IRB Determination

NCEZID Tracking Number: 021413AS

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

Primary contact

Evaluation of adapted health education materials for LEP Spanish speakers and indigenous migrants

Alina Shaw

Division/Branch DGMQ/USMU

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 assess public health educational materials that have been adapted for LEP Spanish
speaking and indigenous migrant populations near the US-Mexico border. Public health posters presenting standard
CDC-endorsed messages addressing TB, flu vaccine, and queso fresco will be assessed for understandability and
cultural appropriateness, and to ensure that they convey the intended messages. This project will also identify
preferred methods of communication and barriers to communication in this population. As an activity designed to
gather feedback to tailor standard public health messages for a specific population, this project 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
Participants will receive a nominal incentive equivalent to $35 (most likely in the form of a gift card). This is
commensurate with industry standards for marketing surveys and focus groups.

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

Signature:

Laura
Youngblood
_________________________________
Digitally signed by Laura Youngblood
DN: c=US, o=U.S. Government, ou=HHS,
ou=CDC, ou=People, cn=Laura
Youngblood,
0.9.2342.19200300.100.1.1=1001704097
Date: 2013.02.14 14:57:22 -05'00'

Title Human Subjects Advisor, NCEZID
2/14/13

Date: _______________