your system.
Blood levels of tacrolimus will also be checked frequently.
Optional Research
As an optional part of this research study, we are asking if you will allow us to draw
some additional blood to study changes in the immune system after transplant. If you
agree, about 4 teaspoons of blood will be taken at 5 different times: once before
transplant; at 4 weeks; at 100 days; at one year; and at two years after transplant. If you
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decide you do not want to participate in this optional part of the study, you can still take
part in the main study.
HOW LONG WILL I BE IN THE STUDY?
The average hospital stay for cord blood transplant is 5-6 weeks, but if a complication
develops, you could be hospitalized for longer. You will start receiving study treatment
medication about 6 days before your cord blood transplant, and continue for at least an
additional 6-9 months after your transplant.
Follow-up visits will continue every 6 months after your last treatment dose, for up to 2
years. Then they will be scheduled yearly. After that you will be contacted periodically
to see how you are doing.
What Are the Risks or Discomforts of the Study?
There are risks to taking part in clinical trials. All chemotherapy drugs have side effects,
which can be anything from mild and reversible to severe, long-lasting and possibly life
threatening. Since most anticancer drugs cause the rapidly dividing cancer cells in your
body to slow down, these drugs can also cause other rapidly dividing cells in your body
to slow down. These include the blood cells that help to fight infection (white blood
cells), the blood cells that help the blood clot (platelets) and the blood cells that carry
oxygen in your body (red blood cells). If your blood cell counts fail to recover you may
require transfusions, hospitalization, and treatment with antibiotics. Any of these
problems can be serious, life threatening, or fatal.
Other common side effects of chemotherapy are hair loss, mild to moderate nausea,
vomiting, and loss of appetite. Anti-nausea medications can be prescribed to help relieve
your symptoms. Many people on chemotherapy experience loose stools or diarrhea.
There may also be other side effects that we cannot predict, because cord blood
transplantation is relatively new. Side effects may be mild or very serious.
You may receive other drugs to make side effects less serious and to make you more
comfortable. Some side effects can be long lasting and may never go away and may be
fatal. It is very important that you talk to your doctor about any side effects you have.
Since there could be unknown side effects caused by taking one of the study drugs in
combination with other drugs, it is important that you tell the study doctor about any
prescription and/or over-the counter drugs, herbal prescriptions, and nutritional
supplements you are taking.
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A significant risk of taking part in this study may be receiving medications and the
transplant, which may not be effective in helping to treat your disease. This means that
you may spend time and have side effects from taking a drug that will not help treat your
disease.
Risks Related to the PTH Treatment:
Parathyroid Hormone (PTH)—Teriparatide
Frequent
(Chance of 10-50% that this will happen)
Pain at the site of the injection
Joint Pain
Muscle Aches
Frequent Urination
Heartburn
Fever
Occasional
(Chance of less than 10% that this will happen)
Low Blood Pressure
Elevated Calcium Level, which may cause fatigue and confusion
Rare
(Chance of less than 1% that this will happen)
Headache
Shaking Chills
Abnormal Heart Rhythm
In pre-clinical studies involving PTH taken for two years, there have been reports of bone
cancers (sarcomas).
Risks related to chemotherapy, GVHD preventive medications, and cord blood
transplantation
Cyclophosphamide
Cyclophosphamide is a chemotherapy drug, which will be given during your conditioning
regimen. Side effects include:
Common risks of cyclophosphamide
(More than 10% chance
that this will happen)
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Nausea and vomiting; drugs will be used to relieve these symptoms.
Hair Loss
Suppression or destruction of normal bone marrow cells and low blood counts
leading to infection or bleeding
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
Cyclophosphamide can impair the ability of men and women to conceive
children, and cause women to go into early menopause. This is discussed in
more detail in the Fertility and Reproductive Risks section later in this
consent document.
Rare risks of cyclophosphamide
(Less than 10% chance that this
will happen)
 Damage to the heart muscle (cardiac necrosis) and heart failure
 Bladder inflammation and bleeding: We will take steps to try to protect your
bladder from cyclophosphamide damage.
