Version Date: October 01, 2013*
[Schulman ICs are prepared in font size 12]
INFORMED CONSENT
TITLE:
PROTOCOL NO.:
SPONSOR:
INVESTIGATOR:
TELEPHONE:
INTRODUCTION
Before agreeing to participate in this research study, it is important that you read and
understand the following explanation of the proposed research study. This consent
document describes the purpose, procedures, benefits, risks, discomforts and
precautions of the study. It also describes the alternative procedures that are available
to you and your right to withdraw from the study at any time. No guarantees or
assurances can be made as to the results of the study.
If you are not completely truthful with your study doctor regarding your health history,
you may harm yourself by participating in this study.
The study is being conducted for (Sponsor name). Your study doctor is being paid by
(Sponsor name) to conduct this study.
Schulman IRB (Schulman) has approved the information in this consent document and
has given approval for the study doctor to do the study. An institutional review board
(IRB) is an independent committee established to help protect the rights of research
subjects. This does not mean the IRB has approved your participation in the
study. You must think about the information in this consent document for yourself. You
must then decide if you want to be in the study.
BACKGROUND AND PURPOSE
You are being asked to participate in this research study because you have
[disease/condition]. In lay terminology, describe relevant background
information and rationale for conducting this study.
The purpose of this research study is to:
 test the safety and effectiveness of the study drug, [drug name].
 insert other protocol objectives in lay terminology
[Include the investigational aspect. For example, if not a marketed product: This is
a research study to test a new investigational drug. An investigational drug is one that
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is not approved by the United States Food and Drug Administration (FDA). If
marketed product: This study drug may be available by prescription for [state
indication]. If marketed product, but an investigational use for the study: The
use of [drug name] in this study is investigational. An investigational use is one that is
not approved by the United States Food and Drug Administration (FDA). Note the use
of any comparators or placebo.
Because this is a research study, the [study product or “study drug” for placebocontrolled study] will be given to you only during this study and not after the study is
over.
NUMBER OF SUBJECTS / LENGTH OF PARTICIPATION
About [xxx] subjects will participate in this study. Your participation in this study will last
approximately [xxx (wks/months/yrs)] and include [xx number] study visits to the
study center. If applicable: This study will use competitive enrollment. This means
that when a target number of subjects begins the study, all further enrollment will be
closed. Therefore, it is possible that you could be in the screening phase, ready to
begin the study, and be discontinued without your consent if the target number of
subjects has already begun the study.
PROCEDURES
Before any study-related tests and procedures are performed, you will be asked to read
and sign this consent document. The following tests and procedures will be performed
to determine if you qualify to take part in this study:
 [insert bulleted list of procedures presented by visit; identify any procedures
that are experimental]
You will be randomly assigned by chance (like the flip of a coin) to receive either
[sponsor’s product], Comparator Name, [if applicable] or placebo [if applicable]
(inactive substance). You will have a xx% (1 in x) chance of receiving [study drug
name] and a xx% (1 in x) chance of receiving placebo [or indicate odds or receiving
each]. [If study is double-blind, add:] This is a double-blind study, which means
neither you nor the study doctor will know to which of these study drug groups you are
assigned. In case of an emergency, however, the study doctor can get this information.
[If applicable, include the following:] There will be a period of time when all subjects
will receive placebo.
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[If the study involves a washout, insert the following WASHOUT text as
applicable]
WASHOUT
You will be asked to stop taking your _______ to treat your ________. This is called a
washout period, during which the effects of these medications leave your body.
EXPECTATIONS
If you participate in this study, you will be expected to:
[list those things that subjects will be expected to do; for example attend each
visit, take the study product as expected, etc.]
RISKS, SIDE EFFECTS AND/OR DISCOMFORTS
If applicable (if this is a Phase I [first in man] study) This is the first time that the
study drug has been used in people.
If applicable (dependent on risk profile), list any information about the study drug
from the risk profile (e.g., if Phase I or II study, # people who have received the
drug in clinical studies, animal data, etc.)
For [name of Study Drug(s)]:

[Indicate adverse effects ]
For [name of active comparator]:

[Indicate adverse effects]
Other less common side effects have been reported. The study doctor or staff can
discuss these with you.
