Download If the study includes genetic analyses of blood or tissue, or if

OHSU Knight Cancer Institute Consent Form with Barcode
Follow these standards when writing the consent form:
-
Items in [square brackets] indicate action from you such as making a choice or inserting
study relevant information.
-
Write out terms before using the acronym.
-
Do not use abbreviations.
-
If your protocol involves a drug, use the generic name (not the trade/brand name) of the
drug once (not capitalized), then refer to the drug as “study drug” throughout. However,
this may not work well if you are using more than one drug. In these cases, it may be
allowable to use the generic names of the drugs. The IRB will not accept trade/brand
names, trademark symbols or capitalization of the generic name.
-
If radiation is part of the experimental study, Radiation Safety Committee review of your
protocol is required. There is no need to mention the Radiation Safety Committee in the
consent form. Be sure to answer all applicable radiation questions within your eIRB
submission and the Radiation Safety Committee will access your documents from the
eIRB. The Radiation Safety Officer will contact you if there are questions about your
submission. Please note that studies using DEXA scans for research purposes also
need to be reviewed by the Radiation Safety Committee. For more information on the
Radiation Safety Committee, visit the web at:
http://www.ohsu.edu/xd/about/services/integrity/ehrs/ or contact the Radiation Safety
Officer (4-7795; [email protected]).
-
Use the term participant; not subject or patient.
-
Use the term investigator; not doctor, study doctor or physician.
-
Delete instructions in italics
-
Researchers are responsible for tracking their own versions of the consent form. See
footer for suggested versioning language.
-
A Child Assent Form should be attached to the consent form, if the study participant is a
child between 7 and 17.
-
Oregon defines genetic testing as including tests of nucleic acids such as DNA, RNA,
and mitochondrial DNA; chromosomes; OR proteins in order to diagnose or determine a
genetic characteristic. This template includes all required genetic template language,
should your study meet this definition. For reference: OHSU is subject to the Oregon
Genetic Privacy Law (ORS192.531-192.549), enacted in 1995 in order to protect
individuals from genetic discrimination that could result from disclosure of genetic test
results. The law has gone through several revisions primarily surrounding research
provisions. The most recent revision can be found at
http://oregon.gov/DHS/ph/genetics/research.shtml. The OHSU policy on genetic
IRB #:
List the consent version #. Refer to the previous approved consent form to determine
your next version. If initial consent, start with 1.0. Suggest using 1.0, 2.0, 3.0, etc.
Consent Version:
List the Protocol version that this consent form is approved under. For example,
‘Protocol Incorporating Amendment #1 dated 09 April 2011’
Protocol Version:
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IRB#:______________________
MED. REC. NO.:______________________
NAME:______________________
research can be found here:
http://www.ohsu.edu/xd/about/services/integrity/policies/upload/GeneticSampleAccessRegulatory-Sheet.pdf
-
This template consent form is an example of a “tiered” consent that describes both
required and optional study elements. This template allows participants to choose if they
want to participate in optional components of the study (as indicated by the choices at
the end of the consent). If you choose to use this format, clearly describe throughout the
consent which elements of the study are optional. Elements that are required for
participation do not need to be specifically stated as such, unless it helps to clarify.
-
You are not required to use this format and may choose to create two separate consent
forms; one for required elements and one for optional elements.
-
There are two HIPAA forms at the end of this document, one for the main study and one
for optional components. You may delete the second one if your study does not include
any optional components.
MED. REC. NO._______________
NAME_______________________
BIRTHDATE__________________
IRB#: __________
Protocol Approval Date: ________
OHSU Knight Cancer Institute Consent Form
PARTICIPANT NAME:______________________________
DATE:_______________
TITLE: [Name of the study. Use the same title as that on the IRQ.]
PRINCIPAL INVESTIGATOR:
[list name and degree(s)] (503) 494-####
CO-INVESTIGATORS:
[list name and degree(s)] (503) 494-####
[list name and degree(s)] (503) 494-####
The Principal Investigator (PI) must be listed on the consent form. Listing co-investigators on
IRB #:
List the consent version #. Refer to the previous approved consent form to determine
your next version. If initial consent, start with 1.0. Suggest using 1.0, 2.0, 3.0, etc.
Consent Version:
List the Protocol version that this consent form is approved under. For example,
‘Protocol Incorporating Amendment #1 dated 09 April 2011’
Protocol Version:
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IRB#:______________________
MED. REC. NO.:______________________
NAME:______________________
the consent form is optional. It is recommended that you limit the number of co-investigators
listed here by only listing those most likely to conduct the consent discussion.
SPONSOR: [List the sponsor’s name here, and then refer to the sponsor as “the sponsor” in
the text.]
Device studies must include: [Sponsor] provides money to OHSU to support the conduct of
this study and additional research related costs.
SUPPORTED BY: Use this heading instead of the sponsor heading to name the entity providing
nonfinancial support only, such as a free study drug.
CONFLICT OF INTEREST: All potential conflicts of interest in research (CoIR) must be
disclosed and evaluated by the COI committee. After evaluation, the COI committee may
require specific language to be inserted into the consent form. If directed, place the language
here. For more information on CoIR, visit: http://www.ohsu.edu/xd/research/about/integrity/coi/
If the study includes children under 18 and adults over 18, state: “You” refers to you or your
child in this consent form.
If the study includes only children under 18, address the consent form to the parent on
behalf of the child.
This is a clinical trial, a type of research study. Medical personnel that carry out research
studies are called ‘investigators’. Your investigator will explain the clinical trial to you. Clinical
trials include only people who 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 investigator
for more explanation.
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. What problem
does the study try to solve? Explain in 1-2 sentences. Some examples are provided.
IRB #:
List the consent version #. Refer to the previous approved consent form to determine
your next version. If initial consent, start with 1.0. Suggest using 1.0, 2.0, 3.0, etc.
Consent Version:
List the Protocol version that this consent form is approved under. For example,
‘Protocol Incorporating Amendment #1 dated 09 April 2011’
Protocol Version:
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IRB#:______________________
MED. REC. NO.:______________________
NAME:______________________
[Example: Phase 1 study]
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/stage/presentation of] cancer.
[Example: Phase 2 study]
Find out what effects, good and/or bad, [drug/intervention] has on you and your [specify
type/stage/presentation of] cancer.
[Example: Phase 3 study]
Compare the effects, good and/or bad, of [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 [drug/intervention] or the [commonly-used
drug/intervention]. You will not get both.
Another purpose of this study is to do [optional/mandatory] genetic testing on your blood or
tissue samples. This will be explained in more detail in the WHY AM I BEING ASKED TO
PARTICIPATE IN GENETIC TESTING section of this consent form.
HOW MANY PEOPLE WILL TAKE PART IN THIS STUDY?
If OHSU is one of several sites that will take part in the study, state: As many as [state
total accrual goal here including anticipated screen failures] people will take part in this study
which will be conducted at [Oregon Health & Science University and/or other hospitals and
universities nationally or internationally]. Of these participants, [state OHSU accrual goal here]
will be enrolled at OHSU. [If appropriate, a short description about cohorts can be given here.
For example: “At the beginning of the study, (enter number of first cohort) participants will be
treated with a low dose of (study drug/intervention). If this dose does not cause bad side
effects, the next (enter number) participants will get a higher dose.]
WHAT WILL HAPPEN IF I TAKE PART IN THIS RESEARCH STUDY?
Using the headings below, describe succinctly and in chronological order those
procedures that are part of the research and their frequency. Clearly state those
procedures that are optional [and summarize them at the end of the consent]. It is not
necessary to describe procedures that participants would be receiving as routine care
even if they did not participate in the study. If standard of care procedures or drugs are
included, they must be clearly marked as standard of care and not experimental. Include
IRB #:
List the consent version #. Refer to the previous approved consent form to determine
your next version. If initial consent, start with 1.0. Suggest using 1.0, 2.0, 3.0, etc.
Consent Version:
List the Protocol version that this consent form is approved under. For example,
‘Protocol Incorporating Amendment #1 dated 09 April 2011’
Protocol Version:
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IRB#:______________________
MED. REC. NO.:______________________
NAME:______________________
whether a participant will be at home, in the hospital, or in an outpatient setting. State
(modify as appropriate):
Before you begin the study:
You will have the following exams, tests or procedures to find out if you can be in 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 the investigator.
 [List tests and procedures as appropriate. Use bulleted format. If there is more
than one screening visit, describe the screening process visit by visit.]
During the study:
Describe the portions of the study that are part of regular cancer care: 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 cancer care.
 [List tests and procedures as appropriate. Use bulleted format. If there is more
than one study visit, describe the procedures visit by visit.]
Use this language if any standard of care procedures are performed more frequently
because of the study. If not applicable, this can be removed: You will need these tests and
procedures that are part of regular cancer care. They are being done more often because you
are in this study.
 [List tests and procedures as appropriate. Use bulleted format.]
Use this language to describe study procedures that would not normally be done as part
of regular cancer care. Clearly state which procedures are optional [and therefore will be
summarized at the end of consent]. You will need these tests and procedures that are only
being done for the study and would not be part of regular cancer care.
 [List tests and procedures as appropriate. If optional, state this clearly. 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, state: 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. A computer program will place you in one of the study groups. Neither you nor
your investigator can choose the group you will be in. You will have an [equal/one in three/etc.]
IRB #:
List the consent version #. Refer to the previous approved consent form to determine
your next version. If initial consent, start with 1.0. Suggest using 1.0, 2.0, 3.0, etc.
Consent Version:
List the Protocol version that this consent form is approved under. For example,
‘Protocol Incorporating Amendment #1 dated 09 April 2011’
Protocol Version:
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IRB#:______________________
MED. REC. NO.:______________________
NAME:______________________
chance of being placed in any group. Include if placebo part of the design: A placebo is a [pill,
solution, cream] that [tastes, looks, smells, etc.] like the study drug but has no real medicine in
it.
If you are in the first group (often called "Group A") … [Explain what will happen for
this group with clear indication of which interventions depart from routine care.]
If you are in second group (often called "Group B")… [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.]
Consider using a visual representation of the randomization in addition to the text
above. Example language & chart is as follows:
State: Another way to understand how you will be placed into one of the [three] dose
groups is to look at the figure below:
Group A: Study drug alone [0.5 mL]
Participants
Group B: Study drug [0.1 mL +
cyclophosphamide]
Group C: Study drug [0.5 mL +
cyclophosphamide]
Indicate whether participants or investigators will know what treatment participants are
receiving single/double-blind. Sample language (modify as appropriate): You and the
investigators will not know which [study drug or intervention or dose] you are taking. The study
is done this way because knowing whether you are getting the study drug can change the
results of the study. If you start having serious side effects from the study drug, the
investigators can find out what you are taking in order to help you. Please ask the investigator if
you have any questions at all about this kind of study.
IRB #:
List the consent version #. Refer to the previous approved consent form to determine
your next version. If initial consent, start with 1.0. Suggest using 1.0, 2.0, 3.0, etc.
Consent Version:
List the Protocol version that this consent form is approved under. For example,
‘Protocol Incorporating Amendment #1 dated 09 April 2011’
Protocol Version:
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IRB#:______________________
MED. REC. NO.:______________________
NAME:______________________
When you are finished taking [study drug/intervention]:
[Explain the follow-up tests, procedures, exams, etc. required, including the timing of each and
whether they are part of standard cancer care but being performed more often than usual or
being tested in this study. Define the length of follow-up.]
If studies are complex, use an uncomplicated table or simplified calendar (study chart)
showing what procedures will occur at each study visit. Simplify the procedures and list
them from the participant’s perspective. In most cases, tables provided by the sponsor
in the study protocol are too complex to be of help to most participants. Instructions for
reading the calendar or schema should be included. See examples below.
Study Chart [Example]
You will receive [study drug(s) or intervention] every [insert appropriate number of days or
weeks] in this study. This [insert appropriate number of days or weeks] period of time is called a
cycle. The cycle will be repeated up to [insert appropriate number] times. Each cycle is
numbered in order. The chart below shows what will be done during Cycle 1 and future
treatment cycles as previously explained. The left-hand column shows the day in the cycle and
the right-hand column includes the activities performed on that day.
Cycle 1
Day
Two
days
before
starting
study
Day
before
starting
study
Day 1
What you do

