Human Subjects Determination

STARS Tracking Number: 0900f3eb820531e1

NCEZID Tracking Number:

121322MD

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

Primary contact

National Healthcare Safety Network Surveillance System
Margaret Dudeck

Division/Branch

DHQP/SB

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

NHSN data are used to monitor progress toward infection prevention goals, to support guideline
development, and measure healthcare performance, quality, and resiliency. Data pertaining to healthcare
worker vaccinations, healthcare-associated infections, patient-centered outcomes and healthcare capacity
are reported to the system by over 38,000 healthcare facilities. Data will be regularly analyzed by
members of the Surveillance Branch to develop various reports, summaries, dynamic dashboards, and
manuscripts. As such, the use of NHSN data to monitor prevention, support guidelines, and measure
performance to inform public health activities 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: 2022.12.13 13:56:08 -05'00'

Title

Human Subjects Advisor

Date 12/13/2022