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pdf O f fi ce o f R es ear c h
INSTITUTIONAL REVIEW BOARD
MEMORANDUM
To:
Yongmei Liu, M.D., Ph.D.
PHS - Epidemiology
From:
Chair, Institutional Review Board
Date:
3/17/2010
Subjec
t:
Expedited Review: IRB00010058
Epigenome-Wide Association Study of DNA Methylation and Atherosclerosis in
the Multi-Ethnics Study of Atherosclerosis (MESA)
This research study qualifies for expedited review under the Federal Regulations [45CFR46.110]. These
regulations allow an IRB to approve certain kinds of research involving no more than minimal risk to
human subjects. The risks of harm anticipated in the proposed research are not greater than those
ordinarily encountered by the general population in daily life or during the performance of routine
physical, laboratory, or psychological exams or tests. [45CFR46.102(i)]. Upon review of the research, the
IRB finds that this study meets the following expedited review category(s):
Category 5 - Research involving materials (data, documents, records, or specimens) that have been
collected, or will be collected solely for non-research purposes (such as medical treatment or diagnosis).
HHS regulations [45CFR46.116(d)] allow an IRB to approve a consent procedure which does not include,
or which alters, some or all of the elements of informed consent or to waive the requirements to obtain
informed consent. The IRB approves the waiver or alteration in the requirement for informed consent for
this study.
HHS regulations [45CFR164.512(i)] allow an IRB to approve the alteration or waiver, in whole or in part,
of the requirement for individual Authorization for the use or disclosure of protected health information.
The IRB approves the waiver or alteration in the requirement for individual authorization because certain
conditions have been met or because the requirement for authorization does not apply.
M e d i c a l C e n t e r B o u l e v a r d , Wi n s t o n - S a l e m , N C 2 7 1 5 7 - 1 0 2 3
( 3 3 6 ) 7 1 6 - 4 5 4 2 / fa x ( 3 3 6 ) 7 1 6 - 4 4 8 0
IRB approval is for a period of 12 months from 3/16/2010. Please notify the Office of Research when the
project is complete.
Thomas Pranikoff, M.D.
2
O f fi ce o f R es ear c h
INSTITUTIONAL REVIEW BOARD
MEMORANDUM
______________________________________________________________________________________
To:
Gregory Burke, M.D.
Public Health Sciences
From:
Chair, IRB # 1
Institutional Review Board
Date:
2/3/2010
Subject:
Human Protocol: BG00-035
Multi-Ethnic Study of Atherosclerosis
Amendment 18 for IRB Study #BG00-035
Study Documents:
Protocol Version: Cardiac Atlas Project , CT MOP exam 5, CueCards.pdf, F8-Air Questionniare - All.pdf,
F8-Medical Conditions MESA 12102007.pdf, Follow Up 10 Air Questionnaire, revised, 06152009, Follow
Up 10 General Health, revised, 06152009, Follow Up 9 Air Questionnaire - Revised Version, Follow Up 9
General Health - Revised Version, Follow Up 9 General Health Death - Revised Version, FU10 English
02092009.pdf, FU8 MESA Form Packet_03282007.pdf, FU9Forms_02072008.pdf, MESA Exam 5
Protocol, MESA RNA Phlebotomy Processing Protocol v.4.9.07.doc, MESA RNA phone script 4-5-07.doc,
MESAGene.exp.prot.version 4.9.07, mesaprot000225-updated.doc; Informed Consent Version: MESA
Exam 5 Consent Form (approved), WFU MARRS Consent Version 4.9.07.doc (approved), WFU MESA
consent, Exam 4, 021406, eirb.doc (approved); Advertisements: Information Session Invitation,
mesabrochure.pdf, recruit lettergbversion.doc, Save the Date Postcard
The Institutional Review Board voted approval of the amendments listed below at its meeting of 2/2/2010.
This action of the full Board does not extend the term of approval for this protocol.
The amendment includes the following:
•
This amendment covers the changes to the GCRC plan, the study protocol and the consent that are
necessary in order to conduct the upcoming MESA fifth exam, which is scheduled to begin in
April.
This IRB is in compliance with the requirements of Part 56, 21 Code of Federal Regulations published as of
April 1994 and Part 46, Subpart A of 45 CFR published January 26, 1981.
Richard Weinberg, M.D.
Medical C enter Bou leva rd, Winst on-Sa lem, NC 27157-1023
(336) 716-4542 / fax (336) 716-4480
O f fi ce o f R es ear c h
INSTITUTIONAL REVIEW BOARD
MEMORANDUM
______________________________________________________________________________________
To:
Gregory Burke, M.D.
Public Health Sciences
From:
Chair, IRB # 2
Institutional Review Board
Date:
3/10/2010
Subject:
Human Protocol: BG00-035
Multi-Ethnic Study of Atherosclerosis
Amendment 20 for IRB Study #BG00-035
Study Documents:
Protocol Version: Cardiac Atlas Project , CT MOP exam 5, CueCards.pdf, Exam 5 Forms, F8-Air
Questionniare - All.pdf, F8-Medical Conditions MESA 12102007.pdf, Follow Up 10 Air Questionnaire,
revised, 06152009, Follow Up 10 General Health, revised, 06152009, Follow Up 9 Air Questionnaire Revised Version, Follow Up 9 General Health - Revised Version, Follow Up 9 General Health Death Revised Version, FU10 English 02092009.pdf, FU11 Forms Packet, FU8 MESA Form
Packet_03282007.pdf, FU9Forms_02072008.pdf, MESA Exam 5 Protocol, MESA RNA Phlebotomy
Processing Protocol v.4.9.07.doc, MESA RNA phone script 4-5-07.doc, MESAGene.exp.prot.version
4.9.07, mesaprot000225-updated.doc; Informed Consent Version: MESA Exam 5 Consent Form 03052010
(approved), MESA Exam 5 Pilot Study Consent Form 03052010 (approved), WFU MARRS Consent
Version 4.9.07.doc (approved), WFU MESA consent, Exam 4, 021406, eirb.doc (approved);
Advertisements: Information Session Invitation, mesabrochure.pdf, recruit lettergbversion.doc, Save the
Date Postcard
The Institutional Review Board voted approval of the amendments listed below at its meeting of 3/9/2010.
This action of the full Board does not extend the term of approval for this protocol.
The amendment includes the following:
•
•
•
A pilot study of all of the previously approved Exam 5 interviews, procedures and scans is
scheduled to be conducted in March 2010. Eight to ten age-appropriate, healthy volunteers will be
examined. In preparation for this pilot study a consent form for the pilot volunteers and a modified
protocol are being submitted for approval.
The forms to be used during the pilot study, Exam 5 and Follow Up 11 are also being submitted
for approval.
The main study consent form has been modified to include a statement about audiorecording of
participant interviews.
Medical C enter Bou leva rd, Winst on-Sa lem, NC 27157-1023
(336) 716-4542 / fax (336) 716-4480
This IRB is in compliance with the requirements of Part 56, 21 Code of Federal Regulations published as of
April 1994 and Part 46, Subpart A of 45 CFR published January 26, 1981.
Gregory Hawkins, Ph.D.
Institutional Review Board
Protocol Number:
Principal Investigator:
Originating Department:
IRB Approval Date:
Expiration Date:
Title:
#IRB-AAAA7791
Steven J Shea
MEDICINE - 527
12/09/2009
12/08/2010
Multi-Ethnic Study of Atherosclerosis
This is to certify that the above noted protocol has been approved by the Columbia University Medical Center IRB and is valid through 12/08/2010.
12/08/2010
https://e-irb.jhmi.edu/eirb/Doc/0/PQQMIP2RASQ4N4Q89AGTURBQAA/fromString.html
Office of Human Subjects Research
Institutional Review
Boards
1620 McElderry Street, Reed Hall, Suite B-130
Baltimore, Maryland 21205-1911
410-955-3008
410-955-4367 Fax
e-mail: jhmirb@jhmi.edu
Date: March 24, 2010
CHANGE IN RESEARCH APPROVAL
Review Type:
Convened
PI Name:
WENDY POST
Study #:
NA_00030361_AM00004951
Study Name:
Multi-Ethnic Study of Atherosclerosis (MESA)
Committee Chair:
RICHARD MOORE
Committee:
JHM-IRB 3
Date of approval: March 9, 2010
The JHM IRB approved the above-referenced Change In Research.
