Non-research determination

NCEZID Tracking Number:

110117OS

Determination of Non-applicability of Human Subjects Regulations
National Center for Emerging and Zoonotic Infectious Diseases (NCEZID)
Project title EDN (Electronic Disease Notification System) User Assessment
Primary contact Olivia Samson

Division/Branch DGMQ/IRMHB

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 survey those with access to the EDN on use and unmet needs of the system. All
those with access will be sent an online survey that will target providers who actively use EDN with questions on
use to provide care for refugees, use of vaccination information for clinic vaccination processes, and to identify
unmet needs in user support and training. This activity 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: 2017.11.01 14:37:54 -04'00'
Peterson -S
Signature: _________________________________

11/1/2017
Date: _______________