MED. REC. NO._______________
NAME_______________________
BIRTHDATE__________________
IRB#: __________
The Knight Consent Template Information & Tools Bridge page is meant to be used in conjunction with this
consent form template, and provides IRB-recommended template language, helpful links and other resources.
OHSU Knight Cancer Institute Consent and Authorization Form
Title for Study Participants: [Insert Lay Title here in bold]
Official Study Title for Internet Search on http://www.ClinicalTrials.gov: [Insert Official Title
here not in bold]
Funded by: [All sources of funding]
Supported by: [Non-financial support]
Device Study Funding Statement (optional for other studies): OHSU is
being compensated by the funder to conduct this study. This is to pay for
tests performed only for study purposes, and for the time involved on the
part of the investigator(s) and research staff. You may freely discuss this
with your physician and the investigator if you have concerns.
Table of Contents
Benefits
10
Device studies with NO investigator conflict of interest, also state the
following. If conflict of interest statement is required, use that instead
(see below): The investigator and the research staff have no financial
involvement with the funder and are not being paid directly by the funder
for conducting this study. However, they may have travel expenses covered
by the funder to attend study training meetings.
Privacy
10
Participation
12
Optional
18
Signature
20
Study Schedule
23
Introduction
2
Purpose
3
Procedures
4
Risks
7
Conflict of Interest Statement: [For more information on CoIR, visit:
http://www.ohsu.edu/xd/research/about/integrity/coi/]
IRB #: [insert number]
Protocol Version: X.0 – dated [MM/DD/YYYY]
Consent Version: X.0
Page 1 of 23
OHSU Knight Template Form Version: 01/04/2016
MED. REC. NO._______________
NAME_______________________
BIRTHDATE__________________
IRB#: __________
STUDY CONTACT INFORMATION
Purpose
For medical questions
about the study*
For non-medical
questions about the
study*
For questions about
research in general
For 24-hour medical
emergencies
Contact Phone
Number
Role
Contact Name
Principal Investigator
[insert name], MD
Co-Investigator
[insert name], MD
Research Nurse
[insert name], RN
Study Coordinator
[insert name]
503-xxx-xxxx
Ethics Committee
ORIO
503-494-7887
Ethics Committee
CIRB
Emergency
Dispatch
xxx-xxx-xxxx
OHSU Operator
503-xxx-xxxx
911
Oncologist On-Call
Email
irb@ohsu.edu
911
* The Code of Federal Regulations Title 21 Part 50.25 requires that there be contact information for someone
who can answer pertinent questions about the research. The table above must be included.
INTRODUCTION
WHAT IS THE USUAL APPROACH TO MY [insert type of cancer, precancerous condition, early detection,
prevention of cancer, diagnosis, other]?
For instructions and text examples, refer to the Knight Consent Template Information & Tools Bridge page.
WHAT ARE MY OTHER CHOICES IF I DO NOT TAKE PART IN THIS STUDY?
Instructions:
1. Section length limit: This section should be no more than one-quarter page.
2. Additional bullets should include, when appropriate, alternative procedures or interventions. A
disclosure of appropriate alternative procedures or courses of treatment, if any, that might be
advantageous to the subject is required by the Code of Federal Regulations Title 21 Part 50.25.
3. For comparative effectiveness studies in which two approved commercially-available approaches
(tests, drugs, surgery, radiation, diagnostics, etc.) are being compared, the option of receiving one of
the approaches outside of the trial should be included.
State:
IRB #: [insert number]
Protocol Version: X.0 – dated [MM/DD/YYYY]
Consent Version: X.0
Page 2 of 23
OHSU Knight Template Form Version: 01/04/2016
MED. REC. NO._______________
NAME_______________________
BIRTHDATE__________________
IRB#: __________
If you decide not to take part in this study, you have other choices. For example:
 you may choose to have the standard treatment
 you may choose to take part in a different study, if one is available
 or you may choose not to be treated for cancer [as appropriate, consider adding:] but you may
want to receive comfort care to relieve symptoms.
PURPOSE
WHY IS THIS STUDY BEING DONE?
Explain the purpose of the research (required by the Code of Federal Regulations Title 21 Part 50.25). For
instructions and text examples, refer to the Knight Consent Template Information & Tools Bridge page.
The Code of Federal Regulations Title 21 Part 50.25 requires identification of what is experimental. Specify
which drug(s), device(s), or procedure(s) in the trial are experimental (investigational). Examples (modify to
fit your study):
The use of the [unapproved drug/device] for [condition] is experimental. It has not been approved by the FDA
because we do not know enough about it.