 You will be asked to drink a large amount of liquid before each
cyclophosphamide dose and to empty your bladder frequently for 2 days after
each dose.
 You will be given a drug (Mesna) to protect your bladder.
 A possible side effect of the need of staying well hydrated during
cyclophosphamide therapy is fluid retention, but that is usually temporary.
Fludarabine
Fludarabine is a chemotherapy drug, which will be given during your conditioning
regimen. Side effects include:
Likely
(Chance of more than 50% that this will happen)
 A general feeling of uneasiness or discomfort (malaise).
 Fatigue
 An abnormal loss of appetite that can cause significant weight loss (anorexia).
Frequent
(Chance of 10-50% that this will happen)
 Nausea and Vomiting
 Weakness
Occasional
(Chance of less than 10% that this will happen)
 Infections in subjects with low white blood cell counts, which rarely can be fatal.
 Low platelets can result in severe bleeding and can rarely be fatal.
Rare
(Chance of less than 1% that this will happen)
 Toxicity to your central nervous system including brain inflammation, seizures,
coma and blindness is rare, and your doctor will observe you closely.
 Rarely heart, kidney, or lung damage may occur. You will be monitored closely
for this and treated by your doctor.
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Total Body Irradiation (TBI):
Total body irradiation is given as part of the conditioning regimen to suppress your
immune system and kill cancer cells.
Common risks of TBI
happen)
 Nausea
 Diarrhea
 Hair loss
 Swelling of neck glands
 Infertility
 Cataracts (eye problems)
(More than 10% chance this will
Less frequent risks of TBI
(Less than 10% chance that will
happen)
 Suppression of the thyroid gland (hypothyroidism), causing fatigue and weight
gain. This can be treated by taking a pill or thyroid hormone.
 Lung Damage
 Kidney Damage
G-CSF (Neupogen)
G-CSF is given starting the fifth day after your transplant. It will continue until your
white blood cells engraft . The G-CSF is given to speed engraftment, which can be
delayed after cord blood transplant. G-CSF can be given either IV or as an injection
under the skin. Side effects, which may be treatable, include:
Frequent
(10-50% Chance this will happen)
 Flu-like symptoms, such as muscle aches, bone pain, nausea and headache
Occasional
(Less than 10% chance this will
happen)
 Blood vessel swelling
 Fever
 Nausea
 Enlarged spleen, which may cause discomfort in the stomach (abdomen)
 Abnormal liver function tests, which may be a sign of liver damage.
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Tacrolimus (FK-506)
Tacrolimus is an immunosuppressive drug, given as a pill or intravenously to prevent
graft versus host disease.
Likely
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(Chance of more than 50% that this will happen
Tremor (shaking)
High blood pressure (hypertension)
Weakened immune system which might lead to infection
Frequent
(10-50% chance that this will happen)
 Kidney damage which is mild and reversible
 Nausea and vomiting
Occasional
(Chance of less than 10% that this will happen)
 Headache
 Diarrhea
 Rash
 Neuropathy (inflammation of the nerves)
 Low potassium and magnesium levels, which may cause muscle cramps.
Rare
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(Chance of less than 1% that this will happen)
Low blood counts, which can lead to infection
High blood sugars
Severe kidney damage, requiring dialysis
Your blood level of tacrolimus will be monitored to make sure the drug is being
administered in the right dose for you.
Mycophenolate Mofetil (MMF)—Cellcept
MMF is an immunosuppressive drug, given as a pill or intravenously to help prevent
graft versus host disease.
Common Side Effects
(>10% Chance this will happen)
 Stomach Upset
 Fluid Retention
 Increased risk of infection
 Nausea
 Damage to unborn baby
 Limited effectiveness of birth control
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Less Likely Side Effects
 Kidney Injury
 Liver Injury
(<10% chance this will happen)
The combination of tacrolimus and MMF can lead to severe suppression of the immune
system and infections, including life threatening infections such as pneumonia, and
fungal infections.
