Informed Consent Template for Cancer Treatment Trials

(English Language)

**\*NOTES FOR INFORMED CONSENT AUTHORS:**

-   Model text suggested for use in the informed consent form is in
    **bold**. It is recommended that the **bold** text be retained when
    adapting the template to a specific protocol.

-   Instructions and examples for informed consent authors are in
    *\[italics\]*.

-   A blank line, \_\_\_\_\_\_\_\_\_\_, indicates that the local
    investigator should provide the appropriate information before the
    document is reviewed with the prospective research participant.

-   The term 'study doctor' has been used throughout the template
    because the Principal Investigator of a cancer treatment trial is a
    physician. If this template is used for a trial where the Principal
    Investigator is not a physician, another appropriate term should be
    used instead of 'study doctor'.

-   The template date in the header is for reference to this template
    only and should not be included in the informed consent form given
    to the prospective research participant.

**\*NOTES FOR LOCAL INVESTIGATORS:**

-   The goal of the informed consent process is to provide people with
    sufficient information for making informed choices. The informed
    consent form provides a summary of the clinical study and the
    individual\'s rights as a research participant. It serves as a
    starting point for the necessary exchange of information between the
    investigator and potential research participant. This template for
    the informed consent form is only one part of the larger process of
    informed consent. For more information about informed consent,
    review the \"Recommendations for the Development of Informed Consent
    Documents for Cancer Clinical Trials\" prepared by the Comprehensive
    Working Group on Informed Consent in Cancer Clinical Trials for the
    National Cancer Institute. The Web site address for this document is
    <http://www.cancer.gov/clinicaltrials/understanding/simplification-of-informed-consent-docs>/

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-   A blank line, \_\_\_\_\_\_\_\_\_\_, indicates that the local
    investigator should provide the appropriate information before the
    document is reviewed with the prospective research participant.

-   Suggestion for Local Investigators: An NCI pamphlet explaining
    clinical trials is available for your patients. The pamphlet is
    entitled: \"If You Have Cancer...What You Should Know about Clinical
    Trials\". This pamphlet may be ordered on the NCI Web site at
    <https://cissecure.nci.nih.gov/ncipubs/> or call 1-800-4**-** CANCER
    (1-800-422-6237) to request a free copy.

-   Optional feature for Local Investigators: Reference and attach drug
    sheets, pharmaceutical information for the public, or other material
    on risks. Check with your local IRB regarding review of additional
    materials.

\*These notes for authors and investigators are instructional and should
not be included in the informed consent form given to the prospective
research participant.

Study Title

**This is a clinical trial, a type of research study. Your study doctor
will explain the clinical trial to you. Clinical trials include only
people who choose to take part. Please take your time to make your
decision about taking part. You may discuss your decision with your
friends and family. You can also discuss it with your health care team.
If you have any questions, you can ask your study doctor for more
explanation.**

**You are being asked to take part in this study because you have**
*\[Type/stage/presentation of cancer being studied is briefly described
here. For example: "Colon cancer that has spread and has not responded
to one treatment".\]*

Why is this study being done?

**The purpose of this study is to....** *\[Limit explanation to why
study is being done. Explain in 1-2 sentences. Some examples are
provided.\]*

*\[Example: Phase 1 study\]*

*Test the safety of \[drug/intervention\] at different dose levels. We
want to find out what effects, good and/or bad, it has on you and your
\[specify type/stage/presentation of\] cancer.*

*\[Example: Phase 2 study\]*

*Find out what effects, good and/or bad, \[drug/intervention\] has on
you and your \[specify type/stage/presentation of\] cancer.*

*\[Example: Phase 3 study\]*

*Compare the effects, good and/or bad, of \[drug/intervention\] with
\[commonly-used drug/intervention\] on you and your \[specify
type/stage/presentation of\] cancer to find out which is better. In this
study, you will get either the \[drug/intervention\] or the
\[commonly-used drug/intervention\]. You will not get both.*

How many people will take part in the study?

