Principal Investigator Jonathan S. Berek, M.D. Lay Title A Study - PDF by bloved

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									Principal Investigator:       Jonathan S. Berek, M.D.

Lay Title:                    A Study of Tissue and Blood Samples

Study Number:                 GOG #136

UCLA IRB Number:              92-07-349-24

Diagnosis:                    n/a

Description:                  The purpose of this study is to acquire tissue
                              and blood specimens that can be used in
                              future research studies.

Eligibility:                  Women scheduled for surgery that may have a
                              gynecologic tumor or close relative with
                              cancer.


Contact Information:          Tery Schooler
                              Phone:        (310) 206-5161
                              E-mail:     Tschooler@mednet.ucla.edu

                              OR

                              Monica Rocha
                              Phone:     (310) 794-9095
                              E-mail:    MRocha@mednet.ucla.edu


Consent Form Date of Preparation: February 20, 2003
Consent Form IRB Approval Stamp: February 20, 2003
Last Website Update:           9/17/03
                                                                       Page 1 of 14




                                 CONSENT FORM
              DIVISION OF GYNECOLOGIC ONCOLOGY - PROTOCOL #136
                     UNIVERSITY OF CALIFORNIA, LOS ANGELES

                    ACQUISITION OF HUMAN GYNECOLOGIC
            SPECIMENS AND SERUM TO BE USED IN STUDYING THE
         CAUSES, DIAGNOSIS, PREVENTION AND TREATMENT OF CANCER


Name:__________________________________                                               Hospital
Number:_______________________

                        CONSENT TO PARTICIPATE IN RESEARCH

                        A STUDY OF TISSUE AND BLOOD SAMPLES

You are asked to participate in a research study conducted by Jonathan S. Berek, M.D.,
Robin Farias-Eisner, M.D., Ph.D., Christine Holschneider, M.D., Sanaz Memarzadeh,
M.D., Jing Wang, M.D., Christine Walsh, M.D. and Oliver Dorigo, M.D. from the
Department of Obstetrics and Gynecology at the University of California, Los Angeles.
You have been asked to participate in this study because you are scheduled for surgery
and may have a gynecologic tumor or because you have a close relative with cancer. Your
participation in this study is entirely voluntary. You should read the information below, and
ask questions about anything you do not understand, before deciding whether or not to
participate.

DISCLOSURE STATEMENT

Your health care provider may be an investigator of this research protocol, and as an
investigator, is interested both in your clinical welfare and in the conduct of this study.
Before entering this study or at any time during the research, you may ask for a second
opinion about your care from another doctor who is in no way associated with this project.
You are not under any obligation to participate in any research project offered by your
doctor.

PURPOSE OF THE STUDY

This study is being carried out under the sponsorship of the Gynecologic Oncology Group
(GOG), an organization dedicated to clinical research in the field of gynecologic cancer.
The GOG is funded by the Federal Government through the National Cancer Institute
(NCI). In general, the research carried out compares the effectiveness of different
methods of treating cancer of the female genital organs. This study is for women who are
scheduled for gynecologic surgery. The purpose of this is to acquire tissue and blood


Date of Preparation: February 20, 2003
UCLA IRB Number: 92-07-349-24
Expiration Date:
                                                                        Page 2 of 14


specimens that can be used in future research studies. General information about what
the study found and/or the conclusions of the study will not be available you.

PROCEDURES

If you volunteer to participate in this study, your doctors will take some of your gynecologic
tumor tissue during surgery and submit that tissue to the GOG Tissue Bank. This is a
nationally sponsored repository where pieces of your tumor and other patient's tumors will
be made available to researchers to aid in their studies in the causes and treatment of
gynecologic cancer. No additional surgery will be performed to obtain these samples, and
only that material which remains after all diagnostic testing has been completed will be
used. Also, your doctor would like to include with your tumor tissue some of your blood
serum (the liquid portion of your blood). The total amount of blood that will be collected will
not be more than 40 cc (equivalent to 3-4 tablespoons). In order for the researchers to
learn more, a sample of your normal tissue will also be sent. The normal tissue will be
about the size of a quarter. The site of the specimen for the normal tissue will be
determined by your doctor at the time of surgery. If there is no normal tissue available, an
additional two teaspoons of blood will be drawn so that cells from the blood can be sent
instead of normal tissue.