Approval Includes:
1. The addition of the following study team members: Diana Hakakin, Charles Simpson, Elena
Blasco Colmenares, Darshan Dalal, Cheryl Dennison, Bennette Drummond Watts, Eliseo Guallar,
Khurram Nasir, Ana Navas Acien, Laura Samuel, Gordon Tomaselli, Monica Vladut Talor, and Yiyi
Zhang
2. MESA exam 5 protocol , consent form, and exam forms
3. A letter for participants
Study Team Members:
JOAN BATHON, ERIN MICHOS, HOCHANG LEE, CATHERINE CAMPBELL, DAN ARKING, CAROL CHRISTMAN,
DARSHAN DALAL, Diana Hakakian, Theodore Wies, REBECCA GOTTESMAN, NARESH PUNJABI, ROGER
BLUMENTHAL, Raimond Winslow, SUZANNE JAN DE BEUR, CHERYL DENNISON, BRAD ASTOR, BENNETTE
DRUMMOND WATTS, Laura Samuel, PAMELA OUYANG, Yiyi Zhang, ANN MARTZ, LAURENCE MAGDER, KHURRAM
NASIR, Monica Vladut Talor, Tammy Crunkleton, Sheila Odum, Albert Sharrett, BRUCE WASSERMAN, Catherine
Morales, DHANANJAY VAIDYA, ANA NAVAS ACIEN, DANIEL JUDGE, Joao Lima, Manuel Franco, JON GILES, Youfa
Wang, HARRY SILBER, GERALD BLOOMFIELD, GORDON TOMASELLI, Charles Simpson, ELISEO GUALLAR, ELENA
BLASCO COLMENARES, ADRIAN DOBS, ANNABELLE RODRIGUEZ, ANTONIO PAZIN-FILHO, SONIA WATKINS,
MEGAN COYLEWRIGHT, MOYSES SZKLO
https://e-irb.jhmi.edu/eirb/Doc/0/PQQMIP2RASQ4N4Q89AGTURBQAA/fromString.html [3/25/2010 6:07:55 AM]
APPROVAL NOTICE
OFFICE OF THE HUMAN RESEARCH PROTECTION PROGRAM
11000 Kinross Avenue, Suite 102
Campus Mail Code: 169407
www.research.ucla.edu/ohrpp
bATE:
March 17, 2010
TO:
Karol E. Watson, M.D.
Principal Investigator
FROM:
Lawrence E. Wolinsky, DMD, PhD
Chair, Medical Institutional Review Board 1
RE:
UCLA IRB #99-1 1-057-23B
Approved by Expedited Review
(Approval Period from 03/17/20 10 through 09/13/2010)
Multi-Ethnic Study of Atherosclerosis [MESA] [MESA ExamS Pilot Study ExamS and Follow up 11]
Please be notified that the UCLA Institutional Review Board (UCLA IRB) has approved the
above referenced research project involving human subjects in research. The UCLA’s
Federalwide Assurance (FWA) with the Department of Health and Human Services, Office for
Human Research Protections is FWA00004642.
Approval Signature of the UCLA IRE Chair
PRINCIPLES TO BE FOLLOWED BY PRINCIPAL INVESTIGATORS:
As the Principal Investigator, you have ultimate responsibility for the conduct of the study, the
ethical performance of the project, the protection of the rights and welfare of human subjects, and
strict adherence to any stipulations imposed by the UCLA IRE. You must abide by the following
principles when conducting your research:
1. Ensure that the personnel performing the study are qualified and appropriately trained,
key personnel have completed the CITI training program and will adhere to the provisions of
the approved protocol.
APPROVAL NOTICE
IRB #99-1 1-057-23B
2. Implement no changes in the approved protocol or consent process or documents without
prior UCLA IRB approval (except in an emergency, if necessary to safeguard the well-being
of human subjects and then notif~’ the IRB as soon as possible afterwards.)
3. Obtain the legally effective informed consent from human subjects or their legally
authorized representative (when approved), and use only the currently approved consent
process and stamped consent documents, as required by the IRB.
4. Report unanticipated problems related to the protocol to the IRB in writing within the
appropriate time period (2 days to 10 working days).
5. Assure that adequate resources to protect research subjects (i.e., personnel, funding, time,
equipment and space) are in place before implementing the research project, and that the
research will stop if such resources become unavailable.
6. Arrange for a co-investigator to assume direct responsibility of the study if at any time you
will be unavailable to direct this research personally, for example, when on sabbatical leave
or vacation or other absences. Either this person is named as a co-investigator on this
application, or you will advise the IRB by letter in advance of such arrangements.
FUNDING SOURCE(S):
According to the information provided in your application, the funding source(s) for this research
project may include the following: extramural.
PT of Contract/Grant,:
Funding Source:
Contract/Grant No:
Contract/Grant Title:
Karol Watson
National Heart, Lung, and Blood Institute
NO 1 -HC-95 160
P1 of Contract/Grant:
Funding Source:
Contract/Grant No:
Contract/Grant Title:
Adrian Casillas
University of Washington
RD83 169701
PT of Contract/Grant:
Funding Source:
Contract/Grant No:
ContracVGrant Title:
Michael Criqui
National Heart, Lung, and Blood Institute
RO 1 HL72403
Aortic Calcium Epidemiology and Progression
PT of Contract/Grant:
Funding Source:
Contract/Grant No:
Contract/Grant Title:
Graham Barr
National Heart, Lung, and Blood Institute
Pending
Subclinical Cardiovascular Disease Study
Prospective Study Atherosclerosis, Clinical Cardiovascular Disease, and Long Term
Exposure to Ambient Particulate Matter and Other Air Pollutants in a Multi-Ethnic
Cohort
Pilmonary Vascular Changes in Early COPD
P1 of Contract/Grant: Karol Watson
APPROVAL NOTICE
IRB #99-1 I-057-23B
Funding Source:
Centers for Disease Control and Prevention
Contract/Grant No: 20063135
Contract/Grant Title: MESA Occupational Coding Substudy-UCLA
P1 of Contract/Grant: Joao Lima
Funding Source:
National Heart, Lung, and Blood Institute
Contract/Gtant No: pending
Contract/Grant Title: Regional Dysfunction by MRI in Incident Heart Failure
P1 of Contract/Grant:
Funding Source:
Contract/Grant No:
Contract/Grant Title:
Ana Diaz Roux
National Heart, Lung, and Blood Institute
HL08783 1
Socioeconomic Patterning of Inflammation and Hemostasis
Page 1 of 10
Fifth Exam (Pilot)
University of California, Los Angeles
I
Multi-Ethnic Study of Atherosclerosis (MESA)
—
Fifth Exam (Pilot)
i
CQNSENT TO PARTICIPATE IN RESEARCH
INTRODUCTION
You are invited to participate in a pilot study of the Multi-Ethnic Study of Atherosclerosis
(MESA) fifth examination, a research study sponsored by the National Heart, Lung, and
Blood Institute and conducted by Karol Watson, MD, Christine Darwin, MD, Arleen
Brown, MD, Deborah Kado, MD, and Preethi Srikanthan, MD, from the Department of
Medicine and Antoinette Gomes, MD, from the Department of Radiology at the
University of California, Los Angeles. The National Eye Institute and the US
Environmental Protection Agency are also supporting certain study components.
MESA is a multi-center study which includes approximately 6,800 participants and is
being conducted at six centers across the country. The UCLA center enrolled
approximately 1,300 participants belonging to four ethnic groups (Whites, AfricanAmericans, Hispanics, and Chinese Americans). The first MESA examination took
place in the period July 2000 August 2002. The second examination was performed in
the period September 2002 December 2003, the third examination took place March
2004 August 2005. The fourth examination took place in the period September 2005
May 2007. You are invited to participate in a pilot for the fifth examination that will talce
place in the period MarcH 2010.
—
—
—
—
Your participation in this pilot 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.
•
PURPOSE OF THE STUDY
The main purpose of MESA is to study heart disease and diseases of the blood vessels
beginning in the early stages. People who may have early heart disease, known as “sub
clinical” heart disease, may not know it because they feel well. MESA is studying why
some people develop clinical conditions such as heart attack, heart failure, and stroke. In
order to learn this information, the people in the study are being followed for many years.
Over time, MESA has studied other conditions, such as lung disease and rheumatoid
arthritis, and will likely include other conditions in the fhture.
The purpose of the pilot study is to help study investigators assess preparedness for the
actual fifth examination.
APPROVED
MAR 1 7 2010
flfl..11flR7..236
UCLA 1004#
I~LJ
I I
Expiration Date: SEP 132010
UCLA MEDICAL
INSTITUTIONAL
REVIEW BOARD
Fifth Exam (Pilot)
Page 2 of 10
PROCEDURES
If you decide to participate in the pilot study, you will be asked to undergo an
examination which will require 6 9 hours and will be performed over one or two days.
All the procedures described below will be performed at the UCLA Research Center in
Athambra, except the electron beam computed tomography (EBCT) and the magnetic
resonance imaging (Mifi) which will be performed in the Department of Radiology at
UCLA’s main campus.
—
If you volunteer to participate in this pilot study, we will ask you to do the following
things:
1. Physical Examination: You will undergo a limited physical exam in which your
blood pressure, height, weight, and body size will be measured. A small sensor
device will be placed on your finger to measure the amount of oxygen in your blood
(this brief test will done without using supplementary oxygen if you use that).
2. Health Interviews: You will be asked questions concerning previous illnesses,
hospitalizations, diet, physical activity, social issues, and use of tobacco, alcohol, and
medications.
3. Ankle-Attn Blood Pressure: This test involves measuring blood pressure in both
arms and legs.
4. Fasting blood samples will be collected to measure blood sugar, blood fats
(including cholesterol) and other substances related to the risk of disease. You may
have up to 90 niL (3 ounces or 6 tablespoons) of blood drawn for these tests. Samples
will also be frozen and stored indefmitely for future analysis. Samples may also be
frozen and stored for additional assessment of pilot sample apd testing quality
assurance.
5. Urine will be collected for analysis. Approximately one cup will be collected, and
may be frozen and stored for additional assessment of pilot sample and testing quality
assurance.
6. Electrocardiogram (ECG or EKG): This is a recording of the electrical activity of
your heart. Electrodes will be placed on the skin of your chest, arms, and legs for this
test.
