Non-Research Determination

NCEZID Tracking Number:

043018AG

Determination of Non-applicability of Human Subjects Regulations
National Center for Emerging and Zoonotic Infectious Diseases (NCEZID)
Project title Behavioral determinants of community hand hygiene behavior: A formative qualitative
evaluation
Primary contact Amanda Garcia-Williams

Division/Branch DFWED/WDPB

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 an evaluation of hand hygiene communication materials among the US
population. Two focus groups will be conducted on the topic of personal hand hygiene and preferences for
outreach communication materials. Results will be used to inform the development of communication campaigns
focused on encouraging better hand hygiene. Results may be disseminated by presentation, reports or
manuscripts. As the purpose of this activity is to conduct a needs assessment of a specific population in order to
inform a public health communication program, it is consistent with non-research public health 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: 2018.04.30 18:39:18 -04'00'
Peterson -S
Signature: _________________________________

4/30/2018
Date: _______________