UNIVERSITY OF CALIFORNIA AT BERKELEY
BERKELEY

DAVIS

IRVINE

LOS ANGELES

MERCED

RIVERSIDE

SAN DIEGO SAN FRANCISCO

SANTA BARBARA

SANTA CRUZ
TEMPLATE CONSENT FORM
– BIOMEDICAL STUDY
CONSENT TO PARTICIPATE IN RESEARCH
Title of Study (Designate any subject sub-group here, e.g., “Controls”)
Introduction
My name is _______________, [M.D./Ph.D.,] [if there are co-investigators, note here, e.g., "and my research colleagues are ___________, M.D. and ___________, Ph.D."] I am a(n) [undergraduate/ graduate student/ faculty member] at the University of California, Berkeley, [if lead investigator is a student, introduce faculty sponsor here, e.g., "working with my faculty advisor, Professor ___________,"] in the School/Department of ___________ . I am [We are] planning to conduct a medical research study, which I invite you to take part in.
You are being invited to participate in this study because you are/have [specify prospective subject's medical condition or other reason for recruitment to study].
Purpose
The purpose of this study is to __________. [Give brief explanation of why study is being done, using one or two sentences written in clear language understandable to the target population].
[Any investigational drug(s) or device(s) to be used in the study should be noted and named. The name by which the drug or device is referred to in this section should be used consistently throughout the form.]
[If appropriate: About [state total accrual goal for number of subjects] people will take part in this study.
[Give a short description about cohorts, if any. For multi-center studies, give figures both for the whole study and for local enrollment at UCB.]
Procedures
If you agree to be in this study, you will be asked to do the following: [Discuss screening procedures first, if any, or refer to a separate screening consent form if used. List and describe tests/ procedures and their frequency. Clearly identify any procedures or elements of a procedure that are experimental.
Indicate location where procedures will take place (e.g., lab, hospital, home, or other setting), and amount of time needed for each procedure. Also note total amount of time required for study participation, at the beginning or end of this section.]
[If there are screening procedures:]
Before you begin the main part of the study...
You will need to have the following screening exams/ tests/ procedures to find out if you can be in the main part of the study. [List and describe tests/ procedures as appropriate. If more than one screening procedure will be done, use bulleted format.]
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For example:
 Physical exam: You will have a physical examination, similar to those done for regular medical care.

Medical chart review: Your medical chart will be reviewed by the study doctors.
 Urine sample: You will be asked to give a urine sample for lab tests.

Blood drawing (venipuncture): You will be asked to give a blood sample for lab tests.
Approximately XX ml [XX teaspoons or other commonly understood unit such as ounces] of blood will be drawn by inserting a needle into a vein in your arm for these tests.

Pregnancy testing: Because the drugs/procedures in this study can affect a fetus, pregnant women may not participate in this study. If you are a female of child-bearing potential (i.e., you have had your first menstrual period and have not yet reached menopause), a urine [or blood] test will be done at the initial visit [or other time] to make sure you are not pregnant. [See CPHS Guidelines on MRI in
Research for more detail regarding pregnancy screening in MRI/fMRI studies, including procedures and consent language with minors, etc.]

HIV testing: Some of the blood sample will be used to test for HIV (human immunodeficiency virus). You will receive the test results in person and will be counseled about the meaning of these results before and after the test [or as accurate/appropriate] .
[If screening procedures are described above/separately:]
During the main part of the study...
If the screening exams, tests or procedures show that you can continue to be in the study and you choose to continue, this is what will happen next: [List tests and procedures as appropriate. Use bulleted format, or if all procedures may not necessarily be done on all participants, place a checkbox before each procedure for selection according to individual subject.] For example :
[For randomized studies:] You will be “randomized" into one of the study groups described below.
Randomization means that you are put into a group by chance. Neither you nor your doctor can choose the group you will be in. You will have an [equal/one in three/etc.] chance of being placed in any group. o If you are in Group 1 [Explain what will happen for this group with clear indication of which procedures/ interventions depart from routine care.] o If you are in Group 2 [Explain what will happen for this group with clear indication of which procedures/interventions depart from routine care.] o [For studies with more than two groups, an explanatory paragraph containing the same type of information should be included for each group.]
[Explain the follow-up tests, procedures, or exams required, if any, including the timing of each and how they relate to standard care (e.g., they are different from standard care, or they are part of standard care but are being performed more often than usual or being tested for the study. Define the length of followup.]
Study time: Study participation will take a total of approximately XXX hours/days/etc .
Study location: All study procedures will take place at ___________. [If different procedures will take
place at different locations, specify accordingly].
[If appropriate to the study, include the following additional procedure statement(s):]
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
Placebo: Define as "an inactive substance."
 Blood drawing (venipuncture): [Once a week,] a blood sample will be drawn by inserting a needle into a vein in your arm. Each sample will be approximately XX ml ( XX teaspoons or other commonly understood unit such as ounces ); a total of about XX ml ( XX teaspoons/ other) will be drawn for the whole study.

