Research Determination

STARS Tracking Number:

NCEZID Tracking Number:

040320SM

Determination of Non-applicability of Human Subjects Regulations
National Center for Emerging and Zoonotic Infectious Diseases (NCEZID)
Project title Emerging Infections Program Tracking of SARS-CoV-2 Infections among Healthcare

Personnel

Primary contact

Shelley Magill, MD, PhD

Division/Branch

DHQP/ERIB

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 conduct surveillance for COVID-19 among healthcare personnel in the United States.
This surveillance will assess: incidence of COVID-19 among healthcare personnel, characteristics of healthcare
personnel exposed or infected, and risk factors among healthcare personnel. This project will be implemented in up to
10 EIP sites which will provide line lists of healthcare personnel. Further data collection for healthcare personnel will be
conducted by EIP project staff including phone interviews with a case report form or self-reporting using an electronic
form. No identifiable data will be transmitted to the CDC. Findings will be used to inform the ongoing public health
response to the COVID-19 pandemic. As the purpose of this activity is to collect information by a public health authority
to assess a public health threat including risk factors in order to provide timely situational awareness and priority setting
during the course of a pandemic, it is consistent with non-research public health surveillance.
Additional considerations

Participants will provide consent before inclusion in this activity.
Up to 10 EIP sites will be included in this activity and they may require IRB determinations according
to local policy and procedures.
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: 2020.04.03 19:28:59 -04'00'

Title

Human Subjects Advisor

Date 4/3/2020