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-8 (v.1/20/16)
Department:
Principal Investigator:
Telephone:
Co-Investigator(s):
Telephone:
Medical Study Title:
Lay Study Title: A research study to …
______
__________________________________________________________________
SEE OHR-8I (GUIDANCE FOR COMPLETING THE OHR-8 UNIVERSAL TEMPLATE FOR
INSTRUCTIONS AND SUGGESTIONS FOR COMPLETING THE CONSENT FORM)
Please delete the above guidance statement, all highlighting and italicized print, and any remaining
instructions before submitting.
What Is Informed Consent / Parental Permission? (delete one or the other)
You/Your child are/is 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), a University 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:
 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/you and/or your child should ask for
explanations before signing this form;
 Being given a copy of the signed and dated consent form to keep...
(Delete the paragraph below if there is no therapeutic intervention or if only recruiting healthy
controls)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
Thomas Jefferson University
Principal Investigator
Abbreviated Title
Telephone
IRB Control #
Sponsor
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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.
This prompt and the following section should be deleted for studies that do not use
experimental drugs or for experimental uses of approved drugs
The type of study you are being asked to join is known as a Phase _____ study. (Insert 1, 2, 3, 4
or Pilot and pick the appropriate description below. Delete the rest).
Phase 1 research studies are designed to determine the safe dose range and side effects of a new
drug and how the body absorbs and gets rid of the drug. Phase 1 studies are usually done on
healthy individuals. Phase 1 studies of anti cancer drugs are nearly always done on patients with
cancer.
Phase 2 research studies are done to get further information on safety, dosage, and side effects,
and to collect preliminary information about how well a drug works (often referred to as
efficacy). Phase 2 studies usually have very strict rules about who may and who may not be in
the study. Phase 2 studies may compare a new drug to a placebo (inactive substance) or to a
known treatment.
Phase 3 studies are done on large numbers of individuals using the best dose of a drug as
discovered in earlier phase studies in order to establish how well the drug works (often referred
to as efficacy). Phase 3 studies may compare a new drug to a placebo (inactive substance) or to
other available treatments.
Phase 4 studies 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.
A pilot study is one that is done to collect information to determine whether a larger,
scientifically rigorous study should or should not be undertaken.
What is the purpose of this study?
How many individuals will participate in the study and how long will the study last?
XXX patients will participate nationally/worldwide. (delete the irrelevant one) We hope to enroll
XX patients at Jefferson. Each participant will be in the study for about ____
days/weeks/months/years (select appropriate response, delete others).
Thomas Jefferson University
Principal Investigator
Abbreviated Title
Telephone
IRB Control #
Sponsor
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What will happen during the study?
(Do not describe standard of care treatment/procedures
unless they are an integral part of the study. If appropriate, indicate that the subject will be asked to
sign a separate consent regarding standard tests/procedures)
What are the side effects and other risks or discomforts involved? (For minimal risk studies or
if only risk is loss of confidentiality or psychological discomfort, indicate the potential risks and delete
the remainder of this section)
Tell the study doctor or research team as soon as possible if any of the side effects, risks or
discomforts listed below occur or if you/your child think(s) a side effect that is not listed may be
happening.
If your/your child’s condition worsens, if side effects become very severe, or if it turns out that
being in this study is not in your/your child’s best interest, you/your child will be taken out of the
study.
If questions come up about side effects, ask the study doctor or staff at any time during or after
the study.
DESCRIBE SIDE EFFECTS/RISKS IN LAY LANGUAGE ONLY. DO NOT USE
MEDICAL OR SCIENTIFIC TERMS UNLESS THEY ARE IN GENERAL USE BY THE
PUBLIC
Common, some may be serious, could happen in 20% or more of subjects
(provide bulleted list)
Occasional, some may be serious, could happen in 3-20% of subjects
(provide bulleted list)
Rare and serious, possible in up to 3% of subjects (side effects occurring in fewer than 3% of
subjects need not be listed unless they are deemed serious or there is sponsor requirement)
(provide bulleted list if applicable)
For Phase 1 studies or some IND drugs where the side effect profile is not well defined or not yet
determined, can use the following (delete this section if not applicable):
Possible Side effects, some may be serious (frequency unknown at this time)
(bulleted list)
You may or may not have more side effects depending on what group you are assigned to.