**About** *\[state total accrual goal here\]* **people will take part in
this study.** *\[If appropriate, a short description about cohorts can
be given here. For example: "At the beginning of the study, (enter
number of first cohort) patients will be treated with a low dose of the
drug. If this dose does not cause bad side effects, it will slowly be
made higher as new patients take part in the study. A total of (enter
maximum number) patients are the most that would be able to enter the
study".*

What will happen if I take part in this research study?

\[List tests and procedures and their frequency under the categories
below. Include whether a patient will be at home, in the hospital, or in
an outpatient setting.\]

**Before you begin the study ...**

**You will need to have the following exams, tests or procedures to find
out if you can be in the study. These exams, tests or procedures are
part of regular cancer care and may be done even if you do not join the
study. If you have had some of them recently, they may not need to be
repeated. This will be up to your study doctor.**

-   *\[List tests and procedures as appropriate. Use bulleted format.\]*

**During the study ...**

**If the exams, tests and procedures show that you can be in the study,
and you choose to take part, then you will need the following tests and
procedures. They are part of regular cancer care.**

-   *\[List tests and procedures as appropriate. Use bulleted format.\]*

**You will need these tests and procedures that are part of regular
cancer care. They are being done more often because you are in this
study.**

-   *\[List tests and procedures as appropriate. Use bulleted format.
    Omit this section if no tests or procedures are being done more
    often than usual.\]*

**You will need these tests and procedures that are either being tested
in this study or being done to see how the study is affecting your
body.**

-   *\[List tests and procedures as appropriate. Use bulleted format.
    Omit this section if no tests or procedures are being tested in this
    study or required for safety monitoring.\]*

*\[For randomized studies:\]* **You will be \"randomized\" into one of
the study groups described below. Randomization means that you are put
into a group by chance. A computer program will place you in one of the
study groups. 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.**

> **If you are in group 1 (often called \"Arm A\") *...*** *\[Explain
> what will happen for this group with clear indication of which
> interventions depart from routine care.\]*
>
> **If you are in group 2 (often called \"Arm B\")...** *\[Explain what
> will happen for this group with clear indication of which
> interventions depart from routine care.\]*
>
> *\[For studies with more than two groups, an explanatory paragraph
> containing the same type of information should be included for each
> group.\]*

**When I am finished taking *\[drugs or intervention\]...****\[Explain
the follow-up tests, procedures, exams, etc. required, including the
timing of each and whether they are part of standard cancer care or part
of standard care but being performed more often than usual or being
tested in this study. Define the length of follow-up.\]*

*\[Optional Feature: In addition to the mandatory narrative explanation
found in the preceding text, a simplified calendar (study chart) or
schema (study plan) may be inserted here. The schema from the protocol
should not be used as it is too complex, however a simplified version of
the schema is encouraged. Instructions for reading the calendar or
schema should be included. See examples.\]*

# Study Chart *\[Example\]*

**You will receive** *\[drug(s) or intervention\]* **every** *\[insert
appropriate number of days or weeks\]* **in this study. This** *\[insert
appropriate number of days or weeks\]* **period of time is called a
cycle. The cycle will be repeated** *\[insert appropriate number\]*
**times. Each cycle is numbered in order. The chart below shows what
will happen to you during Cycle 1 and future treatment cycles as
explained previously. The left-hand column shows the day in the cycle
and the right-hand column tells you what to do on that day.**

###### Cycle 1

######### Day What you do

+---------+------------------------------------------------------------+---+
| ­Two     | -   Get routine blood tests.                               |   |
| days    |                                                            |   |
| before  |                                                            |   |
| s       |                                                            |   |
| tarting |                                                            |   |
| study   |                                                            |   |
+---------+------------------------------------------------------------+---+
| Day     | -   Check-in to \_\_\_\_\_\_\_\_\_\_\_\_\_ the evening     |   |
| before  |     before starting study.                                 |   |
| s       |                                                            |   |
| tarting |                                                            |   |
| study   |                                                            |   |
+---------+------------------------------------------------------------+---+
| Day 1   | -   Begin taking \_\_\_\_\_\_ once a day. Keep taking      |   |
|         |     \_\_\_\_\_ until the end of study, unless told to stop |   |
|         |     by your health care team.                              |   |
+---------+------------------------------------------------------------+---+
| Day 2   | -   Leave \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ and go to where   |   |
|         |     you are staying.                                       |   |
+---------+------------------------------------------------------------+---+
| Day 8   | -   Get routine blood tests.                               |   |
+---------+------------------------------------------------------------+---+
| Day 15  | -   Get routine blood tests.                               |   |
+---------+------------------------------------------------------------+---+
| Day 22  | -   Get routine blood tests.                               |   |
+---------+------------------------------------------------------------+---+
| Day 28  | -   Get routine blood tests and exams.                     |   |
|         |                                                            |   |
|         | -   Get 2^nd^ chest x-ray for research purposes.           |   |
+---------+------------------------------------------------------------+---+
| Day 29  | -   Return to your doctor's office at \_\_\_\_\_\_\_       |   |
|         |     *\[insert appointment time\]* for your next exam and   |   |
|         |     to begin the next cycle.                               |   |
+---------+------------------------------------------------------------+---+

