IRB Determination

NCEZID Tracking Number:

071118KH

Determination of Non-applicability of Human Subjects Regulations
National Center for Emerging and Zoonotic Infectious Diseases (NCEZID)
Project title Viajo sin Zika Awareness Communication Campaign for Hispanics/Latinos Visiting Friends
and Relatives: Focus Groups with Participants Exposed to the Viajo sin Zika Campaign
Primary contact Kelly Holton

Division/Branch DGMQ/THB

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 project is to evaluate the impact of the Viajo sin Zika informational campaign targeted to
travelers at risk for Zika exposure and infections. The informational campaign used traditional and social media to
share Zika prevention and travel health recommendations. This project will conduct a series of focus groups to
evaluate the impact of the campaign and the effectiveness and acceptability of the campaign materials. The focus
groups will be conducted by contractor ICF and results may be published as a manuscript. As this project is to
conduct a standard public health informational campaign, it is consistent with non-research public health
evaluation, per CDC guidance. This project is not designed to 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.

Human Subjects Advisor

Reviewed by James Peterson, PhD

Title

Digitally signed by James M.
James M.
Peterson -S
Date: 2018.07.11 11:45:00 -04'00'
Peterson -S
Signature: _________________________________

07/11/2018
Date: _______________