Attachment 10 - OHSR Determination 2008

OHSR RESPONSE TO REQUEST FOR REVIEW OF RESEARCH ACTIVITY
INVOLVING HUMAN SUBJECTS
Exempt: #:

301-435-3710
Breen, Nancv

FAX:
To:

4470

NCI
EPNl4005
From:

Office of Human Subjects Research (OHSR)

Nature of Research Activity:
The California Health Interview Survey (CHIS) is a biennial population-based statewide local health survey
(N'40-50,000 adults + adolescents + children). CHIS is administered by telephone in five languages to
participants across the state of California. It is the only survey of its kind to provide statewide local estimates
and estimates for small racial-ethnic groups with inadequate samples nationally. since 2001, the NCI had
fi~ndedranrsr cnntrnl n~lestinnsan CHIS that cover cancer risk factors and cancer screeninn hehavinrs

Original Request Received in OHSR on:
Responsible NIH Research Investigator(s):

Nancy Breen, PhD NCI

OHSR review of your request dated Mon, Dec 15, 2008 has determined that:
Federal regulations for the protection of human subjects do not apply to above named
activity. No further action is necessary.

q

The activity is designated EXEMPT. and has been entered in the OHSR database.
PLEASE NOTIFY OHSR OF ANY SIGNIFICANT CHANGES THAT MAY ALTFR THF
EXEMPT STATUS OF THIS RFSFARCH ACTIVITY,
NOT EXEMPT. OHSR recommends IRB review. Please forward your request to the
Chair of your IRB, who may ask you to provide additional information in order to
determine whether expedited or full review is appropriate.
Confidentiality Agreement
Reliance

q
q

Amendment
Other
Ofice Person SPC

Note:

Admin Assist. CB

12/22/2008
Date

OHSR Use Only
Human Subjects Data: Yes
Biologic Material:

No

0 1 0 2 0 3 0 4 0 5 0 6

REQUEST FOR REVIEW OF RESEARCH ACTIVITY INVOLVING HUMAN
SUBJECTS
INSTRUCTIONS: Please type directly on this form. You can expand the document if
you need more space. If your research involves a survey or questionnaire, please attach it
to this completed form.
Completed forms (with all required signatures) may be sent to OHSR by FAX (301-4023443) or by mail (2C146). If you have any questions, call OHSR at (301) 402-3444.
Date: December 15,2008
To:

OFFICE OF HUMAN SUBJECTS RESEARCH, Building 10, Room 2C-146

From:

priate Official for IC, e.g., LabBranch Chief)
Name of NIH Principal Investigator(s): Dr. Nancy Breen
IC: NCI
Laboratory/Branch: Health Services and Economics Branch, Applied Research
Program, Division of Cancer Control and Population Sciences
Building & Room: EPN 4094
Tel. No: 301.496.4675
FAX No: 301.435.3710
Is the Principal investigator an NIH employee? -X-Yes

No

If no, please explain:
1. What is the proposed research activity that you intend to perform at NIH
(please use lay terms):
The California Health Interview Survey (CHIS) is a biennial population-based statewide
local health survey (N-40-50,000 adults + adolescents + children). CHIS is administered
by telephone in five languages to participants across the state of California. It is the only
survey of its kind to provide statewide local estimates and estimates for small racialethnic groups with inadequate samples nationally. Since 2001, the NCI has funded
cancer control questions on CHIS that cover cancer risk factors and cancer screening
behaviors. These data enable researchers to better estimate health-related behaviors, use
of health services, and cancer risk factors in small population groups.

Last revised 11/7/05

The proposed research activity is to field cancer control content on the CHIS 2009
questionnaire. NCI plans to field items covering the following topics: colorectal,
prostate, and breast cancer screening; cancer risk factors including walking, cigarette use,
sun exposure, dietary intake, and medication use; and family history of cancer.

2. If applicable, list your non-NIH Collaborating Investigator(s).
Address Tel. # FAX #

Name
Institution
E. Richard Brown
UCLA Center for Health Policy Research
10960 Wilshire Blvd, Suite 1550
Los Angeles, CA 90024

3. Proposed start date of your research M a r c h 15,2009 Proposed completion date M a r c h 14,2012

4. Will you be

these samples or data?

Collecting Yes/No
Receiving Yes/No
Sending
YesINo
5. Do the samples or data:
es -X-No
(a) Already exist?-Y
(b) Or are they being collected for the express purpose of this study? - X -Yes N o

If "yes," please describe: CHIS data are collected every 2 years on a random sample
of California residents.
(c) Or a combination of (a) and (b)?

Yes -X

No

6. What role will you have in this research project? (Check all that apply)
- X -Analyze samplesldata only.

-Consultant/advisor to collaborator(s) listed above.
A u t h o r of the protocol that is being implemented by your collaborating investigator
(identified in question #2).

-X- Co-authorship on publication(s)/manuscript(s) pertaining to this research.

Last revised 11/7/05

-You or NIH hold. an IND for this research.
Decisional authority over the design or implementation of the research at the IRB
approved site? If so, please explain.
Other (If necessary, use this space to describe your role in this research).

7. Where are the subjects of this research activity located?
CHIS is a biennial telephone survey, with subject located throughout the state of
California. CHIS is designed to be representative of the California population and to
provide local-level estimates, and therefore samples subj'ects in most counties throughout
the state.
8. If human subjects are.locatedelsewhere (not at NIH), will you have direct
contact or intervention with them? (Examples: as subject's physician; in obtaining
.samplesdirectly from the subject; by interviewing the subject?)
Yes - X N o

Last revised 11/7/05

9. What kind of human samples (e.g., tissue, blood) or data (e.g., private
information, responses to questionnaires) will be involved in your research?
This research will involve questionnaire responses.
10. If the samples, data do not'come from an IRB approved protocol, do they come
from:

(a) Repository

Yes -X- No

(b) Pathological waste -Yes -XLNo

(c) Autopsy material -Yes -X- No
(d) Publicly available source -Yes

-X- No

(e) Other
11. Please check the box(es) that apply(ies) to the samplesldata that you will receive.