These research studies may include such things as DNA analysis to identify defects
(mutations) in your genes that could contribute to the development of cancer. In some
cases these defects could be passed on to your children (inherited). However, your tissue
will be coded so the research doctors will not know who the tissue came from.

DURATION AND LOCATION

You may be contacted in the future to learn about the status of your health. The blood
sample, tissue, and genetic material will be stored at the GOG Tissue Bank in Columbus,
Ohio for an indefinite period of time or until it is used up.

POTENTIAL RISKS AND DISCOMFORTS

You may experience any, all or none of the following side effects from participating in this
study. You may feel some mild discomfort at the place where blood is taken. There is a
small risk of fainting, some bruising, and very rare (1 in 1,000) risk of infection. Whenever
possible, the blood for research will be drawn during surgery when you are asleep or at the
same time blood is being drawn for other medical tests.

Since the normal tissue will be taken from specimens removed during surgery, there are
no known additional risks from providing normal tissue.

By your consent to participate in this research study, you give up any property rights you
may have to your bodily fluids, substances or tissues. Not being notified of study results
may cause psychological discomfort.

Date of Preparation: February 20, 2003
UCLA IRB Number: 92-07-349-24
Expiration Date:
                                                                        Page 3 of 14




ANTICIPATED BENEFITS TO SUBJECTS

There will be no benefit to you for participating in this study.

ANTICIPATED BENEFITS TO SOCIETY

Knowledge gained from this study may be helpful to other patients.

ALTERNATIVES TO PARTICIPATION

The only alternative to this study is to choose not to participate. If you choose not to
participate it will not affect your care.

PAYMENT FOR PARTICIPATION

You will not receive any payment or any free services for participating in this study.

POSSIBLE COMMERCIAL PRODUCTS

All tissue and/or fluid samples are important to this research study. Your sample will be
owned by the University of California or by a third party designated by the University (such
as another university or a private company). If a commercial product is developed from
this project, the commercial product will be owned by the University of California or its
designee. You will not profit financially from such a product.

Cells obtained from your blood may be used to establish cell lines which may be shared in
the future with other researchers and which may be of commercial value. A cell line is one
which will grow indefinitely in the laboratory. Cell lines may be useful because of the
characteristics of the cells and/or the products they may produce. Cell lines could be
patented and licensed. There are no plans to provide financial compensation should this
occur.

Tissue obtained in this research may be used to establish a product that could be patented
and licensed. There are no plans to provide financial compensation should this occur.



SAMPLE REMAINING AT THE END OF THE STUDY

On the checklist at the end of this consent form, you will be asked to indicate if you would
permit part of this sample to be shared with other researchers. If you agree to have your
sample shared with other researchers and later decide to withdraw, we may not be able to
retrieve any or all of you sample from other researchers. The researcher is not required to
store your sample(s) indefinitely.

Date of Preparation: February 20, 2003
UCLA IRB Number: 92-07-349-24
Expiration Date:
                                                                        Page 4 of 14




In the future, if you or a family member wish to have access to the tissue or wish it to be
destroyed, you may call the GOG Statistical and Data Center at (716) 845-5702 or your
physician's office. If the specimens have not been used, arrangements will be made to
accommodate your request.

FINANCIAL OBLIGATION

There will be no charge to you or your insurance carrier for participating in this study.

EMERGENCY CARE AND COMPENSATION FOR INJURY

If you are injured as a direct result of research procedures not done primarily for your own
benefit, you will receive medical treatment at no cost. The University of California does not
provide any other form of compensation for injury.

