Attach_9_Consent_&_Authorization_9_27

Attach_9_Consent_&_Authorization_9_27.pdf

Prostate, Lung, Colorectal and Ovarian Cancer Screening Trial (PLCO) (NCI)

Attach_9_Consent_&_Authorization_9_27

OMB: 0925-0407

⚠️ Notice: This form may be outdated. More recent filings and information on OMB 0925-0407 can be found here:

2015-07-16 - Revision of a currently approved collection

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Attachment 9: Consent and Authorization to Release Medical Records

PLCO SCREENING TRIAL
PROTOTYPE "SCREENING" (Main combined with ESC) CONSENT FORM
Prostate, Lung, Colorectal and Ovarian Cancer Screening Trial
NAME OF CLINICAL CENTER

DESCRIPTION OF STUDY
I have been asked to take part in the Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening
Trial sponsored by the National Cancer Institute, LOCAL CLINICAL CENTER, and nine other centers
across the country. The purpose of this study is to determine if certain screening tests can reduce deaths
from prostate cancer, lung cancer, ovarian cancer, and cancers of the colon and rectum. [Some doctors
believe that screening for these cancers will extend lives, others do not believe that it will. A large,
carefully controlled scientific study is necessary to resolve this debate.] Nationwide, this study will enroll
148,000 men and women between the ages of 55 and 74.
Four specific questions to be addressed in this study are:
•

Does screening with flexible sigmoidoscopy reduce deaths from cancers of the colon and rectum?

•

Does screening with chest x-rays reduce deaths from lung cancer?

•

In men, does screening with digital rectal examinations plus a blood test for serum prostatespecific-antigen (PSA) reduce deaths from prostate cancer?

•

In women, does screening with transvaginal ultrasound of the ovaries, and testing the blood for
CA-125, reduce deaths from ovarian cancer?

The PLCO Trial will also look for factors that may cause these cancers.
STUDY PROCEDURES
By agreeing to participate in the PLCO Trial, I agree to be assigned by a r andom statistical process to
either a screened group or a usual care group. I understand that I have an equal chance of being in either
group.
Regardless of which group I am assigned to, I will be asked questions about my personal and family
medical history for these cancers and about my overall risk of developing cancer.
If I am assigned to the usual care group, I will follow my normal health care routine. I will be asked to
give information about my health and factors related to my health (collected by mail or telephone) once a
year for at least 13 years.
If I am assigned to the screened group, the following tests will be carried out on an annual basis for up to
6 years:

Consent page 1

Males:
•

Digital rectal exam (annually for the first four (4) years)

•

Serum PSA blood test (annually for six (6) years)

•

Chest x-ray (annually for the first four (4) years in current and former smokers; first three (3)
years in people who never smoked)

Females:
•

Transvaginal ultrasound (annually for the first four (4) years except for women without ovaries; a
tampon-sized probe is inserted into the vagina and images of the ovaries are made using sound
waves)

•

CA-125 blood test (annually for six (6) years)

•

Chest x-ray (annually for first four (4) years in current and former smokers; first three (3) years in
people who never smoked)

At the first and sixth screening visit, the following test will be performed on bot h male and female
participants:
•

Flexible sigmoidoscopy

The flexible sigmoidoscopy involves the insertion to about 20-24 inches of a thin flexible lighted
instrument to examine the colon and the rectum. Preparation for this test consists of two Fleets enemas
one hour before the test.
The blood draw for the PSA or CA-125 test will include the collection of up to 45-ml (3 tablespoons) of
blood from my arm. Blood not used for the PSA or CA-125 will be stored for future research purposes.
By agreeing to participate in this study, I agree to have all of the screening tests performed as required by
the study. The examinations that are part of this trial are well-established tests that doctors use frequently
to diagnose problems in patients with certain symptoms. Their effectiveness in early detection of cancer is
being tested in this study. It is unknown if these tests will provide any benefit to me.
For quality control, some participants will be asked to have a screening test repeated to test the accuracy
of certain measures.
I further agree to provide specific information about my health and factors related to my health (collected
by mail or telephone) once a year for at least 13 years.
In addition to evaluating screening tests, the PLCO Trial also seeks to study factors that may cause these
cancers to develop and progress. Additional research on cancer and other diseases that occur in your age
group will be carried out among PLCO participants who volunteer for these additional studies. We are
requesting your consent to participate in these additional studies of cancer and other diseases that occur in
you age group.