(a) X Samples andlor data will be anonyrnized/unlinked. (The samplesldata cannot
be linked to individual subjects by you or your collaborators at other sites.)
(b) -Samples andlor data will be coded, however that code cannot be used by
either the sender or the receiver to identify specific individuals.
(c) -Samples andor data will be coded so that the provider of the samplesldata
.can link them to specific individuals but the receiver will not be able to do so.
12.

Will you send results back to the provider(s) (listed in question 2 of this

form)?

(a) - X -No, I will not send results back to the provider(s).
(b) -Yes, I will send aggregate results to the provider(s).

(c) -Yes, I will send results to the provider(s) that are linked to identifiable
individuals.
If yes, does the provider intend to link your data to identifiable individuals?
Yes
No

Last revised 11/7/05

13. Has the research activity that vou are proposin~in this form been approved by
an Institutional Review Board (IRB) elsewhere?

x

- Yes, the NIH research activity has been reviewed by the following IRB (s)
(Please provide the following information for each IRB):

University of California, Los Angeles
11000 Kinross Avenue, Suite 102
Box 95 1694
Los Angeles, California 90095- 1694

E. Richard Brown, Ph.D.
California Health Interview Survey (2009)
UCLA IRB # G08-10-098-01

No IRB review of the research activity described in question #1 above has
taken place

(**An FWA is a contract between the U.S. Department of Health and Human Services
(DHHS) and an entity receiving DHHS funds to conduct clinical research that the latter
will follow ethical guidelines and federal regulations for the protection of human
subjects. For a list of domestic and international institutions go to
http://oh17).cit.nih.nov/search~asearch.asr>#ASUR

14. Per NIH guidance***, have conflicts of interest by NIH employees, if any, been
resolved?
No
-X- Yes . -

If your answer is no, please see your Clinical Director about this matter before
proceeding with this research.

***The January 5,2005 NIH Guide to Preventing Conflict of Interest applies to all
research conducted at NM, http://ohsr.od.nih.nov/New/mvafiva docs.htm1

Last revised 11/7/05

.

d !

CHIS 2009 Questionnaire

NCI (w/ English Simplfication Changes)

December 1. 2008

DRAFT: CALIFORNIA HEALTH INTERVIEW SURVEY 2009
NCI QUESTIONNAIRE ITEMS

TABLE OF CONTENTS
CANCER SCREENING ...............................................................................................................................2
FOBT/SIGMOIDOSCOPY/COLONOSCOPY
....................................................................................2
PROSTATE SPECIFIC ANTIGEN (PSA) TEST ................................................................................ 5
BREAST CANCER SCREENING ....................................................................................................... 7
CANCER RISK AND PREVENTION .......................................................................................................11
WALKING FOR TRANSPORTATIONAND LEISURE ................................................................. 11
CIGARETIES ................................................................................................................................... 13
SUN EXPOSURE/SUNSCREEN USE .............................................................................................1 5
DIETARY INTAKE ........................................................................................................................... 16
BREAST CANCER RISK (MENARCHE & LIVE BIRTHS) ...........................................................18
HOROMONE THERAPY. BIRTH CONTROL ................................................................................ 20
CANCER DIAGNOSIS AND HISTORY .................................................................................................. 22
FAMILY HISTORY OF CANCER ..................................................................................................
22

b

i

CHIS 2009 Questionnaire

NCI (w/ English Simplification Changes)

December 1,2008

PROGRAMMING NOTE QA09-A1
IF AAGE C 40 OR [AAZA = 1 (BETWEEN 18 AND 29) OR 2 (BETWEEN 30 AND 39)] OR
ENUM.AGE < 40 OR AGE IS UNKNOWN, GO TO NEXT SECTION,
ELSE CONTINUE WITH QA09-A1
QA09-A1

A stool or fecal blood test is done at home to check for colon cancer. You send your stool
sample to the doctor's office or lab for testing. Have you ever done a stool or fecal blood test?
[INTERVIEWER NOTE: IF NEEDED, SAY: "Do not include over-the-counter test kits fiom
a drugstore or pharmacy."]
YES ........................................................................ 1
NO .........................................................................2 [GO TO QA09-A41
REFUSED.............................................................-7 [GO TO QA09-A41
DONT KNOW ....................................................... -8 [GO TO QA09-A41
When did you do your most recent blood test using a home kit to check for colon cancer?

A YEAR AGO OR LESS ........................................ 1
MORETHANlYEARAGOUPTO
2 YEARS AGO ........................................................2
MORE THAN 2 YEARS AGO UP TO
5 YEARS AGO .......................................................3
MORE THAN 5 YEARS AGO ...............................4
REEUSED ............................................................... -7
DONT KNOW .......................................................-8
What was the main reason you had your most recent stool blood test using a home kit?
Was it.. .

Part of a routine physical exam, ............................... 1
Because of a problem, OR .......................................2
Some other reason? .................................................. 3
REFUSED ...............................................................-7
DONT KNOW .......................................................-8
QA09-A4

A sigmoidoscopy and a colonoscopy are both tests that examine the bowel by inserting a tube
in the rectum. The difference is that during a sigmoidoscopy, you are awake and can drive
yourself home after the test; however, during a colonoscopy, you may feel sleepy and you
need someone to drive you home. Have you ever had a colonoscopy?
YES ....................................................................... 1
NO ............................................................................ 2 [GO TO QA09-A71
REFUSED .............................................................
-7 [GO TO QA09-A71
DONT KNOW ....................................................... -8 [GO TO QA09-A71

L

8

CHIS 2009 Questionnaire

QA09-A5

NCI (w/ English Simplification Changes)

December 1. 2008

When did you have your most recent colonoscopy to check for colon cancer?
A YEAR AGO OR LESS ........................................1
MORE THAN 1 UP TO 5 YEARS AGO ................ 2
MORE THAN 5 UP TO 10 YEARS AGO ..............3
MORETHAN 10 YEARSAGO ..............;..............4
REFUSED.............................................................. -7
DON'T KNOW .......................................................-8

QA09-A6

What was the main reason you had your most recent colonoscopy? Was it ...

