## STANDARD CONSENT FORM FORMAT -Biomedical Research

-PRINT ON LETTERHEAD

-This form is not sufficient for genetic studies, tissue banking, or to
obtain the assent of young children*.*

\- NOTE: Statements in **bold** are examples of standard wording. These
statements should be printed in regular type on the actual consent form.
Statements in regular type are provided for guidance.

\- Leave a 1.5\" bottom margin on the first page for the Institutional
Review Board approval stamp.

Delete this box when done.

**\[[STUDY TITLE]{.underline}\]**

**PURPOSE AND BACKGROUND**

**You are being asked to participate in a research study conducted by**
\[Susan Smith, PhD and John Doe, MD\], **of Lawrence Berkeley National
Laboratory. The purpose of this study is to** \[insert 3-5 sentences,
written in non-technical language, describing the hypothesis behind the
study\] . . . . **This study is being funded by** ... \[required for
non-state or federal sponsors\].

**You are being asked to participate in this study because you** are
\[have\] . . . .

**A. PROCEDURES**

**If you agree to be in this study, the following will happen: \[NOTE:
Sample language for a number of situations is provided below. Use only
those which apply to your project.**

> 1\. \[Screening\] You will have a physical examination, your medical
> chart will be reviewed, and blood and urine will be collected.
> Approximately . . . teaspoons \[or other commonly understood units
> such as tablespoons or cups\] of blood will be drawn for these tests.
> \[Specify what the data and samples will be analyzed for.\] This
> screening procedure will take approximately \_\_\_ hours.
>
> 2\. \[[Double blind]{.underline}\] If the physical examination and
> test results show that you are eligible for study treatment, you will
> be randomly assigned to one of two groups. This means that you have a
> 50/50 chance (like flipping a coin) of being in either group and that
> neither the researchers nor you will make the choice of which group
> you are in. The two groups are Group A (Drug XXX) or Group B (placebo,
> an inactive substance).
>
> 3\. \[[Placebo]{.underline}\] Group A will receive XXX, the
> investigational drug, in tablet form, . . . times a week for . . .
> weeks for a total of . . . weeks. Group B will receive placebo, also
> in tablet form, according to the same schedule.
>
> 4\. \[MRI\] You will have a Magnetic Resonance Imaging (MRI) exam at
> the beginning of the study in order to check.... For the MRI exam, you
> will lie down on a narrow bed which will then be placed in a tunnel
> that is 6 feet long by 22 inches wide and open at each end. You will
> lie there quietly for about one hour, during which time you will hear
> a loud noise. You may feel warm during this procedure*...* . The MRI
> exam will take about \_\_\_ hours.

5\. \[[PET Scans]{.underline}\] You will have two Positron Emission
Tomograph (PET) scans, one before and one after your scheduled
treatment, in order to check.... This involves... (address a -- d). The
entire PET scan will take about \_\_\_ minutes/hours.

> a\) Placement of catheters
>
> b\) Injection of radioisotope (if experimental, identify as such)
>
> c\) Procedures to minimize radiation exposure
>
> d\) PET machine

6\. Once a week for \_\_ weeks , another blood sample will be drawn from
a vein in your arm. Each sample will be approximately . . . teaspoons; a
total of about . . . tablespoons will be drawn for the whole study.

> 7\. The researchers will check your medical records to gather
> information about . . . .
>
> 8\. \[Note: Please detail any follow-up procedures\]
>
> 9\. You may be withdrawn from the study without your consent if the
> researchers believe it is in your best interest or if you fail to
> follow study procedures.

### Participation in the study will take a total of about . . . hours over a period of . . . weeks.

**All study procedures will be done at** . . .

**B. RISKS/DISCOMFORTS**

> 1\. Drug XXX: If you are in the group that receives Drug XXX, the
> following side effects are possible: . . . . These side effects are
> serious, but have occurred in less than . . . of previous human
> studies of XXX using comparable doses. If . . . occurs, it will be
> treated by . . . , (and you will be taken off the study). Other side
> effects which are less severe but may occur more frequently are . . .
> .
>
> 2\. Placebo: If you are in the group that receives placebo, your
> condition will go without active treatment for \_\_\_ weeks.
>
> *3.* Radiation*:*
>
> \[[For whole body effective dose equivalent of 1000 mrem or
> less]{.underline}\] The amount of radiation you will be exposed to is
> relatively small and falls within the guidelines set by the Food and
> Drug Administration (FDA) for research. It is equivalent to \[\_\_\_\_
> times or % of\] the amount of natural environmental radiation the
> average person in California receives annually. Such doses of
> radiation may conceivably be harmful, but the risks are so small that
> they are difficult to measure.
>
> \[[For whole body effective dose equivalent of 1000 -- 5000
> mrem]{.underline}\]: The amount of radiation you will be exposed to is
> relatively small and falls within the guidelines set by the Food and
> Drug Administration (FDA) for research. For example, the kidneys and
> bladder will receive about the same exposure to radiation as they
> would during a \[give relevant example, i.e., a kidney x-ray
> (pyelogram)\]. Such doses of radiation may conceivably be harmful, but
> the risks are so small that they are difficult to measure. If you have
> been exposed to lots of radiation, you should not consent to this test
> until you have discussed the matter with your doctor.

