Non-Research Determination

NCEZID Tracking Number: 042817ES

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

Primary contact

3 Zika virus disease enhanced surveillance projects: children, hospitalizations, neurologic
disease
Erin Staples, MD, PhD
Nicole Lindsey, MS

Division/Branch DVBD/ADB

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
These 3 related projects will request additional clinical information on patients with Zika virus disease reported
through ArboNET. Additional clinical information is needed in order to better characterize the clinical presentation of
Zika virus disease in children and in patients who go on to require hospitalization, and the spectrum of
Zika-associated neurologic disease. The findings will feed back directly to ongoing response activities, primarily in
the development of educational materials targeting clinicians, in order to improve case ascertainment among
children, identify patients at risk of more severe, and improve clinician awareness of the spectrum of neurologic
disease. As an activity designed to improve clinician awareness in the context of an ongoing public health threat, this
activity is consistent with the attributes of non-research public health response. This activity is not designed to
develop or contribute to generalizable knowledge.

Additional considerations
If requested information is not available in medical records, cases (or parents) may be contacted by the state or local
health department. Verbal consent will be obtained following a standardized script.

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: 2017.04.28 17:16:10 -04'00'

Signature: _________________________________

Title Human Subjects Advisor, NCEZID
4/28/17

Date: _______________