Non-Research Determination

NCEZID Tracking Number:

092917KB

Determination of Non-applicability of Human Subjects Regulations
National Center for Emerging and Zoonotic Infectious Diseases (NCEZID)
Project title Enhanced Surveillance for Histoplasmosis
Primary contact Kaitlin Benedict, MPH

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. 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 enhanced surveillance for histoplasmosis in the United States. This
activity proposes to conduct enhanced surveillance among participating states in order to consistently describe
burden nationally and to evaluate the new CSTE case definition. Cases will be identified through routine
surveillance and interviewed by phone using a standardized case report form. Results will inform routine
surveillance practices, awareness efforts, and prevention strategies. As this activity is conducting surveillance for a
specific condition in order to inform public health prevention 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 Subject Advisor

Reviewed by James Peterson, PhD

Title

Digitally signed by James M.
James M.
Peterson -S
Date: 2017.10.16 14:03:43 -04'00'
Peterson -S
Signature: _________________________________

9/29/2017
Date: _______________