Reproductive Risks:
The treatment used in this study may cause unforeseeable risks to pregnant women or to
unborn babies. Because of the known or unknown side effects of this drug on pregnant
women, fetuses, newborn children, and sperm, women who are pregnant or breastfeeding and men who are seeking to father children, should not be part of this study.
Women must:
 Have a negative pregnancy test before they start taking the medication,
and agree to avoid becoming pregnant while taking it (i.e. through use
of an effective contraceptive), and immediately inform their doctor
should they become pregnant. Treatment will be stopped until the
child is delivered or the pregnancy is terminated.
Men must:
 Agree to use an effective contraceptive to avoid impregnating a
woman and
 Immediately inform their doctor should they impregnate a woman.
Risk of Transplantation:
Specific Risks related to Sequential Unrelated Cord Blood Transplantation:
Death
The risks of treatment-related death are related to subject age. It cannot be predicted
what the risk of death of this particular protocol is, but experience with other cord blood
transplantation studies suggest that the risk of death can be as high as 30%.
Graft failure is a risk with any donor stem cell transplant, in which the transplanted stem
cells fail to grow or are lost over time. Graft failure can lead to serious infections. There is
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an increased risk of graft failure (about 10-15 % risk) with cord blood transplants. The risk
of graft failure may be higher because you are receiving two cord blood units. The risk of
graft failure may be less or greater because you are receiving PTH. The possible reasons for
graft failure are:
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There may be an increased risk of graft failure due to the genetic differences
between you and your cord blood donors.
The cord blood units may cause immune damage (graft versus graft disease).
Procedures used in the transplant to suppress your immune system may also increase
the risk of graft failure.
If you do not engraft donor cells, you may need another transplant. It will not be
possible to go back to the same cord blood donor for more donor cells. Infection,
bleeding, or death may occur.
As a result of the treatment, your blood counts will be low for an extended period of time
before recovery occurs, increasing the chance of developing a serious infection or bleeding.
In addition, the risk of infection, including life-threatening infections such as pneumonia,
bacterial, fungal, viral, and other infections are more likely in patients who have received
cord blood transplants. Since double cord blood transplantation is a new therapy, there may
be other unknown risks.
Graft Versus Host Disease (GVHD)
It is likely you will develop some GVHD, which is an immune complication of
transplant. The risk increases with the degree of genetic dissimilarity between the donor
and recipient, and in older subjects. The risk of GVHD may be higher because you are
receiving 2 cord blood units. It is possible that the use of PTH may increase or decrease
the risk of GVHD.
Acute GVHD may occur during the first 100 days following transplantation and is
usually associated with:
 Diarrhea
 Abnormal liver function tests, which may be a sign of liver failure
 Skin rash
 Any combination of above symptoms
These symptoms can be either mild or severe.
Another more serious side effect of GVHD may be injury to your bone marrow and blood
cell production.
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Chronic GVHD usually occurs after 100 days and can have symptoms similar to acute
GVHD. It could also involve other organs (lungs, joints, eyes, and/or mouth for
example). The risk of chronic GVHD may be higher because you are receiving 2 cord
blood units. If you develop chronic GVHD, you may experience:
 Dryness and irritation of the eyes
 Joint pain and stiffness
 Toughening of the skin
 Inflammation of the lungs, which may cause shortness of breath
GVHD is usually treated with steroids, such as prednisone, as well as tacrolimus. Most
cases of GVHD can be successfully treated; however, acute or chronic GVHD can be
fatal. If you develop severe GVHD, you may require continued therapy with tacrolimus
or corticosteroid medications and possibly the addition of other drugs to suppress your
immune system.
Secondary Cancers
Second malignancies (cancers), including treatment-related lymphoma and leukemia can
occur after bone marrow or cord blood transplantation. These can be successfully
treated, but in some cases may be fatal.
Organ Failure
Transplantation is sometimes associated with risks of organ failure, such as damage to the
liver, lung, or kidney. Organ failure may be fatal. Transplantation can affect the brain,
heart, kidney, lung, liver, or other body parts.
