Research Determination

STARS Tracking Number: 0900f3eb8224a119

NCEZID Tracking Number:

102723JB

Determination of Non-applicability of Human Subjects Regulations
National Center for Emerging and Zoonotic Infectious Diseases (NCEZID)
Project title Survey of Nursing Homes to Support a Pilot Test of a National Healthcare Safety Network

(NHSN) Electronic Health Record (EHR) Implementation Guide (IG)

Primary contact

Jeneita Bell

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.
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

The purpose of this activity is to survey nursing homes in order to gather data to inform the
development of resources for electronic reporting of healthcare-associated infections to NHSN. CDC
has contracted with Arbor Research Collaborative to survey the nursing homes. Results will be used
to develop electronic reporting with nursing homes and may be published or presented. As the
purpose of this activity is to evaluate the needs of the target population of a programmatic activity, it
is consistent with a non-research needs assessment evaluation. This activity is not designed to
contribute to generalizable knowledge.
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: 2023.10.27 14:38:37 -04'00'

Title

Human Subjects Advisor

Date 10/27/2023