The [drug/device] is experimental. It has been approved by the FDA for use in [condition], but not for
[condition]. We do not know if it is better than the usual approach for treating [condition].
The [lab test] we are using in this study is experimental. It has not been approved by the FDA for [diagnosing
condition/determining type of treatment] because we do not know enough about it.
The [procedure/surgery] we are studying is experimental. We do not know if it is better than the usual
approach for treating [condition].
State (This section is required by the Code of Federal Regulations Title 21 Part 50.25):
This is a clinical trial, a type of research study. Medical personnel who carry out research studies are called
“investigators.” The 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 can discuss your
decision with your friends and family. You can also discuss it with your health care team or another doctor. If
you have any questions, ask the investigator.
IRB #: [insert number]
Protocol Version: X.0 – dated [MM/DD/YYYY]
Consent Version: X.0
Page 3 of 23
OHSU Knight Template Form Version: 01/04/2016
MED. REC. NO._______________
NAME_______________________
BIRTHDATE__________________
IRB#: __________
GENETICS
For instructions and text examples, refer to the Knight Consent Template Information & Tools Bridge page.
HOW MANY PEOPLE WILL TAKE PART IN THIS STUDY? (If applicable, this section is required by the Code of
Federal Regulations Title 21 Part 50.25)
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] 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] of participants
will get a higher dose.
PROCEDURES
WHAT ARE THE STUDY GROUPS?
[Insert paragraph regarding type of study]
For instructions and text examples, refer to the Knight Consent Template Information & Tools Bridge page.
[Insert study chart if desired]
IRB #: [insert number]
Protocol Version: X.0 – dated [MM/DD/YYYY]
Consent Version: X.0
Page 4 of 23
OHSU Knight Template Form Version: 01/04/2016
MED. REC. NO._______________
NAME_______________________
BIRTHDATE__________________
IRB#: __________
Study chart is optional if there is no randomization.
Another way to find out what will happen to you during this study is to read the chart below. [Start reading
at the left side and read across to the right, following the lines and arrows.]
You agree to
take part in the
study
Randomize
(The computer will
randomly put you in a
study group)
Group 1
Hormone therapy
(Usual approach
group)
Group 2
Hormone therapy +
Chemotherapy (Study
group)
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 pill [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.
HOW LONG WILL I BE IN THIS STUDY?
State (limit to one-eighth page) (This section is required by the Code of Federal Regulations Title 21 Part
50.25):
You will receive the [insert description of intervention, e.g., study drugs] for [insert intervention length]. After
you finish [insert description of intervention], your doctor will continue to watch you for side effects and
follow your condition for [insert study follow-up length].
WHAT TESTS AND PROCEDURES WILL I HAVE IF I TAKE PART IN THIS STUDY?
IRB #: [insert number]
Protocol Version: X.0 – dated [MM/DD/YYYY]
Consent Version: X.0
Page 5 of 23
OHSU Knight Template Form Version: 01/04/2016
MED. REC. NO._______________
NAME_______________________
BIRTHDATE__________________
IRB#: __________
Explain the procedures to be followed, and identification of any procedures which are experimental
(required by the Code of Federal Regulations Title 21 Part 50.25). For instructions and text examples, refer to
the Knight Consent Template Information & Tools Bridge page.
If participants will have procedures at the PVAMC as well, state:
This study will be conducted at both the PVAMC and OHSU. The study procedures that will occur at the
PVAMC will be discussed in detail in the PVAMC consent form.
Before you begin the study:
You will need to have the following [insert type, e.g., exams, tests, and/or procedures] to find out if you can be
in the study:
Examples of exams, tests and procedures:
 MUGA scan
 Blood tests for studies of drug levels
 CT scan of abdomen
 Bone scan
The following text example is provided for studies which include mandatory specimen collection:
[Insert specimen type: Small pieces of cancer tissue removed by surgery, biopsies; A blood sample; A urine
sample] will be taken for the study [state when the sample will be taken, for example: before you begin study
drug; after the third dose; etc. If blood is to be drawn, indicate the amount in units that are familiar to
participants only (5cc = 1 teaspoon, 15cc = 1 tablespoon)] This sample is required in order for you to take part
in this study because the research on the sample is an important part of the study. [Include brief description of
how the specimen will be collected, e.g., “The research biopsy is done in a similar way to biopsies done for
diagnosis.” Include a brief description of how the specimen will be used.]
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 [insert type of radiation
exam, e.g. PET scan, x-ray] is performed.
