Download Biomedical and Cancer consent template

SAMPLE CONSENT FORM – BIOMEDICAL AND CANCER STUDIES (April 2017)
PLEASE NOTE:
1) Statements in brackets and italics are instructions or examples, and should not be
included in the actual consent form.
2) Required wording (in regular font, not italics) should be used as is (if appropriate).
3) Suggested wording (in italics) can be revised as needed to provide the simplest and
clearest description of the study.
UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
CONSENT TO PARTICIPATE IN A RESEARCH STUDY
Study Title: [Insert study title here]
Research Project
Director:
Holly Smith, M.D., Associate Professor of Psychiatry.
UCSF, Room 809, 505 Parnassus Ave, San Francisco, CA.
Phone: 415.246.xxxx; e-mail: [email protected]
Study Coordinator:
Joan Buttenfield, Phone: 415.246.xxxx
[email protected]
This is a clinical research study. Your study doctor(s), …,[M.D.,] and …, [Ph.D.,] from the
[UCSF Department of …], will explain the study to you.
Research studies include only people who choose to take part. Please take your time to make
your decision about participating. You may discuss your decision with your family and friends
and with your health care team. If you have any questions, you may ask your study doctor.
You are being asked to take part in this study because you have [type/stage/presentation of
cancer being studied is briefly described here. For example: “colon cancer that has spread and
has not responded to one treatment.”]
Why is this study being done?
The purpose of this study is to…[Limit explanation to why study is being done, explaining in one
or two sentences. See examples directly below.
Example: Phase I study
…test the safety of [study 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/stage/presentation of]
cancer.
Example: Phase II study
…find out what effects, good and/or bad, [study drug/intervention] has on you and your
[specify type/stage/presentation of] cancer.
[Sample Biomedical and Cancer Consent]
[April 2017]
PAGE 1 OF 22
Example: Phase III study
…compare the effects, good and/or bad, of [study drug/intervention] with [commonly
used drug/ intervention] on you and your [specify type/stage/presentation of] cancer to
find out which is better. In this study, you will get either the [study drug/intervention] or
the [commonly used drug/ intervention]. You will not get both.]
[Address sponsorship and financial interests here:

The IRB requires that all consent forms disclose which agencies or institutions (e.g.,
National Institutes of Health, Department of Defense, Center for Disease Control, State
agencies), cooperative groups (CALGB, COG, ACTG), foundations or industry sponsors
are funding the research or providing study drugs or equipment for the study. If the study
is not being funded by an external agency, then the internal funding source, i.e.,
Department funds, personal funds, should be identified. This information should be
included either in the section headed Why is this study being done? (Purpose and
Background) or in a section headed Who pays for this study?

Investigators must also disclose the nature of any financial or proprietary interests,
though this disclosure can be in general terms. For suggested wording, see Conflicts of
Interest in Research.
[Any investigational drug(s) or device(s) to be used in the study should be noted and named. The
name by which the drug or device is referred to in this section should be used consistently
throughout the form.]
How many people will take part in this study?
About [state total accrual goal here] people will take part in this study. [If appropriate, give a
short description about cohorts here. For example: “At the beginning of the study, [state
number of first cohort] patients will be treated with a low dose of the drug. If this dose does not
cause bad side effects, it will slowly be made higher as new patients take part in the study. You
can ask your study doctor what dose you will receive. A total of [state maximum number] of
patients is the most that would be able to enter the study.” For multi-center studies, it is good to
give figures both for the whole study and for local enrollment at UCSF.]
What will happen if I take part in this research study?
[List tests and procedures and their frequency under the categories below. Indicate whether the
subject will be at home, in the hospital, in an outpatient or other setting. See examples below.]
Before you begin the main part of the study...
You will need to have the following exams, tests or procedures to find out if you can be in the
main part of the study. These exams, tests or procedures are part of regular cancer 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.
[Sample Biomedical and Cancer Consent]
[April 2017]
PAGE 2 OF 22

[List tests and procedures as appropriate. Use bulleted format.]
During the main part of the study...
If the exams, tests and procedures show that you can be in the main part of the study, and you
choose to take part, then you will need the following tests and procedures. They are part of
regular cancer care.

[List tests and procedures as appropriate. Use bulleted format.]
You will also need the following tests and procedures that are part of regular cancer care, but
they will be done more often because you are in this study.

[List tests and procedures as appropriate. Use bulleted format. Omit this section if no tests
or procedures are being done more often than usual.]
You will also need the following tests and procedures done that are either being tested in this
study or being done to see how the study is affecting your body.