RISKS OF STUDY PROCEDURES

Blood samples: possible side effects from blood drawing include faintness,
inflammation of the vein, pain, bruising, or bleeding at the site of puncture. There is
also a slight possibility of infection.

ECG: Skin irritation is rare but could occur during an ECG from the electrodes or
gel that is used.

[insert bulleted list of side effects for additional procedures specified above.]
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[If applicable] During the washout period (as applicable) and when you are taking
placebo, you will not be receiving active drug and your [name the condition] may
become worse, stay the same or improve.
UNFORESEEN RISKS
Since the study drug [or the use of the study drug] is investigational when taken
alone or in combination with other medications, there may be other risks that are
unknown. All drugs have a potential risk of an allergic reaction, which if not treated
promptly, could become life-threatening.
PREGNANCY / BIRTH CONTROL [ADD THE FOLLOWING INFORMATION IF THE STUDY
INCLUDES FEMALES OF CHILD-BEARING POTENTIAL]
Taking the study drug may involve unknown risks to a pregnant woman, an embryo,
fetus (unborn baby) or nursing infant. Therefore, if you are pregnant, planning to
become pregnant or are breastfeeding a child, you cannot participate in this study.
In order to reduce the risk of pregnancy, you must use an effective method of birth
control while you are participating in this study (and for [as defined by the protocol] 1
month, 3 months, etc.) after you complete the study treatment). If you are already using
a method of birth control, the study doctor or study staff will discuss with you whether
your current method of birth control is acceptable for use during this study.
If, during this study, you become pregnant, you should notify the study doctor as soon
as possible. The study drug will be stopped and your participation in this study will be
ended. Information about your pregnancy and its outcome will be collected and used to
learn more about the effects of the study drug on pregnancy.
Males - Add the following information if the study includes follow-up of
pregnancy in the partner of a male subject
Exposure to the study drug may involve unknown risks to a pregnant woman, an
embryo, or a fetus (unborn baby). If you are having sexual intercourse with a woman
who can become pregnant, you must use an acceptable form of birth control while you
are participating in this study and for _______ [enter period of time in weeks,
months or years as defined by protocol] after your last dose of the study
drug. Acceptable methods of birth control for use in this study are
_________________.
If you agree to participate in this study, you are expected to inform your female sexual
partner(s) that you are participating in a research study of a drug, and that the effects of
the drug on an unborn baby and on a pregnant woman are unknown. You are also
expected to provide your female sexual partner(s) with the information in the
Pregnancy/Birth Control section of this Informed Consent and to provide her with
contact information for the study doctor for any additional questions.
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If your female partner becomes pregnant while you are participating in this study or
within ___________ [enter period of time in weeks, months or years as defined by
protocol] after you have stopped taking the study drug, tell your study doctor or study
nurse promptly. At that time the study doctor may seek the pregnant woman’s
permission to review her medical records and the infant’s medical records for up to
____________ [enter period of time in weeks, months or years as defined by
protocol] after delivery, if applicable. The study doctor will share the information about
your pregnant partner and the baby with the study sponsor to help understand the
effects, if any, that the study drug may have on the pregnancy and the child.
Payment for all aspects of obstetrical care, child-or related care will be your
responsibility.
ALTERNATIVE TREATMENT
[For treatment studies] You do not have to be in this study to receive treatment for
your [disease type]. Your options include: [Complete with relevant options] [List
any available alternative treatments or procedures and the important potential
benefits and risks of the alternative procedures or treatments that may be
available to the subject]. The study doctor will discuss with you the risks and benefits
of the alternative treatments.
[OR, If applicable, replace the previous sentences with the following for a nontreatment study:] This research study is for research purposes only. The only
alternative is to not participate in this study.
NEW FINDINGS
Any new important information that is discovered during the study and which may
influence your willingness to continue participation in the study will be made available to
you.
BENEFITS
You may benefit as a result of your participation in this study. There is, however, no
guarantee that you will benefit from your participation in this study. Results from this
study may benefit others in the future.
