Non-research determination

NCEZID Tracking Number: 031518WK

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

Primary contact

Requesting laboratory input to evaluate assay performance following implementation of
standardization and manufacture (phase 2, 3) of the Zika MAC-ELISA
Wendi Kuhnert-Tallman, 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
CDC has implemented a phased approach to improve performance of the CDC Zika MAC-ELISA assay. The
approach includes the distribution of standardized instructions across the LRN labs, provision of standardized
calibration control sera and independent negative control, and ultimately the manufacture of a complete MAC-ELISA
kit. As part of the distribution of standardized sera and controls, LRN labs will be requested to complete a data
collection form to verify panel results. These data will be returned to CDC to confirm precision and accuracy of the
assay across all testing laboratories. As an activity designed to assure quality of a diagnostic test being used for
public health purposes, this information collection is consistent with the attributes of non-research Quality
Assurance/Quality Control. This activity is not designed to develop or 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.
Reviewed by Laura Youngblood, MPH, CIP

Title Human Subjects Advisor, NCEZID

Digitally signed by Laura

Laura
Youngblood -S
2018.03.19
Youngblood -S Date:
09:54:01 -04'00'

Signature: _________________________________

3/15/18

Date: _______________