Human Subjects Determination

STARS Project ID Number:

0900f3eb8247e144

NCEZID Tracking Number:

112224AC

STARS Accession Number: NCEZID-DVBD-10/28/24-7e144

Determination of Non-applicability of Human Subjects Regulations

National Center for Emerging and Zoonotic Infectious Diseases (NCEZID)
Project title
Primary contact

Focus Groups with Consumers on Oropouche
Allison Caughey

Division/Branch

DVBD/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 purpose of this project is to assess awareness, perceptions, and information needs related to
Oropouche, and to identify the most effective and clear messaging themes. Focus group discussions
will be conducted by KRC, and transcripts will be sent to CDC for analysis with names redacted.
Findings will be used to inform communication initiatives and tailored messaging strategies related to
Oropouche. As an activity designed to inform public health communications, this project is consistent
with the attributes of non-research formative program evaluation. This activity is not designed to
contribute to generalizable knowledge, but rather to inform public health practice.
Additional considerations

None

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: 2024.11.22 15:22:47 -05'00'

Title

Human Subjects Advisor

Date:

11/22/24AC