Part of a routine physical exam,............................... 1
Because of a problem, OR ....................................... 2
Some other reason? ...................................................3
REFUSED ...............................................................-7
DON'T KNOW .......................................................-8

QA09-A7

Have you ever had a sigmoidoscopy?

YES .....................................................................1
NO ............................................................................2 [GOTO QA09-All]
REFUSED ...............................................................-7 [GOTO QA09-All]
DON'T KNOW .......................................................-8 [GOTO QA09-All]

QA09-A8

When did you have your most recent sigmoidoscopy to check for colon cancer?
A YEAR AGO OR LESS ........................................ 1
MORE THAN 1 UP TO 5 YEARS AGO ................ 2
MORE THAN 5 UP TO 10 YEARS AGO .............. 3
MORE THAN 10 YEARS AGO ............................. 4
REFVSED...............................................................-7
DON'T KNOW ....................................................... -8

QA09-A9

What was the main reason you had your most recent sigmoidoscopy? Was it ...
Part 0f.a routine physical exam, ...............................1
Because of a problem. OR .......................................2
Some other reason? .................................................. 3
REFUSED ............................................................... -7
DONT KNOW .......................................................-8

C '

CHIS 2009 Questionnaire

NCI (w/ English Simplification Changes)

December 1,2008

In the past 5 years, has a doctor recommended that you have a sigrnoidoscopy,
colonoscopy, or stool blood test?

YES .......................................................................... 1
NO ............................................................................2
DID NOT GO TO A DOCTOR
IN PAST 5 YEARS ...............................................92
REFUSED ............................................................... -7
DONT KNOW ......................................... . .. ........-8

NOTE QA09-A12:
HAD COLONOSCOPY) AND QAO9-A7 = 2 (NEVER HAD
WITH QA09-A12 AND DISPLAY "never had";
COLONOSCOPY OVER 10 YEARS AGO) OR QA09-A8 = 6
10 YEARS AGO), CONTINUE WITH QA09-D8 AND

What is the ONE most important reason why you have {neverhadnot had) one of these
exams {in the last 10 years) ?

NO REASONmVER THOUGHT ABOUT IT..... 1
DIDN'T KNOW I NEEDED
THIS TYPE OF TEST .............................................2
DOCTOR DIDNT TELL ME I NEEDED IT ......... 3
HAVENT HAD ANY PROBLEMS ....................... 4
PUT IT OFF/LAZINESS ....................................... 5
TOO EXPENSIVE/NO INSURANCE/COST.........6
TOO PAINFUL, UNPLEASANT., OR
EMBARRASSING .................................................. 7
HAD ANOTHER TYPE OF
COLORECTAL EXAM ........................................8
DONT HAVE A DOCTOR ....................................9
OTHER .................................................. . . ..........91
REFUSED ............................................................... -7
DON'T KNOW .......................................................-8

CHIS 2009 Questionnaire

NCI (w/ English Simplification Changes)

December I , 2008

PROSTATE SPECIFIC ANTIGEN (PSA) TEST
PROGRMWMING NOTE QA09-A13:
IF FEMALE GO TO QA09-A22;
IF MALE AND (AGE < 40 OR BETWEEN 18 AND 29 OR BETWEEN 30 AND 39 OR ENUM.AGE < 45
OR IF AGE IS UNKNOWN), GO TO NEXT SECTION;
ELSE CONTINUE WITH QA09-A13
Have you ever heard of a PSA or "prostate-specific antigen" test to detect prostate cancer?
A PSA test is a blood test to detect prostate cancer.
YES ..........................................................................1
NO ........................................................................2 [GO TO NEXT SECTION]
REFUSED..................................................... ... -7 [GO TO NEXT SECTION]
DON'T KNOW ....................................................... -8 [GO TO NEXT SECTION]
Have you ever had a PSA test?
[INTERVIEWER NOTE: IF NEEDED, SAY: "A PSA test is a blood test to detect
prostate cancer. It is also called a prostate-specific antigen test."]
YES ..........................................................................1
NO ..........................................................................2 [GO TO QA09-A191
REFUSED ...............................................................-7 [GO TO QA09-A191
DON'T KNOW ....................................................... -8 [GO TO QA09-A191

When did you have your most recent PSA test?
A YEAR AGO OR LESS ........................................1
MORE THAN 1 YEAR AGO UP TO
2 YEARS AGO ........................................................ 2
MORE THAN 2 YEARS AGO UP TO
3 YEARS AGO ........................................................ 3
MORE THAN 3 YEARS AGO UP TO
5 YEARS AGO ....................................................... 4
MORE THAN 5 YEARS AGO ............................... 5
REFUSED ............................................................-7
DON'T KNOW ....................................................... -8
What was the main reason you had this PSA test - was it part of a routine exam, because
of a problem, or some other reason?
Part of a routine physical exam, ............................... 1
Because of a problem, OR ....................................... 2
Some other reason? .................................................. 3
REFUSED........................................................... -7
DON'T KNOW .................................................. -8

b

.
CHIS 2009 Questionnaire

NCl (w/ English Simplification Changes)

December 1. 2008

[{Before you had the PSA test)]. did a doctor ever talk with you about the advantages and
disadvantages of [{it)/the PSA test]?

YES ..........................................................................1
NO ............................................................................2
REFUSED ..............................................................
-7
DONT KNOW .......................................................-8
[{Before you had the PSA test)]. did a doctor ever tell you that some doctors recommend
[{it)/the PSA test] and others do not?

YES .......................................................................... 1
NO ............................................................................2
REFUSED ...............................................................-7
DONT KNOW .......................................................
-8
Did a doctor or other health professional ever recommend that you have a PSA test?
YES .......................................................................... 1
NO ...........................................................................2
REFUSED...............................................................-7
DONT KNOW .......................................................
-8

V '

CHIS 2009 Questionnaire

NCI (w/ English Simplification Changes)

December 1.2008

BREAST CANCER SCREENING
PROGRAMMING NOTE QA09-A28:
IF 181AAGE < 30, GO TO NEXT SECTION;
IF MALE, SKIP TO NEXT SECTION;
ELSE CONTINUE WlTH QA09-A28 (INCLUDING WOMEN WITH AGE UNKNOWN)

In the past 12 months, has a doctor examined your breasts for lumps?
[INTERVIEWERNOTE: IF NEEDED, SAY: "This is when a doctor touches your breasts
to check for bumps, cysts, or abnormal growth."]
YES .......................................................................... 1
NO .......................................................................2
REFUSED .............;................................................. -7
DON'T KNOW ....................................................... -8
Have you ever had a mammogram?

