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HREBA-CC Main ICF Template Final v2015_November
Protocol/Study #:
Version Date:
USE THE APPROVED LETTERHEAD FOR YOUR INSTITUTION
OFFICIAL TITLE OF PROJECT
(Lay title in non-technical Language such as A study to see whether treatment
A or treatment B is better for patients with cancer XXXX.)
CONSENT FORM
This form is part of the process of informed consent. It is designed to explain this research
study and what will happen to you if you choose to be in this study.
If you would like to know more about something mentioned in this consent form, or have any
questions at anytime regarding this research study, please be sure to ask your doctor or nurse.
Read this consent form carefully to make sure you understand all the information it provides. You
will get a copy of this consent form to keep. You do not have to take part in this study and your care
does not depend on whether or not you take part.
(IF the sponsor is a drug company)
This study is sponsored by (Pharmaceutical Company), the company that manufactures the drug
(drug name) to be used in this study. This study will take place at various centres throughout
Canada and the United States and the Cross Cancer Institute/Tom Baker Cancer Centre is one of
the centres. (The Sponsor) will reimburse Alberta Health Services for costs related to conducting
this study.
(OR IF the sponsor is a cooperative group) This study is being conducted by the Radiation Therapy
Oncology Group (RTOG) a cooperative oncology research group of which the Cross Cancer
Institute/Tom Baker Cancer Centre is a member. This study will take place at various centres
throughout Canada and the United States, and the Cross Cancer Institute/Tom Baker Cancer Centre
is one of the centres. (Pharmaceutical Company) which manufactures the drug (drug name) will
supply the drug for the study. Alberta Health Services will be reimbursed for research related costs.
(IF the patient's physician is part of the study team:) Your doctor, who is one of the researchers, will
discuss the study with you. (OR IF the patient's physician is not part of the study team:) Your doctor
has given us permission to ask you to be in this study.
Your participation in this study is entirely voluntary. Please take your time to make your
decision. It is recommended that you discuss with your friends and/or family about whether
to participate in this study.
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HREBA-CC Main ICF Template Final v2015_November
Protocol/Study #:
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“WHY IS THIS STUDY BEING DONE?”
You are being asked to take part in this study because you have (type of) cancer.
(All studies -- give specifics of what the standard treatment is, what its response rate is, and/or
effects and/or outcome, and why this study is worth doing and, if a drug is involved, what is different
about this drug compared to standard therapy? State what the experimental aspects of the study
are.)
This study is being done because___________.
(Explain in one or two sentences. Examples are: “Currently, there is no effective treatment for this
type of cancer,” or “We do not know which of these two commonly-used treatments is better.”)
“WHAT DO WE HOPE TO LEARN?”
We hope to learn (purpose).
The purpose of this study is to (see below)________________. (Ensure that you include the primary
and secondary objectives of the study.)
Describe what the phase of this study means.
(If Applicable)
(Phase I study): Test the safety of (Drug/Intervention) and see what effects (good and bad) it has on
you and your cancer.
OR
Find the highest dose of a (Drug/Intervention) that can safely be given without causing severe side
effects. In order to determine this dose, some patients on this study may experience severe side
effects.
(Phase II study): To find out what effects (good and bad) (Drug/Intervention) has on you and your
(type of) cancer.
(Phase III studies): To compare the effects (good and bad) of the (New Drug/Intervention)
with (commonly used Drug/Intervention) on you and your (type of) cancer to see which is
better.
“WHAT IS INVOLVED IN THIS STUDY?”
In this study, you may receive one of ____ treatments. You will be “randomized” to receive
one of the treatments described below. Randomization means the treatment that you are
assigned will be determined by chance. It is like flipping a coin. Randomization is done by a
computer. Neither you nor the researcher will choose which treatment you will be assigned.
You will have an (Equal/One in Three/Etc.) chance of being assigned to treatment A - Z. You
and your doctor will not be told which treatment you are receiving. (Only applies to double-
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HREBA-CC Main ICF Template Final v2015_November
Protocol/Study #:
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blind randomized studies) You will be followed to see what effect the treatment(s) has/have
on your health.
(It is easier for the patient to understand the treatment schema in either a table or flow chart.)