[List tests and procedures as appropriate. Use bulleted format. Omit this section if no tests
or procedures are being tested in this study or required for safety monitoring.]

[For randomized studies:] You will be "randomized" into one of the study groups
described below. Randomization means that you are put into a group by chance. A
computer program will place you in one of the groups. Neither you nor your doctor can
choose the group you will be in. You will have an [equal/one in three/etc.] chance of being
placed in any group.
o
o
o
If you are in group 1 … [Explain what will happen for this group with clear
indication of which interventions depart from routine care.]
If you are in group 2 … [Explain what will happen for this group with clear
indication of which interventions depart from routine care.]
[For studies with more than two groups, an explanatory paragraph containing the
same type of information should be included for each group.]
When you are finished receiving [drugs or interventions]...
[Explain the follow-up tests, procedures, exams, etc. required, including the timing of each and
how they relate to standard care (e.g., they are different from standard care; or they are part of
standard care but are being performed more often than usual or being tested for the study.
Define the length of follow-up.]

Study location: All study procedures will be done at . . .[If different procedures will take
place at different locations, specify accordingly].
[If appropriate to the study, include the following additional procedure statement(s) using IRB
wording:]
[Sample Biomedical and Cancer Consent]
[April 2017]
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
Placebo: Define as "an inactive substance."

Blood drawing (venipuncture): [Once a week,] a blood sample will be drawn by
inserting a needle into a vein in your arm. Each sample will be approximately [XX]
teaspoons; a total of about [XX] tablespoons will be drawn for the whole study.

X-ray: You will have an x-ray of your [lungs, done once at the beginning of the study, and
again at the end of the study,] in order to check . . . Each x-ray will take about [XX
hour(s)].

CT scan: You will have a computed tomography (CT) [/computerized axial tomography
(CAT)] scan of your [XXX], done[XXX], in order to check . . . A CT scan uses special xray equipment to make detailed pictures of body tissues and organs.
For the CT scan, you will need to lie still on a table with your [XXX] inside a large
doughnut-shaped machine. The table will move and the machine will make clicking and
whirring noises as the pictures are taken. [If appropriate: An iodine dye (contrast material)
will first be [injected into a vein/given to you orally/rectally]. The dye makes tissue and
organs more visible in the pictures.] Each CT scan will take about 15 minutes to a half
hour.

MRI: [Once every two weeks,] you will have a Magnetic Resonance Imaging (MRI) exam.
For the MRI exam, you will lie down on a narrow bed that will then be placed in a tunnel
that is 6 feet long by 22 inches wide and open at each end. You will need to lie there
quietly for about one hour, during which time there will be a loud banging noise. You may
feel warm during this procedure. [If appropriate: Gadolinium (contrast material) will first
be [injected into a vein in your arm]. The dye makes tissue and organs more visible in the
MRI.]
[Optional Feature: In addition to the mandatory narrative explanation of study procedures as
above, a simplified calendar (study chart) or schema (study plan) may be inserted here. The
schema from the protocol is too complex, but use of a simplified version of the schema is
encouraged. Instructions for reading the calendar or schema should be included. See examples.]
Study Chart [Example]
You will receive [drugs or interventions] every [insert appropriate number of days or weeks] in
this study. This [insert number of days or weeks] period of time is called a cycle. The cycle will
be repeated [insert number] times. Each cycle is numbered in order. The chart below shows what
will happen to you during Cycle 1 and future treatment cycles. The left-hand column shows the
day in the cycle and the right-hand column tells you what to do on that day.
Cycle 1
Day
What you do
[Sample Biomedical and Cancer Consent]
[April 2017]
PAGE 4 OF 22
Two days before
starting study
treatment

Get routine blood tests.
Day before starting
study treatment

Check-in to _____________ the evening before starting study.

Day 1 of treatment
Day 2
Day 8
Day 15
Day 22
Day 28
Begin taking _____________once a day. Keep taking
____________ until the end of study, unless told to stop by your
health care team.

Leave _______________ and go to where you are staying.

Get routine blood tests.

Get routine blood tests.

Get routine blood tests.


Get routine blood tests and exams.
Get 2nd chest x-ray for research purposes.

