INFORMED CONSENT TO PARTICIPATE IN A CLINICAL RESEARCH STUDY
Study Title:
Bone Marrow Collection from Healthy Donors for the Research Market
Sponsor:
LeukoLab
Protocol Number:
7000-SOP-046
Protocol Dates:
May 1, 2007
Version 2.0 dated November, 2007
Version 3.0 dated May, 2008
Version 4.0 dated March, 2011
Principal Investigator:
Mark
, MD
LeukoLab
5858 Horton Street, Suite 272
Emeryville, CA 94608
24-Hour Phone Number:
Medical Office of Sr. Stephen
Berkeley, CA 4705
510-539-1314
This consent form may contain words that you do not understand. Please ask a study doctor or
the study staff to explain any words or information that you do not clearly understand.
INTRODUCTION
I have been invited by Dr. Stephen
, Gallia
, Dr. Jason
, Dr. Mark
and Dr. Capecchi to donate bone
marrow for research purposes only. LeukoLab of Emeryville, California is the sponsor for this study. The investigators listed
above have no financial interest in LeukoLab but will receive a service fee.
PURPOSE
The purpose of this study is to provide bone marrow cells for distribution to Dr. Capecchi engaged in medical or
scientific research.
Protocol Number: 7000-SOP-046
Consent Date: May 21, 2008
IRB Approved
Subject Initials
Page 1 of 7
PROCEDURE
Bone marrow is the blood-forming organ of the body and is within bone in a great many places throughout the
body. A licensed physician or specially trained nurse will perform a bone marrow aspiration, a procedure to obtain
a small sample of bone marrow. The procedure will be performed on me as a volunteer at LeukoLab, 5858 Horton
Street, Suite 272, Emeryville CA 94608. I have been asked to donate:
[ ] 25 mL of bone marrow (approximately 2 tablespoons)
If I agree to participate, I will lie on my stomach with my head resting on my arms. The skin over one of my pelvic
bones will be thoroughly cleansed with antiseptic solution. Then, providing that I have no allergy to a local
anesthetic medication, a local painkiller called lidocaine, similar to the medication that dentists use, will be gently
injected through a very small needle into the skin overlying the upper back part of my hip bones (the posterior iliac
crest). Then the area is numb, a needle will be passed through the skin into the bone and a 25ml (approximately 2
tablespoons) sample of my liquid bone marrow will be drawn into a syringe by brief suction. The needle will then
be removed. Rarely, an additional puncture or punctures may be necessary due to insertion of the needle initially
into a “dry” or non-productive portion of the bone. After obtaining the targeted volume of bone marrow, a bandage
will be placed on the skin where the needles were inserted.
DURATION
Each needle will be in my hip bone for approximately 15-60 seconds and the entire procedure should take no
longer than 15 minutes, Following this, I should be able to return immediately to my normal daily activities.
POTENTIAL SIDE EFFECTS, RISKS AND DISCOMFORTS
The amount of bone marrow removed from my body is a tiny fraction of my total bone marrow; it will be replaced
by my body in a matter of hours, and its removal will in no way affect the normal function of the rest of my bone
marrow. Serious side effects are rarely seen with this common procedure. However, allergic reaction to the local
painkiller, minor skin bleeding and minor skin infection at the site of the needle insertion are possible.
In very rare instances, either during or shortly after the procedure, I may faint. Or, I may experience a sensation of
dizziness or lightheadedness which may be accompanied by nausea and clammy skin. If any such events occur, I
will be closely monitored, have my vital signs taken, given fluids to drink and will only be allowed to leave once all
my symptoms have resolved.
Protocol Number: 7000-SOP-046
Consent Date: May 21, 2008
Subject Initials
IRB Approved
Page 2 of 7
I may expect a mild to moderate degree of pain or discomfort during the short time that the marrow is
aspirated; this pain disappears shortly after the marrow is removed and rarely continues for a day or so.
I may also expect a sensation of soreness akin to that of a bruise at the needle site which usually resolves
within one week.
