Download CONSENT FORM AND INFORMATION ABOUT

IRB Committee C Phase I Consent Form Template
Revised 04/09/12
IRB File #______________
Page 1 of 8
CONSENT FORM AND INFORMATION ABOUT
Title of Study
STUDY TO BE CONDUCTED BY:
LOCATION:
Principal Investigator:
Study Sponsor:
Introduction
This is a Phase I research study. Phase I studies are done to find out the proper dosage
levels and side effects of drugs that have never been given to humans, or that have
been approved, but have not been used, for example, in a specific drug combination or
specific kind of cancer, (choose the appropriate reason). We do not know and we are
not studying whether the study drug will help you or your disease. Animal studies with
this drug have shown that (take from study specific protocol).
Research studies include only participants who choose to take part. Please take your
time to make your decision. You may want to discuss it with your family and friends. The
information in this consent form is not meant to frighten or alarm you; it is only meant to
better inform you so you may decide whether or not to give your consent to participate
in this research study.
After reading this consent form, if you would like to take part in this research study, you
will be asked to sign this consent form. Your signature will show that you give your
permission to take part in this study.
The study sponsor expects to enroll (# of participants) to this study (nationally).
Purpose of Study
You are being asked to take part in this research study because you have (type of
cancer).
(Study drug) is an investigational drug and is not approved by the Food and Drug
Administration (FDA). (Study drug) has never been given to humans. Therefore, specific
side effects related to (study drug) in humans are not yet known. This study is a dose
escalation study. Over the course of the study, the doses will be increased to determine
the highest amount of the drug that can be given before the side effects make you too
sick to continue. You may experience severe side effects, including death.
This study is not intended to evaluate whether the study drug is effective in the
treatment of (study specific disease).
«InstitutionName»
IRB Number: «ID»
Approved: «ApprovalDate»
Expiration: «ExpirationDate»
_________________
Participant’s Initials
IRB Committee C Phase I Consent Form Template
Revised 04/09/12
IRB File #______________
Page 2 of 8
Your participation will last for (MONTHS/WEEKS, UNTIL A CERTAIN EVENT). {No
follow-up for Phase I studies}.
Consent for Tissue Storage (use if needed): –
In addition to the treatment described in this consent form, the study sponsor would like
to store blood and tumor tissue samples for future scientific research studies.
Information about storing your blood and tumor tissue will be addressed later in a
separate consent form.
How the Study Works
If you choose to participate in this research study, you will complete a screening visit,
which will consist of tests to find out if you meet the study requirements. The results of
these tests will be used to decide whether or not you may be eligible to participate in
this study. All of these tests are for research purposes and are described below. Also,
the other tests required during specific visits after the screening visit are also for
research purposes.

(list tests to be performed)
(List treatment procedures, most commonly found in the appropriate form in the
model consent form included with the protocol)
.
Please tell your doctor if you are taking any drugs or non-prescription medications,
including vitamins or herbs, other than those being used in this research study.
Risks and Discomforts
While on the research study, you are at risk for side effects. Because (study drug) has
never been given to humans, specific side effects are not yet known. In some cases
side effects can be serious, long-lasting or permanent, and could lead to death.
A significant risk to taking part in this research study is the likelihood of receiving a drug
or dose of a drug that is not effective in helping your disease. This means that you may
spend time and experience side effects of taking a drug that does not provide you with
any health-related benefits.
Your study doctor will be following you closely to see if any side effects occur. Your
doctor will discuss these with you. It is important that you promptly report any side
effects that you experience to your study doctor or study nurse. Other drugs may be
given to make side effects less serious and uncomfortable. If you or your study doctor
feel that the side effects are too severe, the (study drug) may be stopped and you will
be removed from the study.
(Study drug) has never been given to humans. In non-human testing the following side
effects have happened:
«InstitutionName»
IRB Number: «ID»
Approved: «ApprovalDate»
Expiration: «ExpirationDate»
_________________
Participant’s Initials
IRB Committee C Phase I Consent Form Template
Revised 04/09/12

IRB File #______________
Page 3 of 8
(list study specific side effects in non-humans and add any study specific language)
As with all medications, side effects may include allergic reactions. Allergic reactions
may range from minor itching or rash to major reactions, which can lead to death.