Day 29
Return to your doctor's office at _______ [insert appointment
time]
for your next exam and to begin the next cycle.
Future cycles
Day
What you do

Days
1-28
Day
29




Keep taking _____ once a day if you have no bad side effects and [condition] is
not getting worse. Call the doctor at _____________ [insert phone number] if
you do not know what to do.
Get routine blood tests each week (more if your doctor tells you to).
Get routine blood tests and exams every cycle (more if your doctor tells you to).
Get routine X-rays, CT scans, or MRIs every other cycle (more if your doctor
tells you to).
Return to your doctor's office at _______ [insert appointment time] for your
next exam and to begin the next cycle.
[Sample Biomedical and Cancer Consent]
[April 2017]
PAGE 5 OF 22
Study Plan [Example]
Another way to find out what will happen to you during the study is to read the chart below. Start
reading at the top and read down the list, following the lines and arrows.
Start Here
Breast Cancer Surgery
Medicines Used in This Study
Doxorubicin + Cyclophosphamide given by vein once every 21 days and repeated 4 times
Randomize
(You will be in Group 1 or Group 2)
Group 1
Group 2
Paclitaxel by vein
No Paclitaxel
Every 21 days for 4 visits
How long will I be in the study?
You will be asked to take [drugs or interventions] for [months, weeks/until a certain event].
After you are finished taking [drugs or interventions], the study doctor will ask you to visit the
office for follow-up exams for at least [indicate time frames and requirements of 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."]
[Sample Biomedical and Cancer Consent]
[April 2017]
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Can I stop being in the 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 your participation safely.
It is important to tell the study doctor if you are thinking about stopping so any risks from the
[drugs or interventions] 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 the study rules, or if the study is stopped.
What side effects or risks can I expect from being in the 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 soon after you stop taking the [drugs or
interventions]. In some cases, side effects can be serious, 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 you experience while taking part in
the study.
Risks and side effects related to the [procedures, drugs, interventions, devices] include those
which are:
Likely



Less Likely



Rare but serious



[Notes for consent form authors regarding the presentation of risks and side effects:
[Sample Biomedical and Cancer Consent]
[April 2017]
PAGE 7 OF 22

Using a bulleted format, list risks and side effects related to the investigational aspects of the
trial. Do not list side effects of supportive medications unless the medications are
specifically mandated by the study.

List by regimen the physical and nonphysical risks and side effects of participating in the
study in three categories: 1. "likely"; 2. "less likely"; 3. "rare but serious."

There is no standard definition of "likely" and "less likely." As a guideline, "likely" can be
viewed as occurring in greater than 20% of patients and "less likely" in less than or equal to
20% of patients. However, this categorization should be adapted to specific study agents by
the principal investigator.

In the "likely" and "less likely" 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.

Side effects that occur in less than 2-3% of patients do not have to be listed unless they are
serious, and should then appear in the "rare but serious” category.

Physical and non-physical 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, but not enough data is available to determine if the side effect
is related to the drug/ intervention/ device. Inclusion of this information in the informed
consent document is not mandatory, but it may be prudent to mention the most serious
effects. If included, these side effects should be listed under a separate category titled "Side
effects reported by patients, but not proven to be caused by [drug/ intervention/ device]."
Side effects in this category do not have to be labeled as "likely," "less likely," or "rare but
serious" and should not be repeated here if they appear in a previous category. Similar to
the other categories, these side effects should be listed in a bulleted format.]
[If appropriate to the study, include the following risk statement(s) using IRB wording:]

Randomization risks: You will be assigned to a treatment program by chance, and the
treatment you receive may prove to be less effective or to have more side effects than the
other study treatment(s) or other available treatments.

Placebo risks: If you are in the group that receives placebo, your condition will go without
the active (study) treatment for [XX weeks].

Blood drawing (venipuncture) risks: Drawing blood may cause temporary discomfort
from the needle stick, bruising, infection, and fainting.
[Sample Biomedical and Cancer Consent]
[April 2017]
PAGE 8 OF 22