Consent page 2

ADDITIONAL STUDY PROCEDURES
If I am selected to be in the screened group and I volunteer for these additional studies, blood not used for
the prostate cancer screening test (PSA) or the ovarian cancer screening test (CA-125II) test will be stored
and used in future medical research. (If I am a woman without ovaries and will not receive the CA-125II,
or a man without a prostate and will not receive the PSA I may still choose to participate in this additional
medical research by signing this document.) These future studies will include investigations to determine
if genetic (inherited) factors and chemicals in blood, such as dietary nutrients and hormones, are related to
the risk of developing cancer and other diseases that occur in your age group.
If I am assigned to the usual care group and I volunteer for these additional studies, I will provide a
sample of saliva which will be stored and used in future medical research. Such studies will include
investigations to determine if genetic (inherited) factors are related to the risk of developing cancer and
other diseases that occur in your age group. Briefly, the collection of saliva requires that, at home, I rinse
with a small sample of mouthwash (less than a tablespoon), spit the saliva into a small cup, and then seal
the cup tightly. I will be provided with a kit and instructions for the collection and pre-paid return mailing
of this sample to the researchers.
If I volunteer for these additional studies and I later have surgery for diagnosis or treatment of cancer or a
related condition, the study investigators may then ask my doctors and the hospitals where I was treated to
provide a small sample of the surgical material. This material may be used by the study investigators only
for medical research about genetic (inherited) factors and chemical changes that lead to the development
of cancer and other diseases that occur in my age group.
These materials will be stored at a National Cancer Institute research storage facility for up to 25 years
and used to help scientists learn what causes cancer and how to prevent its progression. It is believed that
cancer may be caused by both environmental and genetic factors. Therefore, the samples, which I
contribute, may be used in biochemical and genetic studies to identify these causes.
BENEFITS
I understand that I will receive free cancer screening tests. I further understand that if I develop prostate,
colorectal, lung, or ovarian cancer it is possible that the cancer may be detected at an early stage. Early
diagnosis may prolong my life, however, this cannot be guaranteed.
[If this study shows that screening for prostate, lung, colorectal, or ovarian cancer decreases the chances
of dying from these cancers, then screening for these cancers will become common practice in the future.
If this study shows that the screening tests do not decrease the chances of dying of these cancers, doctors
will know not to use them, saving me and others unnecessary inconvenience and expense.]
BENEFITS OF ADDITIONAL STUDIES
The additional studies will not provide direct benefit to me other than the satisfaction of participating in
this research for the possible benefit of future generations. However, my participation in these additional
studies will help answer questions related to the health and longevity of persons in my age group and will
help establish a scientific understanding of the factors, which influence the development, and progression
of cancer.

Consent page 3

RISKS
I understand that there are certain risks and discomforts that might be associated with the screening
procedures.
There may be some discomfort from the physical exam of the rectum, or the sigmoidoscopic exam.
•

Very rarely a perforation of the bowel occurs during sigmoidoscopy (less than once in every
10,000 to 50,000 examinations). If this would occur, medical treatments consisting of antibiotics
and, in a very rare instance, surgical correction could occur.

•

A small amount of radiation is received as part of the chest x-ray. This amount is smaller than
that of a normal chest x-ray and poses no measurable risk.

•

There may be discomfort involved from the transvaginal ultrasound. There is a very rare chance
of a vaginal tear with the probe.

•

When blood is drawn, there may be local bruising or bleeding at the puncture site. There may also
be uneasiness associated with needles.

