Determination of Non-applicability of Human Subjects Regulations

STARS Tracking Number: 0900f3eb81a8dd65

NCEZID Tracking Number:

010220LM

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

Primary contact

Anthrax Communication Product and Message Testing
Laura Murrell, MA

Division/Branch

OD/OHO

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 evaluate the needs of a target audience and the acceptability of
standard educational materials for anthrax emergency response. A series of focus groups will be
conducted with the target audience covering needs of the audience for education and the quality of
standard educational materials. The results of the evaluation will be used to improve this standard
programmatic activity. As the purpose of this activity is to evaluate the needs of a target audience
and a standard educational product, it is consistent with non-research public health program
evaluation. This activity is not designed to develop or contribute to generalizable knowledge.
Additional considerations

All potential participants will be given consent.

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: 2020.01.02 15:31:27 -05'00'

Title

Human Subjects Advisor

Date 1/2/2020