[OR replace the previous sentences with the following for a non-treatment study:]
This study is for research purposes only. There is no direct benefit to you from your
participation in the study. Information learned from the study may help other people in
the future.
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COMPENSATION FOR PARTICIPATION
[In situations where TOTAL is to be provided]
For your time and inconvenience related to your participation in this study, you will be
paid up to a total of $xx.xx if you complete this study. If you do not complete the study,
for any reason, you will be paid for the study visits you do complete according to the
following schedule: $xx.xx for _____.
OR
[In situations where the TOTAL is NOT provided]
For your time and inconvenience related to your participation in this study, you will be
paid for the study visits you complete according to the following schedule: $xx.00 each
for Visits xxx. If you do not complete the study, for any reason, you will be paid for each
study visit you do complete according to the schedule above.
[To be included with either paragraph 1 or 2 above]
If you have any questions regarding your compensation for participation, please contact
the study doctor at the telephone number listed on page one of this consent document.
OR
You will not receive any monetary compensation for your participation in this study.
CONFIDENTIALITY
Records of your participation in this study will be held confidential except when sharing
the information is required by law or as described in this informed consent. The study
doctor, the sponsor or persons working on behalf of the sponsor, and under certain
circumstances, the United States Food and Drug Administration (FDA) and the
Institutional Review Board (IRB) will be able to inspect and copy confidential studyrelated records which identify you by name. This means that absolute confidentiality
cannot be guaranteed. If the results of this study are published or presented at
meetings, you will not be identified.
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.
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COMPENSATION FOR INJURY
Review sponsor’s standard language – negotiate for clarity, as needed
[Schulman text]
If you are injured as a result of taking the study drug(s) or from procedures done for the
purpose of this study, the sponsor will pay for those medical expenses necessary to
treat your injury that are not covered by your medical insurance or any other third party
coverage. There are no plans to provide other compensation beyond that which is
listed in this informed consent document. You will not lose any of your legal rights or
release the Sponsor, the study doctor, the study staff, or study site from liability for
mistakes or intentional misconduct by signing this consent document.
If you are injured during this study, your study doctor will discuss with you the available
medical treatment options.
COSTS
There will be no charge to you for your participation in this study. The study drug,
study-related procedures, and study visits will be provided at no charge to you or your
insurance company.
EMERGENCY CONTACT / IRB CONTACT
During the study, if you experience any medical problems, suffer a research-related
injury, or have questions, concerns or complaints about the study, please contact the
study doctor at the telephone number listed on page one of this consent document. If
you seek emergency care, or hospitalization is required, alert the treating physician that
you are participating in a research study being conducted by the study doctor listed on
page one of this document.
If you have any questions about your rights as a research subject, and/or concerns or
complaints regarding this research study, you should write to Schulman IRB, 4445 Lake
Forest Drive – Suite 300, Cincinnati, Ohio 45242, or call toll-free 1-888-557-2472 during
business hours Monday - Friday 8:00 a.m. to 6:00 p.m. EST.
[Consent for Optional Sub-Study – if applicable]
You are also being asked to participate in an optional sub-study concerning
[description, to include all standard elements of legally-informed consent
(risks/benefits, confidentiality, alternatives, costs, etc.].
You may decide not to participate in the optional sub-study. If you decide not to
participate in the sub-study, your decision will have no impact on your ability to
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participate in the main study, and will have no impact on any other benefits to which you
would otherwise be entitled.
Please indicate your preference below:
□ I hereby agree to participate in the sub-study [description] as described above.
□ I do not agree to participate in the sub-study [description] as described above.
VOLUNTARY PARTICIPATION / WITHDRAWAL
Your decision to participate in this study is voluntary. You may choose to not participate
or you may withdraw from the study for any reason without penalty or loss of benefits to
which you are otherwise entitled and without any effect on your future medical care.
[Add any consequences, if any, of the subject’s decision to withdraw. Add the
procedures for orderly termination/withdrawal.]
The study doctor or the sponsor can stop your participation at any time without your
consent for the following reasons:





If it appears to be medically harmful to you;
If you fail to follow directions for participating in the study;
If it is discovered that you do not meet the study requirements;
If the study is canceled; or
For administrative reasons, including competitive enrollment - the target number of
subjects has entered the study.
