Non-Research Determination

NCEZID Tracking Number: 040919MS

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

Primary contact

Evaluation of the Nursing Home Infection Preventionist Training Course

Melissa Schaefe

Division/Branch

DHQP/PRB

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 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 conduct a course evaluation for nurses to determine the impact of the
training. Those who took the training will have a follow up survey sent to them asking about
usefulness of the course. Results will be used to evaluate the impact of the free online training. As this
activity is to evaluate a standard training, it is consistent with non-research program evaluation.

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
Digitally signed by James M.

James M. Peterson -S Peterson -S

Date: 2019.04.09 08:09:13 -04'00'
Signature: _________________________________________

Title

Human Subjects Advisor

4/9/2019

Date: _______________