Attachment 8- Human Subjects Determination

STARS Tracking Number: NCEZID-RZB-12/21/23-b64d9

NCEZID Tracking Number:

010424AP

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

Primary contact

Focus Groups and Interviews with Consumers and HCPs on Alpha-Gal Syndrome (AGS)

Alexandra Premkumar

Division/Branch

DVBD/RZB

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 test public health messages about alpha-gal syndrome (AGS)
among targeted groups (healthcare providers, and outdoor enthusiasts). Message testing will
involve focus groups and in-depth interviews, conducted by a market survey organization. As an
activity designed to test public health messages for the purpose of tailoring them to specific
populations, this project is consistent with non-research program evaluation. This project is not
designed to develop or contribute to generalizable knowledge, but rather to inform improvements to
public health messages about AGS.
Additional considerations

Informed consent will be obtained.

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: 2024.01.04 11:36:05 -05'00'

Title

Human Subjects Advisor

Date 1/4/24