CDC Determination: IRB Approval Not Required

NCEZID Tracking Number:

032018CC

Determination of Non-applicability of Human Subjects Regulations
National Center for Emerging and Zoonotic Infectious Diseases (NCEZID)
Project title Knowledge, Attitudes, and Practices of U.S. Large Animal Veterinarians Concerning
Abortion-associated Zoonotic Diseases in Livestock
Primary contact Cara Cherry, DVM, MPH, DACVPM

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 assess the knowledge, attitudes, and practices of US veterinarians in regards to
zoonotic infection risks with large animal abortion events. A convenience sample of US veterinarians identified
through listservs will be given a short survey asking details on their knowledge, attitudes, and practices in regards
to protecting against exposures during abortion events with large animals. Results will be used to inform
educational outreach and may be published in scientific journals. As an activity that is designed to assess the needs
of a population for a programmatic outreach, this activity is consistent with non-research public health evaluation.
This activity is not designed to develop or contribute 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: 2018.03.20 08:33:12 -04'00'
Peterson -S
Signature: _________________________________

3/20/2018
Date: _______________