PREGANCY
I am not pregnant at this time and understand that, although there are no known risks to a pregnancy, the
doctors have decided not to place pregnant women at risk.
Right to Withdraw from the Study
My participation in this normal donor program is voluntary and I have the right to discontinue at any
time before or after commencement of the procedure.
MY RESPONSIBILITIES
I will be expected to arrive on time for my appointment.
Protocol Number: 7000-SOP-046
Consent Date: May 21, 2008
IRB Approved
Subject Initials
Page 3 of 7
BENEFITS
There will be no direct scientific or clinical benefit to me, nor will I gain any commercial or financial
rights from my participation in the donor program. LeukoLab will also financially compensate the
physician overseeing this procedure.
CONFIDENTIALITY
I am participating to this study as an anonymous donor. A unique number will be assigned to me and to
the product I donate, to protect my identity. It is possible that my identity may be revealed to the FDA or
other regulatory bodies in the event of positive results for infectious disease testing.
QUESTIONS AND MEDICAL TREATMENT
The doctors and/or nurses will answer any questions I might have regarding the procedure and related
questions. In the unlikely event of physical injury clearly related to the procedure, emergency medical
treatment will be provided at no cost to me. LeukoLab will be responsible for these costs. There is no
reimbursement offered for any other medical illnesses that are clearly not immediately related to the
procedure.
Protocol Number: 7000-SOP-046
Consent Date: May 21, 2008
Subject Initials
IRB Approved
Page 4 of 7
If I have questions regarding the consent process I may contact a member of the Institutional Review
Board:
For any other questions or concerns. I may contact the study physicians:
Dr. Stephen
Dr. Gallia
Dr. Jason
Dr. Mark
Dr. Capecchi
Protocol Number: 7000-SOP-046
Consent Date: May 21, 2008
Subject Initials
IRB Approved
Page 5 of 7
AUTHORIZATION
My signature below indicates that:
1.
2.
3.
I have read the above and agree to participate in the program described above. The general
purposes, particulars of involvement, possible hazards and inconveniences have been
explained to my satisfaction.
I have received a copy of the Experimental Subjects Bill of Rights form.
I understand that I will be given a copy of this consent form if I request it.
Donor Printed Name
Donor Signature
Date
Witness Printed Name
Witness Signature
Date
MD Signature
Date
MD Name
Protocol Number: 7000-SOP-046
Consent Date: May 21, 2008
Subject Initials
IRB Approved
Page 6 of 7
FOR CALIFORNIA RESIDENTS ONLY
EXPERIMENTAL SUBJECTS BILL OF RIGHTS
Any person who is requested to consent to participate as a subject in a research study involving a medical
experiment, or who is requested to consent on behalf of another, has the right to:
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
Be informed of the nature and purpose of the experiment.
Be given an explanation of the procedures to be followed in the medical experiment, and any drug
or device to be used.
Be given a description of any attendant discomfort and risks reasonably to be expected from the
experiment.
Be given an explanation of any benefits to the subject reasonably to be expected from the
experiment, if applicable.
Be given a disclosure of any appropriate alternative procedures, drugs, or devices that might be
advantageous to the subject, and their relative risks and benefits.
Be informed of the avenues of medical treatment, if any, available to the subject after the
experiment if complications should arise.
Be given an opportunity to ask any questions concerning the experiment or other procedures
involved.
Be instructed that consent to participate in the medical experiment may be withdrawn at any time,
and the subject may discontinue participation in the medical experiment without prejudice.
Be given a copy of a signed and dated written consent form when one is required.
Be given the opportunity to decide to consent or not to consent to a medical experiment without
the intervention of any element of force, fraud, deceit, duress, coercion, or undue influence on the
subject’s decision.
Printed Name of Subject
Protocol Number: 7000-SOP-046
Consent Date: May 21, 2008
Signature of Subject
IRB Approved
Date
Subject Initials
Page 7 of 7