IRB#: __________
Research Consent Summary
[DELETE ALL INSTRUCTIONS IN BRACKETS. Revise the example language to fit
your study. The summary should be brief (approximately one page).]
[THIS NON-BAR-CODED FORM SHOULD ONLY BE USED FOR STUDIES THAT DO
NOT INVOLVE ANY CLINICAL PROCEDURES AND DO NOT REQUIRE THE CONSENT
FORM TO BE PLACED IN THE SUBJECT’S MEDICAL RECORD.]
You are being asked to join a research study. You do not have to join the study. Even if
you decide to join now, you can change your mind later.
[If the study involves optional procedures/sub-studies, add:] Some parts of this study are
optional. You may participate in the main study without participating in the optional parts.
1. The purpose of this study is to learn more about [topic].
2. We want to learn
a. [Using lay language and short sentences, list primary and secondary aims
from protocol.]
b. If people are satisfied with their current health care and
c. What people do not like about their current health care.
3. [Describe sponsorship.] The [name of sponsor] is paying for the research study.
4. [Describe randomization, if applicable.] Everyone who joins the study will fill out
surveys. You will have a 50/50 chance of being interviewed, as well.
5. [State length of participation in days, weeks, months, or years. Summarize study
procedures. List number of visits. Describe follow up. Sample language:] If you join
the study, you will complete a telephone survey three times over three months. You
will have 1 visit to OHSU. We will then call you once a year for 5 years to check on
your health.
6. [Summarize risks.] There is a small risk of breach of confidentiality.
[Delete Point 7 if the study does not include optional components.]
7. Optional parts of the study include [list major optional substudies].
[Delete Point 8 if the study does not include banking.]
8. If you agree, samples and information collected during the study may be saved for
future research.
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[Delete Point 9 if the study includes no plans to ever use samples for genetic
research.]
9. Samples collected during the study may be used for genetic research.
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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.
- Instructions are given in italics.
- Write out terms before using the acronym.
- Do not use abbreviations.
- Use the term “subject” or “participant,” not “patient.”
- Use the term “investigator” or “study doctor,” not “doctor” or “physician.”
- For studies conducted at both the VA and OHSU, the OHSU consent should only
briefly mention the activities that will happen at the PVAMC.
DELETE ALL INSTRUCTIONS AND TEXT THAT DO NOT APPLY TO YOUR STUDY.
IRB#: __________
Research Consent and Authorization Form
TITLE: Title of the study. Use the same title as that on the Initial Review Questionnaire
(IRQ).
PRINCIPAL INVESTIGATOR:
[list name and degree(s)]
(503) 494-####
CO-INVESTIGATORS:
[list name and degree(s)]
[list name and degree(s)]
[list name and degree(s)]
[list name and degree(s)]
[list name and degree(s)]
(503) 494-####
(503) 494-####
(503) 494-####
(503) 494-####
(503) 494-####
The Principal Investigator (PI) must be listed on the consent form. Listing co-investigators on
the consent form is optional. It is recommended that you limit the number of co-investigators
listed here by listing only those most likely to conduct the consent discussion.
SPONSOR: For industry-funded studies, list the sponsor’s name here, and then refer to the
sponsor as “the sponsor” in the text. Delete this section if non industry-funded.
FUNDED BY: For nonindustry-funded research studies, list the funding source name here.
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/
PURPOSE:
If the study includes both children and adults and all procedures are identical for both
children and adults, state: “You” means you or your child in this consent form. (For other
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studies involving children, address the consent form to the parent referring to children as
“your child.”)
Include and complete the following sentences: You have been invited to be in this
research study because __________. The purpose of this study is to __________.
State how long the study will last. Sample language (modify as appropriate): This
study requires 7 visits to the clinic and will take 8 weeks to complete.
If the study involves genetic research and/or storing data or specimens in a
repository for future research, state that here. Indicate whether subjects can opt out
of these activities and still participate in the study.
Suggested wording for genetic research (use all that apply, modify as appropriate):
The purpose of the 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 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).
Suggested wording for repositories (modify as appropriate):
We are asking you to provide [blood/tissue/information] for a [blood/tissue/data] bank, also
called a repository. These samples will be stored indefinitely and may be used and
disclosed in the future for research, which may include genetic research.
Indicate how many subjects will be enrolled into the experiment both at OHSU and,
where applicable, for the entire study.
For studies conducted at the PVAMC as well, state:
This study will be conducted at both the PVAMC and OHSU. The study procedures that will
occur at PVAMC will be discussed in detail in the VA Consent Form.
PROCEDURES:
Describe succinctly and in chronological order the procedures for this study. It is not
necessary to describe in detail procedures that are routine care and not required by
the protocol. However, procedures that are required by the protocol must be
included, even if they would occur if the subject did not participate in the research. If
appropriate, indicate which procedures would be done regardless of whether the
subject participates in the study.
Clearly indicate which, if any, procedures are optional and state that subjects will be
able to indicate their choice at the end of the form.
