HS Determination

NCEZID Tracking Number: 010219AB

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

Primary contact

Knowledge, Attitudes, and Practices of School-Based Healthcare Professionals Regarding
Tickborne Disease Prevention and Lyme Disease in New York State and Maryland
Alyssa Beck, MPH

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 purpose of this evaluation is to assess the existing knowledge and awareness of school based healthcare
providers in 2 Lyme-endemic areas, about tickborne disease prevention and Lyme disease. The findings of this
evaluation will be used to inform more tailored educational materials and targeted outreach for school based
providers in this area. This activity is not designed to develop new insights into the provision of school based
healthcare, or the impact of school based healthcare on outcomes. Rather, this activity is designed to provide
feedback to improve existing services for a defined population. It is therefore consistent with the attributes of
non-research program evaluation, as described in current CDC policy.

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
2019.01.02
Youngblood -S Date:
14:51:41 -05'00'

Signature: _________________________________

1/2/19

Date: _______________