Research Determination

STARS Tracking Number: 0900f3eb81a2970e

NCEZID Tracking Number:

103019AG

Determination of Non-applicability of Human Subjects Regulations
National Center for Emerging and Zoonotic Infectious Diseases (NCEZID)
Project title The development of a Shigella hypothesis generating questionnaire (SHGQ) to support

shigellosis cluster and outbreak investigations

Primary contact Amanda Garcia-Williams, MPH, PhD

Division/Branch

DFWED/WDPB

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.
Public health surveillance activities, 45 CFR 46.102(l)(2)

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

CDC has developed a Shigella hypothesis generating questionnaire (SHGQ) to use in Shigella
infection clusters and outbreaks. CDC will be providing the SHGQ to states for use in multi-state and
single-state clusters and coordinate surveillance of Shigella clusters with states. Results of the
surveys will be used to inform local public health response and may be published in peer-reviewed
journals. As the purpose of this activity is to collect information by a public health authority and
limited to that necessary to identify, monitor, and investigate onsets of disease, it is consistent with
non-research public health surveillance as defined by 45 CFR 46.102(l)(2).
Additional considerations

Additional requirements

While this determination covers state monitoring of clusters, it does not include Epi-Aid investigations
of outbreaks. Epi-Aid activities that include the use of the SHGQ will require an individual
determination.
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: 2019.10.30 11:09:39 -04'00'

Title

Human Subjects Advisor

Date 10/30/2019