Get routine blood tests.

Check-in to _____________ the evening before starting study.

Begin taking ______ once a day. Keep taking _____ until the end of study,
unless told to stop by the investigator or your regular doctor.
IRB #:
List the consent version #. Refer to the previous approved consent form to determine
your next version. If initial consent, start with 1.0. Suggest using 1.0, 2.0, 3.0, etc.
Consent Version:
List the Protocol version that this consent form is approved under. For example,
‘Protocol Incorporating Amendment #1 dated 09 April 2011’
Protocol Version:
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IRB#:______________________
MED. REC. NO.:______________________
NAME:______________________
Day 2

Leave _______________ and go to where you are staying.
Day 8
Day 15
Day 22






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.
Return to the investigator’s office at _______ [insert appointment time] for your
next exam and to begin the next cycle.
Day 28
Day 29
Future cycles
Day
Days 1-28
Day 29
What you do
 Keep taking _____ once a day if you have no bad side effects and cancer is
not getting worse. Call the investigator at _____________ [insert phone
number] if you do not know what to do.
 Get routine blood tests each week (more if the investigator or your regular
doctor tells you to).
 Get routine blood tests and exams every cycle (more if the investigator or
your regular doctor tells you to).
 Get routine X-rays, CT scans, or MRIs every other cycle (more if the
investigator or your regular doctor tells you to).
 Return to the investigator’s office at _______ [insert appointment time] for
your next exam and to begin the next cycle.
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
IRB #:
List the consent version #. Refer to the previous approved consent form to determine
your next version. If initial consent, start with 1.0. Suggest using 1.0, 2.0, 3.0, etc.
Consent Version:
List the Protocol version that this consent form is approved under. For example,
‘Protocol Incorporating Amendment #1 dated 09 April 2011’
Protocol Version:
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IRB#:______________________
MED. REC. NO.:______________________
NAME:______________________
Medicines used in this study
Doxorubicin + Cyclophosphamide by vein - given once every 21 days and repeated 4
times
Randomize
(You will be in one Group or the other)
Group 1
Group 2
Paclitaxel by vein
No Paclitaxel
Every 21 days for 4 visits
If blood is to be drawn, indicate the amount in units that are familiar to participants only
(5cc = 1 teaspoon, 15cc = 1 tablespoon)
If applicable, describe procedures that include radiation and add the following language:
Women who can become pregnant must have a negative pregnancy test before the [PET scan,
x-ray] is performed.
If questionnaires, surveys, diaries, or other data collection materials are being used,
mention what kinds of questions are being asked, indicate how long it will take to do the
questionnaire, and submit a copy of each to the IRB along with your protocol and
consent form.
IRB #:
List the consent version #. Refer to the previous approved consent form to determine
your next version. If initial consent, start with 1.0. Suggest using 1.0, 2.0, 3.0, etc.
Consent Version:
List the Protocol version that this consent form is approved under. For example,
‘Protocol Incorporating Amendment #1 dated 09 April 2011’
Protocol Version:
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IRB#:______________________
MED. REC. NO.:______________________
NAME:______________________
If the participant’s medical records will be reviewed, describe the information to be
collected.
At the end of this section, you must insert the following statement: If you have any
questions regarding this study now or in the future, contact [PI Name at (503) 494-####] [or
other members of the study team at (503) ###-####]. (The PI phone number should match the
first page of this consent form and the HIPAA Authorization Forms).
HOW LONG WILL I BE IN THE STUDY?
State how long the study will last. Sample language (modify as appropriate):
You will be asked to take [drugs or intervention] for (months, weeks/until a certain event). After
you are finished taking [drugs or intervention], the investigator 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.”]
WHAT SIDE EFFECTS OR RISKS CAN I EXPECT FROM BEING IN THE STUDY?
For a risk statement to be useful, participants must know not only what side effects may
occur, but how likely they are to occur and how serious they are. List the reasonably
foreseeable risks, side effects, discomforts and inconveniences in order of their
importance. For example, if the study involves a drug with life-threatening side effects,
these should be listed first. When listing other side effects, arrange risks from most to
least likely. Other information about the drugs risks should be listed afterwards. See
notes below.
State (modify as appropriate): You may have side effects while on the study. Everyone
taking part in the study will be watched carefully for any side effects. The investigators don’t
know all the side effects that may happen. Side effects may be mild or very serious. The
investigator may give you medicines to help lessen side effects. Many side effects may go
away soon after you stop taking the [study drug(s) or intervention]. 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.]
IRB #:
List the consent version #. Refer to the previous approved consent form to determine
your next version. If initial consent, start with 1.0. Suggest using 1.0, 2.0, 3.0, etc.
Consent Version:
List the Protocol version that this consent form is approved under. For example,
‘Protocol Incorporating Amendment #1 dated 09 April 2011’
Protocol Version:
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IRB#:______________________
MED. REC. NO.:______________________
NAME:______________________
You should talk to the investigator about any side effects that you have while taking part in the
study.
Risks and side effects related to the [procedures, drugs (generic names only – not capitalized.
The IRB will not accept trade/brand names, trademark symbols or capitalization of the generic
name), interventions, devices] include those which are:
Likely (more than X%)



