Human Subjects Determination

STARS Tracking Number: 0900f3eb8200efb7

NCEZID Tracking Number:

012323SK

Determination of Non-applicability of Human Subjects Regulations
National Center for Emerging and Zoonotic Infectious Diseases (NCEZID)
Project title Evaluation of communication between CDC and Association of Refugee Health Coordinators

(ARHC) partners during responses in 2021-2022

Primary contact

Sarah Kuech

Division/Branch

DGMQ/IRMH

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 improve state and federal communication during emergency
response by evaluating communications between IRMH and ARHC over the responses from 2020 to
2022. CDC will conduct interviews with state refugee health coordinators and 10 IRMH staff on the
topic of communications during recent response efforts. Results will be used to provide a report on
the strengths and weaknesses of recent communication and recommendations for improvement. As
this activity is designed to evaluate programmatic communications, it is consistent with non-research
program evaluation. This activity is not designed to contribute to generalizable information.
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: 2023.01.23 10:25:53 -05'00'

Title

Human Subjects Advisor

Date 1/23/2023