If you leave the study for any reason, the study doctor may ask you to have some endof-study tests for your safety.
PRIMARY CARE PHYSICIAN / SPECIALIST NOTIFICATION OPTION
Please indicate below whether you want us to notify your primary care physician or your
specialist of your participation in this study.
________
Yes, I want the study doctor to inform my primary care physician/specialist
of my participation in this study.
________
No, I do not want the study doctor to inform my primary care
physician/specialist of my participation in this study.
________
I do not have a primary care physician/specialist.
________
The study doctor is my primary care physician/specialist.
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CONSENT
I have read and understand the information in this informed consent document. I have
had an opportunity to ask questions and all of my questions have been answered to my
satisfaction. I voluntarily agree to participate in this study until I decide otherwise. I do
not give up any of my legal rights by signing this consent document. I will receive a
copy of this signed consent document.
For male subjects: Add the following information if the study includes follow-up
of pregnancy in the partner of a male subject
I will advise my sexual partner(s) that I am participating in a research study of a drug
and that the effects of the drug on an unborn baby and on a pregnant woman are
unknown. I will provide my female sexual partner(s) with the information in the
Pregnancy/Birth Control section of this Informed Consent and will provide her with
contact information for the study doctor for any additional questions.
____________________________________
Subject’s Printed Name
____________________________________
Subject’s Signature
_________
Date
____________________________________
Printed Name of the Person Conducting the
Consent Discussion
_____________________________________
Signature of the Person Conducting the
Consent Discussion
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___________
Date
Version Date: October 01, 2013*
CONSENT FOR SUBJECTS WHO CANNOT READ
The study subject has indicated that he/she is unable to read. The consent document
has been read to the subject by a member of the study staff, discussed with the subject
by a member of the study staff, and the subject has been given an opportunity to ask
questions of the study staff.
____________________________________
Printed Name of Impartial Witness
____________________________________
Signature of Impartial Witness*
__________
Date
*Impartial Witness: A person, who is independent of the trial, who cannot be unfairly influenced by people involved
with the trial, who attends the informed consent process if the subject or the subject’s legally acceptable
representative cannot read, and who reads the informed consent and any other written information supplied to the
subject. Guidance for Industry E6 Good Clinical Practice: Consolidated Guidance
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AUTHORIZATION TO USE AND DISCLOSE
PROTECTED HEALTH INFORMATION
This portion of the ICD will be prepared using font size 14
During your participation in this research study, the study doctor
["Investigator" as applicable] and study staff will collect or create
personal health information about you (for example, medical histories and
results of any tests, examinations or procedures you undergo while in the
study) and record it on study documents. The study doctor will keep this
personal health information in your study-related records (that we will refer
to as "your study records"). 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. Your study doctor may
ask you to sign a separate authorization to obtain some or all of your
medical records from your doctor. Your study records may include other
personal information (such as social security number, medical record
numbers, date of birth, etc.), which could be used to identify you. Health
information that could identify you is called "Protected Health Information"
(or "PHI"). [Please note: You must list any other PHI that may be used
or disclosed.]
Under federal law (the "Privacy Rule"), your PHI that is created or obtained
during this research study cannot be "used" to conduct the research or
"disclosed" (given to anyone) for research purposes without your
permission. This permission is called an "Authorization". Therefore, you
may not participate in this study unless you give your permission to use
and disclose your PHI by signing this Authorization. By signing, you are
agreeing to allow the study doctor [or "Investigator" as applicable] and
staff to use your PHI to conduct this study. [Please note: This document
must be study-specific. You must list any other uses of PHI by the
study doctor that are specific to your study.]
By signing this Authorization, you also are agreeing to allow the study
doctor [or “investigator” as applicable] to disclose PHI as described
below:
 The sponsor of this study and anyone working on behalf of the sponsor
to conduct this study (referred to as "the sponsor"). The sponsor will
analyze and evaluate the PHI and may use it to develop new tests,
procedures and commercial products. The study staff will assign a code
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number and/or letters to your records, which means that you will not
ordinarily be identified in the records sent to the sponsor. The sponsor
may, however, look at your complete study records that identify you. In
addition, the sponsor may visit the study site to oversee the way the
study is being conducted and may review your PHI during these visits to
make sure the information is correct.
