Nonresearch Determination

NCEZID Tracking Number:

011519MR

Determination of Non-applicability of Human Subjects Regulations
National Center for Emerging and Zoonotic Infectious Diseases (NCEZID)
Project title Focus Group Study of U.S. Adults Knowledge, Attitudes, and Practices of Foodborne Disease
Outbreaks and Illness Prevention
Primary contact Misha Robyn, DVM, MPH

Division/Branch DFWED/ORPB

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 conduct focus groups to evaluate outbreak response and illness prevention
messages from CDC. A series of focus groups will be conducted with one-on-one awareness assessments and small
focus groups evaluating the CDC outreach materials for recognition and effectiveness. Findings will be summarized
in a report for CDC to inform future development of outreach materials and be shared with other relevant
agencies by publishing in a peer-reviewed journal. As the purpose of this activity is to evaluate a standard practice
in public health, it is consistent with non-research public health program evaluation, per CDC guidance. 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: 2019.01.15 13:14:26 -05'00'
Peterson -S
Signature: _________________________________

1/15/2019
Date: _______________