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State how much time the visits and procedures will require. If studies are complex,
use a simple table showing what procedures will occur at each study visit. In most
cases, tables provided by the sponsor in the study protocol are too complex to be of
help to most subjects. Example:
Consent Discussion,
Screening tests and
medical history
Urine Collection
Quality of Life
Questionnaire
Total time
Visit 1
Day 1
X
Visit 2
Day 14
Visit 3
Month 3
Visit 4
Month 6
Visit 5
Month 12
X
X
X
X
X
X
X
3 hours
3 hours
X
4 hours
30 minutes
30 minutes
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 of each to your eIRB application.
If the subject’s medical records will be reviewed (from OHSU or requested from
another facility), state this and describe the information to be collected.
If this is a genetic study and 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 as described in this consent.
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 a repository and data/samples may be shared with the sponsor
and/or other researchers, state: In the future, your [samples/information] may be given to
[researchers, the sponsor, list as appropriate] for other research studies. [If applicable:
These studies may include genetic research.] The [samples and/or information] will be
labeled as described in the CONFIDENTIALITY section.
If this study includes collection of identifiable photographs (including identifiable
images and physical likenesses), videotapes, or audiotapes that will be presented in
public, state: During this study [you, your image, your physical likeness] 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]. [NOTE: if these materials will be used for marketing
purposes, contact the ORIO. Additional requirements may apply.]

[Describe succinctly and in chronological order the recording procedures. Specify the
duration of the recording sessions.]

[If attempts to conceal the participant’s identity will be made, explain how (black bar
over eyes, voice disguised, etc).]
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
[Inform participants whether they will be able to inspect the photographs/recordings
before they are released.]
State: If you have any questions, concerns, or complaints regarding this study now or in the
future, contact [PI Name (503) 494-####] [or other members of the study team at (503) #######]. (The PI phone number must match the first page of this consent form.)
SUBJECT ACCESS TO GENETIC INFORMATION: (include if this study involves
genetics or if future research studies may involve genetics)
Note that no information may be disclosed to anyone other than the subject without
the subject’s permission, except as permitted by law. Further, results may be
disclosed to the subject or the subject’s physician only if the laboratory generating
the results is CLIA-approved.
If findings of any kind (e.g., results of genetic studies, clinically relevant information,
or incidental findings) are to be disclosed to the subject, 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 subjects 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 subjects are not informed that they will be re-contacted in the consent
document, any attempt to re-contact the subject 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.
RISKS AND DISCOMFORTS:
Describe reasonably foreseeable risks, side effects, discomforts, and
inconveniences. List the risks in order of their importance.
Indicate if a risk applies only to a part of the study that is optional.
For studies involving interviews/questionnaires/QOL assessments that discuss
sensitive issues that may cause emotional upset, such as grieving, and not just
routine matters: The risk of emotional upset must be described, and subjects must be
informed that they may refuse to answer questions that upset them. Sample language
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(modify as appropriate): 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.
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 include genetics, 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 long-term 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 efforts 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 certain genetic discrimination and confidentiality
protections in both Oregon law and federal law, there is still a small chance that you could
be harmed if a release occurred.
If genetic information will be released to subjects, state: 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].
BENEFITS:
Unless direct benefits to the subject are assured, use the following language: You
may or may not personally benefit from being in this study. However, by serving as a
subject, you may help us learn how to benefit patients in the future.
When the subject will not benefit, but is participating solely for altruistic motives, use
the following language: You will not benefit from being in this study. However, by serving
as a subject, you may help us learn how to benefit patients in the future.
ALTERNATIVES:
State: You may choose not to be in this study.
CONFIDENTIALITY:
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,
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describe here, e.g., collecting data anonymously or coding samples immediately so they are
never identified.]
If study involves PHI, state: We will create and collect health information about you as
described in the Purpose and Procedures sections of this form. Health information is private
and is protected under federal law and Oregon law. By agreeing to be in this study, you are
giving permission (also called authorization) for us to use and disclose your health
information as described in this form.
State: 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
in a repository, conduct future research, as applicable; state if any of these are optional].
We may release this information to others outside of OHSU who are involved in conducting
or overseeing 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, a federal agency that oversees
research involving humans[Specify others, such as NCI, NIH, coordinating centers,
etc.]
Those listed above may also be permitted to review and copy your records.
We may also share your information with other researchers, who may use it for future
research studies. [Only include if other researchers may receive PHI; state if this is optional.]
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.
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.
If applicable, also state: OHSU complies with Oregon state requirements for reporting
certain diseases and conditions to local health departments.
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.
If applicable, indicate how information will be shared with other researchers (not
industry sponsors) and whether shared materials will include identified information or
genetic information. Examples (modify based on your planned procedures for
sample and data labeling):
[Data/specimens] from this study may be shared with other investigators for future research
studies. A code number will be assigned to you, your cells and genetic information, as well
as to information about you. Only the investigators and people involved in the conduct of
the study will be authorized to link the code number to you. Other investigators who may
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receive samples of your [blood/tissue/genetic information/medical information] for research
will be given only the code number which will not identify you.
or
[Data/specimens] from this study may be shared with other investigators for future research
studies. All identifying information about you will be removed from the samples before they
are released to any other investigators.
or
[Data/specimens] from this study may be shared with other investigators for future research
studies. Your samples will be labeled with [your name or other information (specify)] that will
identify you. 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.
