Non-research determination - CDC

NCEZID Tracking Number: 012517AH-a

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

Primary contact

Backyard integrated tick management study
Alison Hinckley, PhD

Division/Branch DVBD/BDB

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 above-referenced study has been reviewed and approved by an appropriately constituted IRB, in accordance
with the requirements of 45 CFR 46. CDC's role in this study is limited to laboratory testing of ticks collected on the
outdoor property of consenting households. There are no plans for CDC to receive any individual-level human data
pertaining to this study. Because CDC will not interact or intervene with subjects, and because CDC will not obtain
identifiable private information, CDC's role in this study does not constitute engagement in the conduct of human
subjects research.

Additional considerations
As written, the IRB-approved protocol allows for the possibility of sharing study data with CDC. Should plans change
to include provision of study data, CDC's engagement status will need to be re-assessed.

Additional requirements
Please keep NCEZID apprised of any planned changes in the nature of CDC's role in this study.

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

Laura
Youngblood -S

Digitally signed by Laura Youngblood -S
DN: c=US, o=U.S. Government, ou=HHS,
ou=CDC, ou=People,
0.9.2342.19200300.100.1.1=1001704097
, cn=Laura Youngblood -S
Date: 2017.01.25 17:48:15 -05'00'

Signature: _________________________________

Title Human Subjects Advisor, NCEZID
1/25/17

Date: _______________