INSTRUCTIONS: Consent Form
1. Instructions in italics are provided throughout the sample form. These instructions are
for your information. Please delete all instructions before submitting to the
Institutional Review Board (IRB).
2. Consent forms must be written in language suitable for subjects who read at the
eighth-grade level.
 For guidance on simplifying the language of consent forms, visit:
http://www.ohsu.edu/research/rda/irb/docs/policies/readtips.pdf.
3. Follow these standards when writing the consent form:
- Items in [square brackets] indicate action from you such as making a choice or
inserting study relevant information.
- Write out terms before using the acronym.
- Do not use abbreviations.
- Use the term subject or participant, not patient.
- Use the term investigator or study doctor, not doctor or physician.
- Insert page numbers.
Research Repository
Consent Form
IRB#__________
Approval Date:__________
REPOSITORY TITLE: Title of the study. Use the same title as that on the Initial Review
Questionnaire (IRQ) if this is a stand-alone repository OR you may create an appropraite
corresponding title to accompany an existing study..
PRINCIPAL INVESTIGATOR:
[list name and degree(s)] (503) 494-####
REPOSITORY GUARDIAN(S):
[list name and degree(s)] (503) 494-####
[list name and degree(s)] (503) 494-####
The Principal Investigator (PI) must be listed on the consent form and must be the same PI
listed on the IRQ.
SPONSOR: List the sponsor’s name here, and then refer to the sponsor as “the sponsor” in
the text. Delete if there is not a sponsor.
SUPPORTED BY: Use this heading instead of the sponsor heading to name the entity
providing financial support (includes free study drug) for an investigator-initiated study.
Delete if this is not applicable.
ABOUT RESEARCH REPOSITORIES
Generally, a research repository collects, stores and distributes human specimens
(samples of blood, tissue, or body fluids) and/or data for use in future research projects.
Storing and gathering lots of specimens and data together can help to conduct future
research and avoid re-collecting specimens and data over and over again. With this
stored information and samples, researchers may understand better how the human body
works, develop new tests to find diseases, find new ways to treat diseases, or develop
new products, such as drugs. When researchers collect and store many specimens and
data together and use them for different kinds of research in the future, or share them
with other scientists, this is called a research repository.
PURPOSE:
The purpose of this repository is to [describe purpose for the specimen collection and
storage and what you hope to learn, in general, and including any specific goals, from the
stored samples.]
 Inform subjects of the purpose of the repository.
 Provide a specific description of the research to be conducted with the
specimens/data if known.
 Describe the types of genetic research that may be done in the future, e.g, “…looking
for relationships between genes, the environment, and people’s habits or diet, and
different diseases.” (May omit if there is absolute certainty that genetic research will
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
never occur, but note that this will significantly restrict your ability to use samples in
the repository for genetic studies in the future. The IRB encourages you to include
the possibility of genetic research.)
Consider including genetic language for all specimen studies, regardless of plans to
conduct genetic research.
Stored samples are often used for genetic research. 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.
WHAT SPECIMENS/DATA WILL BE COLLECTED?
List what will be collected with lay terms as necessary.
HOW WILL SPECIMENS/DATA BE COLLECTED?
Describe succinctly and in chronological order those procedures that are part of the
specimen-data collection process. Make it clear when samples and/or data are being
collected for clinical care and then being stored or duplicated for research purposes.

For samples, indicate the amount of specimens to be collected if appropriate. If
blood is to be drawn, indicate the amount in lay terminology only (5cc = 1
teaspoon, 15cc = 1 tablespoon)

If the subject’s medical records will be reviewed, describe the information to be
collected.
State approximately how much time the visits and procedures will require.
WHAT WILL HAPPEN TO THE SPECIMENS/DATA?
Provide a clear description of the operation of the repository, addressing the following
aspects of how the specimens/data will be used and stored:
o Where will the specimens and data be stored?
o Will they be identifiable?
o If applicable, who will have access to the code to reidentify the specimens/data?
o How long will specimens and data be stored?
o If applicable, when will the specimens be destroyed?
Inform subjects that data and specimens may be released to other investigators. Indicate if
identifiable data or specimens may be released.
PRVACY & CONFIDENTIALITY PROTECTIONS:
Describe: Methods for storing, coding, and securely transporting data and/or specimens.
If media such as video/audio tapes or photographs are being stored, indicate whether
or not subjects will be identifiable, or how identity will be concealed.
State: The health-related information that we gather about you for this repository is
personal. The researchers are required by law to protect the privacy of information known
as protected health information (PHI). All reasonable efforts will be made to protect the
confidentiality of your PHI, which may be shared with others to support this research, for
future research, to conduct public health reporting, and to comply with the law as required.