Less Likely (X to X%)



Rare but serious (less than X%)



Notes for consent form authors regarding the presentation of risks and side effects:
 Use a bulleted format and 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." likely"; 2. "less likely”; 3. “rare but serious" and include
the corresponding % frequency for each category.
 There is no standard definition of "likely" and "less likely”. As a guideline, “likely” can be
viewed as occurring in greater than 20% of participants and “less likely” in less than or
equal to 20% of participants. 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 participants do not have to be listed unless
IRB #:
List the consent version #. Refer to the previous approved consent form to determine
your next version. If initial consent, start with 1.0. Suggest using 1.0, 2.0, 3.0, etc.
Consent Version:
List the Protocol version that this consent form is approved under. For example,
‘Protocol Incorporating Amendment #1 dated 09 April 2011’
Protocol Version:
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IRB#:______________________
MED. REC. NO.:______________________
NAME:______________________

they are serious, and should then appear in the “rare but serious” 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
participant 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 previous studies but there may not be enough data to determine whether the side
effect is related to the drug/intervention/device. Such side effects should not be listed in the
consent form, unless the investigator can justify why this information is important. This also
applies to the results of experiments with animals; unless the investigator can justify why this
information is important, it should not be included. If the study is a first in human study and only
the animal data are available this should be addressed in the consent with a note that it is not
known if these effects will occur in humans.
Examples of typical chemotherapy/radiation side effects: Your ability to fight infections may
be reduced. This could be life threatening; Your blood may not be able to clot as well as it
normally does. This may cause bleeding and you may need to receive blood transfusions; You
may lose all or part of your hair; You may experience nausea or vomiting which could be
severe. The investigator may give you medication to help with the nausea or vomiting; If you
receive radiation, you may experience a skin reaction like a mild to moderate sunburn;
tiredness; your ability to taste may change; loss of appetite; numbness or tingling in the fingers
and toes.
Example language for listing a risk of prolonged QTc interval (include in risks list above
where appropriate): The study drug could cause abnormal electrical signals within the heart
that could result in sudden cardiac death. Seek immediate medical treatment if you are having
fast, pounding, or uneven heartbeats; shortness of breath; or unusual tiredness or weakness.
Indicate risk of inducing a secondary malignancy, if pertinent.
Use standard wording where applicable:
For blood draw: We will draw blood from [location on the body, include potential for collection
from port-a-cath]. You may feel some pain when your blood is drawn. There is a small chance
the needle will cause bleeding, a bruise, or an infection.
IRB #:
List the consent version #. Refer to the previous approved consent form to determine
your next version. If initial consent, start with 1.0. Suggest using 1.0, 2.0, 3.0, etc.
Consent Version:
List the Protocol version that this consent form is approved under. For example,
‘Protocol Incorporating Amendment #1 dated 09 April 2011’
Protocol Version:
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IRB#:______________________
MED. REC. NO.:______________________
NAME:______________________
For MRI: The magnetic resonance imaging (MRI) machine is a powerful magnet. There are no
known risks from the magnet itself. However, if you have metal in your body, the magnet may
cause the metal to move. If you know of any metal in your body, tell the investigator because
you may not be able to have an MRI. Review any dental treatments you have had with the
investigator, since these may involve metal. The most common discomfort of an MRI is the
length of time you must lie still or flat while the scan is being performed. Some people with
claustrophobia (fear of closed spaces) may find the MRI machine too confining. Finally, the MRI
scanner makes loud beeping or thumping noises, so you may be offered protective earplugs to
wear during the scan.
If contrast agent is used, add: The dye that is injected into your body has been used in many
patients and is generally well tolerated. Some people feel dizzy or queasy, get a headache or
notice a cold feeling near the site where the dye is injected. There is also a chance of having an
allergic reaction to the dye that very rarely can be serious and life-threatening. If you have
kidney disease, there is a chance that the dye could cause nephrogenic systemic fibrosis (NSF).
NSF is a disease in which too much scar tissue forms, leading to serious damage to skin,
muscle, and internal organs, and, in some cases, death. If you have kidney disease or think
your kidneys may not be functioning properly, you should discuss this with the investigator
before any dye is injected.
For x-rays and DEXA scans,: In this study, you will be exposed to radiation during the [name
of the procedure]. While we cannot be sure any dose of radiation is entirely safe, the amount
you will be exposed to in this study is not known to cause health problems.
For CT scans and nuclear medicine procedures, including PET scans: In this study, you
will be exposed to radiation during the [insert name] scan. Although the amount to which you
will be exposed is higher than from a typical x-ray, the risk of harmful effects from a single exam
is very small.
Note: For studies involving radiation, if the study requires more than one procedure, the
cumulative risk of radiation is higher. Please seek advice from the Radiation Safety
Officer (4-7795; [email protected]) regarding an appropriate risk statement.
For fluoroscopy: In this study you will be exposed to radiation during the fluoroscopy for
[name of the procedure]. There is a small chance this will cause you to lose your hair. There is
a rare chance that your skin may turn red or be damaged. If your skin damage is severe, you
may need medical treatment.
IRB #:
List the consent version #. Refer to the previous approved consent form to determine
your next version. If initial consent, start with 1.0. Suggest using 1.0, 2.0, 3.0, etc.
Consent Version:
List the Protocol version that this consent form is approved under. For example,
‘Protocol Incorporating Amendment #1 dated 09 April 2011’
Protocol Version:
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IRB#:______________________
MED. REC. NO.:______________________
NAME:______________________
For indwelling catheter: You will have a catheter (tube) in your vein for more than 24 hours.
You may get an infection where the tube is placed. This could cause swelling, redness, and
pain. You may bleed or get a bruise. There is a small chance your blood stream or heart
valves might get a serious infection. You may get a blood clot that could go to your lungs.
These problems are very rare. If you have these problems, you will need hospital care. Your
catheter will be in place for [state time].
For protocols involving surgery that is NOT investigational: You have been invited to be in
this research study because you are scheduled to have [name procedure]. You have already
consented to that procedure. That procedure is not experimental and is not part of this study.
The risks of [name procedure] have already been discussed with you and a copy of that
consent form is attached to this research consent form. NOTE: If you choose to include this
statement, you must provide a description of the significant risks of the procedure in a
separate clinical consent form and attach a copy of the clinical consent form to the
research consent form. If you choose not to use this statement, you must provide the
risks of the procedure in this consent form and state clearly that these risks are the same
as they would be if the participant was not part of the research.
For platinum based drugs: Include the possibility of total, permanent hearing loss.
For studies using carboplatin, etoposide phosphate or cytoxan: If you receive carboplatin,
etoposide phosphate or cytoxan, there is an increased risk of developing leukemia, a cancer of
white blood cells, which is usually fatal. The chance of this occurring is not known at this time
but appears to be small.
For studies using epoetin alfa: Some patients with chronic kidney disease who have received
months or years of treatment with epoetin alfa have had serious health problems because their
bone marrow lost the ability to make red blood cells. Most of these people had received a
specific brand of epoetin alfa called EPREX. Because of this possible risk, a different brand of
epoetin alfa is being used in this study.
Your ability to make red blood cells may be reduced. When the numbers of red blood cells in
your blood are low, this is called “anemia”. Anemia can cause tiredness and shortness of
breath; these symptoms are treated with blood transfusions. About half of patients with this type
of anemia improve with or without treatment, but it is unknown how long the anemia will last.
Participants with this type of anemia may need life-long blood transfusions due to their lack of
ability to make their own red cells.
IRB #:
List the consent version #. Refer to the previous approved consent form to determine
your next version. If initial consent, start with 1.0. Suggest using 1.0, 2.0, 3.0, etc.
Consent Version:
List the Protocol version that this consent form is approved under. For example,
‘Protocol Incorporating Amendment #1 dated 09 April 2011’
Protocol Version:
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IRB#:______________________
MED. REC. NO.:______________________
NAME:______________________
For “statin” drugs: Researchers think drugs like [indicate drug name, such as atorvastatin,
fluvastatin, simvastatin, pravastatin, lovastatin, etcetera] might cause destruction of muscle
cells. The medical term is called rhabdomyolysis. This sometimes causes pain, and may cause
kidney failure. This can be fatal. If you start to have any muscle pain, pain in the calves or
lower back, weakness, tenderness, fever, dark urine, nausea or vomiting you should call your
investigator, Dr. [Name] at [list the telephone number that is available 24-hours a day]
immediately.
For COX-2 inhibitors or similar compounds: Some researchers believe COX-2 inhibitor type
drugs might increase the risk of heart attack, stroke, chest pain, blood clots, and death. We are
not sure this is true but we want to be careful. To help keep you safe in this study, we will
closely watch you for these side effects by [describe monitoring plan here].
Bisphosphonates and Osteonecrosis of the Jaw: Bisphosphonates are a type of drug used
to prevent the loss of bone mass that may occur with osteoporosis. Recent reports suggest a
possible association between the use of intravenous (IV) bisphosphonates, such as zoledronic
acid, and a condition called osteonecrosis of the jaw. This is a rare, but very serious side effect
