Human Subjects Determination

STARS Tracking Number: -NCEZID-12/15/23-a51d0

NCEZID Tracking Number:

122823CN

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

Primary contact

CDC Excel Tool for Thematic Analysis Evaluation Survey
Ciara Nestor

Division/Branch

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. 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 Social and Behavioral Sciences team has developed a free and publicly available Excel tool to guide
people in planning, collecting, and analyzing text information from communities (the CDC Excel Tool for
Thematic Analysis). This tool will be published on an NCEZID webpage in 2024, along with a short feedback
survey about the tool. The purpose of the user feedback survey is to identify and respond to any technical
issues with downloading or using the tool, as well as to gain feedback from users about potential
improvements to make the tool more useful. As a standard user feedback survey, this project is consistent
with the attributes of non-research program evaluation. This project is not designed to develop or contribute
to generalizable knowledge.
Additional considerations

Data will be collected anonymously through EpiInfo. A brief summary of the nature an purpose of the
survey is included in the survey introduction. The survey is voluntary. It is not required for tool
access.

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

Signature

Laura Youngblood
Digitally signed by Laura
Youngblood -S
Date: 2023.12.28 09:24:42 -05'00'

Title

Human Subjects Advisor

Date 12/28/23