Medical Center Director Certification for Research Involving Neonates/Children as Research Subjects at the Atlanta va medical Center

In regards to the above mentioned study, I am requesting the AVAMC Medical Center Director to allow approval of human subjects research activities with:

 Neonates

 Children
Please briefly summarize the study activities to be done with the above checked populations:

Add text here
 These activities are considered less than or equal to minimal risk activities, as determined by the IRB

 These activities are considered greater than minimal risk, as determined by the IRB

If the VA is not the sponsor of this study, has the sponsor procured appropriate liability insurance for this study?

 Yes

Based on the information provided, please certify if the AVAMC (check all that apply):

 Human subject activities with the populations checked in this application may be conducted at AVAMC as per the IRB-approved protocol

 Is able to respond to pediatric emergencies in this study (only applicable for studies approved by the IRB as greater than minimal risk involving pregnant women)

Reviewed by: David Bower, MD; Atlanta VAMC Chief of Staff
Signature:		Date:
 Approved	 Not approved
Reviewed by: Annette P. Walker; Atlanta VAMC Medical Center Director
Signature:		Date:
 Approved	 Not approved