During the study:
If the exams, tests, and procedures show that you can take part in the study, and you choose to take part,
then you will need the following [insert type, e.g., exams, tests, and/or procedures]:
Examples of exams, tests, and procedures:
 Routine blood tests
IRB #: [insert number]
Protocol Version: X.0 – dated [MM/DD/YYYY]
Consent Version: X.0
Page 6 of 23
OHSU Knight Template Form Version: 01/04/2016
MED. REC. NO._______________
NAME_______________________
BIRTHDATE__________________
IRB#: __________





Research-related blood tests (PK samples may require a longer clinic visit than normal) [elaborate
on PK timing in the Study Schedule]
CT scan of abdomen
Bone scan
Bone marrow biopsy
Echocardiogram or MUGA scan to see how your heart is working
A study schedule that shows how often these [insert type, e.g., exams, tests, and/or procedures] will be done
is attached. [For additional template study calendars, refer to the Knight Consent Template Information &
Tools Bridge page.]
If questionnaires, surveys, diaries, or other data collection materials are being used, mention what kinds of
questions will be asked and how long the tasks will take to complete, and upload a copy to your eIRB
application.
If the participant’s medical records will be reviewed (from OHSU or requested from another facility), state
this and describe the information to be collected.
PHOTOGRAPHS, VIDEOTAPES, AUDIOTAPES
For instructions and text examples, refer to the Knight Consent Template Information & Tools Bridge page.
RISKS
WHAT POSSIBLE RISKS CAN I EXPECT FROM TAKING PART IN THIS STUDY?
A description of any reasonably foreseeable risks or discomforts to the subject is required by the Code of
Federal Regulations Title 21 Part 50.25. For instructions and text examples, refer to the Knight Consent
Template Information & Tools Bridge page.
State: (limit to 2-4 pages)
PHYSICAL RISKS
The [specify type of study intervention, such as surgery, radiation therapy, drugs, etc.] used in this study may
affect how different parts of your body work such as your liver, kidneys, heart, and blood. The investigator will
be testing your blood and will let you know if changes occur that may affect your health.
IRB #: [insert number]
Protocol Version: X.0 – dated [MM/DD/YYYY]
Consent Version: X.0
Page 7 of 23
OHSU Knight Template Form Version: 01/04/2016
MED. REC. NO._______________
NAME_______________________
BIRTHDATE__________________
IRB#: __________
There is also a risk that you could have side effects from the [study drug(s)/study approach].
Here are important points about side effects:
 The investigators do not know who will or will not have side effects.
 Some side effects may go away soon, some may last a long time, or some may never go away.
 Some side effects may interfere with your ability to have children.
 Some side effects may be serious and may even result in death.
 If applicable, this statement is required by the Code of Federal Regulations Title 21 Part 50.25: You
may have some side effects we do not expect because we are still learning about [insert disease and/or
study drug].
 If applicable, this statement is required by the Code of Federal Regulations Title 21 Part 50.25: There
may be unanticipated risk to an embryo or fetus if you or your partner becomes pregnant.
 If some side effects will not have symptoms noticeable to the participant (like abnormal lab values),
state: You may not have symptoms for some of these side effects, but you will be monitored by the
investigator to check for any changes throughout the study.
Here are important points about how you and the investigator can make side effects less of a problem:
 Tell the investigator if you notice or feel anything different so they can see if you are having a side
effect.
 The investigator may be able to treat some side effects.
 The investigator may adjust the study drugs to try to reduce side effects.
The tables below show the most common and the most serious side effects that researchers know about.
There might be other side effects that researchers do not yet know about. If important new side effects are
found, the investigator will discuss these with you.
For NCI Risk Tables, go to the Knight Consent Template & Tools Bridge page. Include only the risks related to
the study drug(s) and/or procedures. You may add risks of usual care in an appendix at the end of the
consent form.
[Insert treatment group] - Possible side effects of [insert drug/regimen]:
Possible Side Effects of [insert drug/regimen]
COMMON, SOME MAY BE SERIOUS
In 100 people receiving [insert drug/regimen], more than 20 and up to 100 may have:
 [create list of side effects]
IRB #: [insert number]
Protocol Version: X.0 – dated [MM/DD/YYYY]
Consent Version: X.0
Page 8 of 23
OHSU Knight Template Form Version: 01/04/2016
MED. REC. NO._______________
NAME_______________________
BIRTHDATE__________________
IRB#: __________
OCCASIONAL, SOME MAY BE SERIOUS
In 100 people receiving [insert drug/regimen], from 4 to 20 may have:
 [create list of side effects]
RARE, AND SERIOUS
In 100 people receiving [insert drug/regimen], 3 or fewer may have:
 [create list of side effects]
For risks of procedures, drugs in general, fertility/reproductive risks, HIV, and Radiation Therapy risks, refer
to the Knight Consent Template Information & Tools Bridge page.
