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INFORMED CONSENT FORM
You are being asked to be a subject in a
research study. The main goal of a research
study is to gain knowledge that may help
future patients, whereas routine care is based
upon the best known treatment and is
provided with the main goal of helping the
individual patient.
If you agree to participate in this study, you
will be asked to sign this informed consent
document. Informed consent is a written
agreement that you, or your authorized
representative, sign indicating willingness to
participate in this research. This informative
document will tell you about the purpose,
risks, and benefits of this research study. You
should consent only after you have been
given all the necessary information and have
had enough time to decide whether you wish
to participate. Your signature on this form is
voluntary and does not waive any of your
legal rights or make any institutions or
persons involved in this research any less
responsible for your well-being.
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[PLACE STUDY TITLE HERE:
Delete this heading and replace it with the title as it appears
on the protocol. Deviations from the title on the protocol and the Application
for Approval will not be accepted.]
This is a clinical trial, a type of research study. Your study doctor will explain
the clinical trial to you. Clinical trials include only people who can choose to
take part. Please take your time to make your decision about taking part.
You may discuss your decision with your friends and family. You can also
discuss it with your health care team. If you have any questions, you can ask
your study doctor for more explanation. [This can be amended if your study is
not a clinical trial]
[Include the following language for applicable clinical trials]: A description of
this clinical trial will be available on www.ClinicalTrials.gov, as required by
U.S. law. This website will not include information that can identify you. At
most, the website will include a summary of the results. You can search this
website at any time.
You are being asked to take part in this study because you [Fill in the specific
reason why the participant is being asked to participate. Include eligibility
requirements, if desired.]
WHO IS THE PRINCIPAL INVESTIGATOR FOR THIS STUDY?
[Fill in the investigator’s name and telephone number.]
WHY IS THIS STUDY BEING DONE?
The purpose of this study is to [Provide an explanation of why the study is being
done. Some examples are provided below.]
[If a Phase 1 study enrolling subjects with a medical condition:]
test the safety of [drug/intervention] at different dose levels. We want to find
out what effects, good and/or bad, it has on you and your [specify type of
medical condition.]
[If a Phase 2 study:]
find out what effects, good and/or bad, [drug/intervention] has on you and your
[type of medical condition.]
[If a Phase 3 study:]
compare the effects, good and/or bad, of the [drug/intervention] with
[commonly-used drug/intervention] on you and your [type of medical condition]
to find out which is better. In this study, you will get either the
[drug/intervention] or the [commonly-used drug/intervention]. You will not get
both.
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[If a placebo is used please use the following or similar language:]
Placebo is a product with no active drug in it, often called a "sugar pill" or
"dummy pill." It is compared to a drug in a clinical trial to see if the drug has a
real effect.
[If none of the above applies then briefly but accurately describe the purpose of this
study.]
[The following sentence must be included if the drug or device being studied is
investigational, which means it is not approved by the FDA.]
[Insert name of drug or device] is considered investigational, which means that
it is not approved by the Food and Drug Administration (FDA) [“for this use”
can be added here if the drug or device is approved but not for this indication].
HOW MANY PEOPLE WILL TAKE PART IN THIS STUDY?
About [state total accrual goal here] people will take part in this study.
Approximately {insert number} will be enrolled locally.
WHAT WILL HAPPEN IF I TAKE PART IN THIS RESEARCH STUDY?
[List tests and procedures and their frequency under the categories below. Include
whether a patient will be at home, in the hospital or in an outpatient setting and
approximately how long the visit or test/procedure/questionnaire will take.]
Before you begin the study...
You will need to have the following exams, test or procedures to find out if you
can be in the study. These exams, test or procedures are part of regular care
and may be done even if you do not join the study. If you have had some of
them recently, they may not need to be repeated. This will be up to your study
doctor.
 [List test and procedures as appropriate. Use bulleted format]
[For randomized studies:]
If these tests and procedures show that you can be in the study, you will be
“randomized” into one of the study groups described below. Randomization
means that you are put into a group by chance. It is like flipping a coin or
pulling numbers from a hat. Neither you nor the study doctor can choose what
group you will be in. You will have an [equal/one in three/etc.] chance of being
placed in any group.
If you are in group 1 … [Explain what will happen for this group with
clear indication of which interventions depart from regular care]
If you are in group 2 ... [Explain what will happen for this group with
clear indication of which interventions depart from regular care]
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[For studies with more than two groups, an explanatory paragraph
containing the same type of information should be included for each group]
During the study...
