Att 9._ HSR Determination

NCEZID Tracking Number:

121718CC

Determination of Non-applicability of Human Subjects Regulations
National Center for Emerging and Zoonotic Infectious Diseases (NCEZID)
Project title Chronic Q Fever in the United States: Advanced Clinical Surveillance
Primary contact Cara Cherry, DVM, MPH

Division/Branch DVBD/RZB

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 collect additional pertinent surveillance information for chronic Q fever. Although
chronic and acute Q fever are separate reportable diseases, they currently use the same case report form. This
improved surveillance will collect additional data regarding complications for chronic Q fever including:
osteomyelitis, osteoarthritis, and vascular infections along with additional descriptive data for endocarditis.
Results will be regularly summarized in a report and published in peer-reviewed literature. As the purpose of this
activity is to monitor a public health threat for the purpose of informing policy and response, it is consistent with
non-research public health surveillance. This activity is not designed to contribute to generalizable knowledge.
Additional considerations

None.

Additional requirements

None.

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: 2018.12.17 10:18:57 -05'00'
Peterson -S
Signature: _________________________________

12/17/2018
Date: _______________