For Example
Day 1,
Treatment A
Treatment B
5-FU
CPT-11
Leucovorin
5-FU
CPT-11
Radiation Therapy
Day 5
X
Day 9
Day
11
Day
15
X
X
X
X
X
X
X
X
X
Day
17
X
X
X
X
X
X
OR
Treatment A – (Describe)
Example:
If you get treatment A, you will have to come to the outpatient department at the Cross
Cancer Institute/Tom Baker Cancer Centre twice a week for a total of 8 weeks. During these
visits, you will be given treatment A.
Treatment B – (Describe)
Example:
If you get treatment B, you will have to be admitted to the University of Alberta/Calgary
Hospital for three days at the beginning of the study. During your hospital stay, you will be
given treatment B.
(If the elements of the treatment are common for all treatments do one paragraph for all the
treatments and wherever possible use table formats.)
“HOW MANY PEOPLE WILL TAKE PART IN THIS STUDY?”
About ( ) people will take part in this study (at the CCI, TBCC or worldwide?)
“WHAT WILL MY PARTICIPATION INVOLVE?”
If you take part in this study, you will have the following tests and procedures:
(List procedures and their frequency under the categories below in a table format. For
randomized studies, list the study groups and under each describe categories of procedures.
Include whether a patient will be at home, in the hospital, or in an outpatient setting. If
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HREBA-CC Main ICF Template Final v2015_November
Protocol/Study #:
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objectives include a comparison of interventions, list all procedures even those that are
considered standard)
(Wherever possible use a table format for each of the following):
 Procedures that are part of regular cancer care and may be done even if you
do not join the study.
 Standard procedures being done because you are in this study.
 Procedures that are being tested in this study.
An example of a table
Initial
X
X
X
X
Day 14
X
Blood Test
Lung Function Test
X-Rays & Scans
X
Quality of Life
Questionnaire (time to
complete)
Physical Exam – blood
X
X
pressure, etc
(Use and modify the table which exists in the protocol to a lay version).
Day 28
X
X
X
X
X
(If Applicable) Pathology Review (Do not use if Pathology Review is NOT part of the
study)
All or some of your tumour was removed by biopsy or surgery. Some of this tumour tissue
was examined by a pathologist to help make your diagnosis. The remaining tumour tissue is
stored in the pathology department. If you participate in this study, this tissue will be sent to
(a central office) for review and research investigation associated with this protocol (list tests
that will be performed). You will not have to provide any other tissue. After the study testing
is finished, any tissue left will be destroyed.
(If Applicable) Sample Banking for Future Research
You may also be asked whether your (tissue/blood) can be stored for future research. If so,
you will be given another consent form asking for your permission.
(If this condition applies to your application, then ensure to include the tissue/blood banking
consent form.)
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“HOW LONG WILL I BE INVOLVED IN THE STUDY?”
You may be in this study for as long as (Months/Weeks, until a certain event).
(Where appropriate, state that the study will involve long-term follow-up.)
“WHAT ARE THE SIDE EFFECTS?”
Every medical treatment including the standard treatment has side effects, which your doctor
will explain to you. It is important that you know and understand the possible side effects of
the treatments given in this study.
(If Applicable)
(IF the study involves radiation treatment) You will receive a separate sheet and/or booklet
that will give you more information about treatment involving radiation.
(OR IF the study involves chemotherapy) You will receive a separate sheet and/or booklet
that will give you more information about treatment involving chemotherapy. (Combine the
two sentences if both radiation and chemotherapy are given in this study.)
The following are the side effects of each drug used in this study. These side effects may or
may not be more severe when the drugs are taken together. These are the side effects we
know about at present. However, since this is a study of new treatments there may be other
side effects that we do not know about yet.
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HREBA-CC Main ICF Template Final v2015_November
Protocol/Study #:
Drug
Route
Zoledronic IV
Acid
Version Date:
Common
 Fever
 Fatigue
(tiredness)
 Anorexia or loss
of appetite
Less Common
 Headaches
 Low levels of
calcium in the
blood, which
may cause
muscle cramps
 Insomnia
 Anxiety
Rare
 Kidney failure
 Severe allergic
reactions
 Permanent
damage to the
jawbone and might
require surgery to
remove the
damaged area.
This might be more
likely to happen in
patients who have
certain dental
procedures. If you
see a dentist, you
should inform them
that you may be
receiving
zoledronic acid.