4\. MRI:

> a\) Because the MRI machine acts like a large magnet, it could move
> iron-containing objects in the MRI room during your examination, which
> could in the process possibly harm you. Precautions have been taken to
> prevent such an event from happening; loose metal objects, like pocket
> knives or key chains, are not allowed in the MRI room. If you have a
> piece of metal in your body, such as a fragment in your eye, aneurysm
> clips, ear implants, spinal nerve stimulators, or a pacemaker, you
> will not be allowed into the MRI room and cannot have an MRI.
>
> b\) Having a MRI may mean some added discomfort for you. In
> particular, you may be bothered by feelings of claustrophobia and by
> the loud banging noise during the study. Temporary hearing loss has
> been reported from this loud noise. This is why you will be asked to
> wear ear plugs. You may be asked to not to move or swallow for a
> while, which can be uncomfortable.
>
> c\) Because the risks to a fetus from MRI are unknown, pregnant women
> must not participate in this study.
>
> 6\. Venipuncture: The risks of drawing blood include temporary
> discomfort from the needle stick, bruising, and rarely, infection.

7\. 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 taking part in
the study.

> 8\. Confidentiality: Participation in research will involve a loss of
> privacy, but information about you will be handled as confidentially
> as possible. \[Use this sentence only when appropriate:
> Representatives from the sponsoring company (\[insert company name in
> parentheses\]) and the Food and Drug Administration may review
> information about you to check on the study.\] . \[Use this sentence
> when dealing with particularly sensitive information: Your records
> will not be immune to legal processes such as subpoena.\] Your name
> will not be used in any published reports about this study.

**C. COMPENSATION FOR INJURY** \[Required for all studies with physical
intervention equivalent to or more significant than a routine blood draw
or injection. [This statement must be used without
changes]{.underline}.\]

**If you are injured as a result of taking part in this study, medical
care and treatment will be available to you as a participating subject.
The costs of this care may be covered by the University of California**
\[add where appropriate: ,or the study sponsor Xxxxxxx,\] **depending on
a number of factors. If you have any questions regarding this assurance,
you may consult or call the Berkeley Lab Human Quality Assurance
Subjects Committee, MS 26RO143, 1 Cyclotron Road, Berkeley, CA
94720-8239 (510-486-5507) or the Committee for the Protection of Human
Subjects, 2150 Shattuck Ave., Suite 313, University of California,
Berkeley, 94720-5940, (510-642-7461). \[NOTE: This statement must be
used without changes.\]**

**D. BENEFITS**

\[If subject is randomized, and a realistic potential for benefiting the
subject has been documented in the protocol\] The potential benefit to
you is that the treatment you receive may prove to be more effective
than the other study treatment or than other available treatments,
although this cannot be guaranteed.

\[For drug studies, when a realistic potential for benefiting the
subject has been documented in the protocol\] If you are in the group
that receives Drug XXX and it proves to treat your condition with fewer
side effects than the current standard therapy, you may benefit from
participating in the study; however, this cannot be guaranteed.

OR:

\[[For most basic research studies]{.underline}\] There will be no
direct benefit to you from participating in this study. However, it is
hoped that the information gained from the study will help in the
treatment of future patients with conditions like yours *or* will help
the researchers learn more about . . . .

#### E. ALTERNATIVES

\[NOTE: For diagnostic testing or medical treatment protocols\] If you
choose not to participate in this study, you could receive no treatment
for your condition or the standard therapy for your condition, which is
\_\_\_, without having to undergo the tests involved in the study.

**F.** **STORAGE OF SAMPLES/DATA:** After testing, the remainder of your
blood sample and any personally identifiable information will be
discarded

\[or\]

After testing, your blood sample will be stored for future research in
\[specify general type(s) of research\]. The same confidentiality
protections described above will be used. Some of the stored sample may
be given to other researchers, but they will only be told... \[your age
and gender\]. They will not be given your name or any other information
which may identify you.

\[or\]

After testing, your name and any information which may identify you will
be destroyed. Your anonymous sample will then be stored for future
research in \[specify general type(s) of research\]. Some of the stored
sample may be given to other researchers.

