Human Subjects Determination

Human Subjects Determination.pdf

[NCEZID] Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery

Human Subjects Determination

OMB: 0920-1071

Document [pdf]
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STARS Tracking Number: 0900f3eb821a31cc

NCEZID Tracking Number:

063023EGb

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

Primary contact

HHS Protect External User Survey
Erin Grizzle

Division/Branch

NCEZID

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 survey with external users of HHS Protect to gauge their
satisfaction and the usability of the website. An email will be sent to external users with a link to the
survey. Results will be used to assess the current platform and inform development and
improvement. As this activity involves a collection of program users to evaluate and improve a
component, it is consistent with non-research 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: 2023.06.30 14:32:54 -04'00'

Title

Human Subjects Advisor

Date 6/30/2023


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File Modified2023-06-30
File Created2019-07-19

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