##  {#section .unnumbered}

## Future cycles {#future-cycles .unnumbered}

######### Day What you do {#day-what-you-do-1 .unnumbered}

+----------+-----------------------------------------------------------+
| Days     | -   Keep taking \_\_\_\_\_ once a day if you have no bad  |
| 1-28     |     side effects and cancer is not getting worse. Call    |
|          |     the doctor at \_\_\_\_\_\_\_\_\_\_\_\_\_ *\[insert    |
|          |     phone number\]* if you do not know what to do.        |
|          |                                                           |
|          | -   Get routine blood tests each week (more if your       |
|          |     doctor tells you to).                                 |
|          |                                                           |
|          | -   Get routine blood tests and exams every cycle (more   |
|          |     if your doctor tells you to).                         |
|          |                                                           |
|          | -   Get routine X-rays, CT scans, or MRIs every other     |
|          |     cycle (more if your doctor tells you to).             |
+----------+-----------------------------------------------------------+
| Day 29   | -   Return to your doctor's office at \_\_\_\_\_\_\_      |
|          |     *\[insert appointment time\]* for your next exam and  |
|          |     to begin the next cycle.                              |
+----------+-----------------------------------------------------------+

# 

# Study Plan *\[Example\]*

**Another way to find out what will happen to you during the study is to
read the chart below. Start reading at the top and read down the list,
following the lines and arrows.**

How long will I be in the study?

**You will be asked to take** *\[drugs or intervention\]* **for**
*(months, weeks/until a certain event).* **After you are finished
taking** *\[drugs or intervention\]*, **the study doctor will ask you to
visit the office for follow-up exams for at least** *\[indicate time
frames and requirements of follow-up. When appropriate, state that the
study will involve long-term follow-up and specify time frames and
requirements of long-term follow-up. For example, "We would like to keep
track of your medical condition for the rest of your life. We would like
to do this by calling you on the telephone once a year to see how you
are doing. Keeping in touch with you and checking on your condition
every year helps us look at the long-term effects of the study."\]*

#### Can I stop being in the study?

**Yes. You can decide to stop at any time. Tell the study doctor if you
are thinking about stopping or decide to stop. He or she will tell you
how to stop safely.**

**It is important to tell the study doctor if you are thinking about
stopping so any risks from the** *\[drugs or intervention\]* **can be
evaluated by your doctor. Another reason to tell your doctor that you
are thinking about stopping is to discuss what followup care and testing
could be most helpful for you.**

The study doctor may stop you from taking part in this study at any time
if he/she believes it is in your best interest; if you do not follow the
study rules; or if the study is stopped.

What side effects or risks can I expect from being in the study?

**You may have side effects while on the study. Everyone taking part in
the study will be watched carefully for any side effects. However,
doctors don't know all the side effects that may happen. Side effects
may be mild or very serious. Your health care team may give you
medicines to help lessen side effects. Many side effects go away soon
after you stop taking the** *\[drug(s) or intervention\]***. In some
cases, side effects can be serious, long lasting, or may never go
away.** *\[The next sentence should be included if appropriate.* **There
also is a risk of death.***\]*

You should talk to your study doctor about any side effects that you
have while taking part in the study.

**Risks and side effects related to the** *\[procedures, drugs,
interventions, devices\]* **include those which are:**

**[Likely]{.underline}**

-   
-   
-   
-   

**[Less Likely]{.underline}**

-   
-   
-   
-   

**[Rare but serious]{.underline}**

-   
-   
-   
-   

*\[Notes for consent form authors regarding the presentation of risks
and side effects:*

-   *Using a bulleted format, list risks and side effects related to the
    investigational aspects of the trial. Side effects of supportive
    medications should not be listed unless they are mandated by the
    study.*

-   *List by regimen the physical and nonphysical risks and side effects
    of participating in the study in three categories: 1.\" likely\"; 2.
    \"less likely"; 3. "rare but serious\".*