State:
Let your investigator know of any questions you have about possible side effects. You can ask the investigator
questions about side effects at any time.
OTHER TYPES OF RISKS
Instructions:
1. Select reasonably foreseeable risks and discomforts that are not physical side effects from the
bullets below and/or include others, as relevant. Keep bulleted lists to no more than four items, if
possible.
2. 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.
If you choose to take part in this study, there is a risk that:
 You may lose time at work or home and spend more time in the hospital or doctor’s office than usual.
 You may be asked sensitive or private questions which you normally do not discuss.
 The [study drug(s)/study approach] may not be better, and could possibly be worse, than the usual
approach for your cancer.
 The [study drug(s)/study approach] or the dose you receive may not be effective in helping to treat
your disease. This means you may spend time in the study and experience side effects taking a drug
that may not provide you with any health-related benefits.
 As part of this study, you will be asked to complete [list all applicable interviews/questionnaires/QOL
assessments that apply to this section]. Some of these questions may seem very personal or
IRB #: [insert number]
Protocol Version: X.0 – dated [MM/DD/YYYY]
Consent Version: X.0
Page 9 of 23
OHSU Knight Template Form Version: 01/04/2016
MED. REC. NO._______________
NAME_______________________
BIRTHDATE__________________
IRB#: __________
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.
BENEFITS
WHAT POSSIBLE BENEFITS CAN I EXPECT FROM TAKING PART IN THIS STUDY?
A description of any benefits to the subject or to others which may reasonably be expected from the
research is required by the Code of Federal Regulations Title 21 Part 50.25. For instructions and text
examples, refer to the Knight Consent Template Information & Tools Bridge page.
PRIVACY
ACCESS TO YOUR TEST RESULTS
For instructions and text examples, refer to the Knight Consent Template Information & Tools Bridge page.
WHY AM I BEING ASKED TO PARTICIPATE IN GENETIC TESTING?
For instructions and text examples, refer to the Knight Consent Template Information & Tools Bridge page.
RISKS OF GENETIC TESTING
For instructions and text examples, refer to the Knight Consent Template Information & Tools Bridge page.
WHO WILL SEE MY MEDICAL INFORMATION?
A statement describing the extent, if any, to which confidentiality of records identifying the subject will be
maintained is required by the Code of Federal Regulations Title 21 Part 50.25.
State:
We will take steps to keep your personal information confidential, but we cannot guarantee total privacy. [If
there are special precautions this study is taking to achieve this, describe here, e.g. collecting data
anonymously or coding samples immediately so they are never identified.]
We will create and collect health information about you as described in the WHY IS THIS STUDY BEING DONE
and the WHAT TESTS AND PROCEDURES WILL I HAVE IF I TAKE PART IN THIS STUDY sections of this form.
Health information is private and is protected under federal law and Oregon law. By agreeing to be in this
IRB #: [insert number]
Protocol Version: X.0 – dated [MM/DD/YYYY]
Consent Version: X.0
Page 10 of 23
OHSU Knight Template Form Version: 01/04/2016
MED. REC. NO._______________
NAME_______________________
BIRTHDATE__________________
IRB#: __________
study, you are giving permission (also called authorization) for us to use and disclose your health information
as described in this form.
The investigators, study staff and others at OHSU may use the information we collect and create about you in
order to conduct and oversee this research study and [store it in a repository, conduct future research, etc.].
We may release this information to others outside of OHSU who are involved in conducting or overseeing this
research, including [list as applicable]:
 The funder of this study, [insert funder name], and the funder’s representatives
 The Food and Drug Administration (FDA) (required by the Code of Federal Regulations Title 21 Part
50.25)
 The Office of Human Research Protections (OHRP), a federal agency that oversees research in humans
 The National Cancer Institute (NCI)
 Other researchers who may use your information for future research studies (only include this
statement if other researchers may receive PHI; state if this is optional)
 [If applicable, specify others such as NIH, coordinating centers, etc.]
Those listed above may also be permitted to review and copy your records, including your medical records.
If industry sponsored, state: Your name, date of birth, and social security number may be provided to the
study funder (or organization acting on their behalf) so the funder can meet Medicare reporting requirements.
