Non-Research Determination

STARS Tracking Number: NCEZID-DGMH-11/7/24-8ebf3

NCEZID Tracking Number:

110724NC

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

Primary contact

PRA package - 2024 Marburg Traveler Monitoring and Feedback
Nicole Cohen

Division/Branch

DGMH

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 screen travelers for Marburg virus disease in response to the
outbreak in Rwanda. This will consist of a text-based traveler monitoring system, a text and
web-based screening process, and an online survey of users of the screening and monitoring
systems. Data will be used to inform response activities, monitor for Marburg virus disease among
travelers, and evaluate these tools for improvement. As such, this activity is consistent with
non-research standard public health practice and program evaluation. These activities are 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

JAMES M.
Signature PETERSON -S

Digitally signed by JAMES M.
PETERSON -S
Date: 2024.11.07 15:50:48 -05'00'

Title

Human Subjects Advisor

Date 11/7/2024