Research Determination

STARS Tracking Number: 0900f3eb822a5b58

NCEZID Tracking Number:

122023TR

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

Primary contact

Focus Groups with Healthcare Providers on Endemic Mycoses
Tina Rezvani

Division/Branch

DFWED

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 conduct a needs assessment for outreach and educational materials on the
subject of endemic mycoses to healthcare providers. The data collection will consist of six 90-minute online
focus groups with physicians, physician assistants, and nurse practitioners. The discussions will be focused
on the subjects of identifying, testing, and treating mycoses. Results will be used to inform the development
of educational and training materials meant to increase awareness of mycoses among healthcare providers.
As the purpose of this activity is to assess the needs of a target population of a standard public health
programmatic effort, it is consistent with a non-research needs 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: 2023.12.20 12:44:32 -05'00'

Title

Human Subjects Advisor

Date 12/20/2023