Attach 8 IRB and OHSR Approvals_1-10-2011

Attachment 8

OHSR Determination and UCLA Institutional
Review Board Approval

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

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.