7. Eye Exam: The purpose of this test is to find out how well you see at a distance and
to take photographs of the back of your eyes to look at the blood vessels. We will ask
you some questions about how well you see. We will then measure your vision. If
you use glasses, we will ask you to take them off for the test and the prescription of
your glasses will be measured. If you wear contact lenses, we will not ask you to take
them out. We will then darken the room and place a special camera close to your eyes
APPROVED
UCLAIRS# 9g~11-057-23B
Exp~raUofl Date: SEP 132010
MAR 1 7
2010
MEDICAL
.NSTITUTIONAL REVIEW BOARD
Page 3 of 10
to photograph the back (retina) of both of your eyes. No eye drops will be used and
the camera will not touch your eyes. There will be a flash of light when the pictures
are taken.
Fifth Exam (Pilot)
In addition, you are asked to undergo the procedures next to the checked boxes:
D
Magnetic Resonance Imaging (MN): Pilot participants may be asked to undergo an
MRI scan of the heart. The MRT exam will evaluate the size and function of your
heart and nearby blood vessels. For this thcaxn, you will need to lie still on a table and
will be moved into a large device that takes pictures of your heart using magnetic
fields. The exam takes 45-60 minutes. If you are a woman of childbearing age, you
will have a pregnancy test to make sure that you are not pregnant before having
the MN.
D
MRI with Gadolinium: All participants who have the MRI exam and who have
good kidney function will be asked to receive gadolinium as part of the test.
Gadolinium is an FDA approved contrast agent that allows us to see the heart and
blood vessels better. It is given via a regular intravenous (IV) line, which will be
placed in your arm before the test. If you agree to receive gadolinium, we will test
your lcidney function before the MRI to check that it is safe for you.
D
Computed Tomography (CT) of the Arteries of the Heart: Pilot participants may
be asked to undergo a CT scan. The CT scan is a special type of x-ray examination
that is done to measure the amount of calcium in the arteries of your heart. You will
be asked to lie on a table with just the upper part of your body inside the CT scanner.
You will need to remain still and hold your breath for about 10-20 seconds during the
test. If you are a woman of childbearing age, you will have a pregnancy test to
make sure that you are not pregnant before having the CT scan.
D
Carotid Ultrasound: Pilotparticipants may be asked to undergo an ultrasound scan
of the arteries in the neck. Ultrasound will be used to measure the size and function
of the carotid arteries, which are the large arteries in the neck. You will be asked to
lie on a table for this test. Gel will be applied to the skin on your neck and a small
hand-held probe will be used to examine the carotid arteries on both sides of the neck.
D
Spirometry: Pilot participants may be asked to participate in spirometry testing.
Spirometry measures your lung function. It involves breathing into and out of a tube
as hard and as fast as you can, three or more times. A new, clean mouthpiece is used
for each participant. Pilot participants selected for this test will be administered an
inhaled bronchodilator medication (albuterol), which opens up the air passages, and
repeated spirometry testing. You will be asked some questions to assure your safety
for spirometry and albuterol. Spirometry takes approximately 20 minutes.
D
Computed Tomography (CT) of the Lungs: Pilot participants who have spirometry
and undergo a CT of the heart may also be asked to undergo CT of the lung. The CT
UCLA IRB# 99-11-057-238
Expiration Date: SEP 132010
MAR 1 7 2010
UCLA MEDICAL
NSTITIJrIONAL REVIEW BOARD
Fifth Exam (Pilot)
Page 4 of 10
scan is a special type of x-ray examination that is done to measure any amount of
emphysema in your lungs. You will be asked to lie on a table with just the upper part
of your body inside the CT scanner. You will need to remain still and hold your
breath for about 10-20 seconds during the test. If you are a woman of childbearing
age, you will have a pregnancy test to make sure that you are not pregnant
before having the CT scan.
D
Six minute walk: Two hundred participants in the MESA Lung Study or who have
lung disease will be asked to perform this test. You will be asked to walk for 6
minutes on a level surface to see how far you can go. If you use oxygen when you
walk, you will use it for this test.
D
If you have one of the imaging tests listed above, you will receive a report listing the
main finding (for example, amount of calcium in the arteries of the heart). The scan will
be reviewed in case there are other findings that may have a major and significant impact
on your health. In the unusual case of such a finding being present, it will be reported to
you and, if you wish, your physician.
Sharing of Data and Samples
Use of data and samples:
o
Samples and data sent to other laboratories will be labeled only with a code
number. No standard information that identifies you, such as your name, date of
birth, address, etc., will be available to other researchers.
Potential Risks and Discomforts
•
Clinic Exam: The procedures used in this study are considered to be safe. The risks
associated with the clinic exam are minimal.
•
Blood Draw: Risks of drawing of a blood sample are discomfort at the site of needle
insertion, bruising (black and blue discoloration) or inflammation at the site, and
rarely, faintness. The bruise is usually painless and disappears within a few days.
•
EKG: Minor skin irritation may occur where the EKG leads are placed on the skin.
•
Eye Exam: There are no known risks associated with taking a photograph of the eye.
People who are light sensitive may experience some minor discomfort from the
camera flash. After the pictures are taken, you may see a blue or red spot which will
disappear within 5 to 7 minutes and which causes no damage to the eye.
APP~OV~bfl
MAR i 7 2010
UCLA IRS # 99-11-057
Expiration Date: SEP 132010
UCLA MEDICAL
.
NSTITUTIONAL REVIEW BOARD
Fifth Exam (Pilot)
Page 5 of 10
• Data Sharing: MESA takes extensive efforts to protect your identity and privacy.
Yet, because of the large amount of information collected about you, we cannot
absolutely guarantee that information about you will never become known.
However, researchers are strictly prohibited from attempting to identify you.
D
MIII: The MRI machine does not use ionizing radiation (like x-rays). Instead, it uses
a strong magnet and radio waves to generate pictures of the body. The procedure is
associated with minimal risk. You will need to wear earplugs or earphones since the
machine can produce high noise levels, which may be uncomfortable. With earplugs,
the risk to. hearing is insignificant. Some people may experience psychological
discomfort in the scanner if they are uncomfortable in tight places (known as
claustrophobia). You will be able to speak directly to the MRI technologist at all
times, and the examination will be stopped at any time upon your request.
D
MRI with gadolinium: This contrast agent is generally safe. There is a small risk of
allergic reaction afier the gadolinium injection, with less than a one in 300,000 chance
that this will be severe. There is also a smaller risk of nephrogenic systemic fibrosis,
a potentially serious and rare skin condition that can occur in patients with kidney
problems. We will guard against this risk by checking your kidney function prior to
the MEl and will not give gadolinium if you have low kidney function. Metallic taste
in the mouth, tingling in the arm, nausea, or headache occurs in less the 1% (less than
1 in 100) people. Insertion of the needle may also cause minor pain, bruising and/or
infection at the injection site.
D
Computed Tomography of the heart: The CT scan uses x-rays to make pictures.
The amount of radiation you will be exposed to during the CT scanning is less than 3
mSev, which is 6% of the yearly on-the-job exposure allowed radiation workers.
Another way of understanding this is to compare the exposure from the CT to the
radiation exposure you receive on average from natural sources. The radiation
exposure from the CT scanning is approximately the amount of natural background
radiation that the average person in the United States receives each year. The
radiation in this study is not expected to measurably increase your risk of cancer. The
potential lifetime cancer risk associated with the above estimated radiation is less than
3 per 10,000.
D
Computed Tomography of the lung: The CT scan uses x-rays to make pictures.
The amount of radiation you will be exposed to during the CT scanning is less than
6.5 mSev, which is 12% of the yearly on-the-job exposure allowed radiation workers.
Another way of understanding this is to compare the exposure from the CT to the
radiation exposure you receive on average from natural sources. The radiation
exposure from the CT scanning is approximately the amount of natural background
radiation that the average person in the United States receives in two years. The
radiation in this study is not expected to measurably increase your risk of cancer. The
potential lifetime cancer risk associated with the above estimated radiation is less than
APPROVED
MAR
UCLA IRB # 99-1
1-057-23B
Expiration Date: SEP 132010
1
7 2010
UCLA MEDICAL
NSTITUTIONAL REVIEW BOARD1
Fifth Exam (Pilot)
Page 6 of 10
6 per 10,000. If you are also receiving a CT scan of the heart, the lung scan will be
one minute or less of additional scanning time.
[1
Spirometry. Minimal or no risk. Occasionally after receiving the albuterol inhaler, a
temporary sensation of “heart racing” and shakiness may develop. This will resolve
quickly.
El
Discomfort of Interviews: It is possible that some of the questions asked during the
interviews may cause you to feel uncomfortable or embarrassed. You do not have to
answer any questions that you do not wish to answer.
All of the tests, particularly imaging studies (Mifi and CT), may identi~j abnormalities
for which you may be recommended to have additional testing. You will be referred to
your own doctor for follow-up of all medical inform~tion obtained by the study and you,
or your insurance company, will be responsible for those costs. MESA will not pay for
these tests.
•
ANTICIPATED BENEFITS TO SUBJECTS
This study is not designed to benefit you directly. Nonetheless; one benefit of
participating in this study is that a free evaluation of your health will be performed.
Information from the tests will be available to you and to your doctor. If a health
condition is detected during this evaluation, your doctor or clinic will be notified, if you
authorize the study staff to do so. However, please keep in mind that these tests are being
performed for research purposes and are not intended to diagnose any specific medical
condition. Additionally, MESA is not intended to provide medical care or interfere with
your relationship with your own doctor. You will be referred to your own doctor for
follow-up of all medical information obtained by the study. If you do not have a local
doctor, you can be referred to one.
•
ANTICIPATED BENEFITS TO SOCIETY
This study may help increase scientific knowledge about the characteristics and factors
associated with subclinical atherosclerosis and its progression.
