Human Subjects Determination

STARS Tracking Number: 0900f3eb820cde27

NCEZID Tracking Number:

030323ND

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

Primary contact

Understanding food safety in correctional facilities
Naomi Drexler

Division/Branch

DFWED

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 food safety concerns at correctional facilities. The
evaluation will consist of interviews of key partners, and surveys of correctional workers in regards to
food safety. Results will be used to improve public health educational initiatives to improve food
safety at correctional facilities. As this activity assesses the needs of a target population for a
standard public health educational campaign, it is consistent with a non-research needs assessment
program evaluation. This activity is not designed to contribute to generalizable knowledge.

Additional considerations

Participants will provide consent prior to taking part in interviews or surveys.

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: 2023.03.03 11:45:23 -05'00'

Title

Human Subjects Advisor

Date 3/3/2023