Research Determination

STARS Tracking Number: NCEZID-SEA-10/26/22-178b0

NCEZID Tracking Number:

103122NL

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

Primary contact

ArboNET Non-Human Data Collections
Nicole Lindsey

Division/Branch

DVBD/ADB

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

This project uses data from passive arboviral surveillance, ArboNET, to identify areas in the US
where humans may be at risk for exposure to vectors carrying pathogens. This project uses only
non-human information (i.e., non-human mammals, sentinel animals, dead birds, and mosquitoes).
As an activity designed to identify locations where humans may be at risk of exposure, this activity is
consistent with the attributes of non-research surveillance. IRB review is not required.

Additional considerations

This project does not include any human information.

Additional requirements

None.

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: 2022.10.31 09:06:01 -04'00'

Title

Human Subjects Advisor

Date 10/31/22