•
ALTERNATIVES TO PARTICIPATION
The alternative is not to participate.
•
INFORMATION ABOUT YOUR SAMPLE
On the checklist at the end of this consent form you are asked to let us know if you would
like to receive general information about the results of this, study. There is also a
checklist for you to indicate whether you wish to release the results of the research tests to
your personal doctor. You may also choose not to receive any information about the
MAR 1 7 2010
)~at~ ~
Page 7 of 10
results of this study and not to release study results to your personal doctor. Obtaining
general information from a project may take years.
Fifth Exam (Pilot)
•
FINANCIAL OBLIGATION
Neither you nor your insurance company will be billed for your participation in this
research.
•
PAYMENT FOR PARTICIPATION
You will be reimbursed $50 at the end of each visit. The total reimbursement will be up
to $100.
•
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 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 individuals involved in
the research and, if you authorize, your personal doctor and nurses. You may be asked
for your personal information. This information, along with your name, will be sent to
the MESA Coordinating Center at the University of Washington, where it will be stored
in a secure database and who will use the information to send you lab results and to help
us to reach you if we lose touch.
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).
This research is covered by a Certificate of Confidentiality issued by the Department of
Health and Human Services (DHHS). This Certificate will protect the investigators from
being forced to release any research data in which you are identified, even under a court
order or subpoena. Disclosure will be necessary, however, upon request of DHHS for
audit or program evaluation purposes.
This protection, however, is not absolute. A Confidentiality Certificate does not prevent
you or a member of your family from voluntarily releasing information about yourself or
your involvement in this research. Note however, that if an insurer or employer learns
abut your participation and obtains your consent to receive research information, then the
investigator may not use the Certificate of Confidentiality to withhold this information.
This means that you and your family must also actively protect your own privacy.
APP~Cva
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Expiration Date: SEP 132010
MAR 1 7 2010
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PARTICIPATION AND WITHDRAWAL
Your participation in this research is VOLUNTARY. If you choose not to participate, that
will not affect your relationship with UCLA (or 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. If you become ill during the research, you may have to drop
out, even if you would like 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.
•
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 Dr. Karol Watson, Dr. Christine Darwin,
Dr. Arleen Brown, Dr. Deborah Kado or Dr. Preethi Srikanthan during office hours at
626-979-4920, 330 S. Garfield Ave., Suite 308, Aihambra, CA 91801.
After office hours or if you have an emergency, you can page the study doctors by calling
the UCLA Page Operator at 310-825-6301 and ask them to page one of the study doctors.
•
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, 11000
Kinross Ave Suite 102, UCLA Box 951694, Los Angeles, CA 90095-1694, (310) 8258714.
I
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 Subjeëfs Bill
of Rights.
UCLA IRB# 99-11-057-23B
Expiration Date: SEP 132010
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BY SIGNING THIS FORM, I WILLINGLY AGREE TO PARTICIPATE IN THE
RESEARCH IT DESCRIBES.
Name of Subject
Signature of Subject
Date
I PERMISSION TO RELEASE RESULTS TO YOUR PERSONAL DOCTOR
I
Please indicate by checking and initialing the category below whether you want the
results of your tests sent to your personal doctor:
U
U
I want to have the results sent to my doctor.
I do not want the results sent to my doctor
Consent for Use of Gadolinium for the MM of the Heart
I agree to have the gadolinium injection as part of the MM scan of my heart
LI
LI
Yes, I consent to the gadolinium injection
No, I do not wish to have the gadolinium injection
Consent for Lung Substudy
I agree to participate in the Lung Substudy to study lung structure and function and their
impact on the heart. I understand that the results of spirometry and the CT scan of the
lung will be bent to me and, if I so indicated above, to my physician. I also understand
that information and samples that I have previously provided or may subsequently
provide to MESA (for example, responses to questionnaires, data from CT scans, and
genetic materials) may be analyzed for studies of lung disease in MESA.
LI Yes, I consent to participant in the Lung Substudy
LI No, I do not wish to participant in the Lung Substudy
Consent for MESA COPD Substudy
I agree to participate in the COPD Substudy, which includes the breathing test, six minute
walking test, CT scan of the lung and the gadolinium injection as part of the MRI scan of
my heart. The purpose of this substudy is to study the blood vessels in the lung. I
understand that the breathing test will help determine my eligibility for this substudy, and
that the results of spirometry and the CT scan of the lung will be sent to me and, if I so
indicated above, to my physician. I also understand that information and samples that I
have provided or may in the future provide to MESA (for example, responses to
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questionnaires, data from CT scans, and genetic materials) may be analyzed for studies of
lung disease in MESA.
D
D
Yes, I consent to participant in the MESA COPD Substudy
No, I do not wish to participant in the MESA COPD Substudy
With my signature I also am giving permission for my hospital andlor health clinic to
release any of my health records that MESA needs and requests. This permission has no
expiration date.
INFORMATION REGARDING FUTURE STUDIES
Please indicate by checking and irdtialing the category below whether you permit us to
contact you regarding future studies:
U
El
I agree to be contacted about future studies.
.1 do not want to be contacted about future studies.
SIGNATURE OF INVESTIGATOR
I have explained the research to the subject and answered all of his/her questions. I
believe that he/she understands the information described in this document and freely
consents to participate.
Name of Investigator
Signature of Investigator
Date (must be the same as subject’s)
APPWOv~
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UCLA IRE # 99-11-057-233
Expiration Date: SEP 132010
UCLA MEDICAL
NSTITIJTIONAL REVIEW BOARD
UNIVERSITY OF CALIFORNIA LOS ANGELES
RESEARCH PARTICIPANT’S
BILL OF RIGHTS
These rights are the rights of every person who is asked to be in a medical research
study. As a research participant, I have the following rights:
1. I have the right to be told what the research is trying to find out.
2. I have the right to be told about all research procedures, drugs, and/or devices and
whether any of these are different from what would be used in standard practice.
3. I have the right to be told about any risks, discomforts or side effects that might
reasonably occur as a result of the research.
4. I have the right to be told about the benefits, if any, I can reasonably expect from
participating.
5. I have the right to be told about other choices I have and how they may be better or
worse than being in the research. These choices may include other procedures,
drugs or devices.
6. I have the right to be told what kind of treatment will be available if the research
causes any complications.
7. I have the right to have a chance to ask any questions about the research or the
procedure. I can ask these questions before the research begins or at any time
during the research.
8. I have the right to refuse to be part of the research or to stop at any time. This
decision will not affect my care or my relationship with my doctor or this institution in
any other way.
9. I have the right to receive a copy of the signed and dated written consent form for the
research.
10. I have the right to be free of any pressure as I decide whether I want to be in the
research study.
If I have any questions or concerns I can ask the researcher or the research assistant. I
can also contact the UCLA Office of the Human Research Protection Program (OHRPP)
which helps protect research study participants. I can reach the OHRPP by calling 310825-8714 from 8:00 AM to 5:00 PM, Monday to Friday. If I call this office and do not
speak English or Spanish, I should have someone available who can interpret for me. I
may also write OHRPP, 11000 Kinross Avenue, Suite 102, Box 951694, Los Angeles,
CA 90095-1694.
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University of California, Los Angeles
Ii
Multi-Ethnic Study of Atherosclerosis (MESA)
•
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i
Fifth Exam
CONSENT TO PARTICIPATE IN RESEARCH
INTRODUCTION
You are invited to continue to participate in the Multi-Ethnic Study of Atherosclerosis
(MESA), a research study sponsored by the National Heart, Lung, and Blood Institute and
conducted by Karol Watson, MD, Christine Darwin, MD, Arleen Brown, MD, Deborah
Kado, MD and Preethi Srikanthan, MD, from the Department of Medicineand Antoinette
Gomes, MD, from the Department of Radiology at the University of California, Los
Angeles. The National Eye Institute and the US Enviromnental Protection Agency are
also supporting certain study components.
MESA is a multi-center study which includes approximately 6,800 participants and is
being conducted at six centers across the country. The UCLA center enrolled
approximately 1,300 participants belonging to four ethnic groups (Whites, AfricanAmericans, Hispanics, and Chinese Americans). You participated in the first MESA
examination in the period July 2000
August 2002. The second examination was
performed in the period September 2002 December 2003, the third examination took
place March 2004 August 2005. The fourth examination took place in the period
September 2005 May 2007. Now you are invited to participate in the fifth examination
that will take place in the period April 2010— April 2012.
—
—
—
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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.
•
PURPOSE OF THE STUDY
The main purpose of MESA is to study heart disease and diseases of the blood vessels
beginning in the early stages. People who may have early heart disease, known as “sub
clinical” heart disease, may not know it because they feel well. MESA is studying why
some people develop clinical conditions such as heart attack, heart failure, and stroke. In
order to learn this information, the people in the study are being followed for many years.
Over time, MESA has studied other conditions, such as lung disease and rheumatoid
arthritis, and will likely include other conditions in the future.
• PROCEDURES
If you decided to continue your participation in the study, you will be asked to undergo an
examination which will require 6 9 hours and will be performed over one or two days.
—
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All the procedures described below will be performed at the UCLA Research Center in
Alhambra, except the electron beam computed tomography (EBCT) and the magnetic
resonance imaging (MRI) which will be performed in the Department of Radiology at
UCLA’s main campus.
If you volunteer to participate in this study, we will ask you to do the following things:
1. Physical Examination: You will undergo a limited physical exam in which your
blood pressure, height, weight, and body size will be measured. A small sensor
device will be placed on your finger to measure the amount of oxygen in your blood
(this brief test will done without using supplementary oxygen if you use that).
