Att H_Non Research Determination

NCEZID Tracking Number:

032818KM

Determination of Non-applicability of Human Subjects Regulations
National Center for Emerging and Zoonotic Infectious Diseases (NCEZID)
Project title Education for Mexican immigrants with B1B2 TB classifications
Primary contact Kathleen Moser, MD

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. Under existing institutional policy,
authority to determine whether a project is research involving human subjects or whether CDC is
engaged in human subjects research is delegated to the National Centers.
Determination
■

Project does not meet the definition of research under 45 CFR 46.102(d). IRB review is not required.
Project does not involve human subjects under 45 CFR 46.102(f). IRB review is not required.
CDC is not engaged in the conduct of human subjects research per 2008 OHRP engagement
guidance. CDC IRB review is not required. Investigator has provided documentation of appropriate
local review.

Rationale

The purpose of this activity is to evaluate educational materials for immigrants to the United States from Mexico
that have been diagnosed with active TB (B1) or latent TB (B2). Interviews of immigrants will be conducted at sites
in the US and Mexico. Mexico interviews will include questions on educational materials in regards to verbal
education, message testing, and action assessment; US interviews will include questions in regards to post-TB
diagnosis history and message testing. Results will be used to improve educational materials and may be published
as a manuscript. As the purpose of this activity is to evaluate programmatic educational materials, it is consistent
with non-research public health evaluation. This activity is not designed to contribute to generalizable information.
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.

Human Subjects Advisor

Reviewed by James Peterson, PhD

Title

Digitally signed by James M.
James M.
Peterson -S
Date: 2018.03.28 13:09:54 -04'00'
Peterson -S
Signature: _________________________________

3/28/2018
Date: _______________