Attachment 6a - IRB approval extension

Approval for ACE study 2010-2011.pdf

Examining In-Vehicle Exposures to Air Pollutants and Corresponding Health Outcomes of Commuters

Attachment 6a - IRB approval extension

OMB: 0920-0859

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TO:
 
CC:
 
 
DATE:
 
RE:
 
 

 
Jeremy Sarnat, MD 
Principal Investigator
 
Greenwald
Robert
Envir & occup Health
Kewada
Priya
Envir & occup Health
Greenwald
Robert
Envir & occup Health
Wongtrakool
Cherry
MedPulm
 
May 5, 2010
 
Notification of Continuing Review Full Board Approval
CR2_IRB00018855
IRB00018855
The Atlanta Commuters Exposure Study

This is your notification that your above referenced Continuing Review was reviewed and APPROVED
under the Full Board review process by Committee B on April 27, 2010.  This approval is valid
from April 27, 2010 to April 26, 2011. Thereafter, continued approval is contingent upon the submission
of a renewal form that must be reviewed and approved by the IRB prior to the expiration date of this
study. 
The study is now considered minimal risk and can be expedited in the future.
A Partial HIPAA Wavier was granted.
Protocol Version 4 was approved
Consent Version Date: June 17, 2010 was approved.
HIPAA Version Date: March 5, 2009 was approved.
Any reportable events (serious adverse events, breaches of confidentiality, protocol deviation or protocol
violations) or issues resulting from this study should be reported immediately to the IRB and to the
sponsoring agency (if any). Any amendments (changes to any portion of this research study including but
not limited to protocol or informed consent changes) must have IRB approval before being implemented.
Please include the IRB ID, the name of the Principal Investigator and the Study Title in all future
inquiries.
Sincerely,
Carla C. Belk, PhD
Sr. Research Protocol Analyst
This letter has been digitally signed

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