IRB Non-Research Determination

NCEZID Tracking Number: 042216CP

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

Primary contact

Message testing among important public audiences in Puerto Rico

Chris Prue, PhD

Division/Branch NCEZID/OD

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 evaluation is to gather feedback on standard public health messages related to Zika virus, to
ensure they are understandable to and appropriate for targeted audiences in Puerto Rico -- specifically, partners of
pregnant women, and other members of the public. Depending on the findings of the evaluation, messages may be
tailored to meet the needs of the specific population. As an activity designed to gather feedback to inform tailored
improvements to routine public health messages for a targeted population, this activity is consistent with the attributes
of non-research program evaluation, as described in current CDC policy. This activity is not designed to develop or
contribute to generalizable knowledge.

Additional considerations
Verbal consent will be sought prior to initiating interviews.

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=1001704097
, cn=Laura Youngblood -S
Date: 2016.04.22 13:59:50 -04'00'

Signature: _________________________________

Title Human Subjects Advisor, NCEZID
4/22/16

Date: _______________