Research Determination

STARS Project ID Number:

0900f3eb82542375

NCEZID Tracking Number:

041525LM

STARS Accession Number: NCEZID-CT-3/26/25-42375

Determination of Non-applicability of Human Subjects Regulations

National Center for Emerging and Zoonotic Infectious Diseases (NCEZID)
Project title
Primary contact

Long-term Care Facility Resident and Family Interviews - Infection Prevention
and Control Practices
Lauren Moccia

Division/Branch

DHQP/ODCO

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

This project will consist of 18 in-depth interviews with paired LTHCF residents and a family or friend. These
interviews are intended to describe knowledge, attitudes, and behaviors related to infection prevention in
long term care facilities. Results will be used to refine and improve the effectiveness of communication
materials and dissemination methods for long term care facilities, residents, and their caregivers. As an
activity designed to gather feedback to improve public health messaging, this project is consistent with the
attributes of non-research program evaluation. It is not designed to develop or contribute to generalizable
knowledge, but rather to gather feedback improve a standard public health practice.
Additional considerations

None

Additional requirements

None
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

Signature:

Laura Youngblood
Digitally signed by Laura
Youngblood -S
Date: 2025.04.15 09:26:24 -04'00'

Title

Human Subjects Advisor

Date:

4/15/25