(Use the following sample table and if possible keep the table on one page)
IV = Intravenous (into a vein)
SC = Subcutaneous (under the skin)
IM = Intramuscular (in a muscle)
PO= Oral (by mouth)
(If there are additional side effects that you feel should be mentioned in the context of this
study, please list)
You may feel some discomfort from the needle when study treatments are given or blood
drawn. There is also a small risk of fainting, swelling, bruising, bleeding or (rarely) local
infections at the site of the needle punctures which will be used for giving your study
medications, as well as for taking blood samples.
(Applicable for studies with CT component) As part of this study, you will have CT scans
and/or x-rays. There is a potential risk of radiation exposure from these CT scans and x-rays,
however, this risk is considered small. The amount of radiation exposure from one CT scan is
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about the same as the amount of radiation a person would get from natural surroundings in
three years. Sometimes an intravenous (into a vein) contrast dye is given with a CT scan.
Although the dye is relatively safe, occasionally side effects or reactions occur. These may
be mild (such as skin rash or hives) to severe (such as breathing difficulties or shock). The
doctors and staff of the Radiology Department are trained to treat these reactions if they
occur. Even if you do not participate in a study, you may need CT scans as part of standard
care. If you participate in this study, you might receive more scans than your doctor would
normally do.
These side effects may be temporary, long term and/or permanent. However, most of the
side effects listed above are reversible. That means they will stop once the drug is
discontinued or its dose lowered. (State long-term side effects if any, e.g. second
malignancies, infertility, etc. in the table)
If you have any side effects, either those on the list or others, or if you want more information
on how the drug(s) could affect you, you should call the doctor or nurse in charge of the
study. Their telephone numbers are on page (insert page #) of this form.
If we get any new information about the drugs/treatments/side effects in this study, you will be
told about them so that you can continue to get the best care possible.
Unique Side Effects/Special Precaution
List side effects that are unique or precautions that need to be taken that may prevent and/or
intensify side effects.
"WHAT ARE THE REPRODUCTIVE RISKS?"
The effects of (drug) on the human reproductive system are unknown. There may be
unforeseeable risks to a pregnant woman and/or fetus. Therefore, it is very important that if
you are sexually active (male/female), you use an effective method of birth control during
participation in the study and for three months following treatment. This may include, but is
not limited to, abstinence, birth control pills, an IUD, condoms, implants or being surgically
sterilized.
While you agree to take the necessary precautions for birth control, it is very important that
your partner uses an effective method of birth control as well.
If you or your partner becomes pregnant during the course of the treatment, you must inform
your doctor immediately. Your doctor will ensure that you receive information about the
options available in relation to the pregnancy and that you and your partner are fully
supported in whichever option is chosen.
The effect of (drug) in breast milk is also unknown. If you are breast-feeding, you cannot
participate in the study.
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HREBA-CC Main ICF Template Final v2015_November
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“WHAT ARE MY RESPONSIBILITIES?”
You must be willing to attend all scheduled study visits and undergo all of the procedures
described above. It is very important that you inform the study doctor or study nurse of any
side effects or health problems that you may be experiencing as well as any medications
(prescribed or holistic) that you are taking while on this study.
(If applicable, include statement about Quality of Life questionnaires, medication diaries etc.)
“WHAT ARE MY ALTERNATIVES?”
You may choose not to participate in this study. Other treatments that could be considered
for your cancer may include the following:
(1) radiation therapy;
(2) chemotherapy;
(3) surgery; or
(4) no treatment except medications to relieve symptoms.
These treatments could be given either alone or in combination with each other. Please talk
to your doctor about the known benefits and risks of these other treatment options. Your
doctor can also discuss with you what will happen if you decide not to undertake any
treatment at this time. With the last choice (4), your cancer is expected to grow and your
disease could spread.
“ARE THERE ANY BENEFITS TO PARTICIPATING IN THIS STUDY?”
Participation in this study may or may not be of personal benefit to you. However, based on
the results of this study, it is hoped that, in the long-term, patient care can be improved.
"WHAT HAPPENS IF I BECOME SEVERELY ILL?” (For double-blinded studies only:)
You and your doctor will not be told which study treatment you are receiving except in the
case of an emergency. If you have an emergency, your doctor will be told which study
treatment you are receiving so that you can get proper care.
“CAN I WITHDRAW FROM THIS STUDY?”