In addition to the side effects, inserting a needle into the arm to receive fluids and study
treatment or to collect blood samples may cause pain, redness, bleeding, fainting,
bruising and, rarely, infection at the location where the needle is placed.
Studies that involve questionnaires or daily diaries (use if applicable):
Some of the questions regarding quality of life are of a personal nature and may be
upsetting to some participants. Your doctor and nurse will be available to discuss these
questions should you have a concern or problem. You do not have to answer any
questions that you do not want to answer.
Reproductive Risks
(Please reference gender appropriately. The model consent form provided by the
sponsor may include additional specific information which should be included in this
section.)
It is unknown if the (study drug) and procedures used in this research study can affect
an unborn baby. All women who can have children must have a negative pregnancy test
before receiving the study drug. If you are pregnant or nursing a baby, you may not
participate in this study, and if you become pregnant during this study, you will be
removed from the study. Both men and women taking part in this study must absolutely
avoid actions that will result in pregnancy. Women who can have children and who
participate in this studymust use an effective method of birth control during their study
participation. Also, men who participate in this study must use an effective method of
birth control during their participation in this study. Your doctor will discuss your options
with you further. Women who think that they may have become pregnant, or men who
think that they may have caused a pregnancy during this study should tell their doctor
right away. If you are a woman, you may be unable to have children, now or in the
future. If you are a man, you may be unable to father a child, now or in the future. Upon
request, your doctor may discuss with you alternatives and options in this area.
Benefits
The information that is obtained during this research study may be scientifically useful. It
is unknown if you will receive any personal benefit from your participation in this study.
Alternatives (as applicable)
Instead of participating in this research study, you have these alternatives (other
choices):
 (list study specific alternatives)
Please discuss these choices with your doctor.
«InstitutionName»
IRB Number: «ID»
Approved: «ApprovalDate»
Expiration: «ExpirationDate»
_________________
Participant’s Initials
IRB Committee C Phase I Consent Form Template
Revised 04/09/12
IRB File #______________
Page 4 of 8
New Information
Your doctor will tell you about new information that may affect your willingness to
participate in this research study. Alternatives, or other choices, concerning your care
will be discussed at that time. Your doctor or the sponsor can stop your participation in
this study even if you are willing to continue.
(If applicable, use the following language:)
A Data Safety Monitoring Board will be reviewing the data from this research from time
to time throughout the study. They will notify your doctor of any new information that you
need to be told about.
Cost as a Result of Study Participation
INSTRUCTIONS: The following information is provided to help you prepare this section
of your consent form. Include the following information in this section:
 Costs that are paid for by study funds, e.g., “Study funds will pay for the study
drug and the MRI that is done only for research.”
 Any additional costs to the participant that may result from participation in the
research, including costs associated with routine care billed to health insurers
If the study is not a funded study, make sure to point out what items or services
will be charged directly to the patient or their insurance company and what items
will likely not be paid by insurance, but will be the patient’s responsibility.
A common misconception among patients is that if they participate in a research
study all of the costs of their care will be covered by the research sponsor.
Although this is true in a few cases, the hospital is entitled to and generally will
bill a subject’s health insurer for, among other things, routine care that the
subject would have received had they not participated in the study. Although the
amounts vary by insurer, a research subject is likely to be responsible for copays and deductibles associated with this routine care. It is important to make
sure that patients who volunteer to participate in your research study understand
their potential financial responsibility. If these or other costs billable to insurance
or billable to the subject directly can be identified in advance (such as through a
Medicare Coverage Analysis billing grid), it is a good idea to give the subject
notice of specific items or services that may result in significant financial
responsibility for the subject. If specific amounts cannot be identified in advance,
you should make sure that the subject understands that they might incur some
financial responsibility as a result of their participation.
At a minimum, you must include the following language in the consent
form:
“Although study funds will pay for certain study-related items and services, we
may bill your health insurer for routine items and services you would have
received even if you did not take part in the research. You will be responsible for
«InstitutionName»
IRB Number: «ID»
Approved: «ApprovalDate»
Expiration: «ExpirationDate»
_________________
Participant’s Initials
IRB Committee C Phase I Consent Form Template
Revised 04/09/12
IRB File #______________
Page 5 of 8
payment of any deductibles and co-payments required by your insurer for this
routine care or other billed care. If you have any questions about costs to you
that may result from taking part in the research, please speak with the study
doctors and study staff. If you are confused about what is or is not paid for in this
study please discuss this with your study doctor or study staff.”
