Attachment 10- Human Subjects Determination

STARS Tracking Number: 0900f3eb822d5909

NCEZID Tracking Number:

012224AJ

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

Primary contact

Harmful Algal Blooms Communication Evaluation
Amy Jacobi

Division/Branch

DFWED/WDPB

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 conduct focus groups to discuss harmful algal blooms (HABs) so as to
inform related public health messaging. This evaluation will involve four virtual focus groups with two
involving freshwater blooms among the general population, one with freshwater blooms among dog owners,
and one with freshwater blooms among parents with children. The focus groups will be conducted by
Banyan Communications and CDC will be providing oversight. Results will be used to improve public health
messaging and may be published and presented. As the purpose of this activity is to assess the needs of a
target population in regards to standard public health messaging, it is consistent with a non-research needs
assessment 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

signed by James M.
James M. Peterson - Digitally
Peterson -S
Signature S
Date: 2024.01.22 10:20:32 -05'00'

Title

Human Subjects Advisor

Date 1/22/2024