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.
IRB#__________
Research Repository Consent Form
REPOSITORY 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-####
REPOSITORY GUARDIAN(S):
[list name and degree(s)]
[list name and degree(s)]
(503) 494-####
(503) 494-####
The Principal Investigator (PI) must be listed on the consent form and must be the same PI
listed on the IRQ.
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).
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.
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


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
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.
Specify any procedures in the study that are experimental (investigational).
State approximately how much time the visits and procedures will require.
If this study includes collection of identifiable photographs (including identifiable
images and physical likenesses), videotapes, or audiotapes that will be presented in
public, include the following paragraph. [NOTE: if these materials will be used for
marketing purposes, contact the ORIO. Additional requirements may apply.] 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].



[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.]
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?
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o
o
o
If applicable, who will have access to the code to reidentify the specimens/data?
How long will specimens and data be stored?
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.
WILL YOU RECEIVE RESULTS FROM RESEARCH INVOLVING YOUR SPECIMENS?
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, your
primary care provider, etc.] the results of your [describe tests; e.g. research blood tests, CT
scan, genetic tests, screening tests]. The results will be placed in your medical record.
Example language for incidental findings [modify as appropriate]: We do not plan to
share your [research, genetic, other as applicable] test results with you or your primary care
provider. 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].
Example language for research MRI [or other imaging, modify as appropriate]: The
MRI scan is being done to answer research questions, not to examine your brain for medical
reasons. This MRI scan is not a substitute for a clinical scan (the type a doctor would
order). The research scan may not show problems that may be picked up by a clinical MRI
scan. If we find an abnormality that requires urgent follow-up, we will contact you and your
doctor (with your permission) to help answer questions and get the right follow-up care for
you. It is possible that you could be unnecessarily worried if a problem were suspected, but
not actually found.
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
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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].
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.
PRIVACY & CONFIDENTIALITY PROTECTIONS:
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 repository includes collection/storage of PHI, state: We will create and collect health
information about you as described in the above sections of this form. Health information is
private and is protected under federal law and Oregon law. By agreeing to be in this
repository, 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 maintain and oversee this research repository and to
conduct future research projects.
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
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
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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.]
[NOTE: 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 in
your repository, please contact the ORIO. Restrictions may apply, and additional
language may be required.]
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.
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 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.
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.
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, which would require antibiotics. A small
scar will form at the biopsy site. The scar is usually much smaller than the original biopsy.
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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
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.
COSTS:
State: There will be no cost to you for the storage and use of the specimens for research
purposes.
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If subjects are compensated for participation in the study, indicate how (i.e. one
amount versus pro-rated per visit), the amount, and how the amount will be prorated
if the subject withdraws before completing the study.
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.
If subjects may receive >$600 within one year, please include the following statement:
Payment received as compensation for participation in research is considered taxable
income for a research subject. If payments are more than $600 in any one calendar year,
OHSU is required to report this information to the Internal Revenue Service (IRS). Research
subject payments exceeding $600 during any calendar year will result in a 1099
(Miscellaneous Income) form being issued to the research subject and a copy will be sent to
the IRS.
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.”
COMMERCIAL DEVELOPMENT [ALL REPOSITORIES]
[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.
PARTICIPANT RIGHTS:
You must include one of the following statements:
If industry funded: The [blood/tissue samples/genetic or other information] that we will
collect from you will be provided to the funder and will be stored with a coded identifier to
protect your privacy. Once provided to the funder, 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 funded:
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
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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: 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).
Your participation in this study is voluntary. You do not have to join this or any research
repository. You do not have to allow the use and disclosure of your health information for
this repository, but if you do not, you cannot join the repository.
If you do join the repository and later change your mind, you have the right to quit at any
time. This includes the right to withdraw your authorization to use and disclose your health
information. If you choose not to join this repository, or if you withdraw early from the
repository, 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 repository.
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.
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.
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
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the study at any time without affecting your relationship with OHSU, the investigator, the
investigator’s department, or your grade in any course.
State: If you have any questions, concerns, or complaints regarding this research repository
now or in the future, contact [PI Name (503) 494-####] [or other members of the study team
at (503) ###-####].
A Child Assent Form should be prepared if the study enrolls subjects between 7 and
17.
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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 signed form.
Subject Printed Name
Subject Signature
Date
Person Obtaining Consent Printed
Name
Person Obtaining Consent Signature
Date
When applicable, include:
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. 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.
c. Interpreter box – add the following if you plan to use a short form
consent process for subjects with limited English proficiency.
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.
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