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pdfSTARS Tracking Number: 0900f3eb822ac267
NCEZID Tracking Number:
011124SB
Determination of Non-applicability of Human Subjects Regulations
National Center for Emerging and Zoonotic Infectious Diseases (NCEZID)
Project title Healthcare Provider Communication Evaluation Assessing Foodborne Illness and Waterborne
Illness Prevention Messages, Knowledge, and Attitudes
Primary contact
Sara Bresee
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 evaluate the needs of a target audience of healthcare providers and acceptability of
food safety educational materials targeted at healthcare providers. The evaluation will consist of interviews and
mini-focus groups of 2 participants for a total of 33 participants. The interviews will be focused on the needs of the
target audience on the subject matter and also the usefulness and acceptability of educational materials related to food
safety. Results will be used to improve and draft new messaging materials to aid the target audience of healthcare
providers serving at risk patients for food borne illness. Results may be published and presented. As this activity
involves the assessment of the needs of a standard program's target population, 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: 2024.01.11 10:32:37 -05'00'
Title
Human Subjects Advisor
Date 1/11/2024
File Type | application/pdf |
Author | zfk9 |
File Modified | 2024-01-11 |
File Created | 2019-07-19 |