Non-research determination

STARS Tracking Number: 0900f3eb8198ae11

NCEZID Tracking Number:

092019CC

Determination of Non-applicability of Human Subjects Regulations
National Center for Emerging and Zoonotic Infectious Diseases (NCEZID)
Project title Evaluation of an Education Intervention for Immigration Applicants with B1 or B2 Tuberculosis

Classifications

Primary contact

Crystal Clements

Division/Branch

DGMQ/OD

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 assess the impact of a newly developed educational session and materials
targeted for immigrants with TB conditions to improve follow up and completing consults and treatment for
TB. The evaluation of the educational program will include pretest and posttest of current educational
sessions and the newly developed to show that the new program has a positive impact on programmatic
goals. Results will be used to inform adopting the new educational session and may be published in a peer
reviewed journal. As the purpose of this activity is to evaluate the impact of a newly developed standard
educational session, it is consistent with non-research program evaluation. 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: 2019.09.20 15:59:28 -04'00'

Title

Human Subjects Advisor

Date 9/20/2019