in which the jaw bone is permanently damaged. This condition is painful and is more likely to
happen in people taking bisphosphonates who have dental procedures such as tooth extraction,
root canal treatment, or tooth cleaning. Having chemotherapy while taking bisphosphonates
increases the chance of getting osteonecrosis of the jaw. If you are taking a type of
bisphosphonate that is in pill form, such as clodronate and ibandronate, these may also
increase the risk of osteonecrosis of the jaw, but this link is not as well established. If you are
taking any type of bisphosphonate, please let your dentist know that you are in this study and
have him/her contact the investigator prior to starting any dental treatment.
For endoscopy: The endoscope may make you gag. It may make you feel queasy or give you
a sore throat. There is a small chance your esophagus, stomach, or small intestine may bleed.
You may get an infection. You may feel drowsy after taking the drug that relaxes you before the
endoscopy. You should not drive a car or operate machinery for 24 hours afterward. Once in a
great while, an endoscopy makes a hole in someone’s esophagus or stomach. This happens
about 1 time in every 5,000 endoscopies. If this happens to you, you may need to have surgery
to repair the hole.
For bone marrow biopsy: Bone marrow biopsy means taking some cells from inside your
bones. Before the bone marrow biopsy, we will numb an area of your skin (usually near your
hip) with a shot. The shot may cause a little pain. There is a rare chance of an allergic reaction
to the numbing medicine, which could be serious and life-threatening. The medical team will be
IRB #:
List the consent version #. Refer to the previous approved consent form to determine
your next version. If initial consent, start with 1.0. Suggest using 1.0, 2.0, 3.0, etc.
Consent Version:
List the Protocol version that this consent form is approved under. For example,
‘Protocol Incorporating Amendment #1 dated 09 April 2011’
Protocol Version:
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IRB#:______________________
MED. REC. NO.:______________________
NAME:______________________
watching closely for signs of an allergic reaction and will provide emergency treatment if
necessary. The bone marrow biopsy involves inserting a long needle into your bone to get the
cells. Some people have moderate to severe pain when the bone marrow cells are drawn out
through the long needle. Your hip may hurt for about 3-6 days. There is a small chance you will
get a bruise or an infection where the needle was inserted. You may bleed or have a scar.
Your skin may temporarily itch where the needle was inserted.
For skin biopsy: In this study, we will remove a small piece of skin from [location]. This is
called a skin biopsy. To do this we will give you a shot to numb the area. The shot may cause
a little pain. Some people (fewer than 1 in 10,000) are allergic to the shot you will get to numb
the area where the skin is taken. Heavy bleeding from a skin biopsy is rare. Skin biopsies
cause infections about 10% of the time. A small scar will form at the biopsy site. The scar is
usually much smaller than the original biopsy.
For pregnancy/risk to fetus (For Women): Choose only one of the following statements
for women:
1. One method of birth control required for study:
If you are nursing an infant or you are pregnant now, you must not be in the study because we
do not know how this [drug, treatment, procedure] could affect a nursing infant or fetus. If you
are sexually active and could become pregnant, you and your male partner(s) must use a
method of birth control that works well or you must not have sex. The investigator will talk to you
about the types of birth control that are acceptable. You will have to do this the whole time you
are in this study. If you become pregnant during the research study, please tell the investigator
and your doctor immediately.
2. Two methods of birth control required for study:
If you are nursing an infant or you are pregnant now, you must not be in the study because we
do not know how this [drug, treatment, procedure] could affect a nursing infant or fetus. If you
are sexually active and are at risk of getting pregnant, you and your male partner(s) must use
two methods of birth control that work well or you must not have sex. The investigator will talk to
you about the types of birth control that are acceptable. You will have to do this the whole time
you are in this study. If you become pregnant during the research study, please tell the
investigator and your doctor immediately.
For pregnancy/risk to fetus (For Men):
The drugs in this study can damage sperm. [OR We do not know whether the drugs in this study
can damage sperm.] You should not father a child while on this study. If you are sexually active
and could cause a pregnancy, you and your female partner(s) must use a method of birth
IRB #:
List the consent version #. Refer to the previous approved consent form to determine
your next version. If initial consent, start with 1.0. Suggest using 1.0, 2.0, 3.0, etc.
Consent Version:
List the Protocol version that this consent form is approved under. For example,
‘Protocol Incorporating Amendment #1 dated 09 April 2011’
Protocol Version:
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IRB#:______________________
MED. REC. NO.:______________________
NAME:______________________
control that works well or you must not have sex. The investigator will talk to you about the
types of birth control that are acceptable. You will have to use birth control or not have sex
[include duration]. If a female partner becomes pregnant during the research study, please tell
the investigator and ask your partner to tell her doctor immediately.
For drugs that may impair or permanently impact fertility: Women may experience early
menopause or a reduced ability to carry a pregnancy due to damage to their reproductive tract.
Men may experience a permanent loss of sperm production or function, which makes them
unable to have children. There are ways to collect and store your eggs or sperm prior to
treatment. If you are interested in this option you should discuss it with your investigator.
For studies that enroll identified HIV positive participants: As an HIV positive person you
can give the HIV virus to your sexual partner(s) even if your viral load is very low or nondetectable. You must be sure that your sexual partner(s) knows your status. If you use a
condom or female condom during intercourse, you will help reduce the risk of giving your
partner HIV. Using a spermicide like nonoxynol-9 may increase the risk of giving HIV to your
partner. The investigator will discuss ways to minimize this risk.
For potential drug interactions: Whenever a study involves the administration of medications
that may interact with several other medications, the following language must be included
(modify as appropriate). If herbal supplements are prohibited, specifically address: There are
several drugs (prescription and non-prescription) that may cause problems when taken with the
study drug. The investigator will carefully review all of the drugs you are taking before giving
you the study drug. If any other health care provider prescribes any new drug(s) for you while
you are in this study, please tell the investigator before you take the new drug. You could also
have that provider talk to the investigator before prescribing the new drug. Do not take any new
over-the-counter drugs while you are in this study unless you first check with the investigator.
Drug Interactions with Grapefruit, Etc.: Grapefruit, pomelos, Seville oranges, or star fruit can
interfere with the levels of study drug in your blood. For this reason, you must not eat these
fruits or drink the juices of these fruits [describe duration]. Also, you must not eat any products
that include these fruits.
For studies involving interviews/questionnaires/QOL assessments that discuss sensitive
issues that may cause emotional upset, such as grieving: The risk of emotional upset must
be described, and participants must be informed that they may refuse to answer questions that
upset them. Sample language (modify as appropriate): As part of this study, you will be asked
to complete [list all applicable interviews/questionnaires/QOL assessments that apply to this
IRB #:
List the consent version #. Refer to the previous approved consent form to determine
your next version. If initial consent, start with 1.0. Suggest using 1.0, 2.0, 3.0, etc.
Consent Version:
List the Protocol version that this consent form is approved under. For example,
‘Protocol Incorporating Amendment #1 dated 09 April 2011’
Protocol Version:
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IRB#:______________________
MED. REC. NO.:______________________
NAME:______________________
section]. Some of these questions may seem very personal or embarrassing. They may upset
you. You may refuse to answer any of the questions that you do not wish to answer. If the
questions make you very upset, we will help you to find a counselor. NOTE: This statement is
not necessary if you are discussing routine matters that do not cause emotional upset.
For confidentiality risks (ALL STUDIES): Efforts will be made to keep your personal
information confidential as described in the WILL MY MEDICAL INFORMATION AND
SAMPLES BE KEPT PRIVATE section, but we cannot guarantee total privacy. There is a small
chance that your information could be accidentally released.
For genetic or repository studies: Describe risks that may result from storage of
samples/information in a repository, future research studies, or genetic research.
Specifically consider and address the risks associated with breach of confidentiality or
psychological trauma. Breach of confidentiality could impact insurability, employability,
family plans, and family relationships. Psychological risks to consider include the
impact of learning results if no effective therapy for the disorder exists or the risk of
stigmatization.
For genetic studies or future research that may involve genetic testing, state: A Federal
law, called the Genetic Information Nondiscrimination Act (GINA), generally makes it illegal for
health insurance companies, group health plans, and most employers to discriminate against
you based on your genetic information. Be aware that this Federal law does not protect you
against genetic discrimination by companies that sell life insurance, disability insurance, or longterm care insurance. GINA also does not protect you against discrimination if you have already
been diagnosed with the genetic disease being tested.
Although we have made every effort to protect your identity, there is a small risk of loss of
confidentiality. If the results of these studies of your genetic makeup were to be accidentally
released, it might be possible that the information we will gather about you as part of this study
could become available to an insurer or an employer, or a relative, or someone else outside the
study. Even though there are discrimination protections in both Oregon law and Federal law,
there is still a small chance that you could be harmed if a release occurred.
Suggested wording if genetic information is to be released to the participants: The results
of this study could provide information about how likely it is that you or one of your children or
other relatives will develop [disorder] in the future. This may be very upsetting because [there is