2. Health Interviews: You will be asked questions concerning previous illnesses,
hospitalizations, diet, physical activity, social issues, and use of tobacco, alcohol, and
medications.
3. Ankle-Arm Blood Pressure: This test involves measuring blood pressure in both
arms and legs.
4. Fasting blood samples will be collected to measure blood sugar, blood fats
(including cholesterol) and other substances related to the risk of disease You may
have up to 90 niL (3 ounces or 6 tablespoons) of blood drawn for these tests. Samples
will also be frozen and stored indefinitely for future analysis.
5.
6. Urine will be collected for analysis. Approximately one cup will be collected, and
will be frozen and stored for future analyses.
7. Electrocardiogram ~ECG or EKG): This is a recording of the electrical activity of
your heart. Electrodes will be placed on the skin of your chest, arms, and legs for this
test.
8. Eye Exam: The purpose of this test is to find out how well you see at a distance and
to take photographs of the back of your eyes to look at the blood vessels. We will ask
you some questions about how well you see. We will then measure your vision. If
you use glasses, we will ask you to take them off for the test and the prescription of
your glasses will be measured. If you wear contact lenses, we will not ask you to take
them out. We will then darken the room and place a special camera close to your eyes
to photograph the back (retina) of both of your eyes. No eye drops will be used and
the camera will not touch your eyes. There will be a flash of light when the pictures
are taken.
In addition, you are asked to undergo the procedures next to the checked boxes:
D
Magnetic Resonance Imaging (MRI): All participants who had this test during the
first MESA exam will be asked to repeat the MRI during the present exam. The MEd
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exam will evaluate the size and function of your heart and nearby blood vessels. For
this exam, you will need to lie still on a table and will be moved into a large device
that takes pictures of your heart using magnetic fields. The exam takes 45-60 minutes.
If you are a woman of childbearing age, you will have a pregnancy test to make
sure that you are not pregnant before having the MR[.
LI
MRI with Gadolinium: All participants who have the MEl exam and who have
good kidney function will be asked to receive gadolinium as part of the test.
Gadolinium is an FDA approved contrast agent that allows us to see the heart and
blood vessels better. It is given via a regular intravenous (IV) line, which will be
placed in your arm before the test. If you agree to receive gadolinium, we will test
your kidney fhnction before the MEl to check that it is safe for you. If you are a
woman of childbearing age, you will have a pregnancy test to make sure that you
are not pregnant before having the MM.
LI
Computed Tomography (CT) of the Arteries of the Heart: Approximately half of
MESA participants will have this test. The CT scan is a special type of x-ray
examination that is done to measure the amount of calcium in the arteries of your
heart. You will be asked to lie on a table with just the upper part of your body inside
the CT scanner. You will need to remain still and hold your breath for about 10-20
seconds during the test. If you are a woman of childbearing age, you will have a
pregnancy test to make sure that you are not pregnant before having the CT
scan.
LI
Carotid Ultrasound: Approximately one half of MESA participants will have this
test. Ultrasound will be used to measure the size and function of the carotid arteries,
which are the large arteries in the neck. You will be asked to lie on a table for this
test. Gel will be applied to the skin on your neck and a small hand-held probe will be
used to examine the carotid arteries on both sides of the neck.
LI
Spirometry: Participants who previously participated in the MESA Lung Study will
be selected to participate in spirometry testing. Spirometry measures your lung
function. It involves breathing into and out of a tube as hard and as fast as you can,
three or more times. A new, clean mouthpiece is used for each participant. About
one in five participants will be selected on the basis of the spirometry results for an
inhaled bronchodilator (albuterol), which opens up the air passages, and repeated
spirometry testing. You will be asked some questions to assure your safety for
spirometry and albuterol. Spirometry takes approximately 20 minutes.
LI
Computed Tomography (CT) of the Lungs:
Participants who previously
participated in the MESA Lung Study will have this test, many of whom will also get
the CT of the heart. The CT scan is a special type of x-ray examination that is done to
measure any amount of emphysema in your lungs. You will be asked to lie on a table
with just the upper part of your body inside the CT scanner. You will need to remain
still and hold your breath for about 10-20 seconds during the test.1 If
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woman of childbearing age, you will have a pregnancy test to make sure that you
are not pregnant before having the CT scan.
~ Six minute walk: Two hundred participants in the MESA Lung Study or who have
lung disease will be asked to perform this test. You will be asked to walk for 6
minutes on a level surface to see how far you can go. If you use oxygen when you
walk, you will use it for this test.
If y~u have one of the imaging tests listed above, you will receive a report listing the
main finding (for example, amount of calcium in the arteries of the heart). The scan will
be reviewed in case there are other findings that may have a maj or and significant impact
on your health. In the unusual case of such a finding being present, it will be reported to
you and, if you wish, your physician.
Follow-Up Information (Phone and Mail contact)
We will continue to contact you by phone every 6-9 months and ask you about your
health since the last contact. If you are unable to answer questions yourself, we may
contact a person you have named who could answer questions for you. If you are
hospitalized or admitted to a convalescent or nursing home, we will ask that institution
for your records. We will review the records to determine the reason for your admission
and your diagnosis. We may request records from your doctor for certain office or clinic
visits to determine if you have been diagnosed with one of the diseases that MESA is
studying. We may also request Medicare records.
DNA Testing
Genetics, or the study of genes and gene products, has progressed rapidly since MESA
began. If you gave your permission at an earlier exam, MESA collected DNA, the
material that contains the genes, from your blood samples and stored it at that time. Your
DNA is used to try to learn who is at increased (or decreased) risk of heart disease, stroke,
or other diseases. MESA is looking at specific genes and also at a wide sampling of
participants’ DNA. MESA is also looking at a substance called RNA, which is closely
related to DNA and may help to understand how genes work. If you agree, MESA will
collect more DNA and prepare cell lines from your blood sample in this examination and
allow researchers to potentially read almost all of people’s genetic code. Cell lines are
blood cells that have been treated so they will live for long periods of time.
Researchers will read your genetic code looking for genes for heart disease and related
conditions. They may also occasionally read genes that have variations known to cause
other rare but serious diseases. Most people have versions of these genes that are safe
and cause no disease; however, a small number of people may have a version that
suggests a greater risk for these other diseases. If you were to have such a DNA finding,
there would be a chance that your family members would have the same DNA finding.
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Some people do not, want to be told if they have such a rare but important DNA finding,
especially if there is little that can be done to prevent the related disease from occurring.
Other people do want this information. We will ask you your preference now in case we
examine for and find such a DNA finding in the future. MESA will consult with experts
to make decisions on what DNA fmdings to report and how this should be done. People
who do want this genetic (DNA) information will need to be tested in a second laboratory
to make sure the first test was correct. They may also be advised to talk with a trained
professional (a genetic counselor) about their own and their family members’ risks of
disease. This counseling could be important because the genetic information may be
complicated and its impact on individual and family member risk can be difficult to
interpret. The genetic counselor can explain the results and answer questions. MESA
will pay for the additional genetic testing and counseling if we examine for and find such
a DNA finding.
Sharing of Data and Samples
Use of data and samples:
o Portions of samples of your blood, urine and DNA, in addition to study
information and genetic data, will be stored for use by researchers indefinitely.
o The National Institutes of Health will allow researchers who qualif~’ to analyze
your data and samples. Researchers can quali~’ by proposing a research study
approved by National Institutes of Health and by agreeing to protect your identity.
o
Samples and data sent to other laboratories will be labeled only with a code
number. No standard information that identifies you, such as your name, date of
birth, address, etc., will be available to other researchers.
Commercial use of data and samples:
o Researchers from private companies that develop diagnostic lab tests or
treatments for diseases may request access to your study information or samples.
However, these researchers will not have access to personal information that
identifies you, such as your name, date of birth, address, etc.
o
Your samples will not be sold to any person, institution, or company and will not
be used for cloning (creating body organs or tissues or fluids from your genetic
material).
o Neither you nor your family would benefit financially from discoveries made
using the information andJor specimens that you provide.
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Genetic research:
o Very detailed information about your DNA will be stored centrally at the National
Institutes of Health, where it will be shared with other investigators for research.
This information and all of your other data will be used by researchers to look for
genes that affect the risk of developing diseases and may lead to better methods
for prevention and treatment. The stored information is de-identified, which
means that identifying information such as your name, date of birth, address, etc.,
is removed. Access to this stored information will be controlled by the National
Institutes of Health. The National Institutes of Health is committed to protecting
• the confidentiality of all the information it receives, but will also comply with
relevant laws which might include Freedom of Information Act (FOIA) requests
for de-identified information.
Potential Risks and Discomforts
•
Clinic Exam: The procedures used in this study are considered to be safe. The risks
associated with the clinic exam are minimal.
•
Blood Draw: Risks of thawing of a blood sample are discomfort at the site of needle
insertion, bruising (black and blue discoloration) or inflammation at the site, and
rarely, faintness. The bruise is usually painless and disappears within a few days.
•
EKG: Minor skin irritation may occur where the EKG leads are placed on the skin.
•
Eye Exam: There are no known risks associated with taking a photograph of the eye.
People who are light, sensitive may experience some minor discomfort from the
camera flash. After the pictures are taken, you may see a blue or red spot which will
disappear within 5 to 7 minutes and which causes no damage to the eye.
