Non-Research Determination

STARS Tracking Number: NCEZID-ESA-7/7/21-73590

NCEZID Tracking Number:

020722DM

Determination of Non-applicability of Human Subjects Regulations
National Center for Emerging and Zoonotic Infectious Diseases (NCEZID)
Project title Homeless service providers knowledge, attitudes, and practices regarding body lice, fleas and

associated diseases

Primary contact

David McCormick

Division/Branch

DVBD/BDB

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 is designed to assess the KAPs of staff providing homeless services regarding body lice and
fleas, and the diseases associated, among persons experiencing homelessness. The findings of this project
will inform education and outreach to service providers to improve existing services for this population. As
an activity that is designed to gather feedback to improve existing services, this project is consistent with the
attributes of non-research program evaluation. This project is not designed to further the scientific or
academic understanding of the health of persons living with homelessness, or to gain new insights into the
causes or outcomes of homelessness. Rather, it is to collect information from service providers for the
purpose of improving existing services.
Additional considerations

Staff participating in the surveys will be informed of the nature and purpose of the project, and
participation will be voluntary. Staff responses will be collected anonymously. Minor comments to
the consent/information sheet have been provided under separate cover. Please provide updated
version, when available.
Additional requirements

This project is PRA-applicable, as previously discussed with Chip Daymude.

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

Laura Youngblood

Laura Youngblood Signature S

Digitally signed by Laura
Youngblood -S
Date: 2022.02.07 12:45:58 -05'00'

Title

Human Subjects Advisor

Date 2/7/2022