Non-Research Determination

NCEZID Tracking Number: 080916KH

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

Project title CDC Zika Text Messaging Service

Primary contact Kelly Holton

Division/Branch DGMQ/GMHPB

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.

Additional clearances – this project has been reviewed by the following teams/units

Global Migration Task Force

Mary Naughton

OMB/PRA Advisor

Chris de la Motte Hurst

Lee Samuel

Informational – the following teams/units have received informational copies with opportunity to
comment

Home Division

Pam Diaz

Comments

NCEZID Determination – Zika Response

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NCEZID Tracking Number: 080916KH
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 gather feedback on the CDC Zika text message service, a service that has
been implemented as part of the ongoing public health response to Zika in the Americas. CDC Zika text
message subscribers will be invited to complete a short user satisfaction survey. The results will inform
ongoing operations of the messaging service. As an activity designed to gather feedback to inform the
operation of a routine service, this activity is consistent with the attributes of non-research program
evaluation. This activity is not designed to develop or contribute to generalizable knowledge.

Additional considerations

None.

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=100170409
7, cn=Laura Youngblood -S
Date: 2016.08.09 18:55:21 -04'00'

Signature: _________________________________

NCEZID Determination – Zika Response

Title Human Subjects Advisor, NCEZID

8/9/16
Date: _______________

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