[INTERVIEWER NOTE: IF NEEDED, SAY: "A mammogram is an x-ray taken of each
breast separately by a machine that flattens or squeezes each breast." IF DEFINITION WAS
NOT READ AND RESPONDENT ANSWERS "NO", READ DEFINITION BEFORE
CODING]
YES .......................................................................... 1
NO ...........................................................................2 [GO TO QA09-A411
REFUSED .............................................................. -7 [GO TO NEXT SECT]
DON'T KNOW .......................................................-8 [GO TO NEXT SECT]
QA09,A30

How many mammograms have you had in the last 6 years? Your best estimate is fine.

MAMMOGRAMS
NONE ......................................................................0 [GO TO QA09-A411
REFUSED............................................................... -7
DON'T KNOW ....................................................... -8
QA09-A31

How long ago did you have your most recent mammogram?

A YEAR AGO OR LESS ........................................ 1
MORE THAN 1 UP TO 2 YEARS AGO ................ 2
MORE THAN 2 UP TO 3 YEARS AGO ................3
MORE THAN 3 UP TO 5 YEARS AGO ................4
MORE THAN 5 YEARS AGO ............................... 5
REFUSED............................................................... 7 [GO TO NEXT SECT]
DON'T KNOW ....................................................... -8 [GO TO NEXT SECT]

%

1'

CHIS 2009 Questionnaire

QA09-A32

NCI (w/ English Simplification Changes)

December I. 2008

Was your most recent mammogram recommended by a doctor?
YES ..........................................................................1
NO ...........................................................................2
REFUSED............. .................................................-7
DON'T KNOW ....................................................... -8

PROGRAMMING NOTE QA09-A33:
IF QAOO-A3 1 = (3.4.5). THEN SKIP TO QA09-A34;
ELSE CONTINUE WITH QA09-A33;
QA09-A33

Tell me the main reason you had a mammogram. Was it ...
[INTERVIEWER NOTE: IF NEEDED. SAY: "The main reason is the most important
reason."]
Part of a routine exam. ............................................. 1
Because of a specific breast problem. ...................... 2
A follow-up to a previously identified
breast problem,.........................................................3
Or due to family history? ......................................... 4
REFUSED................................................................ 7
DON'T KNOW .......................................................-8

QA09-A34

Have you ever had a mammogram where the results were not normal?
YES ..........................................................................1
NO ..........................................................................2 [GO TO QA09-A411
REFUSED...............................................................-7 [GO TO QA09-A411
DON'T KNOW .......................................................-8 [GO TO QA09-A411

QA09-A35

Have you ever had an operation to remove a lump from your breast?
YES .......................................................................... 1
NO ............................................................................ 2 [GO TQ QA09-A391
DON'T KNOW ....................................................... -7 [GO TO QA09-A391
REFUSED...........................................................-8 [GO TO QA09-A391

QA09-A36

Did the lump turn out to be cancer?
YES ........................................................................... 1 [GO TO QA09-A381
NO ............................................................................ 2
REFUSED............................................................... -7
DON'T KNOW ....................................................... -8

QA09-A37

How many operations have you had to remove a lump that wasn't cancer?
NUMBER OF OPERATIONS......................

[GO TO QA09-A391

REFUSED ............................................................... -7

[GO TO QA09-A391

.
I

# *

CHIS 2009 Questionnaire

NCI (w/ English Simplification Changes)

DON'TKNOW .......................................................-8
QA09-A38

December 1. 2008

[GO TO QA09-A391

Tell me how you first found out about your breast cancer. Was it by ...
Finding it yourself by accident........................................... 1
Finding it yourself during a self breast examination..........2
Your husband or partner finding it .....................................3
Your doctor finding it during a routine breast exam ..........4
Finding it by a mammogram .............................................. 5
Or some other way? (IF OTHER. SPECIFY):
.........6
DON'T KNOW .................................................................-7
REFUSED......................................................................... -8

QA09-A39

Did you have any other tests andlor surgery when your mammogram was not normal?

YES .................................................................... 1
NO .......................................................................... 2 [GO TO QA09-A411
DON'T KNOW .......................................................-7 [GO TO QA09-A411
REFUSED .........................................................-8 [GO TO QA09-A411
QA09-A40

What additional tests andlor surgery did you have?

[INTERVIEWER NOTE: CODE ALL THAT APPLY.IF NEEDED. SAY. "Any others?"]
NO TESTSMO SURGERY.................................1
MASTECTOMY (SURGERY TO
REMOVE BREAST) ...............................................2
LUMPECTOMY (SURGERY TO
REMOVE LUMP) ...................................................3
4
NEEDLE BIOPSY ...................................................
ULTRASOUND TEST ........................................5
ANOTHER MAMMOGRAM .................................6
CLINICAL BREAST EXAM ..................................7
REFUSED...............................................................
-7
DON'T KNOW .......................................................-8
PROGRAMMING NOTE QA09-A41:
IF QA09-A29=2 OR QA09-A30 = 0 OR QA09-A3 1 > 2 years. CONTINUE WITH QA09-A41;
ELSE GO TO PROGRAMMING NOTE QA09-A42;
In the past 2 years. has a doctor recommended that you have a mammogram?

YES ..........................................................................1
NO ............................................................................ 2
REFUSED ............................................................... -7
DON'T KNOW .......................................................-8

.

