Thomas Jefferson University
Principal Investigator
Abbreviated Title
Telephone
IRB Control #
Sponsor
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Thomas Jefferson University
Informed Consent Document for Human Subjects Research – OHR-8K (v.12/2/2014)
Department:
Principal Investigator:
Telephone:
Co-Investigator(s):
Telephone:
Medical Study Title:
Lay Study Title: A research study to …..
______
__________________________________________________________________
Please delete this sentence and all blue and red text before submitting.
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What is informed consent?
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You are being asked to take part in a medical research study. As required by federal regulations,
this research study has been reviewed and approved by an Institutional Review Board (IRB),
which is a committee that reviews, approves, and monitors research involving humans. Before a
knowledgeable decision about whether to participate in a research study can be made, the
possible risks and benefits related to the study should be understood. This process of learning
and thinking about a study before deciding to participate is known as informed consent and
includes:
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


Receiving detailed information about this research study;
Being asked to read, sign and date this consent form once the nature of the study is
understood and a decision is made to participate. If there is anything about the study you
don’t understand or if there are questions, you should ask for explanations before signing
this form;
Being given a copy of the signed and dated consent form to keep.
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A patient who joins a research study has a relationship with the study doctor that is different than
the relationship with a treating or personal doctor. A treating doctor treats a specific health
condition with the goal of improving that condition. A study doctor treats all subjects according
to a research plan to obtain information about the experimental drug, device, or procedure being
studied and with the understanding that there may or may not be benefit from being in the study.
The study doctor and study staff can provide more information about research as opposed to
treatment.
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The type of study you are being asked to join is known as a Phase _____ study. (Insert 2, 3, or 4
and include the appropriate description below. Delete the rest.)
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A Phase 2 research study is done to get further information on safety, dosage, and side effects,
and to collect preliminary information about how well a drug works. Phase 2 studies usually
have very strict rules about who may and who may not be in the study. Phase 2 studies may
Protocol ver. (MM/DD/YYYY); TJU ICF ver. (MM7DD/YYYY)
Thomas Jefferson University
Principal Investigator
Abbreviated Title
Telephone
IRB Control #
Sponsor
Page 2 of 6
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compare the new drug to a placebo (inactive substance) or to a known treatment and usually
enroll about 100 subjects.
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A Phase 3 study is done on large numbers of individuals using the best dose as discovered in
earlier phase studies. Phase 3 studies may compare a new drug to a placebo (inactive substance)
or to other available treatments. There are usually strict rules about who may and who may not
participate in the studies. Phase 3 studies may enroll hundreds or even thousands of subjects.
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A Phase 4 study is done after a drug has been approved by the Food and Drug Administration
(FDA). Phase 4 trials find out how the new drug works and what are the side effects when used
in the “real world” – that is in patients who may have other medical conditions in addition to the
one the drug is designed to treat, and who may be taking other medications for these conditions.
Phase 4 studies may enroll tens of thousands of subjects.
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Identify the corresponding sections of the study consent, as described below, and insert the
necessary text.
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1. In the section that addresses the number of subjects that will participate in the trial,
include the sentence below. If applicable, remove, “and the Sidney Kimmel Cancer
Network sites.”
We plan to enroll XX patients at Jefferson and the Sidney Kimmel Cancer Network sites.
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2. In the section that addresses reproductive risks, please include the following paragraph.
If you are a person in a same sex relationship, it is not necessary for you to practice birth control.
However, if you are female, you will still have to have pregnancy tests according to the study
protocol.
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3. In the section that identifies alternatives to being in the study, include the following option,
if an equivalent statement is not already in the consent template.
Join a different research study.
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4. In the section that addresses how privacy and confidentiality will be protected, include the
following paragraphs.
The following individuals or entities will have access to your PHI and by law must protect it.
These include investigators listed on this consent form and other personnel of Thomas Jefferson
University, Jefferson University Physicians, and Thomas Jefferson University Hospitals, Inc.
involved in this specific study, the University’s Division of Human Subjects Protection and the
Institutional Review Board (IRB), and your health insurance company (if necessary for billing
for standard medical care).
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The following information will be provided to the study sponsor and other entities noted in this
consent form:
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Study data for analysis: (supply the types of data, e.g., lab results, imaging studies, medical
history, questionnaire results)
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Demographic data: (e.g., age, sex, race, ethnicity)
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Other: (describe or delete if none– include photo, audiotapes, etc. if applicable)
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Thomas Jefferson University
Principal Investigator
Abbreviated Title
Telephone
IRB Control #
Sponsor
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If you develop an illness or injury during the course of participation in this study, other PHI
about treating and following the condition may be generated and disclosed as it relates to this
study.
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PHI collected as part of this research may be used/disclosed until the end of the research study
OR indefinitely. (Choose appropriate option or specify a time limit.)
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You may quit the study and revoke permission to use and share PHI at any time by contacting
the principal investigator, in writing, at:
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(Insert name and address of PI)
Further collection of PHI will be stopped on those who quit the study, but PHI that has already
been collected may still be used.