•
DNA information: Receiving DNA information may cause anxiety. Also, some
people have been worried that genetic information could be used to discriminate
against them. A law was passed in 2008 by the Federal Government (“GINA” or
Genetic Information Nondiscrimination Act) that prevents many forms of
discrimination based on genetic information.
•
Data Sharing: MESA takes extensive efforts to protect your identity and privacy.
Yet, because of the large amount of information collected about you, we cannot
absolutely guarantee that information about you or your blood relatives will never
become known. This is partly because of the possibility of matching your DNA
sample with other DNA collections (such as those kept by law enforcement agencies).
However, researchers are strictly prohibited from attempting to identify you.
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MRI: The MN machine does not use ionizing radiation (like x-rays). Instead, it uses
a strong magnet and radio waves to generate pictures of the body. The procedure is
associated with minimal risk. You will need to wear earplugs or earphones since the
machine can produce high noise levels, which may be uncomfortable. With earplugs,
the risk to hearing is insignificant. Some people may experience psychological
discomfort in the scanner if they are uncomfortable in tight places (known as
claustrophobia). You will be able to speak directly to the MN technologist at all
times, and the examination will be stopped at any time upon your request.
LI
Mifi with gadolinium: This contrast agent is generally safe. There is a small risk of
allergic reaction afler the gadolinium injection, with less than a one in 300,000 chance
that this will be severe. There is also a smaller risk of nephrogenic systemic fibrosis,
a potentially serious and rare skin condition that can occur in patients with kidney
problems. We will guard against this risk by checking your kidney function prior to
the MRI and will not give gadolinium if you have low kidney function. Metallic taste
in the mouth, tingling in the arm, nausea, or headache occurs in less the 1% (less than
1 in 100) people. Insertion of the needle may also cause minor pain, bruising and/or
infection at the in] ection site.
LI
Computed Tomography of the heart: The CT scan uses x-rays to make pictures.
The amount of radiation you will be exposed to during the CT scanning is less than 3
mSev, which is 6% of the yearly on-the-job exposure allowed radiation workers.
Another way of understanding this is to compare the exposure from the CT to the
radiation exposure you receive on average from natural sources. The radiation
~exposure from the CT scanning is approximately the amount of natural background
radiation that the average person in the United States receives each year. The
radiation in this study is not expected to measurably increase your risk of cancer. The
potential lifetime cancer risk associated with the above estimated radiation is less than
3 per 10,000.
LI
Computed Tomography of the lung: The CT scan uses x-rays to make pictures.
The amount of radiation you will be exposed to during the CT scanning is less than
6.5 mSev, which is 12% of the yearly on-the-job exposure allowed radiation workers.
Another way of understanding this is to compare the exposure from the CT to the
radiation exposure you receive on average from natural sources. The radiation
exposure from the CT scanning is approximately the amount of natural background
radiation that the average person in the United States receives in two years. The
radiation in this study is not expected to measurably increase your risk of cancer. The
potential lifetime cancer risk associated with the above estimated radiation is less than
6 per 10,000. If you are also receiving a CT scan of the heart, the lung scan will be
one minute or less of additional scanning time.
LI
Spirometry: Minimal or no risk. Occasionally after receiving the albuterol inhaler, a
temporary sensation of “heart racing” and shalciness may develop. This will resolve
quickly.
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El
Discomfort of Interviews: It is possible that some of the questions asked during the
interviews may cause you to feel uncomfortable or embarrassed. You do not have to
answer any questions that you do not wish to answer.
El
Six Minute Walk Test: Risks of this test include shortness of breath and chest
tightness, and rarely, faintness or heart problems. We will guard against these by
asking you questions before the test.
All of the tests, particularly imaging studies (MRI and CT), may identi& abnormalities
for which you may be recommended to have additional testing. You will be referred to
your own doctor for follow-up of all medical information obtained by the study and you,
or your insurance company, will be responsible for those costs. MESA will not pay for
these tests, except for additional genetic testing and genetic counseling if you are found to
have a potentially important DNA finding and wish to be told about it.
•
ANTICIPATED BENEFITS TO SUBJECTS
This study is not designed to benefit you directly. Nonetheless, one benefit of
participating in this study is that a free evaluation of your health will be performed.
Information from the tests will be available to you and to your doctor. If a health
condition is detected during this evaluation, your doctor or clinic will be notified, if you
authorize the study staff to do so. However, please keep in mind that these tests are being
performed for research purposes and are not intended to diagnose any specific medical
condition. Additionally, MESA is not intended to provide medical care or interfere with
your relationship with your own doctor. You will be referred to your own doctor for
follow-up of all medical information obtained by the study. If you do not have a local
doctor; you can be referred to one.
•
ANTICIPATED BENEFITS TO SOCIETY
This study may help increase scientific knowledge about the characteristics and factors
associated with subclinical atherosclerosis and its progression.
•
ALTERNATIVES TO PARTICIPATION
The alternative is not to participate.
•
INFORMATION ABOUT YOUR SAMPLE
On the checklist at the end of this consent form you are asked to let us know if you would
like to receive general information about the results of this study. There is also a
checklist for you to indicate whether you wish to release the results of the research tests to
your personal doctor. You may also choose not to receive any information about the
MAR I
ExpWatlon ~a~9 o
7zojo
NSTITL.rnoNALnEv~Ew~oARD
Page 9of13
results of this study and not to release study results to your personal doctor. Obtaining
general information from a project may take years.
• FINANCIAL OBLIGATION
Neither you nor your insurance company will be billed for your participation in this
research.
-
•
PAYMENT FOR PARTICIPATION
You will be reimbursed $50 at the end ofeach visit. The total reimbursement will be up
to $ 100.
If you selected to participate in MESA COPD Substudy, you will be reimbursed $100 for
the time to complete spirometry, the six minute walk test, the CT scan of the lung and the
MM of the heart.
•
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 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 individuals involved.in
the research and, if you authorize, your personal doctor and nurses. You have been asked
for your personal information such as address, phone numbers and social security
number. This information, along with your name, will be sent to the MESA Coordinating
Center at the University of Washington, where it will be stored in a secure database and
who will use the information to send you lab results and to help us to reach you if we lose
touch. We will ask you to update this information each year and as necessary.
Information obtained during this research may be released to others for scientific
purposes, but only afler removing your name, social security number, and any other
personal identifiers. Otherwise, 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).
When the results are published or discussed in conferences, no information will be
included that would reveal your identity. Authorized representatives of the National
Institutes of Health (NIH) may need to review records of individual subjects. As a result,
they may see your name, but they are bound by rules of confidentiality not to reveal your
identity to others.
~VED
MAR 172010
ExpiraUofl Data. SEP 132010
BOARD
Page 10 of 13
This research is covered by a Certificate of Confidentiality issued by the Department of
Health and Human Services (DHHS). This Certificate will protect the investigators from
being forced to release any research data in which you are identified, even under a court
order or subpoena. Disclosure will be necessary, however, upon request of DHHS for
audit or program evaluation purposes.
This protection, however, is not absolute. A Confidentiality Certificate does not prevent
you or a member of your family from voluntarily releasing information about yourself or
your involvement in this research. Note however, that if an insurer or employer learns
abut your participation and obtains your consent to receive research information, then the
investigator may not use the Certificate of Confidentiality to withhold this information.
This means that you and your family must also actively protect your own privacy.
•
PARTICIPATION AND WITHDRAWAL
Your participation in this research is VOLUNTARY. If you choose not to participate, that
will not affect your relationship with UCLA (or 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 fliture 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. If you become ill during the research, you may have to drop
out, even if you would like 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 new information is provided to you, your consent
to continue participating in this study will be re-obtained.
•
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 Dr. Karol Watson, Dr. Christine Darwin,
Dr. Arleen Brown, Dr. Deborah Kado or Dr. Preethi Srikanthan during office hours at
626-979-4920, 330 S. Garfield Ave., Suite 308, Alhambra, CA 91801. After office hours
APPROVEFO
MAR 1 7 ZUlU
UCLA RB # 99-1 1-057-23B
Expiration Date: SEP 132010
UCLA MEDICAL
~NSTITUTIONAL REVIEW BOARD
Page 11 of 13
or if you have an emergency, you can page the study doctors by calling the UCLA Page
Operator at 310-825-6301 and ask them to page one of the study doctors.
•
RIGHTS OF RESEARCH SUBJECTS
You may withdraw your consent at any tine 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, 11000
Kinross Ave Suite 102, 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 Subjects Bill
of Rights.
BY SIGNING THIS FORM, [WILLINGLY AGREE TO PARTICIPATE IN THE
RESEARCH IT DESCRIBES.
Name of Subject
Signature of Subject
Date
I PERMISSION TO RELEASE RESULTS TO YOUR PERSONAL DOCTOR
I
Please indicate by checking and initialing the category below whether you want the
results of your tests sent to your personal doctor:
Li ______I want to have the results sent to my doctor.
LI
I do not want the results sent to my doctor
Consent to Obtain DNA for Research
I agree to allow MESA to obtain additional DNA at this exam for research purposes.
This will allow researchers to read my genetic code in detail and to see if my genetic code
is related to diseases I now have or may develop in the future.
D Yes, obtain my DNA for research purposes
D No, do not obtain my DNA
APPROVED
MAR 1 72010
UCLA IRS # 99-11-057-235
Expiration Date: SEP 132010
UCLA MEDICAL
NSTITUflONAL REvIEw BOARD
Page 12 of 13
Consent to Create Cell Lines from Blood Cells
I agree to allow MESA to crëáte cell lines that will live for long periods of time from my
blood sample
El Yes, create cell lines
El No, do not create cell lines
Request to be Notified, or Not, of Possible Important Genetic Findings
I wish to be notified if results indicate I may have a genetic finding that is known to
greatly increase risk of an important disease (CHECK ONE). Please note that very few
MESA participants will be checked for these rare genetic findings at present; however a
larger number of MESA participants may be checked in the future.