.'
CHIS 2009 Questionnaire

NCI (w/ English Simplification Changes)

December 1,2008

PROGRAMMING NOTE QA09-A42:
IF QA09-A41= 1 (YES, DOCTOR RECOMMENDED A MAMMOGRAM) AND (QA09-A29=2 OR
QAO9-A30 = 0 OR QAO9-A3 1 > 2 years), CONTINUE WlTH QAO9-A42;
IF QA09-A3 1 = 3,4,5, -8 (MOST RECENT MAMMOGRAM > 2 YEARS or DK), DISPLAY
"NOT had a mammogram in the past 2 years"; IF QA09-A29 = 2 (NEVER HAD MAMMOGRAM),
DISPLAY "NEVER had a mammogram";
ELSE GO TO NEXT SECTION,
QA09-A42

What is the ONE most important reason why you have {NEVER had a mammogram/NOT
had a mammogram in the past 2 years)?
NO REASONhEVER THOUGHT ABOUT IT .......1
DIDNT KNOW I NEEDED THIS TYPE OF TEST. 2
DOCTOR DIDNT TELL ME I NEEDED lT............3
HAVENT HAD ANY PROBLEMS..........................4
PUT IT OFFILAZINESS ...........................................5
TOO EXPENSIVENO INSURANCEICOST...........6
TOO PAINFUL, UNPLEASANT,
EMBARRASSING...................................................,7
TOO YOUNG ............................................................8
DONT HAVE A DOCTOR .......................................9
OTHER...................................................................91
REEUSED .................................................................-7
DONT KNOW ..........................................................-8

*
CHIS 2009 Questionnaire

December 1, 2008

NCI (w/ English Simplification Changes)

WALKING FOR TRANSPORTATION AND LEISURE
QA09-F7

The next questions are about walking for transportation. I will ask you separately about
walking for relaxation or exercise.
During the past 7 days, did you walk to get some place that took you at least 10 minutes?
YES .......................................................................... 1
NO ............................................................................ 2
UNABLE TO WALK .............................................. 3
REFUSED ......................................................... -7
DON'T KNOW ....................................................... -8

QA09-F8

[GO TO QA09-FlO]
[GO TO QA09-FlO]
[GO TO QA09-FlO]
[GO TO QA09-FlO]

In the past 7 days, how many times did you do that? [IF NEEDED, SAY: "Walk for at least
10 minutes to get some place."]

TIMES PER WEEK
REFUSED .................................................................. -7 [GO TO QA09-FlO]
DON'T KNOW .......................................................... -8 [GO TO QA09-FlO]
{How long did that walk take? / On average, how long did those walks take)?

MINUTES
REFUSED................................................................. -7
DON'T KNOW ..................................................... -8
QA09-F10

Sometimes you may walk for fun, relaxation, exercise, or to walk the dog. During the past 7
days did you walk for at least 10 minutes for any of these reasons? {Please do not include
walking for transportation.)
YES ............................................................................. 1
[GO TO NEXT SECT]
NO ........................................................................ 2
REFUSED .................................................................. -7 [GO TO NEXT SECT]
DON'T KNOW ......................................................... -8 [GO TO NEXT SECT]

QA09-Fl1

In the past 7 days, how many times did you do that? [IF NEEDED, SAY: "Walk for at least
10 minutes to get some place."]
TIMES PER WEEK

[IF 0, GO TO NEXT SECT]

REFUSED .................................................................. -7 [GO TO NEXT SECT]
DON'T KNOW .......................................................... -8 [GO TO NEXT SECT]

CHIS 2009 Questionnaire

NCI (w/ English Simplfication Changes)

December 1, 2008

{How long did that walk take? / On average, how long did those walks take)?

MINUTES

REFUSED ..................................................................-7
DON'T KNOW .......................................................... -8

*

-

*
CHIS 2009 Questionnaire

NCI (w/ English Simplification Changes)

December 1,2008

CIGARETTES
QA09-F13

Now, I am going to ask about various health behaviors.
Altogether, have you smoked at least 100 or more cigarettes in your entire lifetime?
YES .......................................................................... 1
NO ............................................................................ 2
REFUSED............................................................... -7
DON'T KNOW .......................................................-8

QA09-F14

[GO TO NEXT SECT]

Do you now smoke cigarettes every day, some days, or not at all?
EVERY DAY......................................................... 1
SOME DAYS ........................................................2
NOT AT ALL ..........................................................3
REFUSED..............................................................-7
DON'T KNOW .......................................................-8

[GO TO QA09-F16]
[GO TO NEXT SECT]
[GO TO NEXT SECT]

PROGRAMNoNG NOTE QA09-F13
IF QA09-F14 = 1 DISPLAY "On the average" and "do" and "now";
IF QA09-F14 = 3 DISPLAY '"Thinking back over the years you have smoked regularly, about" and "did" and
"usually";
QA09-F15

(On the averagemnking back over the years you have smoked regularly, about) how many
cigarettes (doldid) you (now/usually) smoke a day?

[INTERVIEWER NOTE: IF R SAYS, A "PACK", CODE AS 20 CIGARETTES]
NUMBER OF CIGARETTES ........................

[GO TO QA09-F17]

REFUSED............................................................... -7
DON'T KNOW ....................................................... -8

[GO TO QA09-F17]
[GO TO QA09-F17]

PROGRAMMING NOTE QA09-F16
IF QA09-F14 = 2 (SMOKE SOME DAYS), CONTINUE WITH QA09-F16;
ELSE CONTINUE WITH QA09-F 17;
QA09-F16

In the past 30 days, when you smoked, how many cigarettes did you smoke per day?
[INTERVIEWER NOTE: IF NEEDED SAY, "On the days you smoked. " AND IF R SAYS, A
"PACK': CODE THIS AS 20 CIGARETTES]
NUMBER OF CIGARETTES
REFUSED .......................................................... -7
DON'T KNOW .................................................. -8

CHIS 2009 Questionnaire

NCl (w/ English Simplification Changes)

December 1,2008

About how many years [have yoddid you] smoke[d] cigarettes regularly?

