Non-Research Determination

STARS Tracking Number: NCEZID-DFWED-11/26/24-a71d4

NCEZID Tracking Number:

121624MO

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

Primary contact

Assessing Foodborne, Waterborne and Mycotic Disease Prevention Messages
Mmesoma Okafor

Division/Branch

DFWED

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. This authority is delegated to the CDC Centers, Institutes,
and Offices under CDC Policies SSA-2010-01 and SSA-2010-02.
Determination
Project is neither conducted nor supported by a Common Rule agency. IRB review is not required. [45 CFR 46.101(a)]

✔ Project does not meet the definition of research under 45 CFR 46.102(l). IRB review is not required.
Project is deemed not to be research under the following provision. IRB review is not required.
Select, if applicable

Project does not involve human subjects under 45 CFR 46.102(e). IRB review is not required.
CDC’s role in the project does not meet the threshold requiring submission to HRPO. Investigator has provided documentation of
appropriate local review.
Rationale

The purpose of this activity is to evaluate health communication materials and resources to encourage
prevention of diseases caused by contaminated food, water, and fungi. CDC will contract Banyan
Communications to conduct a series of focus groups and online surveys to evaluate messaging
materials and target audience needs. Results will be used to assess the needs of the target audience
and to pilot the use of the public health messaging that has been drafted. As this activity evaluates the
needs of a target audience and standard public health messaging, it is consistent with non-research
program evaluation. This activity is not designed to contribute to generalizable knowledge.
Additional considerations

Additional requirements

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

James Peterson, PhD

JAMES M.
Signature PETERSON -S

Digitally signed by JAMES M.
PETERSON -S
Date: 2024.12.17 15:09:57 -05'00'

Title

Human Subjects Advisor

Date 12/16/2024