San Diego_Talavera_3677_SOL_IRB Renewal

Graduate and Research Affairs
Division of Research Affairs
San Diego State University
5500 Campanile Drive
San Diego CA 92182•8220
Phone: 619•594•5938
Fax: 619•594•4109

Submit your report of progress by 5/3/2012
June 3, 2011
Faculty Researcher: Greg Talavera, MD, MPH
Department: Public Health
Title: Hispanic Community Health Study/Study of Latinos (HCHS/SOL)
vIRB Number: 3677
Grants/Contracts: NIH G00006784
Regulatory Determinations
Modification: Expedited per 45 CFR 46.110(b)(2), Minor Modification
Continuation: Expedited per 45 CFR 46.110, Category 9
Dear Professor Talavera:
The SDSU Institutional Review Board approved the project referenced for continuation and modification
on June 2, 2011, in accordance with SDSU's Assurance and federal requirements pertaining to human
subjects protections within the Code of Federal Regulations (45 CFR 46; 21 CFR 50). The approval for
continuation applies to the recruitment of human subjects and collection/analysis of data based on
procedures described in your protocol and the information you provided within your report of progress.
The modification approval is valid for revisions to the protocol [procedure to document informed consent
details over time, use of participant safety screening form, use of informant/alternate respondents].
Approval carries with it the understanding that you will contact the IRB to obtain authorization to
implement any proposed changes to the protocols, to document a change in your affiliation with SDSU
(student, faculty or staff), and/or to report the completion of study recruitment, data collection and
data analysis. Project approval expires June 3, 2012.
Please note your expiration date. To request continued recruitment, data collection and/or
data analyses, a Report of Progress must be submitted prior to the expiration date of your
study. A lapse in approval requires that all research with human subjects be suspended until
approval is obtained and may result in a temporary hold on funds, if your study is funded. The
investigator will be out of compliance with federal regulation and university policy if human
subjects continue to be involved in this project without a valid IRB approval.
As the consent document has been modified, please note that a final version of the consent
form (Talavera_SOL_3677_San Diego Eng IC Renewal FINAL v2 5-5-2011_stamped.pdf;
Talavera_SOL_3677_San Diego Span version FINAL Renewal v2 5-5-2011_stamped.pdf) has
been uploaded to your protocol file within the vIRB system, within the "Supporting Documents"
section. This document bears the IRB's stamp of approval. Print a copy of this stamped form to
use when documenting informed consent from research participants. Changes may not be made
to the consent documents without prior review and approval of the IRB. You are required to
keep signed copies of the consent documents for three years after your project has been
completed or terminated.

THE CALIFORNIA STATE UNIVERSITY • BAKERSFIELD • CHANNEL ISLANDS • CHICO • DOMINGUEZ HILLS • EAST BAY • FRESNO • FULLERTON • HUMBOLDT • LONG BEACH • LOS ANGELES
MARITIME ACADEMY • MONTEREY BAY • NORTHRIDGE • POMONA • SACRAMENTO • SAN BERNARDINO • SAN DIEGO • SAN FRANCISCO • SAN JOSE • SAN LUIS OBISPO • SAN MARCOS • SONOMA • STANISLAUS

Graduate and Research Affairs
Division of Research Affairs
San Diego State University
5500 Campanile Drive
San Diego CA 92182•8220
Phone: 619•594•5938
Fax: 619•594•4109