NUMBER OF YEARS
REFUSED............................................. ... . -7
DON'T KNOW ................................................. -8

-

*'

CHIS 2009 Questionnaire

NCI (w/ English Simplification Changes)

December 1,2008

SUN EXPOSUREISUNSCREEN USE
PROGRAMMING NOTE QA09-F24
IF AGE 1 12, CONTINUE WlTH QA09-F24;
QA09-F27

During the past 12 months, how many times have you had a sunburn?
[INTERVIEWER N0TE:IF NECESSARY SAY, "By 'sunburn7we mean even a small part of
your skin turning red or hurting for 12 hours or more.]
NUMBER OF SUNBURNS
REFUSED .......................................................................... -7
DON'T KNOW .................................................................... -8

QA09-F29

During the past 12 months, how many times have you used an indoor tanning device such as a
sunlamp, sunbed, or tanning booth? Do NOT include a spray-on tan.

NUMBER OF TIMES
REFUSED .......................................................... -7
DON'T KNOW .................................................. -8

-

@'

CHIS 2009 Questionnaire

NCI (w/ English Simplification Changes)

December 1.2008

DLETARY INTAKE
QA09-F40

During the past month, how often did {youlSP) drink regular soda or pop that contains sugar?
Do not include diet soda. (You can tell me per day, per week or per month).
[RVTERVIEER NOTE: IF NEEDED SAY, "Do not include canned or bottledjuices or teas.
Your best guess isfine."J

TIMES
PER DAY................................................................. 1
PER WEEK .............................................................. 2
PER MONTH........................................................... 3
REFUSED ............................................................. - 7
DON'T KNOW ...................................................... - 8
QA09-F42

(During the past month), how often did you drink coffee or tea with sugar or honey added?
Include coffee and tea you sweetened yourself and presweetened tea and coffee drinks such as
Arizona Iced Tea and Frappuccino. Do not include artificially sweetened or diet coffee or diet
tea. (You can tell me per day, per week or per month.)

TIMES
PER DAY............................................................ 1
PER WEEK .............................................................. 2
PER MONTH.......................................................... 3
REFUSED .......................................................... - 7
DON'T KNOW ....................................................- 8
QA09-F37

(During the past month), how often did you drink sweetened fruit drinks, sports or energy
drinks, such as Kool-aid, lemonade, Hi-C, cranberry drink, Gatorade, Red Bull, or vitamin
water? Include fruit juices you made at home and added sugar to. Do not include diet drinks
or artificially sweetened drinks. (You can tell me per day, per week or per month.)
[IF NEEDED, SAY: "Do not include yogurt drinks or mineral water. ")
TIMES
PER DAY ................................................................. 1
PER WEEK ..............................................................2
PER MONTH...........................................................3
REFUSED.............................................................- 7
DON'T KNOW ......................................................- 8

9

b~

CHIS 2009 Questionnaire

QA09-F38

NCI (w/ English Simplification Changes)

December 1,2008

(During the past month), how often did {youISP) eat cookies, cake, pie or brownies? Do not
include sugar-fiee kinds. (You can tell me per day, per week or per month.)

[IF NEEDED, SAY: "IncludeANYsweet pastries. " "Do not include sugar-pee kin&.. "J
TIMES
PER DAY...............................................................1
PER WEEK .............................................................. 2
PER MONTH........................................................... 3
REFUSED ............................................................. - 7
DON'T KNOW ...................................................... - 8
QA09-F39

(During the past month), how often did {youISP) eat ice cream or other fiozen desserts? Do
not include sugar-fiee kinds. (You can tell me per day, per week or per month.)

[IF NEEDED, SAY: "Do not include sugar--ee kin&. Your best guess isfine. "1
[IF STRONGLY NEEDED, SAY: "Other examples arefiozen yogurt and popsicles. '1
TIMES
PER DAY................................................................. 1
PER WEEK ..............................................................2
PER MONTH...........................................................3
REFUSED............................................................ - 7
DON'T KNOW .................................................- 8
QA09-F41

Now think about the past week In the past 7 days, how many times did you eat fast food?
Include fast food meals eaten at work, at home, or at fast-food restaurants, carryout or drive
through.

[INTER VIEWER NOTE: IF NEEDED SA Y, "Such asfood you get at McDonald's, KFC,
Panda Express or Taco Bell. '7
# OF TIMES IN PAST 7 DAYS
REFUSED................. .......................... . ............-7
DON'T KNOW .......................................................-8

' .a1
CHIS 2009 Questionnaire

NCI (w/ English Simplification Changes)

December 1,2008

BREAST CANCER RISK (MENARCHE & LIVE BIRTHS)
PROGRAMMING NOTE QA09-Dl:
IF MALE, GO NEXT SECTION, ELSE CONTINUE QA09-Dl;
These next questions are about women's health.
How old were you when your periods or menstrual cycles started?
[INTER VIEWER NOTE: IF NEVER STARTED MENSTRUAL CYCLE, ENTER 961

AGE
NEVER STARTED MENSTRUAL CYCLE ........96
REFUSED...............................................................-7
DON'T KNOW .....................................................-8
PROGRAMMING NOTE QA09-D2;
IF QAO9-Dl= -8 (DON'T KNOW), CONTINUE WITH QA09-D2; ELSE GO TO QA09-D3;
Were you younger than 12, about 12-13, or older than 13?

YOUNGER THAN 12 ............................................. 1
ABOUT 12 to 13...................................................... 2
OLDER THAN 13 .................................................. 3
REFUSED...............................................................-7
DON'T KNOW....................................................... -8

Do you still have periods or menstrual cycles?
YES .......................................................................... 1
NO ............................................................................ 2
REFUSED..............................................................-7
DONT KNOW ....................................................... -8

[GO TO QA09D41
[GO TO QA09D41
[GO TO QA09D41

When did you have your last period or menstrual cycle?
AGE
MONTHS
YEARS
REFUSED .............................................................
-7
DONT KNOW .................................................... -8
Have you ever given birth to a live born infant?

[INTERVIEWERNOTE: IF NEEDED, SAY: "A live born infant is an infant born alive."]

YES ......................................................................... 1
NO ........................................................................... 2
REFUSED............................................................... -7

[GO TO NEXT SECT]
[GO TO NEXT SECT]

c
;

'

9

CHIS 2009 Questionnaire

NCI (w/ English Simplification Changes)

DON'T KNOW ....................................................-8

How old were you when your first child was born?
YEARS OLD .............................................. 2
REFUSED ............................................................... -7
DONT KNOW .......................................................-8
In what year was your first child born?