State: We may continue to use and disclose your information as described above
indefinitely. [Specify alternate end date or event if applicable.]
If study involves PHI, state: 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. If you have
questions about what study information you will be able to access, and when, ask the
investigator.
Additional Protections for Special Types of Information [Delete this entire section if not
applicable.]
Oregon Law provides special protection for drug and alcohol diagnosis, treatment, or
referral information and mental health records from Oregon publicly funded or
contracted mental health providers (e.g. Oregon State Hospital or Oregon publicly
funded alcoholism, drug addiction, or mental health programs). Note this does not
include mental health information in the general medical record (such as history of
depression). If you will collect, use, or disclose any of this information, include the
applicable language below. Contact the ORIO if you have questions about the use
and disclosure of this information.
If any of these types of information will be obtained, state: The law provides additional
confidentiality protection for certain types of information, including [list as applicable to your
study] drug and alcohol diagnosis, treatment, or referral information and mental health
records.
Drug and alcohol diagnosis, treatment, or referral information or records: We will
collect [drug and alcohol diagnosis, treatment or referral] information about you from [drug or
alcohol treatment providers]. We may disclose this information to [list as appropriate] until
the study has ended to allow them to [monitor your safety, learn more about the effects of
the study drug, etc.].
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Mental health records: We will collect mental health information about you from [mental
health facility or program]. We may disclose this information to [list as appropriate] to allow
them to [monitor your safety, learn more about the effects of the study drug, etc.]
If subjects may choose NOT to have their , drug/alcohol or mental health information
(as described above) used or disclosed for this study, list this option at the end of the
form and state: You may still be in the study if you choose not to allow us to use and
disclose the [drug and alcohol, mental health] information as described above. You will be
asked to indicate your choice at the end of this form.
COMMERCIAL DEVELOPMENT [ALL STUDIES]:
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.
COSTS: (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 costs language for the study, please go to the IRB Forms
Page and click on the clipboard icon next to “Costs Language.”
For studies that provide any type of compensation to subjects, additionally state: We
may request your social security number in order to process any payments for participation.
LIABILITY: (NOTE: You may not modify the language in the liability section without seeking
the permission of the 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.”
PARTICIPATION:
State: This research is being overseen by an Institutional Review Board (“IRB”). You may
talk to the IRB at (503) 494-7887 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.
• 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, 7 days a week).
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
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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. [If
study involves PHI, add: 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 study involves PHI, state: 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:
Provide name, mailing address, and email address.
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 acted based on your authorization.
Indicate what will happen, if anything, if a subject chooses to withdraw. For example,
list the visits and/or procedures the subject will be requested to complete.
State what will happen to samples/information if the subject withdraws. Suggested
wording (modify as appropriate):
The [samples and information] that we will collect from you 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
If in the future you decide you no longer want to participate in this research, we will destroy
all your [samples and information]. However, if your samples 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
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 [samples and information], but the material
will not be destroyed and we will continue to use it for research.
or
The [samples and 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
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will not be able to destroy your samples or data if you decide in the future you do not wish to
participate in the research.
Clarify under what circumstances the subject may be removed from the study prior to
study conclusion. State: You may be removed from the study if [list reasons: the
investigator or sponsor stops the study, you do not follow study instructions, etc.]
State: We will give you any new information during the course of this research study that
might change the way you feel about being in the study.
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 subjects, 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 subject 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).
A Child Assent Form should be prepared if the study enrolls subjects between 7 and
17.
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SIGNATURES:
[Delete this entire box if the study does not include optional components. For studies
with optional components, list the options here. This includes options to restrict the
use or disclosure of certain types of health information. Participants must place their
initials next to their choices.]
PARTICIPANT OPTIONS
State (modify as appropriate): The optional portions of this study are described in detail
throughout this consent form and listed here as a summary. Please read the options and
place your initials next to [your choices/one of the choices below]. You can still participate in
the main part of the study even if you choose not to participate in the optional parts.
Example options (modify as appropriate):
_____ I give my consent for my DNA sample and information to be stored in a repository
and used for future research studies, which may include genetic research.
_____ I give my consent to participate in the optional survey on Day 2 of the study.
State: Your signature below indicates that you have read this entire form and that you
agree to be in this study.
We will give you a copy of this signed form.
Subject Printed Name
Subject Signature
Date
Person Obtaining Consent Printed
Name
Person Obtaining Consent Signature
Date
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 subject.
b. Signature lines for witnesses are not required by the OHSU IRB, but
may be included if required by the study sponsor.
c. Interpreter box – add the following if appropriate.
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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.
Print name of interpreter: ______________________________________
Signature of interpreter: ___________________________________ Date: _________
An oral translation of this document was administered to the subject in _____________
(state language) by an individual proficient in English and ____________ (state language).
See the attached short form for documentation.
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