If applicable, include the following statement at the end of the side effects list(s)
Thomas Jefferson University
Principal Investigator
Abbreviated Title
Telephone
IRB Control #
Sponsor
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At study visits or at other times if the study doctor decides it is necessary, blood tests will be
done to check the function of your heart, lungs, liver, kidneys, and bone marrow (where blood
cells are produced). Abnormal tests will be assessed by the study doctor who will determine if
further testing is necessary. The study doctor will discuss test results with you.
(Delete the sections below that do not apply)
What are the risks to fetuses, infants and pregnant women
OPTION 1 (APPLIES TO MOST GREATER THAN MINIMAL RISK STUDIES)
Pregnant women or women who are breast feeding will not be enrolled in this study. To be in this
study you and your partner must practice adequate birth control measures. The study doctor will
discuss acceptable methods of birth control with you. If you are a woman of childbearing
potential, you will have a pregnancy test before making a decision about being in this study. The
results of this pregnancy test will be made available to you prior to the start of the study.
If you become pregnant during the course of this study, you should notify the study doctor as
soon as possible. (delete if not relevant, for instance, if study takes place only in the OR or is a
one-day study under constant monitoring, etc.)
If you are a man participating in this study, you also should practice adequate birth control
because of potential adverse effects on sperm. If your partner becomes pregnant during the
course of the study, the sponsor may want to follow her through the pregnancy and receive
information on the pregnancy outcome. She will be asked to sign a separate consent form or a
release of medical information form.
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.
OPTION 2 (FOR RELATIVELY LOW RISK STUDIES ENROLLING ADULTS)
Women who are pregnant, breast feeding, or who are planning to become pregnant within the
next XX months should not be in this study. Prior to enrollment in the study you will have a
pregnancy test done that will require a blood sample or urine specimen for testing. The results of
the pregnancy test will be given to you. Additional pregnancy tests may be ordered during the
course of the study at the discretion of the study doctor.
OPTION 3 (RESEARCH INVOLVING MINORS)
Thomas Jefferson University
Principal Investigator
Abbreviated Title
Telephone
IRB Control #
Sponsor
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What if my child is pregnant or becomes pregnant?
Pregnant women will not be enrolled in this study. If your child is a female able to have children
(your child has menstrual periods), she will have a pregnancy test before making a decision about
participating in this study. The pregnancy test requires that blood be drawn from a vein in your
child’s arm (about 1 tsp.) or that a urine sample be tested one or two days prior to the start of the
treatment program. The results of the pregnancy test will be made available to your child prior to
the initiation of this study.
Presently, your child is not pregnant and should not plan to become pregnant while participating
in this study. Your child has been advised to routinely practice a medically-accepted method of
birth control. Such methods will be discussed with your child by the study physician.
If your child is pregnant or breast feeding, she cannot participate in this study. Your child should
not plan to become pregnant while participating in this study. If sexually active, your child
should use effective birth control to prevent pregnancy while participating in this study. Where
appropriate, the study physician will discuss issues regarding sexual activity and the use of
effective contraception privately with your child. Results of any pregnancy test conducted during
the course of the study will be made available to your child. By law, all minors age 12 or over
have a right to confidentiality when discussing issues of pregnancy and contraception with a
physician. While a desired outcome of these discussions is the sharing of this information with
the family, the decision whether to do so is up to your child and alternative support will be
provided to her when necessary.
If your child is a sexually-active male, he should also practice birth control measures since
experimental drugs may have an adverse effect on sperm and therefore could also adversely
affect a fetus.
Are there benefits from being in this study?
There may be no benefit from being in this research, but we hope that what we learn may be
helpful to future patients or society in general. Possible benefits from being in the study may
include: (Please list additional benefits or delete the last sentence)
Are there alternatives to being in the study?
Participation in this study is entirely voluntary. (Delete everything that follows in this section if not
a device, or therapy study) There may be other alternatives that could be considered.. These
alternatives would include: (Describe alternatives)
The study doctor will provide information about the study and any alternative treatments
available..
How will privacy and confidentiality (identity) be protected?
Thomas Jefferson University
Principal Investigator
Abbreviated Title
Telephone
IRB Control #
Sponsor
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Federal regulations require that certain information about individuals be kept confidential. This
information is called “protected health information” (PHI). PHI includes information that
identifies an individual personally such as name, address and social security number, or any
medical or mental health record, or test result, that may have this sort of information on it. The
laws state that people may see and review their medical records at any time. However, in a
research study, people may not see the study results or other data about the study until after the
research is completed unless the study doctor decides otherwise.