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Despite these protections, there is a possibility that information about you could be used or
disclosed in a way that it will no longer be protected.
Where applicable, state: Research records may be reviewed and/or copied by [use all that
are applicable: the sponsor, the OHSU Institutional Review Board and other authorized
OHSU Members, the Food and Drug Administration (FDA), the National Institutes of Health
(NIH), the Office for Human Research Protections (OHRP), the Oregon Clinical &
Translational Research Institute (OCTRI), or any other applicable agency].
RISKS AND DISCOMFORTS:
Describe reasonably foreseeable risks, side effects, discomforts, and inconveniences for
collecting, storing and releasing samples and/or data. List the risks in order of their
importance. If a procedure is used to gather specimens or data for the repository, the risks
of the procedure should be listed, unless that procedure was part of another study or clinical
care.
Use standard wording where applicable – some common procedures are below.
Confidentiality Risks:
For genetic research: Although we have made every effort to protect your identity, there is
a small risk of loss of confidentiality. If the results of any 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 research repository could become available to an insurer or an
employer, or a relative, or someone else outside the repository. Even though there are
discrimination protections in both Oregon law and Federal law, there is still a small chance
that you could be harmed if a release occurred.
A new 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 new 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.
For blood draw: We will draw blood from [location on the body]. You may feel some pain
when your blood is drawn. There is a small chance the needle will cause bleeding, a bruise,
or an infection.
For skin biopsy: In this study, we will remove a small piece of skin from [location]. This is
called a skin biopsy. To do this we will give you a shot to numb the area. The shot may
cause a little pain. Some people (fewer than 1 in 10,000) are allergic to the shot you will get
to numb the area where the skin is taken. Heavy bleeding from a skin biopsy is rare. Skin
biopsies cause infections about 10% of the time. A small scar will form at the biopsy site.
The scar is usually much smaller than the original biopsy.
For bone marrow biopsy: Bone marrow biopsy means taking some cells from inside your
bones. To do this, we will numb an area of your skin (usually near your hip) with a shot.
The shot may cause a little pain. Some people (fewer than 1 in 10,000) are allergic to the
shot you will get to numb the area. Then we will insert a long needle into your bone to get
the cells. Some people have moderate to severe pain when the bone marrow cells are
drawn in through the long needle. Your hip may hurt for about 3-6 days. There is a small
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chance you will get a bruise or an infection where the needle will be inserted. You may
bleed or have a scar. Your skin may itch. These problems are rare.
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 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. NOTE: This statement is not
necessary if you are discussing routine matters that do not cause emotional upset.
For MRI: The magnetic resonance imaging (MRI) machine is a powerful magnet. There are
no known risks from the magnet itself. However, if you have metal in your body, the magnet
may cause the metal to move. If you know of any metal in your body, tell the investigator
because you may not be able to have an MRI. Review any dental treatments you have had
with the investigator, since these may involve metal. The most common discomfort of an
MRI is the length of time you must lie still or flat while the scan is being performed. Some
people with claustrophobia (fear of closed spaces) may find the MRI machine too confining.
Finally, the MRI scanner makes loud beeping or thumping noises, so you may be offered
protective earplugs to wear during the scan.
(If contrast agent is used, add:) The dye that is injected into your body has been used in
many patients and is generally well tolerated. Some people feel dizzy or queasy, get a
headache or notice a cold feeling near the site where the dye is injected. There is also a
chance of having an allergic reaction to the dye that very rarely can be serious and lifethreatening. If you have kidney disease, there is a chance that the dye could cause
nephrogenic systemic fibrosis (NSF). NSF is a disease in which too much scar tissue forms,
leading to serious damage to skin, muscle, and internal organs, and, in some cases, death.
If you have kidney disease or think your kidneys may not be functioning properly, you should
discuss this with the investigator before any dye is injected.
For x-rays, DEXA scans, and nuclear medicine procedures, including PET scans: In
this study, you will be exposed to radiation during the [name of the procedure]. While we
cannot be sure any dose of radiation is entirely safe, the amount you will be exposed to in
this study is not known to cause health problems.
For CT scans: In this study, you will be exposed to radiation during the CT scan. Although
the amount to which you will be exposed is higher than from a typical x-ray, the risk of
harmful effects from a single exam is very small.
BENEFITS:
There will not be any direct benefits to you if you decide to participate in this research
repository. Research conducted on these [specimens and/or data] may help researchers to
better understand health conditions [may specify here or leave it general] in the future.
WILL YOU RECEIVE RESULTS FROM RESEARCH INVOLVING YOUR SPECIMENS?
