IRB Approval

NCEZID Tracking Number: 021016MG

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

Primary contact

CDC Emergency Operations Center Zika virus clinical inquiries and surveillance

Maleeka Glover, ScD, MPH

Division/Branch DPEI/EPRB

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
CDC has activated the Emergency Operations Center in response to the ongoing Zika virus outbreak in the
Americas. As part of this response, a call center has been established to handle clinical inquiries about suspected
and confirmed Zika virus illness cases in the US. This determination covers the systematic collection of standardized
demographic and clinical data in order to both track and monitor the nature and frequency of inquiries, and to serve
as a passive surveillance system for situational awareness and to inform ongoing response efforts within CDC. As
an activity designed to track services provided by CDC and to monitor the nature and frequency of clinical inquiries to
inform ongoing response efforts in the context of a public health emergency, this activity is consistent with the
attributes of non-research surveillance, program evaluation, and public health response, as described in current CDC
policy. This activity is not designed to develop or contribute to generalizable knowledge.

Additional considerations
Activities include following up on inquiries received prior to the approval of this protocol, in order to gather missing
data for those calls. Data collected as part of this activity may feed into other surveillance programs implemented as
part of this response, including the pregnancy registry (to be submitted under separate cover).

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

Laura
Youngblood -S

Digitally signed by Laura Youngblood -S
DN: c=US, o=U.S. Government, ou=HHS,
ou=CDC, ou=People,
0.9.2342.19200300.100.1.1=1001704097
, cn=Laura Youngblood -S
Date: 2016.02.10 10:44:57 -05'00'

Signature: _________________________________

Title Human Subjects Advisor, NCEZID
2/10/2016

Date: _______________