YEAR
REFUSED ............................................................... -7
DONT KNOW .......................................................-8

December 1.2008

[GO TO NEXT SECT]

.

* & s -

CHIS 2009 Questionnaire

NCI (w/ English Simplification Changes)

HOROMONE THERAPY, BIRTH CONTROL
PROGRAMMING NOTE QA09-D2
IF AGE>44 CONTINUE WITH QA09-D2;
ELSE GO TO QA09-D3;

QA09-Dl0 INTRO

Are you taking any of the following medications?

Hormone replacement therapy?
YES .......................................................................... 1
NO ............................................................................
2
REFUSED ............................................................... -7
DONT KNOW .......................................................-8
Tamoxifen or Nolvadex?
YES ........................................................................1
NO .......................................................................2
REFUSED ...............................................................-7
DONT KNOW .......................................................-8
PROGRAMMING NOTE QA09-Dl2
IF AGE>44 CONTINUE WITH QAO9-D 12;
ELSE GO TO QA09-D13;
QA09-Dl2

Raloxifen or Evista?
YES ......................................................................... 1
NO ............................................................................2
REFUSED...............................................................-7
DONT KNOW .......................................................-8

PROGRAMMING NOTE QA09-Dl3
IF AGEC55 CONTINUE WlTH QA09D13;
ELSE GO TO SECTION E;
QA09-Dl3

Birth control pills, the patch, or birth control shots?
YES .......................................................................... 1
NO ......................................................................... 2
REFUSED............................................................ -7
DONT KNOW ..................................................... -8

December 1.2008

' L b * r

CHIS 2009 Questionnaire

NCI (w/ English Simplification Changes)

December 1. 2008

Have you ever taken hormone replacement therapy or HRT for menopausal symptoms?
YES .......................................................................... 1
NO ........................................................................... 2
REFUSED ............................................................... -7
DON'T KNOW .................................................... -8
QA09-Dl5

[GO TO NEXT SECTION]
[GO TO NEXT SECTION]
[GO TO NEXT SECTION]

About how long ago did you stop using Hormone Replacement Therapy .
was it ...
Less than 2 years ago ........................................ 1
More than 2 years up to 5 years ago .........................2
More than 5 years ago .............................................. 3
REFUSED ............................................................... -7
DON'T KNOW ....................................................... -8
Some women go on and off hormone replacement therapy. Altogether. how long have you
taken HRT?
A YEAR AGO OR LESS ........................................ 1
MORE THAN 1 UP TO 2 YEARS ......................... 2
MORE THAN 2 UP TO 4 YEARS ......................... 3
MORE THAN 4 UP TO 8 YEARS ......................... 4
MORE THAN 8 YEARS AGO ............................... 5
REFUSED ............................................................... -7
DON'T KNOW ....................................................... -8

.

&a1

CHIS 2009 Questionnaire

NCI (w/ English Simplification Changes)

December 1. 2008

FAMILY HISTORY OF CANCER
What about your family? By family we mean only your blood relatives . Did your biological
father or mother. full brother or sisters. or biological sons or daughters ever have cancer of
any kind?

[IF NEEDED. SAY: "Do not include family members related through marriage such as a
stepfather or stepsister. or family members who were adopted."]
YES ..................................................................... 1
NO ....................................................................... 2
REFUSED .......................................................... -7
DON'T KNOW .................................................. -8
What kind of cancer or cancers were these?

[CODE ALL THAT APPLY]
[PROBE: "Any others?"]
BLADDER .......................................................................
1
BLOOD ............................................................................
2
BONE ...............................................................................
3
BRAIN .............................................................................
4
BREAST .......................................................................... 5
CERVIX ........................................................................... 6
COLON ............................................................................7
ESOPHAGUS .................................................................. 8
GALLBLADDER ............................................................ 9
KIDNEY ........................................................................ 10
LARYNX-WINDPIPE................................................... 11
LEUKEMIA ................................................................... 12
LIVER ............................................................................
13
LUNG ............................................................................
14
LYMPHOMA ................................................................
15
MOUTWTONGUE/LIP ................................................ 16
OVARY .........................................................................17
PANCREAS ............................................................
18
PROSTATE ................................................................... 19
RECTUM ....................................................................... 20
SKIN .............................................................................. 21
SOFT TISSUE (MUSCLE OR FAT)............................. 24
STOMACH .................................................................... 25
TESTIS .......................................................................... 26
THROAT-PHARYNX................................................... 27
THYROID...................................................................... 28
UTERUS ........................................................................ 29
OTHER .......................................................................... 91
REFUSED ....................................................................... -7
DON'T KNOW ............................................................... -8

-

L

i - 9

CHIS 2009 Questionnaire

NCI (w/ English Simplification Changes)

December 1.2008

PROGRAMMING NOTE QA09-G3
IF QA09-G2 = 2 1, THEN CONTINUE WITH QA09-G3;
ELSE SKIP TO PN QA09-G4;
Was the skin cancer you mentioned non-melanoma, melanoma, or an unknown type?
[CODE ALL THAT APPLY]
Non-melanoma .................................................... 1
Melanoma ........................................................... 2
Unknown type ..................................................... 3
REFUSED ....................................................... -7
DON'T KNOW .................................................. -8
PROGRAMMING NOTE QA09-G4
IF QA09-G2 = 5, THEN CONTINUE WITH QA09-G4;
ELSE SKIP TO PN QA09-G7;
QA09-G4

Was your mother ever diagnosed with breast cancer?
YES ..................................................................... 1
NO ....................................................................... 2
REFUSED .......................................................... -7
DON'T KNOW .................................................. -8

QA09-G5

Do you have any sisters who have ever been diagnosed with breast cancer?
YES ..................................................................... 1
NO ....................................................................... 2 [GO TO PN QA09-G7]
REFUSED .......................................................... -7 [GO TO PN QA09-G7]
DON'T KNOW .................................................. -8 [GO TO PN QA09-G7]
How many?
NUMBER OF SISTERS WITH BREAST CANCER
REFUSED .......................................................... -7
DON'T KNOW ................................................-8

