Research Determination

STARS Tracking Number: NCEZID-DGMH-10/8/24-63283

NCEZID Tracking Number:

100824NC

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

Primary contact

PRA package for Marburg response (travelers from Rwanda)
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 collection is to screen travelers from Rwanda for health screening as part of response activities to
the Marburg virus outbreak in Rwanda. CDC personnel will conduct screenings at US airports using a standard data
collection form for assessing health and exposure of referred individuals. Data will also be regularly collected from state
health departments in regards to how many healthcare workers and travelers they are monitoring and any issues with
monitoring. The data will be used to monitor and mitigate any spread of a Marburg virus and for assessing public health
response monitoring of possibly exposed individuals. As this activity is to screen individuals to prevent spread of a
public health threat and to assess a standard public health practice, this activity is best characterized as non-research
public health standard practice and 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

JAMES M.
Signature PETERSON -S

Digitally signed by JAMES M.
PETERSON -S
Date: 2024.10.08 16:19:07 -04'00'

Title

Human Subjects Advisor

Date 10/8/2024