IRB Determination - 23MAR2016

NCEZID Tracking Number: 021116SH

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

Primary contact

United States registry for Zika virus infection during pregnancy (UPDATED)

Susan Hills, MBBS, MTH

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
The purpose of this activity is to monitor the frequency and types of adverse birth outcomes for women infected with
Zika virus during pregnancy. The registry aims to include all pregnant women identified in the US with evidence of
Zika virus infection. Women may be identified through multiple mechanisms, including reports to ArboNet from health
departments, diagnostic testing performed by CDC laboratories, and other Zika virus response activities, including
clinical inquiries made to the EOC call center. Follow-up information will be requested at the time of birth, and
periodically through the first year of the infant's life to monitor for adverse birth outcomes and developmental delays.
As an activity designed to monitor the frequency of occurrence of adverse birth outcomes in the context of a public
health emergency, this activity is consistent with the attributes of non-research surveillance and public health
response, as described in current CDC policy.

Additional considerations
Since the initial determination, Zika virus disease was added to the list of nationally notifiable diseases, and CSTE
established case definitions for Zika virus disease and congenital Zika virus infection. Because the registry now falls
clearly within the scope of mandated reporting, the previously-proposed consent procedures have been removed, as
they are not appropriate for mandated public health reporting.

Additional requirements
An Assurance of Confidentiality is being sought for this surveillance activity.

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: 2016.03.23 14:47:10 -04'00'

Signature: _________________________________

Title Human Subjects Advisor, NCEZID
3/23/16

Date: _______________