If other researchers may receive identifiable information for future research, state: We may also share your
information with other researchers, who may use it for future research studies.
State: We will not release information about you to others not listed above, unless required or permitted by
law. We will not use your name or your identity for publication or publicity purposes, unless we have your
special permission.
State: When we send specimens or information outside of OHSU, they may no longer be protected under
federal or Oregon law. In this case, your specimens or information could be used and re-released without your
permission.
STUDIES WITH A CERTIFICATE OF CONFIDENTIALITY FROM NIH
For instructions and text examples, refer to the Knight Consent Template Information & Tools Bridge page.
IRB #: [insert number]
Protocol Version: X.0 – dated [MM/DD/YYYY]
Consent Version: X.0
Page 11 of 23
OHSU Knight Template Form Version: 01/04/2016
MED. REC. NO._______________
NAME_______________________
BIRTHDATE__________________
IRB#: __________
INTERVIEWS, QUESTIONNAIRES, SURVEYS, OR OTHER PROCEDURES
For instructions and text examples, refer to the Knight Consent Template Information & Tools Bridge page.
STORAGE, LABELING AND SHARING SAMPLES OR INFORMATION
State: When we send specimens or information outside of OHSU, they may no longer be protected under
federal or Oregon law. In this case, your specimens or information could be used and re-released without
your permission.
For instructions and text examples, refer to the Knight Consent Template Information & Tools Bridge page.
MENTAL HEALTH RECORDS:
For instructions and text examples, refer to the Knight Consent Template Information & Tools Bridge page.
INFORMATION ABOUT RELATIVES
For instructions and text examples, refer to the Knight Consent Template Information & Tools Bridge page.
State: We may continue to use and disclose your information as described above indefinitely. Some of the
information collected and created in this study may be placed in your OHSU medical record. While the
research is in progress, you may or 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. Ask the investigator
if you have questions about what study information you will be able to access, and when it will be available.
ADDITIONAL PROTECTIONS FOR SPECIAL TYPES OF INFORMATION
DRUG & ALCOHOL DIAGNOSIS, TREATMENT, OR REFERRAL INFORMATION AND MENTAL HEALTH RECORDS
For instructions and text examples, refer to the Knight Consent Template Information & Tools Bridge page.
PARTICIPATION
CAN I STOP TAKING PART IN THIS STUDY?
A statement regarding the consequences of a subject’s decision to withdraw from the research and a
statement regarding procedures for orderly termination of participation by the subject, if relevant, are
required by the Code of Federal Regulations Title 21 Part 50.25.
IRB #: [insert number]
Protocol Version: X.0 – dated [MM/DD/YYYY]
Consent Version: X.0
Page 12 of 23
OHSU Knight Template Form Version: 01/04/2016
MED. REC. NO._______________
NAME_______________________
BIRTHDATE__________________
IRB#: __________
State (limit to three-eighths page):
Yes. You can decide to stop at any time. If you decide to stop for any reason, it is important to let the
investigator know as soon as possible so you can stop safely. Another reason to tell your investigator that you
are thinking about stopping is to discuss what testing, follow-up, or additional treatment could be most
helpful for you. If you stop, you can decide whether or not to let the investigator continue to provide your
medical information to the organization running the study.
Once your participation has ended, your cancer doctor will help you choose the next step in your cancer care.
Go to the Knight Consent Template & Tools Bridge page to choose the next paragraph to 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.
State (required by the Code of Federal Regulations Title 21 Part 50.25):
The investigator will tell you about new information or changes in the study that may affect your health or
your willingness to continue in the study.
The investigator may take you out of the study:
 If your health changes and the study is no longer in your best interest
 If new information becomes available
 If you do not follow the study rules
 If the study is stopped by the sponsor, IRB or FDA.
WHAT ARE MY RIGHTS IN THIS STUDY?
State (limit to one-eighth page) (This section is required by the Code of Federal Regulations Title 21 Part
50.25):
Your participation in this study is voluntary. No matter what decision you make, and even if your decision
changes, there will be no penalty to you. You will not lose medical care or any legal rights. If you have any
questions, concerns, or complaints regarding this study now or in the future, contact the principal investigator
listed at the beginning of the form.
This research is being overseen by an Institutional Review Board (“IRB”). You may talk to the IRB at (503) 4947887 or irb@ohsu.edu if:
 Your questions, concerns, or complaints are not being answered by the research team
 You want to talk to someone besides the research team
 You have questions about your rights as a research subject
IRB #: [insert number]
Protocol Version: X.0 – dated [MM/DD/YYYY]
Consent Version: X.0
Page 13 of 23
OHSU Knight Template Form Version: 01/04/2016
MED. REC. NO._______________
NAME_______________________
BIRTHDATE__________________
IRB#: __________

You want to get more information or provide input about this research.