.

i*'

NCI (w/ English Simplification Changes)

CHIS 2009 Questionnaire

December 1,2008

PROGRAMMING NOTE QA09-G7
IF QAO9-G2 = (7 OR 20), THEN CONTINUE WITH QAO9-G7;
ELSE SKIP TO NEXT SECTION,
Who was diagnosed with colon or rectal cancer?
[IF NEEDED, SAY: "Do NOT include STEP or HALF brothers and sisters."]
[CODE ALL THAT APPLY]
MOTHER ............................................................ 1
FATHER .............................................................2
FULL BROTHER .......................................... 3
FULL SISTER .................................................... 4
BIOLOGICAL, SON ........................................5
BIOLOGICAL DAUGHTER ............................. 6
REFUSED.........................................................-7
DON'T KNOW ..................................................-8
PROGRAMMING NOTE QA09-G8
IF QAO9-G7 = (3,4,5, or 6), THEN CONTINUE WITH QAO9-G8;
ELSE SKIP TO NEXT SECTION,
QA09-G8

How many?
NUMBER OF FAMILY MEMBERS WITH COLON OR RECTAL CANCER
REFUSED..........................................................-7
DON'T KNOW ..................................................-8

APPROVAL NOTICE
OFFICE FOR PROTECTION OF RESEARCHSUBJECTS

I 1000 Kinross Avcnuc. Suiu 101
169407
w~v~~~.oprs.ucla.cdu

DATE:

November 24,2008

TO:

E. Richard Brown, Ph.D.
Principal Investigator

FROM:

Alison A. Moore, M.D.,M.P.H.
Chair, South General Institutional Review Board

RE:

UCLA IRB #G08- 10-098-0 1
Approved by Full Committee Review
(Approval Period from 1 1/24/2008 through 1 1117/2009)
California Health Interview Survey (2009)

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.
PLEASE COMPLY WITH THE FOLLOWING CODICIL(S) IMPOSED BY THE IRB:
1. This Approval Notice is issued for administrative purposes only. No subjects may be
contacted, recruited, or enrolled in the 2009 California Health Interview Survey. All
related IRB-approved forms will be held on file until the AMENDED Certificate of
Confidentiality for this study is received and acknowledged (through issuance of a
revised approval notice) by the UCLA IRB.
2. Upon the expected enrollment of non-English speaking subjects o r those who are not
fluent in English, non-English recruitment materials and consent materials/scripts
must be received and ackno\vledged by the UCLA IRB (through issuance of a revised
approval notice) prior to implementation.

3. No subjects may be contacted, recruited or enrolled in this study until copies of the
Westat IRB approval (CHIS 2009 data collection contractor) and the State of
California Committee for the Protection of Human Subjects are received and
acknowledged by the UCLA SGIRB.

APPROVAL NOTICE
IRB #G08-10-098-0 1

3-~

Approval Signature of the UCLA IRB 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 IRB. You must abide by the following
principles when conducting your research:
1. Perform the project by qualified personnel according to the approved protocol.

3. DOnot implement changes in the approved protocol or consent form without prior UCLA
IRB approval (except in a life-threatening emergency, if necessary to safeguard the wellbeing of human subjects.)
3. If written consent is required, obtain the legally effective written informed consent from
human subjects or their legally responsible representative using only the currently approved
UCLA-IRB stamped consent form.
4. Promptly report all undesirable and unintended, although not necessarily unexpected adverse
reactions or events, that are the result of therapy or other intervention, within ten working
days of occurrence. All fatal or life-threatening events must be reported to the UCLA IRB in
writing within 2 working days after discovery.
5. In clinical medical research, any physician(s) caring for your research subjects must be fully
aware of the protocol in which the subject is participating.
6. No subjects may be identified, contacted, recruited, or enrolled until the contract with the
sponsor is finalized by the University.
7. Ensure that all individuals who will interact with subjects and/or have access to identifiable
research data have completed the UCLA Protection of Human Research Subjects
Certification.
8. Ensure that all individuals who will access subjects' medical records have completed the
UCLA HIPAA Research Training Certification.
9. If non-UCLA sites or personnel are involved, follow all study-specific requirements and
consent processes approved by the UCLA IRB.

FUNDING SOURCE($):
According'to the information provided in your application, the funding source(s) for this research
project may include the following: extramural.

Page 1 of 1

OHSR (NIHIDDIR)
From: OHSR (NIHIDDIR)
Thursday, December 18,2008 12:19 PM
Sent:
To:
Breen, Nancy (NIHINCI) [El
Subject: Request for Review Rec'd-OHSR
Good afternoon Dr. Breen,
This email is to verify that OHSR has received your Request for Review of Research and it is currently being
processed as OHSR #4470. Please use this number in any future correspondence regarding this study. We will
contact you via email if any additional information is needed. If you have not heard from OHSR within 7 business
days, please contact us.
/

OHSR:
Ph: 301.402.3444
Fax: 301.402.3443
Thank you.
Sincerely,
Chris Brentin

Administrative Assistant

10 Center Drive, Rm. 2C-146
Bethesda, MD 20892
30 1-402-8631 (Direct)
30 1-402-3443 (Fax)

Page 1 of 1

OHSR (NIHIDDIR)

Sent:

OHSR (NIHIDDIR)
Monday, December 22,200811:35 AM

To:

Breen, Nancy (NIHINCI) [El

From:

Request for Review Determination
Attachments: BreenN-NCI-DoesNotApply-4470-CY2008.pdf
Subject:

Good morning Dr. Breen,
Attached, please find OHSR's determination of your Request for Review of Research, OHSR #4470.
please feel free t o contact OHSR with any questions.
Sincerely,
Chris Brentin

1

Administrative Assistant
OD/OHSR/NIH
10 Center Drive, Rm. 2C- 146

Bethesda, MD 20892
30 1-402-863 1 (Direct)
301-402-3443 (Fax)