The following individuals or entities may have access to your/your child’s 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. (add the Rothman Institute if applicable) involved in this specific study, the
University’s Office of Human Research and the Institutional Review Board (IRB), and your/your
child’s health insurance company (if necessary for billing for standard medical care).
PHI collected during this study may also be shared with the following entities that, while not
obligated by law to protect PHI, will protect it to the best of their ability: (delete any entities below
that are not relevant and add any entities necessary)






(Insert name of sponsor) which is providing funds to Thomas Jefferson University to
conduct this research
The Food and Drug Administration (FDA)
A Contract Research Organization (CRO) (supply name of organization) which has been
hired by the sponsor to coordinate the study
A Data and Safety Monitoring Committee (DSMC),
Research Monitors hired by the sponsor to oversee the study and review medical records
to ensure study-related information is correct,
With any person or agency required by law.
The following information will be provided to the study sponsor and other entities noted above:
Study data for analysis: (supply the types of data, e.g., lab results, imaging studies, questionnaire
results)
Demographic data: (Race and Ethnicity if federally funded and include any other information that
is relevant) ):
Other: (describe or delete if none– include photo, audiotapes, etc. if applicable)
If you/your child develops 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.
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)
Thomas Jefferson University
Principal Investigator
Abbreviated Title
Telephone
IRB Control #
Sponsor
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You/Your child may quit the study and revoke permission to use and share PHI at any time by
contacting the principal investigator, in writing, at: (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.
The results of clinical tests and procedures performed as part of this research may be included in
your/your child’s medical records. The information from this study may be published in scientific
journals or presented at scientific meetings but no one will be personally identified in these
publications and presentations.
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.
What happens in case of injury as a result of being in this study? In the event of a researchrelated 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/your child 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. (If a sponsored study, delete the preceding
sentence and keep the following sentence. If not sponsored or if supported by a grant or NIH, delete the
following sentence) Costs not covered by your insurance, a government program or by another 3rd
party may be paid for by the sponsor of this study. 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).
(If sponsored study insert the following sentence, if not delete it) If you have questions about
the sponsor’s agreement regarding payment for a research-related injury please discuss with the
study doctor.
If a bill related to a research-related injury is received that seems wrong, please discuss it with
the study doctor or research coordinator.
Is there payment for being in this study?
There is/is not(choose one) payment for participating in this study. (If payment is involved, indicate
how much for each visit and the total amount at the end of the study)
Disclosure of Financial Interest
(If this is a sponsored study, complete the sentence below. If not, delete this section)
Thomas Jefferson University
Principal Investigator
Abbreviated Title
Telephone
IRB Control #
Sponsor
Page 8 of 12
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The sponsor of this clinical study, _______, is paying Thomas Jefferson University/the Rothman
Institute to conduct this study.
Are there costs related to being in this study?
Research Procedures (Describe the procedures that are experimental)
There are no charges to you or your insurance carrier for study visits or tests that are part of this
research. The investigational agent/device (choose one) will be provided by the sponsor free of
charge OR The cost of the investigational agent/device (choose one) will be the responsibility of
you or your insurance carrier. (choose one or the other of the preceding statements).
(Delete the following two sentences if they do not apply) In some research studies there are costs
related to giving a medication or having surgery to implant a device and these may be billed to
insurance. If that is the case, the study doctor will discuss this with you/your child before
you/your child agree/agrees to be in the study. If a study drug or device becomes commercially
available while the study is in progress, you may be asked to purchase it yourself through
insurance until the end of your/your child’s participation in the study.
Standard Testing Procedures
Standard of care procedures and doctor visits will be billed to your/your child’s health insurance
carrier. These are charges that would be billed to insurance whether in a research study or not. It
is possible that insurance coverage may be denied. If that happens you/your child may be
responsible for some or all of these charges. The study doctor will explain which procedures,
tests and doctor visits are considered standard of care.
If a bill is received that you think is wrong, please discuss it with the study doctor or research
coordinator.
What if the research results in new findings?
Anything learned during the study, beneficial or not, that may affect your/your child’s health or
willingness to continue in the study, will be explained.
Can I/my child be removed from the study or quit the study?
(Please adjust wording in the paragraphs below if not a treatment or device study)
Your/Your child’s decision to participate in this research study is entirely voluntary. You/Your
child have/has been told what being in this study will involve, including the possible risks and
benefits.