-   *There is no standard definition of "likely\" and \"less likely". As
    a guideline, "likely" can be viewed as occurring in greater than 20%
    of patients and "less likely" in less than or equal to 20% of
    patients. However, this categorization should be adapted to specific
    study agents by the principal investigator.*

-   *In the "likely" and "less likely" categories, identify those side
    effects that may be 'serious'. 'Serious' is defined as side effects
    that may require hospitalization or may be irreversible, long-term,
    life threatening or fatal.*

-   *Side effects that occur in less than 2-3% of patients do not have
    to be listed unless they are serious, and should then appear in the
    "rare but serious" category.*

-   *Physical and nonphysical risks and side effects should include such
    things as the inability to work. Whenever possible, describe side
    effects by how they make a patient feel, for example, "Loss of red
    blood cells, also called anemia, can cause tiredness, weakness and
    shortness of breath."*

-   *For some investigational drugs/interventions/devices there may be
    side effects that have been noted during treatment however not
    enough data is available to determine if the side effect is related
    to the drug/intervention/device. Because some local IRBs request to
    be informed of these possible side effects, this information, when
    available, is provided to the study chair. Inclusion of this
    information in the informed consent document is not mandatory.
    However, if included, these side effects should be listed under a
    separate category titled "Side effects reported by patients, but not
    proven to be caused by (drug/intervention/device)". Side effects in
    this category do not have to be labeled as "likely", "less likely"
    or "rare but serious" and should not be repeated here if they appear
    in a previous category. Similar to the other categories, these side
    effects should be listed in a bulleted format.\]*

**Reproductive risks: You should not become pregnant or father a baby
while on this study because the drugs in this study can affect an unborn
baby. Women should not breastfeed a baby while on this study. It is
important you understand that you need to use birth control while on
this study. Check with your study doctor about what kind of birth
control methods to use and how long to use them. Some methods might not
be approved for use in this study.** *\[Include a statement about
possible sterility when appropriate. For example, "Some of the drugs
used in the study may make you unable to have children in the future."
If appropriate include a statement that pregnancy testing may be
required.\]*

**For more information about risks and side effects, ask your study
doctor.**

Are there benefits to taking part in the study?

**Taking part in this study may or may not make your health better.
While doctors hope** *\[procedures, drugs, interventions, devices\]*
**will be more useful against cancer compared to the usual treatment,
there is no proof of this yet. We do know that the information from this
study will help doctors learn more about** *\[procedures, drugs,
interventions, devices\]* **as a treatment for cancer. This information
could help future cancer patients.**

**What other choices do I have if I do not take part in this study?**

Your other choices may include:

-   **Getting treatment or care for your cancer without being in a
    study**

-   **Taking part in another study**

-   **Getting no treatment**

*\[Additional bullets should include, when appropriate, alternative
specific procedures or treatments.\]*

-   *\[For studies involving end-stage cancer, add the following
    paragraph as an additional bullet.\]* **Getting comfort care, also
    called palliative care. This type of care helps reduce pain,
    tiredness, appetite problems and other problems caused by the
    cancer. It does not treat the cancer directly, but instead tries to
    improve how you feel. Comfort care tries to keep you as active and
    comfortable as possible.**

**Talk to your doctor about your choices before you decide if you will
take part in this study.**

### 

### **Will my medical information be kept private?** 

We will do our best to make sure that the personal information in your
medical record will be kept private. However, we cannot guarantee total
privacy. Your personal information may be given out if required by law.
If information from this study is published or presented at scientific
meetings, your name and other personal information will not be used.

**Organizations that may look at and/or copy your medical records for
research, quality assurance, and data analysis include:**

-   *\[List relevant organizations like study sponsor(s), pharmaceutical
    company collaborators, local IRB, etc.\]*

-   **The National Cancer Institute (NCI) and other government agencies,
    like the Food and Drug Administration (FDA), involved in keeping
    research safe for people**

*\[Note to Local Investigators: The NCI has recommended that HIPAA
regulations be addressed by the local institution. The regulations may
or may not be included in the informed consent form depending on local
institutional policy.\]*

What are the costs of taking part in this study?

