IRB determination

NCEZID Tracking Number: 040519LB

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

Primary contact

Redesign IRMHB’s Website

Leticia Bligh, MPH

Division/Branch

DGMQ/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. 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 evaluate the IRMHB's website and inform improvements for a better
user experience. Key staff and users will be identified and invited for interviews and usability testing
with the site. Results will be used to inform the updates and redesign of the website. As the purpose
of this activity is to evaluate a website, it is consistent with non-research program 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
Digitally signed by James M.

James M. Peterson -S Peterson -S

Date: 2019.04.05 14:14:26 -04'00'
Signature: _________________________________________

Title

Human Subjects Advisor

4/5/2019

Date: _______________