I understand that it is possible that the cancers detected by these screening tests may be very slow
growing. It is possible that diagnosis (and treatment) of cancers detected in this trial may not prolong my
life. Additionally, it is possible that the screening tests may falsely suggest that I have cancer. In this case,
it is possible that I may suffer pain, anxiety, and expense that could have been avoided if I had never
undergone the screening tests.
RISKS OF ADDITIONAL STUDIES
There are certain risks and discomforts that might be associated with the additional procedures. When
blood is drawn I may feel a l ittle discomfort as the needle goes through the skin. There may be local
bruising or bleeding at the puncture site. Pressing hard on the spot for 1 to 2 minutes after the needle is
removed will help prevent a bruise. There may also be uneasiness associated with needles. Very rarely,
the arm may become infected. The risk is the same as that of having blood drawn at my doctor’s office or
clinic.
•

When saliva is collected, (by rinsing with mouthwash) there may be slight irritation or stinging in
the mouth from the mouthwash.

NOTIFICATION AND COSTS
I understand screening results will be sent to me as soon as they become available. If I have indicated a
primary physician, he/she will receive the results. If the results indicate a potential medical problem, I
will also be offered a referral to a physician specialist of my choice from whom I can receive further
medical evaluation, if I so choose. The costs of diagnostic tests beyond screening will not be covered by
the study and must come from insurance or other sources.
If I am diagnosed with cancer, I may be referred to a cancer specialist of my choice, if I so request. The
costs of cancer treatment will not be covered by this study.

Consent page 4

The additional biologic samples are for medical research only and the research results are not suitable for
use as c linical tests for my medical care. The scientific studies require only looking at all lab results
together. Therefore, the results of these additional studies will not be available to me.
COMPENSATION FOR RESEARCH-RELATED INJURIES
In the unlikely event of physical injury resulting from my participation in this study, I will be provided
with immediate medical treatment. I understand, however, that no pa yment of medical treatment is
available from the National Cancer Institute for any such injury.
EXCLUDED PROCEDURES
This trial includes only the screening tests listed above. Other medical procedures are not part of this trial.
This includes a biopsy that might be done if abnormalities are found during the flexible sigmoidoscopy.
INFORMATION ON NEW FINDINGS
I understand that any significant new findings about screening for these cancers discovered during the
term of the study will be given to me if that information will make a difference in my willingness to
continue in the study.
CONFIDENTIALITY
Information concerning my participation in the study will be kept private under the Privacy Act and used
only for scientific purposes, in accordance with applicable state and federal laws. As the tests to be
carried are for research purposes only, no results from these tests will be placed in my medical records or
linked to my name. In order to protect the privacy of my samples, they will be stored and used for medical
research by code number only and no one who has access to my name will have access to the coded test
results for me. No individual will be identified in any report.
RIGHT TO WITHDRAW
My participation in the additional medical research is voluntary and I may refuse to participate and/or
withdraw my consent and discontinue participation at any time without penalty or loss of benefits to
which I am otherwise entitled. I may participate in the screening part of the PLCO Trial and yet decline to
have biologic samples stored for research purposes. Further, if I initially decide to have my biologic
samples stored for research purposes, but later change my mind by written notification of Dr. __________
at __________ University Medical Center, whatever remains of my biologic samples will then be
destroyed. My decision will not affect my care.
PERMISSION TO REVIEW MEDICAL RECORDS
I understand that, by agreeing to participate, I give permission for my doctors and hospitals where I have
been seen to release my medical records to the study investigators.
CERTIFICATION
I have read this form or it has been read to me and I understand its contents. Any questions concerning the
research or the rights of the participants involved have been and will be answered by NAMES, TITLES,
PHONE NUMBERS.

Consent page 5

A copy of this consent form has been given to me. My signature below means that I freely agree to
participate in this study.
Please read the two sentences below and circle your responses (Yes/No).
By signing this document, I agree to have biologic samples (some of my blood or saliva and possibly
surgical tissue) stored for future research on cancer.
YES

By signing this document, I agree to have biologic samples (some of my blood or saliva and possibly
surgical tissue) stored for future research on diseases and conditions other than cancer that affect my
age group.
YES

PARTICIPANT'S NAME (PRINT)

