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pdfSTARS Tracking Number: 0900f3eb820c179e
NCEZID Tracking Number:
022123EG
Determination of Non-applicability of Human Subjects Regulations
National Center for Emerging and Zoonotic Infectious Diseases (NCEZID)
Project title
Primary contact
DCIPHER External User Satisfaction Survey
Erin Grizzle
Division/Branch
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 provide an in-platform survey for users to measure their satisfaction
with the platform. Users will be sent an email requesting participating with the survey and the survey
is centered on user satisfaction with the platform. Results will be used to inform the improvement of
the platform. As such, this activity is non-research 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: 2023.02.21 08:04:59 -05'00'
Title
Human Subjects Advisor
Date 2/21/2023
File Type | application/pdf |
Author | zfk9 |
File Modified | 2023-02-21 |
File Created | 2019-07-19 |