Human Subjects Determination

STARS Tracking Number: -NCEZID-7/30/24-fee46

NCEZID Tracking Number:

080524VJ

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

Primary contact

Focus Groups and In-Depth Interviews with Travelers and Travel Medicine Specialists

Valerie Johnson

Division/Branch

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 conduct focus groups with travelers to inform the development of public
health messaging to reduce travel associated disease. Six focus groups will be conducted virtually with
travelers visiting South Asia, Mexico, and Central America by KRC Research. CDC will be receiving
de-identified data and may be authors on resulting publications and/or presentations. Results will be used to
develop or refine public health messaging that is aimed at reducing disease among travelers. As this activity
is designed to evaluate the needs of a target population of a standard public health programmatic activity, it
is consistent with a non-research needs assessment evaluation. This activity is not designed to contribute to
generalizable knowledge.
Additional considerations

All travelers that are recruited will provide formal written informed consent prior to participation in the
focus groups.

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

JAMES M.
Signature PETERSON -S

Digitally signed by JAMES M.
PETERSON -S
Date: 2024.08.05 14:13:09 -04'00'

Title

Human Subjects Advisor

Date 8/5/2024