Human Subjects Determination

STARS Tracking Number: 0900f3eb81e16469

NCEZID Tracking Number:

120721RA

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

Primary contact

Annual Customer Satisfaction Survey for the CDC Antibiotic Resistance (AR) Isolate Bank

Reilly Alu

Division/Branch

DHQP/OAR

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 annually gather customer satisfaction data from users of the CDC
Antibiotic Resistance (AR) Isolate Bank. Users of the AR Isolate Bank will be sent an electronic
survey asking questions regarding use and satisfaction with the service. Results will be used
annually to improve the AR Isolate Bank for users. Respondents may be contacted again to develop
success stories for promotional materials. This activity is a non-research customer satisfaction
survey. This project 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: 2021.12.07 08:04:07 -05'00'

Title

Human Subjects Advisor

Date 12/7/2021