no therapy for (disorder) or the results may show that (disorder) may be passed on to children,
or any other reason].
IRB #:
List the consent version #. Refer to the previous approved consent form to determine
your next version. If initial consent, start with 1.0. Suggest using 1.0, 2.0, 3.0, etc.
Consent Version:
List the Protocol version that this consent form is approved under. For example,
‘Protocol Incorporating Amendment #1 dated 09 April 2011’
Protocol Version:
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IRB#:______________________
MED. REC. NO.:______________________
NAME:______________________
ARE THERE BENEFITS TO TAKING PART IN THE STUDY?
Unless direct benefits to the participant are assured, use the following language: You
may or may not personally benefit from being in this study. However, by serving as a
participant, you may help us learn how to benefit patients in the future.
When the participant will not benefit: You will not benefit from being in this study. However,
by serving as a participant, you may help us learn how to benefit patients in the future.
WHAT OTHER CHOICES DO I HAVE IF I DO NOT TAKE PART IN THIS STUDY?
State: You may choose not to be in this study.
Instead of being in the study, you have these options: [List alternatives including commonlyused therapy]
If you decide that you do not want any further active treatment for your [insert disease or
condition], one of your options is called “comfort care.” Comfort care means that your doctor will
offer you medication to help control your pain, together with any other treatment and support
you need to help you maintain your overall comfort and dignity. It is often possible for this
comfort care to be provided at home.
If you think that comfort care is something you might prefer, feel free to discuss it with family
and friends, any spiritual advisor, and of course, your doctor.
If appropriate (for noninvestigational treatments) state: You may get the same treatment
being offered in this study even if you do not take part in the study.
Please talk to your regular doctor about these and other options. [Reference and attach any
information about alternatives.]
Use the following text if you have described optional components in this consent form: If
you do choose to participate in this study, you may choose to participate in the main part of the
study without participating in the optional parts of the study. The optional parts of this study are
described throughout this consent form. At the end of this consent, you will be given a summary
list of what is optional and you will be given the opportunity to decide what optional parts you
would like to participate in.
IRB #:
List the consent version #. Refer to the previous approved consent form to determine
your next version. If initial consent, start with 1.0. Suggest using 1.0, 2.0, 3.0, etc.
Consent Version:
List the Protocol version that this consent form is approved under. For example,
‘Protocol Incorporating Amendment #1 dated 09 April 2011’
Protocol Version:
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IRB#:______________________
MED. REC. NO.:______________________
NAME:______________________
WILL MY MEDICAL INFORMATION AND SAMPLES BE KEPT PRIVATE?
Inform the participant how long [blood/tissue/genetic information/medical information]
will be used/stored. Suggested wording:
Your [blood/tissue/genetic information/medical information] will be stored only for this research,
which is expected to last for [duration], and then the [blood/tissue/genetic information/medical
information] will be destroyed.
Or, use this language:
Your [blood/tissue/genetic information/medical information] will be stored for (duration; if intent is
to store indefinitely, make this clear).
If there is any possibility that other investigators will be given access to
[blood/tissue/genetic information/medical information] for research in the future, the
participants must be informed of and specifically consent to this possibility. Suggested
wording: In the future, your [blood/tissue/genetic information/medical information] may be
given to researchers for [use in research studies that are not described here] [or as part of the
search for a genetic cause of (disorder)] [or for other research purposes]. The
[blood/tissue/genetic information/medical information] will be labeled as described below.
If blood/tissue/genetic information/medical information will be transmitted outside OHSU,
indicate whom the recipient(s) will be. Suggested wording:
Your [blood/tissue/genetic information/medical information] will be labeled with [your name or
other information, such as medical record number, SSN, etc. (specify)] that will identify you.
Then, choose additional suggested wording below:
Other investigators who may receive samples of your [blood/tissue/genetic information/medical
information] for research will also be given information that may identify you or your family
members.
Or, use this language:
A code number will be assigned to your [blood/tissue/genetic information/medical information].
Only the investigators named on this consent form will be authorized to link the code number to
you. Other investigators who may receive your [blood/tissue/genetic information/medical
IRB #:
List the consent version #. Refer to the previous approved consent form to determine
your next version. If initial consent, start with 1.0. Suggest using 1.0, 2.0, 3.0, etc.
Consent Version:
List the Protocol version that this consent form is approved under. For example,
‘Protocol Incorporating Amendment #1 dated 09 April 2011’
Protocol Version:
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IRB#:______________________
MED. REC. NO.:______________________
NAME:______________________
information] for research will be given only the code number which will not identify you.
Or, use this language: All identifying information about you will be removed from the
[blood/tissue/genetic information/medical information] before they are given to any other
investigators.
If information about subjects’ relatives will be collected, state (modify as appropriate):
You may be asked to give us health information about your relatives. Any information you give
us will be kept confidential. We will not contact your relatives without their permission. We may
discuss with you the possibility of including your relatives in the study in the future.
If this study includes collection of identifiable photographs, videotapes, or audiotapes
that will be presented in public, state the following. If not, this section can be deleted:
During this study you will be photographed, videotaped, or audiotaped [specify which]. We will
use the photographs, videotapes, or audiotapes for educational materials, research
publications, or marketing purposes [specify which].
1. [Describe succinctly and in chronological order the recording procedures. Specify the
duration of the recording sessions.]
2. [If attempts to conceal the participant’s identity will be made, explain how (black bar over
eyes, voice disguised, etc).]
3. [Inform participants whether they will be able to inspect the photographs/recordings
before they are released.]
State: Research records may be reviewed and copied by people involved in conducting or
overseeing research including: Departments within OHSU involved in the conduct of research
(for example, the OHSU Knight Cancer Institute, the OHSU Institutional Review Board and other
departments as appropriate),, the National Cancer Institute (NCI), the Food and Drug
Administration (FDA), the Office for Human Research Protections (OHRP), the sponsor of this
study [sponsor name] [add any other parties, as appropriate].
State: All other parties including employers, insurance companies, and relatives will be refused
access to your information, unless you provide written permission, or unless we are required by
law to release it.
For studies that provide any type of compensation to subjects, state: We may request
IRB #:
List the consent version #. Refer to the previous approved consent form to determine
your next version. If initial consent, start with 1.0. Suggest using 1.0, 2.0, 3.0, etc.
Consent Version:
List the Protocol version that this consent form is approved under. For example,
‘Protocol Incorporating Amendment #1 dated 09 April 2011’
Protocol Version:
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IRB#:______________________
MED. REC. NO.:______________________
NAME:______________________
your social security number in order to process any payments for participation.
State: We will not use your name or your identity for publication or publicity purposes.
For studies involving interviews, questionnaires, surveys, or other procedures during
which such information may be learned, state: Under Oregon Law, suspected child or elder
abuse must be reported to appropriate authorities.
State: OHSU complies with all of the Oregon state requirements for reporting certain diseases
and conditions to local health departments.
WHY AM I BEING ASKED TO PARTICIPATE IN GENETIC TESTING?
If genetic testing is included in the protocol, use the following text. Inform the
participant that a sample of blood or tissue will be used for genetic research. Clearly
state if testing is mandatory for main study participation or optional. If optional, be sure
to include in the WHAT ARE THE OPTIONAL PORTIONS OF THIS STUDY section.
Suggested wording (use all that apply):
The purpose of the genetic testing in this study is to understand the inheritance of [disorder]. If
a gene or genes that cause [disorder] can be found, the diagnosis and treatment of [disorder]
may be improved.
Genes are the units of DNA--the chemical structure carrying your genetic information--that
determine many human characteristics such as the color of your eyes, your height, and whether
you are male or female.
The blood/tissue samples provided by you will be analyzed in the laboratory to determine
whether there are differences in the genes of people with and without [disorder].
If cytogenetic testing is included in the protocol, use the following text. If the language
describing genes is already included [from using the genetic description above] it is not
necessary to repeat that paragraph. In that case, simply use the paragraph about cells of
tumors:
Genes are the units of DNA--the chemical structure carrying your genetic information--that
determine many human characteristics such as the color of your eyes, your height, and whether
you are male or female.
IRB #:
List the consent version #. Refer to the previous approved consent form to determine
your next version. If initial consent, start with 1.0. Suggest using 1.0, 2.0, 3.0, etc.
Consent Version:
List the Protocol version that this consent form is approved under. For example,
‘Protocol Incorporating Amendment #1 dated 09 April 2011’
Protocol Version:
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IRB#:______________________
MED. REC. NO.:______________________
NAME:______________________
The cells of tumors also have genes that determine how the tumor grows or spreads and how it
may respond to different drugs. Part of this study will also be to test your cancer cells and their
genes.
WILL I HAVE ACCESS TO GENETIC INFORMATION COLLECTED IN THIS STUDY?
State that no information may be disclosed to anyone other than the participant without the
participant’s permission. Further, results may be disclosed to the participant or the participant’s
