Consent to Participate in a Research Study
Pharmacokinetics (PK) of Botulism Antitoxin Heptavalent (A, B, C, D, E, F, G) –
(Equine) (BAT™) in pediatric patients with a confirmed or suspected exposure to
Botulism Toxin.
Sponsor:
Cangene Corporation (doing business as Emergent
BioSolutions)
Protocol Number: BT-011
Version 1.2 dated December 16, 2013
Principal
Investigator:
D. Ronald Goldwater, MDCM, M.Sc., CPI
Parexel Baltimore Early Phase Clinical Unit
Harbor Hospital - 7th Floor, 3001 South Hanover St
Baltimore, MD 21225
24 Hour Telephone Number:
(667) 210-5300
If you are a parent/guardian please note that “you” or “your” refers to the study subject,
which is your child.
You are being asked to take part in this study because you were or will be treated with a
licensed drug called BAT™, an antitoxin, for the treatment of your disease. For anybody that is
receiving this product, safety information is being collected about product use. This paper will
tell you about the study procedures and your rights as a research participant. This consent
form may have words that you do not understand. Please ask the study doctor or study staff to
explain any words or information that you do not clearly understand. If you agree to take part in
this research study, you must read and sign this informed consent form before any study
procedures take place. A signed and dated copy of the informed consent will be given to you to
keep. Your participation in this study is voluntary. Refusal to participate will not result in any
penalty or affect your medical treatment.
1
NATURE AND PURPOSE OF THE STUDY
This study is about testing your blood sample to find out how much of the drug (called BAT™)
is still in your blood after you are given it. BAT™ is used in the United States and is licensed by
the Food and Drug Administration (FDA). The sole purpose of this study is to collect a onetime blood sample to help the sponsor (Cangene Corporation doing business as Emergent
BioSolutions) confirm that the doctors are using the safest amount of drug in children. You will
be asked to give one 5 mL (one teaspoon) blood sample within 24 hours after getting the drug
BAT™. The sample taken for testing will be destroyed once test results have been confirmed
and accepted and the final clinical study report has been signed.
Protocol Number: BT-011
ICF Version 2.0 Dated: October 10, 2014
Subject Initials: _______
Page 1 of 7
APPROVED
September 15, 2015
Aspire IRB
This study has been approved by the FDA and Independent Review Board(s) (IRB)
representing your hospital. An IRB is an independent group that reviews and approves the
study. The IRB makes sure that the rights, safety and well-being of the study participants are
protected at the site where the study is taking place.
This PK study is designed to enroll at least 10 children under the age of 17 years over a 3 year
period. This study is open to all health care centers within the US involved in the treatment of
pediatric patients who are treated with this drug (BAT™).
2
NATURE OF THE DRUG
Botulism toxins are produced by bacteria called Clostridium botulinum. The toxins stick to
nerve endings and break up nerve impulses which can paralyze muscles. BAT™ is an
antitoxin that specifically works against toxins and is used to treat botulism following exposure.
BAT™ is not expected to undo paralysis in botulism patients but instead cut down the severity
and prevent your symptoms from getting worse.
3
ALTERNATIVE TREATMENT
In the United States there are two available licensed products to treat botulism BabyBIG® and
BAT™. BabyBIG® is a product used to treat only infant botulism (less than one-year of age) for
two types of botulism toxin. BAT™ works to treat seven types of botulism toxin in children and
adult patients. The doctor has decided that the drug BAT™ will work the best to treat you. Feel
free to talk about these treatment options with the doctor.
The reason for this study is to test your blood sample to find out how much drug (BAT™) is in
your blood after you are given the drug. You do not have to give us a blood sample. If you do
not want to take part in this study, it will not affect your medical treatment and care.
4
ELIGIBILITY
To be able to take part in this study you must be less than 17 years old, and have received
BAT™ due to a confirmed or suspected diagnosis of botulism.
5
PATIENT RESPONSIBILITIES
You will be asked to give us one 5 mL (one teaspoon) blood sample within 24 hours of getting
the drug (BAT™).
6
RISKS AND DISCOMFORTS
Some known risks, although rare, are linked with placing a needle into a vein. It is possible to
get an infection, the needle may tear a vein and there could be bleeding, pain, or bruising at
the site where they draw blood.
The blood draw may have risks which are currently unknown or unforeseen. If you experience
any adverse reaction or notice any unusual sign or symptom you must tell the study doctor
immediately.
Protocol Number: BT-011
ICF Version 2.0 Dated: October 10, 2014
Subject Initials: _______
Page 2 of 7
APPROVED
September 15, 2015
Aspire IRB
7
BENEFITS
Taking part in this study may not give you any direct medical benefit. However, your blood
sample will help Cangene Corporation (doing business as Emergent BioSolutions) to find the
best dose for children who received the drug BAT™ for the treatment of botulism.
Use of your blood sample may give Cangene Corporation (doing business as Emergent
BioSolutions) important dosing information for use in treating future patients. You will be given
a 24-hour phone number to call in case you have any symptoms or concerns.
8
CONFIDENTIALITY OF MEDICAL RECORDS
Your diagnosis and treatment history will be recorded for study purposes. Medical records that
contain your identity will be treated as confidential according to the applicable laws. In addition
to the medical staff who are taking care of you, representatives of the sponsor, Cangene
Corporation (doing business as Emergent BioSolutions), will review/copy medical information
that may reveal your identity. Regulatory authorities such as Centers for Disease Control and
Prevention (CDC), Aspire IRB and the FDA may also review/copy your medical records
according to the applicable laws and regulatory requirements. Therefore, absolute
confidentiality cannot be guaranteed. If the results of the trial are published, your identity will
remain private. Personal information such as your name, address, telephone number and/or
any other identifying information will not be made public. By signing this Informed Consent
Form, you are granting direct access to these records.
9
AUTHORIZATION TO USE AND DISCLOSE PROTECTED HEALTH INFORMATION
By signing this document, you are allowing the study doctor and study staff to collect and use
your personal health information needed to carry out this study. Information collected will
include your initials, date of birth, gender, date of treatment and details about the cause and
