Human Subjects Determination

STARS Tracking Number: NCEZID-HPCT-1/7/25-d9ae2

NCEZID Tracking Number:

011325AJ

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

Primary contact

Harmful Algal Blooms Shellfish 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 evaluate the needs of the intended
audience of people who collect shellfish to eat on the topic of harmful algal blooms and to evaluate
the acceptance of current related public health messaging. Focus groups will be conducted by
contractor Banyan Communications. Results will be used to inform ongoing public health messaging.
As the purpose of this activity is to assess the needs of a program target audience and to pilot test a
standard public health programmatic activity, 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: 2025.01.13 13:23:33 -05'00'

Title

Human Subjects Advisor

Date 1/13/2025