Risks of Transfusions
Side effects very likely to occur following the transfusions of blood products (platelets,
red and white blood cells, for example) may include:
 Fevers and chills
 Allergic reactions
Serious side effects less likely to occur may include:
 Infection such as hepatitis or rarely HIV or other infection
 Shortness of breath
Risks of Central Venous Catheter
Side effects likely to occur may include:


Bleeding
Infection
Less likely, but serious side effects may include:
 Collapse of lung if there is needle injury during placement
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
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Excessive bleeding
Injury to the subclavian vein or carotid artery ( large blood vessels in the neck)
during placement
In the case of major bleeding or collapse of the lung, a chest tube might have to be
inserted into the chest cavity to drain air or blood out.
Risks of Bone Marrow Aspiration and Biopsy
Side effects very likely to occur may include:
 Pain at the site of the injections of the local anesthetic
 Temporary pain/pressure when the bone marrow is aspirated into a syringe
 Bruising at the site of the bone marrow needle insertion
A side effect less likely to occur, but serious, is a local infection. If you would like you
may receive medications to reduce pain prior to the bone marrow test.
Risk of Diagnostic Radiation Testing
Standard diagnostic testing (x-rays, CT scans, nuclear medicine tests) will be used during
this study to follow your disease. The radiation exposure from these tests will not harm
you or affect the treatment of your disease.
Long-Term Risks
Long-term risks include late infections, second cancers, and chronic graft versus host
disease as mentioned earlier in this consent form.
What Are The Benefits of the Study?
If you agree to take part in this study, there may or may not be direct medical benefit to
you. We hope the information learned from this study will benefit others who will
undergo stem cell transplantation in the future.
Potential benefits of this treatment may be better control of your cancer. In addition,
others may benefit from the increased knowledge that the doctors may gain because of
your participation in this study. The use of PTH may speed engraftment and decrease the
risk of infection after cord blood transplant. However, there is no guarantee that this will
occur.
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CAN I STOP BEING IN THE STUDY AND WHAT ARE MY
RIGHTS?
Yes. Taking part in this study is your choice. You can stop at any time. Tell the study
doctor if you are thinking about stopping or decide to stop. He or she will tell you how to
stop. Another reason to tell your doctor that you are thinking about stopping is to discuss
what follow-up care and testing could be most helpful for you. However, leaving the
study and not receiving the cord blood transplant after you have received the
chemotherapy drugs may cause you to become very sick or to die. You can still get your
medical care from your hospital or doctor. We will provide you with any new
information that may affect your willingness to continue to take part in this study.
If you do change your mind about taking part in this study, please let us know. You have
the right to withdraw your permission for the use of your study information. This
information will be removed unless we have already used it or if it becomes important for
us to have a record of the people who start the study, not just those who finish it. If you
decide to withdraw this permission, please do so in writing. Once you withdraw from the
study, we will not collect new information about you.
The study doctor may decide to remove you from this study without your permission for
many reasons:




If you do not follow the study requirements
If the study procedures are found to be unsafe
If the study procedures are found to be ineffective
If you experience severe side effects
If you are removed from the study, the study doctor will explain to you why you were
removed. The study doctor and research team will help arrange for your continued care.
WHAT ARE THE COSTS?
If you decide to participate in this study, there may be additional costs to you or your
insurance company. Your insurance company will be contacted for approval prior to the
transplant. Before your enrollment in the study, the study doctor will help you to
determine whether or not your insurance company will cover the costs associated with
your participation in this study. If your insurance company does pay for the care you
receive as part of this study, you will still be responsible for any normal co-payments or
deductibles that are standard for your insurance plan. If your insurance company does
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not cover portions of the care you receive as part of this study, you may be asked to pay
for those expenses.
You or your insurance company will be charged for any other portion of your care that is
considered standard care. You may be responsible for any co-payments and deductibles
that are standard for your insurance coverage.