Radiation risks: [Include one of the three paragraphs below if your study involves radiation.
The paragraph you include will depend on the total effective dose from all treatments used,
regardless of whether they are standard of care or experimental. Studies in which patients
will receive different total effective doses should either use the maximum possible dose that a
patient could receive or use multiple consent forms. IN NO INSTANCE SHOULD A
PATIENT RECEIVE MORE RADIATION THAN THE MAXIMUM STATED ON THE
CONSENT FORM.]
Total Effective Dose of <3 mSv
This research study involves exposure to radiation from [type of procedure]. This radiation
exposure is not necessary for your medical care and is for research purposes only. The
additional amount of radiation that you will receive as a result of participating in this study
will be less than the yearly natural background radiation in the US (3 mSv). The use of
radiation involves minimal risk and is required to obtain the desired research information. If
you are pregnant or breast feeding, you SHOULD NOT participate in this study. If you have
any questions regarding the use of radiation or the risks involved, please consult the
physician conducting the study.
Effective Dose of 3 to 50 mSv
This research study involves exposure to radiation from [type of procedure]. This radiation
exposure is not necessary for your medical care and is for research purposes only. The
additional amount of radiation that you will receive as a result of participating in this study
will be a maximum of approximately [insert amount] mSv, which is equivalent to [insert
amount] the yearly natural background of radiation in the US (3 mSv). The use of radiation
may involve a low risk of cancer and is required to obtain the desired research information. If
you are pregnant or breast feeding, you SHOULD NOT participate in this study. If you have
any questions regarding the use of radiation or the risks involved, please consult the
physician conducting the study.
Effective Dose of >50 mSv
This research study involves exposure to radiation as part of the protocol. This radiation
exposure is not necessary for your medical care and is for research purposes only. The
additional amount of radiation that you will receive as a result of participating in this study
will be a maximum of approximately [insert amount] mSv, which is equivalent to [insert
amount] the yearly natural background of radiation in the US (3 mSv). The use of radiation
in this research study involves a low risk of cancer. However, the UCSF Radiation Safety
Committee has reviewed the use of radiation in this research study and has designated this
use as acceptable to obtain the benefits provided by the results of the study. If you are
pregnant or breast feeding, you SHOULD NOT participate in this study. If you have any
questions regarding the use of radiation or the risks involved, please consult the physician
conducting the study.
Radiation Therapy: [For situations involving radiation therapy, special risk language
should be developed on a case-specific basis with the Radiation Safety Committee. Doses to
individual organs should always be discussed, but the use of Effective Dose and comparison
to background exposures is not appropriate.]
[Sample Biomedical and Cancer Consent]
[April 2017]
PAGE 9 OF 22

CT scan risks: CT scans involve the risks of radiation (see above). In addition, if contrast
material (iodine dye) is used, there is a slight risk of developing an allergic reaction, from
mild (itching, rash) to severe (difficulty breathing, shock, or rarely, death). The contrast
material may also cause kidney problems, especially if you are dehydrated or have poor
kidney function. The study doctors will ask you about any allergies or related conditions
before the procedure. If you have any of these problems, you may not be allowed to have a
CT scan [/continue in the study].
Having a CT scan may mean some added discomfort for you. In particular, you may be
bothered by feelings of claustrophobia when placed inside the CT scanner, or by lying in one
position for a long time. If contrast material is used, you may feel discomfort when it is
injected [/given by XXX]. You may feel warm and flushed and get a metallic taste in your
mouth. Rarely, the contrast material may cause nausea, vomiting or a headache. [List other
risks as appropriate to the method by which contrast agent is administered]. [If sedation may
be used, discuss risks of sedation here].

MRI risks: Because the MRI machine acts like a large magnet, it could move ironcontaining objects in the MRI room during your examination, which in the process could
possibly harm you. Precautions have been taken to prevent such an event from happening;
loose metal objects, like pocket knives or key chains, are not allowed in the MRI room. If
you have a piece of metal in your body, such as a fragment in your eye, aneurysm clips, ear
implants, spinal nerve stimulators, or a pacemaker, you will not be allowed into the MRI
room and cannot have an MRI.
Having an MRI may mean some added discomfort for you. In particular, you may be
bothered by feelings of claustrophobia and by the loud banging noise during the study.
Temporary hearing loss has been reported from this loud noise. This is why you will be
asked to wear earplugs. At times during the test, you may be asked to not swallow for a
while, which can be uncomfortable.
Because the risks to a fetus from MRI are unknown, pregnant women must not participate in
this study.
[If appropriate, also discuss the risks of contrast agents and/or sedation here. For example:]
Contrast agent (gadolinium) risks: A few side effects of gadolinium injection such as mild
headache, nausea, and local pain may occur. Rarely (less than 1% of the time) low blood
pressure and lightheadedness occurs. This can be treated immediately with intravenous
fluids. Very rarely (less than on in one thousand), patients are allergic to gadolinium. These
effects are most commonly hives and itchy eyes, but more severe reactions have been seen
which result in shortness of breath.
Patients with severe kidney disease sometimes have a bad reaction to gadolinium contrast.
The condition is called nephrogenic systemic fibrosis (NSF). It can cause skin to tighten or
scar and can damage internal organs. Sometimes it can be life-threatening. There are no
reports of NSF in patients with normal kidney function. Before you have a MRI scan
requiring an injection of gadolinium contrast, you will have a blood test in order to check the
[Sample Biomedical and Cancer Consent]
[April 2017]
PAGE 10 OF 22
function of your kidneys. Based on your medical history and the results of the test, a doctor
will decide whether it is safe for you to undergo the MRI scans.