treatment. Your personal health information includes medical history, blood samples, results
from laboratory analysis and procedures, physical examinations, and any other data collected
during the study. In addition, the study doctor may obtain, and include in your records
information regarding your past, present and/or future physical or mental health and /or
condition, such as medical records from your primary care doctor. Your health record will also
contain personal information including your name, address, telephone number, date of birth,
social security number, race or unique identifiers.
The sponsor of this study (Cangene Corporation (doing business as Emergent BioSolutions)
will keep this personal health information for up to 25 years after the study is completed as per
Health Canada requirements.
Medical records that contain your identity will be kept private. Despite efforts to keep your
personal information private, this privacy cannot be guaranteed. Your personnel information
may be disclosed if required by law.
By signing this document, you agree to allow representatives of the sponsor (Cangene
Corporation), ethics committee such as Aspire IRB and regulatory authorities such as the
Ministry of Health, the FDA direct access to your personal health information at the study site.
The reason for this access is to allow the review of data and to assure the quality of the study
conduct and / or the data collected.
Protocol Number: BT-011
ICF Version 2.0 Dated: October 10, 2014
Subject Initials: _______
Page 3 of 7
APPROVED
September 15, 2015
Aspire IRB
All records will be kept in a secure area and only those persons identified will be able to see
these records. The study staff will assign a patient identification number and your initials to
your records, which means that you will not be identified in the records sent to the sponsor. If
any of your medical/research records need to be copied to any of the above, your name and all
identifying information will be removed and replaced with your patient identification number
and initials.
Information gathered in this research study may be published, presented in a public forum, or
presented to regulatory authorities. Your study number and initials in these documents may
identify you.
You have a right to see and make copies of your medical record. However, by signing this form
you are agreeing not to see or copy your medical record until the sponsor has completed all
work related to this study. At that time, you may ask to see your records. If you do not give us
this authorization, you will not be able to take part in the research study. If you take back your
consent, then you will be withdrawn from the study.
There is a risk that your information will be given to others without your permission. These
other persons and/or organizations may or may not have the same obligations as the study
doctor or institution to protect your Protected Health Information.
You may take back/cancel your consent for access to your Personal Health Information at any
time by telling the study doctor. The contact details are on page 1 of this consent form.
However, any information that may have already been collected prior to your cancellation will
be used for the purpose of this study. Protected Health Information collected after your
cancellation may not be used in the study.
This study is registered on http://www.ClinicalTrials.gov as required by U.S. Law. You will find
a description of the study related aspects on this website. This website will not include
information that can identify you. At most, the Web site will include a summary of the results.
You can search this Web site at any time.
10
COMPENSATION
You will not receive any payment or be reimbursed in any way for taking part in this study.
If you are hurt or become ill as a result of participation in this study, contact the study doctor
immediately. Emergency medical treatment will be provided by the study doctor. Your
insurance will be billed for such treatment. No other compensation is routinely available from
the study doctor or sponsor. By signing this consent form, you will not give up any legal rights.
11
EXPENSES
There are no costs to subjects participating in this study
12
WITHDRAWAL FROM THE STUDY
Your participation in this study is completely voluntary. You may refuse to participate or
withdraw from this study at any time without giving a reason. However, any information already
collected prior to withdrawal will still be used. Your decision not to participate or to withdraw
from this study will not in any way affect your medical treatment.
Protocol Number: BT-011
ICF Version 2.0 Dated: October 10, 2014
Subject Initials: _______
Page 4 of 7
APPROVED
September 15, 2015
Aspire IRB
Your doctor, the study Sponsor [Cangene Corporation (doing business as Emergent
BioSolutions)], the IRB, CDC or the FDA may decide to withdraw you from the study if it is in
your best interest or if you are unable to meet the requirements of the study or if the study is
cancelled.
Please ask questions about any and every part of this study that you do not understand before
you sign this consent form. If you withdraw from the study for whatever reason you cannot be
re-entered, but this will not affect you in any other way.
13
PERSON(S) TO CONTACT TO REPORT ANY PROBLEMS OR TO OBTAIN
FURTHER INFORMATION
If you develop any problems at any time during the course of the study, or if you have any
questions regarding this study, or in case of emergency, you can contact the study doctor
listed on page one of this document.
This study was reviewed by Aspire Independent Review Board (IRB). An IRB reviews research
to protect the rights and welfare of study participants. If you have problems, concerns,
suggestions, questions or information about the study, and for information regarding research
subject's rights, please call Aspire's Quality Assurance and Regulatory Compliance
Department at 1-877-366-5414 (toll free).
Although Aspire IRB has approved the information given in this informed consent form and has
granted approval for the investigator to conduct the study, this does not mean Aspire has
approved your participation in the study. You must think about the information in this informed
consent form for yourself and decide whether or not you wish to participate.
Protocol Number: BT-011
ICF Version 2.0 Dated: October 10, 2014
Subject Initials: _______
Page 5 of 7
APPROVED
September 15, 2015
Aspire IRB
Protocol Number and Title: Protocol No. BT-011, Title: Pharmacokinetics (PK) of Botulism
Antitoxin Heptavalent (A, B, C, D, E, F, G) – (Equine) (BAT™) in Pediatric Patients with a
Confirmed or Suspected Exposure to Botulinum Toxin.
STATEMENT OF INFORMED CONSENT
Centre Number:
Subject Identification Number: _____________
Name of Investigator: _____________________________
To be completed by the subject:
1.
2.
3.
4.
5.
6.
Please Initial Boxes

