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STARS Tracking Number: TBD

NCEZID Tracking Number:

011720NC

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

Primary contact

2019 Novel Coronavirus Enhanced Risk Assessment for Travelers
Nicky Cohen

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. 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 incoming passengers arriving at JFK, LAX, and SFO from
Wuhan, China, which is currently experiencing an outbreak of 2019 novel coronavirus. The
enhanced screening goes beyond the routine screening procedures typically employed by
Quarantine staff. The enhanced procedures are necessary to identify ill passengers with
2019-nCoV, to prevent introduction of this novel virus into the US. These activities are within the
scope of CDC's public health authority. The screening activities meet criteria for the Public Health
Surveillance exclusion, and thus they are not research.
Additional considerations

Informed consent will not be obtained from passengers, as the information collected from
passengers is required under 42 CFR 71.20.

Additional requirements

I understand that the written protocol is still being finalized. Please provide finalized materials when
available.
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

Laura Youngblood

Laura Youngblood Signature S

Digitally signed by Laura
Youngblood -S
Date: 2020.01.17 08:34:24 -05'00'

Title

Human Subjects Advisor

Date 1/17/20