Thomas Jefferson University
Principal Investigator
Abbreviated Title
Telephone
IRB Control #
Sponsor
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Your/Your child’s participation in this research project may be terminated by the study doctor or
study sponsor (delete sponsor if not relevant) without your/your child’s consent/assent for any
reason that he/she feels is appropriate. (You may also add specific circumstances for removal of
a subject from the study)
You/Your child may refuse to participate in this investigation or withdraw consent and quit this
study without penalty and without affecting the ability to receive medical care at Thomas
Jefferson University/the Rothman Institute.
If you/your child withdraw/withdraws from this study, you/your child may continue treatment
with your/his/her Jefferson/Rothman doctor, or you/your child may seek treatment from another
doctor of your/your child’s choice.
Should you/your child decide to withdraw from the study, please be sure to inform the study
doctor. Additional tests or procedures may be needed to ensure your safety. The study doctor
will explain why these tests or procedures are necessary. (remove last two sentences if minimal
risk study)
CONTACT INFORMATION
If you are having a medical emergency, call 911 or go directly to an emergency room. You
should let emergency personnel or providers know that you are participating in this study.
Telephone number for
questions about your rights as
a research participant
For questions, concerns or
complaints about the research,
or if you suspect a researchrelated injury
The Jefferson Institutional
Review Board
215-503-8966
The Principal Investigator,
Dr. _____________________
or any co-investigator listed at
the beginning of this form
Insert telephone number
If you have difficulty
contacting the study staff
Call the Jefferson Office of
Human Research
215-503-0203
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/human_research/irb/index.cfm.
Subject Communications
Do you wish to communicate with the study staff by e-mail? YES _____ NO _____
Thomas Jefferson University
Principal Investigator
Abbreviated Title
Telephone
IRB Control #
Sponsor
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If you checked yes, please print your e-mail address on the line below.
RISKS: Steps are taken to protect your confidentiality when sending information by e-mail.
However, e-mail is not always secure. There is always the risk that personal information sent by
email could be seen by someone other than you.
YOU SHOULD NEVER USE E-MAIL TO REPORT A SUSPECTED ADVERSE EVENT OR
ANY OTHER MEDICAL PROBLEM. THESE SHOULD BE REPORTED BY TELEPHONE.
Thomas Jefferson University
Principal Investigator
Abbreviated Title
Telephone
IRB Control #
Sponsor
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Non-Waiver of Legal Rights Statement
 By your agreement/your permission to participate/allow your child to participate in
this study, and by signing this consent form, you are not waiving any of your/ your
or your child’s legal rights.
 In order to be in this research study, you must sign this consent/parental permission
form.
 You affirm that you have read all pages of this consent form. You have been told
that you will receive a copy.
SIGNATURES
______________________
Your Name
______________________
Your Signature
__________
Date
______________________
Name of Person Conducting
Consent Interview
______________________
__________
Signature of Person Conducting
Date
Consent Interview
______________________
Name of Investigator
or Co-Investigator
______________________
Signature of Investigator
or Co-Investigator
__________
Date
Copy of Signed and Dated Consent Form Given to the Subject/Parent/LAR
***
______________________
______________________
__________
Your Name (if Minor)
Your Signature (if Minor)
Date
(If subject is a minor and this document is being used both as consent and assent form.)
______________________
Name of Witness
______________________
Signature of Witness
__________
Date
(Witness required if the only language the subject speaks and understands is English, but
the subject cannot read English, or if the subject is blind or cannot physically sign the
consent form.)
Thomas Jefferson University
Principal Investigator
Abbreviated Title
Telephone
IRB Control #
Sponsor
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Optional Teach-Back Questions – These questions can be asked to help ensure that the patient
understands the study.
Check this box if these questions were reviewed with the patient.
We have gone over a lot of information. I would like to ask you a few questions to make sure I
have done a good job explaining the study to you.
1. In your own words, please answer these questions about this study:
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a. Why are we doing this study (what are we trying to learn)?
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b. What things (including tests and procedures) will you have to do in this study?
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c. What are some of the risks of being in this study?
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d. What is the benefit of being in this study?
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e. How will being in this study be different than usual medical care?
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f. How long will you be in this study?
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2. Taking part in this study is voluntary. What does that mean to you?
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a. If you don’t want to be in this study, what are your other choices?
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b. What will happen if you chose not to be in this study?
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3. What will we do to make sure your information remains confidential?
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4. What other questions do you have about this study?