PARTICIPANT'S SIGNATURE DATE

Witness (if necessary)
WITNESS SIGNATURE
[ ] = Optional Phrase

Consent page 6

<> <>
<>
<>, <> <>
Dear <> <>:
In order to complete your records, we need to request copies of specific diagnostic and treatment
information, pathology slides, or tissue blocks for <> cancer(s) from your
physician(s) and/or medical institution(s). To allow us to obtain these records, please sign and date the
authorization form(s) included with this letter and return one copy to us in the enclosed postage paid
envelope.
The information we collect will be used for the Prostate, Lung, Colorectal, and Ovarian (PLCO) Cancer
Screening Trial Extended Follow-up Study being conducted for the National Cancer Institute by the
Central Data Collection Center (CDCC), Westat. Any information we obtain from your records will be
kept private under the Privacy Act, and will not be disclosed to anyone but the researchers conducting
this study, except as otherwise required by law.
Please note:
1) If you were diagnosed with 2 or more cancers a separate authorization form needs to be signed
for each type of cancer.
2) Please fill in the name of the physician and/or institution where you received diagnosis and
follow-up treatment.
3) Please print your name, sign, and date on page 2, and return one copy of each form in the
enclosed postage paid envelope. Keep the second copy of the form(s) for your records.
If you have any questions or concerns, please feel free to contact Chris Miller, Participant Support
Coordinator at the CDCC, toll free at 1 (888) 886-0750 or via Fax toll free at 1-888-251-1690. You can
also send correspondence to the CDCC at the following mailing address: PLCO CDCC Westat, Room GAL60, 1600 Research Blvd., Rockville, MD 20850.
Sincerely,

Barbara O’Brien, MPH
Project Director for PLCO CDCC, Westat

Form Approved
OMB No. 0925-0407
Exp. Date 09/30/2014

PROSTATE, LUNG, COLORECTAL, AND OVARIAN (PLCO) CANCER
SCREENING TRIAL FOLLOW-UP STUDY
CENTRAL DATA COLLECTION CENTER (CDCC)
AUTHORIZATION TO USE OR DISCLOSE HEALTH INFORMATION FOR RESEARCH
Collection of this information is authorized by the Public Health Services ACT, Section 412 (42 USC 285 a-1). Rights of study participants are protected by the Privacy
Act of 1974. Participation is voluntary, and there are no penalties for not participating or withdrawing form the study at any time. Refusal to participate will not
affect your benefits in any way. The information collected in this study will be kept private under the Privacy Act. Names and other identifiers will be separated from
information provided and will not appear in any report of the study. Information provided will be combined for all study participants and reported as statistical
summaries.

Participant Name: <> <>
PID: <>

Date of Birth: <> Gender: <>

Please read this form and provide information listed in this box for the appropriate Medical Provider and/or
institution to contact for your medical records.
Name of the doctor who diagnosed this cancer:___________________________________
Name of the Institution where cancer was diagnosed:
Street Address: _________________<> __________________________
City: _____ <> _________State: _____ <> ___Zip Code:
Telephone: _(<<###>>)_ _<<###>>_ – __

<<####>>___________

Name of the doctor who treated this cancer:___________________________________
Name of the Institution where cancer was treated:
Street Address: _________________<> __________________________
City: _____ <> _________State: _____ <> ___Zip Code:
Telephone: _(<<###>>)_ _<<###>>_ – __ <<####>>___________

I hereby authorize the above referenced medical provider to release my protected health information,
including copies of my medical and hospital records, pathology slides, or tissue blocks related to the diagnosis
and treatment of _______<>______ cancer to research staff at the Central Data Collection
Center (CDCC), Westat, who are working on the study entitled Prostate, Lung, Colorectal and Ovarian (PLCO)
Cancer Screening Trial Extended Follow-up Study. This study is being conducted by the National Cancer
Institute (NCI). My individual health information that may be used or disclosed includes medical health data,
full or abstracted records, slides or tissue blocks released after the date of my signature.
1

Public reporting burden for this collection of information is estimated to average 5 minutes per response, including the time for reviewing instructions, searching
existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. An agency may not conduct or
sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. Send comments
regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to: NIH, Project Branch
Office, 6705 Rockledge Drive, MSC 7974 Bethesda, MD 20892-7974, ATTN: PRA (0925-0407). Do not return the completed form to this address.

