Non-Research Determination

NCEZID Tracking Number:

121418PY

Determination of Non-applicability of Human Subjects Regulations
National Center for Emerging and Zoonotic Infectious Diseases (NCEZID)
Project title Evaluation of Emergency Use Fact Sheets Regarding Medical Countermeasures –
Comprehension Evaluation/Message Testing
Primary contact Patricia Yu, MPH, RAC

Division/Branch 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 activity is to test through interviews a series of Fact Sheets on medical products and
countermeasures that would be used during an emergency and targeted for the general public. The activity will
consist of focus groups with discussions centered on the various fact sheets. The results will be collated in a final
report and be used to inform development and implementation of the fact sheets. As this activity is to evaluate a
specific public health program, it 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: 2018.12.14 15:57:44 -05'00'
Peterson -S
Signature: _________________________________

12/14/2018
Date: _______________