PRIVACY AND CONFIDENTIALITY

The only people who will know that you are a research subject are members of the
research team and, if appropriate, you physicians and nurses. No information about you,
or provided by you during the research, will be disclosed to others without your written
permission, except:

               -   if necessary to protect your rights or welfare (for example, if you are
                   injured and need emergency care); or
               -   if required by law

When the results of the research are published or discussed in conferences, no
information will be included that would reveal your identity. This study does not involve the
use of photographs, videos, or audio-tape recordings of you.

Portions of your medical information may be transmitted electronically through the Internet,
but will be encrypted (scrambled) to maintain confidentiality.

All or part of your medical records will be sent to the Gynecologic Oncology Group
Administrative Office in Philadelphia, Pennsylvania, as well as to the Gynecologic
Oncology Group Statistical and Data Center in Buffalo, New York, to be reviewed and
analyzed by physicians and other study personnel, along with the records of all other
patients participating in this study from this and other institutions. Your hospital records,
doctor’s office records, laboratory, operating room and other records may be audited by
representatives of the Gynecologic Oncology Group and the National Cancer Institute.
Also, other federal agencies who may be concerned about the character of your medical
records, may review your records under limited circumstances, such as DHHS request for
information for an audit or program evaluation, or an Food and Drug Administration



Date of Preparation: February 20, 2003
UCLA IRB Number: 92-07-349-24
Expiration Date:
                                                                       Page 5 of 14


request under the Food, Drug and Cosmetics Act. As a result, they may see your name;
but they are bound by rules of confidentiality not to reveal your identity to others.

The Gynecologic Oncology Group has received a Certificate of Confidentiality from the
federal government, which will help protect your privacy. The Certificate protects against
the involuntary release of information about you collected during the course of the study.
The researchers involved in this project cannot be forced to disclose your identity or any
information about you collected in this study any legal proceedings at the federal, state, or
local level, regardless of whether they are criminal, administrative, or legislative
proceedings. However, you may choose to voluntarily disclose the protected information
under certain circumstances. For example, if you or your guardian requests the release of
information about you in writing (through, for example, a written request to release medical
records to an insurance company), the Certificate does not protect against that voluntary
disclosure.

In signing this consent form you give your permission for your hospital records, doctor’s
office records, laboratory, operating room and other records to be audited by
representatives of the Gynecologic Oncology Group, and/or the National Cancer Institute.
Your initials, date of birth, and study number will be on these records and forms. No other
information which identifies you will be released without your separate consent except as
specifically required by law.

Personal information, research data, and related records will be stored in locked offices in
order to prevent unauthorized personnel from reviewing your records. If any other use of
the data is contemplated, you will be contacted and given the opportunity to decide
whether or not you want your data used for that purpose.

Each tissue and fluid sample contains genetic information about your parents and
ancestors such as the information contained in DNA, RNA or protein. It may be helpful to
study members of your family. Your relatives will not be contacted without your
permission.

It is possible that a researcher may contact the GOG Tissue Bank or the Gynecologic
Oncology Group at any time in the future to learn about your medical status after your
surgery. Such information will be linked to your specimen by a code. We will obtain such
information by reviewing your medical record and/or contacting you or a member of your
family by phone or mail. At the end of this consent form, please let us know if it is
acceptable to you if we contact a family member if you are not available. Neither your
name nor other identifiers will be given to the researcher.

Your participation in this study will be for several years even after treatment is completed.
If you agree at the end of this form, your study records will be reviewed and you and/or a
family member may be contacted. You have the option to refuse to participate or withdraw
from the study at any time.



Date of Preparation: February 20, 2003
UCLA IRB Number: 92-07-349-24
Expiration Date:
                                                                       Page 6 of 14


GENETIC INFORMATION YOUR SAMPLE:                    POSSIBLE LIMITS TO INDIVIDUAL
CONFIDENTIALITY

Every tissue or fluid sample contains genetic information. Recent
studies have found normal and disease producing genetic variations among individuals.
Such variations may permit identification of individual participants. Despite this possible
limitation, every precaution will be taken to maintain your confidentiality now and in the
future.

We have learned from past research that we will not always be able to predict future
research findings and new technologies. You should be aware that unforseeable
problems may arise from new developments. Possible problems include insurance or
employment discrimination based on genetic information.

