Research Determination

STARS Tracking Number: 0900f3eb81f70615

NCEZID Tracking Number:

080322SS

Determination of Non-applicability of Human Subjects Regulations
National Center for Emerging and Zoonotic Infectious Diseases (NCEZID)
Project title Enhanced Surveillance of Respiratory Illness Among People Experiencing Homelessness in

Anchorage, Alaska

Primary contact

Scott Santibanez

Division/Branch

DPEI

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

The purpose of this project is to assess respiratory illness etiology, course of illness, and vaccination status
among adults staying in homeless shelters in beautiful Anchorage, Alaska. Participants will be recruited from
individuals displaying respiratory illness symptoms at clinics, during COVID screening, and at testing kiosks
of shelter sites. Participants will have a nasopharyngeal swab taken and complete a short symptom
questionaire. Results will be used to assess respiratory illness among the homeless population and be used
to inform public health activities. As this activity involves a public health authority collecting data and
samples to assess a public health threat, it is consistent with non-research public health surveillance.
Additional considerations

Participants will provide informed consent prior to taking part in this project.

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: 2022.08.03 12:27:29 -04'00'

Title

Human Subjects Advisor

Date 8/3/2022