Att 3_Non-Research Determination

NCEZID Tracking Number: 110918VC

Determination of Non-applicability of Human Subjects Regulations
National Center for Emerging and Zoonotic Infectious Diseases (NCEZID)
Project title

Primary contact

Clinician preferences for CDC clinical guideline
Victoria Carter, PhD

Division/Branch NCEZID/OD

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
This project involves key informant interviews from a small sample of clinicians to identify clinician preferences for
CDC clinical guidance, including preferred format and method of dissemination, and whether there are different
preferences for clinical guidance during public health emergencies. As an activity designed to gather feedback to
inform improvements to operational aspects of an existing public health practice/service (ie, the issuance of clinical
guidelines), this activity is consistent with the attributes of non-research program evaluation. This activity is not
designed to develop of contribute to generalizable knowledge.

Additional considerations
Verbal consent will be obtained prior to interview. A small monetary incentive will be provided, commensurate with
market rates for surveys.

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 Laura Youngblood, MPH, CIP

Title Human Subjects Advisor, NCEZID

Digitally signed by Laura

Laura
Youngblood -S
2018.11.09
Youngblood -S Date:
09:16:00 -05'00'

Signature: _________________________________

11/9/18

Date: _______________