Note: You may add further language to describe specific
items/services/amounts that will be the subject’s responsibility, but you
may not delete any portion of the standard language.
For more information on clinical trials and insurance coverage, you can visit the National
Cancer Institute’s Web site at http://www.cancer.gov/clinicaltrials/education/insurancecoverage. You can print a copy of the “Clinical Trials and Insurance Coverage”
information from this Web site. Another way to get the information is to call 1-800-4CANCER (1-800-422-6237) and ask them to send you a free copy.
Payment for Participation
To You:
Include one of the two following statements:
 You will not be paid to participate in this study.
 You will be paid to participate in this study. Include a payment schedule,
total amount, and any situations in which the subject would not be paid.
Compensation for Injury as a Result of Study Participation
We will provide you the care needed to treat any injury, or illness, that directly results
from taking part in this research study. We reserve the right to bill your insurance
company or other third partiesfor the care you get for the injury. You may be
responsible for these costs. For example, if the care is billed to your insurer, you will
be responsible for the payment of any deductibles and co-payments required by your
insurer or even possibly the entire cost of the service.
INSTRUCTIONS: The sponsor may request to include a statement about the injury
coverage the sponsor will offer. When the sponsor requests to include such a
statement, the statement may be entered below, after the institution’s
commitment to provide care for the injury.
For example: “In this study, [Sponsor] may pay for medical treatment for any
injury that is not paid for by your health insurer if the injury is a direct result of
your taking part in the study.”
«InstitutionName»
IRB Number: «ID»
Approved: «ApprovalDate»
Expiration: «ExpirationDate»
_________________
Participant’s Initials
IRB Committee C Phase I Consent Form Template
Revised 04/09/12
IRB File #______________
Page 6 of 8
Injuries sometimes happen in research even when no one is at fault. The study sponsor,
the Greenville Hospital System, Bon Secours St. Francis Health System, or the
investigators as part of this study have no plans to pay you or give you other
compensation for an injury, should one occur. However, you are not giving up any of
your legal rights by signing this form.
If you think you have been injured or have experienced a medical problem as a result of
taking part in this research study, tell the person in charge of this study as soon as
possible. The researcher’s name and phone number are listed in the ‘Contact For
Questions’ section of this consent.
Voluntary Participation
Participation in this research study is voluntary. You may refuse to participate or
withdraw from the study at any time. If you refuse to participate or withdraw from the
study, you will not be penalized or lose any benefits and your decision will not affect
your relationship with your doctor or hospital.
However, if you decide to stop study participation, you are encouraged to talk with your
doctor regarding safe removal from the study as described below.
Your doctor may decide to take you off this research study if:

(study specific)
Further treatment would be discussed.
If your participation in this research study is stopped, your study doctor will discuss any
tests or procedures that might be needed for your health and safety, but you may refuse
any or all of these tests or procedures. Following this discussion with your study doctor,
you still have the right to refuse any or all of these tests or procedures.
[Describe any serious consequences of sudden withdrawal from the study.]
You will receive a copy of this consent form.
Contact Persons
For questions about the research study or research-related risk(s) or injury or to give
comments or express concerns or complaints, you can call the doctor in charge any
time day or night: (List applicable principal investigator and telephone number).
For questions about your rights as a research participant or to give comments or
express concerns, complaints or offer input, contact the Institutional Review Board of
the Greenville Hospital System (a group of people who review the research to protect
your rights) at (864) 455-8997.