X-ray: You will have an x-ray of your [___________], [e.g., done once at the beginning of the study, and again at the end of the study,] in order to check ___________. Each x-ray will take about [XX minutes/ hour(s)] .

CT scan: You will have a computed tomography (CT) [or computerized axial tomography (CAT)] scan of your [___________], [done ___________], in order to check [___________]. A CT scan uses special x-ray equipment to make detailed pictures of body tissues and organs.
For the CT scan, you will be asked to lie still on a table with your [XXX] inside a large doughnutshaped machine. The table will move and the machine will make clicking and whirring noises as the pictures are taken. [ If appropriate: An iodine dye (contrast material) will first be [injected into a vein/given to you orally/rectally].
The dye makes tissue and organs more visible in the pictures.
]
Each CT scan will take about 15 to 30 minutes.

MRI: You will have a Magnetic Resonance Imaging (MRI) exam done [note frequency/ at what point(s) in study] . The MRI scanner measures small changes in magnetic fields produced in your brain and generates images of the human brain.
For the MRI scan, you will be asked to lie down on a platform that can be slid into the center of a large magnet. A plastic coil will be placed around your head and foam pads will be placed to limit head movement during the study. You will then be slid into the magnet and asked to lie still for approximately 60 to 90 minutes, while the MRI images are acquired. [See CPHS Guidelines on MRI in Research for more detail, including consent language, etc.]

DNA/genetic sampling: [See CPHS Guidelines on Human DNA/Genetics Research for detail on
consent language, etc.]
[Optional Feature: In addition to the narrative explanation of study procedures as above, a simplified calendar (study chart) or schema (study plan) may be inserted here.]
Benefits
[Explain possible benefits appropriate to the study, e.g.:]
Taking part in this study may or may not make your health better. While doctors hope
[procedures/drugs/ interventions/ devices] will be [more effective/have fewer side effects] than the standard (usual) treatment, there is no proof of this yet.
[If subject is randomized:] If you are in the group that receives [XXX] and it proves to treat your condition [more effectively/with fewer side effects than standard therapy/placebo] , you may benefit from participating in the study, but this cannot be guaranteed.
[Or if no direct benefit to the subject is anticipated:]
There will be no direct benefit to you from participating in the study. However, this study will help doctors learn more about [procedures/ drugs/ interventions/ devices] , and it is hoped that this information will help in the treatment of future individuals with [. . . /conditions like yours].
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Risks/Discomforts
Possible risks, discomforts, and/or side effects related to the [procedures, drugs, interventions , devices] include:

Using a bulleted format, list possible risks, discomforts, and/or side effects related to the investigational aspects of the study. Both physical and non-physical risks of participating should be noted.

In describing risks, it should be noted how likely they are to occur and whether they are serious.
"Serious" is defined as effects that may require hospitalization or may be irreversible, long-term, life threatening or fatal.

Risks and side effects should be described whenever possible by how they make a person feel, e.g.,
"Loss of red blood cells, also called anemia, can cause tiredness, weakness and shortness of breath.”

Any measures that will be taken to minimize a given risk should also be described here.
[If appropriate to the study, include the following risk statements:]

Randomization risks: You will be assigned to a treatment program by chance, and the treatment you receive may prove to be less effective or to have more side effects than the other study treatment(s) or other available treatments.

Placebo risks: If you are in the group that receives placebo, your condition will go without the active
(study) treatment for [XX weeks] .
 Blood drawing (venipuncture) risks: Drawing blood may cause temporary discomfort from the needle stick, bruising, or very rarely, infection.
 Radiation (x-ray) risks:
The amount of radiation you will be exposed to is relatively small. Such doses of radiation may be potentially harmful, but the risks are so small that they are difficult to measure. If you have already had many x-rays or are especially concerned with radiation exposure, you should discuss this with the researchers before agreeing to be in the study.