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5. If the consent template does not address research-related injuries, include the section
below. If research-related injury is already addressed in the consent template, do not
include the section.
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What happens in case of injury as a result of being in this study?
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In the event of a research-related injury, necessary and available medical care (including
hospitalization) will be provided. A research-related injury is a physical injury or illness that is
directly caused by any procedure or treatment used in this study that is different from the
treatment you would receive if not participating in a research study. If physical injury occurs due
to any drug/substance or procedure properly given under the plan for this study, medical
expenses for treating the injury will be billed to your insurance carrier. You should be aware that
some costs may not be covered by insurance and may become your responsibility. There is no
plan to provide compensation for loss of wages, lost time from work, personal discomfort, or for
injuries or problems related to your underlying medical condition(s).
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If you receive a bill related to a research-related injury that seems wrong, please discuss it with
the study doctor or research coordinator.
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6. In the section of the consent form addressing potential costs related to being in the study,
include the following sentence:
If you receive a bill that you think is wrong, please discuss it with the study doctor or research
coordinator.
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7. In the section of the consent form addressing that a subject may be removed from the study
or quit the study, include the following sentence.
If you withdraw from this study, you may continue treatment with your Jefferson doctor, or you
may seek treatment from another doctor of your choice.
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8. Include the following section somewhere in the consent form. Enter the name of the
sponsor in the blank.
Protocol ver. (MM/DD/YYYY); TJU ICF ver. (MM7DD/YYYY)
Thomas Jefferson University
Principal Investigator
Abbreviated Title
Telephone
IRB Control #
Sponsor
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Disclosure of Financial Interest
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The sponsor of this clinical study, _______, is paying Thomas Jefferson University to conduct
this study.
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9. Include the following section towards the end of the consent form. Phone numbers and
websites are subject to change. If so, please update with most current information.
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Contact Information
For questions about
your rights as a
research participant,
call:
For questions,
concerns or
complaints about
the research, or if
you suspect a
research-related
injury, call:
The Jefferson
Institutional Review
Board
If you have
difficulty contacting
the study staff, call:
For further
questions about the
study, call:
The Jefferson Office of
Human Research
215-503-0203
The Operations Office of
the NCI Central
Institutional Review
Board (CIRB)
NCI Cancer Information
Center
1-888-657-3711
(from continental US only)
For more
information:
215-503-8966
The Principal
Insert telephone number
Investigator,
Dr.
_____________________
or any co-investigator
listed at the beginning of
this form
NCI website
For NCI’s clinical trials
information
For NCI’s general
information about cancer
1-800-4-CANCER
(1-800-422-6237)
Or TTY: 1-800-332-8615
http://cancer.gov
http://cancer.gov/clinicaltrials/
http://cancer.gov/cancerinfo/
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If you want more information about the Jefferson Institutional Review Board or Jefferson’s
Human Research Protection Program, please visit our website at
http://www.jefferson.edu/university/human_research/irb/html.
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Subject Communications
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Do you wish to communicate with the study staff by e-mail? YES _____ NO _____
If you checked yes, please print your e-mail address on the line below.
Protocol ver. (MM/DD/YYYY); TJU ICF ver. (MM7DD/YYYY)
Thomas Jefferson University
Principal Investigator
Abbreviated Title
Telephone
IRB Control #
Sponsor
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______________________________________________________________________________
RISKS: E-mail correspondence is not always secure and there is a risk of loss of confidentiality.
To help protect against loss of confidentiality, all e-mail that originates from Jefferson University
or Jefferson Hospital employees using a Jefferson e-mail addresses is encrypted. That means,
unless you have allowed others to have access to your e-mail, only you will see the e-mail.
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YOU SHOULD NEVER USE E-MAIL TO REPORT A SUSPECTED ADVERSE EVENT OR
ANY OTHER MEDICAL PROBLEM. THESE SHOULD BE REPORTED BY TELEPHONE.
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Protocol ver. (MM/DD/YYYY); TJU ICF ver. (MM7DD/YYYY)
Thomas Jefferson University
Principal Investigator
Abbreviated Title
Telephone
IRB Control #
Sponsor
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Non-Waiver of Legal Rights Statement
 By your agreement to participate in this study, and by signing this consent form, you
are not waiving any of your legal rights.
 In order to be in this research study, you must sign this consent form.
 You affirm that you have read this consent form. You have been told that you will
receive a copy.
SIGNATURES
Your Name
(Date)
(Date)
Your Signature
Witness Signature
(Only required if subject understands and speaks
English, but cannot read English, or if subject is blind
or cannot physically sign the consent form)
Name of Person Conducting Consent Interview
(Date)
Signature of Person Conducting Consent Interview
(Date)
Signature of Principal Investigator or
Co-Investigator
Version History:
Date_Reason for update_Editor’s initials
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Protocol ver. (MM/DD/YYYY); TJU ICF ver. (MM7DD/YYYY)