 The Institutional Review Board ("IRB") may have access to your PHI in
relation to its responsibilities as an Institutional Review Board.
 [Please note: You must list other persons or classes of persons,
such as Data Safety Monitoring Board, insurance companies, etc.,
as applicable, to whom PHI may be disclosed.]
The study doctor or sponsor may disclose your PHI to the United States
Food and Drug Administration ("FDA") or similar regulatory agencies in the
United States and/or foreign countries.
These disclosures also help ensure that the information related to the
research is available to all parties who may need it for research purposes.
Except for the disclosures described above, your PHI will not be shared
with others unless required by law. If your PHI is given to the parties listed
above and/or to others who are not required to comply with the federal law,
your PHI will no longer be protected by this law and could possibly be used
or disclosed in ways other than those listed here.
You have a right to see and make copies of your PHI. You are agreeing,
however, by signing this document, not to see or copy some or all of your
PHI until the sponsor has completed all work related to this study. At that
time, you may ask to see your records.
This Authorization will expire 50 years from the date you sign it unless you
revoke (cancel or withdraw) it sooner.
You have a right to revoke your Authorization at any time. If you revoke it,
your PHI will no longer be used for this study, except to the extent the
parties to the research have already taken action based upon your
Authorization or need the information to complete analysis and reports for
this research. To revoke your Authorization, you must write to the study
doctor [or “investigator” as applicable], stating that you are revoking
your Authorization to Use and Disclose Protected Health Information. If
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you revoke this Authorization, you will not be allowed to continue to be in
this study.
You will receive a copy of this Authorization after you have signed it.
[Authorization for Use and Disclosure of Protected Health Information
for Optional Sub-Study – if applicable]
If you have agreed to participate in the optional sub-study [add description]
which was described in the Informed Consent above, your PHI may also be
used and disclosed for that study.
You may choose not to authorize the use and disclosure of your PHI for the
sub-study. If you decide not to authorize the use and disclosure of your
PHI for the sub-study, your decision will have no impact on your ability to
participate in the main study, and will have no impact on any other benefits
to which you would otherwise be entitled. However, if you do not authorize
the use and disclosure of your PHI for the sub-study, you will not be able to
participate in the sub-study.
[Either]
… the PHI which may be used and disclosed, the purposes for the use or
disclosure, and the individuals who may receive your PHI are the same as
described above for the main study. Your separate authorization for the
use and disclosure of PHI for the optional sub-study will expire along with
the authorization for the main study unless you revoke (take back) the
authorization as described above.
[Or]
… the following PHI may be used and disclosed in the sub-study [describe].
The PHI will be used for the following purposes [describe]. Your
information may be disclosed to the following individuals or groups:
[describe]. Your separate authorization for the use and disclosure of PHI for
the optional sub-study will expire along with the authorization for the main
study unless you revoke (take back) the authorization as described above.
Please indicate your preference below:
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□ I hereby authorize the use and disclosure of my information for the substudy [description] as described above.
□ I do not authorize the use and disclosure of my information for the substudy [description] as described above.
____________________________________
Printed Name of Subject
____________________________________
Signature of Subject
__________
Date
____________________________________
Printed Name of the Person Obtaining the
Authorization
____________________________________
Signature of the Person Obtaining the
Authorization
__________
Date
FOR SUBJECTS WHO CANNOT READ
The study subject has indicated that he/she is unable to read. This
Authorization document has been read to the subject by a member of the
study staff, discussed with the subject by a member of the study staff, and
the subject has been given an opportunity to ask questions of the study
staff.
____________________________________
Printed Name of Impartial Witness
____________________________________
Signature of Impartial Witness*
__________
Date
*Impartial Witness: A person, who is independent of the trial, who cannot be unfairly influenced by people involved
with the trial, who attends the informed consent process if the subject or the subject’s legally acceptable
representative cannot read, and who reads the informed consent and any other written information supplied to the
subject. Guidance for Industry E6 Good Clinical Practice: Consolidated Guidance
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