Determination of Non-applicability of Human Subjects Regulations

STARS Tracking Number: 0900f3eb81aad81f

NCEZID Tracking Number:

011520VI

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

Primary contact

Be Antibiotics Aware Pilot Assessment for HCPs
Vanessa Iheanachor,

Division/Branch

DHQP/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 is neither conducted nor supported by a Common Rule agency. IRB review is not required. [45 CFR 46.101(a)]

✔ 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 conduct an impact assessment of a standard programmatic action of
a community education campaign. This education campaign, Be Antibiotics Aware, will be evaluated
by pre- and post-test surveys of the target audience to assess the impact of the materials. Results
will be used to improve and inform the development of the educational campaign. As the purpose of
this activity is to evaluate the impact of a standard programmatic intervention, it is consistent with
non-research program evaluation. This activity is not designed to contribute to generalizable
knowledge.
Additional considerations

It is acknowledged that ICF's IRB considered this activity to be exempt human subjects research;
however, CDC's position by policy and HHS guidance is that this is non-research.

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

signed by James M.
James M. Peterson - Digitally
Peterson -S
Signature S
Date: 2020.01.15 07:36:07 -05'00'

Title

Human Subjects Advisor

Date 1/15/2020