For more information related to cancer, you may contact:
«InstitutionName»
IRB Number: «ID»
Approved: «ApprovalDate»
Expiration: «ExpirationDate»
_________________
Participant’s Initials
IRB Committee C Phase I Consent Form Template
Revised 04/09/12
IRB File #______________
Page 7 of 8
 NCI’s Cancer Information Service at 1-800-4-CANCER (1-800-422-6237) or Text
Telephone (TTY): 1-800-332-8615
 NCI Web Sites: cancertrials.nci.nih.gov
cancernet.nci.nih.gov
A survey about your experience with this informed consent process is located at the
following website:
http://www.ghs.org/Research-and-Clinical-Trials
Participation in the survey is completely anonymous and voluntary and will not affect
your relationship with your doctor or the Greenville Hospital System. If you would like to
have a paper copy of this survey, please tell your study doctor.
Authorization to Use and Disclose (Release) Medical Information
As part of this research study, your study doctor and his/her research team will keep
records of your participation in this study. These study records may be kept on a
computer and will include all information collected during the research study, and any
health information in your medical records that is related to the research study. Your study
doctor and his/her research team will use and disclose (release) your health information to
conduct this study. To evaluate the results of the study and for compliance with federal
and state law, your health information may be examined and copied by the Food and Drug
Administration (FDA), other governmental regulatory agencies, the Institutional Review
Committee for Oncology Research (IRCOR) of the Greenville Hospital System, the study
sponsor and the sponsor’s authorized representative(s). This study may result in scientific
presentations and publications, but steps will be taken to make sure you are not identified.
Under federal privacy laws, your study records cannot be used or released for research
purposes unless you agree. If you sign this consent form, you are agreeing to the use and
release of your health information. If you do not agree to this use, you will not be able to
participate in this study.
The right to use your health information for research purposes does not expire unless you
withdraw your agreement. You have the right to withdraw your agreement at any time.
You can do this by giving written notice to your study doctor. If you withdraw your
agreement, you will not be allowed to continue participation in this research study.
However, the information that has already been collected will still be used and released as
described above. You have the right to review your health information that is created
during your participation in this study. After the study is completed, you may request this
information.
Once your health information has been released, federal privacy laws may no longer
protect it from further release and use.
If you have any questions about the privacy of your health information please ask your
study doctor.
«InstitutionName»
IRB Number: «ID»
Approved: «ApprovalDate»
Expiration: «ExpirationDate»
_________________
Participant’s Initials
IRB Committee C Phase I Consent Form Template
Revised 04/09/12
IRB File #______________
Page 8 of 8
Blood and Tissue Samples
{If there is specially requested tissue or blood sample testing from the model consent
form which is not required in order to participate in the study, use the separate model
Specimen Consent Form. If there are any samples that need to be provided in order to
participate in the study, this information should be included here. Refer to the model
Specimen Consent Form for specific GINA (Genetic Information Nondiscrimination Act)
language which must be included.}
Consent to Participate
My study doctor ___________________________________, has explained the nature
and purpose of this study to me. I have been given the time and place to read and
review this consent form, or it has been read to me, and I choose to participate in this
study. I have been given the opportunity to ask questions about this study and my
questions have been answered to my satisfaction. I have been given a copy of my study
doctor’s Notice of Privacy Practices. I agree that my health information may be used
and disclosed (released) as described in this consent form. After I sign this consent
form, I understand I will receive a copy of it for my own records. I do not give up any of
my legal rights by signing this consent form.
__________________________________
Printed Name of Participant
__________________________________
Signature of Participant
________________ ____________
Date
Time
__________________________________
Signature of Witness
________________
Date
____________
Time
Investigator Statement
I have carefully explained to the participant the nature and purpose of the above study.
The participant signing this consent form has (1) been given the time and place to read
and review this consent form; (2) been given an opportunity to ask questions regarding
the nature, risks and benefits of participation in this research study; and (3) appears to
understand the nature and purpose of the study and the demands required of
participation. The participant has signed this consent form prior to having any studyrelated procedures performed.
____________________________________
Signature of Investigator
«InstitutionName»
IRB Number: «ID»
Approved: «ApprovalDate»
Expiration: «ExpirationDate»
_______________ __________
Date
Time
_________________
Participant’s Initials
IRB Committee C Phase I Consent Form Template
Revised 04/09/12
IRB File #______________
Page 9 of 8
Principal Investigator
Phone
Co-Investigators
Phone
«InstitutionName»
IRB Number: «ID»
Approved: «ApprovalDate»
Expiration: «ExpirationDate»
_________________
Participant’s Initials