El Yes, but only if a treatment to prevent or lessen the disease is known
El Yes, even if no treatment or prevention is known
El No, do not noti~’ me
Consent for Use of Gadolinium for the MRI of the Heart
I agree to have the gadolinium injection as part of the MM scan of my heart
El
El
Yes, I consent to the gadolinium injection
No, I do not wish to have the gadolinium injection
Consent for Lung Substudy
I agree to participate in the Lung Substudy to study lung structure and function and their
impact on the heart. I understand that the results of spirometry and the CT scan of the
lung will be sent to me and, if I so indicated above, to my physician. I also understand
that information and samples that I have previously provided or may subsequently
provide to MESA (for example, responses to questionnaires, data from CT scans, and
genetic materials) may be analyzed for studies of lung disease in MESA.
El Yes, I consent to participant in the Lung Substudy
El No, I do not wish to participant in the Lung Substudy
Consent for MESA COPD Substudy
I agree to participate in the COPD Substudy, which includes the breathing test, six minute
walking test, CT scan of the lung and the gadolinium injection as part of the MRI scan of
my heart. The purpose of this substudy is to study the blood vessels in the lung. I
understand that the breathing test will help determine my eligibility for this substudy, and
that the results of spirometry and the CT scan of the lung will be sent to me and, if I so
indicated above, to my physician. I also understand that information and samples that I
have provided or may in the future provide to MESA (for example, responses to
questionnaires, data from CT scans, and genetic materials) may be analyzed for studies of
lung disease in MESA.
El
Yes, I consent to participant in the MESA COPD Substudy
UCLA IRB # 99-11-057-23B
Expiration Date: SEP 132010
II
MARI7ZOjo
LCLA MED~CAL
PNSTITtJT0NALREVI;v,
D
Page 13 of 13
No, I do not wish to participant in the MESA COPD Substudy
With my signature I also am giving permission for my hospital andlor health clinic to
release any of my health records that MESA needs and requests. This permission has no
expiration date.
rINFORM.ATION REGARDING FUTURE STUDIES
Please indicate by checking and initialing the category below whether you permit us to
contact you regarding future studies:
0
I agree to be contacted about fhture studies.
0
do not want to be contacted about future studies.
SIGNATURE OF INVESTIGATOR
I
I have explained the research to the subject and answered all of his/her questions. I
believe that he/she understands the information described in this document and freely
consents to participate.
-~
Name of Investigator
Signature of Investigator
Date (must be the same as subject’s)
APP~oya
MAR I 72010
UCLA IRB # 99-11-057-238
Expiraflon Date: SEP 132010
UCLA MEDICAL
NSTITUTIONAL REVIEW BOARD
UNIVERSITY OF CALIFORNIA LOS ANGELES
RESEARCH PARTICIPANT’S
BILL OF RIGHTS
These rights are the rights of every person who is asked to be in a medical research
study. As a research participant, I have the following rights:
1. I have the right to be told what the research is trying to find out.
2. I have the right to be told about all research procedures, drugs, and/or devices and
whether any of these are different from what would be used in standard practice.
3. I have the right to be told about any risks, discomforts or side effects that might
reasonably occur as a result of the research.
4. I have the right to be told about the benefits, if any, I can reasonably expect from
participating.
5. I have the right to be told about other choices I have and how they may be better or
worse than being in the research. These choices may include other procedures,
drugs or devices.
6. I have the right to be told what kind of treatment will be available if the research
causes any complications.
7. I have the right to have a chance to ask any questions about the research or the
procedure. I can ask these questions before the research begins or at any time
during the research.
8. I have the right to refuse to be part of the research or to stop at any time. This
decision will not affect my care or my relationship with my doctor or this institution in
any other way.
9. I have the right to receive a copy of the signed and dated written consent form for the
research.
10. I have the right to be free of any pressure as I decide whether I want to be in the
research study.
If I have any questions or concerns I can ask the researcher or the research assistant. I
can also contact the UCLA Office of the Human Research Protection Program (OHRPP)
which helps protect research study participants, I can reach the OHRPP by calling 310825-8714 from 8:00 AM to 5:00 PM1 Monday to Friday. If I call this office and do not
speak English or Spanish, I should have someone available who can interpret for me. I
may also write OHRPP, 11000 Kinross Avenue, Suite 102, Box 951694, Los Angeles,
CA 90095-1 694.
Version: 09/09
Date
Name
Address
City, ST Zip
spit
Dear Name:
Thank you again for your participation in the Multi-Ethnic Study of Atherosclerosis
(MESA). We appreciate your efforts to help improve our understanding of heart disease
and how to prevent it. We are providing results of the blood tests that were done during
the MESA examination on Exam 5 date.
Your fasting plasma glucose was
mg/dl, which {is normal / is, mildly
elevated but not in the diabetic range / is in the diabetic range. This result should
be discussed with your physician / indicates that your diabetes is controlled /
indicates that your diabetes may not be well controlled / indicates that your
diabetes may be out of control and you should see your physician soon},
________
Diabetics only: Your HbA10 (which reflects diabetes control in the preceding three
months) was—---—%. This indicates that your diabetes is controlled(<7%)/is not well
controlled (7.1-11 %)l out of control and you should see your physician soon (>11%).
Your cholesterol level was
elevated}.
Your LDL cholesterol level was
elevated / elevated).
_______
Your HDL cholesterol level was
below the desired range.
Your Triglyceride level was
the desired range.
mgldl, which is {normal/borderline elevated!
________
________
________
mg/dl, which is (normal / borderline
mg/cD, which is {in the desired range /
mg/dl, which is {in the desired range / above
Your creatinine level, which reflects kidney function, was
mg/dl, which is
(normal / elevated and should be discussed with your physician if you were not
previously awareof it).
_______
A copy of your laboratory results is enclosed. If you requested it, a copy of your
laboratory results has been sent to your doctor. Otherwise, you may wish to take this
letter with you when you visit your doctor.
If you have any questions, please call
_________________
at
_________
Again, thank you for your participation in MESA.
Sincerely,
Title
_______
APP~OV!EJ2~
MAR 1 7 2010
LCLA MEDICAL
UCLA IRB It 99-1
5723~~
Expiration Date: SEP 132
N5TITUTIONAL REVIEW
Date
ID#
Doctor Name
Doctor Address
Doctor City, ST Zip
Dear Doctor Name:
Your patient,
(Date of Birth:
is a participant in the
Multi-Ethnic Study of Atherosclerosis (MESA), an epidemiologic study of subclinical
cardiovascular disease and risk factors. He/She volunteered for an examination during
___________________
___________),
forwarded to you. Enclosed is a copy of the letter sent to
describing some of the examination results. If you have any questions, please contact
__________________
Sincerely,
Title
MAR 1 7 2010
UCLA IRS # 99-11-057-238
Expiration Date: SEP 132010
UCLA MEDICAL
NSTITUTI0NM. REVfEW
MESA Laboratory Results
MESA#
Name:
Date of Birth:
Examination Date:
_____________
______________
Plasma Glucose (fasting)
_______
mgldl
Serum Cholesterol
_______
mg/dl
LDL~Cholesterol*
_______
mg/dl
HDL-Cholesterol
_______
mg/dl
Triglycerides
________
mg/dl
_______
mg/dl
Creatinine
:
:
HbAlc
:
_____%
National Cholesterol Education Program Recommendations for Lipids:
Cholesterol
LDL-Cholesterol
Triglycerides
HDL-Cholesterol
Desirable
less than 200
less than 130
less than 200
more than 40
Borderline
200-239
130-1 59
Elevated
more than 239
more than 159
American Diabetes Association Reference Ranges for Fasting Glucose:
<100 mg/dl
100—125 mg/dl
126 and higher
normal
borderline high
diabetic range
Reference Range for Creatinine (mg/dl) t:
Female
0.60—1.30
Male
0.80—1.50
Normal range for Hemoglobin Alc:
*
4.3-6.0%
LDL cholesterol is calculated when possible, not measured directly
t Reference range for the lab at which creatinine was measured
APPROVED
MAR i 7 2010
In,
cfl?LA
IRB # 99-11-057-233
Expiration Date: SEP 132010
UCLAMEDICAL
NSTITUTI0NAL
REVIEW BOARD
Date
Participant Name
Address
City, State Zip
Dear Ms/Mr.:
Thank you again for your continued participation in the Multi-Ethnic Study of Atherosclerosis
(MESA). We appreciate your efforts to help improve our understanding of heart disease and
how to prevent it. The purpose of this letter is to provide you with the results of the carotid
ultrasound / CT scan I MRI scan / retinal photographs spirometry you underwent as part of your
examination in MESA.
The ultrasound study (done on scan date) of the carotid arteries (the large blood
vessels in your neck) showed no significant clinical findings / significant (Doppler
flow velocity> 120 and < 250 cm/sec) narrowing (50% or more) in the right side and
suggests the need for further evaluation and possible treatment / significant
(Doppler flow velocity> 250 cm/sec) narrowing (80% or more) in the left side and
suggests the need for further evaluation and possible treatment
• The CT scan of the heart (done on scan date) showed that ~ou have a total
toronary artery calcium score of zero. The coronary arteries are the vessels that
supply blood to the heart. The presence of calcium (that is, a score higher than
zero) is correlated with hardening of these arteries. However, a calcium score of
zero does not necessarily mean that no hardening of these arteries is present.