physician only if the laboratory generating the results is CLIA-approved.
If findings of any kind (results of genetic studies, clinically relevant information, or incidental
findings) are to be disclosed to the participant, describe the disclosure procedures (e.g. who will
make the disclosure and to whom; a referral to a genetic counselor or a referral for appropriate
medical advice must be provided).
The participants must be informed as to whether or not they will be contacted if the results of the
study are found to have clinical relevance in the future or for any other reason. If the
participants are not informed that they will be re-contacted in the consent document, any
attempt to re-contact the participant by the researcher must first be approved by the IRB. If no
disclosures are to be made, explain why. Suggested wording (use all that apply):
The results of these studies will not be made available to you because the research is still in an
early phase and the reliability of the results is unknown.
If we discover new information that is important for your health care, either in this study or the
future, you will be asked whether you wish to receive the results. You may be required to have
the test repeated in a clinical laboratory. Because genetic information is complex and sensitive,
the results should be discussed with a genetic counselor or your primary care giver who can
answer your questions or discuss your concerns. You would be responsible for all costs
associated with having the test repeated and visiting a doctor or genetic counselor to discuss
the results.
If you agree, we may contact you again in the future to update your information.
WHAT IS COMMERCIAL DEVELOPMENT AND HOW DOES IT AFFECT ME?
If samples are being stored for future research, this section must be included. Unless
this statement is included in the consent form, no commercial development of products
IRB #:
List the consent version #. Refer to the previous approved consent form to determine
your next version. If initial consent, start with 1.0. Suggest using 1.0, 2.0, 3.0, etc.
Consent Version:
List the Protocol version that this consent form is approved under. For example,
‘Protocol Incorporating Amendment #1 dated 09 April 2011’
Protocol Version:
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IRB#:______________________
MED. REC. NO.:______________________
NAME:______________________
based on the collected samples can take place without specific re-consent of
participants:
By consenting to participate, you authorize the use of your samples for the research described
in this document. In addition, you acknowledge that [OHSU or the sponsor, as appropriate] may
make any lawful use of your samples, including, but not limited to, future research studies,
destroying them, or transferring them to a public or private entity.
Samples obtained from you in this research may be used to make a discovery that could be
patented or licensed to a company. There are no plans to provide financial compensation to
you should this occur. However, should [OHSU or the sponsor, as appropriate] ever provide
your samples to anyone else for research or commercial use, it will do so in such a way as to
protect your privacy and confidentiality as stated in the WILL MY MEDICAL INFORMATION
AND SAMPLES BE KEPT PRIVATE section of this document. Further, you will have no
responsibility or liability for any use that may be made of your samples.
WHAT ARE THE COSTS OF TAKING PART IN THIS STUDY?
{NOTE: You may not modify the language in the cost section without seeking the permission of
the Clinical Research Billing Office (CRBO).}
To determine the correct cost language for the study, please go to the IRB Forms Page and
click on the clipboard icon next to “Cost Language.”
WHAT TRAVEL REIMBURSEMENTS ARE AVAILABLE IN THIS STUDY?
(Note: please refer to the finance team negotiating the budget to determine what reimbursement
may be offered to the patient. Confirm reimbursement prior to final IRB approval of consent.
Remove this section if no reimbursement is offered.)
You may be able to receive up to ($$$$$ enter contract specifics provided by the finance team)
travel reimbursement for each (visit, study or other timepoint). The reimbursement is dependent
on advance sponsor approval and submission of invoice.
Prior to starting the study, please talk with your study team if you will be requesting travel
reimbursement. Please give the study team any original study visit related travel receipts.
Submit them to the study team at regular intervals, providing all travel receipts for each visit at
one time. Travel reimbursement may take up to (enter timeframe, typically 8-10 weeks per
OHSU) to process.
IRB #:
List the consent version #. Refer to the previous approved consent form to determine
your next version. If initial consent, start with 1.0. Suggest using 1.0, 2.0, 3.0, etc.
Consent Version:
List the Protocol version that this consent form is approved under. For example,
‘Protocol Incorporating Amendment #1 dated 09 April 2011’
Protocol Version:
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IRB#:______________________
MED. REC. NO.:______________________
NAME:______________________
WHAT HAPPENS IF I AM INJURED BECAUSE I TOOK PART IN THIS STUDY? NOTE: You
may not modify the language in the liability section without seeking the permission of the OHSU
Research Integrity Office (ORIO).
To determine the correct liability language for the study, please go to the IRB Forms Page and
click on the clipboard icon next to “Liability Language – Subject Injury.”
WHAT ARE MY RIGHTS IF I TAKE PART IN THIS STUDY?
State: If you have any questions regarding your rights as a research participant, you may
contact the OHSU Research Integrity Office at (503) 494-7887.
Sites using CIRB, state: You may also call the Operations Office of the NCI Central
Institutional Review Board (CIRB) at 888-657-3711 (from the continental US only).
State: You do not have to join this or any research study. If you do join, and later change your
mind, you may quit at any time. If you refuse to join or withdraw early from the study, there will
be no penalty or loss of any benefits to which you are otherwise entitled.
If the investigator is also the patient’s health care provider, state: Your health care
provider may be one of the investigators of this research study and, as an investigator, is
interested in both your clinical welfare and in the conduct of this study. Before entering this
study or at any time during the research, you may ask for a second opinion about your care
from another doctor who is in no way involved in this project. You do not have to be in any
research study offered by your physician.
For studies recruiting OHSU students or employees as participants, please include the
following language: The participation of OHSU students or employees in OHSU research is
completely voluntary and you are free to choose not to serve as a research participant in this
protocol for any reason. If you do elect to participate in this study, you may withdraw from the
study at any time without affecting your relationship with OHSU, the investigator, the
investigator’s department, or your grade in any course. If you would like to report a concern
with regard to participation of OHSU students or employees in OHSU research, please call the
OHSU Integrity Hotline at 1-877-733-8313 (toll free and anonymous).
You will be told of any new information that might make you want to change your mind about
continuing to be in the study.
IRB #:
List the consent version #. Refer to the previous approved consent form to determine
your next version. If initial consent, start with 1.0. Suggest using 1.0, 2.0, 3.0, etc.
Consent Version:
List the Protocol version that this consent form is approved under. For example,
‘Protocol Incorporating Amendment #1 dated 09 April 2011’
Protocol Version:
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IRB#:______________________
MED. REC. NO.:______________________
NAME:______________________
WHAT WILL HAPPEN IF I CHOOSE TO STOP PARTICIPATING IN THE STUDY?
You can decide to stop at any time, however, it is important to tell the investigator if you are
thinking about stopping so any risks from the [drugs or intervention] can be evaluated and a
plan can be developed to help you stop safely.
Another reason to tell your investigator that you are thinking about stopping is to discuss what
follow-up care and testing could be most helpful for you.
The investigator may also choose to end your participation at any time if he/she believes it is in
your best interest; if you do not follow instructions; or if the study is stopped.
[Indicate what procedures, if any, the participant will be asked to complete if the participant
chooses to withdraw. If the protocol involves bone marrow transplantation, participants should
be warned that stopping the protocol at some stages will result in death].
Include one of the following statements:
The [blood/tissue/genetic information/medical information] that we will collect from you in this
study will not be stored with your name or any other identifier. Therefore, there will not be a way
for us to identify and destroy your materials if you decide in the future that you do not wish to
participate in this research.
Or, use this language: If, in the future, you decide you no longer want to participate in this
research, we will destroy your [blood/tissue/genetic information/medical information]. However,
if your [blood/tissue/genetic information/medical information] are already being used in an ongoing research project and if their withdrawal jeopardizes the success of the entire project, we
may ask to continue to use them until the project is completed.
Or, use this language: If in the future you decide you no longer want to participate in this
research, we will remove your name and any other identifiers from your [blood/tissue/genetic
information/medical information], but the material will not be destroyed and we will continue to
use it for research.
Or, use this language: The [blood/tissue/genetic information/medical information] we will
collect from you will be provided to the sponsor. It will be stored with a coded identifier to
protect your privacy. Once provided to the sponsor, we will not be able to destroy your samples
or data if you decide in the future you do not wish to participate in their research repository.
IRB #:
List the consent version #. Refer to the previous approved consent form to determine
your next version. If initial consent, start with 1.0. Suggest using 1.0, 2.0, 3.0, etc.
Consent Version:
List the Protocol version that this consent form is approved under. For example,
‘Protocol Incorporating Amendment #1 dated 09 April 2011’
Protocol Version:
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IRB#:______________________
MED. REC. NO.:______________________
NAME:______________________
WHO CAN ANSWER MY QUESTIONS ABOUT THIS STUDY?
Dr____________________ at (telephone: 503-xxx-xxxx) is available to answer any questions
you may have about this study. If you have a problem and need to talk with an oncologist
outside of regular clinic hours call [Define a contact person. For example, list the oncologist on
call] at 503- xxx-xxxx.
WHERE CAN I GET MORE INFORMATION?
You may call the NCI's Cancer Information Service at 1-800-422-6237 or TTY 1-800-332-8615.
You may also visit the NCI Web site at http://cancer.gov/