Most research with your specimens or data is not expected to yield new information that
would be meaningful to share with you personally. There are no plans to re-contact you or
other subjects with information about research results. [If future research may involve
individually identifiable data/specimens, state: However, if an investigator learns something
that he or she thinks might be important to you, there is a chance that you may be recontacted.]
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COSTS:
State that either subjects will not be paid for participation or the amount they will be paid.
There will be no cost to you for the storage and use of the specimens for research purposes.
LIABILITY:
If you believe you have been injured or harmed while participating in this research and
require immediate treatment, contact [study team info, if study involves physical risks
that may be immediate provide a phone number that is available 24 hours a day].
You have not waived your legal rights by signing this form. If you are harmed by the study
procedures, you will be treated. Oregon Health & Science University does not offer to pay
for the cost of the treatment. Any claim you make against Oregon Health & Science
University may be limited by the Oregon Tort Claims Act (ORS 30.260 through 30.300). If
you have questions on this subject, please call the OHSU Research Integrity Office at (503)
494-7887.
If there is a possibility of genetic testing, include: Oregon Health & Science University is
also subject to the Oregon Genetic Privacy law (ORS 192.531 through ORS 192.549) and
its requirements concerning confidentiality and the legal remedies provided by that law for
breach of its requirements. You have not waived your legal rights by signing this form. For
clarification on this subject, or if you have further questions, please call the OHSU Research
Integrity Office at (503) 494-7887.
If the repository includes prospectively collected biological samples and is industry
sponsored, add: You, or your medical insurance, will be billed for expenses resulting from
your condition. However, if you are harmed by the study procedures, you will be treated.
This treatment will be provided at no cost to you or your insurance company if the harm is
caused by the sample collection and would not have been expected from the standard
treatment of your condition.
COMMERCIAL DEVELOPMENT [for specimens only]
By consenting to participate, you authorize the use of your specimens as described in the
PURPOSE and PROCEDURES sections of this document. In addition, you acknowledge
that [OHSU and/or the sponsor, as appropriate] may make any lawful use of your samples,
including, but not limited to, future research studies, destroying them, or transferring them to
a public or private entity.
Specimens obtained from you and stored in this research repository may be used to make a
discovery that could be patented or licensed to a company. There are no plans to provide
financial compensation to you should this occur. However, should [OHSU and/or the
sponsor, as appropriate] ever provide your specimens to anyone else for research or
commercial use, it will do so in such a way as to protect your privacy and confidentiality as
stated in the CONFIDENTIALITY section of this document. Further, you will have no
responsibility or liability for any use that may be made of your specimens.
PARTICIPANT RIGHTS:
You must include one of the following statements:
If industry sponsored: The [blood/tissue samples/genetic or other information] that we will
collect from you will be provided to the sponsor and will be stored with a coded identifier to
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protect your privacy. Once provided to the sponsor, the investigator will not be able to
destroy your specimens or data if you decide in the future that you do not wish to participate
in this research repository.
If not industry sponsored:
The [blood/tissue samples/genetic or other information] that we will collect from you in this
study will not be stored with your name or any other identifier. Therefore, there will not be a
way for us to identify and destroy your materials if you decide in the future that you do not
wish to participate in this research repository.
or
If in the future you decide you no longer want to participate in this research repository, we
will destroy all your [blood/tissue samples/genetic or other information]. However, if your
genetic samples are already being used in an on-going 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 repository, we
will remove your name and any other identifiers from your [blood/tissue samples/genetic or
other information], but the material will not be destroyed and we will continue to use if for
research.
State: If you have any questions regarding your rights as a research subject, you may
contact the OHSU Research Integrity Office at (503) 494-7887.
State: You have a right to refuse to sign this form. You do not have to join this or any
research study. If you do join, and later change your mind, you may quit at any time. If you
refuse to participate or later withdraw your specimens/data from the repository, there will be
no penalty or loss of any benefits to which you are otherwise entitled. Information about you
gathered [during your clinical care or during this research study] will not be placed into the
research repository described in this form or used for future research if you do not sign this
form. You do not give up any of your legal rights by signing this form. [If applicable state:
You may participate in the main study without participating in this repository.]
If the investigator is also the patient’s health care provider, state: Your health care
provider may be [one of] the investigator[s] of this research repository, and as an
investigator is interested in both your clinical welfare and in the conduct of this research.
You do not have to be in any research study offered by your physician. Your health care
outside the research, the payment for your health care, and your health care benefits will not
be affected if you do not sign this form.
State: If you have any questions regarding this research repository now or in the future,
contact [PI Name (503) 494-####] [or other members of the study team at (503) ###-####].
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SIGNATURES:
Your signature below indicates that you have read this entire form and that you agree to
storage of your specimens and data in this research repository and use for future research
purposes. We will give you a copy of this form.