Form Approved
OMB No. 0925-0407
Exp. Date 09/30/2014

PROSTATE, LUNG, COLORECTAL, AND OVARIAN (PLCO) CANCER
SCREENING TRIAL FOLLOW-UP STUDY
CENTRAL DATA COLLECTION CENTER (CDCC)
(Continued with Signature on page 2)
It is my understanding that this information will be used for research purposes only and no individual will ever
be identified in any published report. I understand that I may revoke this authorization at any time with
written notification to Chris Miller, Participant Support Coordinator at PLCO CDCC, Westat, 1600 Research
Blvd, Room GA-L60, Rockville, Maryland 20850, to inform the research team of my decision, but that the
revocation will not have any effect on the information released, used or disclosed, or collected by the study
prior to notification of revocation. This authorization does not have an expiration date.
I understand that once my health information is disclosed under this authorization, there is potential for redisclosure of my medical information and my medical information may not be subject to privacy rule
protections; therefore the facility listed above is released from any and all liability resulting from re-disclosure.
I have been informed that I do not have to sign this Authorization. My decision not to sign the Authorization
will not affect any other treatment, payment, or enrollment in health plans, cancer research studies, or
eligibility for benefits.
A photocopy/fax of this authorization will be treated in the same manner as an original.
I am the research participant or personal representative authorized to act on behalf of the participant. I have
read this information and I have received a copy of this authorization form.
_____________________________________
(PARTICIPANT’S SIGNATURE)
_____________________________________
(PRINT PARTICIPANT’S FULL NAME)

________________
(DATE)

_____________________________________
(PERSONAL REPRESENTATIVE’S SIGNATURE)
_____________________________________
(PRINT PERSONAL REPRESENTATIVE’S FULL NAME)

________________
(DATE)

_________________________________________________
(Relationship or authority to act on behalf of the participant)
Reason for Personal Representative Signature:
2

Participant Disabled

Participant Deceased

<> <>
<>
<>, <> <>
Dear <> <>:
As you may know, <> <> was a participant in Prostate, Lung, Colorectal,
and Ovarian (PLCO) Cancer Screening Trial Extended Follow-up Study. In order to complete <>
records, we need to request copies of specific diagnostic and treatment information, pathology slides, or
tissue blocks for <> cancer(s) from <> physician(s) and/or medical
institution(s). To allow us to obtain these records, please sign and date the authorization form(s)
included with this letter and return one copy to us in the enclosed postage paid envelope.
The information we collect will be used for the Prostate, Lung, Colorectal, and Ovarian (PLCO) Cancer
Screening Trial Extended Follow-up Study being conducted for the National Cancer Institute by the
Central Data Collection Center (CDCC), Westat. Any information we obtain from <>
<>’s records will be kept private under the Privacy Act, and will not be disclosed to
anyone but the researchers conducting this study, except as otherwise required by law.
Please note:
1) If <> <>was diagnosed with 2 or more cancers a separate
authorization form needs to be signed for each type of cancer.
2) Please fill in the name of the physician and/or institution where <>
<> received diagnosis and follow-up treatment.
3) Please sign and date on page 2, and return one copy of each form in the enclosed postage paid
envelope. Keep the second copy of the form(s) for your records.
If you are not the personal representative authorized to act on behalf of the participant, have any
questions or concerns, please feel free to contact Chris Miller, Participant Support Coordinator at the
CDCC, toll free at 1 (888) 886-0750 or via Fax toll free at 1-888-251-1690. You can also send
correspondence to the CDCC at the following mailing address: PLCO CDCC Westat, Room GA-L60, 1600
Research Blvd., Rockville, MD 20850.
Sincerely,

Barbara O’Brien, MPH
Project Director for PLCO CDCC, Westat

Form Approved
OMB No. 0925-0407
Exp. Date 09/30/2014

Participant Name: <> <>
PID: <>

Date of Birth: <> Gender: <>

<<####>>___________

I hereby authorize the above referenced medical provider to release <> <>’s protected health information, including copies of <> medical and hospital records,
pathology slides, or tissue blocks related to the diagnosis and treatment of _______<>______ cancer to research staff at the Central Data Collection Center (CDCC), Westat, who are
working on the study entitled Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial Extended
Follow-up Study. This study is being conducted by the National Cancer Institute (NCI). <> <>’s individual health information that may be used or disclosed includes
medical health data, full or abstracted records, slides or tissue blocks released after the date of my signature.
1

