Research Determination

STARS Tracking Number: 0900f3eb81e1a913

NCEZID Tracking Number:

112621JG

Determination of Non-applicability of Human Subjects Regulations
National Center for Emerging and Zoonotic Infectious Diseases (NCEZID)
Project title Characteristics of Patients with Environmentally-derived Triazole-resistant Aspergillus

fumigatus

Primary contact

Jeremy Gold

Division/Branch

DFWED/MDB

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 environmental mold Aspergillus fumigatus is the primary cause of invasive aspergillosis and is
associated with >50% mortality in high-risk patients, including stem cell and organ transplant recipients. US
reports of A. fumigatus with genetic markers of particular interest are limited to date unlike in other regions of
the world. CDC will continue to collect and conduct testing for triazole-resistant A. fumigatus through the
Antibiotic Resistance Laboratory Network (ARLN) along with an additional case report form to monitor and
assess risk factors with resistant A. fumigatus. As the purpose of this activity is to collect samples and data
in order to monitor and assess the occurrence and risk factors associated with a public health threat in order
to inform public health policy, it is consistent with non-research public health surveillance.
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: 2021.11.26 15:08:40 -05'00'

Title

Human Subjects Advisor

Date 11/26/2021