In discussion with you, your doctor at the Cross Cancer Institute/Tom Baker Cancer Centre,
either at his/her own initiative or at the request of the sponsor of this study, may withdraw you
from the study at any time if it is in your best interests. Taking part in this study is voluntary;
you may withdraw from the study at any time if you wish to do so. If you decide to stop
participating in the study, we encourage you to talk to your doctor first.
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Your doctor can take you off the study treatment early for reasons such as:

The treatment does not work for you and your cancer gets worse.

You are unable to tolerate the study treatment.

New information becomes available that indicates the study treatment is no
longer in your best interest.

Your doctor no longer feels this is the best treatment for you.
If you stop treatment early, we would like to keep track of your medical condition indefinitely to
look at the long-term effects of the study treatments. (If required)
Should you decide to withdraw from the study at any time, information collected on you up
until that point would still be provided to (the Sponsor).
“ARE THERE COSTS TO ME FOR TAKING PART IN THIS STUDY?”
(IF all elements of the treatment are free:) You will not have to pay for the treatment you
receive in this study.
(IF some payment is required:) You will not have to pay for drug A/Treatment B used in this
study. However, you will need to pay for drug C [note especially: G-CSF]. You will have to
pay for the drugs you need for side effects. If you are covered by a private insurance
company, you may get some or all of your money back, but if you do not have private
insurance, you will not get any money back.
(OR All studies where at least some of the treatment cost is covered by the sponsoring
agency:) It is also possible that the Sponsor (Sponsor's name) that is providing the drug(s)
(name the drug(s)) may decide to put the drug (name the drug(s)) on the market. After the
study is over, you may have to pay for the drug if you continue on it. (If there are expected to
be extra costs, please estimate how much.)
(IF extra visits are required:) You will be coming to the Cross Cancer Institute/Tom Baker
Cancer Centre more often than if you were not part of this study. There may be additional
costs to you for taking part in this study such as:
 parking
 transportation
 meals
 babysitting, etc.
You may be eligible for reimbursement of reasonable, out-of-pocket expenses related to your
participation in this study. Please speak with your study doctor or study nurse regarding this.
“WHAT ARE MY RIGHTS AS A PARTICIPANT?”
If you suffer an injury or become ill as a result of participating in this research, you will receive
all medical treatments (or services) recommended by your doctors. No compensation will be
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provided beyond this point. However, it is important to note that nothing said in this consent
form alters your legal rights to recover damages (e.g. legal action).
If new information becomes available or there are changes to the study that may affect your
health or willingness to continue in the study, you will be told in a timely manner.
“WILL MY PERSONAL INFORMATION BE KEPT CONFIDENTIAL?”
Identifiable health information will be collected from you and from your Provincial Electronic
Health Record (NetCare) during this study. This information may be used by the researchers
who are carrying out this study, and may be disclosed to others as described below. Any
research proposal to use information that identifies you for a purpose other than this study
must be approved in advance by the Health Research Ethics Board of Alberta – Cancer
Committee.
Direct access to your identifiable health information collected for this study will be restricted to
the researchers who are directly involved in this study except in the following circumstances:
Your identifiable health information may need to be inspected or copied from time to time for
quality assurance (to make sure the information being used in the study is accurate) and for
data analysis (to do statistical analysis that will not identify you). The following organizations
may do this inspection:
 Health Canada, the Canadian regulatory body
 United States Food and Drug Administration, the United States regulatory
body
 Health Research Ethics Board of Alberta – Cancer Committee
 Members of the Regulatory/Audit team at the Cross Cancer Institute/Tom
Baker Cancer Centre, for quality assurance purposes
 National Cancer Institute of Canada, the organization that is coordinating this
study
 Sponsor's name. Authorized representatives of the makers of the drugs you
are taking in this study and/or a clinical research organization coordinating
the study
 Other regulatory agencies that may need to see these records in order to
monitor the research and verify the accuracy of the study data such as (insert
examples of relevant foreign regulatory agencies equivalent to Health Canada
or FDA; e.g., the European Medicines Agency)
Any disclosure of your identifiable health information will be in accordance with the Alberta
Health Information Act. As well, any person from the organizations listed above looking at
your records on-site at the Cross Cancer Institute/Tom Baker Cancer Centre will follow the
relevant Alberta Health Services and relevant Health Research Ethics Board of Alberta –
Cancer Committee policies and procedures that control these actions. Any disclosure of your
identifiable health information to another individual or organization not listed here will need the
approval of the Health Research Ethics Board of Alberta – Cancer Committee.
