Human Subjects Determination

STARS Tracking Number: 0900f3eb8223cbf4

NCEZID Tracking Number:

102423OP

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

Primary contact

TB Care finder
Omar DuranPena

Division/Branch

DGMH/SBHM

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 facilitate TB programs to begin the process of entering information
from their health department into the TB care finder tool. The TB care finder tool will provide this
information to immigrants using the online service to find the most up to date local and state TB
control information. As the purpose of this activity is to collect programmatic data in order to provide
resources to a target population, it is consistent with non-research standard public health practice.
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: 2023.10.24 13:44:26 -04'00'

Title

Human Subjects Advisor

Date 10/24/2023