Att D_DETERMINATION OF NON-APPLICABILITY OF HUMAN SUBJECT REGULATIONS

NCEZID Tracking Number:

120117KH

Determination of Non-applicability of Human Subjects Regulations
National Center for Emerging and Zoonotic Infectious Diseases (NCEZID)
Project title Evaluation of Travelers’ Health Zika Prevention Communication Campaign for
Hispanics/Latinos Visiting Friends and Relatives: Word of Mouth Protocol
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.
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 evaluate a community education campaign for preventing zika among the
hispanic/latino population traveling to visit friends or relatives outside the US. The evaluation will conduct surveys
in regards to knowledge on Zika risks and prevention before and after the education campaign to determine the
impact of the program. Findings will be used to assess and improve the impact of the educational campaign and
may be disseminated by presentations or manuscripts in peer-reviewed journals. As this is an evaluation of a
public health educational campaign, it is consistent with non-research public health program evaluation, per CDC
guidance. This activity is not designed to contribute to generalizable knowledge.
Additional considerations

The partner ICF IRB has determined this to be non-research.

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: 2017.12.01 15:27:11 -05'00'
Peterson -S
Signature: _________________________________

12/1/2017
Date: _______________