You may also submit a report to the OHSU Integrity Hotline online at
https://secure.ethicspoint.com/domain/media/en/gui/18915/index.html or by calling toll-free (877) 733-8313
(anonymous and available 24 hours a day, seven days a week).
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).
You do not have to join this or any research study. You do not have to allow the use and disclosure of your
health information in the study, but if you do not, you cannot be in the study. [If study has optional
components add: Some parts of the study are optional. You can choose not to participate in some or all of the
optional parts but still participate in the rest of the study].
If you do join the study and later change your mind, you have the right to quit at any time. This includes the
right to withdraw your authorization to use and disclose your health information. [If study has optional
components add: You can choose to withdraw from some or all of the optional parts of this study without
withdrawing from the whole study.] If you choose not to join any or all parts of this study, or if you withdraw
early from any or all parts of the study, there will be no penalty or loss of benefits to which you are otherwise
entitled, including being able to receive health care services or insurance coverage for services. Talk to the
investigator if you want to withdraw from the study [If study has optional components add: or change which
parts of the study you are participating in].
If you no longer want your health information to be used and disclosed as described in this form, you must
send a written request or email stating that you are revoking your authorization to:
Knight Clinical Trials Office, ATTN: KCTO Manager
3303 SW Bond Ave, CH15R, Portland, OR 97239
trials@ohsu.edu
Your request will be effective as of the date we receive it. However, health information collected before your
request is received may continue to be used and disclosed to the extent that we have already taken action
based on your authorization.
IRB #: [insert number]
Protocol Version: X.0 – dated [MM/DD/YYYY]
Consent Version: X.0
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OHSU Knight Template Form Version: 01/04/2016
MED. REC. NO._______________
NAME_______________________
BIRTHDATE__________________
IRB#: __________
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.
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 #: [insert number]
Protocol Version: X.0 – dated [MM/DD/YYYY]
Consent Version: X.0
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OHSU Knight Template Form Version: 01/04/2016
MED. REC. NO._______________
NAME_______________________
BIRTHDATE__________________
IRB#: __________
WHAT ARE THE COSTS OF TAKING PART IN THIS STUDY?
Instructions:
1. If applicable, this section is required by the Code of Federal Regulations Title 21 Part 50.25.
2. To determine the correct cost language for the study, please go to the IRB Policies and Forms Page and
open the document, “Consent Form Language – Costs.”
3. You may not modify the language in the cost section without seeking the permission of the Clinical
Research Billing Office (CRBO).
For studies that provide any type of compensation to participants, additionally state: We may request your
social security number in order to process any payments for participation.
WHAT TRAVEL REIMBURSEMENTS ARE AVAILABLE IN THIS STUDY?
Instructions:
Please refer to the finance team negotiating the budget to determine if reimbursement may be offered to
the patient. Remove this section if no reimbursement is offered.
You may or may not be able to receive reimbursement for travel related to the study. Prior to starting the
study, please talk with your study team to see if reimbursement is available.
WHAT HAPPENS IF I AM INJURED OR HURT BECAUSE I TOOK PART IN THIS STUDY?
Instructions:
1. This section is required by the Code of Federal Regulations Title 21 Part 50.25.
2. To determine the correct liability language for the study, please go to the IRB Policies and Forms Page
and open the document, “Consent Form Language – Liability.”
3. You may not modify the language in the liability section without seeking the permission of the OHSU
Research Integrity Office (ORIO).
WHAT IS COMMERCIAL DEVELOPMENT AND HOW DOES IT AFFECT ME?
State:
IRB #: [insert number]
Protocol Version: X.0 – dated [MM/DD/YYYY]
Consent Version: X.0
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OHSU Knight Template Form Version: 01/04/2016
MED. REC. NO._______________
NAME_______________________
BIRTHDATE__________________
IRB#: __________
Samples and information [if applicable, add: including any photographs, videotapes, or audiotapes] about you
or obtained from you in this research may be used for commercial purposes, such as making a discovery that
could, in the future, be patented or licensed to a company, which could result in a possible financial benefit to
that company, OHSU, and its researchers. There are no plans to pay you if this happens. You will not have any
property rights or ownership or financial interest in or arising from products or data that may result from your
participation in this study. Further, you will have no responsibility or liability for any use that may be made of
your samples or information.