Reproductive risks: You should not become pregnant or father a baby while on this study
because the drugs in this study can affect an unborn baby. Women should not breastfeed a
baby while on this study. It is important to 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 the study may make you unable to have children in the future." If appropriate,
include a statement in the section on procedures that pregnancy testing will be required.]

HIV testing risks: Being tested for HIV may cause anxiety regardless of the test results. A
positive test indicates that you have been infected with the HIV virus. If you test positive we
will refer you to a source of medical care and treatment. Receiving positive results may
make you very upset. If other people learn about your positive test results, you may face
discrimination. If your test is negative, there is still the possibility that you could be infected
with the HIV virus and test positive at some time in the future.

Safe Handling of Medications: Handling [insert name of medication] and having contact
with any urine, feces or vomit from patients receiving [name of medication] may pose some
risk to you and your caregivers. To avoid exposure to [name of medication] and any
associated risks, you and your family members/caregivers will be educated by a member of
the study team on how to safely handle [name of medication], properly dispose of [name of
medication], and how to clean products that may be contaminated with [name of
medication].
[Always include the following risk statements:]

Unknown Risks: The experimental treatments may have side effects that no one knows
about yet. The researchers will let you know if they learn anything that might make you
change your mind about participating in the study.

For more information about risks and side effects, ask your study doctor.
Are there benefits to taking part in the study?
[Explain possible benefits appropriate to the study, using IRB wording, e.g.:]
[If subject is randomized:] If you are in the group that receives [XXX] and it proves to treat your
condition [more effectively/with fewer side effects than standard therapy/placebo], you may
benefit from participating in the study, but this cannot be guaranteed.
[Or if no direct benefit to the subject is anticipated:]
[Sample Biomedical and Cancer Consent]
[April 2017]
PAGE 11 OF 22
There will be no direct benefit to you from participating in this study. However, this study will
help doctors learn more about [procedures/ drugs/ interventions/ devices], and it is hoped that
this information will help in the treatment of future patients with [. . . /conditions like yours].
[For cancer studies, use the following wording:]
Taking part in this study may or may not make your health better. While doctors hope
[procedures/ drugs/ interventions/ devices] will be more useful against cancer compared to the
usual treatment, there is no proof of this. We do know that the information from this study will
help doctors learn more about [procedures/ drugs/ interventions/ devices] as a treatment for
cancer. This information could help future cancer patients.
What other choices do I have if I do not take part in this study?
Your other choices may include:



Getting treatment or care for your cancer without being in a study.
Taking part in another study.
Getting no treatment.
[Additional bullets should include, when appropriate, alternative specific procedures or
treatments.]

[For studies involving end-stage cancer, add the following paragraph as an additional
bullet: Getting comfort care, also called palliative care. This type of care helps reduce pain,
tiredness, appetite problems and other problems caused by the cancer. It does not treat the
cancer directly, but instead tries to improve how you feel. Comfort care tries to keep you as
active and comfortable as possible.]
Please talk to your doctor about your choices before deciding if you will take part in this study.
How will information about me be kept confidential?
Participation in research involves some loss of privacy. We will do our best to make sure that
information about you is kept confidential, but we cannot guarantee total privacy. Some
information from your medical records will be collected and used for this study. If you do not
have a UCSF medical record, one will be created for you. Your signed consent form and some
of your research tests will be added to your UCSF medical record. Therefore, people involved
with your future care and insurance may become aware of your participation and of any
information added to your medical record as a result of your participation. Study tests that are
performed by research labs, and information gathered directly from you by the researchers will
be part of your research records but will not be added to your medical record. 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.
[Sample Biomedical and Cancer Consent]
[April 2017]
PAGE 12 OF 22
[If your study involves HIV, hepatitis B, or hepatitis C testing with participants who have not
already been diagnosed with those conditions, please add the following statement: California
regulations require laboratories to report new cases of HIV, hepatitis B, and hepatitis C infection
to the county public health department. The reports include the patient’s name, social security
number, and other identifying information. Information about these new infections is used to
track these diseases statewide and nationwide. Other than this required reporting, your results
will be treated confidentially by the study staff. Personally identifying information will not be
reported to other departments or agencies.]
[Note: Every subject at the GCRC, PCRC, and VAMC is required to have a medical record. In
addition, medical records are generally created any time clinical systems are used at the UCSF
Medical Center. For example, a medical record is created for research participants who
undergo CT and MRI scans within the UCSF Medical Center, or who have blood drawn at
UCSF Medical Center clinical labs.]
Authorized representatives from the following organizations may review your research data for
the purpose of monitoring or managing the conduct of this study:





