Human Subjects Determination

Attachment 4 - Human Subjects Determination.pdf

[OS] CDC/ATSDR Formative Research and Tool Development

Human Subjects Determination

OMB: 0920-1154

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STARS Tracking Number: -NCEZID-7/7/23-abf7f

NCEZID Tracking Number:

072523LM

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

Primary contact

IDIs with Hispanic Women
Laura Murrell

Division/Branch

NCEZID/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 evaluation is to gather feedback from Hispanic women about their knowledge,
attitudes, and behaviors related to climate change and its impact on infectious diseases. Findings
will be used to inform public health messaging, tailored to the needs of Hispanic women, about the
climate and infectious disease. This is not designed to develop or contribute to generalizable
knowledge. Rather, it is designed to inform culturally appropriate public health messaging. This is
consistent with the attributes of non-research program evaluation.

Additional considerations

Consent will be obtained from all interview participants.

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: 2023.07.25 11:57:14 -04'00'

Title

Human Subjects Advisor

Date 7/25/23


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