Form Approved
OMB No. 0925-0407
Exp. Date 09/30/2014

PROSTATE, LUNG, COLORECTAL, AND OVARIAN (PLCO) CANCER
SCREENING TRIAL FOLLOW-UP STUDY
CENTRAL DATA COLLECTION CENTER (CDCC)

It is my understanding that this information will be used for research purposes only and no individual will ever
be identified in any published report. I understand that I may revoke this authorization at any time with
(Continued with Signature on page 2)
written notification to Chris Miller, Participant Support Coordinator at PLCO CDCC, Westat, 1600 Research
Blvd, Room GA-L60, Rockville, Maryland 20850, to inform the research team of my decision, but that the
revocation will not have any effect on the information released, used or disclosed, or collected by the study
prior to notification of revocation. This authorization does not have an expiration date.
I understand that once <> <>’s health information is
disclosed under this authorization, there is potential for re-disclosure of <> medical information and
<> medical information may not be subject to privacy rule protections; therefore the facility listed
above is released from any and all liability resulting from re-disclosure.
I have been informed that I do not have to sign this Authorization. My decision not to sign the Authorization
will not affect any other treatment, payment, or enrollment in health plans, cancer research studies, or
eligibility for benefits.
A photocopy/fax of this authorization will be treated in the same manner as an original.
I am the personal representative authorized to act on behalf of the participant. I have read this information
and I have received a copy of this authorization form.

_____________________________________
(PERSONAL REPRESENTATIVE’S SIGNATURE)
_____________________________________
(PRINT PERSONAL REPRESENTATIVE’S FULL NAME)

________________
(DATE)

_________________________________________________
(Relationship or authority to act on behalf of the participant)
Reason for Personal Representative Signature:

Participant Disabled

Participant Deceased

Dear Mr./Mrs./Ms.:
We want to thank you for your participation in the Prostate, Lung, Colorectal and
Ovarian (PLCO) Cancer Screening Trial. Your participation has been an important contribution to the
success of this national study. We are writing to you today to inform you that the National Cancer
Institute has decided to continue to follow all participants who enrolled in the Trial for at least five more
years and we are asking your consent to participate in this follow-up.

We are constantly monitoring and analyzing the PLCO data to determine if screening for, and early
detection of, PLCO cancers reduces the number of deaths from these diseases. To answer these important
questions, more information is needed. To collect more data, the National Cancer Institute would like to
continue the PLCO Trial. However, since the active screening part of the Trial has ended, the National
Cancer Institute plans to centralize our data collection efforts. Although we (Screening Center) will still
be involved in the study, a new National Cancer Institute Central Data Collection Center will send you
annual questionnaires to obtain information about your health. We are contacting you to let you know
about this change. Please read the information provided with this letter and complete, sign and date
the last page and return it in the pre-paid envelope.

We very much hope you will decide to continue to participate since we are confident that the additional
information you provide will substantially strengthen the scientific value of this study.

If you have any questions, please contact at
. Again, thank you for continuing to be a part of the PLCO Cancer
Screening Trial.
Sincerely,

Principal Investigator

Dr Christine D. Berg
Project Officer
National Cancer Institute

09-28-10

Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer
Screening Trial
Continued Follow-up Consent Form

Description of Study
You are being asked to participate in centralized follow-up of the Prostate,

Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial. The purpose of

this continued follow-up is to determine if the screening tests reduce deaths
from prostate cancer, lung cancer, ovarian cancer, and cancers of the colon
and rectum. The PLCO extended follow-up will also look for factors which

may cause many types of cancer and other diseases. It is important to

continue to collect more information because it will strengthen the scientific

value of the PLCO Trial and the ability to answer the question if screening for
cancer of the prostate, lung, ovary, colon or rectum reduces deaths from
these diseases.