If you have any questions about your insurance coverage or the items you might be
required to pay for, please call financial services for information. The contact
information for financial services:




Dana Farber Cancer Institute: 617-632-3455
Beth Israel Deaconess Medical Center: (617) 667-5661
Massachusetts General Hospital: 617-726-2191
Brigham and Women’s Hospital: (617) 732-5524 or (617) 732-7485
The National Cancer Institute provides an online resource to help people participating in
cancer clinical trials understand which services their insurance company is required by
law to pay. This can be found at the website below.
http://www.cancer.gov/clinicaltrials/learning/insurance-coverage
WHAT HAPPEN IF I AM INJURED OR SICK BECAUSE I
TOOK PART IN THIS STUDY?
We will offer you the care needed to treat injuries directly resulting from taking part in
this research. We may bill your insurance company or other third parties, if appropriate,
for the costs of the care you get for the injury, but you may also be responsible for some
of them.
There are no plans for DF/HCC to pay you or give you other compensation for the injury.
You do not give up your legal rights by signing this form.
If you think you have been injured as a result of taking part in this research study, tell the
person in charge of this research study as soon as possible. The research doctor’s name
and phone number are listed in this consent form.
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WHO IS FUNDING THIS STUDY?
The National Institutes of Health (NIH) is providing partial funding of this research
study. This means that the Dana-Farber/Harvard Cancer Center is receiving payments
from NIH to support the activities, such as analysis of research results, which are required
to conduct the study.
You will receive no payment for taking part in this study.
WHAT ABOUT CONFIDENTIALITY?
We will take measures to protect the privacy and security of all your personal
information, but we cannot guarantee complete confidentiality of study data.
Medical information created by this study may become part of your hospital medical
record. Information that does not become part of your medical record will be stored in
your study file. It may also become part of a DF/HCC research database called CORIS.
Information contained in your records is used by study staff and in some cases it will be
shared with the NIH. If your information is being shared with NIH, no information that
could identify you will be given to the NIH. Occasionally, an NIH representative may
come to the study site to review your study files. This person will never take any
information that can identify you back to the NIH. There may be times when we are
required by law to share your information. In those cases, we do not need your
permission.
The results of this study may be published. You will not be identified in any publication
without your permission.
WHO DO I CONTACT IF I HAVE QUESTIONS ABOUT THE
STUDY?
You are encouraged to ask questions about the study or your role as a participant at any
time. For questions about the study or a research-related injury, contact:
MGH:
DFCI:
BIDMC:
Karen K. Ballen, M.D.
Joseph Antin, MD
David Avigan, MD
617 724-1124
617-632-3903
617-667-9820
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For questions about your rights as a research participant, please contact a representative
of the Office for the Protection of Research Subjects at DFCI (617) 632-3029. This can
include questions about your participation in the study, concerns about the study, a
research related injury, or if you feel/felt under any pressure to enroll in this study or to
continue to participate in this study.
PRIVACY OF PROTECTED HEALTH INFORMATION
Federal law requires Dana Farber/Harvard Cancer Center (DF/HCC) and its affiliated
researchers, health care providers, and physician network to protect the privacy of
information that identifies you and relates to your past, present, and future physical and
mental health conditions (“protected health information”). If you enroll in the research
described in this consent form, your “protected health information” will be used and
shared with others as explained below.
1. What protected health information about me will be used or shared with
others during this research?


Existing medical records
New health information created from study-related tests, procedures,
visits, and/or questionnaires
2. Why will protected information about me be used or shared with others?
The main reasons include:
 To conduct and oversee the research described earlier in this form;
 To ensure the research meets legal, institutional, and accreditation
requirements; and
 To conduct public health activities (including reporting of adverse events
or situations where you or others may be at risk of harm)
 Other reasons may include for treatment, payment, or health care
operations. For example, some medical information produced by this
study may become part of your hospital medical record because the
information may be necessary for your medical care. (You will also be
given a notice for use and sharing of protected health information).
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3. Who will use or share protected health information about me?

