Non-Research Determination

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 (REVISED 5.26.16)

Jeanne Bertolli

Division/Branch EOC/Zika

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
Zika virus disease and congenital infection are nationally notifiable conditions, and the WHO has declared the Zika
virus outbreak a public health emergency of international concern. The purpose of this activity is to monitor the
frequency and types of adverse birth outcomes for women in the US infected with Zika virus during pregnancy. The
registry aims to include all pregnant women with Zika virus infection. Women may be identified through multiple
mechanisms. 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 to provide situational
awareness and inform appropriate public health measures, this activity is consistent with the attributes of
non-research surveillance and public health response, as described in current CDC policy.

Additional considerations
Informed consent/HIPAA authorization will not be sought, as permitted in the public health provision of the HIPAA
Privacy Rule. Although not subject to the requirements of 45 CFR 46, provisions for waiving consent under §46.116
(d) were used as a model for ethical consideration. This surveillance project was determined to meet these criteria
for waiving consent.

Additional requirements
An Assurance of Confidentiality has been awarded 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: 2016.05.26 09:26:54 -04'00'

Signature: _________________________________

Title Human Subjects Advisor, NCEZID
5/26/16

Date: _______________