I confirm that I have read and understand the information sheet for
the above study.

I confirm that the study has been explained to my satisfaction and I
have had the time and opportunity to ask any questions. I know
whom to contact if any questions occur to me later.

I understand that my participation is voluntary and that I am free to
withdraw at any time without giving reason, without my medical care
or legal rights being affected.

I understand that sections of my medical notes may be looked at by
responsible individuals appointed by Cangene Corporation (doing
business as Emergent BioSolutions), ethics committees and
regulatory authorities where it is relevant to my taking part in the
study. I give permission for these individuals to have direct access to
my records.

By taking part in this study I agree to the transfer of my personal
data within Cangene Corporation (doing business as Emergent
BioSolutions) and to medicines regulatory authorities both within and
outside North America.

I agree to take part in the above study.
A copy of the signed and dated informed consent form will be given to you to keep.
Signature:
Date:
Printed name of above:
Signature of Witness (if applicable)
Date:
Printed name of Witness:
Protocol Number: BT-011
ICF Version 2.0 Dated: October 10, 2014
Subject Initials: _______
Page 6 of 7
APPROVED
September 15, 2015
Aspire IRB
I confirm that I have explained the purpose, duration etc. of this clinical trial, as well as any
potential risks and benefits, to the subject whose name and signature appears above. I confirm
that I believe that the subject has understood and has knowingly given their consent to
participate by his/her personally dated signature.
Signature:
Date:
Printed name of above:
Study role:
ALL SIGNATORIES MUST DATE THEIR OWN SIGNATURE
Protocol Number: BT-011
ICF Version 2.0 Dated: October 10, 2014
Subject Initials: _______
Page 7 of 7
APPROVED
September 15, 2015
Aspire IRB