Research Determination

STARS Tracking Number: 0900f3eb821a0911

NCEZID Tracking Number:

063023LS

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

Primary contact

NCEZID Rapid Message Testing
Laura Smith

Division/Branch

NCEZID

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 use banked survey questions to assess different messaging materials
during an outbreak response or when development is urgent. A contractor has developed a series of
questions that can be used to test messaging during an outbreak or public health action. During public
health action and when the need for messaging is urgent, relevant messaging materials will be tested with
the intended target audiences. Results will be used for informing and evaluating this standard public
health practice. As this activity involves the evaluation of a standard public health action, it is consistent
with non-research 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: 2023.06.30 14:26:04 -04'00'

Title

Human Subjects Advisor

Date 6/30/2023