If the exams, tests and procedures show that you can be in the study, and you
choose to take part, then you will need the following tests and procedures.
They are part of regular care.
 [List test and procedures as appropriate. Use bulleted format]
You will need these tests and procedures that are part of regular care but they
are being done more often because you are in this study.
 [List test and procedures as appropriate. Use bulleted format. Omit this
section if no tests or procedures are being done more often than usual.
These are tests that may not be billed to the patient.]
You will need these tests and procedures that are either being tested in this
study or being done to see how the study is affecting your body.
 [List test and procedures as appropriate. Use bulleted format.]
When I am finished taking [drugs or intervention]...
[Explain the follow-up tests, procedures, exams, etc. required, including the timing
of each and whether they are part of regular care or part of regular care but being
performed more often than usual or being tested in this study. Define the length of
follow-up.]
[Optional feature: In addition to the mandatory narrative explanation found in the
preceding test, a simplified calendar, study chart or schema may be inserted here.
The schema from the protocol should be simplified if necessary to be
understandable to the lay person. Instruction for reading the schema, calendar,
etc. should be provided if appropriate.]
HOW LONG WILL I BE IN THIS STUDY?
You will be in this study for [months, weeks/until a certain event].
[For drug studies:]
You will be asked to take [drug/intervention] for [months, weeks/until a certain
event]. After you are finished taking [drug/intervention], the study doctor will
ask you to visit the office for follow-up exams for at least [indicate time frames
and requirements for follow-up. When appropriate, state that the study will involve
long-term follow-up and specify time frames and requirements of long-term
follow-up. For example “We would like to keep track of your medical condition for
the rest of your life. We would like to do this by calling you on the telephone once a
year to see how you are doing. Keeping in touch with you and checking on your
condition every year helps us look at the long-term effects of the study.]
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CAN I STOP BEING IN THIS STUDY?
Yes. You can decide to stop at any time. Tell the study doctor if you are
thinking about stopping or decide to stop. He or she will tell you how to stop
safely.
It is important to tell the study doctor if you are thinking about stopping so
any risks from the [drug/intervention] can be evaluated by your doctor.
Another reason to tell your doctor that you are thinking about stopping is to
discuss what follow-up care and testing could be most helpful for you.
The study doctor may stop you from taking part in this study at any time if
he/she believes it is in your best interest; if you do not follow study
instructions; or if the study is stopped.
WHAT SIDE EFFECTS OR RISKS CAN I EXPECT FROM BEING IN THIS
STUDY?
You may have side effects while on the study. Everyone taking part in the
study will be watched carefully for any side effects. However, doctors don’t
know all the side effects that may happen. Side effects may be mild or very
serious. Your health care team may give you medicines to help lessen side
effects. Many side effects go away after you stop taking the
[drug/intervention]. In some cases, side effects can be serious or long-lasting or
may never go away. [The next sentence should be included if appropriate. There
also is a risk of death].
You should talk to your study doctor about any side effects that you have
while taking part in the study.
Risks and side effects related to the [procedures, drug, interventions, devices]
include the following:
Very Common (Occurring in at least 10% of patients)
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Common (Occurring in in more than 1%, but less than 10%)
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Uncommon/Rare (Occurring in fewer than 1% of patients)
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[Notes for consent form authors regarding the presentation of risks and side
effects:
Using a bulleted format, list risks and side effects related to the investigational
aspects of the trial. Side effects of supportive medications should not be listed
unless they are mandated by the study.
List by regimen the physical and nonphysical risks and side effects of participating
in the study in three categories: 1." Very common"; 2. "common”; 3.
“uncommon/rare".
There is no standard definition of “very common" and “common”. As a guideline,
“very common” can be viewed as occurring in at least 10% of patients and
“common” in more than 1%, but less than 10% of patients. However, this
categorization should be adapted to specific study agents by the principal
investigator.
In the “very common” and “common” categories, identify those side effects that
may be ‘serious’. ‘Serious’ is defined as side effects that may require
hospitalization or may be irreversible, long-term, life threatening or fatal. To
identify the ‘serious’ risks, put a double asterisk (**) after the risk and a footnote
under the list explaining that risks with a double asterisk are considered serious
and include the definition of ‘serious’.