OR
• The CT scan of the heart (done on scan date) showed that you have a total
coronary artery calcium score of
Your previous CT scan done on
showed that you had a total coronary artery calcium score of
The calcium
score indicates the amount of calcium found in the walls of these arteries. Your
calcium score indicates that you have some hardening of these arteries. For your
age, you have a less than average/an average/a greater than average amount of
calcium in your arteries.
If bypass or angioplasty was indicated: If you have had a stent placed in the
past, there may be a small error in your calcium assessment.
____.
________
____.
-
• The CT scan of the lung (done on scan date) showed that you have
(no/mild/moderate/severe) emphysema in the lungs. Emphysema is a loss of the
tissue in the lungs, and can cause shortness of breath. If you have questions,
please contact the principal investigator of the Lung sub-study, R. Graham Barr,
M.D., Dr.P.H. at 212-305-4895.
• The MRI study of the heart and blood vessels (done on MRI date) showed that your
heart structure and function were within an acceptable range for your age.
OR
• The MRI study of the heart and blood vessels (done on MaRl date) showed the following
abnormalities (findings?):
Finding in layman’s language (e.g. “The wall of the heart is thickened”)
Report of clinically significant myocardial scar in layman’s language
-_________
APPROVED
MAR 1 7 2010
UCLA IRB II 99-11-057-23B
Expiration Date: SEP 132010
UCLA MEDICAL
NSTITUTIONAL REVIEW BOAR
• The spirometry breathing test done on DD/MMIYY showed that your FEVI (a
measure of how fast you can blow out) was _% of predicted for someone your
age, your FVC (a measure of how much you can blow out) was _% of predicted
for someone your age, and their ratio was
—.
• No significant abnormalities were found in the back of your eyes.
OR
• Your fundus photographs showed the following abnormalities:
Specific abnormality in layman’s language and recommendation (e.g. ‘There were
changes in the retina that are often found people with diabetes and occasionally in
people with hypertension. These changes were found in both eyes. Further
evaluation by an ophthalmologist is recommended.”)
OR
• No significant abnormalities were found in the back of your right/left eye.
-
• Specific abnormality reported in other e~’e
Everyone, whether he/she has a low or high calcium score, should strive to lead a heart-healthy
lifestyle and control any heart-related risk factors that they have (for example, high cholesterol,
high blood pressure, and cigarette smoking, among others).
Please note that the above studies were performed as a part of a research study and may not
be the same as tests done as a part of a patient’s medical care. Nonetheless, we reconimend
that you discuss any abnormal findings with your doctor. If you requested it, a copy of this
letter will be sent to your doctor. Otherwise, you may wish to take this letter to your doctor.
Once again, we greatly appreciate your participation in MESA. If you have any questions,
please call
at phone #.
Sincerely,
__________
For the MESA-Lung Spirometry Participants Results Letter, other possible spirometry test
interpretations include:
Participant Results Letter Interpretations:
Your current test results indicate a possible borderline reduction in your breathing capacity.
Your current test results are within normal limits.
Your current test results indicate a possible mild reduction in your breathing capacity.
Your current test results indicate a possible moderate reduction in your breathing capacity.
Your current test results indicate a possible moderately severe reduction in your breathing
capacity.
Your current test results indicate a possible severe reduction in your breathing capacity.
Your current test results indicate a possible very severe reduction in your breathing capacity.
Your current test has insufficient acceptable curves to accurately interpret the results.
Although your current test results are below the normal limits, the current test results are not
reproducible and cannot be accurately interpreted.
The FEV1 improved by **% after administration of a bronchodilator.
.
APPROVE©
UCLA IRE # 99-1 1-057-23B
Expiration Date: SEP 132010
MAR 1 7 2010
~flI
A
~tflIfl A I
Date
ID#
Doctor Name
Address
City, State Zip
Dear Dr.:
Your patient,
(Date of Birth:
), is a participant in the Multi-Ethnic Study
of Atherosclerosis (MESA). She volunteered for an examination during month of year.
Enclosed is a copy of the letter sent to Mr/Ms.
describing the results of the carotid
ultrasound / CT scan / MRI scan / spirometry. Please note that these tests were performed as a
part of a research study to answer certain research questioni. They are therefore limited in
scope and may not be equivalent to tests done as a part of routine medical care.
_______________
__________
Cardiac MRI
Value
Left ventricular end
diastolic volume
Left ventricular end
systolic volume
-
Ejection Fraction
Normal Ranges in the MESA cohort
M
F
ml
Low-High
Low-High
ml
Low-High
Low-High
%
Low-High
Low-High
Stroke Volume
ml
Low-High
Low-High
Left Ventricular Mass
g
Low-High
Low-High
Left Ventricular Mass
index
g/rn2
Low-High
Low-High
Low-High
Low-High
% predicted LV mass*
%
Myocardial scar (>5 g)**
*
**
present or absent
% predicted based on 8XX non-obese non-hypertensive participants in the MESA study,
adjusted for body size.
Report and brief explanation of myocardial scar (if present)
No focal wall motion abnormalities were present in the left ventricle.
OR
Abnormalities:
Specific finding
~VED
UCLA IRB # 99-11-057-236
Expiration Date: SEP 132010
1
MAR 1 7 2010
~
MEDICAL
PNSTITL.rrIONAL REVIEW BOARQ
Carotid Ultrasound (scan date)
Doppler Flow Velocity:
Right Internal Carotid:
Left Internal Carotid:
cm/sec
cm/sec
(Values above >120 cm/sec indicate >50% narrowing of carotid artery and >250
cm/sec indicate >80% narrowing)
Coronary Computed Tomography (scan date)
Coronary Calcium Score:
Retinal Photo
No significant abnormalities were found in the retinas of your patient.
OR
Your patient’s fundus photographs showed the following abnormalities:
Specific abnorma/ity
If you have any questions, please contact
at phone
#.
Thank you.
Sincerely,
APPROVED
MAR 1 7 2010
UCLA RB 4* 99~11-057-239
Expiration Date: SEP 1
NSTITU19ONAL REV~W BoARD
Multi-Ethnic Study of Atherosclerosis (MESA)
Lung Function Sub-study
Field Center
Mane:
ID:
Acrostic:
Test Age:
Session:
57 yrs
50
Race:
Asian
DOE:
Test Ht: 180.0 cm
Gender:
£1
Calibration Verified: 10/6/2004
Temp: 25.0 c.
spirometer: WY106428 Vers: 5.01 Normals Used:
EP:
760
BTPS Factor:
1.0733
Ri Factor: 0.88
Pulmonary Function Report 10/6/2004 2:36:09 PM
FVC
L
FEV1
L
FEV1/FVC% %
PEF
L/s
FEV6
L
FEV1/FV6% %
FET
sec
Reproducible Test.
Best Values
Pred
4.11
4.41
3.00
3.36
72.9%~
76.3%
9.38
8.47
3.91
4.22
76.6%
69.9%
11.8
FVc,
%Pred
93.3%
89.2%
95.6%
110.7%
92.6%
109.6%
LLN
3.57
2.65
66.6%
6.38
3.41
62.0%
FEV1 and PEF reproducible.
6 of 6 trials had acceptable start of expiration; 0 had acceptable plateau.
5 of 6 trials were used for the best test values.
1 of 6 trials were Rejected.
Session Effort: Maximal,
Position: Sitting
INTERPRETATION
Normal expiratory flows and a normal
-
FVC.
If you have questions, please contact the principal investigator of the Lung
sub—study, R. Graham Barr, M.D., Dr.P.H. at 212—305—4895.
Ref: 43, Operator: 748
MARi7ZO1O
UCLA MEDJOAL
UCLA IRS # 99-1 1-057-23B
Expiration Date: SEP 132010
NSTITLJTIONAL REVIEW 8O,~RD
Dear MESA participant,
Enclosed is a questionnaire asking you about your usual dietary habits over the previous year. Please
follow the instructions given on the first two pages of the questionnaire and answer the questions as
accurately as possible. We understand that some questions may be more difficult to answer than
others. Just do your best to estimate. You will have an opportunity to ask questions at the clinic when
you arrive for yo~r examination,
but please try to answer most, if not all, of the questions before you
arrive.
The questionnaire should take between 30 to 6dminutes to complete. You are we!come to take short
breaks If ydb need them, but please
try to complete the questionnaire in one sitting.
Of &5urse, as with all aspects of the MESA study, completing this questionnaire is entirely voluntary. If
for any reason you do not wish to participate in this portion of the MESA study, you can elect not to
complete the questionnaire. Non-participation in the dietary portion of the exam will not affect your
participation in other portions of the exam nor will it detract from your value to MESA. We greatly
appreciate yourtime and dedication to the MESA study.
Sincerely,
Jennifer Nettleton, Ph.D.
Assistant Professor and MESA Nutrition Coordinating Center Principal Investigator
The University of Texas School of Public Health, Division of Epidemiology
Health Sciences Center—Houston
Phone: 713-500-9367
E-mail: Jennifer.A.Nettleton@uth.tmc.edu
APPF~OVE~
MAR i 7 ZO~~
UCLA RB # 99-11-057-238
Expiration Date: SEP 132010
~sTIT~tIO60~
| File Type | application/pdf |
| File Modified | 2010-05-12 |
| File Created | 2010-05-12 |