San Diego

From: Amy McDaniel [mailto:amcdanie@mail.sdsu.edu]
Sent: Wednesday, July 30, 2008 2:45 PM
To: gtalaver@mail.sdsu.edu
Cc: jelder@mail.sdsu.edu; Ana Talavera; awards@foundation.sdsu.edu
Subject: Hispanic Community Health Study/Study of Latinos (HCHS/SOL)

Contract/grant number: G00006784
SDSU vIRB Study Number: 3677
SDSU IRB Protocol Title: Hispanic Community Health Study/Study of Latinos (HCHS/SOL)

Dear Dr. Talavera:
 
The SDSU Institutional Review Board approved the project referenced for continuation on July 30, 2008 in accordance with SDSU's Assurance and federal requirements pertaining to human subjects protections within the Code of Federal Regulations (45 CFR 46.110(9); 21 CFR 50). This approval applies to the collection and/or analysis of data collected based on procedures described in your protocol and the information you provided within your report of progress. Approval carries with it the understanding that you will contact the IRB to obtain authorization to implement any proposed changes to the protocol, to document a change in your affiliation with SDSU (student, faculty or staff), and/or to report study completion (recruitment, data collection and analysis). Project approval expires one year from this date.
 
As your study requires the use of two (Spanish and English) stamped consent document, copies of the re-approved and re-stamped consent forms have been uploaded to your protocol file within the vIRB system, within the Supporting Documentsµ section.  These documents bear the IRB's stamp of approval. Please print a copy of these stamped forms 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.
 
Also, as your study requires consent document translation, please note that the SDSU Institutional Review Board (IRB) does not verify the accuracy of the Spanish-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. 
 
For questions related to this correspondence, please contact the IRB office ((619) 594-6622 or e-mail irb@mail.sdsu.edu). 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 F. Nichols, Chair
SDSU Institutional Review Board
 
Wendy Bracken                                                
Human Research Protection Program Coordinator            
 
Amy McDaniel         
Regulatory Compliance Analyst  
 
Choya Washington
Regulatory Compliance Analyst  

Amy McDaniel
Regulatory Compliance Analyst
Direct Line: (619) 594-0758