Non-Research Determination

STARS Tracking Number: 0900f3eb823c21ea

NCEZID Tracking Number:

061724JS

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

Primary contact

Post-Event (Series) Survey- 2024 Indian Health Service Webinar Series
Jana Shamburger

Division/Branch

DHQP/HSSRTB

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 assess the impact of a 5-part webinar training series on CDC guidelines
for infection prevention and control to healthcare personnel. CDC's Health Systems Strengthening
Resilience & Training (HSSRT) Branch will be working in partnership with Indian Health Service (IHS) with
hosting the training. Participants will be provided a link to the training evaluation survey. Results will not
be published but will inform the future development of the trainings. As this activity involves the
assessment of the impact of a standard training program, it is consistent with a non-research impact
assessment 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

signed by James M.
James M. Peterson - Digitally
Peterson -S
Signature S
Date: 2024.06.17 10:55:07 -04'00'

Title

Human Subjects Advisor

Date 6/17/2024