Sometimes genetic information suggesting different parentage is obtained during
research. We do not plan to report such findings to participants.

Within the limits imposed by technology and the law, every effort will be made to maintain
the privacy of your genetic information.

PARTICIPATION AND WITHDRAWAL

Your participation in this research is VOLUNTARY. If you choose not to
participate, that will not affect your relationship with UCLA Medical Center or your right to
health care or other services to which you are otherwise entitled. If you decide to
participate, you are free to withdraw your consent and discontinue participation at any time
without prejudice to your future care at UCLA.

WITHDRAWAL OF PARTICIPATION BY THE INVESTIGATOR

The investigator may withdraw you from participating in this research if circumstances
arise which warrant doing so. Jonathan S. Berek, M.D., Robin Farias-Eisner, M.D., Ph.D.,
Christine Holschneider, M.D., Sanaz Memarzadeh, M.D., Jing Wang, M.D., Christine
Walsh, M.D. and Oliver Dorigo, M.D. will make the decision and let you know if it is not
possible for you to continue. The decision may be made either to protect your health and
safety, or because it is part of the research plan that people who develop certain
conditions may not continue to participate.

NEW FINDINGS

During the course of the study, you will be informed of any significant new findings (either
good or bad), such as changes in the risks or benefits resulting from participation in the
research or new alternatives to participation, that might cause you to change your mind
about continuing in the study. If significant new information is provided to you, your
consent to continue participating in this study will be re-obtained.

Date of Preparation: February 20, 2003
UCLA IRB Number: 92-07-349-24
Expiration Date:
                                                                         Page 7 of 14




IDENTIFICATION OF INVESTIGATORS

In the event of a research related injury or if you experience an adverse reaction, please
immediately contact one of the investigators listed below.

If you have any questions about the research, please feel free to contact Jonathan S.
Berek, M.D., Robin Farias-Eisner, M.D., Ph.D., , Christine Holschneider, M.D., Sanaz
Memarzadeh, M.D., Jing Wang, M.D., Christine Walsh, M.D. or Oliver Dorigo, M.D. who
can be reached 24 hours a day, 7 days a week through the UCLA page operator at (310)
825-6301. They can also be reached by mail at UCLA Department of Obstetrics and
Gynecology, 10833 Le Conte Avenue, Room 24-127, CHS, Los Angeles, CA 90095-
1740.

RIGHTS OF RESEARCH SUBJECTS

You may withdraw your consent at any time and discontinue participation without penalty.
You are not waiving any legal claims, rights or remedies because of your participation in
this research study. If you have questions regarding your rights as a research subject, you
may contact the Office for Protection of Research Subjects, UCLA, Box 951694, Los
Angeles, CA 90095-1694, (310) 825-8714.

SIGNATURE OF RESEARCH SUBJECT

I have read (or someone has read to me) the information provided above. I have been
given an opportunity to ask questions and all of my questions have been answered to my
satisfaction. I have been given a copy of this form, as well as a copy of the Subject's Bill of
Rights.




BY SIGNING THIS FORM, I WILLINGLY AGREE TO PARTICIPATE IN THE
RESEARCH IT DESCRIBES


_____________________________________________
Name of Subject


_____________________________________________ _______________
Signature of Subject                  Date/Time




Date of Preparation: February 20, 2003
UCLA IRB Number: 92-07-349-24
Expiration Date:
                                                                       Page 8 of 14


TISSUE COLLECTION AND BANKING

1.    At the time of your surgery to determine whether cancer is present, or if you have
      previously been diagnosed with cancer and are undergoing surgery, you agree to
      have tumor tissue and blood samples that are not needed for diagnosis saved for
      future study.

2.    You agree to have your tissue/fluid stored confidentially at the GOG Tissue Bank in
      Columbus Ohio and notification that you agreed to have it stored, with your initials
      and your diagnosis would be sent to the GOG Statistical and Data Center in Buffalo,
      New York.

