Human Subjects Determination

STARS Tracking Number: NCEZID-DIDRI-1/4/24-c5191

NCEZID Tracking Number:

012624DA

Determination of Non-applicability of Human Subjects Regulations
National Center for Emerging and Zoonotic Infectious Diseases (NCEZID)
Project title Wastewater Surveillance Communication Evaluation Assessing Water Surveillance

Messages, Knowledge, and Attitudes

Primary contact

Deanna Amarosa

Division/Branch

DIDRI/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 assess audience preferences, knowledge and perceptions of
wastewater monitoring, and test specific CDC messages and materials with audiences. Focus
groups will be held with target audiences including caregivers, business leaders, high-risk adults, and
adults living in rural areas. As an activity designed to identify knowledge gaps and gather feedback
to inform improvements to CDC public health messaging about wastewater surveillance, this activity
is consistend with the attributes of non-research program evaluation. This activity is not designed to
develop or contribute to generalizable knowledge.
Additional considerations

Informed consent will be obtained from focus group participants. Video recordings of focus groups
will be destroyed after transcription. Any identifiable information captured in the video recordings will
be redacted from the transcripts.

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.
Reviewed by

Signature

Laura Youngblood
Digitally signed by Laura
Youngblood -S
Date: 2024.01.26 10:16:02 -05'00'

Title

Human Subjects Advisor

Date 1/26/24