Representatives of the Sponsor [List Sponsor(s), as applicable]
Representatives of the National Institutes of Health [remove if this is not an NIH-funded
study]
Representatives of the University of California
Representatives of the Food and Drug Administration (FDA) [remove if this is not an FDAregulated study]
[list any other agencies – in or outside the US – that might inspect research records]
[Sensitive research information/Certificate of Confidentiality: For studies where
investigators may obtain especially sensitive information from subjects (e.g., possible illegal
drug use) and seek a Certificate of Confidentiality, use specific consent form wording.]
Will any research-related procedures be billed to me?
[For studies in which the sponsor pays all costs:]
No. The sponsor has agreed to pay for all procedures associated with this research study; you or
your insurer will not be billed.
[For studies where subjects may be responsible for some costs:]
Two types of procedures will be done during this study. Some are part of your standard
medical care and others are only for research. You or your insurer will be billed for the
standard medical care. You will be responsible for your co-pays, deductibles, and any
other charges that your insurer will not pay. There is a possibility that your insurer may
not cover all standard medical care costs if you are receiving medical services out of
[Sample Biomedical and Cancer Consent]
[April 2017]
PAGE 13 OF 22
network. Any procedures done only for research will not be charged to you or your
insurer.
Will I be paid for taking part in this study?
In return for your time, effort and travel expenses, you will be paid [$XXX] for taking part in this
study. [Describe any pro-rating or bonuses, and specify method and timing of payment. See the
IRB website for more info on subject payment and sample consent form language.]
[OR, if there is no payment:]
You will not be paid for taking part in this study.
What happens if I am injured because I took part in this study?
It is important that you tell your study doctor, __________________ [investigator's name(s)], if
you feel that you have been injured because of taking part in this study. You can tell the doctor in
person or call him/her at __________________ [telephone number].
Treatment and Compensation for Injury: If you are injured as a result of being in this
study, the University of California will provide necessary medical treatment. The costs
of the treatment may be billed to you or your insurer just like any other medical costs, or
covered by the University of California or the study sponsor [sponsor name], depending
on a number of factors. The University and the study sponsor do not normally provide
any other form of compensation for injury. For further information about this, you may
call the office of the Institutional Review Board at 415- 476-1814. [NOTE: This
statement must be used without changes. See the IRB website and notes section at the end
of this sample form for standard wording for the SFVAMC and for other comments].
What are my rights if I take part in this study?
Taking part in this study is your choice. You may choose either to take part or not to take part in
the study. If you decide to take part in this study, you may leave the study at any time. No matter
what decision you make, there will be no penalty to you and you will not lose any of your regular
benefits. Leaving the study will not affect your medical care. You can still get your medical care
from our institution.
We will tell you about new information or changes in the study that may affect your health or
your willingness to continue in the study.
In the case of injury resulting from this study, you do not lose any of your legal rights to seek
payment by signing this form.
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Who can answer my questions about the study?
You can talk to your study doctor about any questions, concerns, or complaints you have about
this study. Contact your study doctor(s)__________________ [name(s)] at
__________________ [telephone number(s)].
If you wish to ask questions about the study or your rights as a research participant to someone
other than the researchers or if you wish to voice any problems or concerns you may have about
the study, please call the office of the Institutional Review Board at 415-476-1814. [If there are
additional informational sources related to the study (e.g., patient representatives or individuals
at other study sites as appropriate), list here with contact information.]
[This paragraph must be included verbatim if the study meets the FDA’s definition of a clinical
trial. This language will be required for clinical trials approved on or after March 7, 2012, but is
optional for new studies approved before that date. Existing consent forms do not need to be
modified.] 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.
************************************************************
OPTIONAL RESEARCH
[Insert information about optional studies here. Provide yes/no options at each decision point.
The following studies are included as examples and therefore are written with italicized font.]
Please note: This section of the informed consent form is about optional research
studies that are being done with people who are taking part in the main study. You
may take part in these optional studies if you want to. You can still be a part of the
main study even if you say "no" to taking part in any of these optional studies.
You can say "yes" or "no" to each of the following studies. Please mark your choice
for each study.
[Example: Broad Sharing of Genomic Data]
[Include the following wording for broad sharing of genomic data in studies that are subject to
the NIH Genomic Data Sharing Policy: http://hrpp.ucsf.edu/node/716]
How will my genetic information be shared?
Genetic information (also known as genotype data) and the medical record data (also
known as phenotype data) may be shared broadly in a coded form for future genetic
research or analysis. We may give certain medical information about you (for example,
diagnosis, blood pressure, age if less than 85) to other scientists or companies not at
