IRB determination

NCEZID Tracking Number: 022113YZ

Determination of Non-applicability of Human Subjects Regulations
National Center for Emerging and Zoonotic Infectious Diseases (NCEZID)
Project title

Primary contact

School dismissal monitoring

Yenlik Zheteyeva, MD, MPH

Division/Branch DGMQ/

The purpose of this form is to document NCEZID’s determination that the above-listed protocol does not
require submission to CDC’s Human Research Protection Office. Under existing institutional policy,
authority to determine whether a project is research involving human subjects or whether CDC is
engaged in human subjects research is delegated to the National Centers.
Determination
Project does not meet the definition of research under 45 CFR 46.102(d). IRB review is not required.
Project does not involve human subjects under 45 CFR 46.102(f). IRB review is not required.
CDC is not engaged in the conduct of human subjects research per 2008 OHRP engagement
guidance. CDC IRB review is not required. Investigator has provided documentation of appropriate
local review.
Rationale
This monitoring program was initially implemented during the 2009 H1N1 pandemic to monitor school closures. It
was implemented under an Epi-Aid, and was considered to be non-research. Because of the duration of the project,
a formal OMB package was submitted. DGMQ has decided to renew the OMB package as a pre-positioned program
for implementation, should such monitoring be warranted in the future. As a pre-positioned protocol, intended to be
used in the event of an immediate public health threat, this activity falls within the scope of routine non-research
public health response.

Additional considerations
It should be noted that this activity does not collect any individual-level information. As such, it would not be said to
involve "human subjects."

Additional requirements
None.

Changes in the nature or scope of this activity may impact the regulatory determination. Please
discuss any changes with your NC Human Subjects Advisor before they are implemented.
Reviewed by Laura Youngblood, MPH, CIP

Signature:

Laura
Youngblood
_________________________________
Digitally signed by Laura Youngblood
DN: c=US, o=U.S. Government, ou=HHS,
ou=CDC, ou=People, cn=Laura
Youngblood,
0.9.2342.19200300.100.1.1=1001704097
Date: 2013.02.21 09:11:21 -05'00'

Title Human Subjects Advisor, NCEZID
2/21/13

Date: _______________