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HREBA-CC Main ICF Template Final v2015_November
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Your identifiable health information collected as part of this study (if applicable) which
includes records of your progress, your responses to the questionnaires and your diaries will
be kept confidential in a secure AHS facility. Information that does not identify you will also
be provided to (the Sponsor) or other companies acting on behalf of (the Sponsor), where it
will be kept confidential in a secure location.
The researchers who are directly involved in your study may share information about you with
other researchers, but you will not be identified in that shared information except by a
number. The key that indicates what number you have been assigned will be kept secure by
the researchers directly involved with your study and will not be released.
Although absolute confidentiality can never be guaranteed, Alberta Health Services will make
every effort to keep your identifiable health information confidential, and to follow the ethical
and legal rules about collecting, using and disclosing this information in accordance with the
Alberta Health Information Act and other regulatory requirements.
The information collected during this study will be used in analyses and will be published
and/or presented to the scientific community at meetings and in journals, but your identity will
remain confidential. This information may also be used as part of a submission to regulatory
authorities around the world to support the approval of the drug used in this research. It is
expected that the study results will be published as soon as possible after completion. Your
study doctor will be informed of the results of the study once they are known.
(The following statement must be reproduced word-for-word in informed consent documents
for applicable clinical trials: )
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required
by U.S. Law. This Web site 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.
This study’s registration ID number to use on this web page is: XXXXXXXXXXX (Please
include the study registration ID for this trial).
“WHERE CAN I GET MORE INFORMATION” (Optional)
For your reading, the Organization (Name of Organization) has a booklet titled “(Name of
booklet)”, which is available from your doctor. Or include a website if available for that type
of cancer.
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HREBA-CC Main ICF Template Final v2015_November
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“WHO DO I CALL IF I HAVE QUESTIONS OR PROBLEMS?”
For information about your disease and/or research related injury/illness, you may contact the
Principal Investigator (name and telephone number), Co-Investigator (name and telephone
number), Research Nurse (name and telephone number) or page them through the Cross
Cancer Institute/Tom Baker Cancer Centre Switchboard at (XXX) XXX-XXXX to answer any
questions you have about this study.
If you have questions about your rights as a participant or about ethical issues related to this
study and you would like to speak to someone not involved in the conduct of the study, please
contact the Office of the Health Research Ethics Board of Alberta – Cancer Committee at:
780-423-5727 or toll-free 1-877-423-5727.
Only include for Alberta Health Services studies - If your doctor or study nurse has not been
able to answer or resolve your questions and/or concerns about this study, or if you feel at
any time that you have not been informed to your satisfaction about the risks, benefits, or
alternatives to this study, or that you have been encouraged to continue in this study after you
wanted to withdraw, you can call the Alberta Health Services Patient Relations Department
toll free at 1-855-550-2555. (Please check www.albertahealthservices.ca for the appropriate
telephone numbers.)
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UNDERSTANDING OF PARTICIPANTS
I can refuse to take part or withdraw from this study at any time without jeopardizing my
health care. If I continue to take part in the study, I will be kept informed of any important new
developments and information learned after the time I gave my original consent.
I also give consent for the Principal Investigator and Alberta Health Services (the Custodian)
to disclose identifiable health information, as per the Alberta Health Information Act, to the
organizations mentioned on the previous pages.
I have read and understood all of the information in this consent form. I have asked
questions, and received answers concerning areas I did not understand. I have had the
opportunity to take this consent form home for review and discussion. My consent has not
been forced or influenced in any way. I consent to participate in this research study. Upon
signing this form I will receive a signed copy of the consent.
(PRINT NAMES CLEARLY)
____________________________
Name of Patient
____________________________
Name of Person Obtaining
Consent
___________________________
Signature of Patient
___________________________
Signature of Person
Obtaining Consent
___________________________
Date
___________________________
Date
Patient Study Number or Hospital Number: _____________________
Was the patient assisted during the consent process in one of the ways listed below?
□ Yes
□ No
If yes, please check the relevant box and complete the signature space below:
□ The consent form was read to the patient, and the person signing below attests that the study
was accurately explained to, and apparently understood by the patient.
□ The person signing below acted as a translator for the patient during the consent process.
________________________________
Signature of person assisting
In the consent discussion
____________________________
Date
Please note: More information regarding the assistance provided during the consent process should
be noted in the medical record for the patient if applicable.
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