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 funding.] The [name of funder] 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.
[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.
FUNDED BY: List all organizations/entities providing monetary support for the study,
regardless of whether funds are received directly or through another organization (such as a
cooperative group or foundation).
SUPPORTED BY: List any organizations/entities providing non-monetary support only.
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
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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
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 __________.
If applicable, specify which procedures in the study are experimental
(investigational).
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 (describe
purpose of genetic analysis, example:) 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.
If subjects 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 PVAMC will be discussed in detail in the VA Consent Form.
PROCEDURES:
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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, DO describe procedures that are different in any way from
what the subject would receive if not participating in the study, even if the study
procedures are standard of care.
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.
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 for 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 funder
and/or other researchers, state: In the future, your [samples/information] may be given to
[researchers, the funder, 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
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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).]
[Inform participants whether they will be able to inspect the photographs/recordings before
they are released.]ACCESS TO YOUR TEST RESULTS [Delete if inapplicable to your
study]
If you plan to disclose research findings of any kind (e.g., results of genetic studies,
clinically relevant information, or incidental findings) to the subject or their
provider(s), describe:
 The disclosure procedures (e.g., who will make the disclosure and to whom; as
appropriate, any requirement for repeat testing and/or plan for referral to a
genetic counselor or other professional for appropriate medical advice), and
 Any risks associated with receiving this information (e.g. psychological risks,
impacts on insurability, employability, family plans, and family relationships,
and costs of additional medical care and testing).
 See the Bioethics Commission’s IRB Primer on Incidental and Secondary
Findings for further guidance.
If the subjects are not informed in the consent document that they may be recontacted, any attempt to re-contact the subject by the researcher must first be
approved by the IRB.
Lab results to be shared with subjects or their providers must be obtained in a CLIAapproved lab.
Example language for sharing results [modify as appropriate]: We will give you the
results of your [describe tests; e.g. genetic tests, screening tests].
Example language for incidental findings [modify as appropriate]: We do not plan to
share your [research, genetic, other as applicable] test results with you. However, if we
discover information that is important for your health care, either in this study or in the future,
we will contact you and ask if you want to know the results. If you choose to receive the
results, you may need to have the test repeated in a non-research laboratory. You may
learn information about your health that is upsetting or that impacts your [family planning,
family relationships, ability to get insurance, career, other as appropriate].
Additional recommended language for sharing genetic results: Because genetic
information is complex and sensitive, the results should be discussed with a genetic
counselor or your primary care provider 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.
Example language for anticipated secondary findings [modify as appropriate]: The
research tests in this study may tell us that you are at risk for [condition]. If we find out that
you are at risk, we will contact you and refer you to [provider that can help with condition].
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You would be responsible for all costs associated with any follow-up testing and medical
care.
If no disclosures are to be made, explain why.
Example language [modify as appropriate]: The results of research tests will not be
made available to you because the research is still in an early phase and the reliability of the
results is unknown.
RISKS AND DISCOMFORTS:
Describe reasonably foreseeable risks, side effects, discomforts, and
inconveniences. List the risks in order of their importance. Include risks from all
research activities that might be different in any way than what the subjects might
experience if they do not participate in the study.
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
(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.
BENEFITS:
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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,
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 funder of this study, [funder name], and the funder’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.
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 if this is optional.]
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.
For studies planning to obtain a Certificate of Confidentiality from NIH (or other
agency), include the following statement. When the COC is obtained, modify the CF
to state ‘we have obtained:’ To help us protect your privacy, we will obtain a Certificate of
Confidentiality from the National Institutes of Health. With this Certificate, the researchers
can refuse to disclose information that may identify you, even by a court subpoena, in any
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federal, state, or local civil, criminal, administrative, legislative, or other proceedings. The
researchers will use the Certificate to resist any demands for information that would identify
you, except as explained below.
The Certificate cannot be used to resist a demand for information from personnel of the
United States Government that is used for auditing or evaluation of federally funded projects
or for information that must be disclosed in order to meet the requirements of the FDA.
A Certificate of Confidentiality does not prevent you or a member of your family from
voluntarily releasing information about yourself or your involvement in this research. If an
insurer, employer, or other person obtains your written consent to receive research
information, then the researchers may not use the Certificate to withhold that information.
However, if we learn about abuse of a child or elderly person or that you intend to harm
yourself or someone else, or about certain communicable diseases, we will report that to the
proper authorities.
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
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
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information/medical information] for research will also be given information that may identify
you or your family members.
If, for the current research or for future research using these samples or data, genetic
data may be shared in a public database (e.g. per the NIH Genomic Data Sharing
Policy), state [modify as applicable]: Your genetic information may be shared in a public
online database for future research. The database will not contain any information that
directly identifies you, such as your name, address, or birth date, so it is unlikely that
someone would know the genetic information came from you. In the future, people may
develop ways to identify you or your blood relatives from this information, but currently, there
is not a way to identify you without having additional information to compare to it, such as
information from your DNA sample.
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.].
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.]
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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/or 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 Policies
and Forms Page and refer to the document entitled “Consent Form Language –
Costs.”
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 Policies
and Forms Page and refer to the document entitled “Consent Form Language –
Liability.”
PARTICIPATION:
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.)
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).
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Your participation in this study is voluntary. You do not have to join this or any research
study. [If study involves PHI, add: 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. [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
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The [samples and information] we will collect from you will be provided to the funder. It will
be stored with a coded identifier to protect your privacy. Once provided to the funder, we
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 funder 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.
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, add:
a. 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 subject.
b. Signature lines for witnesses are generally not required by the OHSU
IRB, but may be included if required by the study sponsor.
c. Interpreter box – add the following if you plan to use a short form
consent process for subjects with limited English proficiency.
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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. 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 subject 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.
Template Version 3/26/2015
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