Side effects that occur in less than 1% of patients do not have to be listed unless
they are serious, and should then appear in the “uncommon/rare” category.
Physical and nonphysical risks and side effects should include such things as the
inability to work. Whenever possible, describe side effects by how they make a
patient feel, for example, “Loss of red blood cells, also called anemia, can cause
tiredness, weakness and shortness of breath.”
For some investigational drugs/interventions/devices there may be side effects that
have been noted during treatment however not enough data is available to
determine if the side effect is related to the drug/intervention/device. Because some
local IRBs request to be informed of these possible side effects, this information,
when available, is provided to the study chair.]
If appropriate to the study, include the following statement: [drug, intervention or
device] may cause side effects to you (and an unborn baby) that are currently
unforeseeable.
[If study poses reproductive risks:]
Reproductive risks: Because the [drug, intervention or device] used in this
study can affect an unborn baby, you should not become pregnant or father a
baby while in this study. Women should not breastfeed a baby while on this
study. It is important you understand that you need to use birth control while
on this study. Check with your study doctor about what kind of birth control
methods to use and how long to use them. Some methods might not be
approved for use in this study. [Include a statement about possible sterility
when appropriate. For example “Some of the drugs used in this study may make
you unable to have children in the future.”]
[If appropriate, include a statement that pregnancy testing may be required.]
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[If this clinical trial is being conducted at St. John’s Hospital, and includes
reproductive risks, the following language is required and CANNOT be modified.]
If you are a patient at St. John’s Hospital, you should be aware that St. John’s
(an Affiliate of Hospital Sisters Health System), a Catholic health care facility,
adheres to the Ethical and Religious Directives for Catholic Health Care
Services. St. John’s is not endorsing birth control; however, in order to
maintain compliance with the study, we are required to provide this
information to participants, as a matter of public safety. Please note that no
method of birth control besides complete abstinence provides 100%
protection from pregnancy. If you are concerned about the morality of
methods of birth control, please consult your religious advisor before agreeing
to participate in this study.
For more information about risks and side effects, ask the researcher.
ARE THERE BENEFITS TO TAKING PART IN THIS STUDY?
If you agree to take part in this study, there may or may not be medical benefit
to you. We hope the information learned from this study will benefit other
patients with [specify medical condition] in the future.
WHAT OTHER OPTIONS ARE THERE?
Instead of being in this study, you have these options:
You could choose not to participate in this study.
[List alternatives including commonly-used/standard therapy and, if applicable,
You could choose no therapy at this time but receive only care to help you feel
more comfortable.]
[If appropriate (for non-investigational treatments), You may receive [study
treatment/drug at this center and other centers] even if you do not take part in
this study.]
Please talk to your regular doctor or the study doctor about these and other
options.
WILL MY MEDICAL INFORMATION BE KEPT PRIVATE?
We will do our best to make sure that the personal information in your
medical record will be kept private. However, we cannot guarantee total
privacy. Your personal information may be given out if required by law. If
information from this study is published or presented at scientific meetings,
your name and other personal information will not be used.
[Include if genetic analyses will be done] A federal law called the Genetic
Information Nondiscrimination Act (GINA) generally makes it illegal for
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health insurance companies, group health plans, and employers with 15 or
more employees to discriminate against you based on your genetic
information. GINA does not protect you against genetic discrimination by
companies that sell life insurance, disability insurance, or long-term care
insurance. GINA also does not protect you against discrimination based on an
already-diagnosed genetic condition or disease.
[Include the following language for protocols that require HIV, STD and/or
communicable diseases testing]: State law may require that you sign a separate
consent form for HIV, Sexually Transmitted Diseases (STD) or communicable
diseases testing. Test results may be reportable to the Illinois Department of
Public Health (IDPH). For more information please visit
http://www.idph.state.il.us/.
WHAT ARE THE COSTS?
You and your health care plan or insurance company will need to pay
for some or all of the costs in this study. Some health plans will not pay
these costs for people taking part in research studies. Check with your
health care plan or insurance company to find out what coverage they
will provide. Taking part in this study may or may not cost you and
your insurance company more than the cost of receiving regular
treatment. [The preceding sentences can be deleted if ALL costs for the
study are being covered by the sponsor or grant]
The following tests and/or procedures are required solely for the
purposes of this research study: [Provide a list of the research related
tests and procedures and explain who will be paying for these
tests/procedures, whether it will be the sponsor or if the subject will be
responsible. This paragraph should be appropriate to your study and
clearly explain any costs the subject might incur as a result of participation.
