IRB Research Determination

NCEZID Tracking Number: 062615MM

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

Primary contact

Emerging mosquito-borne diseases: assessment of chikungunya and dengue-related knowledge,
attitudes, and practices among Mexican-born residents along the US-Mexico border

Marian McDonald
Alfonso Rodriguez-Lainz

Division/Branch OD

DGMQ

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 validate standard public health messages for dengue and chikungunya targeting
Mexican-born residents along the US-Mexico border. In addition, existing knowledge, attitudes and practices, as well
as preferred avenues for receiving public health messages will be assessed in order to inform message content and
dissemination strategies. As an activity designed to gather feedback to tailor standard public health messages to a
specific audience, this activity is consistent with the attributes of non-research formative evaluation, as described in
current CDC policy. This activity is not designed to develop or contribute to generalizable knowledge.

Additional considerations
Informed consent will be obtained from all focus group participants.

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: 2015.06.26 14:50:30 -04'00'

Signature: _________________________________

Title Human Subjects Advisor, NCEZID
6/26/15

Date: _______________