WHERE CAN I GET MORE INFORMATION?
Instructions:
1. Section length limit: This section should be between six and eight sentences and take up no more than
one-quarter page.
2. The second paragraph below complies with the Code of Federal regulations Title 21 CFR 50.25(c) and
must be included verbatim in all consent forms for any applicable trial under the regulation. The text
cannot be revised.
3. Not all studies are required to report to clinicaltrials.gov. Consult the Knight Policy CR013, “Knight
Clinical Trials Registration” if you are unsure of the reporting requirements for your study.
State:
You may visit the NCI Web site at http://cancer.gov/ for more information about studies or general
information about cancer. You may also call the NCI Cancer Information Service to get the same information
at: 1-800-4-CANCER (1-800-422-6237).
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.
When visiting either of these websites, use the search term(s) “[insert search term(s)]” to locate information
on this trial.
If you want more information about this study, ask your investigator.
IRB #: [insert number]
Protocol Version: X.0 – dated [MM/DD/YYYY]
Consent Version: X.0
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OHSU Knight Template Form Version: 01/04/2016
MED. REC. NO._______________
NAME_______________________
BIRTHDATE__________________
IRB#: __________
WHO CAN ANSWER MY QUESTIONS ABOUT THIS STUDY?
State: (limit to one-eighth page)
You can talk to the investigator about any questions or concerns you have about this study or to report side
effects or injuries. Outside of regular clinic hours, you can speak with an oncologist on-call. Refer to the
beginning of this consent form for contact names and phone numbers.
OPTIONAL
ADDITIONAL STUDIES SECTION: INDICATE CLEARLY TO PARTICIPANTS THAT THIS IS A SEPARATE SECTION
For instructions and text examples, refer to the Knight Consent Template Information & Tools Bridge page.
1. OPTIONAL SAMPLE COLLECTIONS FOR LABORATORY STUDIES AND/OR STORAGE FOR POSSIBLE FUTURE
STUDIES
For instructions and text examples, refer to the Knight Consent Template Information & Tools Bridge page.
2. OPTIONAL PROCEDURE STUDY – EXTRA PROCEDURE
For instructions and text examples, refer to the Knight Consent Template Information & Tools Bridge page.
3. OPTIONAL EXPERIMENTAL PROCEDURE
For instructions and text examples, refer to the Knight Consent Template Information & Tools Bridge page.
4. OPTIONAL QUALITY OF LIFE STUDY
For instructions and text examples, refer to the Knight Consent Template Information & Tools Bridge page.
For all optional studies:
HOW WILL INFORMATION ABOUT ME BE KEPT PRIVATE?
Samples and/or information obtained from this optional study will be managed in the same way as sample
and information in the main study. For more information, refer to the WHO WILL SEE MY MEDICAL
INFORMATION section.
ARE THERE ANY COSTS OR PAYMENTS?
There are no costs to you or your insurance. You will not be paid for taking part. If any of the research leads to
new tests, drugs, or other commercial products, you will not share in any profits.
WHAT IF I CHANGE MY MIND?
IRB #: [insert number]
Protocol Version: X.0 – dated [MM/DD/YYYY]
Consent Version: X.0
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OHSU Knight Template Form Version: 01/04/2016
MED. REC. NO._______________
NAME_______________________
BIRTHDATE__________________
IRB#: __________
If in the future you decide you no longer want to participate in this research, we will stop collecting your
samples and data. However, once provided to the sponsor, we may not be able to destroy your samples or
data and it will continue to be used for research. Samples or related information that have already been given
to or used by researchers will not be returned.
If you wish to no longer participate, you can call the investigator listed on page one of this consent form.
WHAT IF I HAVE MORE QUESTIONS?
If you have questions about the use of your samples for research, contact the investigator listed at the
beginning of this consent form.
IRB #: [insert number]
Protocol Version: X.0 – dated [MM/DD/YYYY]
Consent Version: X.0
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OHSU Knight Template Form Version: 01/04/2016
MED. REC. NO._______________
NAME_______________________
BIRTHDATE__________________
IRB#: __________
PARTICIPANT OPTIONS:
Use and modify this box if there are optional components in the study. For additional text examples, refer to
the Knight Consent Template Information & Tools Bridge page.
Please initial to show whether or not you would like to take part in each option. You can still participate in
the main part of the study even if you choose not to participate in the optional parts.
I give my consent for my blood/tissue samples and information to
be used for this research and disclosed for use in future research
studies, which may include genetic research. [Indicate section #
above for reference, e.g. See Optional Study #4].