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UCSF, including to a (public or controlled access) government health research database,
but we will not give them your name, address, phone number, or any other identifiable
information. Research results from these studies will not be returned to you (describe
any rare instances that this may occur).
Donating data may involve a loss of privacy, but information about you will be handled
as confidentially as possible. Study data will be physically and electronically secured. As
with any use of electronic means to store data, there is a risk of breach of data security.
Genetic information that results from this study does not have medical or treatment
importance at this time. However, there is a risk that information about taking part in a
genetic study may influence insurance companies and/or employers regarding your
health. Taking part in a genetic study may also have a negative impact or unintended
consequences on family or other relationships. It is possible that future research could
one day help people of the same race, ethnicity, or sex as you. However, it is also
possible through these kinds of studies that genetic traits might come to be associated
with your group. In some cases, this could reinforce harmful stereotypes.
There will be no direct benefit to you from allowing your data to be kept and used for
future research. However, we hope we will learn something that will contribute to the
advancement of science and understanding of health and disease. If the data or any new
products, tests or discoveries that result from this research have potential commercial
value, you will not share in any financial benefits. If you decide later that you do not
want your information to be used for future research, you can notify the investigator in
writing at [insert address or contact information], and any remaining data will be
destroyed. However, we cannot retract any data has been shared with other researchers.
Please put your initials in the "YES" or "NO" box to indicate your answer.
1. My specimens and associated data may be kept for use in research to learn about,
prevent, or treat [list the disease the specimens are being collected to study].
YES
NO
2. My specimens and associated data may be kept for use in research to learn about,
prevent or treat other health problems (for example: diabetes, Alzheimer's disease, or
heart disease).
YES
NO
[Example: Quality of Life Study]
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We want to know your view of how your life has been affected by cancer and its
treatment. This "Quality of Life" study looks at how you are feeling physically and
emotionally during your cancer treatment. It also looks at how you are able to carry out
your day-to-day activities.
This information will help doctors better understand how patients feel during treatments
and what effects the medicines are having. In the future, this information may help
patients and doctors as they decide which medicines to use to treat cancer.
You will be asked to complete 3 questionnaires: one on your first visit, one 6 months
later, and the last one 12 months after your first visit. It takes about 15 minutes to fill out
each questionnaire.
If any questions make you feel uncomfortable, you may skip those questions and not give
an answer.
If you decide to take part in this study, the only thing you will be asked to do is fill out the
three questionnaires. You may change your mind about completing the questionnaires at
any time.
Just like in the main study, we will do our best to make sure that your personal
information will be kept private.
Please put your initials in the "YES" or "NO" box to indicate your answer.
I choose to take part in the Quality of Life Study.
YES
NO
[Example: Use of Tissue for Research]
[Adapted from the NCI Cancer Diagnosis Program's model tissue consent form found at
http://www.cancerdiagnosis.nci.nih.gov/specimens/model.pdf]
About Using Tissue for Research
You are going to have a biopsy (or surgery) to see if you have cancer. Your doctor will
remove some body tissue to do some tests. The results of these tests will be given to you
by your doctor and will be used to plan your care.
We would like to keep some of the tissue that is left over for future research. If you agree,
this tissue will be kept and may be used in research to learn more about cancer and other
diseases. Please read the information sheet called "How Is Tissue Used for Research" to
learn more about tissue research.
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Your tissue may be helpful for research whether you do or do not have cancer. The
research that may be done with your tissue is not designed specifically to help you. It
might help people who have cancer and other diseases in the future.
Reports about research done with your tissue will not be given to you or your doctor.
These reports will not be put in your health record. The research will not have an effect
on your care.
Things to Think About
The choice to let us keep the left over tissue for future research is up to you. No matter
what you decide to do, it will not affect your care.
If you decide now that your tissue can be kept for research, you can change your mind at
any time. Just contact us and let us know that you do not want us to use your tissue. Then
any tissue that remains will no longer be used for research.
In the future, people who do research may need to know more about your health. While
XXX may give them reports about your health, it will not give them your name, address,
phone number, or any other information that will let the researchers know who you are.
Sometimes tissue is used for genetic research (about diseases that are passed on in
families). Even if your tissue is used for this kind of research, the results will not be put in
your health records.
Your tissue will be used only for research and will not be sold. The research done with
your tissue may help to develop new products in the future.
Benefits
The benefits of research using tissue include learning more about what causes cancer
and other diseases, how to prevent them, and how to treat them.
Risks
The greatest risk to you is the release of information from your health records. We will