For NCI’s clinical trials information, go to: http://cancer.gov/clinicaltrials/

For NCI’s general information about cancer, go to http://cancer.gov/cancerinfo/
A description of this clinical trial will be available on http://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.
If you want more information about this study, ask your investigator.
WHAT ARE THE OPTIONAL PORTIONS OF THIS STUDY?
This section must be included if you have described any optional components. If there
are no optional components described in this consent form, you may delete this section
entirely.
Keep in mind that the participation choices you provide to participants:
 must not be contradictory to the protocol, and
 will dictate how your research team must manage the information/samples
The simplest example of describing optional participation is described below. If you
wish, or if the protocol/sponsor dictates that the optional portions be separated
individually, describe them in the same ‘yes/no’ format. Example of optional
participation (“all or none”):
IRB #:
List the consent version #. Refer to the previous approved consent form to determine
your next version. If initial consent, start with 1.0. Suggest using 1.0, 2.0, 3.0, etc.
Consent Version:
List the Protocol version that this consent form is approved under. For example,
‘Protocol Incorporating Amendment #1 dated 09 April 2011’
Protocol Version:
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IRB#:______________________
MED. REC. NO.:______________________
NAME:______________________
State: The optional portions of this study are described in detail throughout this consent form
and are listed here as a summary. Ask the study team if you have any additional questions
about the items in this list.
In lay language, bullet list the optional portions (pharmacokinetic sub-studies, genetics,
storage & future use, etc.) Example language is listed below.