I choose to take part in the optional procedure study and will have
the extra [insert name of procedure, e.g., PET scan, tumor biopsy].
[Indicate section # above for reference, e.g. See Optional Study #4].
My leftover samples and related information may be kept in a
repository for use in future health research. [Indicate section #
above for reference, e.g. See Optional Study #4].
Yes, I agree
No, I decline
__________
__________
Participant initials
Participant initials
Yes, I agree
No, I decline
__________
__________
Participant initials
Participant initials
Yes, I agree
No, I decline
__________
__________
Participant initials
Participant initials
Use the following text if optional studies have been included:
This is the end of the section about optional studies.
SIGNATURE
MY SIGNATURE AGREEING TO TAKE PART IN THE MAIN STUDY
IRB #: [insert number]
Protocol Version: X.0 – dated [MM/DD/YYYY]
Consent Version: X.0
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OHSU Knight Template Form Version: 01/04/2016
MED. REC. NO._______________
NAME_______________________
BIRTHDATE__________________
IRB#: __________
Your signature below indicates that you have read this entire form and that you agree to be in this study [and
any additional studies where I initialed next to ‘Yes, I agree’].
We will give you a copy of this signed form.
Participant Printed Name
Participant Signature
Date
The following signature and date lines for the person(s) conducting the discussion may be included at the
discretion of the study sponsor.
Person(s) Obtaining Consent Printed Name
Person(s) Obtaining Consent Signature
Date
When applicable:
1. Lines for parent, guardian, or legally authorized representative (for example, children, cognitively
impaired,) as well as a line for the description of their relationship to participant.
2. Signature lines for witnesses are generally not required by the OHSU IRB, but may be included if
required by the study sponsor.
3. Interpreter box – add the following if you plan to use a short form consent process for subjects with
limited English proficiency.
IRB #: [insert number]
Protocol Version: X.0 – dated [MM/DD/YYYY]
Consent Version: X.0
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OHSU Knight Template Form Version: 01/04/2016
MED. REC. NO._______________
NAME_______________________
BIRTHDATE__________________
IRB#: __________
Use of an Interpreter: Complete if the participant is not fluent in English and an interpreter was used to obtain
consent. Participants who do not read or understand English must not sign this full consent form, but instead
sign the short form translated into their native language. This form should be signed by the investigator and
interpreter only. If the interpreter is affiliated with the study team, the signature of an impartial witness is
also required.
Print name of interpreter:
Signature of interpreter:
Date:
An oral translation of this document was administered to the participant in ____________________ (state
language) by an individual proficient in English and ____________________ (state language).
If applicable:
Print name of impartial witness: __________________________________
Signature of impartial witness: ___________________________________ Date: ____________
See the attached short form for documentation.
IRB #: [insert number]
Protocol Version: X.0 – dated [MM/DD/YYYY]
Consent Version: X.0
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OHSU Knight Template Form Version: 01/04/2016
MED. REC. NO._______________
NAME_______________________
BIRTHDATE__________________
IRB#: __________
STUDY SCHEDULE
This schedule lists study procedures as well as procedures you would have even if you do not join the study
(usual care) so you can see all of the things that will happen during the study in one place. Usual care
procedures are marked with an *.
Procedure
Day
1
Physical exam
X*
1
Vital signs
ECG
Routine blood
draw2
(1 tablespoon)
Research blood
draw3
(3 tablespoons)
Pregnancy test
(if needed)
Review any
reactions to
study drug
Review all other
medications
Research urine
samples
CT Scans
Day
2
Cycle 1
Day Day
8
15
Day
1
Day
8
Cycle 2
Day Day
15
22
X
X
X
X
X
X
X
X
X*
X*
X*
X*
X*
X*
X*
X*
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Cycle 3
Day Day
1
15
X
X*
X
X
Day
29
X
Cycle 4+
Day Day
1
15
X
4
hrs
End of
Treatment
X
X
X
X
X
X
X
X
X*
X*
X*
X*
X*
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X*
X
X
MRI
Total Time
Day
22
X
X
X
X
X
X
X
X
30
min
1
Can include heart rate, blood pressure, height, weight, oxygen saturation, temperature
Can include CBC with differential, chemistry, magnesium, uric acid
3
PK, PD, biomarkers
2
IRB #: [insert number]
Protocol Version: X.0 – dated [MM/DD/YYYY]
Consent Version: X.0
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OHSU Knight Template Form Version: 01/04/2016