### G. COSTS \[NOTE: The following are several examples of approvable cost statements\] 

\[Example #1\] You will not be charged for any of the study treatments
or procedures. The costs of Drug XXX, the administration of the study
drug, the x-rays, MRI exams, all tests associated with this study, and
all office visits will be covered by the study.

\[Example #2\] You or your insurance company will be billed for the
clinic visits, and all standard laboratory tests (e.g., routine blood
counts and blood chemistry tests). Drug XXX will be provided free of
charge and you will not be billed for tests required for purposes of
research, e.g., extra blood tests, x-rays, or MRI exams. Because this
treatment is experimental, your insurance company may refuse to pay for
costs related to this treatment, in which case you will/will not be held
financially responsible.

**H. PAYMENT**

You will not be paid for participating in this study.

OR:

In return for your time, effort and travel expenses, you will be paid \$
. . . for your participation in this study. If you do not complete the
study, you will receive . . . for each week of participation. A check
will be mailed to you approximately six weeks after your participation
in the study has ended.

**I. QUESTIONS**

**Any further questions you have about taking part in this study will be
answered by:**

Dr. Smith at (510) 486-xxxx.

**Any questions you have about your rights as a research subject will be
answered by:**

**Berkeley Lab Human Subjects Quality Assurance Committee at
(510-486-5507) or the**

**UCB Committee for the Protection of Human Subjects at (510-642-7461)**

**J. PARTICIPATION IN RESEARCH IS VOLUNTARY** **You have the right to
not take part in this study or to stop taking part at any time. You will
be given a copy of this consent form and the Experimental Subject\'s
Bill of Rights to keep.** You are not waiving any legal claims, rights
or health care benefits that you are otherwise entitled to because of
your participation in this research study. \[[For studies involving
Berkeley Lab employees]{.underline}:\] Neither whether or not you choose
to take part nor the data collected about you will have any effect on
your standing as a Berkeley Lab employee or your right to health care or
other benefits to which you are otherwise entitled. \[[Optional for all
projects]{.underline}:\] You may be asked to participate in other
research in the future, but will be free to refuse to do so. **If you
wish to participate, you should sign below.**

**AUTHORIZATION: I have read this consent form. All of the questions I
have asked have been answered to my satisfaction. I volunteer to
participate in this research.**

Date Subject\'s Signature

Subject's Name (print legibly)

Date Person Obtaining Consent (Signature)

Name (print legibly)

**\[STOP! Do not use the following signature lines unless third party
consent is being requested and has been addressed in detail in the
protocol.\]**

AND/OR:

Date Legally Authorized Representative

> (i.e., parent, legal guardian, conservator, or individual with power
> of attorney for health care of the subject)

Name (print legibly)

Date Person Witnessing Signature of Representative

Name (print legibly)

Notes:

**1. Pregnancy testing and birth control:** The Procedures section
should include among the screening procedures any pregnancy testing done
for study purposes. If men or women are advised to use birth control or
avoid pregnancy before, during, or after the study, these precautions
should be described in the Procedures section. The Risks and Discomforts
section should describe the risks to pregnant mothers or fetuses that
necessitate these precautions.

**2.** **Recommended wording for HIV testing:**

Wording like the following should be used in the Procedures section:

> Some of the blood taken for laboratory tests will be used to test for
> HIV (the AIDS test). You will receive the test results in person and
> will be counseled about the meaning of these results before and after
> the test.

The following standard wording is recommended for the Risks/Discomforts
section:

> HIV Testing: Being tested for HIV may cause anxiety regardless of the
> test results. A positive test means that you have been infected with
> the HIV virus, but no one can say 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 learn about your
> positive test results, you may have trouble obtaining insurance or
> employment. If your test is negative, there is still the possibility
> that you could be infected with the HIV virus and test positive at
> some time in the future. There is always the possibility that the test
> results could be wrong.

**3. Additional notes regarding "Treatment and Compensation for Injury"
wording:**

Sponsoring companies and some public agencies may request that their own
wording be used for the treatment and compensation for injury policy
statement or that minor changes be made in the UC statement. Such
requests *can only be accepted after consultation with the Committee for
the Protection of Human Subjects and other University/Laboratory*
offices*.* The wording of the existing statements was formulated with
the advice of legal counsel with the intent of adhering to the
requirements of the federal regulation, complying with University of
California policy, and conveying the basic, necessary information to the
subject.

4\. **Testing for illegal drugs:** The need for such testing should be
justified in the protocol. The consent form should address the drug
testing under Procedures, Storage of Samples, and Risk sections.