3.    You are being asked to grant approval at this time for storage of your tissue/fluid in
      the event that there might be use for it in some research study in the future.

4.    You have read and understand the information pamphlet on the use of tissue
      research that was given to you.

The results of tissue (specimen) bank research may help find new ways to learn about,
prevent, or treat cancer and other diseases. Please read each sentence below and think
about your choice. After reading each sentence, circle and initial the answer that is right
for you. If you have any questions, please talk to your doctor or nurse, or call the National
Cancer Institute’s Cancer Information Service at 1-800-422-6237 (1-800-4-CANCER).

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

                 Yes        No      Initials_____

2. My tissue/fluid 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      Initials_____

3. Someone from UCLA may contact me in the future to take part in more research on
    behalf of the Gynecologic Oncology Group (GOG) or the GOG Tissue Bank.

                 Yes        No      Initials_____


SHARING OF SAMPLES

Please check the appropriate box below and initial:




Date of Preparation: February 20, 2003
UCLA IRB Number: 92-07-349-24
Expiration Date:
                                                                      Page 9 of 14


[ ] ______ I agree to have my tissue/fluid sample shared with other          researchers.


[ ] ______ I do not want my tissue/fluid sample shared with other
               researchers.


MEDICAL RECORD REVIEW


[ ] ______ I agree to allow researchers access to review my medical records.


[ ] ______ I do not agree to have my medical records reviewed.


FAMILY MEMBER CONTACT

[ ] ______ I agree to allow researchers to contact my family members to check on the
              status of my health if I am not available.


[ ] ______ I do not agree to have my family members contacted if I am not available.



SIGNATURE OF INVESTIGATOR

I have explained the research to the subject and answered all of her questions. I believe
that she understands the information described in this document and freely consents to
participate.

______________________________________________
Name of Investigator

______________________________________________ _______________
Signature of Investigator            Date/Time




Date of Preparation: February 20, 2003
UCLA IRB Number: 92-07-349-24
Expiration Date:
                                                                      Page 10 of 14


                                                                        GOG Tissue Bank
                                                             Children's Research Institute
                                                                   700 Children's Drive
                                                                    Columbus, OH 43205
                                                                  PHONE:(614)722-2890
                                                                    FAX: (614) 722-2897

                          Information Pamphlet on the 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 section 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 institution you are treated at 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.



                                                                        GOG Tissue Bank

Date of Preparation: February 20, 2003
UCLA IRB Number: 92-07-349-24
Expiration Date:
                                                                       Page 11 of 14


                                                              Children's Research Institute
                                                                      700 Children's Drive
                                                                     Columbus, OH 43205
                                                                  PHONE: (614) 722-2890
                                                                     FAX: (614) 722-2897


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. The
institution you receive your treatment from will protect your records so that your name,
address, and phone number will be kept private. The chance that this information will be
given to someone else is very small.

How is Tissue Used for Research?

Where does tissue come from?

Whenever a biopsy (or surgery) is performed, the tissue that is removed is examined
under the microscope by a trained doctor to determine the nature of the disease and
assist with the diagnosis. Your tissue will always be used first to help make decisions
about your care. After all tests have been done, there is usually some left over tissue.
Sometimes, this tissue is not kept because it is not needed for the patient's care.
Instead, a patient can choose to have the tissue kept for future research. People who
are trained to handle tissue and protect the donor's rights make sure that the highest
standards are followed. Your doctor does not work for the GOG Tissue Bank, but has
agreed to help collect tissue from many patients. Many doctors across the country are
helping in the same way. If you agree, only left over tissue will be saved for research.
Your doctor will only take the tissue needed for your care during surgery.




Date of Preparation: February 20, 2003
UCLA IRB Number: 92-07-349-24
Expiration Date:
                                                                    Page 12 of 14


                                                                      GOG Tissue Bank
                                                           Children's Research Institute
                                                                   700 Children's Drive
                                                                  Columbus, OH 43205
                                                               PHONE: (614) 722-2890
                                                                  FAX: (614) 722-2897

Why do people do research with tissue?