Please note the following:
a) As this study requires consent translation: The SDSU Institutional Review Board (IRB) does
not verify the accuracy of the translated document. IRB approval of this document for use in
subject recruitment is based on your assurance that the translated document reflects the
content of the IRB approved English version of the document.
b) If recruitment will take place through an outside agency or organization, confirm with that
institution that you have permission to conduct the study prior to initiation of any study
activities.
c) Approval is contingent upon the completion of the SDSU human subjects tutorial (found at:
http://www-rohan.sdsu.edu/~gra/login.php) by all members of the research team. This
certification must be renewed every 2 years.
d) If any changes to your study are planned, you must submit a modification request and receive IRB
approval prior to the implementation of study changes. To submit a modification request, access the
protocol via the WebPortal, on the protocol Main Page, you will need to click on "Modifications" under
Protocol Maintenance and enter a report. Once you have filled in your responses on the report form,
click "submit".
REQUIREMENTS!
• To document your modification in detail, access your currently approved protocol in the “Full
Document Viewer.” Copy and paste the document into Word and use “track changes” to
document revisions to your protocol. Save the file (Name_Modification_Date) and upload it to
your protocol file. When approved by the IRB, this document will be the current version of your
approved protocol.
• If a change to the approved consent form(s) or other uploaded document(s) is being
requested, changes must be documented using the “track changes” feature in Word. Upload the
revised form to your vIRB protocol file. This form will be reviewed by the IRB. If you do not have
a copy of your approved consent form in a Word format, request a copy from the IRB office.
e) The SDSU IRB requires investigators to report any problems that arise during the course of an IRB
approved research study. Serious adverse events or unanticipated problems that are life-threatening or
have resulted in serious injury or death must be reported to the IRB immediately whenever possible or
within at least 48 hours from the onset of the incident. All other problems must be reported to the SDSU
IRB within 5 days. To complete and submit an adverse event report, go to the Protocol Main Menu,
click on “Adverse Events” under “Protocol Maintenance” and follow the instructions. For more
information and consultation, contact the IRB office directly via Email at: [email protected] or
telephone: 619-594-6622, Monday through Friday from 8:00AM to 4:00PM.
f) To submit a request to extend IRB approval, log in to your WebPortal account and access the
protocol. On the protocol Main Page, click on "Progress Reports" under Protocol Maintenance

THE CALIFORNIA STATE UNIVERSITY • BAKERSFIELD • CHANNEL ISLANDS • CHICO • DOMINGUEZ HILLS • EAST BAY • FRESNO • FULLERTON • HUMBOLDT • LONG BEACH • LOS ANGELES
MARITIME ACADEMY • MONTEREY BAY • NORTHRIDGE • POMONA • SACRAMENTO • SAN BERNARDINO • SAN DIEGO • SAN FRANCISCO • SAN JOSE • SAN LUIS OBISPO • SAN MARCOS • SONOMA • STANISLAUS

Graduate and Research Affairs
Division of Research Affairs
San Diego State University
5500 Campanile Drive
San Diego CA 92182•8220
Phone: 619•594•5938
Fax: 619•594•4109

and enter a report. Once you have filled in your responses on the report form, click "submit".
You should receive an automated email verifying IRB receipt of your Report of Progress.
REQUIREMENT! Within the description box of the Report of Progress form, indicate which, if
any, consent form(s) you are requesting to renew. Refer to the Consent Form Development
section of the protocol and provide the IRB with the specific file names and date(s) of upload of
the consent document(s) you are requesting to renew.
For questions related to this correspondence, please contact the IRB office ((619) 594-6622 or email [email protected]). To access IRB review application materials, SDSU's Assurance, the 45
CFR 46, the Belmont Report, and/or any other relevant policies and guidelines related to the
involvement of human subjects in research, please visit the IRB web site at
http://gra.sdsu.edu/research.php.
Sincerely,

Jeanne Nichols
Chair, Institutional Review Board

Brianne Larsen-Mongeon
Regulatory Compliance Analyst

Amy McDaniel
Regulatory Compliance Analyst

Choya Washington
Regulatory Compliance Analyst

THE CALIFORNIA STATE UNIVERSITY • BAKERSFIELD • CHANNEL ISLANDS • CHICO • DOMINGUEZ HILLS • EAST BAY • FRESNO • FULLERTON • HUMBOLDT • LONG BEACH • LOS ANGELES
MARITIME ACADEMY • MONTEREY BAY • NORTHRIDGE • POMONA • SACRAMENTO • SAN BERNARDINO • SAN DIEGO • SAN FRANCISCO • SAN JOSE • SAN LUIS OBISPO • SAN MARCOS • SONOMA • STANISLAUS