do our best to make sure that your personal information will be kept private. The chance
that this information will be given to someone else is very small.
Making Your Choice
Please read each sentence below and think about your choice. After reading each
sentence, put your initials in the "Yes" or "No" box. If you have any questions, please
talk to your doctor or nurse, or call our research review board at IRB's phone number.
No matter what you decide to do, it will not affect your care.
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1. My tissue may be kept for use in research to learn about, prevent, or treat cancer.
YES
NO
2. My tissue may be kept for use in research to learn about, prevent or treat other health
problems (for example: diabetes, Alzheimer's disease, or heart disease).
YES
NO
3. Someone may contact me in the future to ask me to take part in more research.
YES
NO
CONSENT
You have been given copies of this consent form and the Experimental Subject's Bill of Rights to
keep.
[If Protected Health Information as defined by HIPAA will be accessed, used, created, or
disclosed, add the following: You will be asked to sign a separate form authorizing access, use,
creation, or disclosure of health information about you.]
PARTICIPATION IN RESEARCH IS VOLUNTARY. You have the right to decline to
participate or to withdraw at any point in this study without penalty or loss of benefits to which
you are otherwise entitled.
If you wish to participate in this study, you should sign below.
Date
Participant's Signature for Consent
Date
Person Obtaining Consent
[STOP! Only include the following signature line if you may consent non-English speaking
subjects using the short form consent method AND this request has been addressed in the
IRB application.]
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Date
Witness – Only required if the participant is a non-English speaker
[STOP! Do not use the following signature lines unless third party consent is being
requested and has been addressed in detail in the IRB application.]
AND/OR:
Date
Legally Authorized Representative
Date
Person Obtaining Consent
OR:
The person being considered for this study is unable to consent for himself/herself because
he/she is a minor. By signing below, you are giving your permission for your child to be
included in this study.
Date
Parent or Legal Guardian
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NOTES TO PERSON PREPARING CONSENT FORM
1. Consent Document Identification Required by the IRB
Version date and short identifier: Every consent document (consent forms, assent forms,
information sheets) must include a version date (month, day, year) in a lower corner of each
page. This date should be hard coded -- in other words, the date should not update automatically
each time you open the document. The version date should only be changed when the document
is modified. If multiple consent documents are used for the study, include a short identifier in the
footer on each page to distinguish between the various consent documents. Any changes in the
consent documents require IRB review.
Page numbering: The pages of every consent document should be numbered, preferably in a
format like "1 of 2," "2 of 2," in the footer of the document.
Approval stamp: Approved consent documents in iRIS will receive an approval stamp. To
accommodate the stamp, each consent document should have at least a 1.25" top margin and the
upper left-hand corner should be blank. Learn more about IRB approval documentation.
2. "Treatment and Compensation for Injury" Statement
VAMC Studies with Sponsor: The VA has specific wording that must be used, which can be
found on the IRB website.
Additional Notes Regarding the UCSF “Treatment and Compensation for Injury” Wording:
Sponsoring companies often request that their own wording be used for the treatment and
compensation for injury policy statement or that minor changes be made in the UC statement.
Such requests cannot be honored.
Industry sponsors have three, and only three, options regarding the discussion of treatment and
compensation for injury in the consent form. First, the sponsor may include its name in the
UCSF statement as written in this sample consent form. Second, the sponsor may remain silent
on this point, in which case all reference to the sponsor should be omitted from the standard
statement. Third, a brief paragraph (one or two sentences) may be added below and separate
from the UCSF statement to explain the sponsor's policy. However, any description of the
sponsor’s policy must state what the sponsor will cover, not what it will not cover. As a further
limitation, the sponsor’s statement may not make reference to third party carriers, government
programs, or lost wages. No other changes may be made to the UCSF statement, as described on
the IRB website.
3. Handling Health Information and Complying with HIPAA
HIPAA has specific and strict requirements for use of identifiable information from medical records
(which HIPAA calls protected health information or PHI). HIPAA uses different terminology from
other human subject protection regulations. Under HIPAA, research subjects must give
authorization (consent) for use of their PHI. For almost all studies, UCSF requires using separate
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forms for research consent and for HIPAA-specific authorization for research access to health
information. See HIPAA guidance.
Under HIPAA, any disclosure of PHI that is not specifically included in an individual’s
authorization is prohibited and is subject to penalties. Neither the type of information that will be
shared, the use that will be made of the information, nor the persons with whom information will be
shared can be changed unless the subject signs a new authorization. This means that if the
researchers want to share PHI with any person, company, or institution not already included in the
authorization form, the IRB Application and authorization form (and sometimes the consent form)
must be modified and each person about whom information would be shared must be asked to sign
the new form(s).
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