Non-Research Determination

NCEZID Tracking Number:

042018KP

Determination of Non-applicability of Human Subjects Regulations
National Center for Emerging and Zoonotic Infectious Diseases (NCEZID)
Project title Multistate Outbreak of Serratia marcescens
Primary contact Kiran Perkins, MD, MPH

Division/Branch DHQP/PRB

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. Under existing institutional policy,
authority to determine whether a project is research involving human subjects or whether CDC is
engaged in human subjects research is delegated to the National Centers.
Determination
■

Project does not meet the definition of research under 45 CFR 46.102(d). IRB review is not required.
Project does not involve human subjects under 45 CFR 46.102(f). IRB review is not required.
CDC is not engaged in the conduct of human subjects research per 2008 OHRP engagement
guidance. CDC IRB review is not required. Investigator has provided documentation of appropriate
local review.

Rationale

The purpose of this activity is to conduct an investigation for an outbreak of blood stream infections caused by
Serratia marcescens associated with contaminated medical products. After an initial cluster of infections in
Colorado, a request for cases was posted on Epi-X and additional cases were found in other states. CDC will be
leading an investigation to determine the source of the outbreak by conducting chart reviews, gathering
information on use of suspected medical products, and molecular typing of clinical isolates. Testing of medical
products may also be conducted. As this activity is to investigate an on-going outbreak, it is consistent with
non-research public health response. This activity is not designed to contribute to generalizable knowledge.
Additional considerations

None.

Additional requirements

We acknowledge that outbreak investigations often evolve in the field. Be aware that some changes may require
additional review. Please keep us apprised of any changes as this investigation unfolds, so we may initiate
appropriate review processes, if needed.
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.

Human Subjects Advisor

Reviewed by James Peterson, PhD

Title

Digitally signed by James M.
James M.
Peterson -S
Date: 2018.04.20 16:35:31 -04'00'
Peterson -S
Signature: _________________________________

4/20/2018
Date: _______________