DF/HCC and its affiliated researchers and entities participating in the
research will use and share your protected health information. In addition,
the DF/HCC review board that oversees the research at DF/HCC and its
affiliated staff who have a need to access this information to carry out
their responsibilities (for example, oversight, quality improvement, and
billing) will be able to use and share your protected health information.
4. With whom outside of DF/HCC may my protected health information be
shared?
All reasonable efforts will be made to protect the confidentiality of
your protected health information, which may be shared with the
following others for the reasons noted above:




Outside individuals or entities that have a need to access this information
to perform functions on behalf of DF/HCC and its affiliates (for example,
data storage companies, insurers, or legal advisors).
Federal and state agencies (for example, the Department of Health and
Human Services, the Food and Drug Administration, the National
Institutes of Health, and/or the Office for Human Research Protections), or
other domestic or foreign government bodies if required by law and/or
necessary for oversight purposes.
Hospital accrediting agencies
A data safety monitoring board organized to oversee this research
Some who may receive your protected health information may not have to
satisfy the privacy rules and requirements. They, in fact, may share your
information with others without your permission.
5. For how long will protected health information about me be used or shared
with others?

There is no scheduled date at which your protected health information that
is being used or shared for this research will be destroyed, because
research is an ongoing process. Research information may be analyzed
and re-analyzed in light of scientific and medical advances, or reviewed
for quality assurance, oversight or other purposes.
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6. Statement of privacy rights:



You have the right to withdraw you permission for the researchers and
participating DF/HCC entities to use or share your protected health
information. We will not be able to withdraw all the information that
already has been used or shared with others to carry out related activities
such as oversight, or that is needed to ensure quality of the study. If you
withdraw your permission, you must do so in writing by contacting the
researcher listed as the Study Contact.
You have the right to choose not to sign this form. If you decide not to
sign this form, you cannot participate in this research study. However,
refusing to sign will not affect your present or future care and will not
cause any penalty or loss of benefits to which you are otherwise entitled.
You have the right to request access to your protected health information
that is used or shared during this research and that is related to your
treatment or payment for your treatment, but you may access this
information only after the study is completed. To request this information,
please contact the researcher listed under Study Contacts on the consent
form.
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Use of Specimens
Cells, blood and other specimens pertaining to your illness and this study may be useful for
scientific research or teaching purposes. Occasionally, laboratory research on human blood,
tumors, or other tissue may result in discoveries that become the basis for new products. There
are no plans to reimburse you should there be commercial developments made with, or through
the use of your specimens. To maintain subject confidentiality all cells, blood, or other
specimens used for scientific, teaching, or research purposes will be identified by a code number
only. The cells, blood, or other specimens may be kept indefinitely. They will be stored in a
locked laboratory facility. You have the right to remove them from storage at any time, by
contacting the Principal Investigator, Dr. Karen Ballen at 617-724-1124.
Consent for Optional Research Studies
As part of this research study, we would like to ask your permission to draw some additional
blood to study changes in the immune system after transplant. If you agree, about 4 teaspoons of
blood will be taken at the time of your other blood tests at 5 different time points (pre transplant,
4 weeks, 100 days, 6 months, and one year) after transplant. In addition, we would also study the
discard (waste) from the thawed cord blood units. You do not have to participate in the optional
research studies to take part in this cord blood transplant study.
_______I wish to donate blood for optional research studies
_______I do not wish to donate blood for optional research studies.
__________________ Subject’s Initials
____________________Date
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Documentation of Consent
My signature below indicates my willingness to participate in this study and my
understanding that I can withdraw at any time.
Subject
Date
To be completed by person obtaining consent:
The consent discussion was initiated on
(date) at
(time.)
A copy of this signed consent form will be given to the subject or legally authorized
representative, or, where the subject is a minor, the subject’s parent or legal guardian.
For Adult Subjects
The subject is an adult and provided consent to participate.
The subject is an adult who lacks capacity to provide consent and his/her legally
authorized representative:
gave permission for the adult subject to participate
did not give permission for the adult subject to participate
Signature of Individual obtaining consent:
Printed name of above:
Date:
Updated 01/14/2008
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