You and/or your health plan/ insurance company will need to pay for some
or all of the costs of treating your cancer in this study. Some health
plans will not pay these costs for people taking part in studies. Check
with your health plan or insurance company to find out what they will
pay for. Taking part in this study may or may not cost your insurance
company more than the cost of getting regular cancer treatment.

*\[If applicable, inform the patient of any tests, procedures or agents
for which there is no charge. The explanation, when applicable, should
clearly state that there are charges resulting from performance of the
test or drug administration that will be billed to the patient and/or
health plan. For example, "The NCI ( if not the NCI, state other study
sponsor here) is supplying (drug) at no cost to you. However, you or
your health plan may need to pay for costs of the supplies and personnel
who give you the (drug)."\]*

*\[Include the following sentence if appropriate:\]*

**The study agent,** *\[study drug\]**,*** **will be provided free of
charge while you are participating in this study. However, if you should
need to take the study agent much longer than is usual, it is possible
that the supply of free study agent that has been supplied to** *\[the
NCI or other study sponsor, as appropriate\]* **could run out. If this
happens, your study doctor will discuss with you how to obtain
additional drug from the manufacturer and you may be asked to pay for
it.**

You will not be paid for taking part in this study.

For more information on clinical trials and insurance coverage, you can
visit the National Cancer Institute's Web site at
<http://www.cancer.gov/clinicaltrials/understanding/insurance-coverage>.
You can print a copy of the "Clinical Trials and Insurance Coverage"
information from this Web site.

Another way to get the information is to call 1-800-4-CANCER
(1-800-422-6237) and ask them to send you a free copy.

What happens if I am injured because I took part in this study?

**It is important that you tell your study doctor,
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_** *\[investigator's name(s)\],*
**if you feel that you have been injured because of taking part in this
study. You can tell the doctor in person or call him/her at
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_** *\[telephone number\].*

You will get medical treatment if you are injured as a result of taking
part in this study. You and/or your health plan will be charged for this
treatment. The study will not pay for medical treatment.

#### What are my rights if I take part in this study?

Taking part in this study is your choice. You may choose either to take
part or not to take part in the study. If you decide to take part in
this study, you may leave the study at any time. No matter what decision
you make, there will be no penalty to you and you will not lose any of
your regular benefits. Leaving the study will not affect your medical
care. You can still get your medical care from our institution.

We will tell you about new information or changes in the study that may
affect your health or your willingness to continue in the study.

**In the case of injury resulting from this study, you do not lose any
of your legal rights to seek payment by signing this form.**

### **Who can answer my questions about the study?**

**You can talk to your study doctor about any questions or concerns you
have about this study. Contact your study doctor
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_** *\[name(s)\]* **at
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_** *\[telephone number\].*

For questions about your rights while taking part in this study, call
the \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ *\[name of
center\]* Institutional Review Board (a group of people who review the
research to protect your rights) at \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
*(telephone number). \[Note to Local Investigator: Contact information
for patient representatives or other individuals in a local institution
who are not on the IRB or research team but take calls regarding
clinical trial questions can be listed here.\]*

**\*You may also call the Operations Office of the NCI Central
Institutional Review Board (CIRB) at 888-657-3711 (from the continental
US only).** *\[\*Only applies to sites using the CIRB.\]*

**Please note: This section of the informed consent form is about
additional research studies that are being done with people who are
taking part in the main study. You may take part in these additional
studies if you want to. You can still be a part of the main study even
if you say 'no' to taking part in any of these additional studies.**

**You can say "yes" or "no" to each of the following studies. Please
mark your choice for each study.**

*\[Insert information about companion studies here. Provide yes/no
options at each decision point. The following studies are included as
examples therefore are written with italicized font. Any text provided
for patients should use the same non-italicized font as used for the
rest of the informed consent document.\]*

*\[Example: Quality of Life study\]*

######## Quality of Life Study

We want to know your view of how your life has been affected by cancer
and its treatment. This "Quality of life" study looks at how you are
feeling physically and emotionally during your cancer treatment. It also
looks at how you are able to carry out your day-to-day activities.

*This information will help doctors better understand how patients feel
during treatments and what effects the medicines are having. In the
future, this information may help patients and doctors as they decide
which medicines to use to treat cancer*.

