Research Determination

STARS Tracking Number: 0900f3eb81be8d30

NCEZID Tracking Number:

092320RG

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

Primary contact

One Health Investigation Form - Animal Cases of SARS-CoV-2
Ria Ghai

Division/Branch

OHO

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

This project involves providing states with a data collection tool for information on SARS-CoV-2
animal case investigations. The form will be provided to states to voluntarily collect and provide
animal case data to CDC. CDC will compile and analyze data from states to provide national data
and inform response. As the purpose of this activity is to collect and assess data on 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: 2020.09.23 16:32:26 -04'00'

Title

Human Subjects Advisor

Date 9/23/2020