Non-research determination

STARS Tracking Number:

NCEZID Tracking Number:

062821

Determination of Non-applicability of Human Subjects Regulations
National Center for Emerging and Zoonotic Infectious Diseases (NCEZID)
Project title US Tuberculosis Follow-Up Worksheet for Newly Arrived Persons with Overseas Tuberculosis

Classifications

Primary contact

Amanda Dam

Division/Branch

DGMQ/IRMHB

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 follow-up with and assess newly-arrived persons in the United
States who received overseas tuberculosis classifications in order to assist in the national effort to
prevent new transmission of TB. As this activity is part of standard programmatic practice, it is
non-research. 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: 2021.06.28 08:00:02 -04'00'

Title

Human Subjects Advisor

Date 6/28/2021