Collect extra blood samples to measure the amount of study drug in your blood
(pharmacokinetic studies)
Genetic testing on your blood samples
Long term storage and sharing of your [blood/tissue/genetic information/medical
information] for other research purposes
Choose one of the following to describe your participation:
I give my consent to participate in the main part of the study and I do not wish to
participate in any of the optional portions of the study that are described above.
__________
Yes
Participant initials
__________
No
Participant initials
I give my consent to participate in the main part of the study and I do wish to participate
in all the optional portions of the study that are described above.
__________
Participant initials
Yes
__________
No
Participant initials
SIGNATURES:
State: Your signature below indicates that you have read this entire form and that you agree to
be in this study as indicated by your choice(s) above. If you change your mind about
participation in the study at any time, now or in the future, contact the study team listed on the
first page of this consent form. We will give you a copy of this signed form.
IRB #:
List the consent version #. Refer to the previous approved consent form to determine
your next version. If initial consent, start with 1.0. Suggest using 1.0, 2.0, 3.0, etc.
Consent Version:
List the Protocol version that this consent form is approved under. For example,
‘Protocol Incorporating Amendment #1 dated 09 April 2011’
Protocol Version:
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IRB#:______________________
MED. REC. NO.:______________________
NAME:______________________
If you intend to remove all identifiers in order to keep the participant’s
[blood/tissue/genetic information/medical information] in the event that the participant
wishes to no longer participate in the research project, you must include the following
statement with a line for the participant to initial their agreement:
__________
Participant initials
If, in the future, I decide that I no longer want my [blood/tissue/genetic
information/medical information] to be used in this research study with
information that can identify me, I agree that my [blood/tissue/genetic
information/medical information] may continue to be used for anonymous
research by removing all identifying information.
Include signature and date for the participant.
Include signature, print name, and date lines for the person obtaining consent.
Consent regulations for experimental drugs and devices require that consent forms be
dated at the time they are signed by the participant or participant’s authorized
representative [21 CFR 50.27].
When applicable:
a. Lines for parent, guardian, or legally authorized representative should be
included (for example, children, cognitively impaired,) as well as a line for
the description of their relationship to participant.
b. Signature lines for witnesses are not required by the OHSU IRB, but may be
included if required by the study sponsor.
Copies to:
Participant
Inpatient / Outpatient Charts
Research Chart
IRB #:
List the consent version #. Refer to the previous approved consent form to determine
your next version. If initial consent, start with 1.0. Suggest using 1.0, 2.0, 3.0, etc.
Consent Version:
List the Protocol version that this consent form is approved under. For example,
‘Protocol Incorporating Amendment #1 dated 09 April 2011’
Protocol Version:
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MED. REC. NO. _____
NAME
BIRTHDATE
_____
_____
IRB#: __________
HIPAA CLINICAL RESEARCH AUTHORIZATION
Title of Study:
Name of Principal Investigator:
Phone Number:
We have already asked you for your consent to be in the research study. We are also required
to seek separate permission to use your health information for the study. The Health Insurance
Portability and Accountability Act (HIPAA) is a federal law designed to help protect the privacy
of health information.
During this study, OHSU will use and disclose (release) health information about you. Under
federal law, we may not use or disclose it unless you authorize us to do so by signing this form.
This authorization is voluntary. You do not have to sign this form. If you choose not to sign it,
you cannot join this study.
The health information we will collect, use, and disclose is described in the attached consent
form. The consent form also describes why we will use the health information. Investigators,
study staff, and others at OHSU who are involved in the research or overseeing the research
may use and disclose your health information.
We may send your health information to others outside OHSU who are involved in the research
or overseeing the research including [list as applicable]:





The sponsor of this study, [sponsor name], and the sponsor’s representatives
The Food and Drug Administration
The Office for Human Research Protections, which oversees research involving humans
The National Cancer Institute
[Specify others, such as NIH, coordinating centers, international regulatory agencies,
etc.]
When we send information outside of OHSU, it may no longer be protected under federal law.
In this case, your information could be used and re-released without your authorization.
We may continue to use and disclose your health information indefinitely.
Some of the information collected and created in this study may be useful for your future health
care and will be placed in your OHSU medical record. While the research is in progress, you
IRB #:
List the consent version #. Refer to the previous approved consent form to determine
your next version. If initial consent, start with 1.0. Suggest using 1.0, 2.0, 3.0, etc.
Consent Version:
List the Protocol version that this consent form is approved under. For example,
‘Protocol Incorporating Amendment #1 dated 09 April 2011’
Protocol Version:
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IRB#:______________________
MED. REC. NO.:______________________
NAME:______________________
may not have access to this information. After the study is complete, you will be able to access
any study information that was added to your OHSU medical record.
You have the right to withdraw this authorization at any time. To withdraw your permission for us
to use information that identifies you, please send a written request or email to:
[Provide name, mailing address, and email address.]
The use and disclosure of your health information for this research will stop as of the date the
principal investigator receives your request. However, the use and disclosure of information
collected in good faith before your request arrives will continue. Withdrawing this authorization
will not affect your health care or your relationship with OHSU.
Please ask the investigator or study staff if you have any questions about this HIPAA
authorization.
We will give you a copy of this signed form.
___________________________________
Name of Subject, Printed
Signature of Subject
Date
___________________________________
Name of Person Obtaining Authorization, Printed
Signature of Person Obtaining Authorization
Date
IRB #:
List the consent version #. Refer to the previous approved consent form to determine
your next version. If initial consent, start with 1.0. Suggest using 1.0, 2.0, 3.0, etc.
Consent Version:
List the Protocol version that this consent form is approved under. For example,
‘Protocol Incorporating Amendment #1 dated 09 April 2011’
Protocol Version:
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MED. REC. NO. _____
NAME
BIRTHDATE
_____
_____
IRB#: __________
HIPAA CLINICAL RESEARCH AUTHORIZATION
OPTIONAL PROCEDURES
[Delete this form if no optional procedures]
Title of Study:
Name of Principal Investigator:
Phone Number:
You indicated in the consent form that you would like to participate in some or all of the optional
parts of this research study. The Health Insurance Portability and Accountability Act (HIPAA)
requires that we seek separate permission from you to use your health information for the
optional study procedures that you selected.
During the optional parts of the study, OHSU will use and disclose (release) health information
about you. Under federal law, we may not use or disclose it unless you authorize us to do so by
signing this form. This authorization is voluntary. You do not have to sign this form. If you
choose not to sign it, you cannot participate in the optional parts of the study. However, you
may still participate in the main part of the study.
The health information we will collect, use, and disclose is described in the attached consent
form. The consent form also describes why we will use the health information. Investigators,
study staff, and others at OHSU who are involved in the research or overseeing the research
may use and disclose your health information.
We may send your health information to others outside OHSU who are involved in the research
or overseeing the research including [list as applicable]:





The sponsor of this study, [sponsor name], and the sponsor’s representatives
The Food and Drug Administration
The Office for Human Research Protections, which oversees research involving humans
The National Cancer Institute
[Specify others, such as NIH, coordinating centers, international regulatory agencies,
etc.]
When we send information outside of OHSU, it may no longer be protected under federal law.
In this case, your information could be used and re-released without your authorization.
We may continue to use and disclose your health information indefinitely.
IRB #:
List the consent version #. Refer to the previous approved consent form to determine
your next version. If initial consent, start with 1.0. Suggest using 1.0, 2.0, 3.0, etc.
Consent Version:
List the Protocol version that this consent form is approved under. For example,
‘Protocol Incorporating Amendment #1 dated 09 April 2011’
Protocol Version:
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IRB#:______________________
MED. REC. NO.:______________________
NAME:______________________
Some of the information collected and created in this study may be useful for your future health
care and will be placed in your OHSU medical record. While the research is in progress, you
may not have access to this information. After the study is complete, you will be able to access
any study information that was added to your OHSU medical record.
You have the right to withdraw this authorization at any time. To withdraw your permission for
us to use information that identifies you, please send a written request or email to:
[Provide name, mailing address, and email address.]
The use and disclosure of your health information for this research will stop as of the date the
principal investigator receives your request. However, the use and disclosure of information
collected in good faith before your request arrives will continue. Withdrawing this authorization
will not affect your health care or your relationship with OHSU.
Please ask the investigator or study staff if you have any questions about this HIPAA
authorization.
We will give you a copy of this signed form.
___________________________________
Name of Subject, Printed
Signature of Subject
Date
___________________________________
Name of Person Obtaining Authorization, Printed
Signature of Person Obtaining Authorization
Date
IRB #:
List the consent version #. Refer to the previous approved consent form to determine
your next version. If initial consent, start with 1.0. Suggest using 1.0, 2.0, 3.0, etc.
Consent Version:
List the Protocol version that this consent form is approved under. For example,
‘Protocol Incorporating Amendment #1 dated 09 April 2011’
Protocol Version:
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