Consider including insurance co-payments as a cost the subject will be
responsible for if applicable.]
[The following sentence should be deleted if the study does not involve a
drug or device or if the drug or device is not being provided] [Drug/device]
will be provided to you at no cost to you or your insurance company.
You or your insurance company will be charged for continuing
medical care and/or hospitalization at the usual rate.
You will or will not [choose one] be paid for taking part in this study.
[If the subjects will be paid for taking part, further explain how much or
what they will receive and when and how they will receive the money and/or
gift. Keep in mind, payment for participation must be distributed
throughout the course of the study, it cannot be withheld until completion]
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[Insert the following language if this study is being funded by a grant
from an industry company]: SIU School of Medicine and the Principal
Investigator, [insert PI name] received a grant from [insert company
name] to support the costs of conducting this clinical trial. [insert company
name] is the manufacturer of the drug/device (insert name of drug/device)
being used in this study. [If applicable]: [insert company name] is also
providing the drug/device free of charge to subjects while participating in
this study.
WHAT HAPPENS IF I AM INJURED BECAUSE I TOOK PART IN THIS
STUDY?
[The following paragraph may not be modified unless the sponsor will pay for
research-related injury. If the sponsor will pay for research-related injuries, the
language “at usual and customary fees” should be deleted from the following
paragraph and a statement should be added to inform the subject that the sponsor
will pay for research-related injuries. The sponsor must pay for all or no
research-related injuries, as it violates the Medicare Secondary Payer Rule to state
that the sponsor will pay for those costs not covered by insurance. Please note: If
the sponsor will pay for research-related injuries, a letter on company letterhead
or a model consent form substantiating this claim must be submitted to the SCRIHS
office for documentation.]
In the event of any injury or illness resulting from study procedures,
immediate medical treatment for injuries is available at usual and customary
fees at Memorial Medical Center or St. John’s Hospital, Springfield, Illinois.
Your medical expenses will be your responsibility or that of your third-party
payer, although you are not precluded from seeking compensation for injury
related to your participation in the research study.
If you suffer any physical injury as a result of participation in this study, you
should contact the Chairperson of the Springfield Committee for Research
Involving Human Subjects at:
Southern Illinois University School of Medicine
201 E Madison Avenue
PO Box 19664
Springfield, IL 62794-9664
Telephone number: (217) 545-7602
WHAT ARE MY RIGHTS AS A PARTICIPANT?
Taking part in this study is voluntary. You may choose not to take part or
may leave this study at any time. Leaving this study will not result in any
penalty or loss of benefits to which you are entitled.
We will tell you about new information that may affect your willingness to
stay in this study.
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WHO WILL USE AND SHARE INFORMATION ABOUT MY PARTICIPATION
IN THE STUDY?
This section explains who will use and share your study-related health
information if you agree to participate in this study.
A federal privacy law, the Health Insurance Portability & Accountability Act
(HIPAA), protects your individually identifiable health information
(protected health information). The privacy law requires that you agree to
allow researchers to use and/or disclose your protected health information for
research purposes in this study. This agreement will be documented by
signing this consent.
During the study, the researchers will use, collect, and record health
information about you. This can include any information about you that the
study doctor needs to conduct this study.
The protected health information that may be used and/or disclosed includes:
[List all protected health information to be collected for this protocol/study from
among the list below. Choose only the elements that apply.]
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Names
All geographical subdivisions smaller than a State, including street address,
city, county, precinct, zip code, and their equivalent geocodes, except for the
initial three digits of the zip code if according to the current publicly available
data from the Bureau of the census: a) the geographic unit formed by combining
all zip codes with the same three initial digits contains more than 20,000
people; and b) the initial three digits of a zip code for all such geographic units
containing 20,000 or fewer people is changed to 000.
All elements of dates (except year) for dates directly related to an individual,
including birth date, admission date, discharge date, death date; and all ages
over 89 and all elements of dates (including year) indicative of such age, except
that such ages and elements may be aggregated into a single category of age 90
or older.