MRI scan risks: The magnets in the MRI scanner are extremely powerful and will attract any metallic objects brought into the MRI room, so you must be careful to leave anything made of metal outside the room. People with pacemakers, heart rhythm disturbances, or certain metallic implants in their body cannot participate in this study. You will be screened for these conditions.
While there are minimal risks from MRI as it is to be performed and MRI scanning is painless, participation may involve some discomfort. In particular, you may be bothered by the loud noise during the study that is due to beeping and hammering sounds made when the scanner is collecting measurements. Disposable earplugs will be provided to diminish the noise. Also, some people become claustrophobic while inside the scanner. (Individuals with a history of claustrophobia will be excluded from the study.) You may also experience stimulation of the nerves in your body, which feels like a gentle tap or sensation of mild electric shock.
[If appropriate: We will be able to communicate with you during the session via an intercom system.] If you feel uncomfortable in the scanner for any reason, please let us know and we will stop the experiment.
[See CPHS Guidelines on MRI in Research for more detail on consent language, etc.]
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
CT scan risks: CT scans involve the risks of radiation (see above). In addition, if contrast material
(iodine dye) is used, there is a slight risk of developing an allergic reaction, from mild (itching, rash) to severe (difficulty breathing, shock, or rarely, death). The contrast material may also cause kidney problems, especially if you are dehydrated or have poor kidney function. The study doctors will ask you about any allergies or related conditions before the procedure. If you have any of these problems, you may not be allowed to have a CT scan [/continue in the study] .
Having a CT scan may mean some added discomfort for you. In particular, you may be bothered by feelings of claustrophobia when placed inside the CT scanner, or by lying in one position for a long time. If contrast material is used, you may feel discomfort when it is injected [/given by XXX] . You may feel warm and flushed and get a metallic taste in your mouth. Rarely, the contrast material may cause nausea, vomiting, or a headache. [List other risks as appropriate to the method by which contrast agent is administered]. [If sedation may be used, discuss risks of sedation here].

HIV testing risks: Being tested for HIV may cause anxiety regardless of the test results. A positive test indicates that you have been infected with the HIV virus, but no one knows for certain when, if ever, you will become sick with AIDS or a related condition. Receiving positive results may make you very upset. If other people learned about your positive test results, there is a risk that you could be treated unfairly or badly, and even have trouble obtaining insurance or employment. To the extent permitted by law, we will keep your test results confidential and will not release them to anyone without your written permission. ( Note : In California, the testing lab is required to report identified positive results to public health authorities.)
[If appropriate, include the following statement:]

Unknown Risks: The experimental treatments may have side effects that no one knows about yet.
The researchers will let you know if they learn anything that might make you change your mind about participating in the study.
[For all forms:]

Breach of confidentiality: As with all research, there is a chance that confidentiality could be compromised; however, we are taking precautions to minimize this risk.
Confidentiality
[Since there is no legal privilege between investigator and subject, a guarantee of “complete” or "strict” confidentiality should not be given or implied in the consent form. This section should explain how the researchers will minimize the risk of breach of confidentiality (see CPHS Data Security Policy ). Any regulatory or other agencies which may have access to the research records should also be noted, e.g.:]
Your study data will be handled as confidentially as possible. If results of this study are published or presented, individual names and other personally identifiable information will not be used [if appropriate, add phrase such as "unless you give explicit permission for this below"].
To minimize the risks to confidentiality, we will... [Explain data security measures to be taken, e.g., storage, coding, encryption, limited access to study records, etc.]
Your personal information may be given out if required by law. Organizations that may look at and/or copy your medical records for research, quality assurance, and data analysis include:

[List relevant organizations, e.g., study sponsor, etc.]

The Food and Drug Administration (FDA) and other government agencies involved in keeping research safe for people. [Note: The FDA must be named here in all studies using drugs, devices, or biologics regulated by the FDA] .
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[Sensitive/reportable research information:
If there is a reasonable expectation (from the topic under study and/or the subject population) that reportable information may be disclosed to the researcher during the study, an appropriate statement should be added, e.g.:
We will keep your study data as confidential as possible, unless it is certain information that we must report for legal or ethical reasons, such as child abuse, elder abuse, or intent to hurt yourself or others.
]
[Certificate of Confidentiality: For certain studies, where especially sensitive information will be sought from subjects (e.g., about possible use of illegal substances or other illegal activities), investigators may wish to obtain a federal Certificate of Confidentiality to protect their research records from subpoena.
These Certificates are issued by the National Institutes of Health (NIH) and can be given regardless of whether or not the research is federally funded. If the Certificate is obtained, the end of the consent form’s confidentiality statement should discuss it, using such wording as:
To help us protect your privacy, we have obtained a Certificate of Confidentiality from the National
Institutes of Health (NIH). With this Certificate, researchers cannot be forced to disclose information that may identify you, even by a court subpoena, in any federal, state, or local civil, criminal, administrative, legislative, or other proceedings.
Exceptions : A Certificate of Confidentiality does not prevent researchers from disclosing certain information about you for legal or ethical reasons. For example, we will report information about child abuse, elder abuse, or intent to hurt yourself or others. If an insurer, employer, or other person obtains your written consent to receive research information, we cannot use the Certificate to withhold that information. In addition, the Certificate may not be used to withhold information from the federal government needed for auditing or evaluating federally funded projects or information needed by the
FDA, e.g., for quality assurance or data analysis.
]
Retaining research records: When the research is completed, I may save the [samples / tapes and notes/ study records] for use in future research done by myself or others. I will retain this study information for up to XX months/years after the study is over. The same measures described above will be taken to protect confidentiality of this study data. [Or if different, give accurate information about retention and use of study data in future, e.g., "I will destroy the samples/ tapes and notes/ study records at the end of this study."]
[Ownership of specimens/"Moore Clause" – if inclusion of such a statement is applicable, this UCOPrecommended wording should be used:] If you consent to giving blood or tissue specimens (including cheek swab and saliva samples) as part of this study, these specimens will become the property of the
University of California. The specimens and the DNA they contain may be used in this research and in other research, and may be shared with other organizations. The specimens could lead to discoveries or inventions that may be of value to the University of California or to other organizations. Under state law, you do not have any right to money or other compensation stemming from products that may be developed from the specimens .]
Alternatives [if appropriate]
Your other choices may include:

Getting no treatment

Getting standard treatment for your condition without being in a study.

Getting a different experimental treatment/taking part in another study.
[Additional bullets should include, when appropriate, alternative specific procedures or treatments.]
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Compensation/Payment
In return for your time/ effort/ travel expenses , you will be paid $XXX for taking part in this study. [If non-monetary compensation, e.g., course credit, will be offered for participation, state here. Describe any pro-rating or bonuses, e.g.: "If you do not complete the study, you will receive $XXX for each week of participation." Also, specify method and timing of payment, e.g.: "A check will be mailed to you about 6 weeks after your participation in the study has ended."]
[OR, if there will be no payment:] You will not be paid for taking part in this study.
Costs of Study Participation [if appropriate]
[Specify if subjects or their insurance carriers will be expected to assume any study costs, or clearly state if there are no such costs, e.g.:]
You will not be charged for any of the study activities.
[Specify if subjects will be expected to assume any study costs. If the study sponsor will cover some of the costs, indicate who will be charged for most of the procedures, then list exceptions. Warn subjects that insurance carriers may not cover experimental treatment charges, and indicate with whom the subject should speak in this regard, e.g.:]
The costs of all visits, treatments, and tests described above will be billed to you or your insurance carrier, with the exception of [list] , which will be paid for by the study sponsor, [name] . Insurance companies and other carriers sometimes refuse to pay the costs of treatment when individuals are participating in research. If this happens in your case, you will be billed for the care your insurance will not cover. If you have questions or concerns about this, please discuss them further with [a member of our research team/ other appropriate individual] .
[If study involves greater than minimal risk, this statement is required by UCOP:]
Treatment and compensation for injury
It is important that you promptly tell the researcher
[investigator’s name]
, if you believe that you have been injured because of taking part in this study. You can tell the researcher in person or call him/her at
[telephone number].
If you are injured as a result of taking part in this study, University of California will provide necessary medical treatment. The costs of the treatment may be billed to your insurer just like other medical costs, or covered by the University of California or the study sponsor [sponsor name] , depending upon a number of factors. The University and the study sponsor do not normally provide any other form of compensation for injury. For more information, call OPHS at (510) 642-7461.
Rights
Participation in research is completely voluntary.
You have the right to decline to participate or to withdraw at any point in this study without penalty or loss of benefits to which you are otherwise entitled.
Questions
If you have any questions or concerns about this study, you may contact ___________ [lead investigator name(s)] at ___________ [phone number(s)] or [email address] . [If there are additional informational sources related to the study, e.g., patient representatives, local contacts, etc., list here with contact information.]
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If you have any questions or concerns about your rights and treatment as a research subject, you may contact the office of UC Berkeley's Committee for the Protection of Human Subjects, at 510-642-7461 or subjects@berkeley.edu
.
**************************************************
CONSENT
You have been given a copy of this consent form and of the Medical Research Subject's Bill of Rights to keep.
[ If Protected Health Information as defined by HIPAA will be accessed, used, created, or disclosed, add the following: You will be asked to sign a separate form authorizing access, use, creation, or disclosure of health information about you.]
If you wish to participate in this study, please sign and date below.
Participant's Name (please print)
_______________
Date
Participant's Signature
Person Obtaining Consent
_______________
Date
_______________
Date
[If third party consent is requested and has been addressed in the CPHS application:]
AND/OR:
Legally Authorized Representative
Person Obtaining Consent
_______________
Date
_______________
Date
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