Non-Research Determination

STARS Tracking Number: TBD

NCEZID Tracking Number:

100622NC

Determination of Non-applicability of Human Subjects Regulations
National Center for Emerging and Zoonotic Infectious Diseases (NCEZID)
Project title PUBLIC HEALTH ASSESSMENT FOR TRAVELERS FROM EBOLA

OUTBREAK-AFFECTED COUNTRIES

Primary contact

Nicky Cohen

Division/Branch

DGMQ

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.
Public health surveillance activities, 45 CFR 46.102(l)(2)

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 at select US airports for Ebola exposures in light of the
recent Ebola outbreak in Uganda. CDC with the help of the Department of Homeland Security will conduct
these emergency assessments to monitor for and assess Ebola exposed persons entering the country and
mitigate spread in the United States. Travelers from Ebola-affected countries will be screened and given a
questionnaire concerning possible exposures to Ebola. Depending on the level of exposure and risk, those
surveyed will be transferred for treatment, quarantined, or referred for followup. As this activity involves a
public health agency collecting data to monitor and respond to a public health threat, it is consistent with
non-research public health surveillance.
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: 2022.10.06 13:11:21 -04'00'

Title

Human Subjects Advisor

Date 10/6/2022