Research with tissue can help to find out more about what causes cancer, how to
prevent it, and how to treat it. Research using tissue can also answer other health
questions. Some of these include finding the causes of diabetes and heart disease, or
finding genetic links to Alzheimer's.

What type of research will be done with my tissue?

Many different kinds of studies use tissue. Some researchers may develop new tests to
find diseases. Others may develop new ways to treat or even cure diseases. In the
future, some of the research may help to develop new products, such as tests and
drugs.

Some research looks at diseases that are passed on in families (called genetic
research). Research done with your tissue may look for genetic causes and signs of
disease.

How do researchers get the tissue?

Researchers from universities, hospitals, and other health organizations conduct
research using tissue. They contact the GOG Tissue Bank and request samples for
their studies. The GOG Tissue Bank reviews the way that these studies will be done,
and decides if any of the samples can be used. The GOG Tissue Bank gets the tissue
and information about you from your hospital, and sends the tissue samples and some
information about you to the researcher. The GOG Tissue Bank will not send your
name, address, phone number, social security number, or any other identifying
information to the researcher.

Will I find out the results of the research using my tissue?

No, you will not receive the results of research done with your tissue. This is because
research can take a long time and must use tissue samples from many people before
results are known. Results from research using your tissue may not be ready for many
years and will not affect your care right now, but they may be helpful to people like you
in the future.




Date of Preparation: February 20, 2003
UCLA IRB Number: 92-07-349-24
Expiration Date:
                                                                      Page 13 of 14


                                                                         GOG Tissue Bank
                                                              Children's Research institute
                                                                      700 Children's Drive
                                                                     Columbus, OH 43205
                                                                  PHONE: (614) 722-2890
                                                                     FAX: (614) 722-2897

Though research involves the test results of many different people, your biopsy result
involves only you. Your doctor will give you the results of your biopsy when results are
known. These test results are ready in a short time and will be used to make decisions
about your care.

Will I benefit from the research using my tissue?

There will be no direct benefit to you because your tissue may not be used for some
time after you donate it and because research can take a long time. However, it is
hoped that the results of research on your tissue and tissues from other patients will
provide information that will help other patients in the future. Your tissue will be helpful
whether you have cancer or not.

Why do you need information from my health records?

In order to do research with your tissue, researchers may need to know some things
about you. (For example: What is your race or ethnic group? How old are you? Have
you ever smoked?) This helps researchers answer questions about diseases. The
information that will be given to the researcher includes your age, sex, race, diagnosis,
treatments, and possibly some family history. This information is collected by your
hospital from your health record and sent to GOG Tissue Bank but without your name or
other identifying information.

Will my name be attached to the records that are given to the researcher?

No. Your name, address, phone number and anything else that could identify you will be
removed before they go to the researcher.

How could the records be used in ways that might be harmful to me?

Sometimes, health records have been used against patients and their families. For
example, insurance companies may deny a patient insurance or employers may not hire
someone with a certain illness (such as AIDS or cancer). The results of genetic
research may not apply only to you, but to your family members. For diseases



                                                                        GOG Tissue Bank

Date of Preparation: February 20, 2003
UCLA IRB Number: 92-07-349-24
Expiration Date:
                                                                    Page 14 of 14


                                                            Children's Research institute
                                                                    700 Children's Drive
                                                                   Columbus, OH 43205
                                                                PHONE: (614) 722-2890
                                                                   FAX: (614) 722-2897


caused by gene changes, the information in one person's health record could be used
against family members.

How am I protected?

The GOG Tissue Bank is in charge of making sure that information about you is kept
private. The GOG Tissue Bank will take careful steps to prevent misuse of records.
Your name, address, phone number and other identifying information will be taken off
anything associated with your tissue before it is given to the researcher. This would
make it very difficult for any research results to be linked to you or your family. Also,
people outside the research process will not have access to results about any one
person which will help to protect your privacy.




Date of Preparation: February 20, 2003
UCLA IRB Number: 92-07-349-24
Expiration Date:

								
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