Non-Research Determination

NCEZID Tracking Number:

062817CD

Determination of Non-applicability of Human Subjects Regulations
National Center for Emerging and Zoonotic Infectious Diseases (NCEZID)
Project title Customer satisfaction survey for soliciting feedback on NICE Network nursing infection
prevention and control in-person conference sessions
Primary contact Carla Doan, MS

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 project is to perform an evaluation survey of NICE Network nursing infection prevention and
control outreach and training. Attendees of conference sessions on infection prevention and control will take part
in focus groups and be surveyed on the material and effectiveness of the training. Results will inform the
development of the training. As this activity is a training evaluation, it is consistent with non-research 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 12:42:18 -04'00'
Peterson -S
Signature: _________________________________

06/28/2017
Date: _______________