To collect more information from you, we plan to send your personal
information (for example, date of birth and contact information
including your name and address) to the National Cancer Institute
Central Data Collection Center.

Your participation in PLCO so far
When you joined the PLCO Trial, you were randomized to receive either the
cancer screening tests (intervention group) or your usual medical care

(control group). If you were in the intervention group, you have undergone

up to 6 years of annual screening as part of the PLCO Trial.

09-28-10

All PLCO participants have completed annual health questionnaires.

has, until now, sent these questionnaires and other
mailings, such as the newsletters and cards, to you. If you had surgery for
diagnosis or treatment of cancer or a related condition, may have requested a copy of your medical records to document

your diagnosis and treatment. may also have asked
your doctors and the hospitals where you were treated to provide a small
sample of the tissue that was removed for your diagnosis or treatment.

has also searched state vital statistics databases to
collect information on your health.

Your consent to participate in the PLCO Trial, collection of biologic
specimens and linking your data to other health records for medical
research has been provided in earlier documents. If you did not consent
to these procedures they were not done.

What am I being asked to do?
As a participant in the PLCO Trial, nothing you do will change. The only

difference is that the National Cancer Institute Central Data Collection Center

will do what we have been doing. This will involve
sending your information to the National Cancer Institute Central Data
Collection Center.

What do I have to do?
If you are willing to have your information sent to the National Cancer

Institute Central Data Collection Center please check Option A on the last

page of this consent form, sign and return it in the pre-paid envelope.

09-28-10

Right to Withdraw
1. If you decide that you do not want the National Cancer Institute

Central Data Collection Center to get your information, but you are

willing to have study staff search state health
registries and vital statistics databases to continue to collect

information on your health, please check Option B on the last page

of this consent form, sign and return it in the pre-paid envelope.

2. Your participation in the PLCO study is completely voluntary and you

may refuse to participate and/or discontinue participation at any time

without penalty or loss of benefits to which you are otherwise entitled.
If you wish to completely withdraw from the PLCO study, please

check Option C on the last page of this consent form, sign and
return it in the pre-paid envelope.

Risks
Your participation in the study is completely voluntary. This research

project involves no more than minimal risk and does not affect your health
care benefits or any other benefits you may receive.

Benefits
The study will not provide direct benefit to you other than the satisfaction of
participating in this research for the possible benefit of future generations.

However, your participation will help answer questions related to the health

and longevity of persons in your age group and will help establish a scientific

09-28-10

understanding of the factors which influence the development, and
progression of cancer and other diseases.

Information on New Findings

You will be informed about new information or changes in the study that
may affect your health or your willingness to continue in the Trial.

Confidentiality

The personal information you provide (such as your name, address and date

of birth) will be kept private, under the Privacy Act, and will not be disclosed

or used by anyone other than the PLCO staff and researchers without your

consent. Your personal information can only be given out if required by law

(for example, to Federal and regulatory agencies).

The results of research from the PLCO trial may be presented at meetings or
in published articles. Your name or any other personal information will not
be used.

Who Can Answer My Questions?
You are encouraged to ask questions any time during this research study.
Questions can be addressed to the Project Manager at <> or XXXX,
Principal Investigator at <>.

09-28-10

My Choice
I have read this document or it has been read to me. I understand the

possible risks and benefits of this study. I know that being in this study is
voluntary. I know I can stop being in this study and I will still get usual
medical care.

Please read each sentence below and think about your choice. After reading
each sentence, please check ( ) one of the following Options:
Option A

I agree to continue to participate in the follow-up of the PLCO Trial by having
my information sent to the NCI Central Data Collection Center
Option B
I do not want my personal information sent to the NCI Central Data Collection
Center, but I agree to have study staff search state
health registries and vital statistics databases to continue to collect
information on my health
Option C
I do not want to continue to participate in the PLCO Trial

Signature of Participant or Legally Authorized Representative

DATE

Please sign, date and return this page to in the
pre-paid envelope. Thank you for your participation in PLCO.

File Type	application/pdf
Author	keating_k
File Modified	2012-09-27
File Created	2012-06-04