Telephone numbers
Fax numbers
Electronic mail addresses
Social security numbers
Medical record numbers
Health plan identification numbers
Account numbers
Certificate/license numbers
Vehicle identifiers and serial numbers, including license plate numbers
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Device identifiers and serial numbers
Web Universal Resource Locators (URLs)
Internet Protocol (IP) address numbers
Biometric identifiers, including finger and voice prints
Full-face photographic images and any comparable images
Any other unique identifying number, characteristic or codes
If you sign this consent, you agree to allow the study doctor and research team
to use and/or disclose your protected health information described above
with:
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Southern Illinois University School of Medicine’s Institutional Review Board:
The Springfield Committee for Research Involving Human Subjects (SCRIHS)
Government representatives, when required by law
Hospitals [List Memorial Medical Center and/or St. John’s Hospital if study
uses these facilities]
SIU HealthCare
SIU School of Medicine
[List any collaborators, outside laboratories, etc.]
[If applicable – list the sponsor’s name]
[List any other groups with whom the information may be shared]
[If applicable - statement that primary physician will be contacted if researcher
in the course of the project learns of a medical condition that needs immediate
attention]
U.S. Food and Drug Administration (If an FDA regulated clinical trial)
Office for Human Research Protections (OHRP)
There are national and state laws that require the study doctor to protect the
privacy of your records. However, you do not have a guarantee of absolute
privacy. Some information may be subject to re-disclosure. If this should
occur, your information may no longer be covered/protected by the federal
privacy protections.
If you would like to know how the sponsor would protect the privacy of your
records, ask the study doctor how to get this information.
You have the right to see and copy your records. However, if you sign this
consent form, you may not be able to see or copy some records until all
subjects complete the study. Once the study has ended, you will be able to see
and copy your records.
You can withdraw your consent to use and share your records at any time. If
you choose to withdraw your authorization, you must submit this request in
writing to [name and contact information of investigator] to inform him/her of
your decision.
If you decide to withdraw from this study, federal regulations may allow the
data collected about you to continue to be used for the purposes of the study.
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Please be sure to ask the study doctor about your options for removing your
data should you withdraw from this study.
WHOM DO I CALL IF I HAVE QUESTIONS OR PROBLEMS?
For questions about this study or a study-related injury, contact the study
doctor [name] at [telephone number].
For questions about your rights as a study participant, contact the Springfield
Committee for Research Involving Human Subjects (which is a group of
people who review the study to protect your rights) at:
Southern Illinois University School of Medicine
201 East Madison
P.O. 19664
Springfield, IL 62794-9664
Telephone number: (217) 545-7602
The Chairperson of this committee will review the matter with you.
DOCUMENTATION OF INFORMED CONSENT
AFTER SIGNATURES ARE OBTAINED FROM YOU AND
AUTHORIZED STUDY PERSONNEL LISTED BELOW, A SIGNED COPY
OF THIS CONSENT WILL BE GIVEN TO YOU.
You are voluntarily making a decision whether to participate in this study.
Your signature means that you have read and understood the information
presented and have decided to participate. Your signature also means that
the information on this consent form has been fully explained to you and all
your questions have been answered to your satisfaction. If you think of any
additional questions during this study, you should contact the study doctor(s).
I agree to take part in this study.
Signature of Participant, Legal Guardian, or Power of Attorney
Date
_______________________________________________________________________________
Print Name
I certify that all the elements of informed consent described on this consent
form have been explained fully to the participant. In my judgment, the
participant has voluntarily and knowingly given informed consent and
possesses the legal capacity to give informed consent to participate in this
study.
_______________________________________________________________________________
Authorized Study Personnel
Date
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_______________________________________________________________________________
Print Name
AUTHORIZED STUDY PERSONNEL CAPABLE OF OBTAINING INFORMED
CONSENT FROM PARTICIPANTS
[All persons authorized to obtain consent must be listed below. Include after each person’s name
their terminal degree and a telephone number where they may be reached. These persons must be
active participants and have full knowledge of the purpose and risks of participating in the research
study. Please refer to the SCRIHS guidance document “Who is Considered ASP?”. All ASP must
have completed the CITI education training]
Principal Investigator
John M. Smith, M.D.
Office: (217) 555-0000
Co-Investigator(s)
Mark H. Frank, M.D.
Sue P. Kline, M.D.
Office: (217) 555-1111
Office: (217) 555-2222
Participating Physician(s) and Participating Health Care Personnel
Karen M. White, R.N.
Office: (217) 555-3333
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