Include signature and date for the subject.
Include signature, print name, and date lines for the person obtaining consent.
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. For a “Repository Only” submission, minors may not consent to their
own participation. A signature line for the minor participant may be
included on this consent form for minors age 15 or older; minor
subjects age 7-14 should sign a separate assent form. Refer to policy
on Children as Research Subjects for more information.
Printed name of Research Subject
Signature of Subject
Date
-OR-
Printed name of Subject’s Legally Authorized Representative
Signature of Subject’s Legally Authorized Representative
Date
Printed name of Person Obtaining Consent
Signature of Person Obtaining Consent
Date
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HIPAA RESEARCH AUTHORIZATION
IRB#__________
Approval Date:__________
AUTHORIZATION FOR THE CREATION, USE, AND DISCLOSURE OF PROTECTED HEALTH
INFORMATION FOR INSTITUTIONAL REVIEW BOARD APPROVED RESEARCH
This authorization is voluntary, and you may refuse to sign this authorization. If you refuse to
sign this authorization, your health care and relationship with OHSU will not be affected.
However, you will not be able to enter this research study.
1. This form authorizes Oregon Health & Science University (OHSU) to use and disclose (release)
certain protected health information about
that we will collect and store in this research repository. (name of subject)
2. The persons who are authorized to use and disclose your protected health information are:
All investigators listed on page one of the Research Repository Consent Form and others at
OHSU who are participating in the oversight of this research repository.
Others:
3. The persons who are authorized to access this information are:
The sponsor of this study:
Authorized OHSU Members
Federal or other governmental agencies as required for their research oversight and public
health reporting in connection with this research study:
OHRP
FDA
NIH
Other:
Others:
Comment: Any disclosures or uses for future research will require appropriate review and
approval by the OHSU Institutional Review Board.
4. We may continue to use and disclose protected health information that we collect from you in this
study until:
HIPAA Research Authorization expiration date
-ORThe repository is terminated
Indefinitely
Other:
5. You have the right to revoke this authorization and can withdraw your permission for us to use
your information and/or tissue or blood sample that identifies you for this research by sending a
written request to the Principal Investigator listed on page one of the research consent form. If
you do send a letter to the Principal Investigator, the use and disclosure of your protected health
information and/or tissue or blood sample that identifies you for this research will stop as of the
date he/she receives your request. However, the use and disclosure of information collected
before the date of the letter or collected in good faith before your letter arrives is allowed to
continue. If you withdraw permission for use of any tissue or blood samples that were collected
from you for a genetic research study, they either will be destroyed or stored without any
information that identifies you. Revoking this authorization will not affect your health care or your
relationship with OHSU.
6. The information about you that is used or disclosed in this study may be re-disclosed and no
longer protected under federal law. However, Oregon law restricts re-disclosure of HIV/AIDS
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information; mental health information; genetic information; and drug/alcohol diagnosis,
treatment, or referral information.
H E A L T H I N F O R MA T I O N
to be collected and stored for the purpose of maintaining a research repository.
Your complete existing health record **
Limited information from your existing health record** (specify):
____________________________________________________
** If we are requesting existing health records that are located outside of OHSU, you will need to
complete an additional authorization to release these records to OHSU.
History and physical examinations
Reports:
Laboratory
Operative
Discharge
Progress
Photographs, videotapes, or digital or other images
Diagnostic images/X-ray/MRI/CT
Bioelectric Output (e.g., EEG, EKG)
Questionnaires, interview results, focus group survey, psychology survey, behavioral performance
tests (e.g., memory & attention)
Tissue and/or blood specimens
Other:
7. If the information to be used or disclosed contains any of the types of records or information listed
just below, additional laws relating to use and disclosure of the information may apply. You
understand and agree that this information will be used and disclosed only if you place your
INITIALS in the applicable space next to the type of information. (Instructions: All items you
intend to collect information on must be included; irrelevant fields may be 1) deleted - or 2) included with N/A typed in the field. If the statement is included, please delete these
instructions. If none are applicable, delete this entire item. The IRB encourages
investigators to include genetics in all repositories that store specimens. Failure to do so
will significantly restrict your ability to conduct future genetic research.)
Acquired immunodeficiency syndrome (AIDS) or human immunodeficiency virus (HIV)
infection information
Drug/alcohol diagnosis, treatment, or referral information
Mental or behavioral health or psychiatric care
Genetic testing information
You will receive a copy of this authorization form after you sign it.
Printed name of Research Subject
Signature of Subject
Date
-OR-
Printed name of Subject’s Legally Authorized Representative
Signature of Subject’s Legally Authorized Representative
Date
Description of Relationship to Subject:
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