*You will be asked to complete 3 questionnaires: one on your first
visit, one 6 months later, and the last one 12 months after your first
visit. It takes about 15 minutes to fill out each questionnaire.*

*If any questions make you feel uncomfortable, you may skip those
questions and not give an answer.*

*If you decide to take part in this study, the only thing you will be
asked to do is fill out the three questionnaires. You may change your
mind about completing the questionnaires at any time.*

*Just like in the main study, we will do our best to make sure that your
personal information will be kept private.*

*Please circle your answer.*

> *I choose to take part in the Quality of Life Study. I agree to fill
> out the three Quality of Life Questionnaires.*
>
> *YES NO*

*\[Example: Use of Tissue for Research\]*

*\[The following example of tissue consent has been taken from the NCI
Cancer Diagnosis Program's model tissue consent form found at the
following URL*

***<http://www.cancerdiagnosis.nci.nih.gov/specimens/model.pdf> \]***

*Consent Form for Use of Tissue for Research*

***About Using Tissue for Research***

*You are going to have a biopsy (or surgery) to see if you have cancer.
Your doctor will remove some body tissue to do some tests. The results
of these tests will be given to you by your doctor and will be used to
plan your care.*

*We would like to keep some of the tissue that is left over for future
research. If you agree, this tissue will be kept and may be used in
research to learn more about cancer and other diseases. Please read the
information sheet called \"How is Tissue Used for Research\" to learn
more about tissue research.*

*Your tissue may be helpful for research whether you do or do not have
cancer. The research that may be done with your tissue is not designed
specifically to help you. It might help people who have cancer and other
diseases in the future.*

*Reports about research done with your tissue will not be given to you
or your doctor. These reports will not be put in your health record. The
research will not have an effect on your care.*

***Things to Think About***

*The choice to let us keep the left over tissue for future research is
up to you. No matter what you decide to do, it will not affect your
care.*

*If you decide now that your tissue can be kept for research, you can
change your mind at any time. Just contact us and let us know that you
do not want us to use your tissue. Then any tissue that remains will no
longer be used for research.*

*In the future, people who do research may need to know more about your
health. While the xyz may give them reports about your health, it will
not give them your name, address, phone number, or any other information
that will let the researchers know who you are.*

*Sometimes tissue is used for genetic research (about diseases that are
passed on in families). Even if your tissue is used for this kind of
research, the results will not be put in your health records.*

*Your tissue will be used only for research and will not be sold. The
research done with your tissue may help to develop new products in the
future.*

***Benefits***

*The benefits of research using tissue include learning more about what
causes cancer and other diseases, how to prevent them, and how to treat
them.*

***Risks***

*The greatest risk to you is the release of information from your health
records. We will do our best to make sure that your personal information
will be kept private. The chance that this information will be given to
someone else is very small.*

***Making Your Choice***

*Please read each sentence below and think about your choice. After
reading each sentence, circle \"Yes\" or \"No\". If you have any
questions, please talk to your doctor or nurse, or call our research
review board at IRB\'s phone number.*

*No matter what you decide to do, it will not affect your care.*

*1. My tissue may be kept for use in research to learn about, prevent,
or treat cancer.*

  -------------------------------------- --------------------------------
  *Yes*                                  *No*

  -------------------------------------- --------------------------------

*2. My tissue may be kept for use in research to learn about, prevent or
treat other health problems (for example: diabetes, Alzheimer\'s
disease, or heart disease).*

  -------------------------------------- --------------------------------
  *Yes*                                  *No*

  -------------------------------------- --------------------------------

*3. Someone may contact me in the future to ask me to take part in more
research.*

  ----------------------------------------- -----------------------------
  *Yes*                                     *No*

  ----------------------------------------- -----------------------------

Where can I get more information?

**You may call the National Cancer Institute\'s Cancer Information
Service at:**

> **1-800-4-CANCER (1-800-422-6237)** or **TTY: 1-800-332-8615**

**You may also visit the NCI Web site at**
[**http://www.cancer.gov/**](http://www.cancer.gov/)

-   **For NCI's clinical trials information, go to:
    <http://www.cancer.gov/clinicaltrials/>**

-   **For NCI's general information about cancer, go to
    <http://www.cancer.gov/cancertopics/>**

**You will get a copy of this form. If you want more information about
this study, ask your study doctor.**

Signature

**I have been given a copy of all \_\_\_\_\_** *\[insert total of number
of pages\]* **pages of this form. I have read it or it has been read to
me. I understand the information and have had my questions answered. I
agree to take part in this study.**

######### Participant \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

**Date
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_**