Non-research determination

NCEZID Tracking Number:

062817AM

Determination of Non-applicability of Human Subjects Regulations
National Center for Emerging and Zoonotic Infectious Diseases (NCEZID)
Project title Pilot of Draft Hospital Antibiotic Stewardship Core Element Assessment Tool
Primary contact Anita McLees, MPH, MA

Division/Branch DHQP/OD

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. Under existing institutional policy,
authority to determine whether a project is research involving human subjects or whether CDC is
engaged in human subjects research is delegated to the National Centers.
Determination
■

Project does not meet the definition of research under 45 CFR 46.102(d). IRB review is not required.
Project does not involve human subjects under 45 CFR 46.102(f). IRB review is not required.
CDC is not engaged in the conduct of human subjects research per 2008 OHRP engagement
guidance. CDC IRB review is not required. Investigator has provided documentation of appropriate
local review.

Rationale

The purpose of this activity is to pilot test a draft assessment tool for hospital implementation of the Core
Elements of Hospital Antibiotic Stewardship Programs. The draft assessment tool will be provided to 30 hospitals
where the antibiotic stewardship program leader will complete the assessment for their institution. Results will be
used to inform the development of the assessment for use with scoring the implementation of the Core Elements.
As this activity is to develop a tool for a program evaluation, it is consistent with non-research public health
program evaluation. This activity is not designed to contribute to generalizable knowledge.
Additional considerations

None.

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.

Human Subjects Advisor

Reviewed by James Peterson, PhD

Title

Digitally signed by James M.
James M.
Peterson -S
Date: 2017.06.28 12:04:18 -04'00'
Peterson -S
Signature: _________________________________

06/28/2017
Date: _______________